The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

JOHNS HOPKINS BAYVIEW MEDICAL CENTER 4940 EASTERN AVENUE BALTIMORE, MD 21224 Feb. 28, 2012
VIOLATION: PATIENT RIGHTS: NOTICE OF GRIEVANCE DECISION Tag No: A0123
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on review of documentation, the hospital failed to follow its policy and procedure for the resolution of a grievance involving a possible breach of patient #1's private health information as evidence by:

The hospital Complaint and/or Grievance: Patient Policy (CGP) (reviewed 4/11) identifies a patient grievance as: Any written or verbal concern that is made to the hospital by a patient or patient ' s representative regarding services received that cannot be resolved promptly by staff present. Patient grievances include:

a. A concern that is postponed for later resolution, is referred to other staff for later resolution, requires investigation, and/or requires further actions for resolution.

b. A formal or informal written or verbal concern regarding patient care, safety, abuse or neglect, or compliance with CMS Hospital Conditions of Participation.

c. A written or verbal concern that is identified after an episode of care is complete, which was not identified and/or resolved during the episode of care or the patient did not wish to address during the episode of care.

Patient #1 is a [AGE]-year-old female with a history of morbid obesity who underwent bariatric surgery on 11/9/2011.
On 1/10/2012, patient #1 went in person to the hospital Patient Relations Office (PRO) to relate a complaint that her private health insurance had been accessed without her permission after her former husband made statements to her regarding her recent surgery. Per the hospital CGP policy, patient #1 came to the hospital with a verbal concern, requiring investigation, which represented a CMS compliance issue. By hospital definition, her concern was a Grievance.
Patient #1 spoke with a patient relations representative (PRR) who took detailed information. After consulting with the Patient Relations Manager, it was decided that the issue was a HIPPA complaint. The PRR writes in part, " After meeting with my superiors regarding this case, it is decided that it will be handled as a HIPPA complaint. The contact number for the HIPPA office will be provided (number given) to Mrs.___ (patient #1) to enlist their assistance. Case closed. "
Though comprehensive information was obtained from patient #1, only patient #1 ' s name, patient number, and that there may have been an inappropriate access of private health information was forwarded to the HIPPA office. In closing the case, the PRO office had the expectation that patient #1, who had already presented with the grievance, would yet again have to present her concerns to another hospital department. Interview with a HIPPA office representative reveals the belief that it was also incumbent on patient #1 to call them, and they sought no other information. The CGP delineates responsibilities in part as:
"3. Patient Representative
a. Intake patient complaints/grievances (c/g) and follow the c/g management process.
c. Idenitfy issues for resolution and forward the patient c/g to the clinical department/service involved within 3 days.
d. Oversee the resolution process to facilitate a timely response."
It is unclear why the PRO closed the case prior to resolution, as no policy provision specifies the closure of cases following referral. On the contrary, the PRO maintains the database repository of all C/G, and follows each case through to resolution. As stated in the CGP Procedure:
"3. The appropriate (hospital) personnel will investigate the complaint and/or grievance. Upon completion of the investigation, a verbal or written response will be given to the patient and/or patient ' s representative within 7 business days of complaint/grievance receipt by the Patient Relations representative. If the investigation/resolution cannot be completed within 7 business days, a resolution letter will be sent to the complainant within 30 business days. If a definite date for resolution cannot be determined, the patient and/or representative will be notified and kept informed until the investigation is complete. "
Additionally, the CGP " Procedure " states in part:
"6. C/G that involve quality of care concerns, breaches of confidentiality or any serious issue will be reviewed with Risk Management.
7. C/G that warrant quality review will be referred to Quality Management."
Neither Risk Management nor the Quality Management was made aware of patient #1 ' s concerns.
In summary, patient #1 presented with a complaint which rose to the level of a grievance of special interest by Risk and Quality Management due to potential CMS Compliance issues. While the PRO correctly identified the HIPPA office for referral, the PRO supplied the HIPPA office with scant information, and did not also refer the complaint to Risk and Quality Management per policy.
The PRO placed responsibility back onto patient #1 to yet again contact a hospital office in the interest of her concerns and closed the case prior to resolution. This effectively disabled the oversight described the CGP. Additionally, the HIPPA office did not follow-up with patient #1, and neither did patient #1 call the HIPPA office. Consequently, the hospital failed to follow their Complaint/Grievance policy, and failed to resolve a grievance with patient #1 regarding the possible access of patient #1 ' s private health information.
VIOLATION: PATIENT RIGHTS: PERSONAL PRIVACY Tag No: A0143
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on a review of documentation, and policy, the hospital failed to provide privacy for patient #3 during 2 seclusion and 1 restraint episode as evidenced by:


