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Based on review of the patient record, patient #3 was not assessed for less restrictive interventions prior to the initiation of restraint as evidenced by:
Patient #3 is a 61-year-old female who presented to the ED via police on an emergency petition on 11/9/2011 at 11:23 am after binging on crystal methamphetamine for 3 days, and making statements that she wanted to kill herself. Her toxicology screen was positive for cocaine, benzodiazepines and amphetamines. A primary diagnosis was Psychosis, unspecified. A secondary diagnosis was Drug intoxication, pathological.

At 1:30 PM, a nursing note states " Pt(patient) behavior restless and resistive of attempts from staff for pt safety; verbal and physical threats to staff; 4-point restraints applied to pt and staff safety pt became somnolent after restr (sic) applied; meds canceled pt condition no longer warrants meds " and "NOTE: 4 pt restraints and 1:1 constant obs (observation) by sitter started at 1320." An order sheet timed at 1:15 PM appears in the record, which notes that patient #1 is more than 18 years old, was placed in 4-point vinyl restraint, and the form is only signed by an RN. No documentation for less restrictive interventions is found.

Clinical interventions for patient care required by the Code of Maryland Regulations (COMAR) were not performed for patient #2 and #3 as evidenced by:


Patient #2 is a 23-year-old female who presented to the ED on 12/22/2011 at 4:16 PM via family car following a psychotic break with aggressive behavior. Patient #2 had been at college where she was reported by a roommate to drink and act in a bizarre and aggressive manner. Patient #1' s toxicology screen was positive for marijuana. Patient #2 received a primary diagnosis of psychosis, and a secondary diagnosis of urinary tract infection.
An RN note of 6:03 PM states "Pt. medicated as per order and placed in 2-point restraints for violent aggressive behavior. 1:1 sitter remains at bedside." Patient #2 was removed from restraint at 10:45 PM.

Patient #3 is a 61-year-old female who presented to the ED via police on an emergency petition on 11/9/2011 at 11:23 am after binging on crystal methamphetamine for 3 days, and making statements that she wanted to kill herself. Her toxicology screen was positive for cocaine, benzodiazepines and amphetamines. A primary diagnosis was Psychosis, unspecified. A secondary diagnosis was Drug intoxication, pathological.
At 1:30 PM, a nursing note states "Pt (patient) behavior restless and resistive of attempts from staff for pt safety; verbal and physical threats to staff; 4-point restraints applied ... " Patient #3 remained in restraints until 9 PM.
The Code of Maryland Regulations (COMAR) 10.21.12.08 titled "Clinical Interventions During Restraint" states in part:
"B. While the patient is restrained, in order to provide appropriate clinical care, at a minimum, staff clinically trained to do so shall:

(3) Closely observe the patient at least every 15 minutes, and document each observation by the observer;

(4) Unless contraindicated by circumstances as assessed and documented by a physician or registered nurse, at least hourly, make and document personal contact with the patient for the purpose of:
(b) Checking circulation of the extremities restrained;
(c) Adjusting the restraint; and
(d) Realigning the body or massaging the extremities restrained, or both;

(5) Unless contraindicated by circumstances as assessed and documented by a physician or registered nurse offer or provide the following:
(a) Full range of motion, every 2 hours;
(b) Toilet facilities, at least every 2 hours;
(d) Meals, at the regularly scheduled hours and under the supervision of nursing personnel; and
(e) Fluids, at least every 2 hours; and

(6) As clinically indicated, record temperature, pulse, blood pressure, and respirations.

C. At least once every 2 hours, a physician or registered nurse shall assess the appropriateness of continuing the restraint and document the factors supporting the assessment in the patient's medical record.

D. Unless circumstances suggest a medical problem may exist, staff may not disrupt a patient's sleep during the night to implement the clinical procedures described in ??B and C of this regulation."


Review of care documentation for the approximate 5-hour and 7.5-hour respective restraint events for patients #2 and #3, reveals, no Range of Motion or circulation was performed; and no fluids, meals, or toileting were offered. Additionally, no criteria of discontinuation was described to patients #2 and #3 or noted in the initiation documentation. No RN readiness for discontinuation documentation is noted in the record, and no RN 2-hour assessments for continuation of restraint are noted.



Additionally, though patient #3 was taken out of restraints at 9 PM, every-15-minute documentation for restraints continued through 11:45 PM as if patient #3 had remained in restraint. The 15-minute flows appear to have been filled-in prematurely and without regard for timely assessment data. Items filled are, the type of restraint, 1:1 constant staff monitor, and Psychological status behavior code which is listed in each 15-minute block as "Q" for quiet.


