CONCERN
(D)
Potential for Harm - no one hurt, but risky conditions existed
Deficiency F0604
(Tag F0604)
Could have caused harm · This affected 1 resident
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on observation, interview and record review, the facility failed to ensure that one of two sampled residents (Resident 7) ...
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**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on observation, interview and record review, the facility failed to ensure that one of two sampled residents (Resident 7) was evaluated and informed of the risks and benefits prior to implementing a bed alarm restraint (an alarm that sounds when a resident changes position in bed).
This had the potential to frighten Resident 7 when she moved in bed and result in discomfort and pressure injuries.
Findings:
A review of Resident 7's admission record indicated she was admitted on [DATE] with diagnoses that included, dementia with behavior problems, bipolar depression with manic episodes (episodes of extreme mood changes with states of depression lows and high energy and excitement), restlessness and agitation, and psychosis (episodes of hallucinations, delusions or paranoia). Resident 7 had severe cognitive and memory losses. She was not able to understand or make healthcare decisions, therefore her Responsible Party (RP) made decisions for her.
On 5/3/22 at 12:36 pm, during an observation and interview, Licensed Nurse (LN) C confirmed that there was a bed alarm on Resident 7's bed. LN C stated that the bed alarm was used to help prevent falls and alert staff when Resident 7 tried to get out of bed at night. LN C confirmed that Resident 7 had no ability to ask for help with repositioning or with getting out of bed. LN C confirmed that Resident 7 had no cognitive ability to understand why the alarm sounded when she moved in bed and would not be capable of removing or turning off the alarm.
The facility's policy titled, Use of Restraints revised December 2008, was reviewed. The policy directed the following:
1. Restraints shall only be used after other alternatives have been tried unsuccessfully.
2. The definition of a restraint is based on the functional status of the resident. If a resident cannot remove a device in the same manner in which the staff applied it and this restricts his/her typical ability to change position or place, that device is considered a restraint.
5. Restraints may only be used if/when the resident has a specific medical symptom that cannot be addressed by another less restrictive intervention.
6. Prior to placing a resident in restraints, there shall be a pre-restraining assessment and review to determine the need for restraints. The assessment shall be used to determine possible underlying causes of the problematic medical symptom and to determine if there are less restrictive interventions that may improve the symptoms.
9. Restraints shall only be used upon the written order of a physician and after obtaining consent from the resident and/or representative. The order shall include the specific reason for the restraint and how the resident will benefit from the restraint.
16. Restrained individuals shall be reviewed regularly (at least quarterly) to determine whether they are candidates for restraint reduction, less restrictive methods of restraints, or total restraint elimination.
19. Documentation regarding the use of restraints shall include: full documentation of the episode leading to use of the physical restraint, a description of the resident's medical symptoms that warranted the use of restraints and how the restraint will benefit the resident.
On 5/12/22 at 8:47 am, an interview and record review was conducted with Medical Records staff (MR) B. A Physician's Order was written on 8/4/19, that indicated, Bed Alarm q HS [every bedtime]. There was no medical symptom or reason included in the order or how the bed alarm was to benefit Resident 7. There was no evidence that Resident 7 received a pre-restraining assessment. There was no evaluation of how Resident 7 responded to the restraint at least quarterly, or any other time frame. There was no documentation that underlying conditions had been evaluated, or that alternate interventions had been tried and failed. There was no evidence that Resident 7's RP had been informed of the risks and/or benefits of the bed alarm, or that he had given consent to use the restraint. MR B confirmed the above.
On 5/12/22 at 9:29 am, the Director of Nursing (DON) was interviewed. The DON confirmed that the facility had not followed their Restraint Use policy when they applied a bed alarm to Resident 7's bed. The DON stated, we did not recognize that bed alarms could be restraints, until this survey.
CONCERN
(D)
Potential for Harm - no one hurt, but risky conditions existed
Deficiency F0741
(Tag F0741)
Could have caused harm · This affected 1 resident
Based on interview and record review, the facility failed to ensure that nursing staff received ongoing training and evaluations of their skills to ensure that vulnerable residents with behavioral hea...
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Based on interview and record review, the facility failed to ensure that nursing staff received ongoing training and evaluations of their skills to ensure that vulnerable residents with behavioral health problems were receiving appropriate care for both pharmacological (medication) and non-pharmacological (no medication) interventions, when 15 of 16 sampled residents were found to have received unnecessary psychotropic drugs (drugs that alter mood and behavior). Refer to F758
This resulted in the widespread use of unnecessary psychotropic drugs, substandard quality of care and had the potential to prevent residents from attaining or maintaining their highest practicable level of psychosocial and emotional well-being.
Findings:
During an interview with Licensed Vocational Nurse (LN) C on 5/3/22 at 12:30pm, she confirmed that she had not received education or training regarding the required components (such as safe doses, behavior and side effect monitoring and care planning) to safely administer psychotropic drugs to residents. LN C stated that she has never had her clinical skills or competencies evaluated by the Director of Nursing (DON) or the Director of Staff Development (DSD).
On 5/5/22 at 10:30am, LN D stated during an interview that she has had some experience with psychotropic drug use, however, has not received any formal education, training or competency evaluations by the DON or DSD in the three years she has worked at the facility.
On 5/5/22 at 10:38am, the DON was interviewed. The DON confirmed that he had not conducted ongoing education and training for the nursing staff regarding the use of psychotropic drugs or enlisted the help of the DSD and Consultant Pharmacist in providing nursing education. The DON indicated that he did not conduct regular staff meetings with the nurses. The DON confirmed that he had not ensured that the nursing staff had policies and procedures available to use as a reference and/or guidance when psychotropic drugs were ordered. The DON confirmed that he had not evaluated the clinical skills competencies of the licensed nurses, since I was hired on 3/8/21. The DON was not aware of any facility policies regarding routine evaluations of a nurse's ability to provide quality care to the residents.
On 5/5/22 at 11:20am, the DSD was interviewed. The DSD confirmed that none of the nursing staff, including herself, have received training and education on the use of psychotropic drugs. The DSD confirmed that there was no competency of skills evaluations being done, or regular nurses' meetings to discuss areas that need improvement.
CONCERN
(E)
Potential for Harm - no one hurt, but risky conditions existed
Deficiency F0552
(Tag F0552)
Could have caused harm · This affected multiple residents
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on interview and record review, the facility failed to ensure that 6 of 15 sampled residents (Residents 4, 7, 11, 12, 16, ...
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**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on interview and record review, the facility failed to ensure that 6 of 15 sampled residents (Residents 4, 7, 11, 12, 16, and 22) were provided with sufficient information, in advance, by their physicians which informed them of the risks, benefits, options and alternatives to treating their behaviors with psychotherapeutic drugs (drugs that affect mood, behavior, thoughts, and perception). The facility used a Psychotropic Medication Informed Consent (ICO) which contained all of the necessary information about the psychotherapeutic medication's reason for use, risks, benefits, adverse side effects, and non-pharmacological (non-medicine) interventions that had been tried unsuccessfully prior to offering medication. The form required a signature from either the resident or their responsible party acknowledging that they were informed and understood, however, the ICOs were late, incomplete or non-existent.
This had the potential for those residents who received psychotherapeutic drugs, not to have received the information necessary to make an informed decision and residents were given psychotherapeutic medications prior giving consent.
Findings:
The facility's Informed Consent policy, reviewed 6/2007, indicated, Before initiating the administration of psychotherapeutic drugs, or physical restraints, or the prolonged use of a device that may lead to the inability to regain use of a normal bodily function, facility staff shall verify that the patient's health record contains documentation that the patient has given informed consent for the proposed treatment or procedure.
1. Resident 4 was admitted on [DATE] with diagnoses that included, major depressive disorder (severe depression) and emotional lability (uncontrollable laughing, crying or irritability).
On 5/4/22 at 12:22pm, a review of Resident 4's Physician's Orders for May 2022 and a concurrent interview was conducted with Medical Records staff (MR) B.
Zoloft (an antidepressant medication) 100 milligrams (mg) was ordered to be given once a day (QD) on 12/10/19, the Psychotropic Medication Informed Consent (ICO) was not provided to the resident's responsible party (RP) until 4/25/19, four months after she had been taking the medication.
Risperdal (an antipsychotic medication) 0.5 mg twice a day (BID) was ordered on 12/10/19, and the ICO was not provided to her RP until 2/4/19, two months after she had been taking the medication. MR B confirmed the above and stated that, psychotropic medications cannot be given until there is evidence that the resident or RP, have received the information on the ICO from their physicians.
2. Resident 7 was admitted on [DATE] with diagnoses that included, dementia with behavior problems, bipolar depression with manic episodes (episodes of extreme mood changes with states of depression lows and high energy and excitement), restlessness and agitation, and psychosis (episodes of hallucinations, delusions or paranoia).
On 5/4/22 at 3:44 pm, an interview and concurrent record review was conducted with MR B. A review of Resident 7's Physician's Orders for May 2022 showed that Venlafaxine (an antidepressant medication) 37.5 mg QD was ordered on 4/8/18. The ICO was not provided to her RP until 4/21/22, and the information about what behavior they were treating and what non-pharmacological interventions had been tried and failed, was left blank.
Lithium (a chemical salt compound that is used for bipolar depression) 150 mg at bedtime (HS) was ordered on 8/5/18. The ICO was not provided to Resident 7's RP until 4/22/22, and the behavior symptom and non-pharmacologic interventions sections were left blank.
Risperdal (an antipsychotic medication) 1 mg BID was ordered on 4/9/18, and the ICO was not provided to her RP until 4/21/22, and the behavior symptom and non-pharmacological interventions were left blank.
Ativan (an anti-anxiety medication) 1 mg QD as needed (PRN) was ordered on 12/19/19. The ICO was not provided to her RP until 6/14/19. MR B confirmed the above.
3. Resident 16 was admitted on [DATE] with diagnoses that included, restlessness and agitation, insomnia, dementia and Wernicke's encephalopathy (confusion, incoordination and eye abnormalities caused from a lack of B vitamins usually seen in alcohol abuse and is possibly reversible).
On 5/4/22 at 2:34 pm, an interview and concurrent record review was conducted with MR B.
Resident 16's Physician's Orders for May 2022, were reviewed. Ativan (an anti-anxiety medication) 2 mg intramuscular (IM-a shot) PRN was ordered on 1/19/22. There was no ICO for this medication.
Ativan 1 mg every 8 hours PRN was ordered on 7/22/21. The ICO was not provided to his RP until 3/10/22, and the behavior symptom and non-pharmacological sections were left blank. MR B confirmed the above.
4. Resident 22 was admitted on [DATE] with diagnoses that included, insomnia, dementia with behaviors, psychotic disorder with delusions, and encephalopathy (a brain damage or malfunction with a broad spectrum of symptoms).
On 5/4/22 at 2:43pm, an interview and concurrent record review was conducted with MR B. A review of Resident 22's Physician's Orders for May 2022 showed that Seroquel (an antipsychotic medication) 100 mg every morning and Seroquel 150 mg at bedtime was ordered on 2/28/22. The ICO section to describe the target behavior was delirium with psychotic features which is not a specific target behavior. The non-pharmacological intervention section was blank.
Olanzapine (an antipsychotic medication) 5 mg QD was ordered on 2/28/22. The ICO section for the behavior symptom was for confusion which is not a specific target behavior. The non-pharmacological intervention section was blank.
Geodon (an antipsychotic medication) 20mg QD was ordered on 3/10/22. The behavior symptom was psychotic features which is not a specific target behavior. The non-pharmacological intervention section was blank.
MR B confirmed the above findings.
On 5/3/22 at 2:12pm, during an interview with the Director of Staff Development (DSD), she indicated that she was aware that some residents had missing and/or old ICOs. She stated, I have been in the process of cleaning that up. The DSD added that the facility does not have a dedicated Psychotropic Drug Committee to oversee the use of psychotherapeutic drugs in the facility.
5. A review of Resident 11's record indicated he was admitted on [DATE], with diagnoses that included mood disorder, major depressive disorder and dementia with behavioral disturbance. A review of the current physician's orders included Lithium Carbonate 300 mg every day at bedtime, which had been started on 6/11/21.
During a concurrent interview and record review on 5/11/22 at 11:54 am, MR A confirmed the ICO for lithium was mailed to Resident 11's RP for signature and they were waiting to get it back. According to the consent form the RP had been called on 4/8/22 and a message left.
