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.

ADVENTIST HEALTHCARE SHADY GROVE MEDICAL CENTER 9901 MEDICAL CENTER DRIVE ROCKVILLE, MD 20850 April 10, 2018
VIOLATION: GOVERNING BODY Tag No: A0043
Based on the review of six open and seven closed medical records, policies and procedures, staff interviews, video surveillance, observations, and other pertinent documents it was determined that the hospital was not in compliance with the Condition of Governing Body related to allowing security personnel who were not law enforcement to carry and use forensic weapons including pepper foam, handcuffs, and batons in clinical areas, lack of adequate policies, failure to ensure adequate clinical oversight of patients while security personnel were applying forensic restraint devices, and lack of adequate training for all applicable staff regarding the safe use of restraints. In addition, even though leadership of the hospital had access to the same documents reviewed during the survey they, according to interviews during the survey, were not aware that the forensic restraints should not have been used by hospital-employed security and that at least one patient had been injured during the use of these weapons. No discussion of the use of these weapons were found in the minutes of the emergency department quality committee and there was no indication that either hospital leadership or the ED staff had identified that the use of forensic devices was problematic and inherently unsafe.
VIOLATION: PATIENT RIGHTS Tag No: A0115
Based on review of medical records, interviews with staff, review of policies and procedures, observations of care, along with other documents and review of the video surveillance for the (Emergency Psychiatric Treatment Unit) EPTU, it was determined that the hospital failed to protect patient rights and the Condition of Patient Rights was not met. Standard level deficiencies cited at A0144, A0168, A0175 and A0178 under this Condition indicate that the hospital had a flawed process for restraining patients exhibiting violent and injurious behaviors. The clinical staff relied on security personnel to manage patients with these behaviors, and patients were restrained without clinical oversight and management, and without physician orders. Staff in the EPTU and the Emergency Department verified in interviews done during the survey that they did not consider the use of weapons (including hand-cuffs and pepper foam) by security to be restraints, and thus provided little clinical oversight when they were used on patients. Nor did the staff or leadership perform any retrospective review of the use of these weapons or of any potential or actual patient injuries.


For instance, patient #8 did not receive services in a safe environment when the patient was restrained and subjected to pepper foam by security staff. According to the video surveillance from the hall outside the room, it was apparent that the staff were affected by the pepper foam demonstrated by staff entering and leaving the room while coughing and rubbing their eyes and faces. The conditions in the room made it difficult for staff to monitor the patient resulting in a delay in responding to his worsening condition and eventual cardiac arrest. This restraint episode was not done in accordance with a physicians order or with appropriate monitoring and a face to face evaluation. This patient became pulseless and unresponsive and a code Blue was called. The patient spent seven days in the ICU prior to the cessation of life support by family decision. Records indicate that at least one other patient was harmed during a similar restraint episode.
VIOLATION: PATIENT RIGHTS: NOTICE OF RIGHTS Tag No: A0117
Based on a review of six open and seven closed medical records the hospital failed to provide two Medicare recipients with the second standardized notice, "An Important Message from Medicare," (IMM) as required to beneficiaries within the appropriate time frame.

A review of patient #3's medical record revealed no evidence or documentation of a second IMM given before discharge after a stay of 12 days.

A review of patient #4's medical record revealed no evidence or documentation of a second IMM given before discharge after a stay of 14 days.
VIOLATION: PATIENT RIGHTS: EXERCISE OF RIGHTS Tag No: A0129
Based on the review of seven closed and six open medical records it was found that one of the 13 patients was denied the right to exercise the patient's predetermined Medical Orders for Life-Sustaining Treatment (MOLST).

Patient #11 was an elderly patient emergency sent to the emergency department from an assisted living facility due to aggressive and violent behavior. The patient was sent to the hospital with a copy of their MOLST form, which was stamped as scanned. A copy of the MOLST form was on a clipboard where paper documentation of the hospitalization was kept until post discharge to then be entered in to the permanent electronic medical record. The patient's MOLST form indicated that the patient was not to be resuscitated in the event of cardiac and/or pulmonary arrest, along with other acceptance and refusals of treatment.

Patient # 11's code status was documented as a full code in the electronic medical record, despite the MOLST form. The patient had been receiving treatment for two days at the time of review of this medical record.
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
Based on the review of policies and procedures, staff interviews, video surveillance, and other pertinent documents it was determined that the hospital failed to establish procedures that governed, restricted, and tracked security's use of pepper foam and lacked direction for clinical staff in how to respond to the deployment of hazardous chemicals including but not limited to pepper foam.

Reviewed documents indicated that security interactions with patient # 8 and #10 also included security's deployment of pepper foam on the patient within a clinical environment. Documentation in both cases indicate that the deployment of the pepper foam exacerbated the behavioral situation, with an increase of violent behavior from the patient.