Patient #3 is a [AGE]-year-old female discharged from the Behavioral Health Unit on 8/12/2011 and re-admitted on [DATE] following a suicide attempt at her group home during a "Blacked out episode." She has a diagnosis of Bipolar Disorder with psychotic features, rule out Schizoaffective Disorder. Patient #3 has self-harming behaviors and a history of assaults on others.

Once on the unit, she became agitated and made threats to kill staff members. Per a physician note, "With much convincing" she was able to go to ODS (Open door seclusion) without assistance."

A nursing note of 8/13/11 at 6:15 PM states "Patient started to escalate after dinner. Met with Doctor and were discussing why she was in ODS earlier around 11 am. Pt. (patient) walked up to med room and started to take 2 meds out of the bins."

A Restraint/Seclusion Flow Sheet (RSFS) reveals that at 6:30 PM, patient #3 "Tied a gown around her neck."

On 8/13 at 6:57 PM, a psychiatric admission note states in part "At one point, made gesture of tying socks around neck, and all of her clothing was removed by security."

The Restraint/Seclusion Flow Sheet (RSFS) reveals that at 6:30 PM, patient #3 "tied gown around neck."

The hospital policy for Locked Door Seclusion (LDS for Acute Psychiatric Unit and Emergency Department policy (revised 2/09) reveals a Philosophy in part that seclusion "will only be used:
2. In a humane, safe, effective manner respectful of the patients dignity,
3. Without intent to harm or create undue discomfort to the patient,
6. With maintenance of modesty, and comfortable body temperature,
7. With consideration of each patients cognitive and physical vulnerabilities,
8. With consideration for the risks associated with vulnerable populations such as ...patients with a history of physical or sexual abuse."
Under Acute Psychiatric, the policy states in part, "6. Patients should be permitted to wear all or a portion of their clothes or other attire, unless a physician or a registered nurse determines it is unsafe."

The hospital performs psychiatric and nursing assessments to determine prior patient traumas. Trauma-informed care then helps to lessen more trauma when restrictive interventions are necessary. The comprehensive nursing assessment gives no attribution to prior physical or sexual abuse of patient #3. However, the psychiatric assessment of patient #3 reveals that patient #3 had been physically abused, and may have been sexually abused. While both disciplines assess for previous trauma, no provision or guidance is found in the hospital policy for:
1. Interventions for patients who have suffered physical and/or sexual abuse.
2. A provision for privacy preservation for patients whose clothing has been removed.
At 8:30 PM, a nursing note states in part, "Patient crying & wanting her own clothes. Staff in room explained unable to give her clothing due to her attempt to hurt herself earlier ...security and staff remained with patient ...Remained tearful - requested blanket - again explained not able to have one at this time but heat in room adjusted."

Interview with behavioral health staff revealed that the no privacy options such as specialty clothing/blankets are available for behavioral health patients who are secluded, and have shown self-harming behaviors. Therefore, patient #3 was left naked in the seclusion room while " Security and staff remained " to monitor patient #3 who had no way to cover, or warm herself. Patient #3 had been completely naked since the initiation of seclusion, and it was the continued belief of staff that she should remain so. Additionally, staff was unable to determine and act on the fact that patient #3 was in distress.

