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The hospital failed to promote the rights of patients' as evidenced by the following deficiencies in this report:
(1) Ten of ten closed records reviewed, found no Important Message provided to the patient as cited in A-0117;
(2) Six of eleven grievance files reviewed revealed no resolution letters written to the complainant as cited at A-0123
(3) Four of 15 medical records reviewed, revealed violations of patient rights to refuse treatment as found at A-0131
(4) Two of 15 records reviewed, and environmental concerns revealed violations of care in a safe setting as cited at A-0144
(5) One of 15 records reviewed revealed violations in the hospital regulatory responsibility to investigate allegations of abuse as cited in A-0145.
(6) Six of 15 records reviewed, revealed patients rights were violated by systematically maintaining these patients in restraint or seclusion without sufficient justification as found at A-0154
(7) One of 15 patient records reviewed, revealed a seclusion event without justification as cited at A-0162

(8) Two of 15 patient records reviewed, revealed two episodes of seclusion/restraint without benefit of a physician ' s order as cited at A-0168.

(9) Two of 15 records reviewed revealed evidence of prn (as needed) restraint orders as cited at A-0169
(10) The hospital has no policy for restraint/seclusion training of physicians and other licensed independent practitioners nor do physicians and other licensed independent practitioners receive training, as cited at A-0176

(11) One of 15 records reviewed revealed no face-to-face by a physician, and that face-to-face documentation is not adequate to meet regulatory directives as cited at A - 0179.

(12) Review of training received by staff monitoring restraint/seclusion in the hospital emergency departments, does not include adequate skills to provide safe restraint/seclusion monitoring use as cited at A - 202.
(13) Review of training for clinical staff involved in the care of patients in restraint/seclusion, reveals inadequate training to recognize when restraint/seclusion is no longer necessary as cited in A - 204.
(14) Quality Assessment Performance Improvement staff were unaware of quality data tracking for restraint and seclusion in the hospital behavioral health unit, the Director of Acute Care reported that quality data related to restraint and seclusion is not reported to or shared with the hospital quality assessment department

Based on interview, observation and review of closed records, 10 of 10 closed records reviewed for Medicare beneficiary notification or rights, revealed no notice of the Important Message (IM) from Medicare as evidenced by:
Interview with the Director of Case Management reveals no policy governing the IM notification, but that patients eligible for Medicare receive their first notice from registration. The Director revealed a written hospital process by which case management is reminded of giving Medicare Important Message (IM). The process includes that each physician writes an order for 24-48 hour discharge planning. Once the order is written, both nursing and case management are informed, and IM notification is to proceed from there. Ten close records were chosen from campus (A) and campus (B) for Medicare eligible patients with stays 5 days or longer. Interview with a unit secretary who processes orders, reveals that the physicians do write orders for 24-48 hour discharge planning. However, of 10 closed records reviewed, no such orders are found, nor were any IM notifications found. The hospital failed to inform Medicare beneficiaries of their rights under Medicare, and therefore failed to protect and promote the rights of Medicare patients in the hospital.

Based on interview, and review of 11 grievance records, it is determined that the hospital does not consistently give written resolution letters to patients with grievances as evidenced by:
Six of eleven grievance files reviewed, revealed no resolution letter. Review of the hospital Service Recovery Policy (reviewed 8/07) reveals, "the Director of Patient Advocacy utilizes the appropriate manager, director and Vice President to review the issues. The policy continues, " Written follow-up and resolution or updates of their findings will be provided to the patient within 10 days. Some reviewed files had follow-up through a phone call by the manager or physician who investigated the grievance. Some reviewed files included notes, meant to substitute for a resolution letter.
While the hospital grievance process reveals an actively collaborating staff, and internal documentation in the resolution of grievances, patient resolution letters are not routinely found. Therefore, patients receive no consistent, documented record of information concerning, the steps of investigation, who to contact, and the result of the investigation. The hospital does not meet the regulatory directive and patient right to received a letter of resolution.

Based on review of the Rights of Patients in Psychiatric Hospitals and patient records, the hospital failed to protect and promote the rights of patients # 4, 11, 12, and 14 of 15 patients reviewed, when medications were forced on them without emergency justification for patient #4 in the ED, and in the case of inpatients # 11, and 14, without emergency justification or Clinical Review Panel as evidenced by:
Review of The Annotated Code of Maryland Health General Article 10-708 the Refusal of medication; clinical review panel (b) (1) and (2) reveals that patients have a right to refuse medication used for the treatment of a mental disorder except:
- In an emergency, on order of a physician when a patient presents a danger to the life or safety of themselves or others; or
- In a non-emergency when a patient is hospitalized involuntarily or committed for treatment by order of a court and the medication is approved by Clinical Review Panel.

1. Patient #4 is a 50-year-old female who arrived via ambulance to campus (A) on emergency petition on 7/5/2010 just before midnight after reports of drinking alcohol and taking an overdose of trazodone. Patient #4 admitted to having suicidal ideation, but denied taking an overdose. She stated it was her usual dose. Patient #4 had a diagnosis of alcohol intoxication and depression.

Based on review of the medical records of patient #4 it revealed a RN note of 7/6/2010 at 1:25 am which stated in part, " ...Patient adamantly refusing medication. Explained necessity for medication and patient continued to refuse. Advised patient that as long as she cooperates with staff and remains in her room then the medication would not be administered. Security at bedside with 2 RNs and ED tech. Patient became agitated and attempted to get out of bed. Security prevented patient from exiting bed and plan of care discussed again. Patient agreed to cooperate and lying on stretcher at this time."

On 7/6 at 2:15 am, a Restraint Physicians Order form documents patient #4 as requiring
4-point restraint for "Combative, aggressive, threatening and violent " behaviors. A nursing progress note of 2:19 am detailing events prior to restraint state "Patient advised that she would not be evaluated by BHRT (behavioral health) until 0600. Became extremely agitated and attempted to leave the room. Security and MD with patient. Escorted back to room and plan of care explained to patient again with MD patient. Very argumentative and MD advised patient that medication to be administered. Patient repeatedly refusing and MD explained necessity for medication. In process of medicating patient, and stated, "Don ' t give me that shot." Medicated patient as ordered. Speaking inappropriately to staff. 4 point leather physical restraints placed on patient. "

Patient #4 returned to the ED room with security and the MD. She verbalized her refusal of medication numerous times, yet was given forced IM medication of lorazepam 2 mg IM at 2:19 am, and haldol 5 mg IM at 2:27 am, without demonstration of dangerousness to self or other. The IMs were not medications that patient #4 normally took for depression. Behavioral documentation on the restraint order describes patient #4 as "Combative" which does not correlate to nurses progress notes in which patient #4 was agitated and attempted to elope. Agitation of itself and an attempt to elope does not justify emergency (forced) medication. Only after patient #4 was placed in restraint, does RN documentation of 2:34 am reveal behaviors which may justify restraint, i.e., patient #4 was, " screaming, kicking, spitting, attempting to break out of restraints. " Patient #4 is documented as "calm" by 3:15 am, and "sleeping " by 3:16 am. Restraints were removed in stages by 4:45 am. She was evaluated at 9 am, and discharged at 9:15 am to home.

An emergency petition does not supersede a patient's right to refuse medication. The hospital failed to protect patient #4's right to refuse medication.

2. Patient #11 is a 50-year-old male who was brought to the ED of campus (B) on emergency petition via police after police found him disoriented, psychotic and walking in traffic. Patient #11 has a history of mental illness, with a diagnosis of Schizoaffective Disorder and a medical history of type II diabetes (insulin dependent), hypertension and pancreatitis. He was observed to demand food and drink and to drink pitcher after pitcher of water in the ED. Patient #15 admitted involuntarily to the BHU on 7/7.

On 7/7 at 3:21 pm in the BHU, a psychiatrist wrote medication orders in part for:
Zyprexa 5 mg po daily to begin 7/8
Zyprexa 5 mg po now
Geodon 10 mg IM q 4 (hours) prn agitation, and
Ativan 1-2 mg po or IM q 4 hours prn anxiety/agitation
Trazodone 100 mg q 2100 po

At 6:50 pm, a RN writes "PT up for dinner. Hollering and making strange noises. Pt. in shower, ran over bathroom sink. Water on floor. Pt. then approached for meds, rambling flight of ideas. He did take po zyprexa, but would not take lopid. Pt. then sprayed antiperspirant in his mouth. He is verbally redirectable. No aggressive gestures. VSS. Denies pain."

At 8 pm, the psychiatrist wrote medication orders for "Geodon 20 mg IM now severe agitation, may repeat if needed in 1 hr (hour) with ativan 2 mg IM. Pt. is to remain in locked seclusion for 4 hours."

