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Based on review of the medical record, policies and procedures, and staff interviews the hospital failed to document the less restrictive interventions used prior to placing patient #1 into the geri-chair restraint as evidenced by:

Patient #1 is a 72 year old female with a past medical history of non-ischemic cardiomyopathy, prior cardiac catheterization revealed normal coronary arteries with ejection fracture (EF) of 15%. The patient had multiple medical problems including hypertension, diabetes, chronic kidney disease, status post AICD (Implantable Cardioverter-Defibrillator) placement, hypothyroidism, and symptomatic anemia.

Review of the medical record revealed the patient had been placed in geri-chair restraint sometime between her admission to the unit on 11/5/11 at 4:15am and her transfer from the geri-chair to the bed at 8:30 am in preparation for receiving her blood transfusion. Of note, at 5:01 am the nursing assessment described the patient as alert and oriented times 3. Per interview with the physician assistant that admitted patient #1, she did see the patient who was sitting on the side of her bed and appeared anxious. The physician assistant wrote an order for xanax, which the patient received at 5:30 am. Other than the administration of medication for anxiety, there's no documentation regarding a change in patient #1's mental status and behavior. In addition, no documentation can be found in the medical record regarding what behaviors patient #1 was exhibiting and alternative interventions taken prior to placing the patient in the geri-chair restraint. It was substantiated that patient #1 was placed in geri-chair restraint without documentation of behaviors justifying the restraint nor the alternative interventions taken by staff prior restraint.

Based on review of the medical record, policies and procedures, and staff interviews, the hospital failed to obtain an order of a physician or licensed independent practitioner who is responsible for the care of patient #1 and authorized to order restraint or seclusion by hospital policy in accordance with State law.

Patient #1 is a 72 year old female with a past medical history of non-ischemic cardiomyopathy, prior cardiac catheterization revealed normal coronary arteries with ejection fracture (EF) of 15%. The patient had multiple medical problems including hypertension, diabetes, chronic kidney disease, status post AICD (Implantable Cardioverter-Defibrillator) placement, hypothyroidism, and symptomatic anemia.

Review of the medical record revealed the patient had been placed in geri-chair restraint sometime between her admission to the unit on 11/5/11 at 4:15 am and her transfer from the geri-chair to the bed at 8:30 am in preparation for receiving her blood transfusion . No documentation could be found in the medical record regarding the initiation of the geri-chair as a restraint. Patient #1 was placed in a geri-chair as a form of restraint without an order.

Based on review of the medical record, policies and procedures, and staff interviews the hospital failed to document patient #1's response to the interventions used, including the rationale for continued use of the intervention (restraint).

Patient #1 is a 72 year old female with a past medical history of non-ischemic cardiomyopathy, prior cardiac catheterization revealed normal coronary arteries with ejection fracture (EF) of 15%. The patient had multiple medical problems including hypertension, diabetes, chronic kidney disease, status post AICD (Implantable Cardioverter-Defibrillator) placement, hypothyroidism, and symptomatic anemia.

Review of the medical record revealed the patient had been placed in a geri-chair sometime between her admission to the unit on 11/5/11 at 4:15am and her transfer from the gerichair to the bed at 8:30am in preparation for receiving her blood transfusion . No documentation could be found in the medical record regarding the patient's response to placement in the geri-chair, including the rational for continued use, nor did the nurse document the discontinuation of the geri-chair restraint.

In addition, per the patient's assigned nurse, the patient was placed in 2 point bilateral wrist restraints at 9:00 am due to attempting to pull at her IV, Foley and telemetry monitor leads. The order read: soft limb, bilateral upper and lower extremities. There was documentation regarding alternative interventions used but unsuccessful. Again, no documentation could be found in the medical record regarding the patient's response to the soft wrist restraints nor when the restraints were discontinued. The assigned nurse stated that the patient's right arm had been removed from restraint to apply the blood pressure cuff in order to obtain her vital signs prior to blood transfusion. The vital signs pre-transfusion were obtained at 10:15 am. The patient was described as calmer but confused. No documentation can be found in the medical record regarding the continued need or discontinuation of the 2 point restraints. The medical record revealed the patient was placed in two different type of restraints on 11/5/11. The patient's response to the restraints including the rational to continue or discontinue were not documented in the medical record.

Based on review of the medical record, policies and procedures, and staff interviews, the hospital failed to report the death of patient #1, who had been in restraints prior to her death, to CMS.

Patient #1 is a 72 year old female with a past medical history of non-ischemic cardiomyopathy, prior cardiac catheterization revealed normal coronary arteries with ejection fracture (EF) of 15%. The patient had multiple medical problems including hypertension, diabetes, chronic kidney disease, status post AICD (Implantable Cardioverter-Defibrillator) placement, hypothyroidism, and symptomatic anemia.

