Based on observation, interview, and record review conducted during the recertification survey from 7/10/2023 to 07/14/2023, the facility did not ensure each resident was treated with respect and dignity. This was evident for 2 (Resident #21 and #107) of 35 total sampled resident. Specifically, staff were observed standing over Resident #21 and Resident #107 while feeding them. The findings are: The facility policy titled Meal Assistance dated 3/2019 documented residents receive assistance with meals in a manner that meet the individual needs of each resident. Staff shall not be standing over residents while assisting them with meals. On 07/12/2023 at 12:13 PM, the lunch meal was observed in the 3rd Floor dining room. Certified Nursing Assistant (CNA) #3 was observed standing over Resident #21 while feeding them their lunch from the meal tray. Licensed Practical Nurse (LPN) #3 was observed standing over Resident #107 while feeding them their lunch from their meal tray. On 07/12/2023 at 12:30 PM, CNA #3 was interviewed and stated it is more convenient for both the resident and the staff if they stand while feeding Resident #21. CNA #3 was unaware that they should not feed residents while standing over them in order to promote dignity. On 07/12/2023 at 12:50 PM, LPN #3 was interviewed and stated they were not aware that feeding residents while standing is a dignity concern. LPN #3 usually feeds residents while standing and no one ever corrected them. LPN #3 stated this was the first time they heard standing over a resident while feeding them is a dignity concern. On 07/12/2023 at 12:59 PM, LPN #4, the charge nurse for the 3rd Floor, was interviewed and stated LPN #4 told CNA #3 they cannot stand while feeding residents. LPN #4 saw CNA #3 feeding Resident #21 while standing and told CNA #3 to sit while feeding the resident. LPN #4 was surprised that CNA #2 continues to feed the resident while standing over the resident. 10 NYCRR 415.3(d)(1)(i)

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on observation, interviews, and record review conducted during the recertification and complaint (NY00316765) survey from 7/10/23 to 7/14/23, the facility did not ensure each resident participated in their treatment in a language the resident can understand. This was evident for Resident #77 reviewed for Communication out of 35 total sampled residents. Specifically, Resident #77 was offered a tuberculosis test without being educated in Spanish, their preferred language. Findings are: The facility policy titled Translation Services dated 1/2020 documented this facility's language access program will ensure that individuals with limited English proficiency shall have meaningful access to information and services provided by the facility. Resident #77 was admitted with a diagnosis of right hip fracture status post (s/p) fall. The Minimum Data Set 3.0 (MDS) assessment dated [DATE] documented Resident #77 was cognitively intact and their preferred language is Spanish. The New York State Department of Health Aspen Complaint Tracking System intake dated 5/17/2023 documented Resident #77 speaks Spanish and the nurse did not provide interpretation services to explain an injection the nurse was offering to Resident #77 on 5/17/2023. The Comprehensive Care Plan (CCP) related to language initiated 5/8/2023 documented Resident #77 speaks Spanish, residents/staff who speak Spanish should be encouraged to visit Resident #77 regularly, a telephone translator should be provided, and Resident #77 should have a communication tool in their room and at the nursing station for staff to use. The Medical Doctor Order (MDO) dated 5/2/2023 documented Purified Protein Derivative (PPD) injection (tuberculosis test) 0.1 cc intradermally for Resident #77 on 5/17/2023. The Nursing admission Evaluation dated 5/2/2023 documented Resident #77 required a translator because the resident does not speak English. The Medication Administration Report (MAR) for May 2023 documented Resident #77 refused the PPD injection on 5/17/2023. The Nursing Note dated 5/17/2023 documented Resident #77 refused the PPD injection. There was no documented evidence Resident #77 was provided with translation services when being educated re: the PPD injection. On 7/12/2023 at 3:13 PM, Certified Nurse Aide (CNA #4) was interviewed and stated they are one of the Spanish-speaking staff who translate for the resident in the facility. They did not assist with communicating with Resident #77 in Spanish re: the PPD injection education on 5/17/2023. On 7/12/2023 at 3:34 PM, CNA #5 stated they can have conversation with Resident #77 in Spanish and they were not asked to translate or educate the resident in Spanish re: the PPD injection offered on 5/17/2023. On 7/13/2023 at 4:04 PM, Licensed Practical Nurse (LPN #4) was interviewed and stated on 5/17/2023 LPN #4 used gesture, pointing to their arm, to explain the PPD injection to Resident #77. LPN #4 was aware that Resident #77 speaks primarily Spanish and did not use an interpreter to educate Resident #77 re: the PPD injection. LPN #4 assumed Resident #77 understood their gestures. On 7/14/2023 at 12:18 PM, the Director of Nursing (DON) was interviewed and stated Resident #77 should have been assisted by staff to use the language translation service via telephone. There are Spanish speaking staff on all units who can assist in translating. The DON stated that Resident #77 should have been provided with translator when offered the PPD injection on 5/17/2023. DON further stated that this issue will be reinforced and educated to all staff as a corrective action plan. 10 NYCRR 415.13(f)(1)(i)

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on observation, record review, and interviews conducted during the recertification and abbreviated (NY00302315) survey from 7/10/2023 to 7/14/2023, the facility did not ensure that all alleged violations involving abuse, were reported immediately to the New York State Department of Health (NYSDOH), but not later than 2 hours after the allegation was made. This was evident for 1 (Resident #338) of 3 residents reviewed for Abuse out of 35 total sampled residents. Specifically, Resident #338 reported a Certified Nursing Assistant (CNA) hit them in the head and the facility did not report the allegation to the NYSDOH within 2 hours. The findings are: The facility policy titled Abuse dated 12/2022 documented the facility shall report any allegation of abuse to the appropriate state agency no later than 2 hours after the facility is made aware of the allegation. Resident #338 had diagnoses of coronary artery disease (CAD) and peripheral vascular disease (PVD). The Minimum Data Set 3.0 (MDS ) assessment dated [DATE] documented Resident #338 had intact cognition. The facility Investigative Report dated 9/15/2022 documented at 11:20 AM, Resident #338 reported CNA #1 from the night shift hit Resident #338 on the side of the head on the night shift, at approximately 3AM. The Aspen Complaint Tracking System (ACTS) intake dated 9/15/2022 documented the facility reported the incident involving Resident #338 on 9/15/2022 at 2:39 PM, more than 2 hours after becoming aware of the abuse allegation at 11:20 AM. During an interview on 07/14/2023 at 01:11 PM, the Director of Nursing (DON) stated their abuse prevention training includes reporting abuse to the supervisor timely because the facility is mandated to report abuse to the NYSDOH timely. 10 NYCRR 415.4(b)(2)

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on observation, record review, and interviews conducted during the recertification survey from 7/10/2023 to 7/14/2023, the facility did not ensure that the Physician (MD) reviewed the resident's total program of care, including medications and treatments, at each visit. This was evidenced for 1 (Resident #176) of 35 total sampled residents. Specifically, the MD did not order insulin coverage for Resident #176, a resident with a diagnosis of Diabetes Mellitus (DM). The findings are: The facility policy titled Physician Services dated 04/2019 documented the MD will complete or review, sign, and date medical orders. Resident #176 was admitted to the facility on [DATE] with diagnoses of status post diabetic ketoacidosis (DKA) and DM. The Minimum Data Set 3.0 (MDS) assessment dated [DATE] documented Resident #176 was cognitively intact. The MD Note dated 4/4/2023 documented Resident #176 had hyperglycemia and DKA and fingerstick (FS) baseline range is 150-300, greater than 200. Increase Lantus insulin to 25 units at bedtime and Humalog insulin with meals FS three times daily (TID). The MD Note dated 5/2/2023 documented Resident #176's FS was 216 with no signs or symptoms of hypo/hyperglycemia. DM with FS range 108-348 baseline and Resident #176 is on Humalog insulin. Increase Lantus insulin to 30 units. The MD Note dated 5/30/2023 documented Resident #176 had a FS of 150 and hemoglobin A1c (HgbA1c)of 7.1% (greater than range of 5.6%). Resident's control compromised by noncompliance with recommended diet restrictions. Resident #176 is on Humalog and Lantus insulin. The FS Blood Sugar (BS) reading for Resident #176 dated 7/1/2023 documented the resident had a FSBS of 318 at lunch. The MD Note dated 07/11/2023 documented Resident #176 has a HgbA1c of 7.1% and remains on Humalog and Lantus insulin. The Comprehensive Care Plan (CCP) related to DM last reviewed 7/11/2023 documented Resident #176 was insulin dependent, will be free of episodes of hyper/hypoglycemia, will demonstrate a blood glucose level within acceptable range, have medications administered per MD order, and have FSBS monitored per MD order. The MD Orders renewed 7/12/2023 documented Resident #176 receive have their blood glucose monitored before each meal and notify the MD if lesser than 70 or greater than 300. There was no documented evidence Humalog or Lantus insulin was ordered for Resident #176 in accordance with their DM treatment plan. During an interview on 07/13/2023 at 12:50 PM, Licensed Practical Nurse (LPN) #5 stated Resident #176 does not have an MD order for and is not receiving any medications to treat their DM. FSBS testing is done and documented, but there is no insulin coverage. During an interview on 07/13/2023 at 12:45 PM, Registered Nurse Manager (RNM) #2 stated medication orders drop off the resident's medication list if they have a 30-day limit set. It will not automatically pre-populate the MD Order sheet. RNM #2 stated they are responsible for ensuring the MD Orders are picked up and the monthly visits are performed but the nurses are busy. RNM #2 helps but does not review the list of medications to check what the MD orders. RNM #2 follows whatever the MD orders. During an interview on 07/13/2023 at 12:30 PM, MD #1 stated they did not discontinue Resident #176's Humalog or Lantus insulin. MD #1 was unable to provide a reason Resident #176's MD Orders did not include an order for Lantus or Humalog insulin. MD #1 stated they review medications and conditions of their residents, and they cannot understand why Resident #176's insulin was omitted from their MD Orders since 5/5/2023. 10 NYCRR 415.15(b)(2)(ii)

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on observation, interviews, and record review conducted during the recertification survey from [DATE] to [DATE], the facility did not ensure biologicals were stored in accordance with professional principles. This was evident for 1 (2nd floor) of 5 medication storage rooms observed during the Medication Storage Task. Specifically, an emergency medication box (EMB) with expired medication was not removed the 2nd Floor medication room. The findings are: The facility policy titled Interim, Stat, Emergency Supplies of Medications dated [DATE] documented the emergency supply of medication should be stored in a known, secured location per policy with the contents of the supplies determined by the facility's Administration, Director of Nursing (DON), Medical Director, and along with the Pharmacist in accordance with applicable law. On [DATE] at 9:23 AM, the 2nd Floor Medication Room was observed with the Licensed Practical Nurse (LPN) #3. The EMB was observed sealed and affixed with a label listing the medications contained inside the EMB. The EMB label documented the Box Expires 06-23 and the expiration date of the Dexamethasone Sodium Phosphate Injection (Decadron) contained inside of the box was 6/2023. The Pharmacy slip affixed t the EMB was dated [DATE] and was not countersigned by a nurse from the facility to acknowledge receipt of the EMB. On [DATE] at 9:33 AM, LPN #3 was interviewed and stated the day and evening nurses are responsible to check EMB daily to ensure that items are sealed in the box and items listed on the label are not expired. LPN #3 stated that they did not check the label today to ensure that the box was not expired or close to expiring. LPN #3 further stated that expired box will be removed from the medication room immediately and sent to DON. On [DATE] at 10:32 AM, Registered Nurse Manager (RNM #1) was interviewed and stated the EMB is used in an emergency, and it must be restocked if the medication was used. It should also be monitored for dates to ensure that they are not stored beyond the expiration dates as per the label affixed to the box. RNM #1 stated that they were not aware that the EMB stored in the medication storage room was already expired in [DATE]. On [DATE] at 12:32 PM, the DON was interviewed and stated the [NAME] are checked by DON during their weekly rounds. [NAME] with expiring items/broken seal are immediately removed from the unit and returned to the pharmacy. The DON stated the EMB is only replenished and/or replaced by the pharmacy. The EMB on the 2nd floor was replaced by the pharmacy recently and the DON did not inspect the box sent from the pharmacy. The DON acknowledged that the replenished box should have been inspected to ensure that it is properly sealed and labeled prior to sending it to the 2nd Floor. 10 NYCRR 415.18(e)(1-4)

42 CFR 483.90(i) Other environmental conditions. The facility must provide a safe, functional, sanitary, and comfortable environment for the residents, staff and the public. 10NYCRR 415.29 Physical environment. The nursing home shall be designed, constructed, equipped, and maintained to provide a safe, health, functional, sanitary, and comfortable environment for residents, personnel, and the public. Based on observations and staff interview conducted during a Life Safety Code Recertification survey, the facility did not ensure to maintain a safe, functional, sanitary, and comfortable environment for residents, staff, and the public. Specifically, a) missing cove base within the soiled utility room and b) lights in soiled utility room not functional. This occurred on 2 of 7 floors, including basement. The findings are: Observations during the tour of the facility on 07/19/2023 between 09:00AM - 03:00PM, identified the following: a) two portions of cove base approximately 2 ft X 4 in were observed missing from the walls inside the soiled utility room on the 6th floor. That was revealing interstitial spaces of the walls and could be potential source for infestation. b) light fixture was not functional and not illuminating inside the soiled utility room on the 3rd floor. In an interview on 07/19/2023 at approximately 10:00AM, the Director of Maintenance stated they would address issue immediately. 42 CFR 483.90(i) 415.29(f)(4)

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on observations, record review, and interviews, during the re-certification survey, the facility did not ensure that each resident's person-centered, comprehensive care plan, that includes measurable objectives and timeframes to meet a resident's medical, nursing, and mental and psychosocial needs that are identified in the comprehensive assessment was reviewed and revised timely to address resident's change in dental and Activities of daily Living (ADL) status. Specifically, the Comprehensive Care Plan (CCP) for Dental Care and Oral/Dental Health problems was not reviewed and revised to include the loss of the resident's dentures. This was evident of 1 of 2 residents investigated for dental status out of an Investigative sample of 35 residents (Resident #142). The finding is: The facility policy titled Care Plans- Comprehensive, revised 10/2019, documented the comprehensive, person centered care plan will describe the services that are to be furnished to attain or maintain the resident's highest practicable physical, mental and psychological well-being; incorporate identified problem areas. The comprehensive, person centered plan is developed within seven days of the completion of the required comprehensive assessment (MDS). Assessments of residents are ongoing and care plans are revised as information are about the residents and the resident's conditions change. Resident #142 was re-admitted [DATE] with diagnosis which include Traumatic Brain Injury, hypertension, and Seizures. The Quarterly Minimum Data Set 3.0 (MDS) assessment dated [DATE] documented the resident had moderately impaired cognition. The MDS further documented the resident had no dental problems. On 05/13/21 at 12:35 PM, the resident was observed being fed in the dining area. The resident was eating well with no difficulty chewing and swallowing food, and the resident had no teeth. The CCP titled The resident has oral/dental health problem dated initiated 2/21/2021 documented resident had missing teeth and had dentures. The CCP titled Dental care dated effective 10/1/2020 and last updated 1/15/2021 documented clean teeth/dentures daily. The Dental consult dated 2/4/2021 documented dental admission exam. Patient edentulous upper and lower. No treatment at present. Speech Therapy Note dated 3/12/2021 documented Resident well known to clinician with History of dysphagia and has been on advanced mechanical soft diet since 11/23/20 with full feeding assistance with good intake and tolerance. Dentures previously worn but not routinely with meals despite encouragement however were reportedly lost in the hospital (1/13-1/14/21). Evaluation revealed no significant changes in swallow function and recommend referral to dental for dentures as indicated. There was no documented evidence that the comprehensive care plan was reviewed and revised to include the resident's missing dentures and any interventions and care needs implemented to address it. On 05/20/21 at 10:04 AM, a telephone interview was conducted with the Speech Therapist (ST). ST stated the resident was on therapy secondary to some difficult swallowing regular diet in the past. ST stated when saw the resident in March was informed by the resident that the dentures was lost in the hospital in January and resident verbalized wanting dentures back. ST stated the resident diet was already advanced to regular before they went to the hospital did have dentures but did not use the dentures to eat. ST stated without the dentures the resident was able to manage and continue to manage regular texture foods. ST added they just wanted the dentures back and documented that the process needs to start over by referring to the dentist to get the denture process started. On 05/20/21 at 11:15 AM, an interview was conducted with Registered Nurse, Unit Manager (UM) (RN#1). RN #1 stated the resident was transferred to the unit from another unit. The RN is responsible for updating the dental care plan. RN #1 stated any changes in the resident including missing dentures should be care planned and they will follow up. RN #1 stated care plans are updated at least every 90 days and as needed On 05/20/21 at 11:11 AM, an interview was conducted with the Licensed Practical Nurse (LPN#1). LPN #1 stated assisted the resident was assisted with feeding last Friday and the resident had no dentures. LPN stated the resident ate well and verbalized no complaints during feeding and consumed 100% of meal. 415.11(c)(2)(i-iii)

