HospitalInspections.org

Based on interview and record review, the facility failed to ensure that the quality improvement program: 1) Measure, analyze, and track quality indicators that included the safety and quality of care; 2) Focus on high-risk problem-prone areas; and 3) Measure, analyze, and track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms in the cardiac catheterization laboratory as a result of lack of qualified staffing in three of 20 sampled patients (# 13, 14, and 1); and a medication error in one sampled patient (#1).

Based on interview and record review, the facility failed to ensure that the quality improvement program measure, analyze, and track quality indicators that included the safety and quality of care in the cardiac catheterization laboratory as a result of lack of staffing in three of 20 sampled patients (# 13, 14, and 1); and a medication error in one sampled patient (#1).

The findings:

Review of SP#13's medical record showed that on 10/19/14, the patient had left heart catheterization with coronary angiogram and percutaneous intervention to the right coronary artery. Review of the patient's event log showed that there was only one cath lab RN present during the procedure.

Review of the time cards showed that there was only one Cardiac cath lab RN (Staff E) on call on 10/19/14.

Review of SP#14's medical record showed that on 10/19/14, the patient had left heart catheterization with coronary angiogram and percutaneous intervention to the circumflex artery as well as the ramus intermedius. Review of the patient ' s event log showed that there was only one cath lab RN present during the procedure.

Review of the time cards showed that there was only one Cardiac cath lab RN (Staff E) on call on 10/19/14.


Review of sampled patient (SP)#1 medical record showed that the patient presented to the emergency room on 12/20/14 at 5:15 PM for syncope, weakness and dizziness. The electrocardiogram (EKG) results reported the patient had ST segment elevations in the anterior lead which was consistent with an acute anterior wall myocardial infarction (heart attack). The recommendation was to take the patient to the Cardiac Catheterization Laboratory and perform a diagnostic procedure with possible intervention.

Review of Staff A (The Registered Nurse from the post anesthesia care unit (PACU) cardiac catheterization) notes showed that the patient arrived in the CCL (Cardiac Catheterization Laboratory (Cath Lab) on 12/20/14 at 7:01 PM.

According to SP#1 surgical event log on 12/20/14: At 7:11 PM, a bolus of the drug Angiomax (use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI)), was given by Staff A. The log further recorded that at 7:42 PM; the Angiomax I.V. was not connected, and was noted by the M.D. (medical doctor). At 7:44 PM, the Angiomax I.V. was connected by Staff B -the ICU (intensive care unit) nurse. The log then note that at 8:40 PM, Staff B -the ICU nurse then left the case and the CCL nurse arrived. At 9:15 PM, the case ended and the patient was transported to ICU.

The Operative Report on 12/20/14 showed that the sampled patient #1 had a cardiac catheter procedure. The operative report further reported that the patient had a totally occluded LAD (left anterior descending). The report then showed the Angiomax I.V. bolus was ordered and the Angiomax drip was also ordered and " supposedly started". The operative report further documents the guide-wire became stuck at the midlevel of the LAD and there was moderate degree of difficulty advancing the guide-wire and coronary flow was not achieved. The report further state that after inflation was performed the patient's became hypotensive with significant bradycardia. The heart rate was normalized with insertion of a pacemaker. However, the patient remained hypotensive. Then aspiration to the guiding catheter was performed, and significant amount of red blood clots were obtained, which was dampening the blood pressure. At that point, it was investigated and realized that the line that was not running Angiomax was not connected to the patient. This was corrected. The surgery continued. However, the patient continued to be hypotensive, in shock and respiratory distress. The patient was intubated.

The consultation notes on 12/26/2014 reported that the patient remained comatose and was developing multisystem organ failure. Consideration of withholding, and withdrawing life support was being made.

Review of the patient's medical record then showed that on 12/26/14 at 6:45 PM, the patient was admitted to a hospice. Expiration notification showed that on 12/26/14, the patient expired after withdrawal of life support.

Review of Cath Lab work schedule showed that on Saturday, December 20, 2014, there were two Registered Nurses (RN) On call, including Staff C but not Staff A or Staff B.

