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.

ANNE ARUNDEL MEDICAL CENTER 2001 MEDICAL PARKWAY ANNAPOLIS, MD 21401 March 19, 2012
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0167
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on review of documentation, interview and review of the patient record, hospital staff inappropriately utilized 4-side rails as a safety measure as evidenced by:


Patient #1 was an [AGE]-year-old female who presented to the emergency department (ED) on 2/10 with a urinary tract infection. During that visit, an L2 compression fracture was identified. Patient #1 was discharged with analgesics and Ciprofloxin. Patient #1 had a history of Alzheimer's dementia and lived with family while receiving daily home care visits for assisted activities of daily living. Patient #1 had a partial history of hypertension, coronary artery disease, congestive obstructive heart disease, and vascular surgery.


On 2/14/2012 at 2:44 PM via emergency medical services, patient #1 presented for a second time with a worsening mental status, urinary tract infection and uncontrolled pain from the L2 compression fracture. Patient #1 was unable to move at home, especially while getting in and out of bed. On 2/15, patient #1 who was boarding in the ED was noted to be alert and oriented x 2 to person and place. A head CT was found negative. Patient #1 continued to be treated in the ED until 2/16, when she was transferred to the neurology unit. Patient #1 was a full code status.


A physician note stated in part, "Given pt's inability to walk and worsening confusion, I will consult for admission. Confusion likely secondary to UTI and opiate use." On 2/16, patient #1 was transferred to the neurology unit. Patient #1 was on Plavix at home, and was placed on Lovenox while in the hospital.


Patient #1 was assessed as a high fall risk. Fall prevention for patient #1 consisted of a bed in low position with locked wheels; upper side rails raised x 2, a bed alarm, adjusted lighting and non-skid foot wear.


The Hospital Policy "Restraint/Seclusion (eff. 3/14/2012)" identifies "Side rails up x 4 " as a restraint, and as the least restrictive restraint. The hospital "Side Rails for the Adult Patient" policy states in part, "Four side rails are not considered a restraint when, a. Used to protect a patient from involuntarily falling from the bed..."

On 2/15 at 9:20 PM, a physician's order for a sitter was written. The hospital has no current policy/protocol/guidelines for obtaining sitters. Interview with the hospital Chief Nurse revealed that RN's generally determine when a sitter is needed, and that an order is not required for a sitter. In the case of patient #1, a physician wrote an order for a sitter on 2/15 at 9:20 PM. However, the RN did not obtain a sitter based on the RN's perception that patient #1 did not need a sitter, and that the RN could continue to make that judgment even though an order for sitter existed. Further, the order for a sitter was not communicated during the shift hand-off.


On 2/16 at some time in the evening, a staff member put up all four of patient #1's side rails. During investigation, the staff that put up the side rails did not come forward. However, subsequent observing staff of the 4 raised rails, allowed the rails to remain in the up position, believing this to be a safety measure as opposed to a restraint.


On 2/16 at 10:15 PM, a nurse reported hearing a noise from patient #1's room. On entering the room, patient #1 was found on the floor lying on her side. She was assessed as alert and confused per her baseline. She was able to move all her extremities, but complained of pain to her left hip, left face and back. Patient #1 sustained a hematoma to the left side of her head and a left arm skin tear. Patient #1's pupils reacted equally and briskly on assessment.


A physician note of 2/17 at 12:45 am states "S/P (status post) fall with L (left) frontal SDH (subdural hemotoma) and soft tissue swelling with evidence of small contra coup collection. Will continue frequent neuro checks/CCU charge nurse - no beds- HOC/Dr. ___ made aware of no CCU beds available. Neuro - no intervention/repeat CT in am/ d/c lovenox/plavix."


A Neurology consult at the same time states "Called Dr. ___ and by report patient found on floor. CT head shows thin rim subdural collection-acute, no significant mass effect. Patient seems pleasantly demented which is reportedly her baseline. She follows commands readily and is symmetric throughout. No long-tract signs appreciated. If any surgical intervention were deemed reasonable from a medical standpoint, then transfer to ICU for frequent neurologic checks and repeat CT head in approximately 6 hours would be the recommendations. If patient is not a surgical candidate, then I am not sure what the endpoint of frequent neuro checks and repeat CT would be. I would be happy to review repeat CT when available. No neurosurgical interventions need consideration at this point."


Patient #1 was not considered a surgical candidate, and the recommendation was for comfort measures only. Patient #1 was placed on one-hour neuro checks, and the neuro check of 1:28 am found patient #1's confusion at baseline, with verbal responses, good grasps, and able to move all extremities.


A rapid response was called when patient #1 became unresponsive at 2:20 AM. A central line was placed, and patient #1 was intubated at 3:42 AM, and transferred to the CCU (critical care unit). A repeat CT revealed a massive increase subdural hematoma. The physician documented that given the patient age, pre-morbid status and current neurologic status, that a meaningful recovery from the incident was low. The family was made aware and they asked to have patient #1 made DNR (Do Not Resuscitate).


On 2/17 at 1:35 PM, patient #1 was extubated. She became apneic within 10 minutes, and was pronounced dead at 2:04 PM.