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** 3) The facility policy and procedure regarding Catheter Care dated 05/2019 did not indicate how staff would assist residents with Foley Catheter care maintain their dignity and privacy when in non-private areas with of the unit. Resident #484 was readmitted to the facility on [DATE] with active diagnoses which include: Neuromuscular dysfunction of bladder unspecified, Type 2 Diabetes Mellitus with Diabetic Neuropathy Unspecified, and Cerebral Infarction Unspecified. The Discharge Minimum Data Set 3.0 (MDS) assessment dated [DATE] documented that the resident's cognitive status was intact. The resident required extensive assistance with dressing, toileting, and personal hygiene. The MDS also indicated that the resident had an Indwelling Foley Catheter. Diagnoses included Neurogenic bladder. The admission Minimum Data Set 3.0 (MDS) assessment dated [DATE] documented that the resident's cognitive status was intact. The resident required extensive assistance with dressing, toileting, and grooming. Diagnosis includes Neurogenic Bladder. The MDS also indicated that the resident had an Indwelling Foley Catheter. On 05/14/2021 at 09:47 AM, the resident was observed dressed in a hospital gown by the nurse's station on the unit talking to the doctor. On 05/14/2021 at 4:26 PM, the resident was observed sitting in the dining room dressed in a double gown and interacting with CAN and leg bag strapped to left thigh with no dignity bag and gown was covering bag but straps were still visible. On 05/17/2021 at 09:40 AM, the resident was sitting in his wheelchair using an IPAD that was playing music dressed in hospital gown and urine bag strapped to right leg and not visible. On 05/17/2021 at 1:23 PM and 4:31 Pm, the resident was observed sitting in a wheelchair (w/c) in the dining room wearing a hospital gown and no pants. The resident had a foley catheter drainage bag strapped to the right thigh, that was visible to others in the room. There were other residents in the dining room during the observation. On 05/18/2021 at 10:15 AM, 12:36 PM, and 1:20 PM, the resident was observed sitting in a w/c in the dining room wearing a hospital gown and no pants. The resident's foley catheter drainage bag was strapped to the right thigh, visible to others in the room. On 05/18/2021 at 1:28 PM, the resident was sitting in a w/c by nurses' station still wearing a hospital gown with no pants. The foley catheter drainage bag was still visible on the right thigh. On 05/18/2021 at 4:19 PM, the resident was sitting in the dining room and urine bag visible while resident sitting at table. Catheter care plan dated 2/16/2021 documented the following intervention: wash perineum with water and soap frequently, maintain urine collection bag below the level of the bladder, monitor/record/report to MD for signs/symptoms of urinary tract infection (UTI). There were no interventions related to using a privacy bag or concealing the urinary catheter drainage bag. The Physician's Order dated 05/20/2021 documented the following: Suprapubic catheter Care every shift. Catheter Care/Bowel Continence: Suprapubic Catheter Point of Care Audit report documented audit started on 05/01/2021. On 05/18/2021 at 2:39 PM, an interview conducted with the Certified Nurse Assistant (CNA# 5) who stated in the morning they empty the resident's urine bag. CNA #5 stated they put the catheter leg bag on the resident, dress the resident, and transfer the resident to the w/c. They further stated that the resident has not had clothes since returning to the unit from the hospital. They stated they will let their supervisor know and Director of Nursing (DON) and will find out where the residents' clothes is. CNA #5 stated the resident does not have a privacy bag to cover the catheter bag, and they have not seen the privacy bag in one week. CNA #5 stated they did not inform anyone that the resident did not have a privacy bag. They attempted to cover the resident's urine bag using their hospital gown. On 05/18/2021 at 04:14 PM, an interview conducted with LPN #4 who stated if the resident is out of bed, a leg bag is used. A privacy bag cannot be used with the leg bag. When the resident is in bed, the catheter drainage bag is covered with a privacy bag and attached to the bed rail. The leg bag should be covered, and a blanket or sheet can be placed over the resident's lap so it is not exposed to maintain the resident's privacy and dignity. LPN #4 stated that they were not aware that the resident was missing clothes. LPN #4 confirmed there were no privacy bags in the unit supply closet or the resident's room after a search. On 05/18/2021 at 04:36 PM, an interview conducted with RN #2 who stated that When resident is roaming around the unit the catheter drainage bag has to be covered. If the resident is in the wheelchair, the drainage bag should be covered to maintain the resident's privacy and self-esteem. RN #2 stated that some residents request to have the drainage bag covered, and some residents don't care. Most residents on the unit are alert and have to be dressed. If the resident has no clothing, they ask the family to supply clothing. RN #2 stated they usually put the drainage bag in a cover. On 05/18/2021 at 05:27 PM, an interview conducted with the Director of Nursing (DON) who stated that when the leg bag is in use, residents can be given pants or be given something to cover the lap if wearing a gown. A privacy bag is offered to residents to use when out of the room so the urinary drainage bag is not seen as long the resident cooperates. If the resident is going out of the room, staff should offer the over leg bag if the hospital gown is long enough to cover it. Some residents like to wear a gown and cover the leg bag with a blanket and sheet. The leg bag is offered to maintain privacy. 415.5(a) 2) The facility policy titled Quality of Life/Dignity dated created 9/2014 and last revised dated 9/2019 documented under the section titled procedure Residents will be encouraged and assisted to dress in their own clothes, rather than in hospital gown. Resident #142 was initially admitted to facility on 10/01/2020 and last admitted [DATE] with diagnosis which included Traumatic Brain Injury, hypertension, Seizures and Anxiety Disorder. The Quarterly Minimum Data Set (MDS) dated [DATE] documented the resident has moderately impaired cognition. The MDS further documented the resident required extensive assist of two persons with dressing. On 05/13/21 at 11:22 AM, the resident was observed sitting in a wheelchair (w/c) in the dining room wearing a hospital gown tied in the back around the neck. The resident moved forward in the w/c, and the gown opening exposed the resident's upper to mid lower back. On 05/13/21 at 12:35 PM, the resident was observed sitting in a w/c in the dining area still wearing the hospital gown during lunch. Staff were feeding the resident. The resident had no shirt on underneath the gown, and the back opening exposed the resident's upper back when the resident leaned forward. The resident was wearing gray sweatpants. On 05/14/21 at 11:05 AM, the resident was observed sitting in a w/c in the dining area wearing a hospital gown tied in the back around the neck. The back of the gown opened every time the resident leaned forward in the chair, exposing the upper to mid back of the resident. The resident was not wearing pants. Their bare legs were visible with, and the resident wore sneakers with no socks. On 05/19/21 at 09:56 AM an interview was conducted with Resident #142. The resident stated they have clothing, but most of the clothing is too tight, so the staff put a gown on them. Resident #142 stated they were upset right now and did not want to answer any questions. Resident stated when they are in the dining area and other resident have their own clothing on, they do not think about how they feel. In loud tone of voice resident repeated they just do not think about it. The resident had clothing in the closet. The Comprehensive Care Plan titled ADL's: Dressings dated effective 10/1/2020 documented resident will be dressed according to the season in clothes/shoes that are clean and in good repair. The resident Comprehensive Care Plan (CCP) titled Resident's preferred/prefers dated 5/14/2021 documented dress attire is casual. No documented evidence of resident preference of gown in dining area. The progress notes from 2/2/2021 to 5/19/2021 were reviewed. There was no documented evidence that the resident had a preference for wearing a gown in the dining area, and the notes had no documentation of behaviors of resident refusing own clothing in dining area. The CNA Accountability tasks dated May 2021, with last documentation on 5/19/2021, had no documentation regarding a resident preference to wear a hospital gown in the dining area in the Dressing section. On 05/19/21 at 10:29 AM, an interview was conducted with CNA #2. CNA #2 stated the resident's clothing is mostly clothing given to them by the facility with the facility logo on it. The resident's clothing is too small, and the resident needs larger clothing, especially tops. From admission to present, the resident gained weight so the clothing is too small. The resident is given a gown to wear, depending on the staff that care for the resident. CNA #2 stated, at times, the resident will wear a gown and sweatpants because the larger tops are not available. CNA #2 stated sometimes the resident refuses to go in the dining room because they have a gown on because all the other residents have their own clothing. CNA #2 stated they reported the lack of having a top and they will go downstairs to the laundry room to get a large donated top if it is available, but, at times, it is not available. CNA #2 also stated because of the weight gained it is harder to put the current clothing on resident. CNA also stated it all depends on the CNA assigned to the resident if they have patience to put the resident's clothing on or do the quick thing of putting a gown on. CNA #2 stated they took care of resident this morning and put own clothing on that fits. On 05/19/21 at 12:53 PM an interview was conducted with CNA #3. CNA #3 stated they took care of the resident sometime last week. CNA #3 stated the resident is alert able to make their needs known. CNA #3 stated the resident wore a gown with pants because the resident requested a gown because the resident's shirt did not fit. CNA #3 stated they did not report the shirt did not fit to anyone because the resident is usually in a gown and does not like to wear shirts. CNA #3 stated the resident stated it is easier to wear a gown, and they placed a gown with a pants on the resident. CNA #3 stated the next time they dressed the resident, the resident had no pants to wear. CNA #3 informed the nurse, and the nurse instructed CNA #3 to put a gown on the resident and bring the resident to the day room because the resident had to come out. On 05/20/21 at 11:11 AM, an interview was conducted with the Licensed Practical Nurse (LPN #1). LPN #1 stated they worked on the unit on 5/13/21 and the Certified Nursing Assistance (CNA#3) did report that the resident had no clothing in the closet. LPN #1 stated they instructed the CNA to place a gown on the resident because the resident stated they were fine with the gown on. LPN #1 stated the resident has behaviors of yelling and cursing at staff and they wanted to be nice, so LPN #1 agreed for the resident to go in the dining area with the gown. LPN #1 did not document anything in the resident's chart or report this to the Unit manager (UM). The usual process is to call downstairs to get a facility logo sweat suite for the resident, and report to the UM. LPN #1 stated they did not report this to anyone and call for clothing because the resident was ok with wearing the gown in the dining area. On 05/20/21 at 11:15 AM, an interview was conducted with Registered Nurse #1 (RN#1), the Unit Manager. RN #1 stated they were not aware that the resident had no clothing, and this was not reported by the staff. RN #1 stated if the resident has no clothing this is reported to the social worker to follow-up. RN #1 stated in the interim, the staff immediately go downstairs and get a facility logo sweatsuit and T-shirt to clothe the resident. RN #3 stated they were not aware that the resident prefers using a gown in dining area and added privacy, dignity, and way the resident is presented are very important. RN #1 stated if this is the resident preference, this needs to be care planned and documented; staff must respect the resident's right to use a gown if they choose to do so. RN #1 stated a preference to use a gown in the dining area was not care planned and documented. 05/20/21 at 02:50 PM, the Director of Nursing (DON) was interviewed. The DON stated that the facility is aware of the above concerns including resident wearing a gown in the dining area. The DON stated an in-service was done on the need to maintain resident's dignity and privacy. Laundry was called to check for donation clothes, and they reached out to family members to bring clothes. 415.5(a) Based on observations and interviews during the Recertification Survey, the facility did not ensure that residents were cared for in a manner that maintained or enhanced his or her dignity. Specifically, two resident's Foley catheter bag and tubing were left uncovered and exposed to public view. Two residents were observed in the dining room with a gown on without any pants and the resident back was exposed. This was evident for 3 of 3 residents reviewed for Dignity (Residents# 157, Resident #484 and Resident #142). The findings are: 1) The facility's policy titled Catheter Guidelines, created in 2019, does not document that the nursing staff should ensure and maintain privacy of all residents with the use of dignity bags when the residents are in bed and out of bed. Resident #157 was admitted on [DATE] with diagnoses which include anemia, neurogenic bladder, insomnia, chronic pain and venous hypertension. The Minimum Data Set 3.0 (MDS) assessment dated [DATE] documented that the resident is alert and oriented. The resident requires the total assist of two persons for most activities of daily living. On 05/13/21 at 12:18 PM, and on 05/14/21 at 11:10 AM, the resident was observed lying in the bed closest to the door of the room. The resident's Foley catheter drainage bag and catheter tubing were on the side of the bed facing the door (right side). There was yellow urine draining into the uncovered catheter bag. On 05/18/21 at 02:45 PM, CNA #6 was interviewed and stated that the resident needs extensive assistance and one-person assistance for most activities of daily living. CNA #6 stated that when the catheter bag is emptied, the amount plus color of urine is reported to the nurse. The privacy bag is supposed to be placed on the catheter bag when the resident is seated in the wheelchair and when the resident is in bed. CNA #6 stated that the privacy bag should be on when resident is inside and outside of the room. The catheter bag and tubing should not be visible to others, and the privacy bag should have been on. CNA #6 apologized for the error. On 05/18/21 at 02:56 PM, LPN #6 was interviewed and stated that the catheter bag is supposed to be covered when the resident is in the room. The catheter bag is not supposed to be visible. LPN #6 further stated that there are privacy bags on the unit. LPN #6 stated that she will ensure that the CNAs always apply privacy bags over catheter bags. On 05/18/21 at 03:02 PM, RN supervisor #4 was interviewed and stated that she is responsible for supervising the nursing staff on the unit. RN supervisor #4 stated that she makes rounds several times during the shift. RN supervisor #4 stated that the staff are supposed to apply the privacy bag over the catheter bag. The drainage bag should not be visible to others. If the resident is in bed, the catheter bag should be placed on the left side of the bed. On 05/19/21 at 01:33 PM, the Director of Nursing (DON) stated that the catheter bag should be covered when the resident comes out of bed. When the resident is in bed, the catheter bag should be placed on the left side of the bed. The catheter bag and tubing should not be visible to others. The DON further stated that all staff will be re-trained on using privacy bag at all times for residents with indwelling catheters. The DON further stated that the issue will be corrected right away.