Review of cath lab staff time cards showed that on 12/20/14, Staff P was "on call" from 7:00 AM to 3:00 PM. The Time Card did not show any other RNs On call.


On 02/20/14 at 1:20 PM, Staff P, Registered Nurse (RN), stated that on 12/20/14, she was "on call" for the Cath Lab from 7:00 AM to 3:00 PM. She stated that on 12/20/14, she was called by the Assistant Director of Perioperative Services to come in to Cath Lab . However, it was after 3:00 PM and she was not available. She stated that there are always two RNs and two techs on call for Cath Lab.


On 02/02/15 at 12:33PM, Staff A, RN, stated that she worked in the Recovery Room/Post Anesthesia CareUnit (PACU). She stated that she does not work in the Cath Lab . She stated that she was asked to come in for SP#1's emergency catheterization (cath) lab procedure. She stated that there was an "on call" RN who was not able to come in. Staff A stated that she lived close by. However, she did not work in the cath lab and had no cath lab experience.

On 02/02/15 at 12:52PM, Staff B, RN, stated that he worked in the Intensive Care Unit. He stated that the House Supervisor asked him to come to Cath Lab to assist with SP#1's cath. He stated that when he went into the room to assist that there was confusion with the IV (intravenous) drip and when he went to make sure that the drip was connected and that the rate was correct. However, the drip was not connected to the patient. He stated that was disconnected medication angiomax which opens up blood vessels that have blot clots. Staff B also stated that upon his arrival to the room, the patient was not getting perfusion. He stated that he had to go up to the maximum dose on the Nitroglycerin drip because it was going at half the dose. He stated that after he had double the dose, the patient started perfusing. Staff B stated that he had not worked in a cath lab before.


On 02/20/15 at 4:30 PM, the Associate Administrator of Quality stated that the (Cardiac) Cath Lab schedule and the "on call" staffing was not tracked as a quality indicator. She stated that the "on call" schedule was recognized after SP#1 incident, and will be monitored based on the action plan submitted by the Risk Manager.

Review of the facilty record showed that the incident with SP #1 was not investigated and analyzed by the risk manager at the time of survey.
Review of the "2015 Organizational Performance Improvement Evaluation & Plan", dated january 2015 note that the leaders will assure that there is a planned, systemic and hospital-wide approach to improving the quality of care and services provided to our patients. This approach includes: performance measurement, assessment, and improvement, and setting priorities for performance improvement activies.

Based on interview and record review, the facility failed to ensure that the quality improvement program set priorities for its performance improvement activities that focus on high-risk problem-prone areas in the cardiac catheterization laboratory as a result of the lack of qualified staff in three of 20 sampled patients (# 13, 14, and 1); and a medication error in one sampled patient (#1).

The findings:

Review of SP#13's medical record showed that on 10/19/14, the patient had left heart catheterization with coronary angiogram and percutaneous intervention to the right coronary artery. Review of the patient's event log showed that there was only one cath lab RN present during the procedure.

Review of the time cards showed that there was only one Cardiac cath lab RN (Staff E) on call on 10/19/14.

Review of SP#14's medical record showed that on 10/19/14, the patient had left heart catheterization with coronary angiogram and percutaneous intervention to the circumflex artery as well as the ramus intermedius. Review of the patient ' s event log showed that there was only one cath lab RN present during the procedure.

Review of the time cards showed that there was only one Cardiac cath lab RN (Staff E) on call on 10/19/14.


Review of sampled patient (SP)#1 medical record showed that the patient presented to the emergency room on 12/20/14 at 5:15 PM for syncope, weakness and dizziness. The electrocardiogram (EKG) results reported the patient had ST segment elevations in the anterior lead which was consistent with an acute anterior wall myocardial infarction (heart attack). The recommendation was to take the patient to the Cardiac Catheterization Laboratory and perform a diagnostic procedure with possible intervention.

Review of Staff A (The Registered Nurse from the post anesthesia care unit (PACU) cardiac catheterization) notes showed that the patient arrived in the CCL (Cardiac Catheterization Laboratory (Cath Lab) on 12/20/14 at 7:01 PM.

