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Based on staff interviews, review of policies and procedures, medical records, and observation of hospital physical environment, it was determined that the hospital failed to protect the patient's right to have care in a safe setting for two of 15 patients reviewed as evidenced by the deficiency at A 0144.

On April 17, 2013 at 9:15 am, the staff interviews revealed that a 2 year old patient upon discharge from the hospital received incorrect dosage of pain medication which led to the patient's admission to another acute care hospital and readmission to Sinai Hospital. The child had been prescribed the wrong dose of medication as a result of the failure to use his correct weight for calculating the dose of prescription medication for discharge.

Additionally , a second patient who had a cardiac catheterization as an outpatient, was not monitored while awaiting pick up from her assisted living provider . When the assisted living provider arrived the patient had a significant change in level of consciousness unbeknownst to the hospital staff who should have been monitoring her. ( See A0144)

Based on review of the medical records, staff interviews, policies and procedures, and observations, it was determined that the hospital failed to obtain informed consent or explain to patient #4 in a manner that he could understand information regarding the surgical procedure, risk and benefits and plan of care, as the hospital failed to provide the patient with translation services. Patient #4 was identified as a patient that spoke and understood limited English and his primary language is Greek.

Patient #4 was admitted for outpatient procedure Fistulogram/angio with stent for anteriovenous fistula graft (A-V graft). The patient had an x-ray with contrast for the placement of a stent in order to increase the opening and provide better blood flow through the A-V graft. The A-V graft connects the vein directly to the artery and is used to perform dialysis. The patient on admission was described as alert and oriented x3 and he signed all his consents. The patient spoke limited English.

The hospital's Patient Rights and Responsibilities Policy states that when the patient does not speak or understand the predominant language of the community, access to an interpreter will be provided. The Patient Guide to Services Booklet under Interpreters stated " we offer language interpreters and TTY phones for hearing impaired. For non-English speaking patients, we offer interpreters and the Cyracom Language Line (interpreters for phone calls)."


The policy for Interpreter Services under procedure states " referral guidelines for the health care team will be made to the appropriate Interpreter Service Resource to facilitate communication between patient and/or family with health care team to ensure the patient/family possesses an understanding of the following patient care concerns: a) Informed consent-explanation of proposed treatment or procedures including risk factors, as well as alternatives to proposed care plan."


The surveyor interviewed the Nurse Practitioner on 4/16/13 at 11:15 am about patient #4. She stated the patient spoke Greek with limited English, and that she obtained the patient's consent with the son translating. In addition, the nurse documented on 4/16/13 at 10:20 am that the patient had been given discharge instructions. The patient verbalized understanding but the son again helped to interpret.

The hospital failed to inform patient #4 of his rights and plan of care in a language he could understand. The assessments and explanations of complex treatment, procedures, and care were left to the patient's son to explain to the patient. The procedure was elective and the consent was obtained by the Nurse Practitioner using the son to interpret. The son's interpretation included the explanation of the procedure, risk, benefits, and plan of care. It is not known if the patient's son interpreted the information in a manner that the patient fully understood to have informed consent or whether the patient fully understood the discharge plans.

In 1 of 15 medical record reviewed, the hospital failed to inform the patient or her family of her rights as beneficiaries of Medicare. According to the regulation 42 CFR 489.27(b) which cross references the regulation at 42 CFR 405.1205, each Medicare beneficiary who is in an inpatient must be provided a standardized notice, "An Important message from Medicare" (IM), within two days of admission. The IM is a standardized OMB-approved form and cannot be altered from its original format. The IM is to be signed and dated by the patient to acknowledge receipt. Furthermore,the hospital must present a copy of the IM in advance of the patient's discharge, but no more than two calendar days before the patient's discharge. In the case of short inpatient stays, however, where initial delivery of the IM is within two calendar days of the discharge, the second delivery of IM is not required.

Patient #5 was a patient admitted to the hospital on 3/29/13. The patient had multiple admissions to the hospital and had a durable power of attorney (her daughter). The medical record review conducted on 4/16/13 at 4:00 PM revealed no IM. Registration was asked to determine if they had a copy of the IM but they did not. The daughter had not received the IM within two days of the patient's discharge.