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** 2) Resident #39 was admitted on [DATE] with diagnoses of Dementia, Diabetes Mellitus, Hypertension, and Renal Insufficiency. The Quarterly Minimum Data Set 3.0 (MDS) assessment dated [DATE] documented that the resident's cognitive level is moderately impaired and the resident requires extensive assistance of one person with all Activities of Daily Living (ADLs). The resident prefers to chose which activities to participate in. The Interdisciplinary Care Plan Meeting Attendance sheets from 09/28/17 to 10/25/18 did not document the resident or resident representative attended the Comprehensive Care Plan Meetings. Review of medical record did not document that any member of the IDT had involved the resident or the resident's representative in the development of the resident's plan of care. The facility did not ensure that the resident or the resident's representative was provided an opportunity to participate in care planning. On 01/03/19 at 11:18 AM, a resident interview was conducted and the resident stated that she has not been invited to the quarterly care plan meetings since being admitted to the facility in September 2016. On 01/08/19 at 12:14 PM, the RN Manager #1 stated that she would invite the resident to the care plan meetings once the meetings are scheduled. RN Manager # 1 also stated that usually, the resident would tell us to contact her daughter. The IDT team members communicate with the resident often to see if they are any issues. The RN Manager # 1 further stated that usually the Social Worker would document in the resident's medical record whenever the resident is invited to care plan meetings. On 01/08/19 at 12:17 PM, the Social Worker stated that she regularly contacts the resident's family members when a care plan meeting is scheduled. The Social Worker also stated that she would sometimes invite the resident to participate in the care plan meetings. The Social Worker further stated that she does not document in the electronic medical record when she does invite the resident to upcoming care plan meetings. On 01/08/19 at 03:48 PM, the Director of Social Work stated that the usual practice is we notify the family members when care plan meetings are scheduled. If a resident has the capacity to participate in the care plan meeting, we would invite the resident to participate in the care plan meeting. The Director of Social work further stated that when a resident is contacted about upcoming care plan meeting, it should be documented in the medical record. The Director of Social Work stated that the usual practice is the Social Worker would indicate in the progress notes who attended the care plan meetings and what was discussed. If a resident was in attendance, we would put down they attended. 415.11 (c) (2) (i-iii) Based on observation, record review and staff interviews during the recertification survey the facility did not ensure that a resident's plan of care was revised before the initiation of a psychotropic medication. Specifically, 1) There were no documented non-pharmacological interventions identified and incorporated into the resident's plan of care to address the resident's behavior prior to starting an psychotropic medication. In addition, 2) The facility did not ensure that a resident was afforded the opportunity to participate in formulating a plan of care. Specifically, there was no documentation of the residents involvement in the care plan meetings or discussions. This was evident for 2 of 38 sampled residents. (Resident #184 and # 39). The findings are: The facility policy titled, Care Plans, Comprehensive Person-Centered updated 8/2017 documents: A comprehensive, person centered care plan that includes measurable objectives and timetables to meet the resident's physical, psychosocial and functional needs is developed and implemented for each resident. Policy Interpretation and Implementation 1) The Interdisciplinary Team (IDT), in conjunction with the resident and his/her family or legal representative, develops and implements a Comprehensive, Person Centered Care Plan for each resident. The resident and or their representative is invited to participate in the Comprehensive Care Plan (CCP) meeting. 4) Each resident's comprehensive person-centered care plan will be consistent with the resident's rights to participate in the development and implementation of his or her plan of care, including the right to: a) Participate in the planning process. c) Participate in establishing the expected goals and outcomes of care. h) See the care plan and sign it after significant changes are made. 7) The care planning process will: a) Facilitate resident and/or representative involvement. 10) Identifying problem areas and their causes, and developing interventions that are targeted and meaningful to the resident, are the endpoint of the interdisciplinary process. 13) Assessments of residents are ongoing and care plans are revised as information about the residents and the resident's conditions change. 14) The Interdisciplinary Team must review and update the care plan: a) When there has been a significant change in the resident's condition. b) When the desired outcome is not met. 1) Resident # 184 was admitted to the facility on [DATE] with diagnosis including Non Alzheimer's Dementia, Hypertension, Peripheral Vascular Disease, and Diabetes Mellitus. On 1/7/19 at 12:11 PM, the resident was observed sitting in a wheelchair in the dining room during lunch. The resident was neatly groomed and neatly dressed. The resident was wearing glasses. The resident had a plate containing chicken, white rice, mixed vegetables. A bowl of chicken noodle soup, a slice of white bread, a cup of tea and a container of Glucerna were also on the tray. The resident stated she was not hungry. The resident was quiet and in no distress. On 1/8/19 at 2:30 PM, the resident was observed propelling herself in wheelchair down the hallway past the nurses station. The resident was neatly groomed and neatly dressed. The resident was wearing glasses. The resident was calm and in no distress. On 1/9/19 at 10:01 AM, the resident was observed sitting in wheelchair in the day room at a table with 2 other residents. The resident was neatly groomed and neatly dressed. The resident was wearing glasses. This surveyor greeted the resident and asked how the resident felt. The resident responded I feel sleepy today. The resident was calm and in no distress. On 1/9/19 at 12:14 PM, the resident was observed sitting in her wheelchair and eating lunch in the day room. The resident was neatly groomed and neatly dressed. The resident was wearing glasses. The resident was eating beef stew, noodles and green beans. The tray also contained a cup of tea and a container of Glucerna. The resident was asked how the food tastes today and responded it will do. The resident was eating independently. The resident was calm and in no distress. On 1/10/19 at 9:19 AM, the resident was observed sitting in wheelchair in the day room. The resident was neatly groomed and neatly dressed. The resident was wearing glasses. The resident cleared her throat with a slight cough. The resident was asked how she was today and responded I feel okay but I am kind of sleepy. The resident was watching TV in the day room. The most recent Comprehensive Annual Assessment as documented in the Minimum Data Set (MDS) 3.0 dated 7/4/2018 documents the following: Hearing- minimal difficulty, no hearing aid. Clear speech. Understood. Understands. Vision- impaired, wears corrective lenses. Cognitive Patterns- Brief Interview for Mental Status (BIMS) score = 3. Cognitive patterns- N0- resident was able to complete interview. Delirium- the following behaviors were NOT present - Inattention, Disorganized thinking and Altered level of consciousness. Mood- Total Mood Severity Score = 0. Behavior- No hallucinations. No delusions. Behavioral Symptoms- Presence and Frequency- Behavior not exhibited- Physical behavioral symptoms directed toward others, Verbal behavioral symptoms directed towards others. And other behavioral symptoms not directed toward others. Rejection of Care- Presence and Frequency- 0- Behavior not exhibited. Wandering- Presence and Frequency- 0, Behavior not exhibited. How does resident's current behavior status, care rejection or wandering compare to prior assessment? - same. Functional Status- Extensive assistance- bed mobility, transfer, walk in room, walk in corridor, dressing, eating, toilet use and personal hygiene- all one person assist. No Functional Limitation in range of Motion. Mobility devices- walker and wheelchair. Frequently incontinent of bladder and bowel. Medications received- none documented. The MDS Quarterly assessment dated 12/16 2018 documents- same except for the following- Always incontinent of bladder and bowel. Diagnosis- psychotic disorder (other than schizophrenia). Medications Received - Antipsychotic - 7 days. Antipsychotic medication review- Yes- Antipsychotics were received on a routine basis only. Has a gradual dose reduction been attempted- No. Physician documented GDR as clinically contraindicated - N0. Care Plan - Psychotropic Drug Use - Evidenced by disruptive voice, behavior of inappropriate words to staff, negative behavior towards room -mate- family. Goals- demonstrate decreased need for psychoactive medication. Resident will have decreased incidents of mood or behavior. Interventions- Encourage verbalization of feelings. Establish appropriate diagnosis for medication use. Evaluate action of medication and side effects in terms of medical status profile, including interactions with other medications. Observe for any signs of decline in functional cognitive status. Obtain psychiatric consult or follow up as necessary. The Comprehensive Care Plan did not document a psychotic disorder or a diagnosis that was approved by the FDA as the indication for the use of Risperdal. The Comprehensive Care Plan did not document non- pharmacological interventions that were tried to address the residents behavior prior to the prescribing and administering of Risperdal. Care Plan - Vascular Dementia - Cognitive loss- dementia. Related to impaired decision making, long and short- term memory loss, oriented to self but not to time or place. Judgement - insight- poor. Goals- Resident will demonstrate ability to make decisions in activities. Resident will selfcare within mental and physical limitations. Interventions- Evaluate medication regimen. Evaluate pain management. Promote activities that reduce frustration and support success. Use simple words or instructions. Physicians Monthly Orders dated 9/14/2018 thru 12/18/18 documents- Risperdal 0.5 mg- Give one tablet daily at bedtime. Diagnosis- restlessness and agitation. Physicians Monthly Orders dated 1/7/19 documents- Risperdal 0.5 mg - Give one tablet daily at bedtime. Diagnosis- other psych disorder not due to a sub or known physiol condition. Medication Administration Records dated 9/14/18 thru 1/6/2019 documents the resident received Risperdal 0.5 mg daily at bedtime. Physicians Progress Notes document the following- 9/28/18 - Diagnosis - Dementia with behavioral disturbances. Aggressive behavior towards others. Risperdal ordered. 10/23/18 - Diagnosis- Dementia with psychosis and behavioral disturbances. Tolerating Risperdal. 11/20/18 - Diagnosis - Dementia with psychosis On Risperdal 12/18/18 - Diagnosis- Dementia with psychosis- No new behavioral changed noted. On Risperdal. Psychiatric Consult dated 8/22/18 documents: Follow - up. Patient is a [AGE] year old female with history of Dementia, on no psyche meds. As per staff patient has been stable, no behavioral disturbances. Patient states she is doing okay. Patient did not provide details about history. Patient believes she has been here for one year. Patient denies depression, denies confusion, denies psychotic symptoms and denies memory deficits. No evidence of hopelessness, helplessness or suicidal ideation. No reported side effects of medication. No problems with sleep. Diagnosis- Vascular dementia. Assessment/Plan - no new behavioral issues since last contact. Meds- continue same management, no new recommendations. Psychiatric Consult dated 9/13/18 documents: Follow-up. Chief complaint- agitation, psychosis, belligerent behavior. As per staff patient has been agitated, belligerent and threatening towards other patients. Patient states she is doing okay. Patient did not provide details about history. Patient believes she has been here one year. Same as above. Diagnosis- Vascular dementia, Psychosis. Assessment/Plan -with agitation and psychosis. Psychiatric Consult dated 9/27/18 documents - Reason for follow up, patient recently started on Risperdal. Chief complaint- agitation, psychosis and belligerent behavior. As per staff has been calmer, she is doing okay. Same as above. Diagnosis -Vascular dementia and Psychosis. Assessment/Plan tolerating current psyche meds. No new behavioral issues. Meds- continue same meds. Psychiatric Consult dated 11/1/18 documents- Follow up. As per staff patient has been calmer. She is doing okay. Patient did not provide details about her history. Same as above. Diagnosis - Vascular dementia and Psychosis. Meds- continue same meds. No new recommendations. Psychiatric Consult dated 11/29/18 documents: Patient seen for follow up. Patient is a [AGE] year old female with history of dementia on psyche meds. As per staff patient has been calmer. She is doing okay. Patient did not provide details about history. Patient believes she has been her for years. Patient denies depression. No evidence of hopelessness or suicidal ideation. No reported side effects of meds. No problem with sleep. No new behavioral issues. Tolerating current psyche meds. Psyche med Risperdal 0.5 mg at bedtime. Mental Status Examination - Appearance- alert, awake, cooperative. Gait seated. Muscle tone- normal. Mood- good. Affect- reactive. Suicidal ideation - No. Homicidal ideation- No. speech - normal. Thought process - slowed. Thought content-delusions- No. Paranoid ideation - No. Hallucinations- No. Associations- No. Orientation- person- Yes. Place- No. Time- No. Attention and concentration - decreased. Memory short term- Poor. Memory long term - Poor. Language aphasia- No. Fund of Knowledge- Poor. Insight and Judgement - limited. Abnormal movements- No. Diagnosis- Vascular dementia and Psychosis. Assessment/Plan- tolerating current psyche meds. No new behavioral issues. Meds- continue same meds. No new recommendations. Follow up 4 - 6 weeks and prn. High Risk Management Meeting dated 9/12/18 documents- Risk Area- behavior disruptive. Placed on High Risk ATCH List- Yes. Follow up steps- Non-pharmacological interventions - Re-direct and re-orient, family involvement, Rec on unit Rehab. Psyche consultation. Pharmacist Monthly Drug Regimen Review -Completed Monthly on 7/2/18, 8/9/18, 9/4/18/10/2/18 11/1/18, 12/2/18 and 1/2/19 - documented in the Sigma software system - No Irregularities Noted. The facility presented a copy of the Medication Regimen Review dated 1/2/19. It documents for this resident, Patient is a [AGE] year old with diagnosis of dementia. Risperdal 0.5 mg at bedtime. Please evaluate for Gradual Dose Reduction. Black Box Warning. Physician response is dated 1/8/19 Psych GDR. The FDA approved product labeling documents only three approved indications for the use of Risperdal. Risperdal is indicted for 1) Treatment of Schizophrenia. 2) Treatment of Bipolar disorder. 