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.

SINAI HOSPITAL OF BALTIMORE 2401 WEST BELVEDERE AVENUE BALTIMORE, MD 21215 April 16, 2015
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0169
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on the review of 14 patient records, policies, and staff interviews it was determined that the hospital failed to protect the rights of 2 patients (patient #5 and #6 ) by using an order for restraints on an as needed basis (PRN).
Patient #5, an inpatient on the behavior health unit for mood dysregulation, was admitted on 03/25/2015. Patient #1 had an order for haloperidol, a medication used to treat nervous, emotional, and mental conditions. This order was written for 5 mg, every 6 hours, as needed, for paranoia/agitation, in the form of an intramuscular injection. Patient #1, also had an order for lorazepam, a medication used to treat anxiety. This order was written for 1 mg, every 6 hours, as needed for anxiety/agitation, in the form of an intramuscular injection.
Patient #6 , an inpatient of the behavior health unit for treatment of schizophrenia and delusional behavior, was admitted [DATE]. Patient #6 had an order for lorazepam, 1 mg, every 6 hours, as needed, for anxiety/agitation, in the form of an intramuscular injection. Patient #6, also had an order for Fluphenazine, a medication used to treat psychosis. The order was written for 5 mg, every 6 hours, as needed, for psychosis/severe agitation, in the form of an intramuscular injection.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0174
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on review of 14 medical record reviews, it was determined that on multiple occasions for two patients (patient #5 and patient #6), seclusion was not discontinued at the earliest possible time.
Patient #5 was an inpatient on the behavior health unit for mood dysregulation, admitted [DATE]. Patient #5 was placed in seclusion 03/24/2015 at 7:21pm for verbal abuse, agitation, pacing, profanity, restlessness, screaming, threatening, wondering, and raising fist at staff. Patient #5 was assessed every 15 minutes for behavior while in seclusion. From 03/24/2015 at 8:15 pm to 03/24/2015 at 11:18 pm, patient #5 was assessed as calm, asleep, or quiet, and continued in seclusion. Seclusion discontinued 03/24/2015 at 11:30pm. On 03/25/2015 at 5:15 am , patient #5 was placed in seclusion for verbal abuse, refusal to follow directions, upturning a chair, spilling products, barricading with mattress. Patient #1 was assessed every 15 minutes for behavior while in seclusion. From 03/25/2015 7:17 am to 8:15 am, patient #1 was assessed as quiet and remained in seclusion. From 03/25/2015 at 10: 36 am to 12:02 pm, patient #1 was assessed as quiet and calm and remained in seclusion. From 03/25/2015 from 12:37 pm to 14:52 pm, patient #5 was assessed as quiet and calm and remained in seclusion. Seclusion was not discontinued 03/26/2015 at 6:45 am. eventhough the patient was documented as being calm.

Patient #6 was an inpatient of the behavior health unit for schizophrenia and delusional behavior, admitted [DATE]. Patient #6 was placed in seclusion 04/14/2014 at 9:35 am for verbal abuse, agitation, pacing, seeing things, refusal to follow directions, going in patient's rooms and occupied bedrooms. Patient #6 was assessed every 15 minutes for behavior while in seclusion. From 04/14/2015 from 9:30 am to 10:54 am, patient #2 was assessed as asleep and remained in seclusion. Patient #2 was discontinued from seclusion at 7:30 pm. Patient #6 was placed in seclusion 04/15/2015 at 8 pm for agitation, and being nonsensical. From 04/16/2015 6:00 am to 6:45 am patient #2 was assessed as asleep and remained in seclusion. From 04/16/2015 7:45 am to 8:45 am patient #2 was assessed as asleep and remained in seclusion. Seclusion was not discontinued until 9:00 am. eventhough he is documented as being asleep as early as 6:45 am .
VIOLATION: PATIENT SAFETY Tag No: A0286
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on review of the medical record, policy and procedure, staff interviews and other pertinent documentation, it was determined that the hospital failed to act on an identified adverse event. Based on a review of 14 medical records, two adverse events were identified but no further investigation to analyze the cause, implement preventative actions or provide feedback and learning.

Patient #1 is a [AGE] year old female with history of developmental disability, seizure disorder, diabetes, hypertension, [DIAGNOSES REDACTED] and iron deficiency anemia. The patient was found to have a non-functioning left kidney due to frequent infections. The patient was admitted to the hospital for the removal of the left kidney. The surgery was performed on 1/28/15 and per the operative report and the pathology report the entire kidney was removed. The patient had excessive blood loss 1.5 liter and an extensive stay in the post-operative care unit with subsequent transfer to the intensive care unit. The patient was eventually transferred to a medical-surgical floor. On 1/30/15, the patient had a CT scan of the abdomen/pelvis for evaluation of bleeding. Review of the results of the CT scan revealed the following: "a large staghorn calcification in the left kidney is no longer identified. The left kidney is no diffusely heterogeneous with diminished enhancement. There are surrounding infiltrative changes in the perinephric fat. Peripherally, enhancing collections posterior to the upper whole described previously have mildly decrease in size. A small amount of fluid tracks caudally in the retro-peritoneum. No significant hematoma appreciated. There is a drain entering the left lower quadrant and terminating in the lower abdomen just right to midline. " The impression: " new diffuse heterogeneity of the left kidney with surrounding infiltrative changes, presumably related to removal of a staghorn calculus. Perinephric fluid collections posterior to the upper pole left kidney has decreased in size. " Although the patient's operative report indicated the entire left kidney was removed, the CT scan of 1/30/15 continued to refer to the left kidney.