At 10:30 PM, a nursing note states in part, "MD spoke with pt who awakened as staff called to her ... given fluids & medication, a blanket & pillow. Patient contracts for safety at present. Patient requested to come out & was explained that pt would need to show staff that she can be trusted with blanket & pillow initially to take things step by step."
On 8/14 in a note timed 7:30 - 7:50 am nurse notes, " 3 staff & 4 security entered room - patient asked for a gown- given gown- went to toilet, vs (vital signs) checked, given routine meds, breakfast, water, and orange juice. Patient stated, " I can't guarantee it won't happen again." Face to face with MD. Door locked." A psychiatric note of 8:58 PM states in part, "Grooming: other (naked in LDS room during exam at 7:30 am)".
Patient was released from seclusion at 3 PM, but remained in seclusion with the door open. The Nursing debriefing states "Patient agreed to stay in ODS and follow the simple rules we decided on."
On 8/14 at 6:12 PM, a nursing note states in part, "During process of restraining pt, pt confiscated glasses of security guard. She removed glass from frames and placed it is her mouth. This was removed safely, she was disrobed (r/t (related to) incident with gown in LDS yesterday) with assist from security and door was again locked."
A nursing note of 6:15 PM states in part, "Door locked again after taking off gowns and underwear ....Pt then started to bang back of head into the wall in a rhythmic motion ....Bed was prepared in 4 point restraints and patient was carried to the other seclusion room. Patient placed in 4-point restraints."
On the Restraint/Seclusion Justification and Discontinuation form, nursing documented that "Clothing removed due to self-injurious behavior" and " 6 security & 4 nurses secluded patient."
A nursing note of 8/15 at 8 am states in part, "Pt remains unclothed in 4-pt restraint with 1:1 close observation." At 10:15 am, a nursing note states in part, "Pt remains unclothed with sheet to cover." This is the only reference found that patient #3 was covered at some point during restraint. Patient #3 was restrained until 8/15 at 12:30 PM.
The hospital failed to meet the Patient Rights regulatory requirements to provide for patient #3's privacy.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0162
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on review of documentation, patient #3 was maintained in seclusion, though the hospital called the intervention Open Door seclusion (ODS) and describes the intervention as voluntary as evidenced by:


Patient #3 is a [AGE]-year-old female discharged from the Behavioral Health Unit on 8/12/2011 and re-admitted on [DATE] following a suicide attempt at her group home during a "Blacked out episode." She has a diagnosis of Bipolar Disorder with psychotic features, rule out Schizoaffective Disorder. Patient #3 has self-harming behaviors and a history of assaults on others.


Hospital policies for Restraint Use and Locked door Seclusion reveal less restrictive interventions which nursing may use prior to the use of restraint or seclusion. One of these interventions is the use of "Open door seclusion/time out/quiet room." Interview with staff reveals that these three interventions are one-and-the-same, and represent a voluntary agreement between staff and the patient. Staff further reveals that the patient agrees to stay in the seclusion room, but the door remains open and the patient may leave the room as they wish. However, after review of patient #3's record, the use of the phrase "Open Door Seclusion" appears to cause some confusion for staff as to the voluntary nature of the intervention, and no separate policy is found to guide its use.


Per the Code of Maryland Regulations Title 10.21.13.09 Use of Quiet Room, there is a process by which Quiet Room is utilized as follows:


".09 Use of Quiet Room.

A. Patient Request.
(1) A patient may request the use of a quiet room and, unless clinically contraindicated, may be granted use of a quiet room.
(2) Unless staff terminates use of the quiet room for clinical reasons, the patient may terminate self-initiated use of the quiet room at any time.
B. Staff Request.
(1) When staff, permitted by the facility to initiate and terminate use of a quiet room, determine that the use of the quiet room is clinically indicated, staff may request that a patient voluntarily enter into the quiet room.
(2) Staff may not coerce a patient into entering the quiet room.
(3) When the patient enters the quiet room, staff shall discuss with the patient:
(a) The recommended length of stay in the quiet room;
(b) The behaviors expected of the patient before and upon return to the milieu; and
(c) The primary interventions to be initiated if the use of the quiet room is terminated by the patient before the time recommended by staff or is determined to be ineffective.
C. Staff shall determine the need for removal of any harmful objects in the room or from the patient.
D. If staff determine a need for objects to be removed pursuant to ?C of this regulation, staff shall ask the patient, in a non - threatening manner, to surrender the objects.
E. While a quiet room is in use, the staff shall assure that the quiet room door is not locked or in a position that prevents a patient from exiting the room voluntarily.
F. Observation and Documentation. Staff shall:
(1) Be assigned to monitor the patient and the safety of the environment while a patient is in the quiet room;
(2) When the quiet room is used as a clinical intervention, observe the patient at least once every 30 minutes and document the observation in the patient's medical record; and
(3) At least every 2 hours, evaluate the effectiveness of the outcome and document the clinical rationale for continued use of the quiet room.
G. A physician shall review the use of the quiet room after 6 hours and, if use of the quiet room is continued, at least every 24 hours after that.
H. Use of a quiet room may be terminated at any time:
(1) Upon the decision of the patient; or
(2) As clinically determined by staff. "