Patient # 8's encounter with security guards included: the patient punching the guards, security guards returning punches to patient #8's face, neck and chest, security guards deployed pepper foam on the patient, patient # 8 being subdued, prone on the floor, handcuffed with metal cuffs. While patient #8 was restrained in a prone position a nurse administered an intramuscular injection to calm the patient down. These acts occurred immediately before a "Code Blue" was initiated, due to patient being pulseless and unresponsive. Patient # 8 did not return to baseline function following this encounter. Patient # 8 spent the next 7 days in the Intensive Care Unit (ICU) and expired.

Review of video surveillance within the hallway of the emergency psychiatric treatment unit ( EPTU), during patient #8's encounter revealed the effects of the security guards use of pepper foam. The recording does not show security guard directly deploying the foam, however video surveillance clearly shows that the staff were exposed to the presence of the foam based on their actions.

The recording begins at 0237 when five security staff first arrive in the unit, one guard went into the patient's room as clinical staff entered and exited intermittently.

At 0300, all security guards observed in the room with the patient and the clinical staff. Two nurses and one tech are in the hallway.

At 0301 nurse # 1 enters the patient room, moments later one security guard exits the room coughing and symptomatic, nurse # 2 attended to the officer.

From 0301 until 0318 the recording showed staff coughing, washing faces, rinsing eyes, and retreating away from the patient's room. During this 17 minute time frame, the patient was pulseless and unresponsive, a Code Blue was called. The video showed RN # 2 and tech #1 continuously attempting to enter the patient's room and retreating back coughing. Another security officer also leaves the room appearing to have been compromised by the pepper foam. Unit staff and staff responding to assist with the medical code appeared visibly coughing and unable to be in the patient's room to administer care. The code team staff were seen coughing immediately after arrival in to the EPTU.

Symptoms displayed by clinical staff appear to have hindered ability to provide care to the patient. During the 17 minute recording of staff visibly in respiratory distress, no employees appeared in surgical mask to decrease the effect of the pepper foam. The surveyor asked why staff did not put on a surgical mask or some PPE (Personal Protective Equipment) to lessen the respiratory effects experienced. It was reported that "The EPTU does not take isolation patient and did not have masks in the unit."

The hospital staff lacked available PPE needed to facilitate patient care following the deployment of the pepper foam. Besides its negative impact on the staff. the video shows that the staff experienced delays and difficulty entering the patient's room to provide needed care to the patient after the use of pepper foam .
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0167
Based on the review of five restraint records, policies and procedures, and other pertinent documentation, it was determined that the hospital staff failed to implement and follow their restraint and seclusion policy. This was true for one of the five restraint records reviewed.

Per the hospital's Restraint and Seclusion Policy, #AHC CP 5.0, revised 2/20/18 under Pediatric Requirements for Restraint Use section, it stated "Four-point or locked limb holders are never used on children under 12 years of age."

Patient #9 was an elementary school age pediatric patient who was brought to the emergency department on emergency petition by local law enforcement due to self-harming behavior, aggressiveness and acute alcohol intoxication. The patient was noted as pulling out their intravenous (IV) line, kicking their parent and kicking staff. The physician ordered the pediatric patient to be restrained in 4-point restraints for violent behaviors. Security guards were called to assist. Patient #9 was restrained in four-point restraints and received intramuscular medications. The patient remained restrained for 52 minutes. Restraints were removed once patient #9 had fallen asleep.

Patient #9 was less than 12 years of age, but was placed in 4-point restraints for 52 minutes. The clinical staff failed to ensure that this pediatric patient received treatment in accordance with the hospital policy for the use of restraints on a pediatric patient.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0168
Based on review of six open medical records and seven closed medical records and pertinent documentation, it was determined the hospital failed to obtain orders for restraint episodes for three out of five patients reviewed.

1. Patient #1 presented to the emergency department (ED) with symptoms of alcohol withdrawal. Patient was admitted to an inpatient unit for treatment and monitoring. Per nursing note on the first day of admission at 0033, a code green (for violent behavior) was called around 2200 as patient was assaulting staff. Patient was given an intramuscular injection. Per the note, "Pt became more agitated and aggressive and required security to hold patient."

Per review of staff statement written regarding this event, around 2215 security responded to a code green. The patient was restrained with 3 rubber restraints and 1 metal handcuff because the 4th rubber restraint was missing. Per the statement, restraints were removed around 2337.

There was no order for this restraint episode found in the record.