Based on staff interviews, review of policies and procedures, 15 medical record reviews including patient #1 and patient #2, and observation of hospital physical environment, it was determined that the hospital failed to provide care in a safe setting for patient #1 following treatment for a fracture of his femur and patient #2 following an angioplasty and stent of the left leg. The findings are:

1. Patient #1 is a 2 year old who presented to the Emergency Department (ED) at Sinai Hospital following a fall. It was determined that the patient had a right femur (thigh bone) fracture. The patient was taken to surgery for repair of the fracture and placed in a body cast. The patient was discharged home on the same day. The patient's mother was given a prescription, which was filled by the hospital's retail pharmacy. The patient was given the medication post discharge and several hours later could not be awakened and was turning blue. The child was transported to another area hospital by EMS, stabilized and re-admitted to Sinai Hospital.

The investigation revealed that the patient was weighed in the ED at 16.1 kg (35-lbs/8oz). When transferred to the pre-operative area , the mother was asked the patient's weight and stated 35-lbs. The weight was entered on the hand written pre-operative assessment in a blank space followed by lb/kg ( pounds/kilograms) at the end of the space. The nurse was required to circle either lb.or kg. to identify which measure was used . Neither of the measures were circled on the form. In this case the #35 was entered on the line but no designation of whether the number was in pounds or kilograms. The nurse also documented in the electronic medical record on the height/medication clinical weight pre-operative services form that the patient weighed 35 kg. This automatically populated as 77-lb/3oz on the electronic medical records.

After surgery the patient was prescribed medication based on the inaccurate weight of 77 pounds 3 ounces. Upon discharge the patient's mother was given the prescription which she had filled in the retail pharmacy located in the hospital . The physician wrote the prescription based on the inaccurate weight. The retail pharmacy filled the prescription which was given to the patient. Failure to use a consistent unit of measure in this case kilograms and pounds, appears to be an additional factor in the documentation of the inaccurate weight.

Most drugs in children are dosed according to body weight (mg/kg) (milligram/kilogram) therefore, care must be taken to obtain the weight and properly convert body weight from pounds to kilograms before calculating medication doses based on weight.

The hospital failed to maintain a safe environment of care for patient #1 when (1) despite obtaining an accurate weight in kilograms in the ED , this information was not discussed at the hand off between the ED and surgery nor was it accessed through the electronic medical record by the nurse performing the pre-operative area assessment who instead relied on the mother for the patient's weight; (2) there was also no verification during the preoperative assessment of the weight obtained in the ED; and (3) finally multiple staff failed to correlate the patient's age and weight or question the accuracy of the weight including the physicians, nurses and pharmacist. The hospital's failure to ensure accurate calculation of the patient's weight could have led to serious harm and possible death.

2. Patient #2 is an 88 year old patient who had angioplasty and stent placement of the left leg on 3/21/13 as a outpatient in the catheterization lab . The patient was a resident from an assisted living facility (ALF). The resident was brought to the hospital by ALF staff in the morning for her procedure. When the patient was ready for discharge, the hospital staff was to contact the ALF staff to pick up the patient.

The patient had the procedure performed without complications. Per the catheterization laboratory staff the patient was alert, laughing, and was given something to eat and drink. She was dressed and placed in a wheelchair outside of her room for a planned 5:00 PM discharge to the ALF staff. When contacted the ALF staff, the ALF staff did not respond by phone until 6:30 PM and stated that the patient could not be picked up at that time as she was preparing dinner for the other residents.

The last nursing note for Patient #2 was written at 5:45 PM and it stated "patient was ambulated in the hallway without groin complication. The patient denies pain unless feet are manipulated. Has not voided post procedure." In an interview on 4/16/13 at 9:30 am with the two nurses who provided care to patient #2 on 3/21/13 they reported that the patient appeared to be sleeping in the chair. There was no documented evidence that the patient was monitored for the next 3 hours while she was still under the care of the hospital and not officially discharged to the ALF provider .