On 8/13/2011, a physician-timed note of 3:26 PM, states in part, "On arriving to the unit, the patient became agitated when asked about her interim history and if she was able to contract for safety. She made threatening remarks to staff, after which time security was called. After much convincing, the patient was able to go to ODS without assistance ... "


A nursing note of 8/13/11 at 6:15 PM states "Patient started to escalate after dinner. Met 6:15 PM with Doctor and were discussing why she was in ODS earlier around 11 am ... " Patient #3 had been in ODS from approximately 11 am. However, no nursing documentation is found per COMAR regulation of:


"(3) When the patient enters the quiet room, staff shall discuss with the patient:
(a) The recommended length of stay in the quiet room;
(b) The behaviors expected of the patient before and upon return to the milieu; and
C. Staff shall determine the need for removal of any harmful objects in the room or from the patient.
D. If staff determine a need for objects to be removed pursuant to ?C of this regulation, staff shall ask the patient, in a nonthreatening manner, to surrender the objects.
F. Observation and Documentation. Staff shall:
(1) Be assigned to monitor the patient and the safety of the environment while a patient is in the quiet room;
(2) When the quiet room is used as a clinical intervention, observe the patient at least once every 30 minutes and document the observation in the patient's medical record; and
(3) At least every 2 hours, evaluate the effectiveness of the outcome and document the clinical rationale for continued use of the quiet room."


Patient #3 was initiated into seclusion at 6:30 PM which continued until 8/14 at 3 PM. A Restraint/Seclusion Flow Sheet of 8/14 documents that at 3 PM; patient #3 was "Now in ODS." The Restraint/Seclusion justification & Discontinuation form for Discontinuation of Restraint/Seclusion notes that "Patient agreed to stay in ODS and follow the simple rules we decided on." A nursing note on 8/14 at 3 PM states "Discussed behaviors that lead to LDS. Treatment team along with patient came up with a specific plan to ensure the safety of herself and others. Patient willing to call out for RN when she initially thinks of feeling suicidal. Was able to contract for safety. We now have a security detail 1:1."


No discussion is found in the records related to Maryland regulations for Use of Quiet Room as to:
"(3) When the patient enters the quiet room, staff shall discuss with the patient:
(a) The recommended length of stay in the quiet room;
(b) The behaviors expected of the patient before and upon return to the milieu;"


Nor was ongoing documentation found per COMAR Use of Quiet Room as:


"F. Observation and Documentation. Staff shall:
(1) Be assigned to monitor the patient and the safety of the environment while a patient is in the quiet room;
(2) When the quiet room is used as a clinical intervention, observe the patient at least once every 30 minutes and document the observation in the patient's medical record; and
(3) At least every 2 hours, evaluate the effectiveness of the outcome and document the clinical rationale for continued use of the quiet room."



On 8/14 a nursing note of 6:10 PM states "Pt in ODS with security detail, becoming agitated, loud/throwing cup of juice at nurse. Pt unable to follow directions to stay seated on mat, trying to push her way out of ODS. With assist of 4 security and Dr. __, pt medicated and LDS initiated."