At 8:30 pm, an RN documents patient #11 behaviors as loud, exposing himself, and attempting to go into a female patient's bedroom. He became threatening and postured as though to charge staff, and began writing on the walls. Patient #15 was placed in seclusion at 8:15 pm. An RN addendum note of 7/7 at 9:49 pm states "Pt. was given geodon 20 mg and ativan 2 mg IM in his left deltoid. Pt. tolerated procedure, with security guard present."

The psychiatrist order of 7/7 a 8:30 pm for seclusion includes criteria in part of, " ...the patient is willing to take either po or IM medications ... "

A psychiatric note of 8:56 pm, states in part " ...and threatening to staff, " I will kick your behind.", " I'm gonna spit on you" - and prepared to do it! The pt. couldn't be redirected, did not consent to a timeout, or to take medications. As the pt was clearly out of control, a code purple was called and the pt was placed in the seclusion room resting on his right side, moving his feet. The patient was no longer yelling at the top of his voice and had stopped kicking at the door of the seclusion room. Criteria for release were noted in written orders. The pt. will be (given) medication again in one hour to prevent another episode of escalation in view of the pt's florid psychosis, disorganization and absence of any internal controls."

At 11:29, the psychiatrist writes in part, " ...the pt. stated that he did not like needles and agreed to take his evening meds including zyprexa 15 mg, trazodone 100 mg, and ativan 2 mg," and "The pt. has PRN geodon ordered with ativan, should this be needed. At this point, the pt. is resting quietly in seclusion and has made no attempt to kick the walls or strike out at the window."

A psychiatry note on 7/8 at 5:02 pm states in part "The pt was resting on his left side on his mattress with a plaster water container in pieces at his feet. The pt. stated he was not getting enough food and had been trying to open the water container." Patient #11 asked for car magazines and the security guard stated he would get some. Patient #11 had been banging on the wall "Episodically" during the past 4 hours with "No episodes of crying out loudly. Currently episodically medication compliant."

A psychiatric note of 7/8 at 10:03 states in part, "Pt. was seen in seclusion ....just prior to our entrance, the pt. had been kicking at the wall again ....he complained that he did not have enough food ...he commented that he felt good, and denied hearing voices, seeing things or paranoia ...he remarked that he was comfortable there and did not want to come out of seclusion and be with others because he was "Scared" of them." The note continues that "He was confused about the time lapse of events, was labile and as the conversation continued, he became more irritable and excitable. He was given IM Geodon and ativan" and Restraint and seclusion to be continued as pt. is unable to contract for being able to be responsible for his behavior outside the contained environment of the seclusion room. As noted, consistent medication compliance continues to be an issue." (writers note: Pt was not in physical restraint per the psychiatrist note, though she may have referred to chemical restraint)

An RN note of 7/8 at 11:07 states in part "Dr. ___in to see pt. at 9:30 for face to face for continuation of seclusion. Before Dr. arrival, pt. was kicking door, yelling and banging." Patient #11 spit out his p.o. meds and IMs were to be given per the psychiatrist. Patient #11 stated he would accept the IM s only if an African- American nurse gave them, and "PT. stated that one of the staff members had kicked him in the groin, which was a false statement. Informed pt. when asked when he was getting out, that his behavior would have to be more in control before that would happen.

Patient #11 was in seclusion for almost three days, from 7/7 at 8:30 pm until 7/10 at 2:45 pm. A psychiatry order of 2:50 pm states, (1) Open door to quiet room for 1 hour, will reassess, (2) Discontinue prolixin IM and Ativan IM orders, (3) Prolixin 5 mg po QID. If pt. refuses, any dose, give IM, (4) Ativan 2 mg po QID. If patient refuses any dose, give IM. Patient continued in the quiet room until 11 pm. The last order clearly reveals that despite any objection to medication, patient #11 would be medicated by IM.

On admission, patient #11 initially took po medication. However, the psychiatrist wrote orders for as-needed intramuscular medication for agitation, against the patient right to refuse treatment in addition to seclusion criterion which precluded exit from the seclusion room if he did not take medications. If the psychiatrist IM orders were intended as emergency medication, then the orders represent prn chemical restraint orders. Based on the documentation there was only one administration of IM medication where could be stated that patient #11 was dangerous and that emergency IM medication might have been needed.

Documentation then shows patient #11 received IM medication for being " ...irritable and excitable " and that "The pt. will be (given) medication again in one hour to prevent another episode of escalation in view of the pt's florid psychosis, disorganization, and absence of any internal controls."

Patient #11 expressed not wanting "Needles " and took po medication after being coerced with the prospect of receiving IM medication against his will, when he did not represent a danger to self or other. On entry to quiet room, orders were again written to force any refused dose via IM. The hospital did not consider patient #11' s rights to refuse medication, or take the necessary steps towards a Clinical Review Panel, thus violating patient #11's right to refuse medication.

3. Patient #12 is a 46 year-old female who arrived at the ED of campus (A) on 06/06/2009 with severe hypotension and respiratory distress after an attempted suicide by overdose. Patient #1 was medically stabilized at Easton Memorial. Patient #12 was transferred to the behavioral health unit (BHU) of campus (B) on the morning of 6/07/2009, where she remained into July 2009.
On 07/07/2009 in the BHU, a code green was called when patient #12 began banging her head on the walls after she was dissatisfied with snacks she had been offered. Patient #12 continued to escalate and at 4:30 pm wrapped a sheet around her neck. The record indicated that 2 codes were called to place patient #12 into seclusion and then to place her into 4-point restraints because she was banging her head into the wall while in seclusion. At 4:45 pm, the order was entered for 4-point restraint.
A telephone order of 4:45 pm am reads, "haldol 1-2 mg IM q2hrs prn as needed for agitation, do not exceed 8 mg in 24 hours. " Another order written at 5:30 pm states, " Start Zyprexa IM prn agitation, MBR (may be repeated?) x 2 for total of 30 mg in 24 hour period, " and, Start haldol 5 mg IM prn agitation, confrontation q4H, use only if zyprexa 30mg has been used. " Neither of these orders offers by-,mouth medication. Had patient #12 been consenting, IM medication would not be necessary. If patient #12 was not consenting to medications by-mouth, and a clear emergency was not demonstrated, then IM medication administration is a violation of patient #12 ' s rights to refuse treatment until such time as a clinical review panel states otherwise. The physician orders were written prn agitation, and agitation/confrontation which do not in themselves demonstrate an emergency, and therefore, violates patient #1 ' s right to refuse.

4. Patient #14 is a 60-year-old female who on 3/27/2010, came via ambulance to the ED of campus (B) following a reported mental status change over three days. Patient #14 ' s family called emergency services on each of three days, but patient #14 refused to go. Patient #14 has a psychiatric history including psychosis. Her history includes, diabetes type II, hyperlipidemia, and positive ppd. A reported history of dementia was not confirmed by the record. It was also noted that patient #14 had just returned from Haiti, where relatives were found safe.

On presentation, patient #1 was "Floridly psychotic, and not responsive to initial contacts with the behavioral health assessor. Patient #14 was given a diagnosis of Schizophrenia, and was involuntarily admitted to the BHU of campus (B). While in the BHU, patient #14 attempted to leave, and postured at times, as if to fight. She was given emergency IM medications of prolixin and ativan. A psychiatrist order of 3/29 at 3 am states, "Can give a dose of prolixin 5 mg + ativan 2 mg po or if refuses IM at time of expiration of restraint/seclusion order prn for agitated behavior. " The order clearly reveals that patient #14 would be unable to refuse medication as is her right, if she was agitated. Agitation does not, in and of itself, indicate dangerousness. A psychiatrist order of 3/29 at 8:07 am states;

Start prolixin 5 mg TID, po, may be given IM if necessary.
Start Ativan 1 mg po or IM, prn Q 4 H.

No indications for these prn orders are given, nor does the psychiatrist clarify what "necessary" means. Presumably, "necessary " means if the patient refuses the medication by mouth. This is a violation of the patient rights to refuse medication except in emergency or by clinical review panel.

At 10:28 am, patient #14 took metformin, then refused other psychotrophic medication. Nursing documented in part, " Sat down and allowed vitals to be checked. The CNA was a male, and when this female staff asked for her to take her meds, she became irritable and angry and threw the medicine cup at my face. Walked with assistance of male CNA and ___(staff) to quiet room. Explained to patient that the medications will be given IM. Patient laid on her side and the CNA ' s assisted. On mat in open door quiet room .... " Patient #14 was given IM medication though she had refused. Patient #14 had the right to refuse medications except in emergency or following a Clinical Review Panel (CRP) in which it is determined that medication may be given without consent. Patient #14 was " Irritable and angry, " and she threw her medication at the nurse. These behaviors do not indicate an emergency, and no CRP had been done.

