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Tag No.: A0115
Based on a review of clinical records and facility documentation, the facility failed to protect and promote each patient's rights, as evidenced by:
* 7 of 8 patients received psychoactive medications prior to providing informed consent. (refer to A0131)
* 5 of 8 patients were not observed at the monitoring level most recently specified in the patient's medical record. (refer to A0144)
* 1 of 8 patients did not receive skin assessments at the frequency dictated by facility policy. (refer to A0144)
* 8 of 8 patients did not receive fall risk assessments that were scored accurately and/or were performed at the frequency dictated by (refer to A0144)
Tag No.: A0131
Based on a review of clinical records and facility documentation, the facility denied the patients' right to refuse treatment by administering psychoactive medications without informed consent, as evidenced by:
* 7 of 8 patients received psychoactive medications prior to providing informed consent.
Findings were:
Patient #1 was prescribed the following psychoactive medications during her stay:
* Risperdal
* Sertraline
* Alprazolam
* Vistaril
The patient received one dose each of Risperdal and Sertraline prior to obtaining informed consent from the patient. The patient received 4 doses of Alprazolam and 5 doses of Vistaril without obtaining any informed consent during the patient's stay.
Patient #2 was prescribed Vistaril, Cymbalta and Trazodone during their stay. Patient #2 received 4 doses of Trazodone prior to signing a consent form on 5-5-23 at 8:29 pm.
Patient #3 was prescribed Haldol, Ativan and Risperdal during their stay. Patient #3 received a dose each of Haldol and Ativan at 6:05 pm on 5-3-23, although the consent was marked "patient unwilling/unable to sign" and contained no witness signatures. The patient received Risperdal on 5-5-23 at 9:14 am and no consent for this medication was present in the chart.
Patient #4 was prescribed Vistaril, Haldol and Ativan during their stay. Vistaril was given on 4-27-23 at 1:38 pm, although the chart contained no signed consent for it. The patient received doses of Haldol and Ativan on 4-29-23 at 4:27 pm. The consent form for Haldol was dated 4-29-23 at 4:05 pm by a staff nurse but contained no witness signature, although the patient signature portion stated "patient unable/unwilling to sign the consent". The consent form for the Ativan contained no staff or witness signature, although the patient signature portion stated "patient unable/unwilling to sign the consent".
Patient #5 was prescribed Vistaril during their stay. Vistaril was given on 4-26-23, although signed consent had never been obtained from the patient.
Patient #6 was prescribed Zyprexa, Prozac and Risperdal during their stay. Zyprexa was given on 4-24-23 at 10:25 pm, although signed consent was not obtained from the patient until 5-8-23 at 5:51 pm. Prozac was given on 4-25-23 at 9:41 am, although signed consent was not obtained from the patient until 4-25-23 at 7:01 pm. risperdal was given on 4-30-23 at 8:56 am, although signed consent was not obtained from the patient until 5-1-23 at 11:32 am.
Patient #7 was prescribed Zoloft and Vistaril during their stay. 18 doses of Zoloft had been given as of 5-9-23, although signed consent had never been obtained from the patient. The patient received doses of Vistaril on 4-21-23 and 4-23-23 prior to signed consent obtained 4-28-23 at 4:45 pm.
Facility policy MM-02 titled "Psychoactive Medication Administration/Consent-Texas" states, in part:
PURPOSE:
To ensure the safe, appropriate, and accurate administration and handling of medications.
To provide a process for ensuring patients and/or families are involved in decisions about care, treatment and services.
POLICY:
Medications are administered to patients by qualified licensed personnel in compliance with regulatory bodies after verbal informed consent has been provided by the patient. Qualified licensed personnel are defined as Registered Nurses, Licensed Vocational Nurses, Licensed Practical Nurses, Physicians and Non-Physician Practitioners (NPP). If psychoactive medications are prescribed by a Physician or NPP, a written informed consent must be obtained from the patient or legally authorized representative.
PROCEDURE:
1. Only licensed prescribers are allowed to provide orders for medications. All medications require an order which is written on the physician/NPP order form and must contain the name, dose, time to be administered, route, and indication.
2. The initiation or continuation of any psychoactive medications prescribed at admission or during the hospital stay requires a signed informed psychotropic medication consent form regardless if the patient was admitted as voluntary or involuntary. The patient or legal representative must sign or give verbal consent with two staff witnesses.