The next note on the medical records timed at 9:00 PM on 3/21/13 included the events that occurred from 8:15 PM until patient #2's transport to the ED. The note stated that the ALF staff arrived at approximately 8:30 PM and found the patient unresponsive. The registered nurse responsible for the patient documented in the 3/21/13, 9:00 PM note that the patient was sitting in the wheelchair sleeping when the ALF staff arrived. When the ALF staff tried to arouse her the patient would not wake up. The note included a nursing assessment of patient #1 who was placed back in bed. The assessment included vital signs, pulses, gag-reflex, right groin assessment, and oxygen saturation, all of which were within normal limits. The patient eyes were open.

The ALF staff felt uncomfortable about taking the patient back to the ALF, therefore the nurse was trying to arrange for the patient's transport to the ED. While the nurse was trying to arrange to transport the patient to the ED, she observed the ALF staff slapping the patient in the face, shaking her, and knocking her head up and down. The nurse asked the ALF staff to stop touching the patient in her face in that manner. The nurse reported that the ALF staff put the patient in a sitting position and let go of her twice with the patient swaying in the bed and the ALF staff caught her twice. The nurse reported the ALF staff stated this was not like the patient "she would be hitting and screaming if I did this."

The nurse notified the hospital supervisor, ED and the patient's power of attorney regarding the patient's condition and the behavior of the ALF staff. The patient was sent to the Emergency Department with one transporter staff and the ALF staff.

There was no documented evidence of monitoring or care provided beyond the note written at 5:45 PM. The patient was next assessed when she was found to be unresponsive at 8:30 PM. The medical record revealed the staff was not aware of the change in the patient's level of consciousness until the ALF staff could not awaken the patient. Although the patient's assessment and vital signs were stable the patient was unresponsive and the cause unknown.

The hospital has an emergency medical procedure to illicit additional help to assess individuals who are at the hospital to receive outpatient services. The team that responds to these emergencies is the staff of the hospital's Intensive Care Unit and ED. The emergency medical procedure was not implemented for this patient . Nonetheless the patient was sent to the ED with only a transporter staff and the ALF staff . There were no nurses or clinical staff with the patient whose condition could have deteriorated during transport.

Lastly per the nurse's observations and documentation, the patient was shaken, slapped about the face and lifted to sitting position and allowed to fall back with the ALF catching the patient. The nurse had to tell the ALF staff several times to discontinue the behavior but at no time did she contact security to seek assistance and the ALF staff was ask to go with the patient to the ED department with transportation. The patient should have been separated from the ALF staff and transported to the ED with medical staff in case her condition deteriorated while in transition from the catheterization laboratory and the ED.


Based on interview with nursing staff caring for patient #2 and the investigation of the complaint it was revealed that the hospital did not maintain a safe environment of care for patient #2. Patient #2 was a vulnerable patient who the hospital failed to monitor, recognize change in LOC, failed to provide appropriate care and transportation to the ED and to protect the patient from abuse.

Based on review of open and closed medical records, and staff interviews, it was determined that patients discharged from the Emergency Department did not have evidence of the hospital query regarding whether the patient had an advance directive.

While on survey in the Emergency Department on 4/16/13 at 9:21 am, the surveyors were able to view the response to the query regarding advance directive in the electronic medical record reviews. The survey of the closed medical records revealed that all patients admitted to the hospital had a response to the question regarding their advance directive but all patients discharged from the Emergency Department had no documentation that they were queried regarding an advance directive. This area of the medical record was grayed out on the records. The surveyors observed the process and found the question was being asked by the registrars and nursing staff, and documented in the medical record. However, the closed records failed to show whether the patient had an advance directive.

The hospital was unable to answer why the information was not showing up in the medical record but will investigate.