6. A review of Resident 12's record indicated he was admitted on [DATE] with diagnoses that included paranoid schizophrenia, anxiety disorder, and panic disorder. The current physician's orders included Seroquel 50 mg every day, Perphenazine (an antipsychotic medication) 8 mg every morning and 16 mg every evening, and Risperdal 8 mg every evening.
During an interview and review of the consents for antipsychotic medications on 5/11/22 at 11:22 am, MR A confirmed no dose, no behaviors, and no non-pharmacological interventions were listed on the consent for Seroquel. There were no behaviors or non-pharmacological interventions listed on the consent for Risperdal. There were no non-pharmacological interventions listed on the consent for Perphenazine.
CONCERN
(E)
Potential for Harm - no one hurt, but risky conditions existed
Deficiency F0838
(Tag F0838)
Could have caused harm · This affected multiple residents
Based on interview, record review and policy review, the facility failed to ensure that they thoroughly assessed the needs of their resident population as a foundation to ensure that they had the nece...
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Based on interview, record review and policy review, the facility failed to ensure that they thoroughly assessed the needs of their resident population as a foundation to ensure that they had the necessary resources to provide quality care to their residents, when they had not conducted a facility-wide risk assessment.
This failure contributed to substandard quality of care findings, an extended survey, unnecessary use of psychotropic drugs (drugs that alter mood and behavior), implementation of standardized immunization practices, competent nurses and the unrealized resident care areas that needed improvement. Refer to F758 and F883
Findings:
The facility's policy titled, Safety and Supervision of Residents revised December 2008, indicated, Our facility strives to make the environment as free from accident hazards as possible. Resident safety and supervision and assistance to prevent accidents are facility-wide priorities. 1. Our facility-oriented approach to safety addresses risks for groups of residents. 2. Safety risks and environmental hazards are identified on an ongoing basis through a combination of employee training, employee monitoring, and reporting processes; QA&A reviews of safety and incident/accident reports; and a facility-wide commitment to safety at all levels of the organization.
On 5/5/22 at 12:30pm, an interview was conducted with the facility's Administrator (Admin) regarding their development of a facility-wide assessment. The Admin confirmed that a facility assessment had not been done and she was not familiar with that requirement.
CONCERN
(E)
Potential for Harm - no one hurt, but risky conditions existed
QAPI Program
(Tag F0867)
Could have caused harm · This affected multiple residents
Based on interview and record review, the facility's Quality Assessment and Assurance (QAA) committee failed to identify, develop, and implement a plan of action to correct deficiencies related to unn...
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Based on interview and record review, the facility's Quality Assessment and Assurance (QAA) committee failed to identify, develop, and implement a plan of action to correct deficiencies related to unnecessary psychotropic medications (any drug that affects brain activities associated with mental processes and behavior) and infection control (Refer to F 756, 758, 880, 881, and 883). As a result, widespread deficiencies were present regarding unnecessary psychotropic medications and infection control that had the potential to harm all residents who resided in the facility.
Findings:
A review of the facility's last survey included deficiencies relating to unnecessary psychotropic medications, inadequate drug regimen reviews by the pharmacist and the necessary follow up, infection control, antibiotic stewardship, and immunizations. The plan of correction the facility submitted had not been implemented and the same deficiencies were found during the present survey.
During a concurrent interview and document review on 5/11/22 at 2 pm, the above was discussed with the Quality Assurance Coordinator (MR A). She said she sends reminders to department heads, and they turn in reports monthly that go over past deficiencies.
MR A said around 12/2021, she recognized problems with pharmacy related Medication Regimen Review (MRR) issues due to no follow up on the pharmacist's recommendations but had not yet brought it to the QAA committee's attention and no plan had been made to correct the issues. She and Medical Records staff (MR B) came up with a plan to discuss with the interdisciplinary team (IDT) but it was not taken to the QAA committee. She said she had a calendar from the pharmacist with due dates for Gradual Dose Reductions for residents' psychotropic medications, that he started sending in 11/2021, but no other information from him. The pharmacist does not attend QAA meetings. The QAA committee had no specific drug/pharmacy related quality indicators to monitor.
MR A said there was no Infection Preventionist (IP) for about three months (10/15/21 - 1/15/22). She said the prior IP was not on top of things, but after she left, there was a lag before the new IP started and completed his training. MR A said she was unaware of any infection control issues.
CONCERN
(E)
Potential for Harm - no one hurt, but risky conditions existed
Deficiency F0868
(Tag F0868)
Could have caused harm · This affected multiple residents
Based on interview and record review, the facility did not have the required membership at its Quality Assessment and Assurance (QAA) meetings when the Medical Director did not attend any of the meeti...
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Based on interview and record review, the facility did not have the required membership at its Quality Assessment and Assurance (QAA) meetings when the Medical Director did not attend any of the meetings, and the Administrator (Admin B) and the Director of Nurses (DON) missed one quarter of the meetings. This had the potential for unidentified resident care issues to occur, as well as a lack of medical oversight, which could lead to negative clinical outcomes.
Findings:
During a concurrent interview and document review on 5/11/22 at 2 pm, the Quality Assurance Coordinator (MR A) reviewed minutes of the nine meetings which occurred from 5/2021 through 4/2022. She said they had no QAA meetings for the months of 7/2021, 12/2021 and 1/2022. MR A confirmed the Medical Director (or designee) did not attend any of the nine meetings. Admin B did not attend any meetings during the last quarter from 2/2022 through 4/2022. DON did not attend any meetings from 9/2021 through 11/2021.
On 5/5/22 at 10:30 am, DON provided copies of the schedule for the above quarter, which indicated he spent 24 hours of each week in providing direct care in the hospital, due to short staffing of registered nurses. This led to less time available for quality and other administrative duties in the skilled nursing unit.
CONCERN
(E)
Potential for Harm - no one hurt, but risky conditions existed
Antibiotic Stewardship
(Tag F0881)
Could have caused harm · This affected multiple residents
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on interview and record review, the facility failed to establish an antibiotic stewardship program that followed nationall...
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**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on interview and record review, the facility failed to establish an antibiotic stewardship program that followed nationally recognized standards and included antibiotic use protocols and a system to monitor antibiotic use for two of three sampled residents reviewed for antibiotic use (Residents 10 and 14). These residents were prescribed antibiotics for a urinary tract infection (UTI) without signs or symptoms of infection or a physician's note indicating the need for antibiotics in the absence of symptoms.
This resulted or had the potential to result in Residents 10 and 14 receiving antibiotics which were unnecessary with a potential for adverse side effects.
Findings:
1. The facility's Antimicrobial Stewardship Program, approved 2/2018, was reviewed. 3. Support of the Antimicrobial Stewardship Program is provided by a physician or pharmacist with antimicrobial stewardship training from a recognized professional organization or post graduate education: A. The facility's consultant pharmacist (Pharm E) was the pharmacist providing support for the Antimicrobial Stewardship Program at the facility.
During an interview on 5/5/22 at 8:30 am, Pharm E said he was not involved in antibiotic stewardship at the facility.
During an interview on 5/11/22 at 4:27 pm, the Infection Preventionist (IP) confirmed that their policy required the participation of the pharmacist in the antibiotic stewardship, but the pharmacist did not participate in the program.
2. During an interview on 5/11/22 at 4:27 pm, the Infection Preventionist (IP) said they used the Revised McGeer's criteria (national standard for infection surveillance in long term care facilities). The Revised McGeer's Criteria for UTI lists specific symptoms (usually at least two) the resident must have in combination with microbiology criteria from a urine culture (test that shows if bacteria are present, what kind, and how many).
A review of Resident 14's record indicated she was admitted on [DATE] with diagnoses that included anxiety, tremors, urinary incontinence (inability to control bladder) and mood disorder. There was a physician's order for Bactrim DS (antibiotic used to treat UTI) one tablet two times per day, for ten days, from 1/29/22 to 2/8/22.
During a concurrent interview and record review on 5/4/22 at 10:40 am, MR A confirmed a urine test (urinalysis, UA) and blood test had been ordered on 1/27/22. The UA was done on 1/28/22 with a culture to follow. Antibiotics were then ordered and started on 1/29/22. The culture was completed and reported on 2/1/22, two days after the antibiotics had been started. The culture was positive for bacteria. The blood test that was also done was negative for any signs of infection. MR A confirmed there were no signs and symptoms of a UTI documented either before or after the UA was done and it looked like antibiotics were given based on the lab culture only.
During a concurrent interview and record review on 5/11/22 at 4:27 pm, the IP said there were no symptoms for this resident so there was no need to get the UA. He said even with the positive culture, because she was asymptomatic (had no symptoms) the McGeer's UTI criteria was not met so she shouldn't have had the antibiotics. He said this happened shortly after he started as IP, so he had not started to monitor this yet.
3. A review of Resident 10's record indicated she was re-admitted on [DATE] with diagnoses that included major depressive disorder, dementia without behavior disturbance, UTI, and lung disease.
During a concurrent interview and record review on 5/4/22 at 10:40 am, MR A confirmed there was a physician's progress note dated 4/21/22 which indicated the resident would have a repeat UA and blood test to assess success of treatment. No symptoms of UTI were included in this note and other notes made on 4/21/22. A UA was done with results ready on 4/22/22, with a culture to follow. Resident started on Septra (an antibiotic) DS (double strength) one tablet twice per day for ten days on 4/23/22 . The urine culture result was not reported until 4/29/22 (six days after Resident 10 had been started on antibiotics) at which time it was positive for bacteria. The blood test that was also done on 4/21/22, was negative for any signs of infection. One nursing note dated 4/23/22 indicated this resident had symptoms of UTI but did not say what symptoms, or the number of symptoms. The resident was noted to not have a fever (a fever is a symptom of UTI). MR A confirmed she did not know what symptoms of a UTI meant and there were no other notes before or after that which mentioned any symptoms.
During a concurrent interview and record review on 5/11/22 at 4:35 pm, the IP said the signs and symptoms need to be charted in order to know if the UTI criteria is met or not met, according to McGeer's criteria. According to the note, there were no symptoms before the UA was done on 4/21/22, so there was no reason to do the UA. Based on the record even with the positive culture it was unknown if UTI criteria was met because there was no indication of what symptom or how many symptoms this resident had on 4/22/22.
CONCERN
(F)
Potential for Harm - no one hurt, but risky conditions existed
Comprehensive Care Plan
(Tag F0656)
Could have caused harm · This affected most or all residents
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on observation, interview and record review, the facility failed to ensure that 11 of 16 sampled residents (Residents 3, 4...
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**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on observation, interview and record review, the facility failed to ensure that 11 of 16 sampled residents (Residents 3, 4, 5, 7, 12, 11, 12, 14, 16, 21, and 22) had interdisciplinary (interventions from all departments) and comprehensive person-centered care plans that addressed their preferences (choices), goals (measurable expected outcomes) and interventions (care and services necessary to achieve those goals) when;
1.
Resident 4 was taking Zoloft (an antidepressant medication) and Risperdal (an antipsychotic medication) and a care plan was not developed which included the specific medications being used, the specific target behaviors for each medication, the expected goals to be achieved from using each medication, potential unwanted adverse side effects, or resident specific interventions that included approaches from all disciplines and described the care and services necessary, including non-pharmacological (non-medication) interventions, in order for Resident 4 to achieve her goals.
2.
2. Resident 7 was taking as needed (PRN) Ativan (an anti-anxiety medication), Lithium (a chemical compound use for depression), Remeron (an SSRI antidepressant, these types of antidepressants have the potential to cause Serotonin Syndrome a potentially serious clinical condition resulting from overstimulation of serotonin receptors. It is commonly related to the use of multiple serotonin-stimulating medications e.g., SSRIs, SNRIs, triptans, certain antibiotics. Symptoms may include restlessness, hallucinations, confusion, loss of coordination, fast heartbeat, rapid changes in blood pressure, increased body temperature, overactive reflexes, nausea, vomiting and diarrhea), Venlafaxine (an SSRI antidepressant medication) and Risperdal (an antipsychotic medication which can cause serious adverse and irreversible side effects in the elderly, especially with dementia). A care plan was not developed which included the specific medications being used, the specific target behaviors for each medication, the expected goals to be achieved from each medication, potential unwanted adverse side effects including Serotonin Syndrome, or resident specific interventions that included approaches from all disciplines and described the care and services necessary, including non-pharmacological interventions, in order for Resident 7 to achieve her goals.