The hospital utilized 4 side rails up as a safety precaution, yet in doing so, restrained patient #1 and created a safety risk, which may have contributed to the seriousness of her fall.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0168
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on a review of patient records, patient #10 of 10 had two episodes of restraint, but only one physician's order as evidenced by:

Patient #10 is a [AGE]-year-old male brought to the ED on 1/4/2012 at 3:39 PM by police on emergency petition after his mother alerted authorities to her belief that he would kill himself. Once in the ED, it was reported that he had been drinking alcohol, and had taken 30 Klonopin the previous day. Patient #10 had also been drinking on the 1/4 and had taken some Klonopin . Patient #10 stated to staff, "Just kill me." Patient #10 has a history of depression and anxiety.
On 1/4/2012 at 3:54 PM an order for Velcro restraint due to Combative/Severity (sic) Aggressive Behavior is found in the record. Patient #10 was placed in 4-point Velcro restraints on 1/4 at 4:03 PM due to combative behaviors. Patient #10 was taken out on 1/4 at 5:35 PM .
A sitter was placed with patient #10, but he became increasingly agitated and attempted to hit the sitter in the face when it became apparent that he was being admitted involuntarily. He was placed back in restraint on 1/4 at 7 PM until 9:30 PM. A nursing progress note states in part, "Pt attempted to hit sitter in face when told he was not going home. Security was called and security had to get patient back onto the bed and put restraints back on. Dr. __ made aware .... " Though the physician was made aware of a second application of restraint, no new physician order appears in the record. The hospital failed to use restraint in accordance with the order of a physician and per regulatory directives.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0169
Based on a review of the hospital restraint/seclusion policy, staff are given guidance that they may "trial release" medical surgical patients in restraint as evidenced by:

Review of the hospital Restraint/Seclusion Policy (RSP) under Medical Surgical Restraints (approved 3/12), states in part, " 2. Standing orders and orders written on an as-needed basis (PRN orders) are not allowed." Contrary to this statement, the RSP under "Discontinuation of Restraints," reveals the statement, "2. A registered nurse may "trial release" and/or discontinue a patient from the physical restraint if clinically indicated, i.e. the specific signs/symptoms requiring restraints are no longer present or less restrictive alternatives are warranted" and, "3. If the same signs/symptoms return, the restraint may be reapplied if alternatives remain ineffective. The order is still in effect through the remainder of the calendar day." These policy statements in effect; allow nursing to reapply restraints as needed without a new physician order.

Interview with hospital Administrators reveals their belief that the hospital does not actually perform trial releases in practice. However, the reference to "Trial release " has been a part of the restraint/seclusion policy since at least 8/2008. It is realistic and desirable to expect that staff will read, and follow hospital policy. Therefore, it is realistic to think that occurrences of trial release have occurred. Whether or not such trial releases have occurred, hospital policy guidance does not meet regulatory directives.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0178
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on a review of hospital policy, interview and 10 patient records, the face to face for restraint and seclusion may be performed by untrained Physician Assistants; and no appropriate face-to-face (FTF) documentation is found for patients # 7, and #10 who were in restraints for violent behaviors as evidenced by:

Per hospital policy, only Physicians, Physician Assistants and Nurse Practitioners may perform face to face (FTF) assessments for patients in seclusion or restraint. Under the Medical Staff credentialing policy physicians may attest to their understanding of hospital policy, including their understanding of the restraint/seclusion (R/S) policy and the FTF. Likewise, the hospital states that according to policy, Physician Assistants also make an attestation to their understanding of hospital policies including R/S and the FTF. Interview reveals that Physician Assistants receive no actual training for performing a FTF as required by regulation. Physician assistants are not licensed independent practitioners (LIPs), an attestation does not meet the regulatory directives for the training of Physician Assistants to perform FTF.


Patient #7 is a [AGE]-year-old male who on 1/6/2012 at 3:17 AM, presented to the emergency department (ED) via police and emergency petition with suicidal ideation, agitation and behavioral problems. Patient #7 would not disclose a plan, but stated he had been thinking about jumping off a bridge or cutting off his toe. Patient #7 has diagnoses of Major Depression, and Personality Disorder, not otherwise specified.
At 6:08 AM, patient #7 was noted by the physician to begin biting his wrist. Patient #7 requested restraints to prevent injuring himself. The physician wrote an order for restraint at 6:30 AM. A soft restraint was applied, but patient #7 chewed through it by 6:44 AM. Therefore, Velcro wrist restraints were applied which were discontinued at 8 AM. While the physician was present and noted patient #7's behaviors, no FTF was documented at the time of restraint or within one hour of restraint.

Patient #10 is a [AGE]-year-old male brought to the ED on 1/4/2012 at 3:39 PM by police on emergency petition after his mother alerted authorities to her belief that he would kill himself. Once in the ED, it was reported that he had been drinking alcohol, and had taken 30 Klonopin the previous day. Patient #10 had also been drinking on the 1/4 and had taken some Klonopin . Patient #10 stated to staff, "Just kill me." Patient #10 has a history of depression and anxiety.
At 3:54 PM an order for Velcro restraint due to Combative/Severity (sic) Aggressive Behavior is found in the record. Patient #10 was placed in 4-point Velcro restraints on 1/4 at 4:03 PM. No FTF is noted in the record. Patient #10 was taken out of restraint at 5:35 PM.
A sitter was placed with patient #10, but he became increasingly agitated and attempted to hit the sitter in the face when it became apparent that he was being admitted involuntarily. He was placed back in restraint at 7 PM until 9:30 PM. A nursing progress note states in part, " Pt attempted to hit sitter in face when told he was not going home. Security was called and security had to get patient back onto the bed and put restraints back on. Dr. __ made aware .... " Again, no FTF is noted in the record.
Though the physician was made aware of a second application of restraint, no new physician order appears in the record. The hospital failed to use restraint in accordance with the order of a physician and per regulatory directives.
The hospital failed to meet regulatory directives for the training of Physician Assistants and implementation of FTF requirements for patients placed in R/S.