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.

MEDSTAR SAINT MARY'S HOSPITAL 25500 POINT LOOKOUT ROAD LEONARDTOWN, MD 20650 March 29, 2011
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0167
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on review of 11 records, 2 of 11 records, revealed inappropriate restraint technique as follows:

1) Patient #3 ' s record, revealed hourly checks instead of the 15-minute checks required by the Code of Maryland Regulations 10.21.08 for the safe use of restraint.

2) Patient #10 record revealed "Active range of motion" with all 15-minute checks, making it impossible to tell when this (every two-hour) intervention was actually made.

3) Patient #14's record revealed "Active range of motion" with all 15-minute checks, making it impossible to tell when this (every two-hour) intervention was actually made.

4) Documentation reveals that the initiation time of restraint was 7:15 am. However, no entry for 15-minute checks appear until 9:30 am.

Findings include:

Patient #3 is a [AGE]-year-old female who (MDS) dated [DATE] by police when found wandering the street intoxicated.

Patient #3 was placed in 4-point restraint from 12:07 pm until 2:30 pm after becoming very agitated, spitting in the face of a nurse, and "Grabbing at staff with long fingernails." The standard of 15-minute monitoring was not met. The record reveals a monitoring gap from 12:27 pm to 1:31, approximately one hour's time. At 1:31 pm, the nurse notes that patient #3 is "Combative, Inappropriate, and Uncooperative." From 1:31 pm until 2:30 pm, no monitoring documentation is found in the record, but a nursing note of 2:30 pm states in part, "Pt. (Patient) awakened easily." This entry reveals that patient #3 was asleep for some period, and no longer a threat prior to 2:30 pm when she was released. Patient #3 could have been released though this was not documented in the record.

The hospital failed to document monitoring of patient #3 who was in 4-point restraint per the standard of care.

Patient #10 is a [AGE]-year-old female who on 8/17/2010 admitted to the Psychiatry Unit on two physician's certificates upon discharge from Medical Service where she was admitted on [DATE]. Patient was admitted after an overdose on benzodiazepines, which left her unconscious. She required intubation and mechanical ventilation. Patient #10 has had multiple admissions to the Psychiatric Unit for depressive complaints. She has a history of suicidal threats, alcohol and tranquilizer abuse.

Patient #10 was placed into restraint at 8:40 am, until 3:20 pm. Documented at every 15-minute interval is "Active range of motion." Active range of motion (ROM) is required to prevent joint problems, and per regulation is performed every two hours while the patient is awake. It requires the patient's arm or leg to be taken out of restraint for exercise, and then returned to the restraint. Due to the amount of time it would take to perform range of motion it was not possible to for range of motion to performed at each 15 minute check as documented . As a result, the documentation does not provide an accurate record of when or how often the range of motion was actually done. The hospital Self Learning Packet states in part, " ...Documentation must include " Circulation and range of motion of the extremities." However, the SLP does not specify how often range of motion should be conducted.

Patient #14 is a [AGE]-year-old male who (MDS) dated [DATE] to the ED on emergency petition following a change in mental status in which he went in and out of consciousness. Patient #14 had not slept in some time, had gone to a party, consumed alcohol, and began with bizarre behaviors the next day with confusion and varying levels of consciousness.

Patient #14 was admitted for further evaluation. He continued with intermittent confusion, psychosis, and was worked-up for a possible encephalitis On 12/19/2010 at approximately 2:20 am, patient #14 struck out at his father. He received haldol, was reoriented, and per staff documentation, "Calmed down." At 9:29 am, a nursing note states that patient #14 became very combative, pulled the PICC line out and tried to run out of the room. A code green was called, and patient #14 was placed in 4-point restraint with a sitter. Documentation reveals that the initiation of restraint was actually at 7:15 am. No order appears in the record until 9:24 am. Restraint monitoring documentation for patient #14 begins at 9:30 am, and continues every 15-minutes until 2:17 pm. Every 15-minute entries indicate that patient #12 received "Active range of motion." Due to the amount of time it would take to perform range of motion it was not possible to for range of motion to performed at each 15 minute check as documented . As a result, the documentation does not provide an accurate record of when or how often the range of motion was actually done.

The hospital failed to implement restraint in accordance with safe and appropriate restraint and seclusion techniques as determined by hospital policy in accordance with State law.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0168
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on an onsite review of 11 records:

1) Patient #1 had no order restraints for non-violent behavior;

2) Patient #2 had an order for a restraint for non violent behavior of a duration spanning 4 hours and 45 minutes, with no second order.