3. Resident 16 had two PRN Ativan orders, one by injection and the other in a pill form. A care plan was not developed which included the specific medications being used, the specific target behaviors for each medication, the expected goals to be achieved from using each medication, potential unwanted adverse side effects, or resident specific interventions that included approaches from all disciplines and described the care and services necessary, including non-pharmacological (non-medication) interventions, in order for Resident 16 to achieve his goals.
4. Resident 21 was taking Zoloft (an SSRI antidepressant medication), Trazodone (a [NAME], like an SSRI, antidepressant) and Klonopin (a long acting anti-anxiety medication). A care plan was not developed which included the specific medications being used, the specific target behaviors for each medication, the expected goals to be achieved from using each medication, potential unwanted adverse side effects including Serotonin Syndrome, or resident specific interventions that included approaches from all disciplines and described the care and services necessary, including non-pharmacological (non-medication) interventions, in order for Resident 21 to achieve her goals.
5. Resident 22 was taking three antipsychotic medications; Seroquel, Olanzapine, and Geodon at the same time. A care plan was not developed which included the specific medications being used, the specific target behaviors for each medication, the expected goals to be achieved from using three medications from the same drug class, potential unwanted adverse side effects, or resident specific interventions that included approaches from all disciplines and described the care and services necessary, including non-pharmacological (non-medication) interventions, in order for Resident 22 to achieve his goals.
6. Resident 3 was taking Prozac (an SSRI antidepressant medication). A care plan was not developed which included the specific medication being used, the specific target behavior for the medication, the expected goals to be achieved from using the medication, potential unwanted adverse side effects including Serotonin Syndrome, or resident specific interventions that included approaches from all disciplines and described the care and services necessary, including non-pharmacological interventions, in order for Resident 3 to achieve her goals.
7. Resident 11 had no care plan for Lithium, a psychotropic medication (any drug that affects brain activities associated with mental processes and behavior), and Geodon for for aggressive behaviors.
8. Resident 12 received three antipsychotic medications, but his care plan did not include the target behaviors for these medications.
9. Resident 14 received an antipsychotic medication and had no care plan for the medication or the target behaviors.
10. Resident 5 had a fall on 1/3/22, and his care plan was not updated with interventions to prevent future falls.
11. Resident 10 was treated for a urinary tract infection in 4/2022 but had no care plan.
These failures had the potential for necessary care and services to go unrecognized and prevent the residents from attaining or maintaining their highest practicable level of medical and psychosocial well-being.
Findings:
The facility's policy titled, Care Plans-Comprehensive revised December 2010, directed the following:
An individualized comprehensive care plan that includes measurable objectives and timetables to meet the resident's medical, nursing, mental and psychosocial needs is developed for each resident. 3. Each resident's comprehensive care plan is designed to: a. Incorporate identified problem areas; b. Incorporate risk factors associated with identified problems; c. Build on the resident's strengths; d. Reflect the resident's expressed wishes regarding care and treatment goals; e. Reflect treatment goals, timetables and objectives in measurable outcomes; f. Identify the professional services that are responsible for each element of care; g. Aid in preventing or reducing declines in the resident's functional status and/or functional levels; h. Enhance the optimal functioning of the resident by focusing on a rehabilitative program; and i. Reflect currently recognized standards of practice from problem areas and conditions.
1. Resident 4 was admitted on [DATE] with diagnoses that included, major depressive disorder (severe depression) and emotional lability (uncontrollable laughing, crying or irritability). She had orders for Zoloft and Risperdal.
On 5/2/22 at 1:30pm, Resident 4 was observed in her room, alert and able to answer simple questions, well-groomed and dressed in her own clothes.
On 5/4/22 at 12:22pm, an interview and concurrent care plan review was conducted with Medical Records staff (MR) B. A care plan was developed that indicated Resident 4 was at risk for adverse side effects from psychotropic medications but did not specify what medications she was taking, or the specific side effects for each medication. There was a care plan developed for Chronic Depression but no target behavior or interdisciplinary interventions, including non-pharmacological interventions, were in place to manage her depression. MR B confirmed the above.
2. Resident 7 was admitted on [DATE] with diagnoses that included, bipolar depression with manic episodes (episodes of extreme mood changes with states of depression lows and high energy and excitement), restlessness and agitation, and psychosis (episodes of hallucinations, delusions or paranoia).
On 5/2/22 at 1:50pm, Resident 7 was observed in the dining room in a Merry Walker. Nicely dressed and well groomed.
On 5/4/22 at 3:44pm, an interview and concurrent care plan review was conducted with MR B.
Resident 7 was taking Venlafaxine, Lithium, Risperdal, Remeron and PRN Ativan. A care plan was developed for Episodes of Aggression but had not described the specific target behavior or interventions, pharmacological and non-pharmacological, to manage her behaviors. There were no care plans developed with specific target behaviors and what medications were being used for each behavior and their specific side effects, including her risk for Serotonin Syndrome, and there were no interdisciplinary non-pharmacologic interventions. MR B confirmed the above.
3. Resident 16 was admitted on [DATE] with diagnoses that included, restlessness and agitation, dementia and Wernicke's encephalopathy (confusion, incoordination and eye abnormalities caused from a lack of B vitamins).
On 5/2/22 at 2:10pm, Resident 16 was observed in his room. He was alert and oriented, pleasant and well groomed.
On 5/4/22 at 2:34pm, an interview and a concurrent care plan review was conducted with MR B.
Resident 16 was taking Ativan IM and PO on a PRN basis. There was a care plan developed for At Risk for Aggression that had not included the target behavior, specific medication, specific medication adverse side effects, or interdisciplinary non-pharmacologic interventions. MR B confirmed the above.
4. Resident 21 was admitted on [DATE] with diagnoses that included, major depression, dementia, irritability and anger, restlessness and agitation, and an anxiety disorder.
On 5/2/22 at 2pm, Resident 21 was observed in her room. She was well groomed and nicely dressed.
On 5/4/22 at 5:12pm, an interview and care plan review was conducted with MR B.
Resident 21 was taking Zoloft, Trazodone, and Klonopin. There were no care plans developed for the use of these medications which included a specific target behavior, specific medication, adverse side effects of the medications, including her risk for Serotonin Syndrome, or interdisciplinary interventions, including non-pharmacological interventions. MR B confirmed the above.
5. Resident 22 was admitted on [DATE] with diagnoses that included, a psychotic disorder, dementia and insomnia.
On 5/2/22 at 2:15pm, Resident 22 was observed in the dining room in a Merry Walker. He is nicely dressed and well groomed.
On 5/4/22 at 2:43pm, an interview and concurrent care plan review was conducted with MR B.
Resident 22 was taking Seroquel, Olanzapine, and Geodon. There was no care plan developed for the specific target behaviors for these medications, what the adverse side effects were, what his goals were, or interdisciplinary approaches to meet his goals, including non-pharmacological interventions. MR B confirmed the above.
6. Resident 3 was admitted on [DATE] with diagnoses that included, major depression and vascular dementia (caused from having multiple strokes).
On 5/2/22 at 1:40pm, Resident 3 was observed in her room. She was pleasant, nicely dressed and well groomed. She was sitting in her recliner.
On 5/4/22 at 5:41pm, an interview and concurrent care plan review was conducted with MR B.
Resident 3 was taking Prozac for depression. There was an At Risk for Major Depression care plan but had not included the specific medication she was taking, the specific target behavior, the specific adverse side effects of Prozac, what her goals were, or interdisciplinary approaches, including non-pharmacological interventions.
MR B confirmed the above findings.
7. A review of Resident 11's record indicated he was admitted on [DATE], with diagnoses that included mood disorder, major depressive disorder and dementia with behavioral disturbance. A review of the current physician's orders included Selegiline (an anti-depressant and monoamine oxidase type B, MAO-B drug) 5 milligrams (mg) every morning, Paxil (an anti-depressant and a selective serotonin reuptake inhibitor, SSRI) 40 mg every day at bedtime, Geodon 40 mg every 12 hours (antipsychotic medication use to treat schizophrenia and bipolar disorder, Clonazepam (treats anxiety and panic disorders) 1 mg every day at bedtime, and Lithium Carbonate (used to treat bipolar disorder and major depressive disorder) 300 mg every day at bedtime, which had been started on 6/11/21.
During a concurrent interview and record review on 5/4/22 at 9:30 am, Medical Records and Quality Assurance staff (MR A) confirmed the above medications. She confirmed there was not a care plan for the antipsychotic medication Geodon or a care plan for lithium. Aggressive behaviors were noted as the target behavior on the Medication Administration Record (MAR) for both lithium and Geodon. MR A confirmed there was no care plan regarding these types of behaviors.
8. A review of Resident 12's record indicated he was admitted on [DATE], with diagnoses that included paranoid schizophrenia, anxiety disorder, and panic disorder. The current physician's orders included Seroquel (antipsychotic medication used to treat schizophrenia) 50 mg every day, Perphenazine (antipsychotic medication used to treat schizophrenia) 8 mg every morning and 16 mg every evening, Risperdal (antipsychotic medication used to treat schizophrenia) 8 mg every evening, and Clonazepam (used to treat anxiety and panic disorders) 1 mg every evening.
During a concurrent interview and record review on 5/4/22 at 10:44 am MR A confirmed Resident 12 was taking Seroquel, Perphenazine, and Risperdal all for paranoid schizophrenia with the behavior of psychosis to be monitored on the MAR, and Clonazepam for panic disorder with the behaviors of panic to be monitored on the MAR.
During a concurrent interview and record review on 5/5/22 at 9:35 am, MR A confirmed there was a care plan for antipsychotic medications with an intervention to monitor target behaviors but does not specify or list those target behaviors.
9. A review of Resident 14's record indicated she was admitted on [DATE], with diagnoses that included anxiety and mood disorder. The current physician's orders included Seroquel 25 mg twice per day and Lorazepam 1 mg twice per day PRN for panic and anxiety.
During a concurrent interview and record review on 5/11/22 at 12:05 pm, MR A reviewed the MAR and confirmed there were no target behaviors listed for Seroquel and no care plan for this medication or any target behaviors.
10. A review of the facility's Managing Falls and Fall Risk policy, dated 12/2007, indicated Based on previous evaluations and current data, the staff will identify interventions related to the resident's specific risks and causes to try to prevent the resident from falling and to try to minimize complications from falling. 4. If falling recurs despite initial interventions, staff will implement additional or different interventions, or indicate why the current approach remains relevant. 5. If underlying causes cannot be readily identified or corrected, staff will try various interventions, based on assessment of the nature or category of falling, until falling is reduced or stopped, or until the reason for the continuation of the falling is identified as unavoidable. 6. In conjunction with the attending physician, staff will identify and implement relevant interventions to try to minimize serious consequences of falling.
A review of Resident 5's record indicated he was admitted on [DATE] with diagnoses that included major depressive disorder and chronic pain syndrome.
During a concurrent interview and record review on 5/11/22 at 12:36 pm, MR A said Resident 5's last fall was on 1/3/22. Prior to that he had slipped and fallen while trying to get into his wheelchair. He suffered no injuries after either fall. The nursing note, dated 1/3/11 at 5 am, indicated Resident 5 was found on the bathroom floor, sitting on his bottom. The raised toilet seat was noted on the floor and bent. There were no other notes regarding an investigation into how the fall happened. MR A confirmed the falls care plan was updated with interventions to prevent a future fall after the fall on 3/30/21, but it had not been updated after Resident 5's last fall on 1/3/22.
During an interview on 5/12/22 at 7:36 am, the DON said they thought the resident got up and was confused and somehow bent the toilet riser seat, where it was attached to the toilet. During an observation with the DON at 7:40 am, there was no riser on the toilet, and it was a low sitting toilet. The DON said the low sitting toilet would be hard for Resident 5 to get up from because it was so low. Maintenance staff was then contacted and installed a raised toilet seat.
11. A review of Resident 10's record indicated she was re-admitted on [DATE] with diagnoses that included major depressive disorder, dementia without behavior disturbance, and lung disease. She had been treated for a urinary tract infection (UTI) in 1/2022 and 4/2022.
During a concurrent interview and record review on 5/5/22 at 9:43 am MR A confirmed Resident 10 had a UTI in 1/2022 and 4/2022. No permanent care plan had been developed for Resident 10 relating to the UTI's and there was no short term, temporary care plan, for the UTI, Resident 10 had been treated for in 4/2022.