An order of 10:57 discontinued the 8:07 am medication orders, and another order written at 11:42 reads,

Start prolixin 5 mg po or IM BID prn, agitation
Start ativan 1 mg po or IM for restlessness or agitated Q 6 H. Ativan may be given without prolixin.
Start prolixin 5 mg at 2100, po or IM as a standing order, total 24 hr dose of prolixin is no more than 15 mg.

At 5:09 pm, a nursing note reads, "Offered po medications patient stated " Hand it to me. " This staff gave patient the medicine and she threw it at me. Refused to go to the bathroom after asking to use the toilet by stating, " I ' ve got to pee. " Aggressive toward staff, swinging her arms. Directed by four staff members to the anteroom. "

At 5:13 pm, the attending psychiatrist wrote in part " ...When the pt. began to escalate, could not be redirected, and was continuing to become more disorganized, the pt. was placed in the seclusion room with the door open and medicated with prolixin 5 mg and ativan 1 mg. " The psychiatrist seclusion order of 5:30 pm reveals part of a lengthy criteria for release as, " ...willing to take oral medication or an IM ... "

At 5:33 pm per RN documentation "Patient walked to quiet area with assistance. IM prolixin given in the right upper outer quadrant. Patient lying on the mattress crying. The patient was offered the evening meal and fluids by this nurse. Encouraged to eat. Patient refused. Screaming and banging loudly on window and walls" 6:01 pm, "Continues to cry and sing and chant in a loud voice banging on the walls and pacing."

Orders of 6:37 pm, and 6:59 pm respectively state "chloral hydrate 500 mg/5ml. Give 10 ml (1000 mg) po stat, and, ativan 2 mg IM stat. "

At 7:10 pm, the RN writes, Opened door with Dr. and six staff members. Patient assisted to mattress. Encouraged to drink orange juice. Two sips taken. Injection of ativan 2 mg given in left outer quadrant. Orange (juice) placed in oral syringe while staff held patient and talked with her quietly and patient took the juice with 500 mg of Chloral hydrate. Explained what behaviors are needed to have the door opened/encouraged her to drink to keep hydrated. Patient speaking in French Creole at this time and not in English. "

A psychiatrist note of 8:47 pm states in part "The patient was given the injection of 2 mg of ativan followed by ~ 500mg of Chloral Hydrate in orange juice. Because the patient refused to drink, the Chloral Hydrate in orange juice mixture, the mixture was drawn up in a 5 cc syringe and injected into the pt's cheek. ___, a member of the nursing staff, stroked the pt ' s cheek and the pt. eventually swallowed the orange juice containing the Chloral Hydrate. These medication were given at 18:50. The patient was restrained by a security guard on each arm and a staff member at each leg, but the pt did not kick and these staff members were standing by.___held the pt's head and stroked the pt ' s cheeks while the orange juice was given. After the medication was given, the pt. was released. The pt was encouraged to rest on the mattress, a pillow was in place under her head, and she was covered with a blanket. Within 20 minutes, the pt. was sleeping soundly. The seclusion door was unlocked at 9:30 pm.

At 7:10 pm, patient #14 was agitated, but documentation does not reveal a clear danger to herself or other. However, multiple staff gave a show of force, and administered IM medication and chloral hydrate against her will. A nursing note of 3/29 at 9:45 pm states in part, Client was asleep and quiet. Seclusion completed at 2130. Door unlocked ... "

A nursing note of 3/29 at 10:45 pm states "Client awake and more cooperative than earlier in evening. 4 staff and 2 security officers in room to assure that client took prescribed meds. She did take meds by mouth and completed her orange juice via syringe, she would not drink from a cup. Will continue to monitor and support. Client remains in quiet room, and 1:1 observation continues." Again, staff gave a show of force to coerce patient into taking medications without regard for her right to refuse.

A nursing note of 3/30 at 8:17 am states in part "Entered room with four assists, Patient took medications with orange juice ... "

On multiple occasions during this hospitalization, patient #14 was given medication via IM or, on one occasion, via a syringe inside her cheek. Patient #14 agreed to taking medication for diabetes, but refused other psychotropic medication. While patient #14 did receive some emergency medication, she received other medication without justification of dangerousness to self or other, and without the benefit of a clinical review panel.

Based on observation, interview, and review of patient records, the hospital, (1) failed to provide a safe restraint process for patient #3 of 15 records reviewed, and, (2) failed to securely store cleaning solutions in the Behavioral Health Unit of campus (B), and (3) failed to safely store cleaning materials the Emergency Department behavioral health bathroom of campus (B), contributing to an attack on a security guard by patient #13 as evidenced by:
(1) Patient #3 is a 45-year-old male who on 8/4/2010, came via ambulance on emergency petition to campus (A) following a presumed drug overdose with baclofen (a muscle relaxant). According to the Continuous Visual Observation sheet, patient #3 was placed in 4-point restraint at 6:15 pm, though an order for restraint begins at 7 pm. Patient #3 was placed in 4-point restraint due to "Agitation, aggression, and violent behaviors, per the Restraint Physician ' s Order" form. An RN note of 6:32 pm states "Pt. alternating between yelling & fighting & snoring resp. (respirations) with no response. Attempt at inserting nasal airway unsuccessful. Security at doorway. Police officer at bedside. " A 6:35 pm note states "Nasal O2 applied earlier, pulse ox (oxygenation) 97." Patient #3 was on a non-rebreather O2 mask.

The RN monitored patient #3, writing notes every 5-10 minutes. At 6:51 pm, the RN notes " PD (period) of apnea (non-breathing) x 20-25 seconds. Pulse ox remained 98-99. Mask rebreather applied. Dr. ___at bedside. At 7:21 pm, an oncoming RN writes "Report received, care assumed, patient laying on stretcher snoring respirations. VS (vital signs) charted, sr (sinus rhythm) with occ pacs (occasional premature ventricular contractions) on cardiac monitor. Remains in 4-point leather restraints, security at bedside. "

A security notation of 8:15 pm states " still in restraint/jumping." Nursing notation on the Restraint Flowsheet for the same time period reveals the patient to be "agitated and disoriented. " At 8:37 pm the RN writes "Patient very restless on stretcher, Dr. aware no orders received, remains in 4-point leather restraints. Security at bedside, patient incontinent of very small amount of urine, orders received to repeat straight catheter " and at 9:16 pm "Patient responding to painful stimuli at this time. Having periods of apnea at least 15-seconds in length, Dr. at bedside, made aware, ABG (arterial blood gases ) ordered RT (respiratory therapy) called. "

At 9:43, the RN "Removed and repositioned" the restraints. Restraints were not completely removed until 10:30 pm when patient #3 became unresponsive. At 10:49 pm, the RN documented "Patient continues to have apneic periods becomes very tachycardic then diaphoretic, then bradycardic with 30-40 seconds of apnea, pulse ox 100% on NRB (non-rebreather)15L (liter), however now unresponsive to painful stimuli, Dr. aware, patient moved to room 22 for intubation and CT scan of head." Patient #3 was intubated at 11:28 pm CODE BLUE, and admitted to the Intensive Care Unit. Final diagnosis for patient #3 were Acute Respiratory Failure, and Acidosis.

Due to 4-point restraints, patient #3 was required to be on his back for five (5) hours and was unable to reposition himself while the baclofen overdose made breathing increasingly difficult, until the CODE BLUE intubation intervention. No evidence during those 5 hours suggests that staff positioned patient #3 in a manner which enabled his ability to breathe such as, with the head of the bed elevated, or on his side. While patient #3 required restraint on entry to the ED, the hospital failed to provide safe management of those restraints for a patient with compromised breathing.

(2) The hospital consists of two campus (campus A and B). Campus B houses the 17-bed behavioral health unit (BHU) serving emergency departments at both campuses.
During an 8/13/2010 tour of the campus (B) behavioral health unit (BHU), a storage closet was observed in a hallway used by patients on the way to the kitchen area. The closet was found unlocked. Noted just inside the unlocked door, on top of waist-level stored items, was a large spray can of Down and Dirty Rug Cleaner, to which patients had access if any had opened the closet door.
Patient #13 is a 32-year-old female brought to the ED of campus (B) by ambulance after police found her wandering the grounds of a local psychiatric facility. The hospital campus (A) has an ED behavioral health (BH) pod, allowing privacy and space to BH patients.

Per staff documentation, patient #13 was " Delirious and making psychotic statements. " She claimed that she was pregnant which staff learned, was an ongoing delusion. However, the hospital obtained an HCG to establish her non-pregnant state prior to medicating. Patient #13 has a history of schizophrenia, and was eventually admitted to the hospital BHU.During patient #13 ' s stay in the ED, she went into the bathroom. On exiting the bathroom, she approached the security guard on duty, and sprayed him in the eyes with a spray cleaner she found in the bathroom.