2. Patient #2 was brought to the emergency department (ED) via an emergency petition due to drug intoxication. Once medically clear, patient was placed in the emergency psychiatric treatment unit (EPTU) for further evaluation. Per nursing ED note at 18:40, patient was attempting to leave the locked unit and became "frantic and powerful." Patient #1 tried to forcibly open the locked doors and attempted to enter another patient's room. Per the note, the RN attempted to block the patient from entering the other patient's room stating "I tried to calm the situation and hold the patient but (patient) began to wrestle free and we began to struggle against each other .....two security guards arrived and helped to bring the patient to the ground and cuff (metal handcuff) the patient for (his/her) safety as (he/she) was not responding and harmful to staff and patients." The note goes on to mention the cuffs were removed once an intramuscular injection was given.

There was no order for the physical hold by the nurse or the use of the metal handcuffs by security found in the record.

3. Patient # 8 was emergency petitioned to the emergency department by local law enforcement due to (making) threats, aggressive behavior and homicidal ideation. The patient was under observation and received treatment in the Emergency Psychiatric Treatment Unit (EPTU). Patient #8 initially was cooperative with EPTU staff. After about two hours into patient's visit, the patient refused to have (his/her) blood drawn, provide a urine sample, take medications and ceased cooperating with the clinical staff. Security guards were called to assist clinical staff in obtaining a blood and urine sample from the patient. At 0235, a total of five security guards responded to the EPTU. The patient's behavior escalated with pressured speech, yelling verbal threats, swinging arm, becoming more agitated and combative with staff. Per provider and nursing notes post episode, Patient # 8's encounter with security guards included: security guards being punched by patient, the patient being punched in return by security guards to patient # 8 's face, neck and chest, security guards also deployed pepper foam on patient, patient # 8 was subdued, prone on the floor, and handcuffed with metal handcuffs. While patient was restrained in a prone position a nurse administered an intramuscular injection to calm the patient down. These acts occurred immediately before a "Code Blue" was initiated, due to patient being pulseless and unresponsive. Patient # 8 did not return to baseline function following this encounter. Patient # 8 spent the next 7 days in the Intensive Care Unit (ICU) and expired.

The review of medical record for patient # 8 failed to reveal a physician's order for the time the patient was subdued prone by security while clinical staff administered an intramuscular medication to calm the patient down. This restraint encounter with security was not documented within the patient's medical record. Nursing staff notes mentioned this incident but did not document it as a restraint episode. The medical record lacked a physician's order and all other subsequent restraint documentation requirements.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0175
Based on review of six open medical records and seven closed medical records and pertinent documentation, including five restraint records, it was determined the hospital failed to conduct a face to face evaluation for restraint episodes for three patients.

1. Patient #1 presented to the emergency department (ED) with symptoms of alcohol withdrawal. Patient was admitted to an inpatient unit for treatment and monitoring. Per nursing note on first day of admission at 0033, a code green was called around 2200 as patient was assaulting staff. Patient was given an intramuscular injection. Per the note, "Pt became more agitated and aggressive and required security to hold patient."

Per review of staff statement written regarding this event, around 2215 security responded to code green. The patient was restrained with 3 rubber restraints and 1 metal handcuff because the 4th rubber restraint was missing. Per the statement, restraints were removed around 2337.

There was no restraint monitoring found in the record while the patient was in restraints. There was no documentation found on the restraint flow sheet that indicated a restraint occurred.

2. Patient #2 was brought to the emergency department (ED) via an emergency petition due to drug intoxication. Once medically clear, patient was placed in emergency psychiatric treatment unit (EPTU) for further evaluation. Per nursing ED note at 18:40, patient was attempting to leave the locked unit and became "frantic and powerful." Patient #1 tried to forcibly open the locked doors and attempted to enter another patient's room. Per the note, the RN attempted to block the patient from entering the other patient's room stating "I tried to calm the situation and hold the patient but (patient) began to wrestle free and we began to struggle against each other .....two security guards arrived and helped to bring the patient to the ground and cuff (metal handcuff) the patient for (his/her) safety as (he/she) was not responding and harmful to staff and patients." The note goes on to mention the cuffs were removed once an intramuscular injection was given.
There was no documentation found in the restraint flow sheet that indicated a restraint occurred or monitoring was done.

3. Patient # 8 was emergency petitioned to the emergency department by local law enforcement due to (making) threats, for aggressive behavior and homicidal ideation. The patient was under observation and received treatment in the Emergency Psychiatric Treatment Unit (EPTU). Patient # 8 initially was cooperative with EPTU staff. After about two hours into patient's visit, the patient refused to have (his/her) blood drawn, provide a urine sample, take medications, and ceased cooperating with the clinical staff. Security guards were called to assist clinical staff in obtaining a blood and urine sample from the patient.