CONCERN
(F)
Potential for Harm - no one hurt, but risky conditions existed
Drug Regimen Review
(Tag F0756)
Could have caused harm · This affected most or all residents
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** 8. On 5/4/22 at 12:22pm, an interview and a concurrent review of Resident 4's MRRs was conducted with Medical Records staff (MR)...
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**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** 8. On 5/4/22 at 12:22pm, an interview and a concurrent review of Resident 4's MRRs was conducted with Medical Records staff (MR) B. MR B described that the facility's process for managing the Consultant Pharmacist's (Pharm) D's monthly MRRs was that Pharm D emailed the reviews to the MR Director (MRD). The MRD then brought them to the weekly clinical IDT meeting for the physicians to review and address. MR B stated, the DON is not involved in this process. MR B stated the MR department will give the nurses any MRRs that have order changes and then the MR department scans the completed MRRs into the residents' records.
Resident 4 was admitted on [DATE] with diagnoses that included, major depressive disorder (severe depression) and emotional lability (uncontrollable laughing, crying or irritability).
A review of Resident 4's MRRs for the past year showed that Risperdal (an antipsychotic) 0.5mg was ordered on 3/18/19. The MRRs requested that a GDR be done from May 2021 to December 2021, but one was never done and there was no rationale documented by her physician for not following the recommendation. The GDR was not recommended again, until the March 2022 MRR and Resident 4's physician documented that a GDR was contraindicated. The physician had not documented a resident specific clinical rationale for not doing a dose reduction at that time. Therefore, a GDR had not been attempted for 3 years.
Zoloft (an SSRI antidepressant) 100mg QD was ordered on 5/15/19. The MRRs requested that a GDR be done from May 2021 through December 2021, but one was never done. The April 2022 MRR indicated no irregularities and had no further recommendations for a GDR. MR B confirmed the above findings.
9. On 5/4/22 at 3:44pm, an interview and a concurrent review of Resident 7's MRRs was conducted with MR B.
Resident 7 was admitted on [DATE] with diagnoses that included, dementia with behavior problems, bipolar depression with manic episodes (episodes of extreme mood changes with states of depression lows and high energy and excitement), restlessness and agitation, and psychosis (episodes of hallucinations, delusions or paranoia).
The April and September 2021, MRRs indicated that Resident 7 had been on Ativan (an anti-anxiety) 1mg every 24 hours PRN since 6/24/19, and that CMS regulations limits all PRN psychotropic use to 14 days and cannot be continued unless the prescriber evaluates the resident for appropriateness and documents rationale for continuation. This recommendation was not addressed, and Pharm D did not make that recommendation again.
Lithium (a salt chemical used for depression) 150mg at bedtime was ordered on 8/5/18. The August 2021 MRR indicated that a required annual GDR was due. This was not done and not recommended again. Pharm D had not identified that a target behavior was not being monitored Lithium. MR B confirmed the above findings.
On 5/4/22 at 3:40pm, an interview was conducted with Pharm D. He was asked what his process was for ensuring that PRN orders did not exceed the 14-day limit. Pharm D indicated that if he made the recommendation to re-evaluate and the facility did not do that, at some point he would stop recommending it.
10. On 5/4/22 at 2:34pm, an interview and a concurrent review of Resident 16's MRRs was conducted with MR B.
Resident 16 was admitted on [DATE] with diagnoses that included, restlessness and agitation, insomnia, dementia and Wernicke's encephalopathy (confusion, incoordination and eye abnormalities caused from a lack of B vitamins).
MRRs from May 2021 through April 2022, showed no irregularities and had no recommendations, even though Resident 16 had two PRN Ativan (an anti-anxiety) orders without specific indications for use (target behaviors) or monitoring done for adverse side effects and were ordered in an excessive dose. Ativan 2mg IM PRN QD had been ordered since 1/19/22. Ativan 1mg orally (PO) every 8 hours PRN was ordered on 7/22/21. Both orders were to treat, restlessness and agitation (not specific). Neither of these PRN medications had been reviewed within the 14-day limit and were still available for use. According to LexiComp, the recommended dose limit for Ativan for adults aged 65 or older is 2mg. Resident 16 had the potential to receive up to 5mg of Ativan per day.
MR B confirmed all of the above findings.
11. On 5/4/22 at 5:12pm, an interview and a concurrent review of Resident 21's MRRs was conducted with MR B.
Resident 21 was admitted on [DATE] with diagnoses that included, major depressive disorder, anxiety disorder, restlessness and agitation, dementia with behaviors, and irritability and anger.
Zoloft (an SSRI antidepressant) 40mg QD was ordered on 1/4/22. There was no target behavior monitored (indication for use) or monitoring done for adverse side effects.
Trazodone 100mg PRN was ordered on 1/4/22. There was no 14-day re-evaluation. No target behavior was identified (reason for use) or monitored. No monitoring had been done for adverse side effects.
Klonopin 0.25mg every 12 hours PRN was ordered on 1/4/22. There was no 14-day reevaluation done. A target behavior was not identified or monitored. No monitoring was done for adverse side effects. These irregularities were not identified on the MRRs from January 2022 to April 2022. The MRR for February 2022 was missing. MR B confirmed the above findings.
On 5/4/22 at 3:40pm, during an interview with Pharm D, he confirmed that the January, March and April 2022 MRRs for Resident 21, had not included any irregularities or recommendations. Pharm D confirmed that the MRR for February 2022 was missing, I may have missed one.
12. On 5/4/22 at 2:43pm, an interview and a concurrent review of Resident 22's MRRs was conducted with MR B.
Resident 22 was admitted on [DATE] with diagnoses that included, insomnia, dementia with behaviors, psychotic disorder with delusions, and encephalopathy (a brain damage or malfunction with a broad spectrum of symptoms).
Seroquel (an antipsychotic) 100mg every morning and Seroquel 150mg at bedtime was ordered on 2/28/22. There was no target behavior (reason for use) or side effect monitoring being done.
A second antipsychotic, Olanzapine 5mg QD was ordered on 2/28/22. There was no target behavior or side effect monitoring being done.
A third antipsychotic Geodon 20mg QD was added on 3/10/22. There was no target behavior or side effect monitoring being done. There was no documented clinical rationale by Resident 22's physician to justify the use of three antipsychotic medications (duplicate therapy). The March 2022 MRR indicated that, the resident is taking more than one antipsychotic .Please evaluate this combination for duplication of therapy and, if no changes, document risk vs. benefit for taking multiple antipsychotics. The physician did not document a resident specific clinical rationale and responded, Patient is stable only on both these meds and had not recognized that Resident 22 was actually taking three antipsychotics. The April 2022 MRR identified, no irregularities and had no recommendations and Resident 22 continues to take three antipsychotic medications without an adequate indication for use or adverse side effect monitoring. MR B confirmed the above findings.
13. On 5/4/22 at 5:41pm, an interview and a concurrent review of Resident 3's MRRs was conducted with MR B.
Resident 3 was admitted on [DATE] with diagnoses that included, gastroesophageal reflux disease (GERD), major depressive disorder, and vascular dementia (brain damage caused by multiple strokes) without behaviors.
Prozac (an SSRI antidepressant) 10mg QD was ordered on 9/29/19. The target behavior and adverse side effects were not being monitored. There was no evidence that a GDR had been done since the Prozac was ordered, 3 years ago. On the September 2021 MRR, Pharm D recommended a dose reduction. This was never done and not recommended again.
Omeprazole (a proton pump inhibitor (PPI) stomach acid reducer) 20mg QD was ordered on 5/18/18. According to LexiComp, PPI medications should not be taken long term. They can cause kidney damage, vitamin B-12 deficiency, osteoporosis (bone mineral depletion) and stomach cancer. On the May 2021 MRR, Pharm D recommended changing Omeprazole to Pepcid (a stomach acid reducer that is not a PPI), this was never done and Resident 3's physician had not documented a reason for not following the recommendation.
The MRRs from October 2021 to April 2022, showed no irregularities or recommendations.
MRB confirmed the above findings.
On 5/5/22 at 8:10am, Pharm D was interviewed. Pharm D indicated that he did not have remote access to the resident's records, which made his ability to do the MRRs, more difficult and possibly less thorough. Pharm D indicated that he did not have the email addresses of the Administrator, DON or Medical Director, therefore, those individuals did not get the MRRs. Pharm D indicated that he does not attend the facility's QA/QAPI (Quality Assurance) meetings, there's not enough time in the day (the facility is in a rural area more than 3 hours from any city). Pharm D confirmed that he was aware that residents in the facility were receiving duplicate psychotropic drugs and PRNs over the 14-day limit. Pharm D added, when they lost their previous DON things changed and I did not change my routine when things stopped working. Pharm D confirmed that has not tried to meet with the Medical Director to discuss a plan to reduce the use of unnecessary drugs in the facility.
Based on interview and record review the facility's pharmacy consultant failed to identify drug irregularities which included duplicate therapy (According to the Centers for Medicare and Medicaid Services or CMS, Duplicate therapy refers to multiple medications of the same pharmacological class/category or any medication therapy that substantially duplicates a particular effect of another medication that the individual is taking), the CMS requirement to limit as needed (PRN) antipsychotic (drugs that work by altering brain chemistry to help reduce psychotic symptoms including hallucinations, delusions, and disordered thinking) and psychotropic (any drug that affects brain activities associated with mental processes and behavior) medications to 14 days, unless there was a re-evaluation of the resident and drug and rationale as to why the medication needed to be extended past 14 days, necessary indications for each psychotropic drugs, and necessary gradual dose reductions (GDR) for 13 of 16 sampled residents (Residents 3, 4, 7, 9, 10, 11, 12, 14, 16, 17, 18, 21, and 22). The facility's consultant pharmacist did not send his monthly medication regimen reviews (MRR) to the physician or the Director of Nurses (DON). The facility had no process for ensuring timely follow up on a recommendation of the pharmacist by the physician.
1. Resident 11 received the following medications in combination that were contraindicated due to risk of serious clinical deterioration: Selegiline (an anti-depressant and monoamine oxidase type B, MAO-B drug), Paxil (an anti-depressant and a selective serotonin reuptake inhibitor, SSRI), and Lithium Carbonate (used to treat bipolar disorder and major depressive disorder), the necessary labs were not done to assess the levels of the Lithium medication in the blood, which could have led to toxicity, and these issues were not noted by the pharmacist.
2. Resident 12 received duplicate therapy when he received Seroquel (antipsychotic medication used to treat schizophrenia), Perphenazine (antipsychotic medication used to treat schizophrenia), and Risperdal (antipsychotic medication used to treat schizophrenia) for the same diagnosis of paranoid schizophrenia with the same behavior of psychosis to be monitored, and these issues were not noted by the pharmacist during the past year.
3. Resident 17 received PRN Seroquel, since 1/9/22, in excess of 14 days, without a re-evaluation and rationale documented by the physician, and this was not noted by the pharmacist in the past year.
4. Resident 14 received Lorazepam (psychotropic drug used to treat anxiety), since 12/29/20, in excess of 14 days without a re-evaluation and rationale documented by the physician, and this was not noted by the pharmacist in the past year.
5. Resident 9 had received Lorazepam PRN since 12/19/19, in excess of 14 days, without a re-evaluation and rationale documented by the physician and this was not noted by the pharmacist in the past year. A recommendation, on 4/26/21 (more than one year ago), by the facility's pharmacy consultant for a GDR for Seroquel (ordered 12/28/18) was not acted upon by the facility.
6. Resident 10 had received Lorazepam PRN since 1/5/22, in excess of 14 days, without a re-evaluation and rationale documented by the physician, and this was not noted by the pharmacist.
7. Resident 18 had received Lorazepam PRN since 8/4/21, in excess of 14 days, without a re-evaluation and rationale documented by the physician and this was not noted by the pharmacist. A recommendation, on 12/31/21, by the facility's pharmacy consultant for a GDR for Citalopram (an anti-depressant ordered 6/22/21) was not acted upon by the facility.
8. Resident 4 received Zoloft (an antidepressant) and Risperdal for 3 years without a GDR.
9. Resident 7 had an order for PRN Ativan (an anti-anxiety) for 3 years without being reevaluated every 14 days and Lithium (a chemical compound use for depression) for 3 years without an indication for use (target behavior), and this was not noted by the pharmacist.