Based on these incidences of unsafe storage, the hospital has not secured cleaning chemicals appropriately, creating a potentially unsafe environment for patients and staff.

Review of patient records reveals that for patient #11 of 15 records reviewed, staff ignored his allegation of abuse as evidenced by:
Patient #11 is a 50-year-old male who was brought to the ED of campus (B) on emergency petition via police after being found disoriented, psychotic, and walking in traffic. Patient #11 has a history of mental illness, (bipolar vs. schizoaffective disorder). Patient #11 has a medical history of type II diabetes (non-insulin dependent), hypertension and pancreatitis. He was to demand food and drink, and to drink pitcher after pitcher of water in the ED.

Patient #11 was admitted involuntarily to the BHU, and was secluded due to dangerous behaviors. On 7/8 at 11:07 pm, an RN note states " Pt. stated that one of the staff members had kicked him in the groin which was a false statement." Patient #11 made an allegation of abuse. The RN had an obligation to report the allegation, whether she believed the patient or not. The hospital had an obligation to follow-up with patient #11 by way of examination and investigation, and information regarding his rights within the allegation. No further documentation in the patient record reveals any reporting on the part of the RN. Based on a lack of reporting, the hospital failed to investigate an allegation of abuse, and the validity of the allegation remains unknown.

Based on a review policies, procedures and patient records, it is determined that (6) patients #1, 4, 5, 11, 12, and 13, of 15 records reviewed were not released from seclusion or restraint at the earliest possible time. In addition, hospital staff used coercion to gain compliance of patients #4, 11, and 12 as evidenced by:

1. Patient #1 is a 56-year-old male with a history of mental retardation, psychosis, depression, and obsessive-compulsive disorder. Patient #1 had (4) ED visits, (3) in July 2010, and one in August 2010. Two of these visits, on 7/21/2010 and 8/8/2010, both at campus (A), were due to behavioral issues.

On the 7/21 entry to the ED, patient #1 began throwing things, and assaulted a staff member. Patient #1 was placed in 2-point wrist restraint at 10:10 am. No nursing 15-minute flows are found in the record to indicate monitoring, and thus, readiness for release. A nursing progress note of 10:35 am states "No longer fighting. Spoke with ER MD. OK to hold medication right now." A nursing note of 12:04 states, Pt. resting quietly with caregiver at bedside ..., " and at 12:15pm, "Restraints removed .... " Patient #1 continued in restraint for nearly two hours beyond the time when he was no longer a danger to himself or others.

On the 8/8, ED presentation, patient #1 was reported to have been refusing meals, had locked himself in his room, had become violent with staff and peers, and threatened to cut off his arms and legs. Patient #1 was made involuntary with a physician clinical impression of "Intermittent Explosive Disorder."

At 6:51 pm, staff called a psychiatric Code Green due to a violent outburst from patient #1. The Physical Exam sheet of the ED documents "CODE GREEN required 4 pt-restraint." An every-half-hour Continuous Visual Observation sheet, indicates that patient #1 was in restraint at 7 pm. No physician order accompanies the restraint. No nursing 15-minute flows are found. A nursing progress note does not justify patient #1 ' s continued restraint. A nursing progress note at 7:39 pm states " Pt. calm at this time. Family at bedside." Patient #1 remained calm per nursing notes, until all restraints were removed by 11:05 pm. Patient #1 remained in restraints for approximately 3 ? hours beyond the time he is documented as calm.

Patient #4 is a 50-year-old female who arrived via ambulance to campus (A) by emergency petition on 7/5/2010 just before midnight after reports of drinking alcohol and taking an overdose of trazodone. Patient #4 admitted to having suicidal ideation, but denied taking an overdose. She stated it was her usual dose.

An RN note of 7/6/2010 at 1:25 am states in part " ...Patient adamantly refusing medication. Explained necessity for medication and patient continued to refuse. Advised patient that as long as she cooperates with staff and remains in her room then the medication would not be administered. Security at bedside with 2 RN ' s and ED tech. Patient became agitated and attempted to get out of bed. Security prevented patient from exiting bed and plan of care discussed again. Patient agreed to cooperate and lying on stretcher at this time."

The hospital Restraint & Seclusion use for Behavior Management Policy (revised 1/10), states in part "A situation where a patient is restricted to a room alone and staff are physicially intervening to prevent the patient from leaving the room or giving the perception that threatens the patient with physical intervention if the patient attempts to leave the room is considered seclusion."

The RN and the security guard used coercion and a show of force to keep patient #4 in the room and in the bed by threatening forced medication, and " Preventing " exit from the bed. This represented seclusion.

On 7/6 at 2:15 am, a Restraint Physicians Order form documents patient #4 as requiring 4-point restraint for "Combative, aggressive, threatening and violent " behaviors. A nursing progress note of 2:19 am detailing events prior to restraint states "Patient advised that she would not be evaluated by BHRT (behavioral health) until 0600. Became extremely agitated and attempted to leave the room. Security and MD with patient. Escorted back to room and plan of care explained to patient again with MD patient. Very argumentative and MD advised patient that medication to be administered. Patient repeatedly refusing and MD explained necessity for medication. In process of medicating patient, and stated, " Don ' t give me that shot." Medicated patient as ordered. Speaking inappropriately to staff. 4 point leather physical restraints placed on patient. "

The restraint order detailing combative behavior does not correlate to nursing documentation of patient #4's attempted elopement. Patient Rights regulatory requirements exclude elopement as a criteria for restraint. It was not until staff restrained patient #4 that she became combative " screaming, kicking, spitting, attempting to break out of restraints." In addition, patient #4 verbalized her refusal of medication numerous times, yet was given IM medication of lorazepam 2 mg IM at 2:19 am, and haldol 5 mg IM at 2:27 am, medications which she did not normally take.

Patient #4 is documented as "calm" by 3:15 am, and "sleeping" by 3:16 am. However, she was not completely removed from restraint until 4:45 am. Patient #4 was evaluated by behavioral health at 9 am, and was discharged at 9:15 am to home.

An emergency petition does not supersede patient right to appropriate justification and use of restraint (physical/chemical), or seclusion.

2. Patient #5 is a 44-year-old male, who on 7/11/2010 went to the campus (A) ED via family. Patient #1 had taken an overdose of blood pressure medication with alcohol. Patient #5 verbalized suicidal and homicidal ideations towards a man who harmed his family years ago. Per a physician's order, 4-point restraint was initiated for violent/destructive behaviors at 2:55 pm, and which continued with a new order at 6:55 pm. Patient #5 was released from 4-point restraint at 9:38 pm.

RN 15-minute Restraint Flowsheet revealed that patient #5 was agitated from 2:55 pm until 3:25 pm, a period of ?-hour. All other documentation indicates that patient #5 was sleeping. Nursing removed his hands at 8:30 pm, and his legs at 9:30 pm. However, patient #5 remained in restraint for 5 hours in a calm and sleeping state before staff attempted to release him.

3. Patient #11 is a 50-year-old male who was brought to the ED of campus (B) on emergency petition via police after police found him disoriented, psychotic, and walking in traffic. Patient #15 has a history of mental illness, with a diagnosis of schizoaffective disorder. Patient #15 has a medical history of type II diabetes (non-insulin dependent), hypertension and pancreatitis. He was observed to demand food and drink, and to drink pitcher after pitcher of water in the ED. Patient #15 was admitted involuntarily to the BHU.

An order of 7/7 at 8:30 pm detailed multiple criterions for release from restraint which reads "(1) Criteria for release from locked door seclusion, (2) The pt. must be redirectable by staff, (3) The pt. must be willing to take either po or IM medication, (4) The patient may be released when the pt. is able to talk and work cooperatively with staff - to go to toilet, to follow specific directions, to cooperate with snacks ingestion (diabetic), and (5) The patient must have no episodes of yelling, banging (door, walls, furniture), or threatening behaviors or verbal threats for at least two hours."

A seclusion order of 11:30 pm states "Renew seclusion for combative, resistive, threatening behavior. Criteria for rules remain as above" (referencing first order criterions). The Restraint Flowsheet identifies patient #11 as sleeping. A nursing note of 2:08 am states "Patient remains in seclusion at this time, observed lying on mattress. Appears to be resting comfortably, respirations steady and even. Pt. has been toileted and given hydration. Will continue to monitor. "

A seclusion order on 7/8 at 3:29 am states "Renew seclusion order additional 4 hours. Criteria for release remains as noted earlier order 7/7/10 - 2030 order. Will reevaluate in 4 more hours." A nursing note of 3:29 am states " Dr. ___ contacted to renew seclusion order for additional 4 hours. Pt. continues to be in the seclusion, observed by staff thru observation window at this time. Appears to have steady respirations, positional changes noted. Continue to monitor."

