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2434 WEST BELVEDERE AVENUE

BALTIMORE, MD 21209

PATIENT RIGHTS: INFORMED CONSENT

Tag No.: A0131

Based on review of 10 medical records, policies and procedures, and interviews with staff, it was determined that the hospital failed to involve the patient/family representative in the treatment planning, including decision making regarding medication adjustment for 1 of 10 patients reviewed.

Surveyors reviewed the facility's policy "Informed Consent", effective on 10/2018, which stated in part:

"Consent: Patients/residents have the right to informed participation in decisions involving their health care. This should be based on a clear explanation of their condition, all proposed procedures, including the possibilities of any risks, serious side effects, problems related to recuperation, alternative treatments or no treatments, benefits, and likely and unanticipated outcomes."

Patient #1 (P1) was a 90+ year old patient who was transferred to the hospital from another area hospital to assist with medication management. P1 was deemed incapable of decision-making, and a family member for P1 signed all appropriate consent forms and was in communication with the hospital throughout P1's admission. An Administrative Consent form, signed by P1's family member, was located in P1's chart and stated in part: "I understand that I have the right to consent or refuse any proposed procedure or therapeutic course."

During P1's stay in the hospital, P1 received medication adjustment to assist with control of P1's behavior, including agitation, restlessness, and aggression. The adjustments occurred on days 3, 4, 5, 10, and 14 of the patient's admission. The medication dosage was consistently increased and had the ability to alter P1's mood and behavior, and also caused drowsiness. The provider noted that the patient was unable to participate in an interview, but did not document that P1's family was notified of the medication adjustments.

It was also documented that P1's family did not want P1 to receive "as needed" medications in addition to P1's scheduled medications, as P1 experienced excessive drowsiness. However, it was documented on day 12 that P1 received an unscheduled medication "as needed" to control an episode of undesired behavior; this was 2 days after P1's family made the request to omit any additional medications given "as needed" to control P1's behavior. Further review of the medical record failed to reflect that P1's family was made aware of this one time dose.

While touring the unit, an informal interview was conducted with a medical physician on February 4, 2020 around 10:30 am. When asked if the providers notified the family (in a case where the family was the decision maker) regarding changes in medication, the provider stated that due to frequent adjustments and the number of patients, it was not possible to always notify the family.

P1's care was also discussed with the treatment team during weekly care conferences. The facility's "Resident/Patient Care Conferences" policy, revised on 02/2017, stated in part: "Patient /family members are invited to attend rounds on the unit weekly ...Issues addressed at all conferences include but not limited to: directives of care, change of condition since last conference (falls, unexpected weight loss/gain, mental status, vital signs, new wound, consultations/hospitalizations) current medical problems, pain management, review of current medications, quality of life issues, behavioral/ psychological issues, restraints/ wanderguard/ special device needs, restorative nursing needs, vaccination status, resident/family concerns."

P1 had four documented care conferences, which occurred on day 5, 11, 13, and 18 of P1's admission to the facility. A review of all of the care conference documents showed the "Family Updated" section left blank, which implied that P1's family was not made aware of the outcome of care conference. Further review of P1's medical record revealed no documentation of P1's family being invited to attend a care conference.

For patients with a documented certification of incapacity, the surrogate decision maker/responsible party should be notified of changes in the treatment plan. The obligation to update and discuss the treatment plan should be incumbent upon all providers in order to promote the right of the patients and/or their representatives to participate in the decision making process. The hospital's failure to notify P1's family member of the medication changes precluded P1's representative from exercising the right to make informed decision about P1's care and the ability to accept/refuse treatment.

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0175

Based on review of 10 medical records, and hospital's policies and procedures, it was determined that the hospital failed to document appropriate restraint monitoring for 2 of 10 patients reviewed.

Surveyors reviewed the hospital's policy pertaining to restraint usage and monitoring, titled "Restraint Use-Chronic Hospital Only" (revised 07/2018) which stated in part:

"Family or, as applicable, guardian or designated health care agent, will be informed of the application of the restraint as soon as possible after implementation but generally not later than the end of that shift ...Maximum timeframes for monitoring and assessment are: 1. Nonviolent and/or Non Self-Destructive Restraints - Every 2 hours, with the exception of vital signs, respiratory status, intake and output, and cardiac status which may be taken as clinically indicated and/or ordered. 2. Violent/Self-Destructive Restraint/Seclusion - Monitoring will be documented every 15 minutes and assessments every 1-2 hours for restraints and seclusion. With the exception of vital signs, respiratory status, intake and output, and cardiac status which may be taken as clinically indicated and/or ordered...Readiness for discontinuation (if individual is not an RN or LIP [Licensed Independent Practitioner] and identifies that the patient is ready for the restraint/seclusion to be discontinued per criteria, this MUST be assessed, confirmed and documented by the responsible RN or LIP)."

Patient #1 (P1) was a 90+ year old patient who was transferred to the hospital from another area hospital to assist with medication management. Record review determined that P1 was placed into restraints via a waist belt due to wandering, agitation, impulsive behaviors, and not responding to redirection throughout the admission. Orders for the waist belt restraint were placed on three occasions while the patient was hospitalized.

