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4301 MAPLESHADE LANE

PLANO, TX 75093

PATIENT RIGHTS

Tag No.: A0115

Based on a review of the clinical record, facility documentation and an interview with staff, the hospital failed to protect and promote each patient's rights, as evidenced by:

*Patient was given psychoactive medication without his consent (cross refer to A0131)

*Patient was not provided care in a safe setting, as he was not assessed appropriately by licensed staff per facility policy, professional scope of practice and physician's orders. He also was not observed at the precaution or observation level ordered by his treating physician (cross refer to A0144)

PATIENT RIGHTS: INFORMED CONSENT

Tag No.: A0131

Based on a review of the clinical record, facility documentation and an interview with staff, the facility violated the patient's right to refuse treatment when he was provided psychoactive medication without a properly executed consent form.

Findings were:

Review of the clinical record for patient #1, a 78-year-old male, revealed that the patient was admitted to WH on 4-16-22 at 12:55 am involuntarily from a nursing home. The psychiatric evaluation stated, in part:
"Patient [#1] is a poor historian, speaking random words which doesn't(sic) make any sense, states it's about chicken and 50s. Completely nonsensical and out to touch(sic) with reality. Reportedly patient was grabbing at his wife and pulling her away from leaving and pulling her away from leaving(sic). Grabbed her(sic) wife's wrist and would not let it go. Patient is talking to self." The patient had a history of dementia.

Risperdal (an antipsychotic) and Zoloft (an antidepressant) were ordered by patient #1's psychiatrist on 4-16-22. A consent dated 4-19-22 (which listed both medications) stated "verbal consent" but was not cosigned by a witness. The consent form was not signed by the treating physician.

The patient received doses of Risperdal on the following dates and times:
* 4-16-22 at 9:40 pm
* 4-17-22 at 9:00 pm
* 4-19-22 at 9:17 pm
* 4-20-22 at 9:00 pm
* 4-21-22 at 9:00 pm
* 4-22-22 at 9:08 pm
* 4-23-22 at 9:00 pm
* 4-24-22 at 9:20 pm
* 4-25-22 at 10:00 pm

The patient received doses of Zoloft on the following dates and times:
* 4-17-22 at 9:57 am
* 4-18-22 at 9:00 am
* 4-22-22 at 9:47 am
* 4-23-22 at 9:12 am
* 4-24-22 at 9:00 am
* 4-27-22 at 9:40 am
* 4-28-22 at 9:42 am
* 4-29-22 at 9:57 am

Facility policy B-MM 0-012 titled "Psychoactive Medication Informed Consent" states, in part:
"Purpose:
It is the policy of the facility to seek informed consent from the patient or guardian for the psychoactive medications specified below, and to respect the rights of the patient or guardian if he or she refuses consent. Patients must consent to take psychotropic drugs unless otherwise stipulated by psychiatric crisis or legal order.

Policy:
1. The treatment physician, RN, LVN, PA or registered pharmacist will explain to the patient and to the patient's legally authorized representative, information related to psychoactive medications in a simple, nontechnical language in the person's primary language. If the explanation is not provided by the treating physician, he or she must confirm the explanation with the patient and to the patient's legally authorized representative with two working days.
...
Documentation of Informed Consent:
Evidenced by a copy of the Consent for Psychoactive Medications
...
2. If the LAR or patient consents to the administration of the psychoactive medication but refuses or us unable to execute the form, a witness to the consent is obtained."

In interviews with staff #2 on 7-11-22 and 7-12-22, staff #2 confirmed that appropriate consent had not been obtained prior to administration of the psychoactive medications.

PATIENT RIGHTS: CARE IN SAFE SETTING

Tag No.: A0144

Based on a review of the clinical record, facility documentation and an interview with staff, the patient was not provided care in a safe setting, as he was not assessed appropriately by licensed staff per facility policy, professional scope of practice and physician's orders. He also was not observed at the precaution or observation level ordered by his treating physician.

Findings were:

Review of the clinical record for patient #1, a 78-year-old male, revealed that the patient was admitted to WH on 4-16-22 at 12:55 am involuntarily from a nursing home. The psychiatric evaluation stated, in part:
"Patient is a poor historian, speaking random words which doesn't(sic) make any sense, states it's about chicken and 50s. Completely nonsensical and out to touch(sic) with reality. Reportedly patient was grabbing at his wife and pulling her away from leaving and pulling her away from leaving(sic). Grabbed her(sic) wife's wrist and would not let it go. Patient is talking to self." The patient had a history of dementia.