10. Resident 16 had two PRN Ativan orders (duplicate therapy) that exceeded the 14-day limit and without an inadequate indication for use, adequate monitoring (a target behavior and side effects) and in an excessive dose), and this was not noted by the pharmacist.
11. Resident 21 received Zoloft without an indication for use and adequate monitoring. Trazodone (an antidepressant) and Klonopin (a long-acting anti-anxiety) were ordered PRN without adequate indications for use, adequate monitoring and exceeded the 14-day limit), and this was not noted by the pharmacist.
12. Resident 22 received three antipsychotics (duplicate therapy); Seroquel, Olanzapine, and Geodon at the same time without adequate indications for use and adequate monitoring, and this was not noted by the pharmacist.
13. Resident 3 received Prozac (an antidepressant) without an adequate indication for use and adequate monitoring and had no GDR in 3 years. Omeprazole (a PPI stomach acid reducer intended for short term use) has been taken for 4 years and the medication change recommended a year ago, was not followed.
This resulted in or had the potential to result in residents receiving unnecessary medication or inappropriate dosages with adverse side effects, some of which could be permanent.
Findings:
The facility's pharmacy services agreement required their consultant pharmacist to review the drug regimen for all skilled nursing patients monthly, review use of psychotropic drugs with a letter to the physician every three months requesting consideration of a gradual dose reduction as appropriate and ensure the pharmacy services were in compliance with all state and federal regulations regarding pharmaceutical services.
1 a. A review of Resident 11's record indicated he was admitted on [DATE] with diagnoses that include mood disorder, major depressive disorder and dementia with behavioral disturbance. A review of the current physician's orders included Selegiline 5 milligrams (mg) every morning, Paxil 40 mg every day at bedtime, Geodon 40 mg every 12 hours (antipsychotic medication use to treat schizophrenia and bipolar disorder), Clonazepam (treats anxiety and panic disorders) 1 mg every day at bedtime, and Lithium Carbonate 300 mg every day at bedtime, which had been started on 6/11/21.
During a concurrent interview and record review on 5/4/22 at 9:30 am, Medical Records and Quality Assurance staff (MR A) confirmed the above medications.
Lexi-comp (a nationally recognized drug reference) included a warning for the following drug interactions, the use of Lithium and Paxil (SSRI) could lead to serotonin syndrome. As defined by the Centers for Medicare and Medicaid Services (CMS): Serotonin Syndrome is a potentially serious clinical condition resulting from overstimulation of serotonin receptors. It is commonly related to the use of multiple serotonin-stimulating medications (e.g., SSRIs, SNRIs, triptans, certain antibiotics). Symptoms may include restlessness, hallucinations, confusion, loss of coordination, fast heartbeat, rapid changes in blood pressure, increased body temperature, overactive reflexes, nausea, vomiting and diarrhea. Lexi-comp also included a warning Risk X: avoid combination for the use of Lithium and Selegiline. MAO-B may enhance the serotonergic effects of Serotonergic Agents. Avoid concomitant use of Type B MAOs with Lithium. At least 14 days should elapse between discontinuance of Type B MAOs and initiation of Lithium.
During an interview on 5/4/22 at 7:04 pm, a pharmacist (Pharm F) with the pharmacy that supplies the facility its medications, confirmed the combination of Selegiline and Lithium was a Risk X - avoid combination and other information from Lexi-comp, including the risk of Serotonin Syndrome from the use of Lithium and Paxil.
During an interview on 5/05/22 at 8:10 am, the facility's consultant pharmacist (Pharm E) confirmed he had performed monthly medication reviews for Resident 11. He said the combination of Lithium and Paxil could result in serotonin syndrome and he said he did not inform the facility staff or physicians about this in his medication reviews. Pharm E said he uses Lexi-comp but disagreed that the combination of Lithium and Selegiline was a Risk X. He admitted that the combination of Lithium and Selegiline could cause clinical deterioration of the resident. He also confirmed he did not inform the facility's staff or physician about this in his medication reviews.
b. The following was also noted in Lexicomp, regarding Lithium. ALERT: US Boxed Warning - Monitoring: Lithium toxicity is closely related to serum lithium levels and can occur at doses close to therapeutic levels. Facilities for prompt and accurate serum lithium determinations should be available before initiating therapy. Only prescribe in settings where serum concentration monitoring is available. Toxic effects occur with serum concentrations =1.5 mEq/L and may be seen in some patients with serum concentrations as low as 1.2 mEq/L (Janicak 2021); . serum electrolytes (baseline, then periodically); ECG with rhythm strip (baseline for all patients >[AGE] years of age or if underlying cardiac risk factors, repeat as clinically indicated); . serum lithium levels (twice weekly until both patient's clinical status and levels are stable, then repeat levels every 1 to 3 months or as clinically indicated; closely monitor in patients with significant renal or cardiovascular disease, debilitation, dehydration, sodium depletion, or those taking concomitant medications that impact renal function); . signs of lithium toxicity (e.g., diarrhea, vomiting, tremor, mild ataxia, drowsiness, muscular weakness). Toxic concentrations:
>1.5 mEq/L (SI: >1.5 mmol/L): Early signs and symptoms of intoxication may include marked tremor, nausea, diarrhea, blurred vision, vertigo, confusion, and decreased deep tendon reflexes (APA 2002).
>2.5 mEq/L (SI: >2.5 mmol/L): Intoxication symptoms may progress to include severe neurological complications, seizures, coma, cardiac dysrhythmia, and permanent neurological impairment (APA 2002).
>3.5 mEq/L (SI: >3.5 mmol/L): Potentially lethal toxicity ([NAME] 2001).
During an interview on 5/4/22 at 9:30 am, MR A said there had been only one Lithium level done on 8/17/21 which was 1.0.
During a concurrent interview and record review on 5/4/22 at 4 pm, MR B confirmed baseline labs were done (as indicated in Lexicomp) and repeated every two to three months, except no EKG had been done when Lithium was initiated or afterwards.
During an interview on 5/05/22 at 8:10 am, Pharm E confirmed he did not make a recommendation about a lithium level during his medication reviews for Resident 11.
2. A review of Resident 12's record indicated he was admitted on [DATE] with diagnoses that included paranoid schizophrenia, anxiety disorder, and panic disorder. The current physician's orders included Seroquel 50 mg every day, Perphenazine 8 mg every morning and 16 mg every evening, Risperdal 8 mg every evening, and Clonazepam 1 mg every evening.
During a concurrent interview and record review on 5/4/22 at 10:44 am MR A confirmed Resident 12 was taking Seroquel, Perphenazine, and Risperdal all for paranoid schizophrenia with the behavior of psychosis to be monitored, and Clonazepam for panic disorder with the behaviors of panic to be monitored. The pharmacist's medication regimen reviews (MRR) from 5/29/21 - 4/30/22 were reviewed. On the MRR dated 10/24/21, Pharm E recommended a gradual dose reduction (GDR) for all of the four meds above due on 10/31/21. There was no mention by the pharmacist during the past year in his MRR's of duplicate/triplicate therapy for the same diagnosis and behaviors. There was no mention by the pharmacist during the past year of his MRR's of triplicate therapy for the same diagnosis and behaviors. There was a MRR dated 4/30/22 wherein a GDR for Lorazepam PRN was recommended. MR A said this medication was no longer ordered for this resident and he hadn't received it since 2/1/21.
During an interview on 5/05/22 at 8:20 AM, Pharm E was asked if he had advised the facility that this resident was receiving duplicate therapy, since he was receiving three antipsychotic medications for the same diagnosis and behavior. He said, in a review on 10/23/19, he advised the facility that this resident was on three antipsychotic meds and asked for a risk benefit statement. He said he had not included this recommendation since that time although he had since recommended GDRs for these medications. He said he does not repeat the same recommendations month to month so those MRRs will indicate that there are no irregularities. He said he tries to give the physicians time to respond and repeat the recommendation quarterly or at least yearly. He said he sent the MRRs to the medical records manager not the DON. Pharm E was asked why his 4/2022 review asked for a GDR for the Lorazepam PRN order when it was discontinued in 2/2021. He said he did not have remote access to the residents' records and explained this drug was on the pharmacy profile as an active order or he may not have taken it off his list and schedule, probably the latter. He said he does not have remote access and it would be easier if he did. He talked to one of the nurses who told him he would need access to the facility server and had to talk to the facility's Information Technology manager.
During a concurrent interview and record review on 5/5/22 at 9:35 am, MR A confirmed the first MRR done by the pharmacist was 11/26/19 which indicated no irregularities. She said there was not a MRR done in October 2019 and said Resident 12 was admitted on [DATE].
b. During a concurrent interview and record review on 5/4/22 at 10:44 am, MR A confirmed on the MRR dated 10/24/21, the Pharmacist recommended a GDR was due on 10/31/21, for Seroquel, Perphenazine, Risperdal and Clonazepam, all of which had been ordered on 10/18/19. This MRR was signed by Resident 12's physician on 11/1/21 and indicated I reviewed this resident's current medication regimen and agree with the consultant pharmacist's medication review. However, there was no note or order from the physician that actually noted which medication and dosage should be changed or no risk benefit statement as to why a GDR should not be done. MR A said she thought the DON was supposed to follow up on that.
During an interview on 5/5/22 at 11:16 am, the DON confirmed if the physician signed he agreed with the pharmacist's recommendation but does not make a change in the medication dosage, they have no process at this time to follow up to see what changes the physician wants to make.
3. A review of Resident 17's record indicated he was admitted on [DATE], with diagnoses that included major depressive disorder and dementia without behavioral disturbance. A review of the current physician's orders included an as needed PRN order for Seroquel 25 mg for agitation at bedtime, dated 1/9/22.
During a concurrent interview and record review on 5/04/22 at 10:30 am, MR A confirmed the Seroquel PRN order had started on 1/9/22. The pharmacy consultant noted during his MRR on 1/31/22, that CMS restricts prn use of antipsychotics for 14 days. There was no physician signature or response on this MRR. There was no re-assessment by the physician for this med. The pharmacy consultant did not mention this issue in subsequent MRRs done from 2/2022 through 4/2022.
During an interview on 5/5/22 at 8:30 am, Pharm E said he does not repeat the same recommendations month to month so those MRR's will indicate that there are no irregularities. He said he tries to give the physicians time to respond and repeat the recommendation quarterly or at least yearly. Pharm E said he sent the MRRs to the medical records director (MRD) not the DON.
During an interview on 5/05/22 at 11:07 am, the DON said he had not received the MRRs, and they have been sent to MRD. He said Pharm E did not have his email address and he just found out about that today.
4. A review of Resident 14's record indicated she was admitted on [DATE], with diagnoses that included anxiety and mood disorder. The current physician's orders included Seroquel 25 mg twice per day and Lorazepam 1 mg twice per day PRN for panic and anxiety.
During a concurrent interview and record review on 5/4/22 at 10:55 am, MR A reviewed the MRRs done by the pharmacy consultant over the past year. There was no mention of the PRN Lorazepam although the MRRs did include a GDR recommendation for Lorazepam. Resident 14 had not received this medication for several months.
During an interview on 5/5/22 at 8:30 am Pharm E said the Lorazepam 1 mg PRN BID was started on 12/29/20. He said he recommended the re-evaluation after 14 days for the Lorazepam on 2/26/21. He was unable to say if he had repeated this recommendation in later reviews during the past year. He said he tries to repeat the recommendations quarterly or at least yearly.
5. A review of Resident 9's record indicated she was admitted on [DATE], with diagnoses that included major depressive disorder, dementia with behavioral disturbance, and restlessness. A review of the current physician's orders included Seroquel 100 mg at bedtime and Ativan 0.5 mg twice per day PRN.
During a concurrent interview and record review on 5/5/22 at 9:59 am, MR A confirmed the above medication orders. She said Resident 9 had not received any Ativan in the past eight months. A review of the MARs showed no Ativan was given from 12/2021 through the present. MR A reviewed the MRR's from the past year and confirmed there was no report from the pharmacist regarding the CMS restriction of PRN psychotropics to 14 days and the need to document the rational to extend the drug beyond 14 days. MR A confirmed there was no rationale or risk benefit statement documented by the physician to extend the use of the Ativan after 14 days.
b. During a concurrent interview and record review on 5/5/22 at 9:59 am, MR A confirmed the pharmacy consultant included a GDR recommendation for Seroquel on 4/30/22. The prior GDR recommendation was on 4/26/21 and the physician signed he agreed with pharmacist's recommendation on 5/10/21, but no changes in the dose were made at that time.