3) Patient #14 had one late order for a behavioral restraint spanning 8 hours until transfer to the behavioral health unit.

The findings include:

Patient #1 is an [AGE]-year-old male admitted on [DATE]. Patient #1 had a change in mental status secondary to pneumonia. Patient #1 attempted to pull out his intravenous line. According to documentation, the physician was made aware, an order was obtained, and soft wrist restraints were applied on or about 9:09 pm. Patient #1 admitted on or about 10:50 pm. On review of the record, no restraint order is found.

Patient #2 is a [AGE]-year-old male who on 8/9/2010 presented on emergency petition after overdosing on medications. Patient #2 has a history of substance abuse. He received diagnoses of Intentional overdose on bentyl and Seroquel, Polysubstance abuse, and Intermittent Explosive D/O.

On evaluation, patient #2 could open his eyes spontaneously, and could obey simple commands, but was not oriented to time or place. Nursing documentation states "Pt. started to become agitated, (nursing) went to take pants off, pt became combative. Pt placed in 4-point leather restraints. Pt. became restless and agitated when Foley catheter was being inserted, police and security at bedside to help hold pt legs down while Foley being inserted. Once Foley done being inserted, pt laying quietly on stretcher, sitter at bedside."

Patient #2 was placed in leather behavioral restraints. However, an order placed at 2:41 am states "Reason for Restraint: Other Medically Approved Protocol, Restraint Type: Cuff Limb, Special Instructions: Order valid for 1 Calendar Day. Evaluate patient & order restraint. Continue order set if needed."

Per documentation, patient #1 became calm by 3:03 am. However, staff kept patient #2 restrained until 7:30 am.

A non-violent restraint order was inappropriate for patient #2 who was restrained in 4-point leather restraints for behavioral purposes, and should have had orders of no more than 4-hours duration. Restraint orders for patient #2 of 4 hours and 45 minutes required 2 such orders, only one which is found on review of the record.


Patient #14 is a [AGE]-year-old male who (MDS) dated [DATE] to the ED on emergency petition following a change in mental status in which he went in and out of consciousness. Patient #14 had not slept in some time, had gone to a party, consumed alcohol, and began with bizarre behaviors the next day with confusion and varying levels of consciousness.

Patient #14 was admitted for further evaluation. He continued with intermittent confusion, psychosis, and was worked-up for a possible encephalitis On 12/19/2010 at approximately 2:20 am, patient #14 struck out at his father. He received haldol, was reoriented, and calmed down. At 9:29 am, a nursing note states that patient #14 became very combative, pulled the PICC line out and tried to run out of the room. A code green was called, and patient #14 was placed in 4-point restraint with a sitter. However, documentation reveals that the initiation of restraint was actually at 7:15 am. A single order appears in the record at 9:24 am for a restraint that continued through his transfer to the behavioral health unit at 3:01 pm. Due to the actual restraint time of 7:15 am, a new order was also needed at 11:15 am. but there were no additional orders on the records.


The hospital failed to provide appropriate restraint orders for patients # 1, 2, and 14.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0171
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on review of 11 records, patient #2 of 11 who required a restraint order limited to 4 hours, had a restraint order for up to one calendar day.

Patient #2 is a [AGE]-year-old male who on 8/9/2010 presented on emergency petition after overdosing on medications. Patient #2 has a history of substance abuse.

On evaluation, patient #2 could open his eyes spontaneously, and could obey simple commands, but was not oriented to time or place. Nursing documentation states "Pt. started to become agitated, (nursing) went to take pants off, pt became combative. Pt placed in 4-point leather restraints. Pt. became restless and agitated when Foley catheter was being inserted, police and security at bedside to help hold pt legs down while Foley being inserted. Once Foley done being inserted, pt laying quietly on stretcher, sitter at bedside."

Patient #2 was placed in leather behavioral restraints. However, an order placed at 2:41 am states "Reason for Restraint: Other Medically Approved Protocol, Restraint Type: Cuff Limb, Special Instructions: Order valid for 1 Calendar Day. Evaluate patient & order restraint. Continue order set if needed."

Per documentation, patient #2 became calm by 3:03 am. However, staff kept patient #2 restrained until 7:30 am.