The patient presented to the Emergency Department at Saint Agnes Hospital on 11/4/11 at 11:16 pm complaining of chest pain in the left anterior chest radiating to her left shoulder. The patient took nitroglycerin with some relief, but the pain returned and she called 911 and was brought to the ED. On 11/5/11 at 4:15 am the patient was admitted to Telemetry with diagnosis non-ischemic cardiomyopathy. The patient received Xanax at 5:30 am for complaint of anxiety. On 11/5/11 at 8:20 am, it was documented in the medical record that patient #1 was agitated, described as confused, disoriented, pulling catheter and wires, climbing out of bed, screaming and yelling, verbally and physically aggressive and not following directions. The staff documented that they tried other less restrictive alternatives without success. The assigned nurse for patient #1 stated she and another staff transferred patient #1 from a ger-chair to her bed at 8:30 am. The medical record review revealed an order written at 9:00 am, which read: the patient was placed in 4 point soft limb restraints to prevent removal of lines and catheters and was provided a sitter. Per the assigned nurse, the patient was placed in two point soft wrist restraints, no sitter provided but the nurse stayed with the patient. The assigned nurse stated she had released the patient's right arm to apply the blood pressure cuff to monitor the patient's blood pressure for the blood transfusion. The pre-transfusion vital signs were taken and recorded at 10:15 am. The patient was calmer but remained confused. The patient arrested at 10:50 am and was successfully resuscitated. Patient #1 was transferred to ICU where she arrested two additional times and after 1 hour and 40 minutes of resuscitation the patient was pronounced dead at 12:33 pm on 11/5/11. Upon review of the medical record, it was determined that the patient had been placed in two different types of restraints on 11/5/11: the geri-chair restraint and two point soft wrist restraints. The restraints were not documented per hospital policy and procedure.

On the 2/17/12 on-site survey, review of patient #1's medical record revealed that the patient had been placed in restraints. Per nursing staff all restraints are documented on an auditing tool, which is reviewed with nursing supervisory staff, used to track restraint use and restraint related deaths. The Director of Risk Management was questioned regarding whether the patient's death had been reported to the Centers for Medicare and Medicaid Services (CMS). The patient's death had not been reported. The Director of Risk Management stated she was not aware that the patient had been in restraints. Review of the auditing tool (non-violent/non-self-destructive and violent/self-destructive form) for 11/5/11 to 11/6/11 revealed no reported restraints.

At the time of the site visits and interviews with administrative staff, it was determined that the hospital's internal quality reporting process had not been followed by staff and there was no report of a possible restraint related death to the Quality/Risk Management staff for follow-up, tracking and trending.

When risk management staff were made aware of the circumstance of patient #1's death (possibly restraint related) during the on-site survey of 2/17/11, the hospital staff did not perform an internal review of the death including why the internal quality reporting process was not followed, nor did they report the event to CMS. On the surveyor's second visit to the hospital on 2/22/12, the patient's death had still not been reported but after discussion with the hospital staff, the death was reported to CMS on 2/22/12 and CMS notification was entered into the patient's medical record on the same day.

Based on a medical record review, quality assessment/performance improvement documentation and interviews with staff, it was determined that the hospital staff failed to internally report, analyze, and track two serious events involving patient #1 (possible restraint related death and possible blood transfusion reaction) that occurred on November 5, 2011 through the hospital's quality assessment and performance improvement process as evidenced by:

Patient #1 is a 72 year old female with a past medical history of non-ischemic cardiomyopathy, prior cardiac catheterization revealed normal coronary arteries with ejection fracture (EF) of 15%. The patient had multiple medical problems including hypertension, diabetes, chronic kidney disease, status post AICD (Implantable Cardioverter-Defibrillator) placement, hypothyroidism, and symptomatic anemia.