According to SP#1 surgical event log on 12/20/14: At 7:11 PM, a bolus of the drug Angiomax (use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI)), was given by Staff A. The log further recorded that at 7:42 PM; the Angiomax I.V. was not connected, and was noted by the M.D. (medical doctor). At 7:44 PM, the Angiomax I.V. was connected by Staff B -the ICU (intensive care unit) nurse. The log then note that at 8:40 PM, Staff B -the ICU nurse then left the case and the CCL nurse arrived. At 9:15 PM, the case ended and the patient was transported to ICU.

The Operative Report on 12/20/14 showed that the sampled patient #1 had a cardiac catheter procedure. The operative report further reported that the patient had a totally occluded LAD (left anterior descending). The report then showed the Angiomax I.V. bolus was ordered and the Angiomax drip was also ordered and " supposedly started". The operative report further documents the guide-wire became stuck at the midlevel of the LAD and there was moderate degree of difficulty advancing the guide-wire and coronary flow was not achieved. The report further state that after inflation was performed the patient's became hypotensive with significant bradycardia. The heart rate was normalized with insertion of a pacemaker. However, the patient remained hypotensive. Then aspiration to the guiding catheter was performed, and significant amount of red blood clots were obtained, which was dampening the blood pressure. At that point, it was investigated and realized that the line that was not running Angiomax was not connected to the patient. This was corrected. The surgery continued. However, the patient continued to be hypotensive, in shock and respiratory distress. The patient was intubated.

The consultation notes on 12/26/2014 reported that the patient remained comatose and was developing multisystem organ failure. Consideration of withholding, and withdrawing life support was being made.

Review of the patient's medical record then showed that on 12/26/14 at 6:45 PM, the patient was admitted to a hospice. Expiration notification showed that on 12/26/14, the patient expired after withdrawal of life support.

Review of Cath Lab work schedule showed that on Saturday, December 20, 2014, there were two Registered Nurses (RN) On call, including Staff C but not Staff A or Staff B.

Review of cath lab staff time cards showed that on 12/20/14, Staff P was "on call" from 7:00 AM to 3:00 PM. The Time Card did not show any other RNs On call.


On 02/20/14 at 1:20 PM, Staff P, Registered Nurse (RN), stated that on 12/20/14, she was "on call" for the Cath Lab from 7:00 AM to 3:00 PM. She stated that on 12/20/14, she was called by the Assistant Director of Perioperative Services to come in to Cath Lab . However, it was after 3:00 PM and she was not available. She stated that there are always two RNs and two techs on call for Cath Lab.


On 02/02/15 at 12:33PM, Staff A, RN, stated that she worked in the Recovery Room/Post Anesthesia CareUnit (PACU). She stated that she does not work in the Cath Lab . She stated that she was asked to come in for SP#1's emergency catheterization (cath) lab procedure. She stated that there was an "on call" RN who was not able to come in. Staff A stated that she lived close by. However, she did not work in the cath lab and had no cath lab experience.

Review of Staff A personnel file showed that she was the Associate Nurse Manager of Recovery and was hired 07/01. Staff A previous experience was PACU and ICU. She did not have experience in circulating, monitoring and scrub assist with a physician. She did not have training in preparation of all equipment and supplies necessary to perform cardiac diagnostic and cardiac interventional procedures and appropriate documentation.


On 02/02/15 at 12:52PM, Staff B, RN, stated that he worked in the Intensive Care Unit. He stated that the House Supervisor asked him to come to Cath Lab to assist with SP#1's cath. He stated that when he went into the room to assist that there was confusion with the IV (intravenous) drip and when he went to make sure that the drip was connected and that the rate was correct. However, the drip was not connected to the patient. He stated that was disconnected medication angiomax which opens up blood vessels that have blot clots. Staff B also stated that upon his arrival to the room, the patient was not getting perfusion. He stated that he had to go up to the maximum dose on the Nitroglycerin drip because it was going at half the dose. He stated that after he had double the dose, the patient started perfusing. Staff B stated that he had not worked in a cath lab before.

Review of Staff B personnel filed showed that he was the Associate Nurse Manager of ICU. He was hired 11/84. Staff B had previous experience in the OR. He did not have training in preparation of all equipment and supplies necessary to perform cardiac diagnostic and cardiac interventional procedures and appropriate documentation.