3) Treatment of irritability associated with autistic disorder in children and adolescents. A United States Food and Drug Administration Alert dated 6/16/2008 documents the following: FDA is notifying healthcare professionals that both conventional and atypical antipsychotics are associated with an increased risk of mortality in elderly patients treated for dementia related psychosis. In April 2005, FDA notified healthcare professionals that patients with dementia related psychosis treated with atypical antipsychotic drugs are at an increased risk of death. Since issuing that notification, FDA has reviewed additional information that indicates the risk is also associated with conventional antipsychotics. Antipsychotics are NOT indicated for the treatment of Dementia related psychosis. The following BLACK BOX WARNING is included in the prescribing information product labeling in the package insert of the drug Risperdal: WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA -RELATED PSYCHOSIS. Elderly patients with dementia related psychosis treated with antipsychotic drugs are at an increased risk of death. RISPERDAL is not approved for use in patients with dementia related psychosis. On 1/7/19 at 12:34 PM, the covering Attending Physician was interviewed and stated, The resident is taking Risperdal 0.5 mg at bedtime. I am checking the Psychiatrist consult and it states the resident is taking Risperdal due to vascular dementia with psychosis. This resident is [AGE] years old. I don't think this is an appropriate drug to give this resident. The dose of Risperdal 0.5 mg is a little too high. Maybe we need to lower the dose. I know elderly residents with dementia do not need antipsychotic medications. The Psychiatrist usually comes and evaluates the resident and recommends the medication. As the Attending Physician I review the medication. I just signed the renewal order today for this medication. The Black Box warning means we have to follow the resident's EKG. The patients have high risk for falls. I don't remember what else the Black Box warning covers. On 1/7/19 at 12:50 PM, the 4th floor Registered Nurse(RN) #3 Unit Manager was interviewed and stated, The resident was started on Risperdal 0.5 mg at bedtime on 9/14/18. The resident was started on this medication because she was aggressive towards staff. She was going into the other resident's space in her room, telling them that this is her room, she paid for it and the roommate should not be there. She was staying up late at night and using inappropriate language to the staff when they tried to redirect her. The resident did not want to go to bed. It was hard to get her compliant with care such as taking a shower and getting washed up in the evening for bed. She would go in and out of the dining room. She would eat a little then leave the dining room. We try to talk to her. We try to redirect her from the room. We take her to the dining room. We tried to get her involved in the recreation programs. We took her off the unit to participate in church programs and craft programs. She will tell staff after she is brought off the unit to the other programs, she does not want to be there. I told the Psychiatrist about her behavior. He recommended to redirect her but it was not working. After she was seen by the Psychiatrist we called her granddaughter to explain the behavior and the Psychiatrist recommendation. The resident has never hit any staff member to my knowledge. The resident has not hit any other resident. The resident never expressed any notions of suicidal tendencies by saying she wants to kill herself. Since the resident has been on the Risperdal she still has a mouth on her. She says what she wants to say if it is appropriate or not. She now speaks to the roommates family. All the nurses are responsible to write behavior notes on a resident. They should be documenting the behavior as it occurs. We do not have a separate section in the Sigma software computer system to document resident behaviors. We document all inappropriate behaviors in the Progress Notes. I only have Progress Notes written on 3 days. The first day is 9/11/18 prior to the Risperdal being prescribed. The second note is dated 9/14/18 on the day Risperdal was prescribed. The third note was written on 10/1/18 Where I wrote the resident was seen by the Psychiatrist on 9/26/18, she was recently started on Risperdal, there has been a decrease in agitation and disruptive behaviors. The Risperdal was prescribed due to behaviors of being disruptive, loud, not going to bed and using inappropriate language. The nurses on the floor myself included are responsible to write progress notes. The resident should have been monitored by the nursing staff including myself and if need be behavior notes should have been written for behaviors exhibited by the resident after the Risperdal was prescribed. The medication was working. Her behavior issues decreased and there was less of it seen. I should have documented this, but I did not. I should have written behavior notes in between the visits of the Psychiatrist not just after his visit. Nurses are responsible to monitor residents for any side effects of medications. The nurses are supposed to monitor if the non-pharmacological interventions are working. If they are not working, we discuss and report it to the doctor. The Certified Nursing Assistants (CNA) do not document any issues with resident behavior in their Personal Digital Assistance(PDS) records. On 1/9/19 at 11:23 AM, the 4th floor RN #3 Unit Manager was interviewed and stated, I am the person that writes and updates the care plans as needed. After the Interdisciplinary Team (IDT) meeting, I tried to redirect her. I tried to get her involved in the recreation programs. She did not want to go off the unit to the programs. So on the unit she liked movies and musical singing activities. We tried to get her involved in yoga. She like to go to rehab. I did NOT update the care plan to reflect these non-pharmacological interventions that I just told you were done. I do not have any written notes or documentation to show you that these things were done. As far as her complaining about other people being in the room and she pays the rent for the room and nobody should be there but her. As far as I know I did not offer her a private room. I don't remember anybody offering her a private room. On 1/7/19 at 1:04 PM, the Licensed Practical Nurse (LPN) #3 was interviewed and stated, The resident is taking Risperdal 0.5 mg at bedtime. She takes this medication because she is angry and really mad. I saw her taking things such as pillows from her roommate. I saw her make the roommate cry. I saw her wheeling herself up and down the floor and complaining that nobody takes care of me. She will see other residents being given care by the staff and then will say nobody takes care of me. I see she sometimes gets mad and wants all the attention to her. She never hit me. She has never hit any other resident. She has yelled at me and said she will tell her daughter. She yells at other residents and says her roommate took her things. I will offer her something to drink or to eat when she acts up. I offer to get her another pillow. On 1/7/19 at 1:33 PM, the 4th Floor Certified Nursing Assistant CNA #2 was interviewed and stated, The resident is calm and nice when I come in to give her care in the morning. I say good morning and I take her to the bathroom. to wash her up. I will then get her dressed. I tell her I want to take her to the dining room for breakfast and she curses at me. She says I have to get another job. The resident has never hit me. She has raised her hands and shook her fingers at me. I have never seen her hit another resident. She does not like the other person in the room. She says she paid for the room and does not want another person in the room with her. In the day room she will yell and scream at other residents if they pass behind her and hit her chair by mistake. Some of the residents in the day room make noise and she will scream at them. Sometimes she wants to talk to other residents and they tell her leave me alone and she will yell at them. When she yells and screams I will leave her alone until she calms down. When I leave her alone and go back to her she is calm. I will ask her if she wants to go to the bathroom, if she wants to lie down or if she wants something to drink. I never saw her hit any other residents. When I see the issues with behavior I sometimes report it to the nurse. I don't report every time she has a behavior problem or outburst, because she has this behavior every day and it is her way. She gets upset about every little thing. I only report the behavior to the nurse if it gets out of control. If I can't get her to calm down or if I go away and then go back to her and she is still acting up I will report this to the nurse. I don't write anything concerning the resident's behavior in my accountability notes On 1/8/19 at 10:07 AM, the Psychiatrist was interviewed and stated, I prescribed Risperdal to this resident because she is agitated, paranoid and aggressive. She would not allow nursing care or people to interact with her. I have been working in the facility one year. My diagnosis of her is dementia and psychosis NOS. Before I started her on the Risperdal I recommended behavior management work with a specific staff member, to place her in a single room and redirection. The Food and Drug Administration approves Risperdal to treat Psychosis. This is the primary indication. It is also approved for schizophrenia. It can be used to treat psychosis with depression and schizoaffective disorders. It can be used to treat hallucinations. The resident was paranoid which is a form of psychosis. She says I was trying to hurt her and attacking her. I know what the Black Box Warning is. It says that patients on psyche drugs with dementia tend to have increased mortality when compared to patients not on antipsych medications. My understanding is the Psychosis is not solely attributed to her Dementia. The dosage forms of Risperdal are 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg. I started her on Risperdal 0.5 mg which allows once a day dosing. Most residents tolerate 0.5 mg. I have not seen a tremendous response on 0.25 mg. I have not read the Federal regulations concerning the use of antipsychotic medications in nursing homes. The plan was to do a Gradual Dose Reduction(GDR) and do a rapid GDR once her behavior came under control. The patient is aggressive to other patients. No one ever told me she hit anyone, either staff or any other resident. Your point is taken that a lower dose should have been prescribed or that probably more intensive behavior management should have been done before I recommended the start of the Risperdal. Based on this conversation I intend to do a rapid GDR to taper it down and then stop the medication. On 1/8/19 at 11:31 AM, the Attending Physician was interviewed and stated, I write the monthly orders for this resident. The resident is taking Risperdal 0.5 mg at bedtime. The resident has been with us a few years. The resident had behavioral changes and she was noted with a change in her quality of life. The behaviors were she was more agitated, issues with redirection, at times responding to stimuli. There was a question if she was paranoid. The initial plan was to redirect her with behavior management. When those measures failed we involved the Psychiatrist. We felt she would benefit from medication. The resident does not have Schizophrenia and does not have a diagnosis of Bipolar Disorder. The FDA says you can use Risperdal for Schizoaffective and Bipolar Disorders. The Psychiatrist recommended Risperdal as he felt the resident might benefit form a small dose of these antipsychotics. I have heard of the Black Box Warning. It says there are increased incidents of adverse events such as death, cardiac disorders, infections and pneumonia. The Psychiatrist wrote a diagnosis of Vascular Dementia and Psychosis. I am aware of the Black Box Warning that Risperdal should not be used in patients with Dementia related Psychosis. The resident should be started on the lowest dose. She was prescribed Risperdal 0.5 mg at bedtime which is not the lowest dose. The lowest dose Risperdal 0.25 mg. The resident is not violent. She has not hit staff or any other residents. I would give this a second review. On 1/9/19 at 9:16 AM, the Psychiatrist was interviewed and stated, I felt the conversation we had was helpful as I come from the hospital setting. We frequently use psychiatric medication for off label uses. I started working here in December 2017. This is the first nursing home where I am working as a Consultant Psychiatrist. The attending doctor wrote the clinical indication for prescribing the Risperdal which is restlessness and agitation. This is NOT a reason to prescribe Risperdal. On my Psyche consults I have been writing the diagnosis for the resident as having Vascular Dementia and Psychosis and then I recommended the Risperdal. On 9/13/18 I was called to the see the resident for a follow visit. Before I see the resident, I talk to the nursing staff. I was told that the resident had become increasingly agitated, belligerent, restless and not responsive to redirection. She has not had any aggressive interaction with another resident, but staff was concerned that it might happen. I did not look up the Federal regulations as pertains to Antipsychotic medications, but my understanding is that you try to minimize the dose, use the lowest dose for the shortest duration and the prescribing should be a last resort after all other options failed. For agitated residents, limit setting, redirection, modify the environment, placing the resident in a single room, having her work with the same staff consistently and trying to anticipate her needs. As far as I know these were tried. The resident was never placed in a single room. I did not start the resident on the lowest possible dose. I felt Risperdal 0.5 mg although not the lowest dose in an effective dose. If she would not do well on this dose we would reduce it. The FDA approves this medication for Schizophrenia, Schizoaffective disorder and autism. This resident does NOT have any of these 3 diagnoses. The Black Box Warning says there is an increased mortality associated in elderly patients that are being prescribed antipsychotic medications. It also says that Risperdal should NOT be prescribed in patients with Dementia, related Psychosis. After our conversation I would be very reluctant to prescribe these medications again to elderly residents with Dementia. I know what a GDR is. I do NOT know what the Federal regulations are for performing GDR's in nursing homes. I should know what the Federal regulations are. I know that if residents are on Antipsychotic medications you try to taper the dose every 3- 4 months. I have recommended to the Attending Physician and the nursing staff that the Risperdal 0.5 mg at bedtime be reduced to Risperdal 0.25 mg at bedtime. We will monitor her for the reemergence of psychotic symptoms. We will reinforce to the nursing staff that we continue to implement behavior management. I have learned a lot from this experience. On 1/8/19 at 11:10 AM, the Director of Nursing was interviewed and stated, The resident is taking Risperdal 0.5 mg at bedtime. The Psychiatrist recommended the medication for this resident and the Attending Physician prescribed it. He wrote a diagnosis of Vascular Dementia with Psychosis which is why he recommended this medication. I know this resident displays disruptive behaviors. This is evidenced by verbal outbursts toward her roommate, secondary to her belief she owns the room. The resident has had verbal outbursts towards the staff. The resident has not hit any staff or any other residents. The resident has no history of physical aggression. The resident gets agitated easily when she perceives something does not go her way. An example is sharing her room, or she does not like her lunch or dinner. She seems to repeat that she pays the rent here and when she perceives something is not to her liking she gets upset. We should implement non-pharmacological interventions before a resident is given antipsychotic medications. We involved the family. The resident has a granddaughter that comes to visit her. We do reorientation and redirection. On 1/9/19 at 10:46 AM, the Director of Nursing was interviewed and stated, The non -pharmacological interventions[TRUNCATED]

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on observation, record review and staff interviews during the recertification survey the facility did not ensure the Consultant Pharmacist identified and reported to the Attending Physician an irregularity concerning an psychotropic medication being prescribed and administered to a resident in a timely manner. Specifically, one resident received an Antipsychotic medication for a diagnosis that was not approved by the United States Food and Drug Administration (FDA). This was evident for 1 of 5 sampled residents reviewed for Unnecessary Medications out of a sample of 38 residents. (Resident #184). The findings are: The facility policy titled, Medication Regimen Review -Pharmacy Consultant dated 4/18 documents: The facility shall employ and maintain the services of a Licensed Pharmacist (Pharmacy Consultant), who shall review the medication regimen review (MRR) of each resident at least monthly and more frequently, as needed. Policy Interpretation and Implementation documents- 1) The Pharmacy Consultant provides: Consultation of all aspects of the provisions of pharmacy services in the facility. Monitors for psychotropic for gradual dose reduction and prn medication use and that it is in accordance with CMS guidelines. Reporting/Documentation documents-- 1) The Pharmacy Consultant reports irregularities to the attending physician, medical director and DON with the residents's medication regimen. If the situation is serious enough to represent a risk to a resident's life, health, or safety, the Pharmacy Consultant will contact the Physician directly. Resident # 184 was admitted to the facility on [DATE] with diagnosis including Non Alzheimer's Dementia, Hypertension, Peripheral Vascular Disease, and Diabetes Mellitus. On 1/7/19 at 12:11 PM, the resident was observed sitting in a wheelchair in the dining room during lunch. The resident was neatly groomed and neatly dressed. The resident was wearing glasses. The resident had a plate containing chicken, white rice, mixed vegetables. A bowl of chicken noodle soup, a slice of white bread, a cup of tea and a container of Glucerna were also on the tray. The resident stated she was not hungry. The resident was quiet and in no distress. On 1/8/19 at 2:30 PM, the resident was observed propelling herself in wheelchair down the hallway past the nurses station. The resident was neatly groomed and neatly dressed. The resident was wearing glasses. The resident was calm and in no distress. On 1/9/19 at 10:01 AM, the resident was observed sitting in wheelchair in the day room at a table with 2 other residents. The resident was neatly groomed and neatly dressed. The resident was wearing glasses. This surveyor greeted the resident and asked how the resident felt. The resident responded I feel sleepy today. The resident was calm and in no distress. On 1/9/19 at 12:14 PM, the resident was observed sitting