The surgeon's note dated 1/31/15 at 9:00 a.m. stated " CT reviewed, repeat review. Patient had left nephrectomy. No kidney on left side. " On 2/4/15 at 10:13 a.m. the surgical physician assistant documented that patient #1 had elevated white blood cell count and order was written for another CT scan of the abdomen/pelvis. Patient #1 had a CT scan without IV or oral contrast on 2/4/15 at 11:15 a.m. The CT scan focus was to look for fluid collection. The report revealed: "previously noted diffuse heterogeneity of the left kidney is again appreciated with surrounding infiltrative changes within the perinephric fat."


Again the CT scan referred to the left kidney. On 2/4/15 at 3:15 p.m. the surgeon documented regarding the CT scan including the dilated loops of the bowels (ileus) and stable kidney post-op hematoma, no other collections. On 4/15/2015, the hospital did conduct a peer review of the CT scans since the CT scans reports contradict that the left kidney was removed as per the surgeon reports which indicated that the kidney was removed in its entirety. The report comments are as follows: " The CT obtained on January 30, 2015 and February 4, 2015 were reviewed to clarify the initial readings and re-evaluate for a retained foreign body. In both instances the reason for the exam did not indicate that the patient was status post left nephrectomy. The area in question appears to be a kidney but in retrospect is a retroperitoneal hematoma which is kidney-shaped involving the intra-op bed. No foreign body is appreciated in either study. There are radio densities in the post-op space which could be sutures. No addendum to either study, no deviation from standard of care. "

There is no documentation to indicate that the documented presence of a kidney on the CT scan triggered follow-up or an attempt to clarify how the left kidney was visualized on the CT scans in complete contradiction of the operative and pathology reports.

The patient was transferred to another area acute care hospital for further care and consultation for a thrombosis (blood clot) of the mid left common iliac artery . It was during this work-up at the other hospital that a CT scan of the abdomen/pelvis with/without contrast was performed on 2/7/15 at 10:46 a.m. The findings state: " on the non-contrast imagines, there is poorly defined hypodense fluid collection in the surgical bed of what appears to be a left partial nephrectomy. Hyperdense surgical material is noted in the surgical bed as well. There are surgical staples in the left flank as well as moderate amount of subcutaneous air. In the arterial phase, there is no extravasation of contrast in the surgical site. The proximal left renal artery is visualized and there is an arterial branch going to the surgical area. In the venous phase, there appears to be a left kidney, a portion of the left kidney with trimmed parenchyma and [DIAGNOSES REDACTED] present. The patient must have had a partial nephrectomy. "

The CT scans from both hospitals indicate that the patient had a left kidney. The patient's extended stay in the post-operative area and eventual transfer to the intensive care unit should have triggered an evaluation related to an unexpected outcome following the surgery. The Sinai hospital CT scans ordered for evaluation of bleeding and elevated white blood count did not indicate that the patient was status post removal of the left kidney which may have triggered the Radiology department to speak with the surgeon regarding the results. Although the surgeon documented that the patient had no left kidney, the second CT scan again referred to a left kidney but there was no further follow-up in an attempt to clarify whether the patient had a remnant of the left kidney.

In addition, the surveyor reviewed the medical record of patient #2 on 4/15/15 at 1:00 p.m. Patient #2 is an [AGE] year old female with history of angina and acute myocardial infarction. The patient was referred to the hospital for multi-vessel bypass. The patient had coronary artery bypass graft surgery on 4/13/15. During the procedure the patient was receiving plasma and platelets. As soon as the platelets had completely infused, the patient had an elevation in her pulmonary embolus pressures. Both the operative note and report indicated that patient #2 may have had a platelet transfusion reaction. The patient was treated for the possible blood transfusion reaction. No event report was generated and no bloods obtained from the patient to determine if a reaction occurred. The hospital identified the possible adverse reaction as evident by information in the operative report but did not follow through to determine if the patient had a reaction. This could have created a problem for the patient if she was required further blood products. The hospital performed blood work on patient #2 on 4/15/15 which confirmed that she did not have a blood transfusion reaction.

In both cases the hospital staff clearly identified the problems but failed to follow through with investigation of the problems, and initiation of reports that would have triggered an investigation and analysis of the problem: allowed for mplementatation of changes in process and education of staff to prevent future adverse events.