On 02/20/15 at 4:30 PM, the Associate Administrator of Quality stated that the (Cardiac) Cath Lab schedule and the "on call" staffing was not tracked as a quality indicator. She stated that the "on call" schedule was recognized after SP#1 incident, and will be monitored based on the action plan submitted by the Risk Manager.

Review of the facility record showed that the incident with SP #1 was not investigated and analyzed by the risk manager at the time of survey.

Based on interview and record review, the facility failed to ensure that the quality improvement program measure, analyze, and track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms in the cardiac catheterization laboratory as a result of lack of qualified staffing in three of 20 sampled patients (# 13, 14, and 1); and a medication error in one sampled patient (#1).

The findings:

Review of SP#13's medical record showed that on 10/19/14, the patient had left heart catheterization with coronary angiogram and percutaneous intervention to the right coronary artery. Review of the patient's event log showed that there was only one cath lab RN present during the procedure.

Review of the time cards showed that there was only one Cardiac cath lab RN (Staff E) on call on 10/19/14.

Review of SP#14's medical record showed that on 10/19/14, the patient had left heart catheterization with coronary angiogram and percutaneous intervention to the circumflex artery as well as the ramus intermedius. Review of the patient ' s event log showed that there was only one cath lab RN present during the procedure.

Review of the time cards showed that there was only one Cardiac cath lab RN (Staff E) on call on 10/19/14.


Review of sampled patient (SP)#1 medical record showed that the patient presented to the emergency room on 12/20/14 at 5:15 PM for syncope, weakness and dizziness. The electrocardiogram (EKG) results reported the patient had ST segment elevations in the anterior lead which was consistent with an acute anterior wall myocardial infarction (heart attack). The recommendation was to take the patient to the Cardiac Catheterization Laboratory and perform a diagnostic procedure with possible intervention.

Review of Staff A (The Registered Nurse from the post anesthesia care unit (PACU) cardiac catheterization) notes showed that the patient arrived in the CCL (Cardiac Catheterization Laboratory (Cath Lab) on 12/20/14 at 7:01 PM.

According to SP#1 surgical event log on 12/20/14: At 7:11 PM, a bolus of the drug Angiomax (use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI)), was given by Staff A. The log further recorded that at 7:42 PM; the Angiomax I.V. was not connected, and was noted by the M.D. (medical doctor). At 7:44 PM, the Angiomax I.V. was connected by Staff B -the ICU (intensive care unit) nurse. The log then note that at 8:40 PM, Staff B -the ICU nurse then left the case and the CCL nurse arrived. At 9:15 PM, the case ended and the patient was transported to ICU.

The Operative Report on 12/20/14 showed that the sampled patient #1 had a cardiac catheter procedure. The operative report further reported that the patient had a totally occluded LAD (left anterior descending). The report then showed the Angiomax I.V. bolus was ordered and the Angiomax drip was also ordered and " supposedly started". The operative report further documents the guide-wire became stuck at the midlevel of the LAD and there was moderate degree of difficulty advancing the guide-wire and coronary flow was not achieved. The report further state that after inflation was performed the patient's became hypotensive with significant bradycardia. The heart rate was normalized with insertion of a pacemaker. However, the patient remained hypotensive. Then aspiration to the guiding catheter was performed, and significant amount of red blood clots were obtained, which was dampening the blood pressure. At that point, it was investigated and realized that the line that was not running Angiomax was not connected to the patient. This was corrected. The surgery continued. However, the patient continued to be hypotensive, in shock and respiratory distress. The patient was intubated.

The consultation notes on 12/26/2014 reported that the patient remained comatose and was developing multisystem organ failure. Consideration of withholding, and withdrawing life support was being made.

Review of the patient's medical record then showed that on 12/26/14 at 6:45 PM, the patient was admitted to a hospice. Expiration notification showed that on 12/26/14, the patient expired after withdrawal of life support.

Review of Cath Lab work schedule showed that on Saturday, December 20, 2014, there were two Registered Nurses (RN) On call, including Staff C but not Staff A or Staff B.

