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CARLISLE REGIONAL MEDICAL CENTER 361 ALEXANDER SPRING ROAD CARLISLE, PA 17015 July 8, 2014
VIOLATION: COMPLIANCE WITH LAWS Tag No: A0020
Carlisle Regional Medical Center was not in compliance with the following State Law related to Act 13 of 2002, Medical Care Availability and Reduction of Error(MCARE) Act 40 PS. 1303.313 Medical facility reports and notifications.

Section 313. Medical facility reports and notifications.
(a) Serious event reports.--A medical facility shall report the occurrence of a serious event to the department and the authority within 24 hours of the medical facility's confirmation of the occurrence of the serious event. The report to the department and the authority shall be in the form and manner prescribed by the authority in consultation with the department and shall not include the name of any patient or any other identifiable individual information.

This is not met as evidenced by:

Based on review of facility policy, "Pennsylvania Patient Safety Reporting System" form, and medical records (MR), it was determined that the facility failed to completely report one serious event to the Department for one of one medical records reviewed (MR1).

Findings include:

A review on July 8, 2014, of the facility "Patient Safety Plan" last reviewed January 2013 revealed, "...Policy:...Full disclosure of serious event medical errors or unanticipated outcomes will be made to patients/families and to accrediting and licensing bodies as appropriate."

A review on July 8, 2014, of "Pennsylvania Patient Safety Reporting System" form revealed, "...9. Describe the event. Please include all relevant information, including details on how or why the event occurred:..."

A review of MR1 on July 8, 2014, revealed the patient (MR1) had a procedure done in Interventional Radiology on February 20, 2014. The patient was given a narcotic pain medication intravenously. The procedure was completed without incident. Immediately after the procedure, staff stepped away from the patient. The patient was left unattended on the procedure table. According to staff, the patient did not have a safety belt on and fell off of the table and landed on her front side. The patient was unresponsive to questions and only "groaned and moaned", went into respiratory arrest, was intubated, and had a CT scan which showed "Large subdural hematoma with midline shift and herniation." The patient was life flighted to another facility where the patient died the next day. The cause of death on the "Local Registrar's Certificate of Death" was "Traumatic Brain Injury" due to "Fall."

Further review of facility documentation revealed the facility did report the patient fall from the table as a serious event. The report did not include all relevant information. The report did not indicate that the patient was unresponsive to questions, went into respiratory arrest, had an emergent CT scan, which showed a "large subdural hematoma with midline shift and herniation," and then life flighted to another facility.
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
Based on policy review, medical record (MR) review, and staff interviews (EMP), it was determined the facility failed to ensure the patient received care in a safe setting for one of ten medical records reviewed (MR1).

Findings include:

A review of facility policy "Patient Bill of Rights and Responsibilities" last reviewed July 2014, revealed, "...Care Delivery, You have the right to:...Receive efficient and quality care with high professional standards that are continually maintained and reviewed.

A review of the medical record on July 8, 2014, revealed the patient (MR1) had a procedure done in Interventional Radiology on February 20, 2014. The patient was given a narcotic pain medication intravenously. The procedure was completed without incident. Immediately after the procedure, staff stepped away from the patient. The patient was left unattended on the procedure table. According to staff, the patient did not have a safety belt on and fell off of the table and landed on her front side. The patient was unresponsive to questions and only "groaned and moaned", went into respiratory arrest, was intubated, and had a CT scan which showed "Large subdural hematoma with midline shift and herniation." The patient was life flighted to another facility where the patient died the next day. The cause of death on the "Local Registrar's Certificate of Death" was "Traumatic Brain Injury" due to "Fall."

An interview conducted on July 8, 2014, at 12:15 PM with EMP2 revealed patient safety is "everyone's responsibility, but this was a nursing failure."

An interview conducted on July 8, 2014, at 2:00 PM with EMP8 revealed that leaving the patient unattended "Was a critical error in judgment."
VIOLATION: CONTENT OF RECORD - OTHER INFORMATION Tag No: A0467
Based on a review of facility policy, medical records (MR) and staff interview (EMP), it was determined that the facility failed to ensure that nursing records, which reflect the progress of each patient, be pertinent, accurate and concise so they contribute to the continuity of patient care for three of ten medical records reviewed (MR1, MR6 and MR8).