in her wheelchair and eating lunch in the day room. The resident was neatly groomed and neatly dressed. The resident was wearing glasses. The resident was eating beef stew, noodles and green beans. The tray also contained a cup of tea and a container of Glucerna. The resident was asked how the food tastes today and responded it will do. The resident was eating independently. The resident was calm and in no distress. On 1/10/19 at 9:19 AM, the resident was observed sitting in wheelchair in the day room. The resident was neatly groomed and neatly dressed. The resident was wearing glasses. The resident cleared her throat with a slight cough. The resident was asked how she was today and responded I feel okay but I am kind of sleepy. The resident was watching TV in the day room. The most recent Comprehensive Annual Assessment as documented in the Minimum Data Set (MDS) 3.0 dated 7/4/2018 documents the following: Hearing- minimal difficulty, no hearing aid. Clear speech. Understood. Understands. Vision- impaired, wears corrective lenses. Cognitive Patterns- Brief Interview for Mental Status (BIMS) score = 3. Cognitive patterns- N0- resident was able to complete interview. Delirium- the following behaviors were NOT present - Inattention, Disorganized thinking and Altered level of consciousness. Mood- Total Mood Severity Score = 0. Behavior- No hallucinations. No delusions. Behavioral Symptoms- Presence and Frequency- Behavior not exhibited- Physical behavioral symptoms directed toward others, Verbal behavioral symptoms directed towards others. And other behavioral symptoms not directed toward others. Rejection of Care- Presence and Frequency- 0- Behavior not exhibited. Wandering- Presence and Frequency- 0, Behavior not exhibited. How does resident's current behavior status, care rejection or wandering compare to prior assessment? - same. Functional Status- Extensive assistance- bed mobility, transfer, walk in room, walk in corridor, dressing, eating, toilet use and personal hygiene- all one person assist. No Functional Limitation in range of Motion. Mobility devices- walker and wheelchair. Frequently incontinent of bladder and bowel. Medications received- none documented. The MDS Quarterly assessment dated 12/16 2018 documents- same except for the following- Always incontinent of bladder and bowel. Diagnosis- psychotic disorder (other than schizophrenia). Medications Received - Antipsychotic - 7 days. Antipsychotic medication review- Yes- Antipsychotics were received on a routine basis only. Has a gradual dose reduction been attempted- No. Physician documented GDR as clinically contraindicated - N0. Care Plan - Psychotropic Drug Use - Evidenced by disruptive voice, behavior of inappropriate words to staff, negative behavior towards room -mate- family. Goals- demonstrate decreased need for psychoactive medication. Resident will have decreased incidents of mood or behavior. Interventions- Encourage verbalization of feelings. Establish appropriate diagnosis for medication use. Evaluate action of medication and side effects in terms of medical status profile, including interactions with other medications. Observe for any signs of decline in functional cognitive status. Obtain psychiatric consult or follow up as necessary. The Comprehensive Care Plan did not document a psychotic disorder or a diagnosis that was approved by the FDA as the indication for the use of Risperdal. The Comprehensive Care Plan did not document non- pharmacological interventions that were tried to address the residents behavior prior to the prescribing and administering of Risperdal. Care Plan - Vascular Dementia - Cognitive loss- dementia. Related to impaired decision making, long and short- term memory loss, oriented to self but not to time or place. Judgement - insight- poor. Goals- Resident will demonstrate ability to make decisions in activities. Resident will selfcare within mental and physical limitations. Interventions- Evaluate medication regimen. Evaluate pain management. Promote activities that reduce frustration and support success. Use simple words or instructions. Physicians Monthly Orders dated 9/14/2018 thru 12/18/18 documents- Risperdal 0.5 mg- Give one tablet daily at bedtime. Diagnosis- restlessness and agitation. Physicians Monthly Orders dated 1/7/19 documents- Risperdal 0.5 mg - Give one tablet daily at bedtime. Diagnosis- other psych disorder not due to a sub or known physiol condition. Medication Administration Records dated 9/14/18 thru 1/6/2019 documents the resident received Risperdal 0.5 mg daily at bedtime. Physicians Progress Notes document the following- 9/28/18 - Diagnosis - Dementia with behavioral disturbances. Aggressive behavior towards others. Risperdal ordered. 10/23/18 - Diagnosis- Dementia with psychosis and behavioral disturbances. Tolerating Risperdal. 11/20/18 - Diagnosis - Dementia with psychosis On Risperdal 12/18/18 - Diagnosis- Dementia with psychosis- No new behavioral changed noted. On Risperdal. Psychiatric Consult dated 8/22/18 documents: Follow - up. Patient is a [AGE] year old female with history of Dementia, on no psyche meds. As per staff patient has been stable, no behavioral disturbances. Patient states she is doing okay. Patient did not provide details about history. Patient believes she has been here for one year. Patient denies depression, denies confusion, denies psychotic symptoms and denies memory deficits. No evidence of hopelessness, helplessness or suicidal ideation. No reported side effects of medication. No problems with sleep. Diagnosis- Vascular dementia. Assessment/Plan - no new behavioral issues since last contact. Meds- continue same management, no new recommendations. Psychiatric Consult dated 9/13/18 documents: Follow-up. Chief complaint- agitation, psychosis, belligerent behavior. As per staff patient has been agitated, belligerent and threatening towards other patients. Patient states she is doing okay. Patient did not provide details about history. Patient believes she has been here one year. Same as above. Diagnosis- Vascular dementia, Psychosis. Assessment/Plan -with agitation and psychosis. Psychiatric Consult dated 9/27/18 documents - Reason for follow up, patient recently started on Risperdal. Chief complaint- agitation, psychosis and belligerent behavior. As per staff has been calmer, she is doing okay. Same as above. Diagnosis -Vascular dementia and Psychosis. Assessment/Plan tolerating current psyche meds. No new behavioral issues. Meds- continue same meds. Psychiatric Consult dated 11/1/18 documents- Follow up. As per staff patient has been calmer. She is doing okay. Patient did not provide details about her history. Same as above. Diagnosis - Vascular dementia and Psychosis. Meds- continue same meds. No new recommendations. Psychiatric Consult dated 11/29/18 documents: Patient seen for follow up. Patient is a [AGE] year old female with history of dementia on psyche meds. As per staff patient has been calmer. She is doing okay. Patient did not provide details about history. Patient believes she has been her for years. Patient denies depression. No evidence of hopelessness or suicidal ideation. No reported side effects of meds. No problem with sleep. No new behavioral issues. Tolerating current psyche meds. Psyche med Risperdal 0.5 mg at bedtime. Mental Status Examination - Appearance- alert, awake, cooperative. Gait seated. Muscle tone- normal. Mood- good. Affect- reactive. Suicidal ideation - No. Homicidal ideation- No. speech - normal. Thought process - slowed. Thought content-delusions- No. Paranoid ideation - No. Hallucinations- No. Associations- No. Orientation- person- Yes. Place- No. Time- No. Attention and concentration - decreased. Memory short term- Poor. Memory long term - Poor. Language aphasia- No. Fund of Knowledge- Poor. Insight and Judgement - limited. Abnormal movements- No. Diagnosis- Vascular dementia and Psychosis. Assessment/Plan- tolerating current psyche meds. No new behavioral issues. Meds- continue same meds. No new recommendations. Follow up 4 - 6 weeks and prn. High Risk Management Meeting dated 9/12/18 documents- Risk Area- behavior disruptive. Placed on High Risk ATCH List- Yes. Follow up steps- Non-pharmacological interventions - Re-direct and re-orient, family involvement, Rec on unit Rehab. Psyche consultation. Pharmacist Monthly Drug Regimen Review -Completed Monthly on 7/2/18, 8/9/18, 9/4/18/10/2/18 11/1/18, 12/2/18 and 1/2/19 - documented in the Sigma software system - No Irregularities Noted. The facility presented a copy of the Medication Regimen Review dated 1/2/19. It documents for this resident, Patient is a [AGE] year old female with diagnosis of Dementia. Risperdal 0.5 mg at bedtime. Please evaluate for Gradual Dose Reduction. Black Box Warning. Physician response is dated 1/8/19 Psych GDR. The FDA approved product labeling documents only three approved indications for the use of Risperdal. Risperdal is indicted for 1) Treatment of Schizophrenia. 2) Treatment of Bipolar disorder. 3) Treatment of irritability associated with autistic disorder in children and adolescents. A United States Food and Drug Administration Alert dated 6/16/2008 documents the following: FDA is notifying healthcare professionals that both conventional and atypical antipsychotics are associated with an increased risk of mortality in elderly patients treated for dementia related psychosis. In April 2005, FDA notified healthcare professionals that patients with dementia related psychosis treated with atypical antipsychotic drugs are at an increased risk of death. Since issuing that notification, FDA has reviewed additional information that indicates the risk is also associated with conventional antipsychotics. Antipsychotics are NOT indicated for the treatment of Dementia related psychosis. The following BLACK BOX WARNING is included in the prescribing information product labeling in the package insert of the drug Risperdal: WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA -RELATED PSYCHOSIS. Elderly patients with dementia related psychosis treated with antipsychotic drugs are at an increased risk of death. RISPERDAL is not approved for use in patients with dementia related psychosis. On 1/7/19 at 12:34 PM, the covering Attending Physician was interviewed and stated, The resident is taking Risperdal 0.5 mg at bedtime. I am checking the Psychiatrist consult and it states the resident is taking Risperdal due to vascular dementia with psychosis. This resident is [AGE] years old. I don't think this is an appropriate drug to give this resident. The dose of Risperdal 0.5 mg is a little too high. Maybe we need to lower the dose. I know elderly residents with dementia do not need antipsychotic medications. The Psychiatrist usually comes and evaluates the resident and recommends the medication. As the Attending Physician I review the medication. I just signed the renewal order today for this medication. The Black Box warning means we have to follow the resident's EKG. The patients have high risk for falls. I don't remember what else the Black Box warning covers. On 1/7/19 at 12:50 PM, the 4th floor Registered Nurse (RN) #3 Unit Manager was interviewed and stated, The resident was started on Risperdal 0.5 mg at bedtime on 9/14/18. The resident was started on this medication because she was aggressive towards staff. She was going into the other resident's space in her room, telling them that this is her room, she paid for it and the roommate should not be there. She was staying up late at night and using inappropriate language to the staff when they tried to redirect her. The resident did not want to go to bed. It was hard to get her compliant with care such as taking a shower and getting washed up in the evening for bed. She would go in and out of the dining room. She would eat a little then leave the dining room. We try to talk to her. We try to redirect her from the room. We take her to the dining room. We tried to get her involved in the recreation programs. We took her off the unit to participate in church programs and craft programs. She will tell staff after she is brought off the unit to the other programs, she does not want to be there. I told the Psychiatrist about her behavior. He recommended to redirect her but it was not working. After she was seen by the Psychiatrist we called her granddaughter to explain the behavior and the Psychiatrist recommendation. The resident has never hit any staff member to my knowledge. The resident has not hit any other resident. The resident never expressed any notions of suicidal tendencies by saying she wants to kill herself. Since the resident has been on the Risperdal she still has a mouth on her. She says what she wants to say if it is appropriate or not. She now speaks to the roommates family. All the nurses are responsible to write behavior notes on a resident. They should be documenting the behavior as it occurs. We do not have a separate section in the Sigma software computer system to document resident behaviors. We document all inappropriate behaviors in the Progress Notes. I only have Progress Notes written on 3 days. The first day is 9/11/18 prior to the Risperdal being prescribed. The second note is dated 9/14/18 on the day Risperdal was prescribed. The third note was written on 10/1/18 Where I wrote the resident was seen by the Psychiatrist on 9/26/18, she was recently started on Risperdal, there has been a decrease in agitation and disruptive behaviors. The Risperdal was prescribed due to behaviors of being disruptive, loud, not going to bed and using inappropriate language. The nurses on the floor myself included are responsible to write progress notes. The resident should have been monitored by the nursing staff including myself and if need be behavior notes should have been written for behaviors exhibited by the resident after the Risperdal was prescribed. The medication was working. Her behavior issues decreased and there was less of it seen. I should have documented this, but I did not. I should have written behavior notes in between the visits of the Psychiatrist not just after his visit. Nurses are responsible to monitor residents for any side effects of medications. The nurses are supposed to monitor if the non-pharmacological interventions are working. If they are not working, we discuss and report it to the doctor. The Certified Nursing Assistants (CNA) do not document any issues with resident behavior in their Personal Digital Assistance(PDS) records. On 1/9/19 at 11:23 AM, the 4th floor RN #3 Unit Manager was interviewed and stated, I am the person that writes and updates the care plans as needed. After the Interdisciplinary Team (IDT) meeting, I tried to redirect her. I tried to get her involved in the recreation programs. She did not want to go off the unit to the programs. So on the unit she liked movies and musical singing activities. We tried to get her involved in yoga. She like to go to rehab. I did NOT update the care plan to reflect these non-pharmacological interventions that I just told you were done. I do not have any written notes or documentation to show you that these things were done. As far as her complaining about other people being in the room and she pays the rent for the room and nobody should be there but her. As far as I know I did not offer her a private room. I don't remember anybody offering her a private room. On 1/7/19 at 1:04 PM, the Licensed Practical Nurse #3 (LPN) was interviewed and stated, The resident is taking Risperdal 0.5 mg at bedtime. She takes this medication because she is angry and really mad. I saw her taking things such as pillows from her roommate. I saw her make the roommate cry. I saw her wheeling herself up and down the floor and complaining that nobody takes care of me. She will see other residents being given care by the staff and then will say nobody takes care of me. I see she sometimes gets mad and wants all the attention to her. She never hit me. She has never hit any other resident. She has yelled at me and said she will tell her daughter. She yells at other residents and says her roommate took her things. I will offer her something to drink or to eat when she acts up. I offer to get her another pillow. On 1/7/19 at 1:33 PM, the 4th Floor Certified Nursing Assistant (CNA) #2 was interviewed and stated, The resident is calm and nice when I come in to give her care in the morning. I say good morning and I take her to the bathroom. to wash her up. I will then get her dressed. I tell her I want to take her to the dining room for breakfast and she curses at me. She says I have to get another job. The resident has never hit me. She has raised her hands and shook her fingers at me. I have never seen her hit another resident. She does not like the other person in the room. She says she paid for the room and does not want another person in the room with her. In the day room she will yell and scream at other residents if they pass behind her and hit her chair by mistake. Some of the residents in the day room make noise and she will scream at them. Sometimes she wants to talk to other residents and they tell her leave me alone and she will yell at them. When she yells and screams I will leave her alone until she calms down. When I leave her alone and go back to her she is calm. I will ask her if she wants to go to the bathroom, if she wants to lie down or if she wants something to drink. I never saw her hit any other residents. When I see the issues with behavior I