Review of cath lab staff time cards showed that on 12/20/14, Staff P was "on call" from 7:00 AM to 3:00 PM. The Time Card did not show any other RNs On call.


On 02/20/14 at 1:20 PM, Staff P, Registered Nurse (RN), stated that on 12/20/14, she was "on call" for the Cath Lab from 7:00 AM to 3:00 PM. She stated that on 12/20/14, she was called by the Assistant Director of Perioperative Services to come in to Cath Lab . However, it was after 3:00 PM and she was not available. She stated that there are always two RNs and two techs on call for Cath Lab.


On 02/02/15 at 12:33PM, Staff A, RN, stated that she worked in the Recovery Room/Post Anesthesia CareUnit (PACU). She stated that she does not work in the Cath Lab . She stated that she was asked to come in for SP#1's emergency catheterization (cath) lab procedure. She stated that there was an "on call" RN who was not able to come in. Staff A stated that she lived close by. However, she did not work in the cath lab and had no cath lab experience.

Review of Staff A personnel file showed that she was the Associate Nurse Manager of Recovery and was hired 07/01. Staff A previous experience was PACU and ICU. She did not have experience in circulating, monitoring and scrub assist with a physician. She did not have training in preparation of all equipment and supplies necessary to perform cardiac diagnostic and cardiac interventional procedures and appropriate documentation.

On 02/02/15 at 12:52PM, Staff B, RN, stated that he worked in the Intensive Care Unit. He stated that the House Supervisor asked him to come to Cath Lab to assist with SP#1's cath. He stated that when he went into the room to assist that there was confusion with the IV (intravenous) drip and when he went to make sure that the drip was connected and that the rate was correct. However, the drip was not connected to the patient. He stated that was disconnected medication angiomax which opens up blood vessels that have blot clots. Staff B also stated that upon his arrival to the room, the patient was not getting perfusion. He stated that he had to go up to the maximum dose on the Nitroglycerin drip because it was going at half the dose. He stated that after he had double the dose, the patient started perfusing. Staff B stated that he had not worked in a cath lab before.

Review of Staff B personnel filed showed that he was the Associate Nurse Manager of ICU. He was hired 11/84. Staff B had previous experience in the OR. He did not have training in preparation of all equipment and supplies necessary to perform cardiac diagnostic and cardiac interventional procedures and appropriate documentation.

On 02/20/15 at 4:30 PM, the Associate Administrator of Quality stated that the (Cardiac) Cath Lab schedule and the "on call" staffing was not tracked as a quality indicator. She stated that the "on call" schedule was recognized after SP#1 incident, and will be monitored based on the action plan submitted by the Risk Manager.

Review of the facilty record showed that the incident with SP #1 was not investigated and analyzed by the risk manager at the time of survey.
Review of the "2015 Organizational Performance Improvement Evaluation & Plan", dated january 2015 note that the leaders will assure that there is a planned, systemic and hospital-wide approach to improving the quality of care and services provided to our patients. This approach includes: performance measurement, assessment, and improvement, and setting priorities for performance improvement activies.

Based on record review and interview the facility failed to ensure:1)The Director of Nursing services is responsible for determining the types and numbers of qualified nursing personnel and staff including the " on call " staff are available to provide nursing care in the Cardiac Catheterization Laboratory; and 2) The nursing staff had the appropriate training with the specialized cardiac catheterization qualifications and competence in 3 of 23 sampled patients (#1, #13, and # 14). 3) The Intravenous drugs Angiomax and Nitroglycerin were administered in accordance with the practitioner ' s orders and according to accepted standards of practice in 1 of 10 sampled patients (SP) #1.

Based on record review and interview the facility failed to ensure the director of nursing service is responsible for determining the types and numbers of qualified nursing personnel and staff including the "on call" staff are available to provide nursing care in the Cardiac Catheterization Laboratory in 3 of 23 sampled patients (SP) #1, # 13, and # 14).