A non-violent restraint order was inappropriate for patient #2 who was restrained in 4-point leather restraints for behavioral purposes, and should have had orders of no more than a 4-hour duration. Restraint orders for patient #2 of 4 hours and 45 minutes required 2 such orders. The hospital failed to limit the restraint order for patient # 2 to 4 hours.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0174
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on review of 11 records, patients # 2, and #10 of were not released from restraint/seclusion at the earliest possible time.

Patient #2 is a [AGE]-year-old male who on 8/9/2010 presented on emergency petition after overdosing on medications. Patient #2 has a history of substance abuse.

On evaluation, patient #2 could open his eyes spontaneously, and could obey simple commands, but was not oriented to time or place. Patient #2 was placed in restraint at 2:41 am. Nursing documentation states "Pt. started to become agitated,(nursing) went to take pants off, pt became combative. Pt placed in 4-point leather restraints. Pt. became restless and agitated when Foley catheter was being inserted, police and security at bedside to help hold pt legs down while Foley being inserted. Once Foley done being inserted, pt laying quietly on stretcher, sitter at bedside." Patient #2 was "laying quietly" yet he was not removed from restraint, nor were there documented attempts to discuss his compliance.

The 15-minute flows of 3:17, 3:44, and 3:51 am document patient #2's affect and behavior as "appropriate." Documentation of 4:31, 4:44, 4:57, and 5:12 am reveals that patient #2 was "Calm." A nursing note of 5:10 am states in part, " ...speech is starting to become more clear and comprehendible, pt is talking fast though. Pt right wrist restraint taken off. Pt states he will cooperate with us. Pt. informed that we will slowly take one restraint off at a time as long as he cooperates with us .... " Patient #2 had been calm, and appropriate for two hours. The restraints were not removed. He was able to state his continued compliance. The restraints were not removed. A nursing note of 6:04 am states, "Pt has remained calm and cooperative so far. Pt left leg removed from restraint. Sitter at bedside." Further documentation states that patient #1 was "Restless and confused" until 7:02 am.

A nursing note of 7:11 am, 9 minutes after shift change, states in part, "Assumed care of pt. Pt A&O x 3 (alert and oriented to person, place and time). Pt in two-point restraint." A nursing note of 7:29 am states in part, "Consulted with Dr. ___ regarding NPO status and restraint removal. Called security and 2-point restraints removed."

Patient #2 was calm, appropriate and stated his intention to comply with staff, yet he was not removed from restraint until just after shift change. Patient #2 was assessed as restless and confused from 6:04 am until shift change, which are not criteria for remaining in restraint, nor was there medical justification for restraint. Minutes after shift change, the oncoming nurse found patient #2 to be alert and oriented to 3 spheres. Patient #2 who became calm shortly after he was restrained at 3:03 am, staff kept patient #2 restrained until 7:30 am without justification, revealing he was not released at the earliest possible time.

Patient #10 is a [AGE]-year-old female who on 8/17/2010 admitted to the Psychiatry Unit on two physician's certificates upon discharge from Medical Service where she was admitted on [DATE]. Patient was admitted after an overdose on benzodiazepines which left her unconscious. She required intubation and mechanical ventilation. Patient #10 has had multiple admissions to the Psychiatric Unit for depressive complaints. She has a history of suicidal threats, alcohol and tranquilizer abuse.

On 8/18/2010, patient #10 was initiated into restraint at 8:40 am. A nursing note of 8/18 at 9:48 am states in part, " ...banging her head on wall several times," and " ...because of escalating behavior and inability to tolerate 1:1 staff supervision. Pt. took threatening stance when security arrived, and yelling, 'Bring it on!' Began throwing punches and struggling so hard that a code green had to be called to subdue pt. Placed in 4-point restraints at 0840 for her safety and the safety of others." Patient #10 was offered as-needed medication but refused " ....Interspersed periods of quiet with the yelling at this time and pt appears to be settling down from peak of agitation." Patient #10 exhibited behaviors, which were dangerous to herself and others, and noted less agitation within the first hour.

A nursing restraint initiation note of 9:18 am documents in part, that patient #10 received education regarding, "Hospital policy regarding use, Reason for restraint, Release criteria." The stated reason for continuation of restraint is written as, "Restraints should continue for safety of pt/others until pt regains a measure of control." This criterion is subjective, non-specific, and does not address actual criterion for restraint.