Findings include:

1) A review of facility policy "Nursing Documentation" last reviewed April 2013, revealed, "...Procedure...3. Documentation process follows the schema of charting by exception. For any body system assessed to be within normal limits, the nurse will document all pertinent info as it applies to that body system. The nurse will also chart all details of the nursing process related to that exception to include nursing interventions and outcomes of those interventions....4. Documentation of other assessments, intervention and evaluations of the patient response to care will occur as dictated by the patient's condition and associated need...."

A review of MR1 on July 8, 2014, revealed there was no nursing documentation of the fall from the table, assessment after the fall, or documentation of monitoring, vital signs, and neuro checks immediately after the fall.

Further interview with EMP3 on July 8, 2014, at 11:30, revealed that after the fall, EMP3 assessed the patient, monitored the patient, obtained vital signs on the ICU monitor, and completed neuro checks. There was no documentation in the record of any post fall assessment, continued monitoring, vital signs documentation, or neuro checks.

An interview conducted on July 8, 2014, at 12:25 PM with EMP7 revealed "We don't document the event in the medical record, it goes into the event report."

2) A review on July 8, 2014, of facility policy "Vital Signs" last reviewed February 2013, revealed, "...Procedure:...Frequency of vital signs:...6. Before, during and after interventions or procedures influencing vital signs.

A review of MR1 revealed the patient had a procedure done in Interventional Radiology (IR)on February 20, 2014, that could have involved influencing the vital signs. There was no evidence in the medical record that any vital signs were documented during the IR procedure.

An interview conducted on July 8, 2014, at 10:15 AM with EMP3 revealed the patient came to Interventional Radiology (IR) with ICU portable monitor. Staff in IR continued to use the portable ICU monitor to monitor the patient. EMP3 stated he/she set the monitor to take vital signs every five minutes. EMP3 confirmed that he/she thought that when the patient went back upstairs, the vital signs would get "printed out" and placed on the chart.

An interview conducted on July 8, 2014, at 10:50 AM with EMP7 revealed that staff would use the ICU monitors for the ICU patients instead of utilizing IR monitors. EMP7 stated staff was under the impression that the vital signs on the ICU monitor would be downloaded and become part of the medical record once the patient returned to the ICU. The facility could not provide documentation of vital signs during the IR procedure.

A review of MR6 revealed the patient had a procedure done in Interventional Radiology (IR)on March 13, 2014, that could have involved influencing the vital signs. There was no evidence in the medical record that any vital signs were documented during the IR procedure.

A review of MR8 revealed the patient had a procedure done in Interventional Radiology (IR)on January 31, 2014, that could have involved influencing the vital signs. There was no evidence in the medical record that any vital signs were documented during the IR procedure.

An interview conducted on July 8, 2014, at 3:00 PM with EMP2 confirmed that MR 6 and MR8 should have had vital signs taken during the procedure even though only local anesthesia was used.
VIOLATION: SAFETY POLICY AND PROCEDURES Tag No: A0535
Based on policy review, medical record (MR) review, and interviews with staff (EMP), it was determined the facility failed to safely meet the needs of one patient for one of ten medical records reviewed (MR1).

Findings include:

A review of facility policy "Falls Prevention Program" last reviewed October 2013, revealed,"...Radiology. 1. All patients, indicated as a falls risk, will be treated according to the guidelines stated within this policy. Falls risk patients will not be left unattended, in the radiology department, at any time.

A review of the medical record on July 8, 2014, revealed the patient (MR1) had a procedure done in Interventional Radiology on February 20, 2014. The patient was given a narcotic pain medication intravenously. The procedure was completed without incident. Immediately after the procedure, staff stepped away from the patient. The patient was left unattended on the procedure table. According to staff, the patient did not have a safety belt on and fell off of the table and landed on her front side. The patient was unresponsive to questions and only "groaned and moaned", went into respiratory arrest, was intubated, and had a CT scan which showed "Large subdural hematoma with midline shift and herniation." The patient was life flighted to another facility where the patient died the next day. The cause of death on the "Local Registrar's Certificate of Death" was "Traumatic Brain Injury" due to "Fall."

An interview conducted on July 8, 2014, at 12:15 PM with EMP2 revealed patient safety is "everyone's responsibility, but this was a nursing failure."

An interview conducted on July 8, 2014, at 2:00 PM with EMP8 revealed that leaving the patient unattended "Was a critical error in judgment."