At 6:15 PM, a nursing note states in part "Patient was in ODS until 1500. Became agitated because she felt her needs were not being met. At the point in which she was told by Dr. ___ she would not be able to come out of the room, she picked up a glass of liquid and threw on staff. "


While staff did not, per COMAR regulation, discuss time limits of Quiet Room with patient #3, though she agreed to utilize the voluntary process of Quiet Room which (according to hospital policy), is synonymous with ODS. Therefore, patient #3, had been 1:1 with security in the Quiet Room for approximately 3 hours when she began to feel agitated (per nursing), and that her needs were not being met.


No documentation indicates behaviors or threats prior to being told she could not leave the quiet room, which would have required more restrictive interventions such as seclusion or restraint. Consequently, when patient #3 agreed to Quiet Room as a voluntary process, believed herself to be progressing, and was then informed Quiet Room was no longer voluntary, she acted out, and then required more restrictive intervention.


The hospital failed to meet regulatory requirements for the voluntary use of Quiet Room. Though the door of the seclusion room was open (ODS), refusing patient #3 exit was tantamount to seclusion.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0166
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on a search of documentation, the hospital failed to modify patient #3's plan of care for two seclusion and one restraint episode as evidenced by:

Patient #3 is a [AGE]-year-old female discharged from the Behavioral Health Unit on 8/12/2011 and re-admitted on [DATE] following a suicide attempt at her group home during a "Blacked out episode." She has a diagnosis of Bipolar Disorder with psychotic features, rule out Schizoaffective Disorder. Patient #3 has self-harming behaviors and a history of assaults on others.

On 8/13/2011, patient #3 went into seclusion where she remained until 8/14 at 3 PM. On 8/14 at 6:15 PM, patient #3 again went into seclusion, and shortly after, restraint where she remained until 12:30 PM on 8/15. No modification of patient #1 ' s care plan is found in the record.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0167
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on a review of documentation, a seclusion event revealed an unsafe holding/transporting technique in the seclusion process of patient #3 as evidenced by:


Patient #3 is a [AGE]-year-old female discharged from the Behavioral Health Unit on 8/12/2011 and re-admitted on [DATE] following a suicide attempt at her group home during a "Blacked out episode." She has a diagnosis of Bipolar Disorder with psychotic features, rule out Schizoaffective Disorder. Patient #3 has self-harming behaviors and a history of assaults on others.

A nursing note of 8/13/11 at 6:15 PM states "Patient started to escalate after dinner. Met with Doctor and were discussing why she was in ODS earlier around 11 am. Pt. (patient) walked up to med room and started to take 2 meds out of the bins."

On 8/13 a related nursing note of 6:15 PM states in part, "Pt was being restrained by nurses until security arrived in which it took 5 security guards & several nurses to drag into LDS. Pt was kicking, spitting, biting, screaming, hitting."

The Restraint/Seclusion Justification and Discontinuation (RSJD) form asks for a brief description of the intervention, who assisted, and if security was called. An RN wrote "5 security & 3 nurses dragged pt into seclusion."

Interview with hospital staff revealed the hospital trains emergency staff, behavioral health staff, and security in the management of aggressive patients, which may require staff to place a patient in holds, and may involve transport of a patient by way of holds from one area to another. However, documentation of how staff "Dragged" patient #3 to the seclusion room is inconsistent general staff training and safe seclusion techniques.

The hospital failed to use safe holds and transport techniques to seclude patient #3.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0174
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on review of the Seclusion/Restraint policies and patient #3's record, the hospital failed to release patient #3 from seclusion and from restraint at the earliest possible time as evidenced by:

Patient #3 is a [AGE]-year-old female discharged from the Behavioral Health Unit on 8/12/2011 and re-admitted on [DATE] following a suicide attempt at her group home during a "Blacked out episode." She has a diagnosis of Bipolar Disorder with psychotic features, rule out Schizoaffective Disorder. Patient #3 has self-harming behaviors and a history of assaults on others.
Once on the unit, she became agitated and made threats to kill staff members. Per a physician note, "With much convincing," she was able to go to ODS (Open door seclusion) without assistance. "
A nursing note of 8/13/11 at 6:15 PM states "Patient started to escalate after dinner. Met with Doctor and were discussing why she was in ODS earlier around 11 am. Pt. (patient) walked up to med room and started to take 2 meds out of the bins." A related nursing note of 6:15 PM states in part, "Pt was being restrained by nurses until security arrived in which it took 5 security guards & several nurses to drag into LDS. Pt was kicking, spitting, biting, screaming, hitting."
The hospital Restraint/Seclusion Justification and Discontinuation (RSJD) form reveals a subsection entitled, Discontinuation of Restraint/Seclusion which lists check-off boxes for Behavior criteria for release with instruction to check all that apply for patient as: "1) Calm, quiet, 2) Able to participate in debriefing process, 3) Able to follow directions of staff, and 4) No longer exhibiting behaviors that justified use of restraint/seclusion." The nurse checked all boxes except #4, which is the only regulatory-based criterion of the 4 listed.
Review of staff training reveals a Competency Evaluation Tool. One of the competencies is to identify specific behavioral changes that indicate when seclusion/restraint is no longer necessary. However, staff did not identify when seclusion/restraint was no longer necessary for patient #3 who was secluded from 8/13/2011 at 6:15 PM until 8/14 at 3 PM; a total of 21 hours; then briefly secluded and changed to restraints from 8/14 6:15 PM, until 8/15 at 12:30 PM, for a total of 18 hours.
During the first seclusion episode, documentation on the Restraint Seclusion Flow Sheet (RSFS) indicates that within the first 45 minutes of seclusion, patient #3 had "tied a gown around neck" and was "Ripping mattress, banging wall." After this documentation, patient #3 is alternately documented as sleeping, quiet, and talking with staff. No behaviors over the next 20 hours indicated a need for seclusion. Patient #3 had no imminent appearance of being of harm to herself or other.
Nursing documentation on 8/13 at 11:30 PM after patient #3 was given a blanket and pillow, states in part, "Pt. requesting to come out & it was explained that pt would need to show staff that she can be trusted with blanket and pillow initially, to take things step by step."
On 8/14 at 7:30 am after sleeping all night, patient #3 stated on assessment that "I can't guarantee that it won't happen again." Staff continued seclusion, though patient #3 was not, and had not exhibited violent behaviors toward herself or others, for approximately 13 hours. Patient #3 was admitted with a chronic mental illness which in part, causes her to do harm to herself and others. The expectation that patient #3 would not attempt self-harm again was not a realistic goal, nor is there a regulatory directive which states a patient must guarantee their future behavior in order to be free of seclusion or restraint. At the time of assessment, patient #3 showed no behaviors indicating she was an imminent danger to herself or others.
At 11:30 am, a nursing note states in part, "Asked to have door open. admitted to being impulsive, not sure what triggers her suicidal thoughts that have lead to LDS x 2. Denies hearing voices at present or seeing shadows or people. When told the door needed to be locked, patient called me a bitch and raised her voice. Patient remains unpredictable." Patients are not required to have solved their problems of impulsivity, or to know what triggers their adverse behaviors in order to be free of seclusion or restraint. Likewise, name-calling is not a criterion for seclusion/restraint. The term used by the RN of "unpredictable" is subjective, does not describe behaviors in real-time and cannot be used as a criterion for release from seclusion/restraint. Additionally, the 15-minute documentation on the RSFS indicates that patient #3 had been laying quietly on the mat for hours prior to this assessment.
At 1:30 PM, a nursing note states in part, "Pt not sure of a plan she could use to keep herself safe out on the unit. Encouraged to come up with a plan and will discuss in one hour. After locking door, patient made a loud noise into her pillow venting her frustration." While it is desirable for patients to participate in their plan of care, it is not a required as criterion to exit seclusion/restraint.
At 3 PM, a nursing note states "Discussed behaviors that lead to LDS. Treatment team along with patient came up with a specific plan to ensure the safety of herself and others. Patient willing to call out for RN when she initially thinks of feeling suicidal. Was able to contract for safety. We now have a security detail 1:1."
While it is desirable for patients to participate in their plan of care, patients are not required to meet with their team or state a safety contract as criterion for exit from seclusion/restraint. Patient #3 had been demonstrating calm, non-threatening behaviors since one hour after secluding, similarly as she continued to do so during the meeting with team members. Therefore, it is unclear why patient #3 was not released at an earlier time.
The RSFS indicates that at 3 PM, patient #3 was "Now in ODS (open door seclusion) " Interview with staff reveals that ODS (also called quiet room and time out) are all considered the same intervention, which is a voluntary process where a patient agrees to stay in a room, and is not prevented from leaving.
On 8/14 at 6:10 PM, a nursing note states in part, "Pt. in ODS with security detail; becoming agitated, loud/throwing cup of juice at nurse. Unable to follow direction to stay seated on mat-trying to push her way out of ODS. With assist of 4 security and Dr.___, pt medicated and LDS initiated." During the secluding process, patient #3 took the glasses of a security guard, removed the lenses, and attempted to swallow them. Shortly after that, patient #3 began to hit her forehead and the back of her head against the wall. Therefore, staff restrained her in 4-point restraints by 6:25 PM.
A nursing note of 6:15 PM states in part, "Patient was in ODS until 1500. Became agitated because she felt her needs were not being met. At the point in which she was told by Dr. ___ she would not be able to come out of the room, she picked up a glass of liquid and threw on staff. Security told patient to sit back down in which patient started hitting and kicking security and myself. Door was closed."
At 8:40 PM, patient #3 requested to be taken out of restraint. The RN states in part, " ...wants to be out of restraints. Pt reminded that her impulsive self-harming behavior must be under control before restraints can be removed." It is unclear how the RN could determine when patient #3's impulses were under control. Documentation on the RSFS revealed no demonstrated violent behaviors or statements since patient #3 had been placed in restraint.
On 8/15 at 6:30 am, "Pt continues to sleep .... 4 pt restraints remain due to pts. Violent & unpredictable behavior. Pt able to ask when she will be out of restraints." The RN assessment of patient #3 is not consistent with regulatory directives to perform real-time assessments for imminent risk of harm. Patient #3 had no demonstrated violent behaviors for 11 hours, nor had she made any threats of harmful toward herself or other. Additionally, the staff used the term "Unpredictable," which is subjective and does not address actual patient behaviors.
At 8 am, a nursing note states in part, "Pt remains unclothed in 4-point restraint with 1:1 observation ...Spoke with pt about her behavior last evening and pt states 'I feel bad' about what she did. Pt. denies suicidal ideation."
At 9:05 am, an RN writes, in part, " ...Pt cooperative ...Pt made aware of restraint removal process and that she must be cooperative. Pt verbalizes understanding." Staff began a process of removing patient #3 from restraint by taking one restraint off at a time in intervals.
At 10:15 am, a nursing note states "Pt remains unclothed with sheet to cover self ...patient verbalizes understanding of gradual weaning process of restraints and agrees to be cooperative with staff ... " Restraints were not completely removed until 12:30 PM.
In summary, patient #3 had a 21-hour episode of seclusion and an 18-hour episode of seclusion/restraint. During these events, staff applied changing, sometimes unrealistic, subjective, and non-regulatory criterion that patient #3 was required to meet. Patient #3 who has a history of more than 30 hospitalization s, assaultive and self-injurious behaviors, and who had just admitted for acute suicidal ideation was alternately expected to control her impulsivity, cite triggers to her suicidal ideations, and guarantee she would not have similar occurrences. Likewise, patient #3 was expected to formulate a plan to keep herself safe. While it is desirable to have communication, and plan participation with the patient, such communication and plans cannot be the requirement for release.
Patient #3 is documented to have frequently spoken with staff, and at least twice asked to come out of seclusion or restraint, all of which were opportunities to affect a release. However, staff gave new criterion such as the ability to "trust her with a blanket and pillow " and the "gradual" weaning of restraints, which took more than 3-hours (even after many previous hours of no violence or threats of violence). Additionally, when patient #3 consistently demonstrated no violent or self-harming behaviors or threats, staff subjectively labeled patient #3 as "Unpredictable," which gave no justification to the seclusion/restraint events which require assessment of behaviors, in real time.
One constant was that within the first hour of all seclusion/restraint episodes, patient #3 ceased the violent and self-harming behaviors, which had initially justified seclusion/restraint. Patient #3 then maintained herself free of those behaviors while staff continued restrictive interventions for which there was no justification. The hospital failed to release patient #3 at the earliest possible time.
VIOLATION: PROGRAM DATA, PROGRAM ACTIVITIES Tag No: A0283
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on complaint investigation and review of the medical record, it was determined that the hospital failed to provide care in accordance with acceptable standards of practice in diagnosing and treatment of pulmonary embolism in patient #1. There was a delay in obtaining the chest CT scan result, the results were mis-read and essential care/treatment information was not obtained from a prior hospitalization on ce aware of patient #1 diagnosis and treatment for pulmonary embolism.