The hospital failed to provide appropriate care and status assessments for patients #2 and #3 as required by state regulations.

Based on a review of documentation and hospital audit of emergency department behavioral restraint records: 1) 8 of 26 behavioral restraints in the emergency department were found without initial physician orders, and 2) 3 of 26 emergency department behavioral restraints had no physician restraint renewal orders for behavioral restraints continuing beyond 4 hours.


Patient #3 is a 61-year-old female who presented to the ED via police on an emergency petition on 11/9/2011 at 11:23 am after binging on crystal methamphetamine for 3 days and making statements that she wanted to kill herself. Her toxicology screen was positive for cocaine, benzodiazepines and amphetamines. A primary diagnosis was psychosis, unspecified. A secondary diagnosis was Drug intoxication, pathological.
At 1:30 PM, a nursing note states " Pt (patient) behavior restless and resistive of attempts from staff for pt safety; verbal and physical threats to staff; 4-point restraints applied to pt and staff safety pt became somulent after restr (sic) applied; meds cancelled pt condition no longer warrants meds; " and "NOTE: 4 pt restraints and 1:1 constant obs (observation) by sitter started at 1320." An order sheet timed at 1:15 PM appears in the record which notes that patient #1 is more than 18 years old, was placed in 4-point vinyl restraint, and the form is signed by an RN under the MD/LIP signature section.
At 5:10 PM, an order sheet for continuation of restraint notes that restraints were continued for "elopement risk and agitation." It is unclear who signed the order, but a hospital audit of the record indicates that there was no repeat MD signed order on the chart. Patient #1 was noted to be sleeping for at least 45 minutes at the time the order was written. No physician assessment note is found.
A nursing note of 8:08 PM states " Reorder for 4 pt restraints done by Dr. ___. Pt arousable; agitated refused to answer question; resistive to staff; attempts screaming" let me go out of here now." No new physician order is found. While a new order was not strictly due, until 9:10 PM, it is unclear why the RN thought an order was written that was not.
Patient #3 was initiated into restraints by an RN who had an obligation to obtain a physician order within one hour. This was not done. Consequently, the hospital failed to restrain patient #3 in accordance with the order of a physician.

Based on a review of documentation for 4-point behavioral restraints applied to patient #3 for 7.5 hours, the patient was not released from restraint at the earliest possible time as evidenced by:

Patient #3 is a 61-year-old female who presented to the ED via police on an emergency petition on 11/9/2011 at 11:23 am after binging on crystal methamphetamine for 3 days, and making statements that she wanted to kill herself. Her toxicology screen was positive for cocaine, benzodiazepines and amphetamines. A primary diagnosis was Psychosis, unspecified. A secondary diagnosis was Drug intoxication, pathological.

At 1:30 PM, a nursing note states "Pt (patient) behavior restless and resistive of attempts from staff for pt safety; verbal and physical threats to staff; 4-point restraints applied to pt and staff safety pt became somulent after restr (sic) applied; meds canceled pt condition no longer warrants meds."

Fifteen minute flow charts reveal that patient #3's behavior was documented as "Disoriented" through 2 PM following initiation of restraint, then "Quiet" at 2:15 PM, and sleeping until 3:30 PM. Behavioral documentation does not support the continuance of restraint for patient #3.

At 3:43 PM, a nursing note states "Pt has been quiet for some time and suddenly sat up in bed screaming. Pt is now very agitated, cursing, screaming and yelling to let her go. Pt now receiving ativan. Patient #3 received haldol 5 mg IM (intramuscular) and diphenhydramine (Benadryl) 50 mg IM at 3:58 PM. Additionally, she received ativan 2 mg IV at 3:46 PM. At 3:55 PM, a nursing note states "episode of screaming and verbal threats to staff meds given pt resumed sleeping after 10 minutes. "

At 5:10 PM, an order sheet for continuation of restraint notes that restraints were continued for "elopement risk and agitation." Per the 15-minute flows, patient #1 was noted to be sleeping for at least 45 minutes at the time the order was written. No physician assessment note is found.

A nursing note of 5:14 PM states "reorder for 4 pt restraints done by Dr. ___; pt arousable; agitated refuses to answer question; resistive to staff; attempts screaming, "let me out of here now." Fifteen minute flows indicate that patient #3 was sleeping at the time this note was written.