During an interview on 5/12/22 at 7:27 am, the DON reviewed the MRR dated 4/26/21 and signed 5/10/21 and said they had no process for following up when the physician signs the MRR from pharmacist but did not change the dosage. He said the MRRs went to MRD and he not get them, but after last week, the pharmacy consultant would now be sending them to him.
6. A review of Resident 10's record indicated she was re-admitted on [DATE] with diagnoses that included major depressive disorder, dementia without behavior disturbance, and lung disease. The current physician's orders included Ativan 0.5 mg every six hours PRN for anxiety and restlessness.
During an interview on 5/4/22 at 3:55 pm, Pharm E said he made a recommendation regarding the use of prn Ativan on 1/31/22.
During a concurrent interview and record review on 5/5/22 at 9:43 am, MR A confirmed the Ativan PRN order. She said this resident was admitted with this order. The pharmacy consultant's MRRs for 2/22, 3/22, 4/22 indicated there were no medication irregularities. A review of the physician notes did not include a re-evaluation of this drug and why it needed to continue after 14 days.
During an interview on 5/11/22 at 11:45 am, MR A reviewed the copy of the MRR dated 1/31/22. It asked for a GDR of Ativan but did not mention PRN use and CMS restriction of PRN psychotropics to 14 days and the need to document the rational to extend the drug beyond 14 days.
7. A review of Resident 18's record indicated she was admitted on [DATE], with diagnoses that included anxiety disorder, depressive disorder, and dementia with behavioral disturbance. Her current orders included Citalopram (anti-depressant) 10 mg daily and Ativan (treats anxiety) 0.5 mg every 12 hours PRN.
During a concurrent interview and record review on 5/05/22 at 10:07 am, MR A confirmed the Ativan 0.5 mg PRN was ordered on 8/4/21. A review of the pharmacy consultant's MRRs, each month since 8/8/21, did not mention the CMS restriction of PRN psychotropics to 14 days and the need to document the rational to extend the drug beyond 14 days. A MRR dated 10/24/21 included a GDR recommendation for Ativan and its PRN use should be considered and a Citalopram GDR due 11/30/21. This was signed by the MD that he was in agreement with the pharmacist's recommendation on 11/1/21. The MRR dated 12/31/21 included a recommendation for a GDR for Citalopram. This was not signed by a physician. Subsequent MRRs through 3/2022 contained no irregularities. MRR dated 4/30/22 included a recommendation for GDR for Citalopram. MR A confirmed there was no rationale or risk benefit documented by the physician to extend the use of the Ativan after 14 days. A review of the MARs showed no Ativan was given from 12/2021 through the present.
During an interview on 5/5/22 at 11:16 am, the DON confirmed if the physician signs he agrees with the pharmacist's recommendation but does not make a change in the medication dosage, they have no process at this time to follow up to see what changes the physician wants to make.
CONCERN
(F)
Potential for Harm - no one hurt, but risky conditions existed
Medication Errors
(Tag F0758)
Could have caused harm · This affected most or all residents
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** On 5/3/22 at 2:12 pm, an interview was conducted with the Director of Staff Development (DSD). The DSD stated that the facility ...
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**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** On 5/3/22 at 2:12 pm, an interview was conducted with the Director of Staff Development (DSD). The DSD stated that the facility does not have a psychotropic drug committee (staff members who provide oversight of the use of psychotropic medications including, care planning, required dose reductions, evaluating target behaviors to determine the effectiveness and/or ineffectiveness of the medications and present these findings to the physicians), I'm working on that. The DSD stated that resident psychotropic drug use was discussed at their weekly Clinical Interdisciplinary Team (IDT- facility managers and supervisors) meeting. The DSD stated that she recognized that there was a problem with psychotropic drug use and dual therapy usage but the [Medical Director] refuses to discontinue any medications. The DSD confirmed that behavior symptoms are not being tallied or presented to the physicians so that a determination can be made as to whether or not the psychotropic medications are effective, ineffective, causing adverse side effects, or due for a gradual dose reduction (GDR). The DSD stated, I have no clue whether or not GDRs are getting done we are not keeping track or monitoring that, and we don't tally up the behaviors for the doctors.
10. Resident 4 was admitted on [DATE] with diagnoses that included, major depressive disorder (severe depression) and emotional lability (uncontrollable laughing, crying or irritability).
On 5/4/22 at 12:22 pm, a review of Resident 4's Physician's Orders for May 2022, and a concurrent interview was conducted with Medical Records staff (MR) B.
Zoloft (an SSRI antidepressant) 100 milligrams (mg) was ordered to be given once a day (QD) on 12/10/19, for isolating self and not eating. Failure to eat and withdrawn behaviors were being monitored on the Electronic Treatment Administration Record (ETAR) together therefore, there was no way to determine how many episodes of each behavior Resident 4 was having, which would indicate whether or not the Zoloft was effective. There were no non-pharmacological interventions (any type of health intervention which is not primarily based on medication) identified to try before giving the medication (non-medication interventions based on what the facility knows about the resident's past or present routines). The ETAR did not describe what specific adverse side effects were to be monitored. There was no evidence that a GDR had been attempted since the Zoloft was ordered, 3 years ago.
On 12/10/19, Risperdal (an antipsychotic) 0.5 mg twice a day (BID) was ordered for a diagnosis of Emotional lability. The ETAR had not included what specific target behavior (the primary behavior that warranted the Risperdal), Resident 4 had when she was considered to be emotionally labile. The EMAR did not contain what the specific adverse side effects to expect from using Risperdal were. There were no non-pharmacological interventions included. There was no evidence that a GDR had been attempted since the Risperdal was ordered, 3 years ago. MR B confirmed the above findings.
11. Resident 7 was admitted on [DATE] with diagnoses that included, dementia with behavior problems, bipolar depression with manic episodes (episodes of extreme mood changes with states of depression lows and high energy and excitement), restlessness and agitation, and psychosis (episodes of hallucinations, delusions or paranoia).
On 5/4/22 at 3:44 pm, an interview and concurrent record review was conducted with MR B. A review of Resident 7's Physician's Orders for May 2022 showed that Venlafaxine (an SNRI antidepressant) 37.5 mg QD was ordered for a diagnosis of bipolar depression with the target symptom of irritability and anger on 4/8/18. Irritability and anger are not target behaviors and could be a negative response to either an underlying medical condition or environmental stressor. There was no evidence that a GDR had been attempted since the Venlafaxine was ordered, 4 years ago. There was a monitor for serotonin syndrome on the Electronic Medication Administration Record (EMAR) however, the description of what to look for was not there. There were no non-pharmacological interventions listed.
Lithium (a chemical salt compound used for bipolar depression and can also contribute to Serotonin Syndrome)150 mg at bedtime (HS) was ordered on 8/5/18. There was no target behavior identified or monitored. There was no evidence that a GDR had been attempted since the Lithium was ordered, 4 years ago. There were no non-pharmacological interventions listed.
Risperdal (an antipsychotic) 1 mg BID was ordered on 4/9/18, for a diagnosis of Psychosis and a target behavior of agitation. Resident 7's agitation was not an adequate indication for use as there was no specific behavior identified. Agitation could be a response to thirst, hunger, pain, toileting need and boredom. There was no documented evidence that a GDR had been attempted since the Risperdal was ordered, 4 years ago. There were no non-pharmacological interventions listed.
According to Lexicomp, Risperdal is not approved for patients with dementia related behaviors and can cause heart problems leading to death.
Ativan (an anti-anxiety) 1 mg QD as needed (PRN) was ordered on 12/19/19, for trying to choke, slap or throw things. There was no reevaluation of the Ativan PRN use by a physician every 14 days, as mandated by the Centers for Medicare and Medicaid (CMS) regulations, since the Ativan was ordered 3 years ago. This requirement is done to determine if the medication should be stopped or reordered and given on a routine basis. There were no non-pharmacological interventions listed to try before giving the Ativan.
Remeron (an SSRI antidepressant) 30 mg every evening was ordered on 4/9/18, for emotional lability manifested by, cursing, disrobing, wandering and stealing. All of the behaviors were monitored together so it was impossible to know which behavior she was exhibiting at any one time or which of these behaviors were the most distressing to Resident 7 and warranted the use of Remeron (inadequate monitoring). There was no evidence that a GDR had been attempted since the Remeron was ordered, 4 years ago. There were no non-pharmacological interventions listed. There was no resident specific rationale documented by Resident 7's physician as to why she required two SSRI antidepressants (dual therapy). MR B confirmed that Resident 7 was on 5 psychotropic medications and had inadequate monitoring, inadequate indications for use, a PRN that exceeded the 14-day limit, no justification for dual antidepressant therapy and no GDRs done.
On 5/4/22 at 4:20 pm, LN C stated during an interview that Resident 7, Has not had behaviors in a very long time.
5/4/22 3:40 pm, an interview was conducted with the Consultant Pharmacist (Pharm) D. Pharm D indicated that if PRN medication orders went longer than 14 days without reevaluation, he would have made the recommendation to evaluate that. Pharm D added, if the facility did not follow my recommendations, at some point I would stop recommending it. Pharm D confirmed that he had not met with the Physicians or Medical Director to discuss the unnecessary use of psychotropic drugs in the facility, although he recognized that there was a problem.
12. Resident 16 was admitted on [DATE] with diagnoses that included, restlessness and agitation, insomnia, dementia and Wernicke's encephalopathy (confusion, incoordination and eye abnormalities caused from a lack of B vitamins usually seen in alcohol abuse and is possibly reversible).
On 5/4/22 at 2:34 pm, an interview and concurrent record review was conducted with MR B.
Resident 16's Physician's Orders for May 2022, were reviewed. Ativan (an anti-anxiety medication) 2 mg intramuscularly (IM-a shot) PRN agitation (not a specific target behavior) was ordered on 1/19/22, four months ago. The Ativan was not reevaluated after 14 days. There were no non-pharmacological interventions to try before giving Resident 16 a shot of Ativan. There was no monitoring for a target behavior, agitation could be a negative response to an underlying medical condition or environmental stressor that, once corrected, would correct the behavior. There was no monitoring done for adverse side effects.
Ativan 1 mg every 8 hours PRN was ordered on 7/22/21, for restlessness and agitation (not a specific target behavior). PRN use was not reevaluated after 14 days. There were no non-pharmacological interventions listed to try before giving the Ativan. There were no monitors for a target behavior or for adverse side effects. There were no indications in either Ativan order, that described under what circumstances the nurse would administer the pill or the shot.
Resident 16 had no routine behavior management medications to treat his restlessness and agitation. He was being treated only with PRN Ativan use either by a shot or a pill, at the discretion of the nursing staff. According to Lexicomp, Ativan 2 mg in 24 hours is the maximum recommended dosage for adults aged 65 or older due to adverse consequences. Resident 16 had the potential to receive 5 mg of Ativan (an excessive dose) in one day, according to his current orders.
Resident 16 had a psychiatric evaluation on 10/18/21. The Psychiatrist identified several behaviors and post-traumatic stress disorder (PTSD); however, the facility had not incorporated this information into Resident 16's non-pharmacological interventions or care plan. The Psychiatrist documented, staff are saying his symptoms have improved.
MR B confirmed all of the above findings.
13. Resident 21 was admitted on [DATE] with diagnoses that included, major depressive disorder, anxiety disorder, restlessness and agitation, dementia with behaviors, and irritability and anger.
On 5/4/22 at 5:12 pm, an interview and concurrent record review was conducted with MR B.
A review of Resident 21's Physician's Orders for May 2022 was reviewed.
Zoloft (an SSRI antidepressant) liquid 40 mg QD was ordered on 1/4/22, for major depressive disorder. No specific target behavior or adverse side effects were monitored on the EMAR or ETAR. There were no non-pharmacological interventions listed.
Trazodone (a [NAME], similar to SSRI antidepressant) 100 mg PRN was ordered on 1/4/22, for restlessness and agitation. No specific target behavior or adverse side effects, including the potential for serotonin syndrome, were monitored. Her physician had not reevaluated the PRN use every 14 days, for 5 months. There were no non-pharmacological interventions listed to try before giving the Trazodone, as in determining if the restlessness or agitation was caused from a basic need that was not met (need to toilet, thirst, hunger, pain, boredom), or an environmental stressor (bright lights, noise, too hot, too cold etc .).