sometimes report it to the nurse. I don't report every time she has a behavior problem or outburst, because she has this behavior every day and it is her way. She gets upset about every little thing. I only report the behavior to the nurse if it gets out of control. If I can't get her to calm down or if I go away and then go back to her and she is still acting up I will report this to the nurse. I don't write anything concerning the resident's behavior in my accountability notes On 1/8/19 at 10:07 AM, the Psychiatrist was interviewed and stated, I prescribed Risperdal to this resident because she is agitated, paranoid and aggressive. She would not allow nursing care or people to interact with her. I have been working in the facility one year. My diagnosis of her is dementia and psychosis NOS. Before I started her on the Risperdal I recommended behavior management work with a specific staff member, to place her in a single room and redirection. The Food and Drug Administration approves Risperdal to treat Psychosis. This is the primary indication. It is also approved for schizophrenia. It can be used to treat psychosis with depression and schizoaffective disorders. It can be used to treat hallucinations. The resident was paranoid which is a form of psychosis. She says I was trying to hurt her and attacking her. I know what the Black Box Warning is. It says that patients on psyche drugs with dementia tend to have increased mortality when compared to patients not on antipsych medications. My understanding is the Psychosis is not solely attributed to her Dementia. The dosage forms of Risperdal are 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg. I started her on Risperdal 0.5 mg which allows once a day dosing. Most residents tolerate 0.5 mg. I have not seen a tremendous response on 0.25 mg. I have not read the Federal regulations concerning the use of antipsychotic medications in nursing homes. The plan was to do a Gradual Dose Reduction(GDR) and do a rapid GDR once her behavior came under control. The patient is aggressive to other patients. No one ever told me she hit anyone, either staff or any other resident. Your point is taken that a lower dose should have been prescribed or that probably more intensive behavior management should have been done before I recommended the start of the Risperdal. Based on this conversation I intend to do a rapid GDR to taper it down and then stop the medication. On 1/8/19 at 11:31 AM, the Attending Physician was interviewed and stated, I write the monthly orders for this resident. The resident is taking Risperdal 0.5 mg at bedtime. The resident has been with us a few years. The resident had behavioral changes and she was noted with a change in her quality of life. The behaviors were she was more agitated, issues with redirection, at times responding to stimuli. There was a question if she was paranoid. The initial plan was to redirect her with behavior management. When those measures failed we involved the Psychiatrist. We felt she would benefit from medication. The resident does not have Schizophrenia and does not have a diagnosis of Bipolar Disorder. The FDA says you can use Risperdal for Schizoaffective and Bipolar Disorders. The Psychiatrist recommended Risperdal as he felt the resident might benefit form a small dose of these antipsychotics. I have heard of the Black Box Warning. It says there are increased incidents of adverse events such as death, cardiac disorders, infections and pneumonia. The Psychiatrist wrote a diagnosis of Vascular Dementia and Psychosis. I am aware of the Black Box Warning that Risperdal should not be used in patients with Dementia related Psychosis. The resident should be started on the lowest dose. She was prescribed Risperdal 0.5 mg at bedtime which is not the lowest dose. The lowest dose Risperdal 0.25 mg. The resident is not violent. She has not hit staff or any other residents. I would give this a second review. On 1/9/19 at 9:16 AM, the Psychiatrist was interviewed and stated, I felt the conversation we had was helpful as I come from the hospital setting. We frequently use psychiatric medication for off label uses. I started working here in December 2017. This is the first nursing home where I am working as a Consultant Psychiatrist. The attending doctor wrote the clinical indication for prescribing the Risperdal which is restlessness and agitation. This is NOT a reason to prescribe Risperdal. On my Psyche consults I have been writing the diagnosis for the resident as having Vascular Dementia and Psychosis and then I recommended the Risperdal. On 9/13/18 I was called to the see the resident for a follow visit. Before I see the resident, I talk to the nursing staff. I was told that the resident had become increasingly agitated, belligerent, restless and not responsive to redirection. She has not had any aggressive interaction with another resident, but staff was concerned that it might happen. I did not look up the Federal regulations as pertains to Antipsychotic medications, but my understanding is that you try to minimize the dose, use the lowest dose for the shortest duration and the prescribing should be a last resort after all other options failed. For agitated residents, limit setting, redirection, modify the environment, placing the resident in a single room, having her work with the same staff consistently and trying to anticipate her needs. As far as I know these were tried. The resident was never placed in a single room. I did not start the resident on the lowest possible dose. I felt Risperdal 0.5 mg although not the lowest dose in an effective dose. If she would not do well on this dose we would reduce it. The FDA approves this medication for Schizophrenia, Schizoaffective disorder and autism. This resident does NOT have any of these 3 diagnoses. The Black Box Warning says there is an increased mortality associated in elderly patients that are being prescribed antipsychotic medications. It also says that Risperdal should NOT be prescribed in patients with Dementia, related Psychosis. After our conversation I would be very reluctant to prescribe these medications again to elderly residents with Dementia. I know what a GDR is. I do NOT know what the Federal regulations are for performing GDR's in nursing homes. I should know what the Federal regulations are. I know that if residents are on Antipsychotic medications you try to taper the dose every 3- 4 months. I have recommended to the Attending Physician and the nursing staff that the Risperdal 0.5 mg at bedtime be reduced to Risperdal 0.25 mg at bedtime. We will monitor her for the reemergence of psychotic symptoms. We will reinforce to the nursing staff that we continue to implement behavior management. I have learned a lot from this experience. On 1/8/19 at 11:10 AM, the Director of Nursing was interviewed and stated, The resident is taking Risperdal 0.5 mg at bedtime. The Psychiatrist recommended the medication for this resident and the Attending Physician prescribed it. He wrote a diagnosis of Vascular Dementia with Psychosis which is why he recommended this medication. I know this resident displays disruptive behaviors. This is evidenced by verbal outbursts toward her roommate, secondary to her belief she owns the room. The resident has had verbal outbursts towards the staff. The resident has not hit any staff or any other residents. The resident has no history of physical aggression. The resident gets agitated easily when she perceives something does not go her way. An example is sharing her room, or she does not like her lunch or dinner. She seems to repeat that she pays the rent here and when she perceives something is not to her liking she gets upset. We should implement non-pharmacological interventions before a resident is given antipsychotic medications. We involved the family. The resident has a granddaughter that comes to visit her. We do reorientation and redirection. On 1/9/19 at 10:46 AM, the Director of Nursing was interviewed and stated, The non -pharmacological interventions that should be tried, include music therapy, pet therapy, if a person likes Bingo or the movies. I involved the family for input. We can provide 1:1 to calm the person down. We redirect and reorient the person. For this resident we reorient her. I know she participates on the unit in group activities. The resident has a semi -private 2 bedded room. To my knowledge the resident was never offered a private room. The IDT team had a meeting on 9/12/18. The Psychotropic Drug Use Care Plan was updated on 11/2/18, 11/29/18 and initiated on 10/1/18. The updates only document the Psychiatrist Consults. The care plan does list any non-pharmacological interventions that were tried prior to the start of the Risperdal. There is a Vascular Dementia Care Plan. I do NOT have any documentation to show you that the Vascular Dementia Care Plan or the Psychotropic Drug Use Care Plan was updated after the IDT meeting on 9/12/18 and before the Risperdal was prescribed. The Care Plan for the Vascular Dementia should have reflected what non-pharmacological interventions were in place and whether they were effective. If they were not, then what is the next step which in this case was a Psych consult. The Nurse Unit Managers are supposed to update the care plans to reflect the non-pharmacological interventions. The Vascular Dementia Care Plan has an entry on 9/14/18 that mentions the resident starts Risperdal 0.5 mg at bedtime. The note should have included non-pharmacological interventions that were implemented. There is no documentation on the Care Plan that new non-pharmacological interventions were added and updated on this Care Plan. I don't see anything written here. The Nurse Unit Manager should have updated the Care Plan. We do in-service the CNA's and the Nursing Staff on how to interact with residents who have dementia. On 1/9/19 at 10:09 AM, the Pharmacy Consultant was interviewed and stated, The resident has not had any irregularities in the last 3 months. When I do a drug, regimen review I look at the doctor's orders, Medication Administration Record, relevant labs, progress notes and consults. I might speak to the nurse. I might speak to the Physician. I do not speak to anyone else. The resident was diagnosed as having Vascular Dementia and Psychosis. The Psychiatrist recommended Risperdal 0.5 mg at bedtime. It was not a textbook reason for prescribing Risperdal. The FDA clinical indications for Risperdal are Schizophrenia, Schizoaffective disorder, hallucination, auditory visual delusions, psychosis and depression. You know very well, off label prescribing is not illegal. Other interventions were prescribed and the resident was monitored closely for side effects. It was a small dose. Risperdal 0.5 mg is a small dose. The Black Box Warning on antipsychotic medications says in the elderly there is an increased risk of mortality when these drugs are used. It says Risperdal is NOT approved for patients with Dementia related, Psychosis. This seems to be an irregularity. I did NOT pick this up because I deferred to the Psychiatrist who felt it was appropriate for the resident. I picked this up in January 2019. I did not pick it up sooner. The lowest dose available is Risperdal 0.25 mg. The monthly doctor orders' says the Risperdal is being prescribed for restlessness and agitation. Restlessness and agitation are NOT appropriate reasons to prescribe Risperdal. I usually do not look at the resident when I do a drug regimen review. I did NOT look at this resident. I did a review on this resident on January 2, 2019. I wrote, [AGE] year old with diagnosis of Dementia on Risperdal 0.5 mg at bedtime. Please evaluate for gradual dose reduction. Black Box Warning. I should have picked this up sooner [TRUNCATED]

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on observation, record review and staff interviews during the recertification survey the facility did not ensure that a resident was free from an unnecessary Antipsychotic medication. Specifically, one resident received an Antipsychotic medication for a diagnosis that was not approved by the United States Food and Drug Administration (FDA). This was evident for 1 of 5 sampled residents reviewed for Unnecessary Medications out of a sample of 38 residents. (Resident #184). The findings are: The facility policy titled, Antipsychotic Medication Use dated 12/2017 documents, Antipsychotic medications will be prescribed at the lowest possible dosage for the shortest period of time and are subject to gradual dose reduction and re-review. 1) Residents will only receive antipsychotic medications when necessary to treat specific conditions for which they are indicated and effective. 7) Antipsychotic medications shall generally be used only for the following conditions/diagnoses as documented in the record, consistent with the definitions in the Diagnostic and Statistical Manual of Mental Disorder: a) Schizophrenia b) Schizo - affective disorder c) Schizophreniform disorder d) Delusional disorder e) Mood disorders (e.g. bipolar disorder with psychotic features and treatment refractory major depression), f) Psychosis in the absence of dementia. g) Medical illness with psychotic symptoms and/or treatment-related psychosis or mania (e.g. high dose steroids). h) Tourette's Disorder. i) Huntington's Disease. j) Hiccups (not induced by other medications). or k) Nausea and vomiting associated with cancer or chemotherapy. Resident # 184 was admitted to the facility on [DATE] with diagnosis including Non Alzheimer's Dementia, Hypertension, Peripheral Vascular Disease, and Diabetes Mellitus. On 1/7/19 at 12:11 PM, the resident was observed sitting in a wheelchair in the dining room during lunch. The resident was neatly groomed and neatly dressed. The resident was wearing glasses. The resident had a plate containing chicken, white rice, mixed vegetables. A bowl of chicken noodle soup, a slice of white bread, a cup of tea and a container of Glucerna were also on the tray. The resident stated she was not hungry. The resident was quiet and in no distress. On 1/8/19 at 2:30 PM, the resident was observed propelling herself in wheelchair down the hallway past the nurses station. The resident was neatly groomed and neatly dressed. The resident was wearing glasses. The resident was calm and in no distress. On 1/9/19 at 10:01 AM, the resident was observed sitting in wheelchair in the day room at a table with 2 other residents. The resident was neatly groomed and neatly dressed. The resident was wearing glasses. This surveyor greeted the resident and asked how the resident felt. The resident responded I feel sleepy today. The resident was calm and in no distress. On 1/9/19 at 12:14 PM, the resident was observed sitting in her wheelchair and eating lunch in the day room. The resident was neatly groomed and neatly dressed. The resident was wearing glasses. The resident was eating beef stew, noodles and green beans. The tray also contained a cup of tea and a container of Glucerna. The resident was asked how the food tastes today and responded it will do. The resident was eating independently. The resident was calm and in no distress. On 1/10/19 at 9:19 AM, the resident was observed sitting in wheelchair in the day room. The resident was neatly groomed and neatly dressed. The resident was wearing glasses. The resident cleared her throat with a slight cough. The resident was asked how she was today and responded I feel okay but I am kind of sleepy. The resident was watching TV in the day room. The most recent Comprehensive Annual Assessment as documented in the Minimum Data Set (MDS) 3.0 dated 7/4/2018 documents the following: Hearing- minimal difficulty, no hearing aid. Clear speech. Understood. Understands. Vision- impaired, wears corrective lenses. Cognitive Patterns- Brief Interview for Mental Status (BIMS) score = 3. Cognitive patterns- N0- resident was able to complete interview. Delirium- the following behaviors were NOT present - Inattention, Disorganized thinking and Altered level of consciousness. Mood- Total Mood Severity Score = 0. Behavior- No hallucinations. No delusions. Behavioral Symptoms- Presence and Frequency- Behavior not exhibited- Physical behavioral symptoms directed toward others, Verbal behavioral symptoms directed towards others. And other behavioral symptoms not directed toward others. Rejection of Care- Presence and Frequency- 0- Behavior not exhibited. Wandering- Presence and Frequency- 0, Behavior not exhibited. How does resident's current behavior status, care rejection or wandering compare to prior assessment? - same. Functional Status- Extensive assistance- bed mobility, transfer, walk in room, walk in corridor, dressing, eating, toilet use and personal hygiene- all one person assist. No Functional Limitation in range of Motion. Mobility devices- walker and wheelchair. Frequently incontinent of bladder and bowel. Medications received- none documented. The MDS Quarterly assessment dated 12/16 2018 documents- same except for the following- Always incontinent of bladder and bowel. Diagnosis- psychotic disorder (other than schizophrenia). Medications Received - Antipsychotic - 7 days. Antipsychotic medication review- Yes- Antipsychotics were received on a routine basis only. Has a gradual dose reduction been attempted- No. Physician documented GDR as clinically contraindicated - N0. Care Plan - Psychotropic Drug Use - Evidenced by disruptive voice, behavior of inappropriate words to staff, negative behavior towards room -mate- family. Goals- demonstrate decreased need for psychoactive medication. Resident will have decreased incidents of mood or behavior. Interventions- Encourage verbalization of feelings. Establish appropriate diagnosis for medication use. Evaluate action of medication and side effects in terms of medical status profile, including interactions with other medications. Observe for any signs of decline in functional cognitive status. Obtain psychiatric consult or follow up as necessary. The Comprehensive Care Plan did not document a psychotic disorder or a diagnosis that was approved by the FDA as the indication for the use of Risperdal. The Comprehensive Care Plan did not document non- pharmacological interventions that were tried to address the residents behavior prior to the prescribing and administering of Risperdal. Care Plan - Vascular Dementia - Cognitive loss- dementia. Related to impaired decision making, long and short- term memory loss, oriented to self but not to time or place. Judgement - insight- poor. Goals- Resident will demonstrate ability to make decisions in activities. Resident will selfcare within mental and physical limitations. Interventions- Evaluate medication regimen. Evaluate pain management. Promote activities that reduce frustration and support success. Use simple words or instructions. Physicians Monthly Orders dated 9/14/2018 thru 12/18/18 documents- Risperdal 0.5 mg- Give one tablet daily at bedtime. Diagnosis- restlessness and agitation. Physicians Monthly Orders dated 1/7/19 documents- Risperdal 0.5 mg - Give one tablet daily at bedtime. Diagnosis- other psych disorder not due to a sub or known physiol condition. Medication Administration Records dated 9/14/18 thru 1/6/2019 documents the resident received Risperdal 0.5 mg daily at bedtime. Physicians Progress Notes document the following- 9/28/18 - Diagnosis - Dementia with behavioral disturbances. Aggressive behavior towards others. Risperdal ordered. 