At 0230, five security guards responded to the EPTU. The patient's behavior escalated with pressured speech, yelling verbal threats, swinging arms, becoming more agitated and combative with staff. Per provider and nursing notes post episode, Patient # 8's encounter with security guards included: security guards being punched by patient, the patient being punched in return by security guards to patient #8's face, neck and chest, security guards also deployed pepper foam on patient, patient # 8 was subdued, prone on the floor, and handcuffed with metal handcuffs. While patient was restrained in a prone position a nurse administered an intramuscular injection to calm the patient down. These acts occurred immediately before a "Code Blue" was initiated, due to patient becoming pulseless and unresponsive. Patient # 8 did not return to baseline function following this encounter. Patient # 8 spent the next 7 days in the Intensive Care Unit (ICU) then expired.

Review of patient # 8's medical record, video surveillance and other documents lacked evidence that the patient was appropriately monitored by clinical staff while being restrained by security guards. Clinical staff failed to provide oversight as security guards returned punches, deployed pepper foam, subdued and handcuffed patient #8 in a prone position. Following these acts a "Code Blue" was immediately required due to patient # 8 becoming pulseless and unresponsive. Clinical monitoring and continuous presence were lacking during the duration of the patient # 8's encounter with security leading up to the patient being coded.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0178
Based on review of six open medical records and seven closed medical records and pertinent documentation, including five restraint records, it was determined the hospital failed to conduct a face to face evaluation for three restraint episodes.

1. Patient #1 presented to the emergency department (ED) with symptoms of alcohol withdrawal. Patient was admitted to an inpatient unit for treatment and monitoring. Per nursing note on first day of admission at 0033, a code green was called around 2200 as patient was assaulting staff. Patient was given an intramuscular injection. Per the note, "Pt became more agitated and aggressive and required security to hold patient."

Per review of staff statement written regarding this event, around 2215 security responded to code green. Patient was restrained with 3 rubber restraints and 1 metal handcuff because the 4th rubber restraint was missing. Per the statement, restraints were removed around 2337.

There was no face to face evaluation found for this restraint episode in the record.

2. Patient #2 was brought to the emergency department (ED) via an emergency petition due to drug intoxication. Once medically clear, patient was placed in emergency psychiatric treatment unit EPTU for further evaluation. Per nursing ED note at 1840, patient was attempting to leave the locked unit and became "frantic and powerful." Patient #1 tried to forcibly open the locked doors and attempted to enter another patient's room.

Per the note, the RN attempted to block the patient from entering the other patient's room stating "I tried to calm the situation and hold the patient but (patient) began to wrestle free and we began to struggle against each other .....two security guards arrived and helped to bring the patient to the ground and cuff (metal handcuff) the patient for (his/her) safety as (he/she) was not responding and harmful to staff and patients." The note goes on to mention the cuffs were removed once an intramuscular injection was given.

There was no face to face for the physical hold by the nurse or the use of the handcuffs by security found in the record.

3. Patient # 10 presented to the emergency department with homicidal ideation against (his/her) neighbor. Documentation stated "needs help before (he/she) kills (his/her) neighbor". The patient was agitated and made threats against clinical staff when told of the need for admission to an inpatient psychiatric facility for treatment. Due to patient # 10's behavior and threats against clinical staff, security was called to unit for support. An order was placed for patient to be restrained and medicated. However, prior to the order being executed the patient made an attempt to harm staff, at which time security deployed pepper foam. The patient continued to fight and strike staff. Security guards took the patient to the ground and placed patient in metal handcuffs.

Patient #10's restraint episode lacked documentation of a physician face- to- face examination in the patient's medical record.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0200
Based on the review of five closed record in which patients were restrained, policies and procedures, staff interviews, personnel files and other pertinent documents, it was determined that the hospital failed to ensure that the security staff were trained on safe application and positioning of restrained patients, recognizing when patients were in distress, or in the appropriate use of security equipment.

Review of the medical records and other documentation indicated that patient's #1, #2, #8, #9, and #10 all experienced a physical encounter with security guards that involved these patients being placed in metal handcuffs by the security staff. Patient # 8's encounter with security required a "Code Blue" medical response, due to patient becoming pulseless and unresponsive. Patient # 8 never regained baseline function following this encounter. Patient # 8 spent the next 7 days in the Intensive Care Unit (ICU) before expiring.

Security guard interactions with patient's # 8 and #10 also included security deploying pepper foam on patients within a clinical environment.

The hospital lacked documentation of training for Security guards on uses of security equipment including: pepper foam, metal handcuffs, and batons. Documentation of officer's training could not be found and was not presented during the survey. The hospital lacked training verification despite security carrying and utilizing these items in clinical areas in the hospital.

The hospital lacked a policy that governed, directed, or limited Security Officer's use of pepper foam, batons, and metal handcuffs on patients within the hospital.