3. The prescriber and nurse provide education from the system portal to the patient and/or the patient's legally authorized representative in nontechnical language in the patient's primary language. If the information is not provided by the treating physician, the physician must confirm the explanation with the patient and the patient's legally authorized representative within two business days.
4. The patient must be informed of:
* The name of the medication and the beneficial effects on the patient's mental illness or condition expected as a result of treatment with that medication;
* The probable health and mental health consequences to the patient of not taking the medication, including the occurrence, increase, or reoccurrence of symptoms of mental illness;
* The existence of generally accepted alternative forms of treatment, if any, that could reasonably be expected to achieve the same benefits as the medication and why the physician rejects the alternative treatment;
* The description of the proposed course of treatment with medication including any necessary evaluations and lab work;
* The fact that side effects of varying degrees of severity are a risk of all medication; The relevant side effects of the medication, including:
· any side effects which are known to frequently occur in most persons;
· any side effects to which the particular patient may be predisposed; and
· the nature and possible occurrence of the potentially irreversible symptoms of tardive dyskinesia.
* The need to advise mental health facility staff immediately if any of these side effects occur;
* Instruction that the patient may withdraw consent at any time without negative actions on the part of staff.
5. Refusal to consent to the administration of a psychoactive medication includes the following behaviors:
· The patient or legally authorized representative communicates orally, through sign language, or in writing that he or she refuses psychoactive medication.
· The patient communicates through ANY behavior that he or she refuses psychoactive medication, e.g., refusing to swallow oral medication or refusing to submit to hypodermic injection of psychoactive medication.
· The patient pretends to swallow oral psychoactive medications, and the attending physician determines that the pretending behavior is due to an unwillingness to take the medication.
· The patient gives either no response or a noncommittal response after he or she has received the standard risk-benefit explanation.
6. All first doses administered will be closely monitored and documented. The first dose administered is documented on the first dose/PRN form and the response, tolerance, and effects monitored.
7. Informed consent may be provided via phone conversation. Phone consents require two signatures of staff or the prescriber to validate that verbal consent was provided via phone by the authorized patient representative.
8. If consent for psychotropic medications cannot be obtained, the treating psychiatrist or physician can apply for the administration of involuntary psychotropic medications with an accompanying affidavit supporting the opinion that the patient is mentally ill and/or incompetent to participate in treatment decisions, and that the medications are clinically indicated. The statement also may need to review the patient's prior noncompliance with medication and expected benefit and potential side effects.
9. Court-ordered involuntary medications can be granted by a court ordered medication commitment, often lasting only as long as the patient's civil commitment or for a period set by the judge. are granted by a court in non-emergent situations. Mentally ill persons who require chronic administration of medication and yet have minimal insight into their need may warrant involuntary medications."
The above was confirmed in an interview with the CEO and other administrative staff on 5-9-23.
Tag No.: A0144
Based on a review of clinical records and facility documentation, the facility failed to ensure the patients' right to care in a safe setting, as evidenced by:
* 5 of 8 patients were not observed at the monitoring level most recently specified in the patient's medical record.
* 1 of 8 patients did not receive skin assessments at the frequency dictated by facility policy.
* 8 of 8 patients did not receive fall risk assessments that were scored accurately and/or were performed at the frequency dictated by facility policy.
As the facility cares for a population age 40 and older, this puts the patients at an increased of (including, but not limited to) falls, elopement, violence, suicide and bleeding and skin breakdown.
Findings were:
Patient #1 was admitted to the facility on 3-1-23 and discharged on 3-27-23 She was admitted on q 15 minute checks as well as additional precautions for falls, elopement, violence and suicide/self-harm.