Klonopin (a long-acting anti-anxiety medication) 0.25 mg every 12 hours PRN was ordered on 1/4/22, for an anxiety disorder. No specific target behavior was identified, and potential adverse side effects were not monitored. The PRN use was not reevaluated every 14 days by her physician. There were no non-pharmacological interventions listed to try before giving the Klonopin.
MR B confirmed that Resident 21 had inadequate monitoring, inadequate indications for use and PRN psychotropic drugs that exceeded the 14-day limit.
14. Resident 22 was admitted on [DATE] with diagnoses that included, insomnia, dementia with behaviors, psychotic disorder with delusions, and encephalopathy (a brain damage or malfunction with a broad spectrum of symptoms).
On 5/4/22 at 2:43 pm, an interview and concurrent record review was conducted with MR B. A review of Resident 22's Physician's Orders for May 2022, showed that Seroquel (an antipsychotic) 100 mg every morning and Seroquel 150 mg at bedtime was ordered on 2/28/22, for a diagnosis of psychotic disorder with delusions. A specific target behavior symptom was not identified or monitored (inadequate indication for using Seroquel). There was no monitor for adverse side effects (inadequate monitoring). No non-pharmacological interventions were developed.
A second antipsychotic, Olanzapine 5 mg QD was ordered on 2/28/22, for the same diagnosis. A target behavior was not identified or monitored. There was no monitor for adverse side effects. No non-pharmacological interventions were developed.
A third antipsychotic Geodon 20 mg QD was added on 3/10/22, for the same diagnosis. A target behavior was still not identified or monitored. There was no monitor for adverse side effects. No non-pharmacological interventions were not developed. There was no care plan or resident specific clinical justification by the physician, as to why Resident 22 needed three antipsychotic medications for one diagnosis (triple therapy), which increased his risk for uncomfortable side effects, falls, and unwanted involuntary movements and/or tremors.
MR B confirmed the above findings.
15. Resident 3 was admitted on [DATE] with diagnoses that included, gastroesophageal reflux disease (GERD), major depressive disorder, and vascular dementia (brain damage caused by multiple strokes) without behaviors.
On 5/4/22 at 5:41 pm, an interview and concurrent record review was conducted with MR B.
Resident 3's Physician's Orders for May 2022 showed that Prozac (an SSRI antidepressant) 10 mg QD was ordered on 9/29/19. Monitors for adverse side effects from Prozac and a target behavior of isolation were on the EMAR but were blank. There was no evidence that a GDR had been done since the Prozac was ordered, 3 years ago. There were no non-pharmacological interventions listed.
Omeprazole (a proton pump inhibitor (PPI) stomach acid reducer) 20 mg QD was ordered on 5/18/18. According to Lexicomp, PPI medications should not be taken long term. They can cause kidney damage, vitamin B-12 deficiency, osteoporosis (bone mineral depletion) and stomach cancer. On 5/29/21, Pharm D recommended changing Omeprazole to Pepcid (a stomach acid reducer that is not a PPI), this was never done. Resident 3's physician had not documented why it was necessary to continue subjecting Resident 3 to the risks of long-term Omeprazole use. MR B confirmed the above findings.
Based on interview and record review, the facility failed to ensure 15 of 16 sampled residents (Residents 3, 4, 5, 7, 8, 9, 10, 11, 12, 14, 16, 17, 18, 21, and 22) who received psychotropic drugs (any drug that affects brain activities associated with mental processes and behavior), received the necessary monitoring of labs (tests used to evaluate the level of medications in the body), adverse side effects, target behaviors to assess effectiveness, gradual dose reductions (GDR); and did not receive duplicate therapy (Duplicate therapy refers to multiple medications of the same pharmacological class/category or any medication therapy that substantially duplicates a particular effect of another medication that the individual is taking) and as needed (PRN) psychotropic and antipsychotic drugs (drugs that work by altering brain chemistry to help reduce psychotic symptoms including hallucinations, delusions, and disordered thinking) past 14 days, without the necessary re-evaluation and rationales by the physician.
1. Resident 11 received the following medications in combination that were contraindicated due to risk of serious clinical deterioration: Selegiline (an anti-depressant and monoamine oxidase type B, MAO-B drug), Paxil (an anti-depressant and a selective serotonin reuptake inhibitor, SSRI), and Lithium Carbonate (used to treat bipolar disorder and major depressive disorder), the necessary labs were not done to assess the levels of the Lithium medication in the blood, which could have led to toxicity, adverse side effects of Lithium were not monitored, and behaviors were not monitored to assess the effectiveness of the medications.
2. Resident 12 received duplicate therapy when he received Seroquel (antipsychotic medication used to treat schizophrenia), Perphenazine (antipsychotic medication used to treat schizophrenia), and Risperdal (antipsychotic medication used to treat schizophrenia) for the same diagnosis of paranoid schizophrenia with the same behavior of psychosis to be monitored without a rationale by the physician as to why three were necessary, and no gradual dose reductions for these medications.
3. Resident 17 received PRN Seroquel, since 1/9/22, in excess of 14 days, without a re-evaluation and rationale documented by the physician.
4. Resident 14 received Lorazepam (psychotropic drug used to treat anxiety), since 12/29/20, in excess of 14 days without a re-evaluation and rationale documented by the physician and received no behavior monitoring for Seroquel.
5. Resident 9 had received Lorazepam PRN, since 12/19/19, in excess of 14 days, without a re-evaluation and rationale documented by the physician. A recommendation, on 4/26/21 (more than one year ago), by the facility's pharmacy consultant for a GDR for Seroquel (ordered 12/28/18) was not acted upon by the facility.
6. Resident 10 had received Lorazepam PRN since 1/5/22, in excess of 14 days, without a re-evaluation and rationale documented by the physician.
7. Resident 18 had received Lorazepam PRN since 8/4/21 in excess of 14 days, without a re-evaluation and rationale documented by the physician. A recommendation, on 12/31/21, by the facility's pharmacy consultant for a GDR for Citalopram (an anti-depressant ordered 6/22/21) was not acted upon by the facility. There were no target behaviors to monitor the effectiveness of Citalopram and Lorazepam.
8. Resident 5 received Duloxetine (anti-depressant) since 12/11/19, without a GDR or statement by the physician as to why the GDR was contraindicated.
9. Resident 8 received Cymbalta (an anti-depressant) since 10/8/21, without a re-evaluation, when the order was for a trial for two weeks and then re-evaluate.
10. Resident 4 received Zoloft (an antidepressant) and Risperdal (an antipsychotic) for 3 years without a GDR.
11. Resident 7 had an order for PRN Ativan (an anti-anxiety) for 3 years without being reevaluated every 14 days. Risperdal (an antipsychotic medication) was given without an adequate indication for use as there was no specific behavior identified. There was no documented evidence that a GDR had been attempted since the Risperdal was ordered, 4 years ago. Lithium (a chemical compound use for depression) for 3 years, without an indication for use (target behavior).
12. Resident 16 had two PRN Ativan orders (duplicate therapy) that exceeded the 14-day limit and without an inadequate indication for use, adequate monitoring (a target behavior and side effects) and in an excessive dose.
13. Resident 21 received Zoloft without an indication for use and adequate monitoring. Trazodone (an antidepressant) and Klonopin (a long-acting anti-anxiety) were ordered PRN without adequate indications for use, monitoring and exceeded the 14-day limit.
14. Resident 22 received three antipsychotics (duplicate therapy); Seroquel, Olanzapine, and Geodon at the same time without adequate indications for use and monitoring.
15. Resident 3 received Prozac (an antidepressant) without an adequate indication for use and adequate monitoring and had no GDR in 3 years. Omeprazole (a PPI stomach acid reducer intended for short term use) had been taken for 4 years and the medication change recommended a year ago, was not followed.
This widespread failure resulted in substandard quality of care for the facility residents and had the potential to result in permanent neurological side effects and a deterioration in the clinical condition of these residents.
Findings:
During a document review of the facility's Antipsychotic Medication Use policy, dated 4/2007, was reviewed. It indicated, Antipsychotic mediation therapy shall be used only when it is necessary to treat a specific condition 3. Nursing staff will document in detail an individual's target symptom(s). 4. The attending physician will identify, evaluate, and document, with input from other disciplines and consultants as needed, symptoms that may warrant the use of antipsychotic medications. 6. The staff will observe, document and report to the attending physician information regarding the effectiveness of any interventions, including antipsychotic medications.
During a document review of the facility's Tapering Medication and Gradual Drug Dose Reduction policy, dated 4/2007, was reviewed. It indicated, Residents who use antipsychotic drugs shall receive gradual dose reductions and behavioral interventions, unless clinically contraindicated, in an effort to discontinue these drugs. 11. Within the first year after a resident is admitted on an antipsychotic medication or after the resident has been started on an antipsychotic, the staff and practitioner shall attempt a GDR in two separate quarters (with at least one month between the attempts), unless clinically contraindicated. After the first year, the facility shall attempt a GDR at least annually, unless clinically contraindicated.
During a document review of the facility's pharmacy services agreement, dated 5/8/18, required their consultant pharmacist to review the drug regimen for all skilled nursing patients monthly, review use of psychotropic drugs with a letter to the physician every three months requesting consideration of a gradual dose reduction as appropriate and ensure the pharmacy services were in compliance with all state and federal regulations regarding pharmaceutical services.
1 a. A review of Resident 11's record indicated he was admitted on [DATE], with diagnoses that included mood disorder, major depressive disorder and dementia with behavioral disturbance. A review of the current physician's orders, dated 5/2022, included Selegiline 5 milligrams (mg) every morning, Paxil 40 mg every day at bedtime, Geodon 40 mg every 12 hours (antipsychotic medication use to treat schizophrenia and bipolar disorder), Clonazepam (treats anxiety and panic disorders) 1 mg every day at bedtime, and Lithium Carbonate 300 mg every day at bedtime, which had been started on 6/11/21.
During a concurrent interview and physician orders record review on 5/4/22 at 9:30 am, Medical Records and Quality Assurance staff (MR A) confirmed the above medications and doses.
A review of Lexi-comp (a nationally recognized drug reference) on 5/4/2022, included a warning for the following drug interactions, the use of Lithium and Paxil (SSRI) could lead to serotonin syndrome. As defined by the Centers for Medicare and Medicaid Services (CMS): Serotonin Syndrome is a potentially serious clinical condition resulting from overstimulation of serotonin receptors. It is commonly related to the use of multiple serotonin-stimulating medications (e.g., SSRI's, SNRIs, triptans, certain antibiotics). Symptoms may include restlessness, hallucinations, confusion, loss of coordination, fast heartbeat, rapid changes in blood pressure, increased body temperature, overactive reflexes, nausea, vomiting and diarrhea. Lexi-comp also included a warning Risk X: avoid combination for the use of Lithium and Selegiline. MAO-B may enhance the serotonergic effects of Serotonergic Agents. Avoid concomitant use of Type B MAOs with Lithium. At least 14 days should elapse between discontinuance of Type B MAOs and initiation of Lithium.
During an interview on 5/4/22 at 7:04 pm, a pharmacist (Pharm F) with the pharmacy that supplies the facility its medications, confirmed the combination of Selegiline and Lithium was a Risk X - avoid combination and other information from Lexi-comp included the risk of Serotonin Syndrome from the use of Lithium and Paxil.