The patient presented to the Emergency Department at St. Agnes Hospital via EMS on 11/4/11 at 11:16 pm with complaint of chest pain. While in the ED it was determined that the patient required a blood transfusion which the patient provide signed consent. The patient was admitted to the Telemetry Unit on 11/5/11 at 4:15 am. She became anxious and received medication by mouth to help decrease her anxiety at 5:30 am. The patient was placed in geri-chair restraint sometime after her admission to the unit at 4:15 am. Per the medical record at 8:20 am, the patient's behavior escalated to screaming, yelling, verbally and physically aggressive, confused, restless, pulling at Foley catheter, IVs, and telemetry monitoring wires. Per the assigned nurse and medical record, patient #1 was transferred from the geri-chair to her bed at 8:30 am in preparation for the blood transfusion. Per the patient's assigned nurse, patient #1 was placed in two point soft wrist restraints at 9:00 am. The right arm was removed from restraint to apply the blood pressure cuff to monitor vital signs prior to blood transfusion. The pre-transfusion vital signs were taken at 10:15 am. The patient's blood transfusion began at 10:27 am and she arrested at 10:50 am. The blood transfusion was stopped at 11:00 am. The patient was resuscitated and transferred to ICU with the blood attached but not infusing. The patient arrested twice in ICU and died at 12:33 pm on 11/5/11. The family declined organ donation and autopsy. The unit of blood, tubing, and post-transfusion specimens were not sent to the Blood Bank for testing. During the 2/22/12 interview with the patient's assigned nurse, she stated that during the code there was discussion at the bedside of possible transfusion reaction. Per the nurse, the physician felt the patient's reaction was not related to the blood transfusion.

On 12/13/11, after reviewing patient #1's case, the Quality and Patient Safety Committee notified the hospital's Blood Bank that the patient was receiving blood at the time of her arrest. The hospital's Blood Bank investigated the case as a possible transfusion reaction. The decision was made to notify the FDA and the blood supplier, the American Red Cross. The hospital's investigation was led by the Director of Laboratory Services. The investigation primarily focused on the Blood Bank. The hospital investigation was not expanded to include nursing and medical staff. A complete investigation would have to include these other departments who are intricately involved in the blood transfusion process from ordering the blood to administering the blood. In addition, the investigation by surveyors revealed that although the hospital discussed splitting the unit of blood for patient #1, the hospital does not have a policy for use of the sterile containment device used in this laboratory process. Per the Director of Laboratory Services, the hospital is in the process of revising the policy to describe the process for splitting units of blood into smaller quantities. The Blood Bank has a communication log used to communicate between shifts. Review of the log for 11/5/11, revealed no documentation regarding the splitting of blood discussion for patient #1, nor the outcome after clarification of policy and procedure.

The hospital failed to document restraints per policies and procedures and failed to follow the blood transfusion policies and procedures designed to ensure safety in administration of these products. At the time of the site visits and interviews with administrative staff, it was determined that the hospital's internal quality reporting process had not been followed by staff and there was no report of a possible restraint related death and transfusion reaction to the Quality/Risk Management staff for follow-up, tracking and trending.

Based on review of the medical record and staff interviews, it was determined that the hospital failed to evaluated the nursing care of patient #1, who exhibited a significant change in mental status and behavior.

Patient #1 is a 72 year old female with a past medical history of non-ischemic cardiomyopathy, prior cardiac catheterization revealed normal coronary arteries with ejection fracture (EF) of 15%. The patient had multiple medical problems including hypertension, diabetes, chronic kidney disease, status post AICD (Implantable Cardioverter-Defibrillator) placement, hypothyroidism, and symptomatic anemia.

The patient presented to the Emergency Department at Saint Agnes Hospital on 11/4/11 at 11:16 pm complaining of chest pain in the left anterior chest radiating to her left shoulder. The patient took nitroglycerin with some relief, but the pain returned and she called 911 and was brought to the ED. While in the ED the patient was described as alert and oriented x 3. On 11/5/11 at 4:15 am the patient was admitted to Telemetry with a diagnosis non-ischemic cardiomyopathy. A nursing note written at 5:01 am described patient #1 as awake, alert, oriented to person, place and time. Per interview with the physician assistant that admitted patient #1, she went to see the patient at the request of nursing staff and found the patient sitting on the side of the bed. The patient appeared anxious and was given Xanax, a medication for anxiety at 5:30 am. The assessment and plan to administer medication could not be found in the medical record. There were no notes regarding patient #1's response to medication, assessment of mental status and behavior. The 8:20 am nursing note revealed a change in the patient's mental status and behavior. The patient was described as confused, and attempting to remove IV, Foley catheter, and telemetry monitor wires. There was also a note regarding contacting the patient's family to provide assistance with sitters. The patient's assigned nurse documented that at 8:30 am, she and another staff transferred the patient from a geri-chair to her bed in preparation for a blood transfusion. This was the first mention of the geri-chair, which was being used as a restraint. In regards to the geri-chair, there was no order, no description of the patient's behavior justifying restraint use, no alternative interventions prior to restraint, no documented response to restraint, no documentation regarding continued use of restraint or a note to terminate restraint.