Fall risk assessments were performed on the following dates:
* 3-1-23 at 6:25 pm - Assessment did not include the patient's diagnosis of dementia or delirium (worth 12 points)
* 3-10-23 at 10:39 pm - Assessment did not include the patient's diagnosis of major depression (worth 10 points)
* 3-18-23 at 2:30 pm - Assessment did not include the patient's diagnosis of major depression (worth 10 points)
* 3-26-23 at 7:48 am - Assessment did not include the patient's diagnosis of major depression (worth 10 points) or the fact that she was taking cardiac medications (worth 10 points)
Skin assessments were performed on the following dates:
* 3-1-23
* 3-9-23
* 3-11-23
* 3-12-23
* 3-20-23
* 3-26-23
A review of the observation sheets for patient #1 revealed that a total of 47 observation sheets (completed every 12-hour shift) should have been completed during the patient's stay. A review of observation sheets present during the patient's stay revealed the following:
* No observation sheets were found for 3 of the 47 shifts
* Of the 44 sheets present, 9 of the 44 sheets were missing RN assessments (to be completed q 2 hours, per facility policy)
* Of the 44 sheets present, 1 of the 44 sheets was missing a q 15 minute staff check at 6:45 pm
None of the 44 observation sheets noted the patient's additional precautions for falls, elopement, violence and suicide/self-harm.
On 3-27-23, patient #1 was noted to have unexplained bruising and abrasions to her face, as well as an alteration in mental status. She was sent via ambulance to a nearby medical hospital for evaluation and did not return to the facility.
Patient #2 was admitted to the facility on 4-30-23 and was still inpatient as of 5-9-23. He was admitted on q 15 checks as well as additional precautions for falls and suicide/self-harm.
Fall risk assessments were performed on the following dates:
* 4-30-23 - Assessment did not include the fact that the patient was taking cardiac medications (worth 10 points) or the patient's diagnosis of substance abuse (worth 8 points)
* 5-6-23 - Assessment did not include the fact that the patient was taking cardiac medications (worth 10 points) or the patient's diagnosis of substance abuse (worth 8 points)
A review of observation sheets for patient #2 revealed a total of 18 observation sheets. The following was noted:
* Observation sheet for 4-30-23 contained no q 15 checks for 7:00 am or 7:15 am
* Observation sheet for 5-1-23 contained no q 15 checks for 7:00 am through 7:30 am
None of the 18 observation sheets noted the patient's additional precautions for falls or suicide/self-harm.
Patient #3 was admitted to the facility on 5-3-23 and was still inpatient as of 5-9-23. He was admitted on q 15 checks as well as additional precautions for violence/homicide, suicide/self-harm and elopement.
Fall risk assessments were performed on the following dates:
* 5-3-23 - Assessment did not include the fact that the patient was taking psychoactive medications (worth 8 points) or the patient's diagnosis of depression (worth 10 points)
* 5-6-23 - Assessment did not include the fact that the patient was taking psychoactive medications (worth 8 points) or the patient's diagnosis of depression (worth 10 points)
A review of observation sheets for patient #3 revealed a total of 12 observation sheets. The following was noted:
* The observation sheet for 5-7-23 contained no q 15 checks for 6:30 am or 6:45 am.
None of the 12 observation sheets noted the patient's additional precautions for violence, suicide or elopement.
Patient #4 was admitted on 4-26-23 and was still inpatient as of 5-9-23 The patient was admitted on q 15 checks as well as additional precautions for violence/homicide, falls and elopement.
Fall Risk assessments were performed on the following dates:
* 4-26-23
* 5-6-23
The fall risk assessments were performed with greater than a 7-day span in between, in violation of facility policy.
A review of the patient's observation sheets revealed that none noted the patient's additional precautions for violence, falls or elopement.
Patient #5 was admitted on 4-18-23 and discharged on 5-8-23. The patient was admitted on q 15 checks as well as additional precautions for falls.
Fall Risk assessments were performed on the following dates:
* 4-18-23
* 4-23-23
* 5-6-23
The fall risk assessment performed on 5-6-23 was performed with greater than 7 days after the prior assessment, in violation of facility policy.
A review of the patient's observation sheets revealed that none noted the patient's additional precautions for falls.
Patient #6 was admitted on 4-24-23 and was still inpatient as of 5-9-23. The patient was admitted on q 15 checks as well as additional precautions for violence, falls, bleeding and elopement.
Fall Risk assessments were performed on the following dates:
* 4-24-23 - Assessment did not include the fact that the patient was taking cardiac medications (worth 10 points) or that the patient experienced altered elimination/incontinence, as evidenced by the fact that the patient was taking medication for overactive bladder (worth 12 points)
* 5-6-23 - performed greater than 7 days after the prior assessment, in violation of facility policy.