Patient #1 was a [AGE] year old male who presented to John Hopkins Bayview Medical Center Emergency Department on 11/6/11 with complaint of shortness of breath and chest pain. The hospital was made aware that patient #1 had a history of blood clots. The patient's other diagnoses included history of hypertension, diabetes type II, history of venous thrombosis and embolism and Barrett's Esophagus. The patient had an elevated D-dimer therefore the chest CT scan was ordered at 8:55 AM on 11/6/11. The chest CT scan with IV contrast was performed and completed at 9:49 AM. Per the patient's history of PE and presenting symptoms of chest pain and shortness of breath this test was ordered stat and performed within one hour of the order. Per a progress note written by the ED physician titled ED course: "patient updated on reason for wait. Still awaiting read for CT scan. Spoke to radiologist in reading room-patient's study was performed before 12:30 PM, so is responsibility of previous radiologist, Dr. S. I paged Dr. S. at 1:fpm. I paged Dr. S. again at 1:42 PM. No answer from Dr. S. but read placed on image at 1:47 PM. The copy of the chest CT scan revealed it was dictated on 11/6/11 at 1:47 PM. The impression: there is no evidence of pulmonary embolus. As part of peer review, the chest CT scan was re-read on 12/15/11 and revealed that patient #1 had bilateral pulmonary embolisms which were originally reported as negative for PE.