During an interview on 5/05/22 at 8:10 am, the facility's consultant pharmacist (Pharm E) confirmed he had performed monthly medication reviews for Resident 11. He said the combination of Lithium and Paxil could result in serotonin syndrome and he said he did not inform the facility staff or physicians about this in his medication reviews. Pharm E said he uses Lexi-comp but disagreed that the combination of Lithium and Selegiline was a Risk X. He admitted that the combination of Lithium and Selegiline could cause clinical deterioration of the resident. He also confirmed he did not inform the facility's staff or physician about this in his medication reviews.
b. The following was also noted in Lexicomp on 5/4/22, regarding Lithium. ALERT: US Boxed Warning (a type of warning that appears on the package insert for certain prescription drugs)- Monitoring: Lithium toxicity is closely related to serum lithium levels and can occur at doses close to therapeutic levels (concentration usually expected to achieve the desired effect). Facilities for prompt and accurate serum lithium levels should be available before initiating therapy. Only prescribe in settings where serum concentration (the amount of a given medication present in the blood at the time of testing) monitoring is available. Toxic effects occur with serum concentrations =1.5 mEq/L and may be seen in some patients with serum concentrations as low as 1.2 mEq/L (Janicak 2021); . serum electrolytes (baseline, then periodically); ECG with rhythm strip (baseline for all patients >[AGE] years of age or if underlying cardiac risk factors (particular habits, behaviors, circumstances or conditions that increase a person's risk of developing cardiovascular disease), repeat as clinically indicated); . serum lithium levels (twice weekly until both patient's clinical status and levels are stable, then repeat levels every 1 to 3 months or as clinically indicated; closely monitor in patients with significant renal or cardiovascular disease, debilitation, dehydration, sodium depletion, or those taking concomitant medications that impact renal function); . signs of lithium toxicity (e.g., diarrhea, vomiting, tremor, mild ataxia, drowsiness, muscular weakness). Toxic concentrations:
>1.5 mEq/L (SI: >1.5 mmol/L): Early signs and symptoms of intoxication may include marked tremor, nausea, diarrhea, blurred vision, vertigo (a sensation of whirling and loss of balance), confusion, and decreased deep tendon reflexes (an involuntary reaction of a muscle to being passively stretched by percussion of the tendon) (APA 2002).
>2.5 mEq/L (SI: >2.5 mmol/L): Intoxication symptoms may progress to include severe neurological complications, seizures, coma, cardiac dysrhythmia, and permanent neurological impairment (APA 2002).
>3.5 mEq/L (SI: >3.5 mmol/L): Potentially lethal toxicity ([NAME] 2001).
During an interview on 5/4/22 at 9:30 am, MR A said there had been only one Lithium level done on 8/17/21 which was 1.0, since the medication was ordered on 6/11/21.
During a concurrent interview and record review on 5/4/22 at 4 pm, MR B confirmed baseline labs were done (as indicated in Lexicomp) and repeated every two to three months, but no EKG had been done when Lithium was initiated on 6/11/21 or afterwards.
During an interview on 5/05/22 at 8:10 am, Pharm E confirmed he did not make a recommendation about a lithium level during his medication reviews for Resident 11.
c. A review of Resident 11's medication administration record (MAR) listed the adverse side effects for all the psychotropic medications and included a place for the licensed nurses to document such, except for Lithium.
During a concurrent interview and physician orders record review on 5/4/22 at 9:30 am, MR A confirmed the adverse side effects for Lithium were not listed on the MAR.
During an interview on 5/04/22 at 5:30 pm, Licensed Nurse (LN) C reviewed the MAR and said the adverse side effects for Lithium were added today and prior to today, they did not appear on the MAR. She said she would not have known the side effects of Lithium, unless they were listed on the MAR, or she looked it up in a drug reference book.
d. Further review of Resident 11's MAR listed the target behaviors that were being monitored for both Lithium and Geodon, as aggressive combative behaviors.
During a concurrent interview and record review on 5/05/22 at 9:24 am, MR A confirmed the target behaviors for both Lithium and Geodon were the same and were for aggressive behaviors.
2 a. A review of Resident 12's record indicated he was admitted on [DATE] with diagnoses that included paranoid schizophrenia, anxiety disorder, and panic disorder. The current physician's orders included Seroquel 50 mg every day, Perphenazine 8 mg every morning and 16 mg every evening, Risperdal 8 mg every evening, and Clonazepam (used to treat anxiety and panic disorders) 1 mg every evening.
During a concurrent interview and record review on 5/4/22 at 10:44 am MR A confirmed Resident 12 was taking Seroquel, Perphenazine, and Risperdal since 10/18/19, all for paranoid schizophrenia with the behavior of psychosis to be monitored, and Clonazepam for panic disorder with the behaviors of panic to be monitored. The pharmacist's medication regimen reviews (MRR) from 5/29/21 - 4/30/22 were reviewed. On the MRR dated 10/24/21, Pharm E recommended a gradual dose reduction (GDR) for all of the four medications above due on 10/31/21. There was no mention by the pharmacist during the past year in his MRR's of duplicate/triplicate therapy for the same diagnosis and behaviors.
During an interview on 5/05/22 at 8:20 AM, Pharm E was asked if he had advised the facility that this resident was receiving duplicate therapy since he was receiving three antipsychotic medications for the same diagnosis and behavior. He said, in a review on 10/23/19, he advised the facility that this resident was on three antipsychotic medications and asked for a risk benefit statement (a comparison between the risks of a situation and its benefits). He said he has not included this recommendation since that time, although he has since recommended GDRs for these medications. He said he does not repeat the same recommendations month to month, so those MRR's will indicate that there are no irregularities. He said he tries to give the physicians time to respond and repeat the recommendation quarterly or at least yearly.
During a concurrent interview and record review on 5/05/22 at 9:35 am MR A confirmed the first MRR done by the pharmacist was 11/26/19 which indicated no irregularities. She said there was not a MRR done in October 2019 and said Resident 12 was admitted on [DATE].
b. During a concurrent interview and record review on 5/4/22 at 10:44 am MR A confirmed on the MRR dated 10/24/21, the Pharmacist recommended a GDR was due on 10/31/21, for Seroquel, Perphenazine, Risperdal and Clonazepam, all of which had been ordered on 10/18/19. This MRR was signed by Resident 12's physician on 11/1/21 and indicated I reviewed this resident's current medication regimen and agree with the consultant pharmacist's medication review. However, there was no note or order from the physician that actually noted which medication and dosage should be changed or no risk benefit statement as to why a GDR should not be done. MR A said she thought the Director of Nurses (DON) was supposed to follow up on that.
During an interview on 5/05/22 at 11:16 am, the DON confirmed if the physician signed, he agreed with the pharmacist's recommendation but does not make a change in the medication dosage, they have no process at this time, to follow up to see what changes the physician wants to make.
c. During a concurrent interview and clinical record review on 5/11/22 at 11:14 am MR A said the only target behavior to be documented for the three antipsychotic medications was psychosis. She said the MAR included the behaviors documented for 5/1/22 for psychosis, as well as the other behaviors of panic and anxiousness, and all indicate Resident 12 had 20 episodes for each behavior for th[TRUNCATED]
CONCERN
(F)
Potential for Harm - no one hurt, but risky conditions existed
Infection Control
(Tag F0880)
Could have caused harm · This affected most or all residents
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on interview, record and policy review, the facility failed to provide a safe, sanitary, and comfortable environment when ...
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**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on interview, record and policy review, the facility failed to provide a safe, sanitary, and comfortable environment when they failed to ensure that there was a dedicated facility-wide Infection Control Program (ICP) that prevented, identified, reported, investigated and controlled infections based on national standards; (Centers for Disease Control (CDC), Society for Healthcare Epidemiology of America ([NAME]), McGeer's Criteria and National Healthcare Safety Network (NHSN) are examples of nationally accepted standards), and failed to review their ICP policies annually.
This had the potential not to control infectious and communicable diseases before they spread to residents, staff, and visitors.
Findings:
The facility's policy titled, Infection Preventionist revised January 2012, was reviewed. The policy indicated that the Infection Preventionist (IP) .shall coordinate the development and monitoring of our facility's established Infection control policies and practices and .collect, analyze and provide infection data and trends to nursing staff and health care practitioners; consult on infection risk assessment and prevention control strategies; provide education and training; and implement evidence-based infection control practices.
On 5/11/22 at 5:01pm, an interview and review of the facility's ICP and ICP policies was conducted with the IP. The IP stated that he reviews facility infections under the Infections tab in the electronic health records however, that was not an accurate account of the infections in the facility because, the nurses don't always fill that out. The IP confirmed that he had not established a current system for infection surveillance (a process for reviewing staff implementation of the ICP and analyzing compliance), based upon national standards of practice. The IP confirmed that he did not have a routine, ongoing, and systematic way to collect information about infections and communicable diseases (such as conducting a facility risk assessment, what and when to report, reviewing orders and care plans for antibiotic therapy and reviewing laboratory cultures). The IP stated that he had no system for analyzing and interpreting facility infections (such as maintaining tracking documentation about the types of infections, organisms, symptoms, locations, antibiotic treatment, resolution, or the facility's overall infection rate percentages) and stated, I don't know how to do that yet. I need guidance. The IP confirmed that the ICP policies had not been reviewed since August 2019, three years ago, and should have been reviewed annually.
CONCERN
(F)
Potential for Harm - no one hurt, but risky conditions existed
Deficiency F0883
(Tag F0883)
Could have caused harm · This affected most or all residents
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on interview, record, and policy review, the facility failed to ensure that 20 of 20 residents (Residents 1, 3, 4, 5, 7, 8...
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**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on interview, record, and policy review, the facility failed to ensure that 20 of 20 residents (Residents 1, 3, 4, 5, 7, 8, 9, 10, 14, 16, 17, 18, 21, 22, 23, 24, 25, 26, 27, and 28) who were over the age of 65, were educated, offered and/or received the pneumococcal (a serious pneumonia in the lungs caused by streptococcal bacteria) vaccine according to the facility's policy.
This widespread failure represented a systemic failure which resulted in substandard quality of care for the facility residents and had the potential for vulnerable residents to be unprotected from pneumococcal pneumonia which could result in increased risk for contracting pneumonia with its associated complications.
Findings:
The facility's policy titled, Pneumococcal Vaccine revised 4/2013, indicated that all residents would be offered the pneumococcal vaccine to aid in preventing infectious diseases (pneumonia). Policy implementation directed that:
1. Residents will be assessed for eligibility to receive the pneumococcal vaccine prior to or upon admission and will be offered the vaccine within 30 days of admission.
2. Assessment of the resident's pneumococcal vaccination status will be conducted within 5 working days of admission.
3. Before receiving the vaccine, the resident or legal representative shall receive information and education regarding the benefits and potential side effects of the vaccine as outlined in the CDC vaccine publications. Such education will be documented in the resident's medical record
5. Residents/representatives have the right to refuse vaccination. If refused, documentation in the medical record will include the date and reason for refusal.
6. For residents who receive the vaccine, the date of the vaccination, lot number, expiration date, person administering, and the site of the vaccination will be documented in the resident's medical record.
7. Administration of the pneumococcal vaccine or revaccinations will be made in accordance with current CDC recommendations at the time of the vaccination.
A review of CDC website for Pneumococcal vaccine recommendations, as of 1/24/22, indicated adults of age [AGE] or older who have never received a pneumococcal vaccine or those who have an unknown vaccination history, should be offered a PCV15 (Vaxneuvance) or PCV20 (Prevnar20). If the Vaxneuvance is used, then this should be followed by a PPSV23 (Pneumovax) in one year. If the Prevnar20 is used, the vaccination is complete. If the resident had already received the Pneumovax first, then it should be followed with a Vaxneuvance or Prevnar20, in one year. If the resident had received the PCV13 (Prevnar13), regardless of age, then at [AGE] years of age or older, they should receive a Pneumovax.
On 5/3/22 at 8:15am, an interview and resident vaccination status review was conducted with the Infection Preventionist (IP). The IP presented an undated and untitled log of residents who had received pneumococcal vaccines. Of the 20 residents in the facility over the age of 65, the IP showed that only Resident 18 was recently (6/30/21) vaccinated, but had not indicated which pneumococcal vaccine was used, Resident 21 had refused the vaccine and the reasons were not documented, Residents 3, 4, 5, 8, 9, 24 and 26 had vaccine dates that were far more than one year old and did not describe which vaccine they were given, the IP did not have the pneumococcal vaccine status of Residents 1, 7, 10, 14, 16, 17, 22, 23, 25, 27 and 28. There was no evidence that education had been provided to the residents according to CDC vaccine publications.
The IP indicated that he has been in his position for 3 months. He stated, I'm trying to get organized and get caught up. I need someone to advise me. I did not get any training for this position. The IP indicated that he did not know the current CDC guidelines and timeframes for administering pneumococcal vaccines. The IP was not familiar with the different types of pneumococcal vaccines or in what order they were to be given. He indicated that he was not familiar with the facility's policy regarding pneumococcal vaccinations. The IP did not know that residents should be reviewed and offered the vaccine annually, even if they had previously refused. The IP indicated that he was not aware of the CDC educational materials that residents were supposed to receive.