The findings:

1. Review of sampled patient (SP)#1 medical record showed that the patient presented to the emergency room on 12/20/14 at 5:15P M for syncope, weakness and dizziness. The electrocardiogram (EKG) results reported the patient had ST segment elevations in the anterior lead which was consistent with an acute anterior wall myocardial infarction (heart attack). The recommendation was to take the patient to the Cardiac Catheterization Laboratory and perform a diagnostic procedure with possible intervention.

Staff A (The Registered Nurse from the post anesthesia care unit (PACU) cardiac catheterization nursing documentation showed that the patient arrived in the CCL (Cardiac Catheterization Laboratory (Cath Lab) on 12/20/14 at 7:01 PM.

According to SP#1 surgical event log on 12/20/14: At 7:11 PM, a bolus of the drug Angiomax (use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI)), was given by Staff A. The log further recorded that at 7:42 PM; the Angiomax I.V. was not connected, and was noted by the M.D. (medical doctor). At 7:44 PM, the Angiomax I.V. was connected by Staff B -the ICU (intensive care unit) nurse. The log then note that at 8:40 PM, Staff B -the ICU nurse then left the case and the CCL nurse arrived. At 9:15 PM, the case ended and the patient was transported to ICU.

The Operative Report on 12/20/14 showed that the sampled patient #1 had a cardiac catheter procedure. The operative report further reported that the patient had a totally occluded LAD (left anterior descending). The report then showed the Angiomax I.V. bolus was ordered and the Angiomax drip was also ordered and " supposedly started". The operative report further documents the guide-wire became stuck at the midlevel of the LAD and there was moderate degree of difficulty advancing the guide-wire and coronary flow was not achieved. The report further state that after inflation was performed the patient ' s became hypotensive with significant bradycardia. The heart rate was normalized with insertion of a pacemaker. However, the patient remained hypotensive. Then aspiration to the guiding catheter was performed, and significant amount of red blood clots were obtained, which was dampening the blood pressure. At that point, it was investigated and realized that the line that was not running Angiomax was not connected to the patient. This was corrected. The surgery continued. However, the patient continued to be hypotensive, in shock and respiratory distress. The patient was intubated.

The consultation notes on 12/26/2014 reported that the patient remained comatose and was developing multisystem organ failure. Consideration of withholding, and withdrawing life support was being made.

Review of the patient's medical record then showed that on 12/26/14 at 6:45 PM, the patient was admitted to a hospice. Expiration notification showed that on 12/26/14, the patient expired after withdrawal of life support.

Review of the Cardiac Catheterization Laboratory staff work schedule showed that on Saturday, December 20, 2014, there were(2) Registered Nurses (RN) on call, including Staff C.

Review of the "Unit Specific Selection Criteria of Job Specifics for Clinical Staff Nurse for Cardiac Catheterization Lab" showed that a minimum of 500 hours of documented experience in a dedicated cardiac interventional laboratory at a hospital with a level II adult cardiovascular services program , a Minimum of 1 (one) year of ICU, CCU, or cardiac cath lab experience meeting the above 500 hours requirement, and experience in coronary angioplasty(open narrowed or blocked blood vessels), coronary stenting (tube placed in a coronary artery to keep the grafted vessel open), IVUS (Intravascular Coronary Ultrasound) , FFR( Fraction Flow Reserve (measures blood pressure through the coronary artery) , pacemakers, device implants, and pericardiocentesis ( a removal of fluid from the pericardial sac) is required. Experience in circulating, monitoring and scrub assist with physician., and preparation of all equipment and supplies necessary to perform cardiac diagnostic and cardiac interventional procedures is required and appropriate documentation for all the above.


On 02/02/15 at 12:33 PM, Staff A, RN, stated that she worked in the Recovery Room/PACU. She stated that she does not work in the Cardiac Catheterization Laboratory. She stated that she was asked to come in for SP#1 ' s emergency catheterization (cath) lab procedure. She stated that there was an " on call " RN who was not able to come in. Staff A stated that she lived close by. However, she did not work in the cath lab and had no cath lab experience. She stated that she gave Neo-Synephrine and atropine and that she had previous experience giving these medications. Staff A stated that the patient was stable when the case was finished and was transported to ICU by the Assistant Director of Perioperative Services, and Staff C. On 02/02/15 at 3:00 PM, Staff A stated that the Angiomax drip was started in the ER and that the ER calculated the dose. She stated that the Angiomax drip was based on the patient ' s weight and that there was no titration. She stated that the Nitroglycerin drip was discontinued by the surgeon.