The patient's medical history included the following:
* Arthritis
* Hypertension
* Parkinson's disease
* Anemia
* Oropharyngeal phase of dysphagia
* Dementia of Lewy bodies
* Hearing problems
* RA
* CKD
* BPH

RA - Rheumatoid Arthritis
CKD - Chronic Kidney Disease
BPH - Benign Prostatic Hypertrophy

The patient presented as confused, paranoid and unkempt in appearance. The patient was admitted to the facility with primary diagnoses of:
* Bipolar disorder, current episode manic & severe with psychotic features
* Lewy body dementia with behavioral disturbance
He was placed on q 15-minute checks and assault precautions.

The facility's nursing shift assessment tool listed the following areas to be assessed:
* Appearance
* Behavior
* Speech
* Orientation
* Medication compliance
* Sleep
* Appetite
* Bowel movement (yes/no)
* Elimination
* Intellectual functioning
* Thought content
* Affect
* Precautions
* Pain
* Respiratory system
* Cardiovascular system
* Neuromuscular system
* Gastrointestinal system
* Urinary system

A review of nursing shift assessments performed during the patient's stay revealed the following:
* 4-16-22 day shift - bowel movements, elimination, thought content, affect, precautions, respiratory system, cardiovascular system, neuromuscular system, gastrointestinal system and urinary system all not addressed
* 4-16-22 night shift - behavior, bowel movements, elimination, intellectual functioning, precautions, respiratory system, gastrointestinal system all not addressed
* 4-17-22 day shift - speech, bowel movements, elimination, thought content, precautions, respiratory system, cardiovascular system, neuromuscular system, gastrointestinal system, urinary system all not addressed
* 4-17-22 night shift - not done
* 4-18-22 day shift - sleep, bowel movements, elimination, precautions, all not addressed and assessment was performed by a LVN
* 4-18-22 night shift - shift assessment completed in its entirety by a Registered Nurse
* 4-19-22 day shift - bowel movements, respiratory system, gastrointestinal system all not addressed
* 4-19-22 night shift - respiratory system, gastrointestinal system, all not addressed
* 4-20-22 day shift - thought content, precautions, respiratory system, gastrointestinal system, all not addressed
* 4-20-22 night shift - not done
* 4-21-22 day shift - bowel movements not addressed and assessment was performed by a LVN
* 4-21-22 night shift - shift assessment completed in its entirety by a Registered Nurse
* 4-22-22 day shift - intellectual functioning, thought content, respiratory system, cardiovascular system, neuromuscular system, gastrointestinal system, urinary system all not addressed
* 4-22-22 night shift - shift assessment completed in its entirety by a Registered Nurse
* 4-23-22 day shift - not done
* 4-23-22 night shift - bowel movements, respiratory system all not addressed and assessment was performed by a LVN
* 4-24-22 day shift - not done
* 4-24-22 night shift - thought content not addressed
* 4-25-22 day shift - bowel movement, respiratory system, gastrointestinal system all not addressed
* 4-25-22 night shift - bowel movement, neuromuscular system all not addressed
* 4-26-22 day shift - bowel movement, precautions, respiratory system, gastrointestinal system all not addressed
* 4-26-22 night shift - not done
* 4-27-22 day shift - shift assessment completed in its entirety by a Registered Nurse
* 4-27-22 night shift - bowel movement not addressed
* 4-28-22 day shift - intellectual functioning, thought content, affect, precautions, pain, respiratory system, cardiovascular system, neuromuscular system, gastrointestinal system, urinary system all not addressed
* 4-28-22 night shift - sleep, bowel movement all not addressed and assessment was performed by a LVN
* 4-29-22 day shift - bowel movement not addressed

Of the nursing assessments, 5 of 27 were not performed, 4 of the 22 performed were performed by a Licensed Vocational Nurse and 18 of 22 performed were incomplete with regard to the areas to be addressed using the assessment tool.

The patient experienced a fall on the morning of 4-28-22. A physician's order that read "neuro checks q 4 hours for 24 hours" was written on 4-28-22 at 10:55 am. A review of the clinical record revealed that neuro checks were performed only at the below noted times:
* 4-28-22 at 12:33 pm
* 4-28-22 at 3:36 pm
* 4-28-22 at 6:44 pm
* 4-28-22 at 11:39 pm
* 4-29-22 at 5:49 am