Nursing notes of 4:35 am, and 5:40 am respectively state "Continues to be resting in seclusion area. Observed to (through?) glass, respirations noted, as well as positional changes. Continue to monitor" and " Pt remains in seclusion room, appears to be resting lying on mattress, respirations steady and even. Positional changes noted. Continue to monitor. "

An RN note for behaviors noted at 6:37 am states, Pt. was assessed by 3 staff members while in seclusion. Pt. awaken with numerous requests to wash his eyes, and demanding to get out, informed pt. that the Dr. will be in at 7:30 am to speak with him at (and) will be her decision of when he would be getting out. Will continue to monitor. "

A seclusion order of 7/8/2010 7:05 am states " Renew seclusion for 4 hours for safety of patients and staff. Criteria for release as per order of 07-07-2010 at 20:30. " The psychiatrist renewed seclusion, and wrote the following progress note. " Seclusion 07-08-2010 The pt. has been in locked door seclusion through the night. When checked by nursing staff at - 6:30, the pt. wanted a shower and made multiple requests to wash his eyes. When he demanded to get out, the nursing staff informed him that he would be seen by the doctor who would make that decision, " and, The pt. was laying on his right side sleeping, but was aroused with verbal stimulation " ... " When asked how he felt, the pt. stated that he was tired and wanted to rest for another ten minutes. " When asked, the patient did not recall his behaviors of the previous day and night. He was informed that it was important he control himself and be appropriate in the community. When patient # 11 indicated he wanted 10 more minutes to sleep, the psychiatrist informed him he would be allowed to rest. " The psychiatrist continued, " Seclusion was renewed for another four hours. The nursing staff will toilet and feed the pt. and offer morning medications. If the pt. is able to control his behavior, and cooperates with unit procedures, the pt. will be tapered out of seclusion as all criteria are net and the pt. is stable for at least 2 hours. "

The Restraint flow for 7 am reveals patient #11 to be disoriented. No documentation at that time indicates that patient #11 was a danger to self or other.

A nursing note of 10 am states in part, " Pt. remains agitated with pressured speech and intense stares noted. " A seclusion order of 7/8 at 10:45 am states, "Renew seclusion for 4 hours for safety of pts. and staff. Criteria for release as per order of 07-08-2010 at 20:30. Fingerstick glucose before every meal x 3 days.

A psychiatrist note of 12:33 pm states in part, "The pt. propped himself up on his right arm and used his left hand to eat bacon from his tray, " and, " The pt stated that he was hungry and requested additional food, " and, " Dr. __ informed him that she had seen him earlier in the day, but the pt. had no memory of this. When asked whether he was having any problems, the pt. stated that he was OK. When asked about his pounding on the walls and shouting at the top of his voice at 9 and 9:30, the pt. stated that he was exercising. Dr. ___informed the pt. that he could receive extra food for today only as he worked to become more stable, " and, " The pt ' s contact with reality remains tenuous and ability for self-control is very variable. For the safety of the pt, the pts on the unit and staff, locked door seclusion is renewed for another 4 hours. " Patient #11 ' s glucose was 246 prior to eating. "

Nursing notes of 1:39 pm and 2:36 pm respectively, state in part, "Pt is calmer but remains guarded and selective with meds. Pt. denies and current issues with pain and is able to follow simple commands, " and Pt was informed of conditions for seclusion to be discontinued. Pt. was receptive. Will continue to monitor, " and, " Remains in seclusion - laying on the mat while hovering over his feed tray. Has his clothing on. Quieter. Will continue to monitor closely. "

At 5 pm, patient #11 is documented on the Restraint Flow as sleeping. A psychiatry note on 7/8 at 5:02 pm states in part, "The pt was resting on his left side on his mattress with a plaster water container in pieces at his feet. The pt. stated he was not getting enough food and had been trying to open the water container. " Patient #11 asked for car magazines, and the security guard stated he would get some. Patient #11 had been banging on the wall " Episodically " during the past 4 hours, with " No episodes of crying out loudly. Currently episodically medication compliant. "

A psychiatric note of 7/8 at 10:03 pm states in part, " Pt. was seen in seclusion ....just prior to out entrance, the pt. had been kicking at the wall again ....he complained that he did not have enough food ...he commented that he felt good, and denied hearing voices, seeing things or paranoia ...he remarked that he was comfortable there and did not want to come out of seclusion and be with others because he was " Scared " of them. " The note continues that, " He was confused about the time lapse of events, was labile and as the conversation continued, he became more irritable and excitable. He was given IM Geodon and ativan, " and, " Restraint (writers note: Pt was not in restraint) and seclusion to be continued as pt. is unable to contract for being able to be responsible for his behavior outside the contained environment of the seclusion room. As noted, consistent medication compliance continues to be an issue. "

An RN note of 7/8 at 11:07 states in part, " Dr. ___in to see pt. at 9:30 for face to face for continuation of seclusion. Before Dr. arrival, pt. was kicking door, yelling and banging. " Patient #11 spit out his p.o. meds and IM ' s were to be given per the psychiatrist. Patient #11 stated he would accept the IM ' s only if an African- American nurse gave them, and, " PT. stated that one of the staff members had kicked him in the groin, which was a false statement. Informed pt. when asked when he was gettingout, that his behavior would have to be more in control before that would happen. It is noted on the Restraint Flow that patient #11 was documented as sleeping from 5 pm until 9:15 pm, and again from 10:45 pm until 7/9 at 5:15 am.

Patient #11 remained in seclusion until 7/10/2010 2:50 pm, when the psychiatrist wrote, (1) Open door to quiet room for 1 hour, will reassess. (2) Discontinue prolixin IM and ativan IM orders. (3) Prolixin 5 mg po QID. If patient refuses any dose, give IM, and (4) Ativan 2 mg po QID. If pt. refuses any dose, give IM. "