Observation and review of inpatient pharmacy services and interview of Pharmacy staff revealed that not all on site pharmacy services are integrated into the hospital's QAPI and Pharmacy Therapeutic Committee activities. This was evidenced by the following findings:
A) Interview of the Inpatient Pharmacy Director (IPD)[LP] on 04/16/13 at 2:30 PM during the tour in the Inpatient Pharmacy Service area revealed the following: 1) the hospital does have a retail pharmacy on site and it is a separate entity or stand alone pharmacy within the hospital, 2) inpatient pharmacy services has no oversight or have any responsibility for the retail pharmacy and their related activities, and 3) the retail pharmacy does not participate in the pharmacy therapeutic committee meetings. Additional interview of the IPD revealed that she had awareness of a 03/13 medication error that occurred involving the hospital staff, the retail pharmacy (who filled pain medication prescription), and a pediatric patient's weight. As a result of that event, the IPD immediately sent a reference pediatric kilogram weight sheet to all staff to prevent future errors and the plan was to have further staff education and review.
B) Observation and review of the hospital organizational charts (LifeBridge Health Sinai Organizational Chart and Corporate Director of Pharmacy) indicated that : 1) the Director of the Retail Pharmacy reports to the Vice President of Finance[DK], and 2) the retail pharmacy is not listed on the Corporate Director of Pharmacy chart.
C) Observation and review of the pharmacy therapeutic committee meeting (PTCM) minutes from 12/2012-04/2013 showed no mention of the retail pharmacy inclusion. The pediatric medication error of 03/13 per the IPD will be discussed at the 05/13 or 06/13 PTCM.
D) Surveyors queried hospital administrative staff multiple times throughout the day (up to late afternoon) as to whether the retail pharmacy was under the hospital Medicare CCN provider number and services ( provider based services). The staff was unable to verify and confirm that the retail pharmacy was under the hospital auspices until after business hours. The hospital Vice President confirmed at the exit conference that the retail pharmacy was a separate entity, reports to Finance, and is under the hospital CCN provider number.
Integration, continuity and coordination of all pharmacy services is important in the prevention of medication errors and harm to patients.

Observation through a tour of the Emergency Department and interview of the licensed staff revealed that the Pediatric Emergency Equipment were not maintained in a clean , safe and up to date manner.
The findings were:
On 04/16/13 at 9:21 am, a tour of the Emergency Department(ED) was conducted which included the following areas: Urgent Care, Emergent Care, Chest Pain, Pediatric, and Observation. The ED Director reported on interview that the ED census was a total of 31 patients at that time.
During the tour of Pediatric ED Room #33 at 9:49 am while inspecting emergency equipment, the surveyors observed two (2) plastic tackle boxes sitting on separate shelves on the wall in close proximity of the pediatric emergency code cart. One box was red and labeled "Airway Box." The second box was yellow and labeled "Pediatric Trauma Kit."
Based on interview of the ED Pediatric staff, the surveyors were informed that:
1) the boxes are not used,
2) the boxes are checked and stocked by respiratory staff, and
3) the nursing staff or other designated staff do not conduct a daily check of this emergency equipment.
Additional interview of the staff as to why the boxes remained in the emergency equipment inventory revealed that they were unsure and stated that respiratory therapy staff are responsible for maintenance and stocking of the boxes. However, staff mentioned that the boxes had been used during transport of patients.
Further inspection of the boxes and related contents indicated that the emergency supplies were either soiled or expired, for example:
Pediatric Trauma Kit- contained vacutainer blood tubes that were expired and outdated. Specifically: 6-Hematology tubes- 4 of 6 expired as of 01/2013 and 1-expired 03/2009, and 5-coagulation tubes expired as of 07/2012.
Airway Box-contained laryngoscope found partially enclosed in an open plastic bag and upon visual examination was soiled with a whitish substance. Also, un-cuffed tracheal tubes (4.5 mm and a 5.0 mm in sterile packaging) were found opened rendering them unsterile. In addition, one tracheal tube (4.5 mm) was missing the internal stylet (glide) used for placement. One of four batteries to be used in the laryngoscope had expired as of 03/2011.
The manager of the respiratory therapy was consulted at 10:05 AM and confirmed that: 1) respiratory therapy was responsible for checking the boxes and the contents on a daily basis; however, there was not a written log to validate this was being done.
At 10:12 AM a pediatric syringe pump (#22507) was observed located on a counter/table in the pediatric medication room. Further inspection of the device revealed that the biomedical tag indicated expiration of 02/13.
The availability of the unsterile, soiled and expired emergency equipment placed patients at potential risk for: 1) infection, 2) inaccurate blood studies, and 3) delay in treatment.