At 8:10 PM, a nursing note states "pt awakened from sleeping uncoop (uncooperative) agitated screaming commands to staff. At 8:22 PM, a nurse notes "ankle restraints removed; pt decreased agitation." Wrist restraints were not removed until 9 PM.

In summary, patient #3 became "somnolent" following the initiation of 4-point restraint, and remained quiet or sleeping for the next two hours. Upon awakening, patient #3 yelled for staff to let her go, and again, fell asleep after receiving emergency medication. Approximately two hours later, the nurse continued restraints for elopement risk and agitation, resistance to staff and refusing to answer questions, none of which of is a criterion for restraint, and none of which was demonstrated at the time of continuance. Patient #3 continued in 4-point restraints at 8:10 PM with described behaviors, again inconsistent with 15-minute flow chart at 9 PM when restraints were removed when nursing described her as having "Decreased agitation." It is unclear why nursing did not identify that patient #3 had decreased agitation when she became somnolent shortly after restraints were initiated.

Patient #3 was kept in restraint for 7.5 hours with only behaviors documented at initiation meeting appropriate restraint criteria. Patient #3 was not released at the earliest possible time.

Based on a review of documentation for patient #2 and #3, no physician/LIP face-to-face is noted in the record as evidenced by:

Patient #2 is a 23-year-old female who presented to the ED on 12/22/2011 at 4:16 PM via family car following a psychotic break with aggressive behavior. Patient #2 had been at college where she was reported by a roommate to drink and act in a bizarre and aggressive manner. Patient #1's toxicology screen was positive for marijuana. Patient #2 received a primary diagnosis of psychosis, and a secondary diagnosis of urinary tract infection.
An RN note of 6:03 PM states "Pt. medicated as per order and placed in 2-point restraints for violent aggressive behavior. 1:1 sitter remains at bedside." No face to face evaluation was found.
Patient #1 was admitted to the unit. At 4:05 am, a telephone order for physical hold for IM medication x 1, and an order for seclusion for "uncontrolled agitation and disruptive and aggressive behavior " was written. At 5:05, an order for 4-point restraints is found. However, no face-to-face evaluation was found.

Patient #3 is a 61-year-old female who presented to the ED via police on an emergency petition on 11/9/2011 at 11:23 am after binging on crystal methamphetamine for 3 days, and making statements that she wanted to kill herself. Her toxicology screen was positive for cocaine, benzodiazepines and amphetamines. A primary diagnosis was Psychosis, unspecified. A secondary diagnosis was Drug intoxication, pathological.

At 1:30 PM, a nursing note states "Pt (patient) behavior restless and resistive of attempts from staff for pt safety; verbal and physical threats to staff; 4-point restraints applied to pt and staff safety pt became somulent after restr (sic) applied; meds canceled pt condition no longer warrants meds."

The hospital's Restraint and Seclusion (R/S) Policy for Violent/Self destructive Behavior does not describe performing the face to face evaluation is only addressed in the policy for "Renewal of Order," which states in part, "1. A face to face assessment must be performed by a physician or LIP or a physician assistant or RN trained per regulation within one hour of the restraint or seclusion. The assessment includes the following ... " While the policy states the appropriate time of a face to face evaluation, it is unclear why this assessment is found under the heading of "Renewal of Order." Further, interview with the hospital risk manager reveals that nurses are not currently trained, and do not perform the face-to-face evaluations.

The Restraint Policy specifies restraint and seclusion training for physicians as "Physician education will be completed by the facilities designee at time of hire/orientation to the hospital, when there is a change in standards or policy, and at time of reappointment to the medical staff. "

While physicians are trained to perform face-to-face assessments, the hospital failed to perform appropriate face-to-face assessments for patient #2 and #3 per hospital policy, and regulatory directives.

Data collection related to restraint episodes in the emergency department is not integrated into the hospital quality process, and consequently lacks an integrated plan for improvement as evidenced by:
During the survey, a list of emergency department restraints over a two month period spanning November and December 2011 was requested. A list of patients was offered, which also revealed an audit tool. The tool audits for multiple restraint related data (not limited to) the date, patient number, age, type of restraint or sitter, total hours, and physician orders. According to the list, it was determined that almost one third of restraint occurrences had no physician order. However, the tool is not integrated into the hospital quality process, and therefore, no appropriate plan is in place for improvement. Additionally, the tool does not collect data on the face-to-face evaluations or on the actual care provided during restraint/seclusion. Therefore, these areas remained unidentified as needing improvement.