Patient #11 was kept in seclusion for a total of 66 hours from 7/7 at 8:30 pm until 7/10 at 2:45 pm, largely based on arbitrary criterions. The hospital failed to protect and promote the rights of patient #11.
Patient #12 is a 46 year-old female who arrived at the Emergency Department of campus (A) on 06/06/2009 with severe hypotension and respiratory distress after an attempted suicide by overdose. Patient #1 was medically stabilized at Easton Memorial.
At 1:45 am on 06/07 a nurse-initiated restraint order was completed to place patient #12 in 4-point restraints due to escalating behavior including throwing a chair, and a 2:00 am telephone order for the same was entered into the physician orders section of the medical record. Patient #12 was not seen face-to-face within one hour to evaluate her, including no physician determination of whether or not restraints should end. A physician signature on the order and beneath an inadequate preprinted face-to-face declaration was timed at 6:30 am, nearly 5 hours later. The order form had a preprinted statement indicating, " I have examined the patient and have determined the need for continued restraint based on above clinical justification. "
The medical record showed that restraints were not ended at the earliest possible time. Observation sheets only showed that patient #12 was agitated from 2 am through 2:45 am, and that patient #12 had calmed down by 3 am. Patient #12 remained in restraint another 4 hours until 7 am without justification for the continuation documented in the record.
Patient #12 was transferred from the ED to the (BHU) behavioral health unit at campus (B) on the morning of 6/07, where she remained into July 2009. Nursing notes at 4:27 pm on 7/7 indicated that a code green was called when patient #12 began banging her head on the walls after she was dissatisfied with snacks she had been offered. Patient #12 continued to escalate and at 4:30 pm wrapped a sheet around her neck. The record indicated that 2 codes were called to place patient #12 into seclusion and then to place her into 4-point restraints because she was banging her head into the wall while in seclusion. At 4:45 pm, the order was entered for 4-point restraint. Once restraints were initiated, they were not appropriately ended. Patient #12 remained in restraints without sufficient justification for more than 17 hours. The initial order for restraint of 7/7 at 4:45 pm designates no criteria for release. It reads, " Restraint (4 pt.) for up to 4 hours x agitation. " This was followed by medication orders.
A second order at 8 pm reveals that patient #12 was required to meet an extensive list of criteria for release as written, "Renew 4 point restraints. Criteria for release: (1) Pt. can be redirected and is cooperative, (2) Pt. demonstrates the ability to make no self-injurious behaviors for a 6-hour period, (It is unclear how the psychiatrist could assess a 6-hour criteria within the confines of a 4-hour order.), (3) Pr. is cooperative with medications, toileting, and drinking fluids without making it a contest or requiring a code green, (4) Pt. is able to make a statement and to remember is 15-minutes & 60-minutes later, and (5) Pt. makes not attempts to take food or other items from others. " On each of 4 ensuing restraint orders, the psychiatrist referred to the initial criterions as remained the same. It is unclear how the psychiatrist could assess a 6-hour criteria within the confines of a 4-hour order.
The record demonstrated that the physician was aware that patient #1 had calmed down, was cooperative, and was able to converse with staff (including the physician). For example, the 4 am physician note indicated that the patient was seen again at 4 am and she was initially sound asleep but was rousable to verbal stimuli. The patient stated she was sleeping and verbalized understanding as to why the physician was there to reevaluate her. Patient #12 stated that she wanted to return to sleep. Physician confirmed with nursing staff that the patient was voiding on a bed-pan, was cooperative, and continued to take liquids by mouth. Nonetheless, four point restraints were continued because " criteria for release are not met ... Criteria for release remain the same and were placed in the order. "
A 7/8 RN note of 9 am indicates that permitting the patient food and toileting was predicated on patient #12 promising to return to restraint, which was by then, ongoing for more than 16 hours. The nurse wrote that the patient " agreed to return to restraint if allowed to ambulate to the bathroom and have breakfast. Escorted to bathroom by 2 staff. Given morning medications and permitted to sit up for her breakfast. Appetite is good. Pleasant conversation. Patient tended to her lense care. Returned to restraint area and placed in right wrist restraint. " Patient #12 was placed in one-point wrist restraint. No restraint discontinuation note is found, though 15-minute flows end at 9:45 am, the same time that patient #12 is described as going into one-point wrist restraint.
Patient #12 ' s rights were violated when she was kept in restraint for more than 16 hours with no evidence of continued dangerousness. In addition, arbitrary criterions were superimposed over regulatory criterion, which continued through four more orders. The hospital failed to protect patient #12 ' s rights to be free from restraint.
4. Patient #13 is a 40 year-old female involuntarily admitted to the campus (B) behavioral health unit (BHU) on 06/15/2010. Patient #13 received a diagnosis of acute psychosis, paranoid type.
On 06/15 at 12:11 pm the medical record revealed a verbal order for Haldol 5 mg IM now and Ativan 2 mg IM now, and these were administered. At approximately 12:20 pm - 12:25 pm a CODE GREEN was called and the patient was placed into locked-door seclusion. The order for locked door seclusion was justified by behaviors of " ...agitated, upset, throwing furniture, threatening, swearing, and out of control. " Although sufficient justification was entered to initiate the use of locked-door seclusion the following inappropriate criteria for release was detailed in the order:
The physician wrote, that in order to be released from locked door seclusion, she would have to (1) demonstrate ability to respond to redirection, (2) be calm, (3) be cooperative including, (4) demonstrating an ability to cooperate in taking medications, (5) be " in control " , and (6) cease being threatening. The record reveals that patient #13 had calmed down by 1 pm, but was maintained in locked door seclusion for approximately 6 hours on the basis of not meeting all criteria. There is no documentation in the medical record of behavior to justify continuation of locked door seclusion after 1 pm. After 1 pm, the record reveals patient #13 as calm, laying on a mattress, and at times sleeping. When the order was renewed at 3:50 pm the physician included the following descriptive discussion: " Patient rousable but unable to contract to inform staff if she feels that she is unable to control herself and inform staff if she needs a time out. Reassess patient at dinner-time and see if patient is able to meet all the criteria for release from locked-door seclusion. " In the related progress note the physician wrote that the patient was seen in seclusion with staff present.
No clear time reveals when patient #13 came out of seclusion, though a nursing progress note states that patient #13 was " Out of seclusion " by 6:54 pm. The hospital violated patient #13's rights by keeping her in seclusion for almost seven hours beyond the time when she became calm.

Based on a review policies, procedures and patient records, it is determined that (3) patients #4, 11 and 13 of 15 records reviewed were not released from seclusion at the earliest possible time when they were no longer violent or self destructive as evidenced by:

1. Patient #4 is a 50-year-old female who arrived via ambulance to campus (A) by emergency petition on 7/5/2010 just before midnight after reports of drinking alcohol and taking an overdose of trazodone. Patient #4 admitted to having suicidal ideation, but denied taking an overdose. She stated she took her usual dose.

An RN note of 7/6/2010 at 1:25 am states in part, " ...Patient adamantly refusing medication. Explained necessity for medication and patient continued to refuse. Advised patient that as long as she cooperates with staff and remains in her room then the medication would not be administered. Security at bedside with 2 RNs and ED tech. Patient became agitated and attempted to get out of bed. Security prevented patient from exiting bed and plan of care discussed again. Patient agreed to cooperate and lying on stretcher at this time.

The hospital Restraint & Seclusion use for Behavior Management Policy (revised 1/10), states in part, "A situation where a patient is restricted to a room alone and staff are physically intervening to prevent the patient from leaving the room or giving the perception that threatens the patient with physical intervention if the patient attempts to leave the room is considered seclusion. "

The RN and the security guard used coercion and a show of force to keep patient #4 in the room and in the bed by threatening forced medication, and " Preventing " exit from the bed. This represented seclusion. An emergency petition does not supersede patient right to appropriate justification and use of seclusion.

2. Patient #11 is a 50-year-old male who was brought to the ED of campus (B) on emergency petition via police after police found him disoriented, psychotic, and walking in traffic. Patient #15 has a history of mental illness with a diagnosis of schizoaffective disorder. Patient #15 has a medical history of type II diabetes (non-insulin dependent), hypertension and pancreatitis. He was observed to demand food and drink, and to drink pitcher after pitcher of water in the ED. Patient #15 was admitted involuntarily to the BHU.

An order of 7/7 at 8:30 pm detailed multiple criterions for release from restraint that read (1) Criteria for release from locked door seclusion, (2) The pt. must be redirectable by staff, (3) The pt. must be willing to take either po or IM medication, (4) The patient may be released when the pt. is able to talk and work cooperatively with staff - to go to toilet, to follow specific directions, to cooperate with snacks ingestion (diabetic), and (5) The patient must have no episodes of yelling, banging (door, walls, furniture), or threatening behaviors or verbal threats for at least two hours."

A seclusion order of 11:30 pm states, " Renew seclusion for combative, resistive, threatening behavior. Criteria for rules remain as above " (referencing first order criterions). The Restraint Flowsheet identifies patient #11 as sleeping. A nursing note of 2:08 am states, " Patient remains in seclusion at this time, observed lying on mattress. Appears to be resting comfortably, respirations steady and even. Pt. has been toileted and given hydration. Will continue to monitor. "

A seclusion order on 7/8 at 3:29 am stated " Renew seclusion order additional 4 hours. Criteria for release remains as noted earlier order 7/7/10 - 2030 order. Will reevaluate in 4 more hours." A nursing note of 3:29 am stated " Dr. ___ contacted to renew seclusion order for additional 4 hours. Pt. continues to be in the seclusion, observed by staff thru observation window at this time. Appears to have steady respirations, positional changes noted. Continue to monitor."

Nursing notes of 4:35 am, and 5:40 am respectively stated "Continues to be resting in seclusion area. Observed to (through?) glass, respirations noted, as well as positional changes. Continue to monitor" and "Pt remains in seclusion room, appears to be resting lying on mattress, respirations steady and even. Positional changes noted. Continue to monitor."

An RN note for behaviors noted at 6:37 am stated "Pt. was assessed by 3 staff members while in seclusion. Pt. awaken with numerous requests to wash his eyes, and demanding to get out, informed pt. that the Dr. will be in at 7:30 am to speak with him at (and) will be her decision of when he would be getting out. Will continue to monitor."

A seclusion order of 7/8/2010 7:05 am stated "Renew seclusion for 4 hours for safety of patients and staff. Criteria for release as per order of 07-07-2010 at 20:30." The psychiatrist renewed seclusion, and wrote the following progress note. "Seclusion 07-08-2010 The pt. has been in locked door seclusion through the night. When checked by nursing staff at - 6:30, the pt. wanted a shower and made multiple requests to wash his eyes. When he demanded to get out, the nursing staff informed him that he would be seen by the doctor who would make that decision" and "The pt. was laying on his right side sleeping, but was aroused with verbal stimulation " ... " When asked how he felt, the pt. stated that he was tired and wanted to rest for another ten minutes." When asked, the patient did not recall his behaviors of the previous day and night. He was informed that it was important he control himself and be appropriate in the community. When patient #11 indicated, he wanted 10 more minutes to sleep, the psychiatrist informed him he would be allowed to rest." The psychiatrist continued "Seclusion was renewed for another four hours. The nursing staff will toilet and feed the pt. and offer morning medications. If the pt. is able to control his behavior, and cooperates with unit procedures, the pt. will be tapered out of seclusion as all criteria are net and the pt. is stable for at least 2 hours."

The Restraint flow for 7 am reveals patient #11 to be disoriented. No documentation at that time indicates that patient #11 was a violent or self destructive.

A nursing note of 10 am states in part " Pt. remains agitated with pressured speech and intense stares noted. " A seclusion order of 7/8 at 10:45 am states, "Renew seclusion for 4 hours for safety of pts. and staff. Criteria for release as per order of 07-08-2010 at 20:30. Fingerstick glucose before every meal x 3 days.'