10/23/18 - Diagnosis- Dementia with psychosis and behavioral disturbances. Tolerating Risperdal. 11/20/18 - Diagnosis - Dementia with psychosis On Risperdal 12/18/18 - Diagnosis- Dementia with psychosis- No new behavioral changed noted. On Risperdal. Psychiatric Consult dated 8/22/18 documents: Follow - up. Patient is a [AGE] year old female with history of Dementia, on no psyche meds. As per staff patient has been stable, no behavioral disturbances. Patient states she is doing okay. Patient did not provide details about history. Patient believes she has been here for one year. Patient denies depression, denies confusion, denies psychotic symptoms and denies memory deficits. No evidence of hopelessness, helplessness or suicidal ideation. No reported side effects of medication. No problems with sleep. Diagnosis- Vascular dementia. Assessment/Plan - no new behavioral issues since last contact. Meds- continue same management, no new recommendations. Psychiatric Consult dated 9/13/18 documents: Follow-up. Chief complaint- agitation, psychosis, belligerent behavior. As per staff patient has been agitated, belligerent and threatening towards other patients. Patient states she is doing okay. Patient did not provide details about history. Patient believes she has been here one year. Same as above. Diagnosis- Vascular dementia, Psychosis. Assessment/Plan -with agitation and psychosis. Psychiatric Consult dated 9/27/18 documents - Reason for follow up, patient recently started on Risperdal. Chief complaint- agitation, psychosis and belligerent behavior. As per staff has been calmer, she is doing okay. Same as above. Diagnosis -Vascular dementia and Psychosis. Assessment/Plan tolerating current psyche meds. No new behavioral issues. Meds- continue same meds. Psychiatric Consult dated 11/1/18 documents- Follow up. As per staff patient has been calmer. She is doing okay. Patient did not provide details about her history. Same as above. Diagnosis - Vascular dementia and Psychosis. Meds- continue same meds. No new recommendations. Psychiatric Consult dated 11/29/18 documents: Patient seen for follow up. Patient is a [AGE] year old female with history of dementia on psyche meds. As per staff patient has been calmer. She is doing okay. Patient did not provide details about history. Patient believes she has been her for years. Patient denies depression. No evidence of hopelessness or suicidal ideation. No reported side effects of meds. No problem with sleep. No new behavioral issues. Tolerating current psyche meds. Psyche med Risperdal 0.5 mg at bedtime. Mental Status Examination - Appearance- alert, awake, cooperative. Gait seated. Muscle tone- normal. Mood- good. Affect- reactive. Suicidal ideation - No. Homicidal ideation- No. speech - normal. Thought process - slowed. Thought content-delusions- No. Paranoid ideation - No. Hallucinations- No. Associations- No. Orientation- person- Yes. Place- No. Time- No. Attention and concentration - decreased. Memory short term- Poor. Memory long term - Poor. Language aphasia- No. Fund of Knowledge- Poor. Insight and Judgement - limited. Abnormal movements- No. Diagnosis- Vascular dementia and Psychosis. Assessment/Plan- tolerating current psyche meds. No new behavioral issues. Meds- continue same meds. No new recommendations. Follow up 4 - 6 weeks and prn. High Risk Management Meeting dated 9/12/18 documents- Risk Area- behavior disruptive. Placed on High Risk ATCH List- Yes. Follow up steps- Non-pharmacological interventions - Re-direct and re-orient, family involvement, Rec on unit Rehab. Psyche consultation. Pharmacist Monthly Drug Regimen Review -Completed Monthly on 7/2/18, 8/9/18, 9/4/18/10/2/18 11/1/18, 12/2/18 and 1/2/19 - documented in the Sigma software system - No Irregularities Noted. The facility presented a copy of the Medication Regimen Review dated 1/2/19. It documents for this resident, Patient is a 96 year olf with diagnosis of dementia. Risperdal 0.5 mg at bedtime. Please evaluate for Gradual Dose Reduction. Black Box Warning. Physician response is dated 1/8/19 Psyche GDR. The FDA approved product labeling documents only three approved indications for the use of Risperdal. Risperdal is indicted for 1) Treatment of Schizophrenia. 2) Treatment of Bipolar disorder. 3) Treatment of irritability associated with autistic disorder in children and adolescents. A United States Food and Drug Administration Alert dated 6/16/2008 documents the following: FDA is notifying healthcare professionals that both conventional and atypical antipsychotics are associated with an increased risk of mortality in elderly patients treated for dementia related psychosis. In April 2005, FDA notified healthcare professionals that patients with dementia related psychosis treated with atypical antipsychotic drugs are at an increased risk of death. Since issuing that notification, FDA has reviewed additional information that indicates the risk is also associated with conventional antipsychotics. Antipsychotics are NOT indicated for the treatment of Dementia related psychosis. The following BLACK BOX WARNING is included in the prescribing information product labeling in the package insert of the drug Risperdal: WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA -RELATED PSYCHOSIS. Elderly patients with dementia related psychosis treated with antipsychotic drugs are at an increased risk of death. RISPERDAL is not approved for use in patients with dementia related psychosis. On 1/7/19 at 12:34 PM, the covering Attending Physician was interviewed and stated, The resident is taking Risperdal 0.5 mg at bedtime. I am checking the Psychiatrist consult and it states the resident is taking Risperdal due to vascular dementia with psychosis. This resident is [AGE] years old. I don't think this is an appropriate drug to give this resident. The dose of Risperdal 0.5 mg is a little too high. Maybe we need to lower the dose. I know elderly residents with dementia do not need antipsychotic medications. The Psychiatrist usually comes and evaluates the resident and recommends the medication. As the Attending Physician I review the medication. I just signed the renewal order today for this medication. The Black Box warning means we have to follow the resident's EKG. The patients have high risk for falls. I don't remember what else the Black Box warning covers. On 1/7/19 at 12:50 PM, the 4th floor Registered Nurse(RN) #3 Unit Manager was interviewed and stated, The resident was started on Risperdal 0.5 mg at bedtime on 9/14/18. The resident was started on this medication because she was aggressive towards staff. She was going into the other resident's space in her room, telling them that this is her room, she paid for it and the roommate should not be there. She was staying up late at night and using inappropriate language to the staff when they tried to redirect her. The resident did not want to go to bed. It was hard to get her compliant with care such as taking a shower and getting washed up in the evening for bed. She would go in and out of the dining room. She would eat a little then leave the dining room. We try to talk to her. We try to redirect her from the room. We take her to the dining room. We tried to get her involved in the recreation programs. We took her off the unit to participate in church programs and craft programs. She will tell staff after she is brought off the unit to the other programs, she does not want to be there. I told the Psychiatrist about her behavior. He recommended to redirect her but it was not working. After she was seen by the Psychiatrist we called her granddaughter to explain the behavior and the Psychiatrist recommendation. The resident has never hit any staff member to my knowledge. The resident has not hit any other resident. The resident never expressed any notions of suicidal tendencies by saying she wants to kill herself. Since the resident has been on the Risperdal she still has a mouth on her. She says what she wants to say if it is appropriate or not. She now speaks to the roommates family. All the nurses are responsible to write behavior notes on a resident. They should be documenting the behavior as it occurs. We do not have a separate section in the Sigma software computer system to document resident behaviors. We document all inappropriate behaviors in the Progress Notes. I only have Progress Notes written on 3 days. The first day is 9/11/18 prior to the Risperdal being prescribed. The second note is dated 9/14/18 on the day Risperdal was prescribed. The third note was written on 10/1/18 Where I wrote the resident was seen by the Psychiatrist on 9/26/18, she was recently started on Risperdal, there has been a decrease in agitation and disruptive behaviors. The Risperdal was prescribed due to behaviors of being disruptive, loud, not going to bed and using inappropriate language. The nurses on the floor myself included are responsible to write progress notes. The resident should have been monitored by the nursing staff including myself and if need be behavior notes should have been written for behaviors exhibited by the resident after the Risperdal was prescribed. The medication was working. Her behavior issues decreased and there was less of it seen. I should have documented this, but I did not. I should have written behavior notes in between the visits of the Psychiatrist not just after his visit. Nurses are responsible to monitor residents for any side effects of medications. The nurses are supposed to monitor if the non-pharmacological interventions are working. If they are not working, we discuss and report it to the doctor. The Certified Nursing Assistants (CAN) do not document any issues with resident behavior in their Personal Digital Assistance(PDS) records. On 1/9/19 at 11:23 AM, the 4th floor RN #3 Unit Manager was interviewed and stated, I am the person that writes and updates the care plans as needed. After the Interdisciplinary Team (IDT) meeting, I tried to redirect her. I tried to get her involved in the recreation programs. She did not want to go off the unit to the programs. So on the unit she liked movies and musical singing activities. We tried to get her involved in yoga. She like to go to rehab. I did NOT update the care plan to reflect these non-pharmacological interventions that I just told you were done. I do not have any written notes or documentation to show you that these things were done. As far as her complaining about other people being in the room and she pays the rent for the room and nobody should be there but her. As far as I know I did not offer her a private room. I don't remember anybody offering her a private room. On 1/7/19 at 1:04 PM, the Licensed Practical Nurse (LPN) #3 was interviewed and stated, The resident is taking Risperdal 0.5 mg at bedtime. She takes this medication because she is angry and really mad. I saw her taking things such as pillows from her roommate. I saw her make the roommate cry. I saw her wheeling herself up and down the floor and complaining that nobody takes care of me. She will see other residents being given care by the staff and then will say nobody takes care of me. I see she sometimes gets mad and wants all the attention to her. She never hit me. She has never hit any other resident. She has yelled at me and said she will tell her daughter. She yells at other residents and says her roommate took her things. I will offer her something to drink or to eat when she acts up. I offer to get her another pillow. On 1/7/19 at 1:33 PM, the 4th Floor CNA #2 was interviewed and stated, The resident is calm and nice when I come in to give her care in the morning. I say good morning and I take her to the bathroom. to wash her up. I will then get her dressed. I tell her I want to take her to the dining room for breakfast and she curses at me. She says I have to get another job. The resident has never hit me. She has raised her hands and shook her fingers at me. I have never seen her hit another resident. She does not like the other person in the room. She says she paid for the room and does not want another person in the room with her. In the day room she will yell and scream at other residents if they pass behind her and hit her chair by mistake. Some of the residents in the day room make noise and she will scream at them. Sometimes she wants to talk to other residents and they tell her leave me alone and she will yell at them. When she yells and screams I will leave her alone until she calms down. When I leave her alone and go back to her she is calm. I will ask her if she wants to go to the bathroom, if she wants to lie down or if she wants something to drink. I never saw her hit any other residents. When I see the issues with behavior I sometimes report it to the nurse. I don't report every time she has a behavior problem or outburst, because she has this behavior every day and it is her way. She gets upset about every little thing. I only report the behavior to the nurse if it gets out of control. If I can't get her to calm down or if I go away and then go back to her and she is still acting up I will report this to the nurse. I don't write anything concerning the resident's behavior in my accountability notes On 1/8/19 at 10:07 AM, the Psychiatrist was interviewed and stated, I prescribed Risperdal to this resident because she is agitated, paranoid and aggressive. She would not allow nursing care or people to interact with her. I have been working in the facility one year. My diagnosis of her is dementia and psychosis NOS. Before I started her on the Risperdal I recommended behavior management work with a specific staff member, to place her in a single room and redirection. The Food and Drug Administration approves Risperdal to treat Psychosis. This is the primary indication. It is also approved for schizophrenia. It can be used to treat psychosis with depression and schizo affective disorders. It can be used to treat hallucinations. The resident was paranoid which is a form of psychosis. She says I was trying to hurt her and attacking her. I know what the Black Box Warning is. It says that patients on psyche drugs with dementia tend to have increased mortality when compared to patients not on Antipsychotic medications. My understanding is the Psychosis is not solely attributed to her Dementia. The dosage forms of Risperdal are 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg. I started her on Risperdal 0.5 mg which allows once a day dosing. Most residents tolerate 0.5 mg. I have not seen a tremendous response on 0.25 mg. I have not read the Federal regulations concerning the use of antipsychotic medications in nursing homes. The plan was to do a Gradual Dose Reduction(GDR) and do a rapid GDR once her behavior came under control. The patient is aggressive to other patients. No one ever told me she hit anyone, either staff or any other resident. Your point is taken that a lower dose should have been prescribed or that probably more intensive behavior management should have been done before I recommended the start of the Risperdal. Based on this conversation I intend to do a rapid GDR to taper it down and then stop the medication. On 1/8/19 at 11:31 AM, the Attending Physician was interviewed and stated, I write the monthly orders for this resident. The resident is taking Risperdal 0.5 mg at bedtime. The resident has been with us a few years. The resident had behavioral changes and she was noted with a change in her quality of life. The behaviors were she was more agitated, issues