A review of the patient observation sheets revealed the following:
* The observation sheet for 4-26-23 contained no RN checks from 7:00 am to 6:45 pm.
* The observation sheet for 4-26-23 contained no q 15 check from 6:45 pm through 7:30 pm.
None of the patient's observation sheets noted the patient's additional precautions for violence, falls, bleeding or elopement.
Patient #7 was admitted on 4-20-23 and was still inpatient as of 5-9-23. The patient was admitted on q 15 checks as well as additional precautions for falls and suicide/self-harm.
Fall Risk assessments were performed on the following dates:
* 4-20-23 - Assessment did not include the fact that the patient was taking cardiac medications (worth 10 points)
* 4-22-23 - Assessment did not include the fact that the patient was taking cardiac medications (worth 10 points)
* 5-6-23 - Performed greater than 7 days after the prior assessment, in violation of facility policy.
A review of patient observation sheets revealed the following:
* The observation sheet for 4-20-23 contained no q 15 checks for 7:00 pm or 7:15 pm.
* The observation sheet for 5-4-23 contained no RN check for 6:00 pm.
None of the patient's observation sheets noted the patient's additional precautions for suicide or falls.
Patient #8 was admitted on 5-4-23 and was still inpatient as of 5-9-23. The patient was admitted on q 15 checks as well as additional precautions for falls and suicide/self-harm.
Fall Risk assessments were performed on the following dates:
* 5-4-23 - Assessment did not include the fact that the patient was taking psychoactive medication (worth 8 points)
* 5-6-23 - Assessment did not include the fact that the patient had a diagnosis of depression (worth 10 points)
A review of the patient's observation sheets revealed that none of the sheets noted the patient's additional precautions for suicide or falls.
Facility policy AS-12 titled "Fall Assessment/Re-Assessment & Precautions" states, in part:
"POLICY:
Inpatient:
1. All patients will be assessed and identified for the potential of being at risk for falls within the first 8 hours of admission at the time of their initial nursing assessment, immediately after a fall, or change in mobility status, and/or every 7 days if identified as "at risk for falls".
2. In the event of a fall occurrence, patients will be re-assessed and additional fall prevention interventions will be implemented.
3. The Registered Nurse (RN) utilizing the Fall Risk criteria on the Fall Risk Assessment Tool, will assess/re-assess and determine the risk of all patients with regard to falls and implement fall precautions if so indicated.
...
PROCEDURE:
Inpatient:
1. The admitting RN shall complete an initial assessment within 8 hours of patient's admission, evaluates patient's ambulatory status and completes Fall Risk criteria. If a Fall Risk Score indicates the patient is "at risk for falls", the immediate initiation of fall precautions will occur.
2. If a patient scores as "at risk for falls" during the initial nursing assessment, a Treatment Plan to address the risk for falls will be initiated by the RN.
3. Criteria that may be used to determine fall risk:
o Age
o Mental Status
o Elimination
o Medications
o Diagnoses
o Ambulation/Balance/Mobility Deficits/Use of assistive devices
o Nutrition
o Sleep Disturbances
o History of Falls
4. The patient shall be re-assessed by the RN for fall risk at a minimum of every 7 days, immediately after a fall, and as needed based on patient's condition.
5. Interventions shall include:
o Mandatory fall precautions - Interventions for patients "at risk for falls"
o Apply yellow fall risk arm band
o Provide nonskid slipper socks or ensure appropriate skid-proof footwear is used
o Provide patient education
o Initiate Fall Risk treatment plan
o Additional fall precautions - (must select at least 2 additional interventions from below that are appropriate to the patient's individual needs)
o Bed alarm
o Chair alarm
o Ambulate with staff assistance
o Ensure assistive devices ( ex: eyeglasses, hearing aids) are available
o Keep pathways clear
o Line of Sight observation level
o 1: 1 observation level
o Reclining chair
o Assist with ADLs"
Facility policy NSG-39 titled "Skin/Wound Care" states, in part:
"PURPOSE:
To identify patients at risk for skin breakdown and pressure injury formation and skin abnormalities and provide interventions for the prevention, assessment and treatment of such.