A psychiatrist note of 12:33 pm states in part "The pt. propped himself up on his right arm and used his left hand to eat bacon from his tray, " and, " The pt stated that he was hungry and requested additional food, " and, " Dr. __ informed him that she had seen him earlier in the day, but the pt. had no memory of this. When asked whether he was having any problems, the pt. stated that he was OK. When asked about his pounding on the walls and shouting at the top of his voice at 9 and 9:30, the pt. stated that he was exercising. Dr. ___informed the pt. that he could receive extra food for today only as he worked to become more stable, " and "The pt's contact with reality remains tenuous and ability for self-control is very variable. For the safety of the pt, the pts on the unit and staff, locked door seclusion is renewed for another 4 hours. " Patient #11's glucose was 246 prior to eating."

Nursing notes of 1:39 pm and 2:36 pm respectively, state in part "Pt is calmer but remains guarded and selective with meds. Pt. denies and current issues with pain and is able to follow simple commands" and "Pt was informed of conditions for seclusion to be discontinued. Pt. was receptive. Will continue to monitor" and " Remains in seclusion - laying on the mat while hovering over his feed tray. Has his clothing on. Quieter. Will continue to monitor closely. "

At 5 pm, patient #11 is documented on the Restraint Flow as sleeping. A psychiatry note on 7/8 at 5:02 pm states in part, "The pt was resting on his left side on his mattress with a plaster water container in pieces at his feet. The pt. stated he was not getting enough food and had been trying to open the water container." Patient #11 asked for car magazines, and the security guard stated he would get some. Patient #11 had been banging on the wall "Episodically" during the past 4 hours, with "No episodes of crying out loudly. Currently episodically medication compliant."

A psychiatric note of 7/8 at 10:03 pm states in part "Pt. was seen in seclusion ....just prior to out entrance, the pt. had been kicking at the wall again ....he complained that he did not have enough food ...he commented that he felt good, and denied hearing voices, seeing things or paranoia ...he remarked that he was comfortable there and did not want to come out of seclusion and be with others because he was " Scared " of them." The note continues that "He was confused about the time lapse of events, was labile and as the conversation continued, he became more irritable and excitable. He was given IM Geodon and ativan," and "Restraint (writers note: Pt was not in restraint) and seclusion to be continued as pt. is unable to contract for being able to be responsible for his behavior outside the contained environment of the seclusion room. As noted, consistent medication compliance continues to be an issue."

An RN note of 7/8 at 11:07 states in part "Dr. ___in to see pt. at 9:30 for face to face for continuation of seclusion. Before Dr. arrival, pt. was kicking door, yelling and banging." Patient #11 spit out his p.o. meds and IMs were to be given per the psychiatrist. Patient #11 stated he would accept the IMs only if an African- American nurse gave them" and "PT. stated that one of the staff members had kicked him in the groin, which was a false statement. Informed pt. when asked when he was getting out, that his behavior would have to be more in control before that would happen." It is noted on the Restraint Flow that patient #11 was documented as sleeping from 5 pm until 9:15 pm, and again from 10:45 pm until 7/9 at 5:15 am.

Patient #11 remained in seclusion until 7/10/2010 2:50 pm, when the psychiatrist wrote "(1) Open door to quiet room for 1 hour, will reassess. (2) Discontinue prolixin IM and ativan IM orders. (3) Prolixin 5 mg po QID. If patient refuses any dose, give IM, and (4) Ativan 2 mg po QID. If pt. refuses any dose, give IM."

Patient #11 was kept in seclusion for a total of 66 hours from 7/7 at 8:30 pm until 7/10 at 2:45 pm, largely based on arbitrary criterions.

3. Patient #13 is a 40 year-old female involuntarily admitted to the campus (B) behavioral health unit (BHU) on 06/15/2010. Patient #13 received a diagnosis of acute psychosis, paranoid type.
On 06/15 at 12:11 pm the medical record revealed a verbal order for Haldol 5 mg IM now and Ativan 2 mg IM now, and these were administered. At approximately 12:20 pm - 12:25 pm a CODE GREEN was called and the patient was placed into locked-door seclusion. The order for locked door seclusion was justified by behaviors of " ...agitated, upset, throwing furniture, threatening, swearing, and out of control." Although sufficient justification was entered to initiate the use of locked-door seclusion, the following inappropriate criteria for release was detailed in the order:
The physician wrote that in order to be released from locked door seclusion, she would have to (1) demonstrate ability to respond to redirection, (2) be calm, (3) be cooperative including, (4) demonstrating an ability to cooperate in taking medications, (5) be "in control" and (6) cease being threatening.
The record reveals that patient #13 had calmed down by 1 pm, but was maintained in locked door seclusion for approximately 6 hours on the basis of not meeting all criteria. There is no documentation in the medical record of behavior to justify continuation of locked door seclusion after 1 pm. After 1 pm, the record reveals patient #13 as calm, laying on a mattress, and at times sleeping. When the order was renewed at 3:50 pm the physician included the following descriptive discussion: "Patient rousable but unable to contract to inform staff if she feels that she is unable to control herself and inform staff if she needs a time out. Reassess patient at dinner-time and see if patient is able to meet all the criteria for release from locked-door seclusion." In the related progress note, the physician wrote that the patient was seen in seclusion with staff present.
No clear time reveals when patient #13 came out of seclusion, though a nursing progress note states that patient #13 was "Out of seclusion" by 6:54 pm. Patient #13 was kept in seclusion for almost seven hours beyond the time when she became calm.

Based on interviews, review of policy and procedure, and patient records, it is determined that 2 patients (#1 and 3) of 15 patients reviewed, were placed in seclusion/restraint without evidence of a physician order as evidenced by:
Patient #1 is a 56-year-old male with a history of mental retardation, psychosis, depression, and obsessive-compulsive disorder. Patient #1 had (4) recent ED visits, (3) in July, and one in August. Two of the visits were not due to behavioral issues. The other two on 7/21/2010 and 8/8/2010, both at campus (A) were for behavioral issues.

On 8/8 patient #1 was reported to have been refusing meals, had locked himself in his room, became violent with staff and peers, and threatened to cut off his arms and legs. The physician clinical impression was " Intermittent Explosive Disorder, and patient #1 was made involuntary.

On or about 6:50 pm of 8/8/2010, staff called a psychiatric Code Green due to a violent outburst from patient #1. The Physical Exam sheet of the ED documents "CODE GREEN required 4 pt restraint." An every-half-hour Continuous Visual Observation sheet indicates that patient #1 was in restraint at 7 pm. No physician order accompanies the restraint.

Patient #3 is a 45-year-old male who on 8/4/2010, came by ambulance to campus (A) following a drug overdose with baclofen. Patient #3 was placed in 4-point restraint due to combativeness. The Restraint Physician ' s Order form reveals that restraint began at 7 pm. However, the Continuous Visual Observation sheet reveals that patient #3 was in restraint at 6:15 pm. Therefore, staff restrained patient #3 for 45-minutes without a physician's order.

Based on policy and procedure, and review of patient records, 2 patients (#5, and 12) of 15 records reviewed revealed a seclusion orders that constituted PRN orders as evidenced by:
1. Patient #5 is a 44-year-old male, who on 7/11/2010 went to the ED of campus (A) via family. Patient #1 had taken an overdose of blood pressure medication with alcohol. Patient #5 verbalized suicidal and homicidal ideations towards a man who harmed his family years ago. Per the physician's order, 4-point restraint was initiated for violent/destructive behaviors at 2:55 pm, and that continued with a new order written at 6:55 pm. Patient #5 was released from 4-point restraint at 9:38 pm.

A physician-signed restraint order appears in the record for 7/11 at 10:55 pm until 7/12 at 2:55 am. The physician did not time his signature. The restraint order form reveals boxes that give attribution to the patient's mental status as "confused, disoriented, and suicidal ideation." The Behavioral Management Restraint section is checked, as are behaviors of "Restless, threatening, violent, and suicidal ideation." The type of restraint that was applied was left unchecked. No documentation during the cited time period supports that patient #5 had behaviors that posed a safety threat to patients or staff that would have justified the use of restraint. The patient was in restraints until 9:38 pm.

Interview with the Director of Acute Care and the Director of Emergency and Outpatient Services reveals that the order of 10:55 pm indicates that patient #5 was on close observation at that time, evidenced by no restraint type being checked.

Per interview, if close observation were to commence following restraint termination, the order for close observation would have been written at 9:38 pm when patient #5 came out of restraint, more than one hour before the restraint order was written. Had patient #5 remained in restraint, a renewal order would have been written from 10:55 to 2:55 am, the exact times listed on the signed order. No documentation indicates that close observation was the intent of the order.