with redirection, at times responding to stimuli. There was a question if she was paranoid. The initial plan was to redirect her with behavior management. When those measures failed we involved the Psychiatrist. We felt she would benefit from medication. The resident does not have Schizophrenia and does not have a diagnosis of Bipolar Disorder. The FDA says you can use Risperdal for Schizo -affective and Bipolar Disorders. The Psychiatrist recommended Risperdal as he felt the resident might benefit form a small dose of these antipsychotics. I have heard of the Black Box Warning. It says there are increased incidents of adverse events such as death, cardiac disorders, infections and pneumonia. The Psychiatrist wrote a diagnosis of Vascular Dementia and Psychosis. I am aware of the Black Box Warning that Risperdal should not be used in patients with Dementia related Psychosis. The resident should be started on the lowest dose. She was prescribed Risperdal 0.5 mg at bedtime which is not the lowest dose. The lowest dose Risperdal 0.25 mg. The resident is not violent. She has not hit staff or any other residents. I would give this a second review. On 1/9/19 at 9:16 AM, the Psychiatrist was interviewed and stated, I felt the conversation we had was helpful as I come from the hospital setting. We frequently use psychiatric medication for off label uses. I started working here in December 2017. This is the first nursing home where I am working as a Consultant Psychiatrist. The attending doctor wrote the clinical indication for prescribing the Risperdal which is restlessness and agitation. This is NOT a reason to prescribe Risperdal. On my Psyche consults I have been writing the diagnosis for the resident as having Vascular Dementia and Psychosis and then I recommended the Risperdal. On 9/13/18 I was called to the see the resident for a follow visit. Before I see the resident, I talk to the nursing staff. I was told that the resident had become increasingly agitated, belligerent, restless and not responsive to redirection. She has not had any aggressive interaction with another resident, but staff was concerned that it might happen. I did not look up the Federal regulations as pertains to Antipsychotic medications, but my understanding is that you try to minimize the dose, use the lowest dose for the shortest duration and the prescribing should be a last resort after all other options failed. For agitated residents, limit setting, redirection, modify the environment, placing the resident in a single room, having her work with the same staff consistently and trying to anticipate her needs. As far as I know these were tried. The resident was never placed in a single room. I did not start the resident on the lowest possible dose. I felt Risperdal 0.5 mg although not the lowest dose in an effective dose. If she would not do well on this dose we would reduce it. The FDA approves this medication for Schizophrenia, Schizo affective disorder and autism. This resident does NOT have any of these 3 diagnoses. The Black Box Warning says there is an increased mortality associated in elderly patients that are being prescribed antipsychotic medications. It also says that Risperdal should NOT be prescribed in patients with Dementia, related Psychosis. After our conversation I would be very reluctant to prescribe these medications again to elderly residents with Dementia. I know what a GDR is. I do NOT know what the Federal regulations are for performing GDR's in nursing homes. I should know what the Federal regulations are. I know that if residents are on Antipsychotic medications you try to taper the dose every 3- 4 months. I have recommended to the Attending Physician and the nursing staff that the Risperdal 0.5 mg at bedtime be reduced to Risperdal 0.25 mg at bedtime. We will monitor her for the reemergence of psychotic symptoms. We will reinforce to the nursing staff that we continue to implement behavior management. I have learned a lot from this experience. On 1/8/19 at 11:10 AM, the Director of Nursing was interviewed and stated, The resident is taking Risperdal 0.5 mg at bedtime. The Psychiatrist recommended the medication for this resident and the Attending Physician prescribed it. He wrote a diagnosis of Vascular Dementia with Psychosis which is why he recommended this medication. I know this resident displays disruptive behaviors. This is evidenced by verbal outbursts toward her roommate, secondary to her belief she owns the room. The resident has had verbal outbursts towards the staff. The resident has not hit any staff or any other residents. The resident has no history of physical aggression. The resident gets agitated easily when she perceives something does not go her way. An example is sharing her room, or she does not like her lunch or dinner. She seems to repeat that she pays the rent here and when she perceives something is not to her liking she gets upset. We should implement non-pharmacological interventions before a resident is given antipsychotic medications. We involved the family. The resident has a granddaughter that comes to visit her. We do reorientation and redirection. On 1/9/19 at 10:46 AM, the Director of Nursing was interviewed and stated, The non -pharmacological interventions that should be tried, include music therapy, pet therapy, if a person likes Bingo or the movies. I involved the family for input. We can provide 1:1 to calm the person down. We redirect and reorient the person. For this resident we reorient her. I know she participates on the unit in group activities. The resident has a semi -private 2 bedded room. To my knowledge the resident was never offered a private room. The IDT team had a meeting on 9/12/18. The Psychotropic Drug Use Care Plan was updated on 11/2/18, 11/29/18 and initiated on 10/1/18. The updates only document the Psychiatrist Consults. The care plan does list any non-pharmacological interventions that were tried prior to the start of the Risperdal. There is a Vascular Dementia Care Plan. I do NOT have any documentation to show you that the Vascular Dementia Care Plan or the Psychotropic Drug Use Care Plan was updated after the IDT meeting on 9/12/18 and before the Risperdal was prescribed. The Care Plan for the Vascular Dementia should have reflected what non-pharmacological interventions were in place and whether they were effective. If they were not, then what is the next step which in this case was a Psyche consult. The Nurse Unit Managers are supposed to update the care plans to reflect the non-pharmacological interventions. The Vascular Dementia Care Plan has an entry on 9/14/18 that mentions the resident starts Risperdal 0.5 mg at bedtime. The note should have included non-pharmacological interventions that were implemented. There is no documentation on the Care Plan that new non-pharmacological interventions were added and updated on this Care Plan. I don't see anything written here. The Nurse Unit Manager should have updated the Care Plan. We do in-service the CNA's and the Nursing Staff on how to interact with residents who have dementia. On 1/9/19 at 10:09 AM, the Pharmacy Consultant was interviewed and stated, The resident has not had any irregularities in the last 3 months. When I do a drug, regimen review I look at the doctor's orders, Medication Administration Record, relevant labs, progress notes and consults. I might speak to the nurse. I might speak to the Physician. I do not speak to anyone else. The resident was diagnosed as having Vascular Dementia and Psychosis. The Psychiatrist recommended Risperdal 0.5 mg at bedtime. It was not a textbook reason for prescribing Risperdal. The FDA clinical indications for Risperdal are Schizophrenia, Schizo-affective disorder, hallucination, auditory visual delusions, psychosis and depression. You know very well, off label prescribing is not illegal. Other interventions were prescribed and the resident was monitored closely for side effects. It was a small dose. Risperdal 0.5 mg is a small dose. The Black Box Warning on antipsychotic medications says in the elderly there is an increased risk of mortality when these drugs are used. It says Risperdal is NOT approved for patients with Dementia related, Psychosis. This seems to be an irregularity. I did NOT pick this up because I deferred to the Psychiatrist who felt it was appropriate for the resident. I picked this up in January 2019. I did not pick it up sooner. The lowest dose available is Risperdal 0.25 mg. The monthly doctor orders' says the Risperdal is being prescribed for restlessness and agitation. Restlessness and agitation are NOT appropriate reasons to prescribe Risperdal. I usually do not look at the resident when I do a drug regimen review. I did NOT look at this resident. I did a review on this resident on January 2, 2019. I wrote, [AGE] year old with diagnosis of Dementia on Risperdal 0.5 mg at bedtime. Please evaluate for gradual dose reduction. Black Box Warning. I should have picked this up s[TRUNCATED]

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on resident interview and observation, the facility did not ensure that menus are followed in accordance with established national guidelines. Specifically, a resident who is on renal diet with a diet order that specified no potatoes was served potatoes. (Resident #145) This was evident for 1 of 1 resident reviewed for the care area Food out of a sample of 38 residents. The findings are: Resident # 145 was admitted on [DATE] with diagnoses of Renal Osteodystrophy, Chronic Kidney Disease, and Hyperkalemia (elevated potassium levels). The Annual Minimum Data Set 3.0 (MDS) assessment dated [DATE] documented the resident's cognitive status is moderately impaired and the resident requires extensive assistance of two persons with Activities of Daily Living (ADLs). The Physician Order dated 12/24/18 documented that the resident is ordered a low salt and low potassium diet. The dietary order dated 12/24/18 further documented no banana, orange, orange juice, cantaloupe, no tomato, tomato sauce, spinach, broccoli, kale, collard green. No potato, beans, no fish and no crab salad. The resident's meal tickets documented no banana, orange, orange juice, cantaloupe, no tomato, tomato sauce, spinach, broccoli, kale, collard green. No potato, beans, no fish and no crab salad. During a resident interview conducted on 01/07/19 at 09:46 AM, the resident stated that on a daily basis staff serve food that the resident is not supposed to eat due to kidney problems. The resident stated that these foods include beans, potatoes, cantaloupe, spinach and any leafy vegetables. The resident further stated that the meal ticket clearly documents all the food the resident is not supposed to eat. On 01/08/19 at 12:33 PM, Certified Nursing Assistant (CNA) #1 was observed serving the resident potatoes. On 01/08/19 at 03:16 PM, Licensed Practical Nurse (LPN) # 2 stated that the Dietary Aide serves the food. The CNA's check the meal tickets and then they ask the Dietary Aide for a plate. LPN# 2 stated that the residents' diets are documented on the meal tickets. LPN # 2 also stated that the CNA's would take the tray to the resident. LPN # 2 further stated that the CNA's are supposed to check the meal ticket prior to serving the resident to ensure that the meal on the resident's tray is correct. On 01/09/19 at 09:48 AM, the Dietary Aide stated that right before lunch she would set up the steam table. The Dietary Aide also stated that she waits for the CNA's and Nurses to assist her. The Dietary Aide stated that she would provide the CNA's and nurses with the meal tickets. The Dietary Aide also stated that the CNA's assigned to serve the residents would give her the resident names and would tell her what kind of diet the residents are on and she would provide the food requested by the CNA's. The Dietary Aide further stated that she would serve the food and hand the plates to the CNA. On 01/09/19 at 10:12 AM, CNA # 1 stated that she checks the meal tickets and informs the dietary aide who she needs food for and what diet the resident is on. CNA # 1 stated if the resident is on a special diet, she would let dietary aide know that as well. CNA #1 stated that she would then place food in the tray and take the tray to the residents. CNA # 1 stated that during lunch meal on 1/8/19, she checked the resident tray and did not realize that the resident received potatoes for lunch. On 01/09/19 at 03:24 PM, RN Manager # 1 stated that during meals, her role is to ensure the residents are getting the proper diet as ordered. RN Manager # 1 stated that she checks the meal tickets before meals on a regular basis to ensure the residents receive the correct diet. RN Manager #1 stated that the CNA's are supposed to read out the tickets to the dietary aide. The dietary aide would provide the CNA's with the meals that match the meal tickets. RN Manager # 1 further stated that the food trays are checked to ensure that resident are getting the correct diet per the menu. The RN Manager also stated that the resident is on low salt and low potassium diet. The resident is not supposed to have potatoes, oranges, bananas, cantaloupe, tomatoes, spinach, broccoli, kale, collard green and beans. RN Manager # 1 further stated that she was not in the dining room when the resident received potatoes. On 01/10/19 at 10:46 AM, Dietitian # 1 stated that the resident is on a low sodium and low potassium diet. The resident is not supposed to eat anything with potassium which include fruits, vegetables, potatoes and beans. Dietitian # 1 stated the resident is on fluid restrictions. Dietitian # 1 stated that on a daily basis, she observes meals in the dining rooms to ensure the residents are getting the proper diet. Dietitian # 1 stated that on 1/8/19 around 12:30 PM, she was observing meals on a different floor. Dietitian # 1 also stated that she constantly provides in-service to the CNA's as well as nurses to ensure residents are served their prescribed diet. Dietitian # 1 further stated that she will in-service the CNA's and the nurses again. 415.14 (c) (1-3)

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** The findings are: During review of the facility's Infection Prevention and Control Program (IPCP) the policies titled Antibiotic Stewardship and Infection Control Program were observed with an initiation date of 10/2017. The date revised fields for both of these policies was blank. There was no documented evidence that the policies were reviewed and/or updated annually. An interview was conducted on 01/10/19 at 12:27 PM, with the Assistant Director of Nursing (ADON) who stated that she was unaware that the IPCP policies regarding the Infection Control Program and Antibiotic Stewardship were not updated within the last year. The ADON further stated that she unaware that an annual update of the IPCP policies was required. 415.19 (a) (1-4) Based on observations, and staff interviews during the recertification survey, the facility did not ensure that infection control practices and procedures were maintained. Specifically, (1) an oxygen tubing was observed touching the floor. This was evident for 1 of 38 residents reviewed in the investigation sample. (Resident # 35). (2) The facility policy and procedure for Antibiotic Stewardship and Infection Control Program were not reviewed within the last calendar year. The findings are. Resident #35 was admitted on [DATE] with diagnoses which include Acute Respiratory Distress, Hypertension, Parkinson's Disease and Dementia. The Minimum Data Set 3.0 (MDS) assessment dated [DATE] documented the resident's cognitive level is moderately impaired and the resident requires total assistance of two persons with all Activities of Daily Living (ADLs). On 01/04/19 at 09:39 AM and at 11:33 AM, on 01/08/19 at 09:59 AM and 12:50 PM, and on 01/09/19 at 10:33 AM, the resident's oxygen tubing was observed touching the floor. On 01/09/19 at 10:01 AM, CNA # 1 stated that if a resident is on oxygen, she would check the resident oxygen level. She would ensure that the resident is breathing without difficulties and she ensure oxygen is flowing. CNA # 1 stated that the oxygen tubing should not be touching the floor. CNA # 1 further stated that the oxygen tubing should be placed in way that it does not touch the floor. CNA # 1 also stated that she received infection control training two months ago. On 01/09/19 at 10:52 AM, LPN # 1 stated that when a resident is on oxygen, he ensures that the head of the bed is elevated. He checks the flow rate of oxygen and ensure the resident is breathing. LPN #1 stated that he ensure oxygen tubing is dated and is clean. LPN # 1 further stated that the oxygen tubing should be placed very close to the resident and the tubing should never be touching the floor. On 01/09/19 at 10:56 AM, RN Manager # 1 stated that when a resident is on oxygen, she ensures the head of bed is elevated and the nasal cannula is properly placed. RN Manager also stated that she ensures oxygen tubing is not touching the floor. RN Manager # 1 stated that she make rounds several times throughout her shift. RN Manager # 1 stated that moving forward, she would ensure the oxygen tubing is placed in a way so that if the resident moves, the tubing does not touch the floor. RN Manager # 1 also stated that she will in-service the CNAs again to ensure that they check on residents who are on oxygen often throughout the shift and also ensure oxygen tubing is not touching the floor.