At 10:44 am, a nursing note states in part, "Writer approached patient in an attempt to assess readiness to release from restraint. As soon as writer opened door, patient made above statement (Called her Filipino trash)." Patient #10 is reported to repeat the statement four times, and would not talk with the nurse otherwise.

At 10:03 am, patient #10 is noted as "Asleep," and at 10:20 and 10:30 am is noted as "Agitated, Combative Inappropriate, and Uncooperative." No descriptors as to the nature of patient #10's combativeness are noted. Patient #10 was in 4-point restraint to prevent combativeness, so it is unclear how, while in restraint, she could continue with this behavior.

At 11:09 am, patient #10 is again noted as "Asleep" until 12:45 pm. A nursing note of 1:06 pm states "Pt continues periodically agitated, but accepted 12 noon serax plus seroquel 100 mg po. At 1300 spit on floor x 2 and said, That Filipino bitch threw me the finger and made faces at me. Unable to say she could refrain from fighting or racial slurs." Agitation of itself is not a criteria for restraint, nor is stating that the patient could refrain from fighting or racial slurs. The only criteria for restraint is the immediate threat of harm to self and other. At 1:13 pm, patient #10 is noted as "Agitated crying, hostile, inappropriate, restless" and at 1:27 pm, the same plus "Uncooperative." Staff failed to document violent behaviors requiring restraint continuation

From 1:45 pm until her release of 3:20 pm, patient #1 is noted as "calm" and "asleep." Patient #1 was in restraint for a total time of 6.67 hours.

Patient #14 is a [AGE]-year-old male who (MDS) dated [DATE] to the ED on emergency petition following a change in mental status in which he went in and out of consciousness. Patient #14 had not slept in some time, had gone to a party, consumed alcohol, and began with bizarre behaviors the next day with confusion and varying levels of consciousness.

Patient #14 was admitted for further evaluation. He and continued with intermittent confusion, psychosis, and was worked-up for a possible encephalitis On 12/19/2010 at approximately 2:20 am, patient #14 struck out at his father. He received haldol, was reoriented, and per staff documentation, "Calmed down." At 9:29 am, a nursing note states that patient #14 became very combative, pulled the PICC line out and tried to run out of the room. A code green was called, and patient #14 was placed in 4-point restraint with a sitter. However, documentation reveals that the initiation of restraint was actually at 7:15 am. Restraint monitoring documentation for patient #14 begins at 10 am, and continues every 15-minutes until 2:17 pm. Every 15-minute entry indicates that patient #12 is "Calm." Patient #12 did not continue in restraint on transfer to the behavioral health unit at 3:05 pm. However, the end time of the restraint is not found.

The hospital did not release patient #14 at the earliest possible time.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0178
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based of review of 11 records, interviews, documentation and employee education, it is revealed that the hospital allows RNs to perform a face to face, but that RNs are not trained to do so. Additionally, information in the Self-learning Packet is not consistent with these regulations related to restraint/seclusion discontinuation criterion. Therefore, patients #1, 2, 3, and 14 did not have appropriate face-to-face assessments by a trained physician, Licensed Independent Practitioner or specially trained RN.

The findings include:

Hospital administration states that nursing may perform the face-to-face (FTF) assessment for restrained or secluded patients. However, the hospital does not provide training specific to the FTF, though they state in their training that there must be a FTF. Hospital administration states that RN staff are trained in the need to continue or terminate the restraint/seclusion by way of the self-learning packet (SLP). However, the SLP does not formally address the parts of the FTF. Additionally, the SLP instruction in part states:

2) Under " Discontinuation ....Criteria for discontinuation may include, but is not limited to the patient's ability to contract for safety, whether a patient is oriented to the environment, and/or cessation of verbal threats. Discontinuation should occur as soon as possible and when the patient gains control of his or her behavior."

The ability to contract for safety, and the patient orientation to the environment may not be the sole criterion for discontinuation. If these were criterion, then individuals who are developmentally disabled, psychotic or with dementia could be in continuous restraint/seclusion. This educational instruction should be revise to further address appropriate behavioral criteria for the use and continuation of restraint and seclusion.

In the following examples the hospital failed to provide the required face to face evaluation:

Patient #1 is an [AGE]-year-old male admitted on [DATE]. Patient #1 had a change in mental status secondary to pneumonia. Patient #1 attempted to pull out his intravenous line. According to documentation, the physician was made aware, an order was obtained, and soft wrist restraints were applied on or about 9:09 pm. Patient #1 was admitted on or about 10:50 pm. On review of the record, no order is found.