A progress note of 10:35 pm reveals, that the RN who had been caring for patient #5 gave report to the oncoming RN. The oncoming RN documented the order at 10:55 pm, time minutes after getting report on patient #5. In addition, she documented the order at a time when the off-going RN otherwise documents patient #5 as sleeping. Therefore, between 10:35 pm and 10:55 pm, the oncoming RN obtained a restraint order in advance of needing it (PRN), for a patient who was lying quietly on a stretcher. Likewise, the physician signed the order (PRN) for the restraint of a patient who was not at that time, a danger to self or other.
2. Patient #12 was a 46 year-old female who arrived at the Emergency Department of campus (A) on 06/06/2009 with severe hypotension and respiratory distress after an attempted suicide by overdose. Patient #1 was medically stabilized at Easton Memorial.
On 06/06 at 6 am, the campus (A) ED medical record revealed that patient #12 went into non-behavioral restraints with a nurse-initiated order. The name of the RN is signed, and printed at the bottom of the physician order form. The order is not noted as a telephone order. A physician signature is missing, though a name appears in the physician printed space. No date or time accompanies the name, and it is not possible to tell when the physician saw patient #12 based the order sheet.
At 10:40 pm, another nurse-initiated non-behavioral restraint order was entered into the record. Again the physician signature, when entered, was placed in the printed area, and again, was neither timed nor dated. Regulation allows for "nurse-initiated" orders for restraint and seclusion. However, orders that are not signed with appropriate dates and times allows for PRN use of restraint and seclusion
On 6/7 at 1:45 am, a nurse-initiated behavioral restraint order was completed to place the patient in 4-point restraints after patient #12 threw a chair. A physician signature appears on the order beneath an inadequate preprinted face-to-face declaration, which was timed at 6:30 am, nearly 5 hours later. order was followed by another related telephone order for 4-point restraints for which a second nurse-initiated restraint order form had been completed at 0145. The sign off of the noted 2:00 am telephone order had no identifier, no date, no time, and the signature was not legible.
This behavioral restraint but no face-to-face evaluation was documented in the record. The order form not signed until 6:30 am, has a preprinted statement indicating "I have examined the patient and have determined the need for continued restraint based on above clinical justification. A preprinted statement fails to meet the regulatory requirement for documenting a face-to-face assessment, and in this case even the preprinted statement wasn't signed until nearly 5 hours after restraints had been initiated by nursing. This system of utilizing nurse-initiated orders without requiring physician authentication including both a date and time, allows for PRN (as needed) use of orders for restraint and seclusion by nursing staff.

Based on interview, review of policy and procedures, and patient records, it is determined that physicians receive no training in restraint and seclusion requirements, nor does training for physicians and other licensed independent practitioners appear in hospital policy as evidenced by:

Interview with the Director of Compliance reveals that physicians and other independent practitioners do not receive education on restraint/seclusion requirements. Consequently, the 15 restraint/seclusion records reviewed, evidenced physician-related violations of restraint/seclusion requirements.

A review of policy, and patient records, reveals the hospital Restraint Physician Order sheet, does not comply with requirements of the face-to-face, and patient #12 of 15 patients reviewed had no face-to-face until 5 hours following the time of restraint as evidenced by:
The hospital Restraint Physician Order sheet is usually filled in by the RN for (1) Mental status, (2) type of restraint, (3) Patient behavior, and (4) Clinical justification. The sheet contains a Physician Signature area with the date and time, which when signed, acknowledges that "I (the physician) have examined the patient and have determined the need for continued restraint based on above clinical justification."
The sheet does not address the patient's reaction to the intervention, or the medical condition of the patient. In addition, the physician acknowledgement appears to be based on the RN assessment. The inpatient face-to-face consists of a progress note .
The hospital fails to meet the regulatory requirements for the physician face-to-face in the hospital emergency departments of campus (A) and (B).
Patient #12 is a 46-year-old female who arrived at the Emergency Department of campus (A) on 06/06/2009 with severe hypotension and respiratory distress after an attempted suicide by overdose. Patient #1 was medically stabilized at campus (A).
On 6/7 at 1:45 am, a nurse-initiated restraint order was completed to place the patient in 4-point restraints. No nursing signature accompanies the order. A physician signature appears on the order beneath an inadequate preprinted face-to-face declaration, which is timed at 6:30 am, nearly 5 hours later. Regulations allow for a physician face-to-face within one hour of restraint/seclusion initiation. Based on the fact that patient #12 was restrained for nearly 5 hours without a physician assessment, the hospital failed to provide for the required face to face evaluation that must be performed by the physician or other licensed personnel specifically trained to perform evaluations.

Based on interview, policy and procedure and review of patient records # 1, 2, 3, 4, 5, and 6 of 15 patients reviewed were placed at risk due to the (1) potential of being restrained by untrained security staff, and (2) being monitored by security staff untrained in identifying patient distress, and (3) demonstrated by the ED restraining event of patient #3 as evidenced by:
Hospital policy for Restraint & Seclusion Use for Behavior Management (revised 1/10), reveals part 4.0 as "Guiding Principles for the Use of Behavioral Health Restraints", subsection 4.6, as "Only staff that have completed restraint/seclusion education, and have demonstrated competency, may care for patients in restraint/seclusion."
An onsite survey of 8/18/2010 reveals that in the emergency department (ED), security staff is largely responsible to monitor each patient in restraint with every-half-hour Continuous Visual Observation sheet. RNs enter the psychiatric area to monitor each patient every 15-minutes.
Interview with a security staff member reveals that when a patient is in restraint, he sits in the anteroom keeping the ? hour observation sheet. When asked if he has occasion to restrain patients, he stated that nursing usually restrains patients, but that he has restrained patients when the ED has been "short-handed. " When asked what training he receives regarding restraint, he indicated that he " does not " specifically receive training in restraining patient, but does receive "training in types of holds."
Patient #3 is a 45-year-old male who came by ambulance to campus (A) following a presumed drug overdose with baclofen. Patient #3 was placed in 4-point restraint at 6:45 pm due to agitation, aggression, and violent behaviors. Patient #3 was noted immediately following restraint to have periods of agitation and yelling with periods of snoring. Patient #3 developed 15-second periods of apnea, and over 4.5 hours became " bradycardic with 30-40 seconds of apnea" while still in 4- point restraint, and became unresponsive to painful stimuli. A code was called and patient #3 was removed from restraint and intubated. Patient #3 was admitted to ICU.

During the 4.5 hours in restraint, an RN was observing and documenting on the restraint flow sheet every 15-minutes. RN progress notes were documented regularly, excepting one hour-long period from 7:21 pm to 8:37 pm in which no progress notes are noted. A security guard sat in the anteroom at all times while patient #3 was in restraint, and documented each ?-hour, the content of which states "Still restrained on bed " and "Still restraint/jumping." Review of the hospital training of security guards reveals that they have no clinical training, no restraint training, and no training to identify, or respond to signs of patient distress. Wall-mounted panic buttons are available to the security guard, but the guard must be able to identify patients distress in order to use them.

The hospital failed to provide appropriate training for staff charged with monitoring seclusion/restraint episodes in the emergency department.

Based on interview, review of policy and procedures, and patient records, it is determined that (6) patients #1, 4, 5, 11, 12, and 13, of 15 records reviewed, were not appropriately identified by clinical staff for termination of seclusion or restraint as detailed in A-0154 as evidenced by;

Hospital policy for Restraint & Seclusion Use for Behavior Management (revised 1/10), part 6.0 Training Requirements reveals, staff authorized to perform assessments or monitor patients are to be educated and able to demonstrate competency in: (1) application of restraint/seclusion (R/S), (2) Implementing R/S, (3) Monitoring patients in R/S, (4) Assessment of patients in R/S, (5) Providing care for a patient in R/S before performing any R/S activities, (6) Documentation requirements. The policy appears complete for all restraint/seclusion requirements; including 6.3.5 Clinical notification of specific behavioral changes that indicate that restraint or seclusion is not longer necessary.

Review of the actual Competency List for Behavioral Health reveals, only three points of education, written as " (1) The Restraint/Seclusion Policy will be discussed, (2) Be prepared to: Discuss care of the patient in restraints including restraint alternatives, types of restraints and restraint application and seclusion, and (3) Discuss documentation of the patient in restraint/seclusion." The competency includes "(1) Discusses care of patient in R/S, (2) Discusses documentation of patient in R/S, and (3) Demonstrates release and tying of quick release knot."

Actual hospital competencies do not correlate to the depth and detail of the hospital R/S policy, and are inadequate to initiate, assess, care for, and discontinue restraint and seclusion for patients who require such intervention. Consequently, the hospital fails to provide adequate education for those staff involved in the the restraint/seclusion process.