The patient's observation frequency was increased by the physician from q 15 minutes to q 5 minutes on 4-28-22 at 9:38 am. A review of observation sheets revealed that the patient was never observed at the q 5-minute level and continued to be observed at the q 15-minute level until he was transferred to a medical hospital the next day. The sheets also revealed that he was not observed on assault precautions throughout his stay, as that precaution was not listed on his observation sheet. The observation sheets revealed the following discrepancies:
* 4-16-22 at 1:15 am listed the patient's location as "+3 min" and no behavior was listed
* 4-16-22 at 5:45 am listed the patient's location as "+6 min" and no behavior was listed
* 4-16-22 at 9:45 pm listed the patient's location as "+0 min" and no behavior was listed
* 4-17-22 at 5:30 am listed the patient's location as "+0 min" and no behavior was listed
* 4-17-22 at 7:15 pm listed the patient's location as "+0 min" and no behavior was listed
* 4-18-22 at 9:15 pm listed no location, no behavior and was not electronically signed
* 4-19-22 at 1:30 am listed the patient's location as "+0 min" and no behavior was listed
* 4-19-22 at 11:30 pm listed the patient's location as "+1 min" and no behavior was listed
* 4-20-22 at 12:45 am listed the patient's location as "+0 min" and no behavior was listed
* 4-20-22 at 2:30 am listed the patient's location as "+7 min" and no behavior was listed
* 4-22-22 from 6:15 am to 6:45 am contained no location, behavior or electronic signature
* 4-22-22 at 7:00 am listed the patient's location as "+13 min" and no behavior was listed
* 4-22-22 at 9:00 pm listed the patient's location as "+2 min" and no behavior was listed
* 4-22-22 at 10:00 pm listed the patient's location as "+1 min" and no behavior was listed
* 4-23-22 at 3:15 pm listed the patient's location as "+12 min" and no behavior was listed
* 4-23-22 at 4:30 pm contained no location, behavior or electronic signature
* 4-23-22 at 4:45 pm listed the patient's location as "+1 min" and no behavior was listed
* 4-23-22 at 9:30 pm listed the patient's location as "+0 min" and no behavior was listed
* 4-24-22 at 10:30 am listed the patient's location as "+2 min" and no behavior was listed
* 4-24-22 at 11:00 am listed the patient's location as "+0 min" and no behavior was listed
* 4-24-22 at 11:30 am contained no location, behavior or electronic signature
* 4-24-22 at 1:45 pm listed the patient's location as "+2 min" and no behavior was listed
* 4-24-22 at 8:45 pm listed the patient's location as "+8 min" and no behavior was listed
* 4-25-22 at 6:30 pm listed the patient's location as "+2 min" and no behavior was listed
* 4-26-22 at 6:15 am contained no location, behavior or electronic signature
* 4-26-22 at 6:30 am listed the patient's location as "+3 min" and no behavior was listed
* 4-27-22 at 6:00 am listed the patient's location as "+10 min" and no behavior was listed
* 4-27-22 from 7:15 pm to 7:45 pm contained no location, behavior or electronic signature
* 4-27-22 at 7:45 pm listed the patient's location as "+4 min" and no behavior was listed
* 4-27-22 at 10:00 pm listed the patient's location as "+0 min" and no behavior was listed
* 4-28-22 at 3:45 am listed the patient's location as "+0 min" and no behavior was listed
* 4-28-22 at 5:45 am contained no location, behavior or electronic signature
* 4-28-22 at 6:00 am listed the patient's location as "+6 min" and no behavior was listed
* 4-28-22 at 10:45 am listed the patient's location as "+4 min" and no behavior was listed
* 4-28-22 at 7:00 pm listed the patient's location as "+1 min" and no behavior was listed
* 4-28-22 at 8:30 pm listed the patient's location as "+13 min" and no behavior was listed
* 4-28-22 at 10:45 pm listed the patient's location as "+7 min" and no behavior was listed
* 4-29-22 at 5:45 am listed the patient's location as "+0 min" and no behavior was listed
* 4-29-22 at 6:15 am listed the patient's location as "+9 min" and no behavior was listed
The final documentation on the patient's electronic observation sheets was at 10:15 am on 4-29-22. A note at the bottom of the 4-29-22 observation sheet stated, "out of facility 2022-04-29 10:33 [AM in military time] ...accompanied by other".

A fall risk assessment was performed on the patient 25 times during his stay. No fall risk assessments were found for 4-17-22 night shift, 4-20-22 night shift, 4-22-22 day shift, 4-24-22 day shift or 4-28-22 night shift. The categories on the assessment included age, mental status, elimination, medications, diagnosis, ambulation/balance, nutrition, sleep disturbance and whether or not the patient had a history of falls in the last 3 months. Only 1 of the 25 fall risk assessments performed listed both his bipolar disorder diagnosis (worth 10 points) and his delirium diagnosis (worth 12 points). Although the patient fell on 4-28-22, the fall risk assessment performed on 4-29-22 stated that he had had no falls in the past 3 months and was performed at 6:15 pm, although the patient's discharge time was listed as 5:30 pm on his demographic sheet and 10:33 am on his 4-29-22 observation sheet.