A physician saw patient #1 at 5:25 pm, approximately 4 hours prior to restraint. No attempt to document a FTF by a physician or nursing is found.

Patient #2 is a [AGE]-year-old male who on 8/9/2010 presented on emergency petition after overdosing on medications. Patient #2 has a history of substance abuse.

On evaluation, patient #2 could open his eyes spontaneously, and could obey simple commands, but was not oriented to time or place. Patient #2 was placed in restraint at 2:41 am. Nursing documentation states "Pt. started to become agitated,(nursing) went to take pants off, pt became combative. Pt placed in 4-point leather restraints. Pt. became restless and agitated when Foley catheter was being inserted, police and security at bedside to help hold pt legs down while Foley being inserted. Once Foley done being inserted, pt laying quietly on stretcher, sitter at bedside."

No FTF is found in the record of patient #2

Patient #3 is a [AGE]-year-old female who (MDS) dated [DATE] by police when found wandering the street intoxicated. Patient #3 states she took 5 Xanax tabs, and refused to answer other questions, though she stated she wanted to harm self.

Patient #3 was placed in 4-point restraint from 12:07 pm until 2:30 pm after becoming very agitated, spitting in the face of a nurse, and "Grabbing at staff with long fingernails." No FTF is found in the record.


Patient #14 is a [AGE]-year-old male who (MDS) dated [DATE] to the ED on emergency petition following a change in mental status in which he went in and out of consciousness. Patient #14 had not slept in some time, had gone to a party, consumed alcohol, and began with bizarre behaviors the next day with confusion and varying levels of consciousness.

Patient #14 was admitted for further evaluation. He and continued with intermittent confusion, psychosis, and was worked-up for a possible encephalitis On 12/19/2010 at approximately 2:20 am, patient #14 struck out at his father. He received haldol, was reoriented, and calmed down. At 9:29 am, a nursing note states that patient #14 became very combative, pulled the PICC line out and tried to run out of the room. A code green was called, and patient #14 was placed in 4-point restraint with a sitter.

An RN attempted FTF done at 9:23 am, two hours following the initiation of the restraints, states in part:
1) "What is the patient's reaction to the intervention? Once on the bed and restraints applied, apologetic and patient calmed down."
2) "What is the patient's medical condition: Confusion."
3) "Does the Restraint/Seclusion need to continue: Yes"

The RN FTF assessment reveals that although patient #14 stopped the behavior which required restraint, he was not released from restraint, and that the restraints should continue. The FTF was not timely, was not a thorough assessment of the patient's medical or psychiatric condition nor did it document continued justification for the use of restraints.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0186
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on review of 11 records, patient #2 of 11 reviewed did not receive less restrictive interventions as evidenced by:

Patient #2 is a [AGE]-year-old male who on 8/9/2010 presented on emergency petition after overdosing on medications. Patient #2 has a history of substance abuse. His diagnoses were Intentional overdose on bentyl and Seroquel, Polysubstance abuse, and Intermittent Explosive disorder.

Patient #2 was placed in 4-point restraint at 2:41 am. Nursing documentation states "Pt. started to become agitated, (nursing) went to take pants off, pt became combative. Pt placed in 4-point leather restraints. Pt. became restless and agitated when Foley catheter was being inserted, police and security at bedside to help hold pt legs down while Foley being inserted. Once Foley done being inserted, pt laying quietly on stretcher, sitter at bedside."

No documentation of less restrictive interventions is documented. No agitation or combativeness is noted until staff attempted to remove patient #2's clothing, and insert a urine catheter. An evaluation of 2:53 am, just minutes after he was restrained, revealed that patient #2 could "Open his eyes spontaneously, and could obey simple commands " but was not oriented to time or place.

No staff attempts were made to gain patient #2's compliance with taking off his clothing, or with obtaining a noninvasive urine sample, which may have prevented a restraint occurrence that lasted nearly 5 hours. Additionally, while there were orders for urine testing, no physician order is found for a Foley catheter, or for catheterization, apparently inserted by decision of the nurse.

During the debriefing, patient #2 stated that he "Freaked out because I had to take my clothes off." Patient #2 may have been able to give consent for the removal of his clothing, and cooperate with obtaining a urine sample, or at least understand what was happening to him, had staff explained and engaged his compliance.

The hospital did not attempt less restrictive interventions