The hospital reported that they had several traumas in the ED on this date and that they had one radiologist on duty with another radiologist reporting to work at 12 noon. This lapover is the hospital's process to deal with an increase in volume within the ED. The weekends are typically slow and this Sunday was an aberration. The radiology department and the ED physicians collaborate to triage the cases as they come into the ED. The patient film could have been read without archiving but due to the volume of patient's and trauma cases the patient was felt to be stable and therefore his films were archived for later read.

Whatever, the reason for the increase volume in the ED, the hospital contingency plan failed to prevent the delay in the reading of patient #1's CT scan along with the mis-read which led to the delay in diagnosis and treatment of a life-threatening disorder of pulmonary embolism.

In addition, Although the patient made statements regarding subtherapeutic and supratherapeutic INR during treatment in Kansas with coumadin, no documentation could be found in his medical record regarding follow-up or attempts to obtain the treatment/care information from his 2010 medical record from Kansas University. There was documented medication non-compliance including use of prior (old) prescription medication (Lovenox) after the 12/16/11 discharge which was an incorrect dosage and per the patient made him sick. The patient missed a dose of medication (Lovenox) due to feeling sick after taking this old prescription. Although the patient reported that the old prescription was good through February, it was an incorrect dosage since the patient had been discharged on 130 mg of Lovenox and the old prescription was for 120 mg Lovenox. The patient's self reported medication non-compliance warranted review of his history/treatment at Kansas University and re-education regarding medications. The patient's INR were subtherapeutic from 1.3 and 1.9 on his last visit to the coagulation clinic. The hospital should requested and documented that patient #1's medication supply at home be brought in for review by pharmacy.

The hospital failed to reassess patient #1 on several levels including obtaining as much information about his prior treatment for venous thrombosis and pulmonary embolism and re-education for patient/family regarding medications and laboratory testing compliance. There is no documentation that the medical staff obtained a complete history which would include past treatment, response to treatment, compliance issues, and options offered to the patient. Review of this information would provided insight and direction for further testing and treatment in view of the patients recurrent pulmonary embolism.