A total number of points from the assessment classified the patient as follows:
* Low fall risk 51-89 points; interventions included reassess per shift, bed locked in lowest position, appropriate footwear, area free of clutter, nightlight in bathroom and personal items within reach
* Fall risk 90-105 points; interventions included all low fall risk interventions, create treatment plan for falls, educate on fall prevention strategies, yellow arm bracelet, encourage ambulation with assist
* High fall risk 106-123 points; interventions included all low and moderate fall risk interventions, increase observation to q 10, consider bed/chair alarm, consider OT/PT consult, consult with MD for 1:1 if needed, initiate RN hourly rounding, increase toileting with assist and pharmacological review by RN and MD
* Extreme fall risk 124+ points; interventions included all low, moderate and high-risk interventions, bed/chair alarm and 1:1 to be assessed every shift

As only one assessment was completed correctly, it cannot be said with certainty that the patient was observed at the appropriate fall risk level during his stay.

The patient was transferred to a medical hospital via ambulance at 5:30 pm on 4-29-22 for evaluation of his injuries sustained in the fall on 4-28-22.

Facility policy B-PC 02-004 titled "Interdisciplinary Assessment and Reassessment" states, in part:
" ...
Procedure:
Licensed, qualified staff assess each patient's care needs throughout the patient's hospital stay and provide patient specific care at the time based on assessment data. The assessment framework is structured around two components: Initial screening and assessment/reassessment of each patient as appropriate to the clinical discipline and individual patient condition changes.
...
3. Nursing Department
...
f. Patients are re-evaluated by a licensed nurse (RN, LPN/LVN - according to state specific practice acts) at a minimum every 12 hour shift - based on level of care and patient care needs."

Per the Texas BON at https://www.bon.texas.gov/faq_nursing_practice.asp.html#a22 Licensed vocational nurses may only conduct focused health assessments. A focused assessment is an appraisal of an individual client's status and situation at hand [what is occurring at that moment], contributing to the comprehensive assessment by the RN, supporting on-going data collection, and deciding who needs to be informed of the information and when to inform (Board Rule 217.11(2)(A)(i) and the Position Statement 15.27 LVN Scope of Practice.)

Facility policy B-PC 03-009 titled "Screening for Falls Risk" states, in part:
"Purpose:
This procedure establishes guidelines for fall prevention of falls during the behavioral health admission. The Edmonson Fall Risk Screening tool, as an evidenced based program, will be utilized for all hospital patients."

Facility policy WB-PC 01-010 titled "Observation Precautions" states, in part:
"Purpose:
The purpose of observations is to provide a system of progressive intensity of patient observation, precaution and oversight based on patient acuity, severity and type of symptoms and overall needs. This policy establishes guidelines for the delivery of patient care and to promote the safety of all patients in care.

Policy:
The policy is to provide all patients with a safe environment conducive to effective treatment of and improvement in the condition for which the patient admitted to the hospital. Precaution levels are used to promote these goals. It is the policy of the facility to provide levels of observation in compliance with physician orders and prescribed protocols.

Procedure:
1. The physician orders observation level at admission, and may change the level of the patient's condition warrants a change:
a. Q 15 minute
b. Q 5 minute
c. One-to-one

2. The physician will order a specific precaution for (including but not limited to):
a. Suicide
b. Assault
c. Elopement
d. Self-harm
e. Sexually acting out
f. Fall
g. Detox[ification]
h. Seizure
i. Other
...
4. Assignment of Rounding:
a. The Nurse Supervisor assigns staff to perform observations on a designated set of patients. These assignments are communicated at the beginning of the shift.
b. Patients placed on special precautions or are identified as high risk are identified to the assigned staff.
c. The Unit Nurse arranges for assigned staff to be relieved for breaks and meals.
d. Staff will complete the patient observation record as rounds are made, using the record described coding system.
e. Staff assigned to observations of patients are responsible for hand-off to other staff in order to maintain observations for any break. Change in assignment of rounding should be verbally communicated to the charge nurse/house supervisor prior to the staff member leaving the unit.
5. Completing Observation Rounds
a. Staff will observe patient and document on the correlating Level of Observation Sheet (Q5, Q15, or 1:1).
b. Assigned staff make direct visual contact with patients and confirm they are in no danger or distress.
c. Staff are vigilant for potential risk factors identified for specific patients (levels of assigned precautions).
d. If patient is sleeping or in bed, staff conducting observation rounds enter the room, approach the patient, check their identity and ensure that they are not in distress. To determine the patient is not in distress, the staff member watches, at a minimum, of three respirations (rise and fall of the chest). Also, staff is required to carry a flashlight to watch respirations.
e. Staff attempt to maintain the patient's privacy as much as possible. However, patient safety must be the main consideration. Therefore, rounding should never be omitted due to activities of daily living or hygiene.
f. Staff will log on and off rounding tool, as applicable, as they assume responsibilities."

In interviews with staff #2 on 7-11-22 and 7-12-22, staff #2 confirmed that patient #1 was neither assessed or monitored appropriately.