At 9:00 am an order was written to place patient #1 in four point soft wrist bilateral upper and lower extremities restraints with sitter. The assigned nurse stated that she placed the patient in two point soft wrist restraints and remained with the patient, no sitter was provided. Although the patient was placed in less restrictive restraint, there was no order for the restraint, no documentation of care while in restraints, no assessment for discontinuation of restraint nor note for termination of restraint. The assigned nurse stated she had released the patient's right arm to apply the blood pressure cuff to monitor the patient's blood pressure for the blood transfusion. The pre-transfusion vital signs were taken and recorded at 10:15 am. The patient was calmer but remained confused. None of the nurses actions including removing the restraint and assessment of the patient's mental status and behavior were documented in the medical record.

The hospital failed to document the change in patient #1's mental status including behaviors leading to the use of geri-chair restraint as well as the patient's anxiety and response to medication and restraints.

Based on review of the medical record, staff interviews, policies and procedures and other pertinent documentation, the hospital failed to administer blood/blood products to patient #1 in accordance with State law and approved medical staff policies and procedures.

Patient #1 is a 72 year old female with a past medical history of nonischemic cardiomyopathy, prior cardiac catheterization revealed normal coronary arteries with ejection fracture (EF) of 15%. The patient had multiple medical problems including hypertension, diabetes, chronic kidney disease, status post AICD (Implantable Cardioverter-Defibrillator) placement, hypothyroidism, and symptomatic anemia.

The patient presented to the Emergency Department at Saint Agnes Hospital on 11/4/11 at 11:16 pm complaining of chest pain in the left anterior chest radiating to her left shoulder. The patient took nitroglycerin with some relief, but the pain returned and she called 911 and was brought to the ED. It was determined in the ED that patient #1 would need a blood transfusion. The patient consented for blood transfusion at 3:00 am. On 11/5/11 at 4:15 am the patient was admitted to Telemetry with diagnosis non-ischemic cardiomyopathy.

During review of patient #1's admission orders, the night nurse noted that the blood transfusion order was written to give one unit of packed red blood cells (350 mls) over six hours. The nurse contacted the physician assistant to inform her of the hospital's policy regarding blood products which can be given up to four hours only. This discussion was documented in a 6:30 am note on 11/5/11. The note revealed discussion regarding the patient's ejection fraction of 15% and the need to administer the blood slowly in smaller quantities to prevent fluid overload. The physician assistant stated during interview on 2/22/12 that she discussed the issue with a resident who suggested splitting the unit of blood. The note revealed that the Blood Bank was contacted regarding splitting the unit of blood. It was documented that the Blood Bank technologist would contact the Director of Laboratory Services for policy and procedure clarification. No documentation beyond the 6:30 am note regarding the blood transfusion concerns could be found in the medical record. No documentation could be found in the laboratory communication log used to provide information across shifts for continuity of care. The assigned nurse during the 2/22/12 interview stated she spoke to the Blood Bank technologist who stated due to labeling issues the blood could not be split. The final decision was to send the entire unit and administer the blood up to the four hour limit. In the 2/22/12 interview with the Director of Laboratory Services, he stated the technologist did contact him regarding splitting the blood. The blood could be split but it was determined that the hospital does not have a policy and procedure for the use of the "sterile containment device" needed to split a unit of blood.

Per the patient's assigned nurse and medical record, the pre-transfusion vital signs were obtained at 10:15 am. The next part of the note states transfusion started see TAR (Transfusion Administration Report). Per the complaint and TAR, the transfusion began at 10:27 am. Per the medical record the next transfusion vital signs were taken again at 10:42 am, Temperature 97.6, Pulse 98, Respiration 20, Blood pressure 110/60, the blood pressure position was supine. At 10:48 am, oxygen saturation was 98% on 2L/NC. Per the complaint and the assigned nurse, the code blue was called at 10:50 am and at 11:00 am the blood was stopped. At 11:00 am the intake was documented as 350 mls of packed red blood cells and 40 mls of normal saline in Meditech. Per the patient's assigned nurse, the patient's blood was infused via a pump at 40 mls/hour and she did not receive the total 350 mls of blood as found in the Meditech record. At most the patient received approximately 20 mls of blood and 40 mls of saline. Per the assigned nurse, the physician on-site did not feel the patient's arrest was related to the blood transfusion since she did not get enough blood. The patient was transferred to ICU with the blood still attached but turned off. It's unknown what happened to the blood, except that it was not returned to the Blood Bank. The possibility of a blood transfusion reaction could not be addressed since the blood unit, tubing and post-transfusion samples for testing were not sent to the Blood Bank. Regardless of the discussion at the patient's bedside regarding possible transfusion reaction, the hospital failed to follow the blood transfusion policies and procedures designed to ensure safety in administration of these products.