POLICY:
The hospital recognizes the importance of managing skin integrity throughout a patient's stay. Nursing, in collaboration with the healthcare team, will assess and managed skin integrity for all patients upon admission and throughout their stay
PROCEDURE:
Skin Assessment
1. A skin assessment is completed by the registered nurse on all patients at admission, weekly, after a fall/injury, upon new skin findings and at discharge.
2. Description of skin abnormalities should be documented according to assessed findings including the initiation of the impaired skin integrity treatment plan.
3. Wound care protocol/prevention will be implemented as applicable and as ordered by the Physician/Non-Physician Practitioner (NPP)."
Facility policy CS-23 titled "Level of Observations" states, in part:
"PURPOSE:
To provide staff with a framework for monitoring patients to ensure safety. Observation should be both safe and therapeutic. Respect should be shown for the patient's need for autonomy while ensuring safety.
POLICY:
Three levels of observation are utilized: every 15-minute (Q 15 minute) observation; Line of Sight (Constant Observation); and one-to-one observation. The level of observation is determined by the individual needs of the patient and treatment team recommendation and ultimately requires a physician order.
Observation Levels:
o Every 15 minutes - the staff member will visually observe the patient every 15 minutes to monitor their location and activity, with an emphasis on any noticeable behaviors of escalation, aggression, and unsafe activities.
o Line of Sight (Constant Observation) - the staff member will ensure the patient is visually within sight at all times
One-to-one observation - The staff will ensure the patient is visually within sight and within arms-reach of a staff member at all times and in all circumstances. See Appendix A for more information.
PROCEDURE:
1. The initial patient observation level is determined and ordered by the physician upon patient admission. The decision to utilize one of the observation levels is made based on the patient's needs and presenting symptomology. The following are considered when the decision for an observation level is made:
o Suicidal ideation
o Violence/ aggressive threats
o Poor judgment
o Poor impulse control
o Actively psychotic
o High Fall risk
o Manic behavior
o Intrusive behavior placing patient, hospital employees and/or peers at risk.
2. The physician and treatment team members are charged with the responsibility of accurately assessing each patient's needs. A patient's observation level should be increased or decreased in intensity based on ongoing assessment findings.
3. Staff members utilize the close observation checklist form (Q 15 check sheet) to document the ongoing observation and location of the patient. Additional information regarding, activities are included on the form when relevant, (i.e. water offered, activities of daily living). The observing staff initials the 15-minute increments on the form to indicate the patient was observed. This form or vital sign form will also be utilized for 1:1 monitoring when a stricter level of monitoring is ordered and will be notated as such on top of form.
The staff member signs the signature line at the bottom of the form to validate their initials and credentials. The Registered Nurse (RN) will conduct routine rounds to visually observe each patient for safety at least once every 2 hours (unless more often is warranted) and will validate rounds by initialing in the appropriate section( s) of the form.
Every 15 Minute Observation:
o Physician/NPP provides order for observation level. Considers patient's individual needs and risks.
Note: The Charge Nurse may utilize clinical judgment to increase the intensity of observation when the patient's need indicates it. Will notify the Physician/NPP for order and notify Director of Nursing for staffing considerations.
o RN assigns staff members to q 15-minute observations, Line of Sight or one-to-one observation based on physician/NPP orders and assigns breaks and meal-time relief.
o RN makes observations at least every 2 hours during the shift and initials the RN observations on the close observation sheet.
Assigned Nursing Staff (Mental Health Technician) performs the following:
Visually observes the patient every 15 minutes to monitor their location and activity with an emphasis on any noticeable behaviors of escalation, aggression, and unsafe activities.
o Indicates the type of specialty observation on the form (Q 15,Line of Sight, 1: 1) according to observation level ordered per physician/NPP order.
o Special precautions such as fall, elopement, etc will be communicated on the handoff report at shift change and communicated to the MHT by the nurse if the precautions change throughout the shift so the report can be updated.
o Physically walks to find each patient on q 15-minute observation.
o Documents patient's location and reports identified risk to RN when indicated.
o Documents the location on the close observation form and documents the activity when indicated, e.g., water offered, and etc.
o Initials the form every 15 minutes.
o Notifies the Charge nurse immediately of any patient who cannot be observed or located."
The above was confirmed in an interview with the CEO and other administrative staff on 5-9-23.