Review of restraint documentation on day 1 of admission, showed that the hospital failed to document when the restraints were discontinued. The restraint order was placed at 8:45 am. Nursing restraint monitoring documentation began at 8:25 am and ended at 6:00 pm. The restraint monitoring documentation at 6:00 pm stated that it was for "ongoing restraint monitoring", not for discontinuing the restraints. There was no documentation found in the medical record which indicated when the restraints were discontinued for this episode.

On day 12, P1 had a waist belt restraint order entered which stated, "Unable to remember safety precautions" as the reason for the restraint. Restraint documentation on day 12 did not identify at what time P1 was placed into restraints. The restraint order was placed at 3:34 pm; however, the monitoring documentation began at 8:00 pm. There was no documentation found which stated at what time the restraints were initiated. The initiation documentation would have also reflected what behaviors were present to justify the use of a restraint.

On day 13, P1 was placed into the waist belt restraint for climbing out of the bed/chair/stretcher and being unable to follow directions. Restraint monitoring documentation showed that the patient remained in restraints for 17 hours and 25 minutes; however, bi-hourly documentation for 6:00 am was not found within the medical record.

Due to lack of documented restraint monitoring within P1's medical record, it could not be ascertained when the patient was placed and taken out of the restraints, if the patient's family was aware of the restraint episode, or if behaviors were present that warranted the continued use of restraints.

Patient #5 (P5) was a 75-year old nursing home resident who was admitted due to behavior disturbances, secondary to progressive mental decline. P5 was documented as oriented to self only, with presenting symptoms of combativeness, aggressiveness, and poor insight, per admitting history and physical.

Review of P5's medical record showed a restraint episode on day 1 of admission. The order for Restraints, Nonviolent/Non-Self Destructive, was entered at 9:54 pm for a waist belt with justification for this restraint as "unable to remember safety precautions". In addition to the waist belt, an antipsychotic medication was ordered at the same time and administered via an intramuscular (IM) injection. P5's behavior leading up to this restraint episode was documented as "very aggressive, confused, attacking a nurse, kicking, punching, and scratching staff". Despite the patient's documented behavior, the order was entered for a nonviolent/ non-self-destructive restraint, which was not reflective of the hospital's policy for restraints.

Surveyors reviewed the hospital's policy titled "Restraint Use- Chronic Hospital Only" (last revised on 07/18). Section B- Clinical Justification Criteria detailed the two categories of restraints and indications for their use: "1. Nonviolent and/ or Non-self -destructive, indication examples, line protections and surgical/wound maintenance; and 2. Violent and/or Self-Destructive, indication examples, combative, harmful to self and others, aggressive, self-destructive, severely agitated, threatening behaviors, and significant disturbances to the therapeutic environment."

Based on the hospital's Restraint Use policy, P5's behavior warranted an application of violent and/or self-destructive restraints. The patient was unable to self-regulate, posing a threat to self and others, required an intervention and assessment by a clinician. The lack of an appropriate order prevented the patient from receiving 15-minute monitoring required for violent and/or self-destructive restraints.

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0178

Based on review of 10 medical records, policies, and procedures, it was determined that the hospital failed to provide a face-to-face evaluation and appropriate monitoring to 1 of 10 patients reviewed, who was restrained due to violent behaviors, but without a violent restraint order.

Surveyors reviewed the hospital's policy titled "Restraint Use- Chronic Hospital Only" (last revised on 07/18). Section B- Clinical Justification Criteria detailed the two categories of restraints and indications for their use: "1. Nonviolent and/ or Non-self -destructive, indication examples, line protections and surgical/wound maintenance; and 2. Violent and/or Self-Destructive, indication examples, combative, harmful to self and others, aggressive, self-destructive, severely agitated, threatening behaviors, and significant disturbances to the therapeutic environment."

Patient #5 (P5) was a 75-year old nursing home resident who was admitted due to behavior disturbances, secondary to progressive Dementia. P5 was documented as oriented to self only, with presenting symptoms of combativeness, aggressiveness, and poor insight, per admitting history and physical.

Review of P5's medical record showed a restraint episode on day 1 of admission. The order for Restraints, Nonviolent/Non-Self Destructive was entered at 9:54 pm for a waist belt with justification for this restraint "unable to remember safety precautions". In addition to the waist belt, an antipsychotic medication was ordered at the same time and administered via an intramuscular (IM) injection. P5's behavior leading up to this restraint episode was documented as "very aggressive, confused, attacking a nurse, kicking, punching, and scratching staff". Despite the patient's documented behavior, the order was entered for a nonviolent/ non-self-destructive restraint, which was not reflective of the hospital's policy for restraints.

Based on the hospital's Restraint Use policy, P5's behavior warranted an application of violent and/or self-destructive restraints. The patient was unable to self-regulate, posing a threat to self and others, required an intervention and assessment by a clinician. The lack of an appropriate order prevented the patient from receiving an assessment in the form of a face-to-face evaluation by a provider within an hour of restraint application.

In summary, the hospital staff's failure to appropriately identify and order the correct restraint intervention for P5 prevented P5 from receiving a required face-to-face assessment within an hour of initiation of the restraint.