Based on review of the medical record for patient #1, it was determined that the documentation was lacking or incomplete regarding the significant change of mental status and behavior and the documentation of two adverse patient events.

Patient #1 is a 72 year old female with a past medical history of nonischemic cardiomyopathy, prior cardiac catheterization revealed normal coronary arteries with ejection fracture (EF) of 15%. The patient had multiple medical problems including hypertension, diabetes, chronic kidney disease, status post AICD (Implantable Cardioverter-Defibrillator) placement, hypothyroidism, and symptomatic anemia.

The patient presented to the Emergency Department at Saint Agnes Hospital on 11/4/11 at 11:16 pm complaining of chest pain. The patient took nitroglycerin with some relief, but the pain returned and she called 911 and was brought to the ED. While in the ED the patient was described as alert and oriented x 3, consented and signed for blood transfusion. On 11/5/11 at 4:15 am the patient was admitted to Telemetry with diagnosis non-ischemic cardiomyopathy. A nursing note written at 5:01 am described patient #1 as awake, alert, oriented to person, place and time. Per interview with the physician assistant that admitted patient #1, she went to see the patient at the request of nursing staff and found the patient sitting on the side of the bed. The patient appeared anxious and was given Xanax for anxiety at 5:30 am. The 8:20 am nursing note revealed a change in the patient's mental status and behavior. The patient was described as confused, and attempting to remove IV, Foley catheter, and telemetry monitor wires. There was also a note regarding contacting the patient's family to provide assistance with sitters. The patient's assigned nurse documented that at 8:30 am, she and another staff transferred the patient from geri-chair to her bed in preparation for blood transfusion. This was the first mention of the geri-chair which was being used as a restraint. In regards to the geri-chair, there was no order, no description of the patient's behavior justifying restraint use, no alternative interventions prior to restraint, no documented response to restraint, no documentation regarding continued use of restraint or a note to terminate restraint.

At 9:00 am an order was written to place patient #1 in four point soft wrist bilateral upper and lower extremities restraints with sitter. The assigned nurse stated she placed the patient in two point soft wrist restraints and remained with the patient, no sitter was provided. Although the patient was placed in less restrictive restraint, there was no order for the restraint, no documentation of care while in restraints, no assessment for discontinuation of restraint or a note for termination of restraint. The assigned nurse stated she had released the patient's right arm to apply the blood pressure cuff to monitor the patient's blood pressure for the blood transfusion. The pre-transfusion vital signs were taken and recorded at 10:15 am. The patient was calmer but remained confused.

Per the complaint and TAR the transfusion began at 10:27 am. Per the medical record the next transfusion vital signs were taken again at 10:42 am, Temperature 97.6, Pulse 98, Respiration 20, Blood pressure 110/60, blood pressure position was supine. At 10:48 am oxygen saturation was 98% on 2L/NC. Per the complaint and the assigned nurse, the code blue was called at 10:50 am and at 11:00 am the blood was stopped. At 11:00 am the intake was documented as 350 mls of packed red blood cells and 40 mls of normal saline in Meditech. Per the patient's assigned nurse the patient's blood was infused via a pump at 40 mls/hour and she did not receive the total 350 mls of blood as found in the Meditech record. At most the patient received approximately 20 mls of blood and 40 mls of saline. Per the assigned nurse, the physician on-site did not feel the patient's arrest was related to the blood transfusion since she did not get enough blood. The patient was transferred to ICU with the blood still attached but turned off. It's unknown what happened to the blood, except that it was not returned to the Blood Bank. The possibility of a blood transfusion reaction could not be addressed since the blood unit, tubing and post-transfusion samples for testing were not sent to the Blood Bank. Regardless of the discussion at the patient's bedside regarding possible transfusion reaction, the hospital failed to follow the blood transfusion policies and procedures designed to ensure safety in administration of these products. The nurse failed to document the discussion regarding the decision to administer the blood via pump at 40 mls/hour up to four hours as well as the adjust in the amount of blood infused in the Meditech field. The laboratory staff failed to document the discussion regarding splitting the unit of blood in the communication log.

The hospital failed to document the change in patient #1's mental status including behaviors leading to the use of geri-chair restraint as well as the patient's anxiety and response to medication and restraints. None of the nurses actions including conversation with the blood bank technologist, initiation and removal of restraints, blood transfusion process and potential transfusion reaction were documented in the medical record. The hospital failed to ensure that the medical record for patient #1 was accurate and complete with documentation of orders, evaluations, assessments/reassessments, treatments, interventions and the patient's response to those treatments, interventions and care.