Review of Staff A personnel file showed that she was the Associate Nurse Manager of Recovery and was hired 07/2001. Staff A previous experience was in PACU and ICU. She did not have experience in circulating, monitoring and scrub assist with a physician. She did not have training in preparation of all equipment and supplies necessary to perform cardiac diagnostic and cardiac interventional procedures with the appropriate documentation.

On 02/02/15 at 12:52PM, Staff B, a Registered Nurse, stated that he worked in the ICU. He stated that the House Supervisor asked him to come to CCL to assist with SP#1 ' s cath. He stated that when he went into the room to assist that there was confusion with the Angiomax IV (intravenous) drip and he went to make sure that the drip was connected, and that the rate was correct. However, the drip was not connected to the patient. He stated that it was disconnected. The medication Angiomax opens up blood vessels that have blot clots. Staff B also stated that upon his arrival to the room, the patient was not getting perfusion. He stated that he had to go up to the maximum dose on the Nitroglycerin drip because it was going at half the dose. He stated that after he had double the dose, the patient started perfusing. Staff B also stated that he left the Cardiac Catheterization Laboratory because the patient was intubated and stable and another nurse had come in to help. He stated that he had been called down to CCL before to help with drug calculation and to give medications. Staff B stated that he had not worked in a Cardiac Catheterization Laboratory before.

Review of Staff B personnel filed showed that he was the Associate Nurse Manager of ICU. He was hired in 11/1984. Staff B had previous experience in the OR. He did not have training in preparation of all equipment and supplies necessary to perform cardiac diagnostic and cardiac interventional procedures with the appropriate documentation.

On 02/02/15 at 11:00 AM, the Assistant Director of Perioperative Services stated that she helped out in Cardiac Catheterization Lab in emergencies. However, she did not assume patient care. On 02/02/15 at 12:35 PM, the Assistant Director of Perioperative Services stated that the "on call" nurse (on 12/20/14) had a problem getting to the facility quickly. She stated that she lived minutes away from the facility and that she asked Staff A to help. Assistant Director of Perioperative Services further stated that no other RNs were available to come in. She stated that Staff A was the primary nurse in the cath lab (on 12/20/14). The Assistant Director of Perioperative Services stated that in an emergency, she is qualified to help cath lab. She stated that Staff A was more qualified to be in the cath lab and that was why Staff A gave medications to SP#1. Assistant Director of Perioperative Services stated that one medication got disconnected from SP#1 and as soon as it was discovered, the medication was reconnected. She stated that the medication that was disconnected was Angiomax which was an anticoagulant. She stated that a bolus of Angiomax was given and the patient was also on continuous Angiomax drip which got dislodged. She stated that Staff B, an ICU nurse discovered the disconnected medication. She stated that Staff C, a CCL nurse came in during the case.

Review of the Assistant Director of Perioperative Services personnel file showed that she was hired in 08/2012. She had 20 years of experience in the Operating Room. She did not have training in preparation of all equipment and supplies necessary to perform cardiac diagnostic and cardiac interventional procedures with the appropriate documentation.


On 02/02/15 at 2:55 PM, Staff C, RN (CCL Nurse), stated that he was not "on call" on 12/20/14. He stated that the schedule was altered to reflect that he was "on call". Staff C stated that he was asked to come in and he came in. He stated that he assisted with the patient ' s balloon pump procedure and transfer to ICU. Staff C stated that there always has to be someone "on call" in the CCL. He stated that during procedures, the RN documents medications given and vital signs in the medical record. He stated that a technician also documents the Cardiac Catheterization Lab procedure on the event log. Staff C stated there was no staffing problem at this time.

On 02/02/15 at 10:30AM, the Nursing Interim Director of Cardiac Catheterization Lab stated that there are two RNs and four technicians in CCL at all times. He stated that all RNs are qualified to assist with all procedures. He stated that after CCL procedures, patients go to PACU or ICU.


2. Review of SP#13's medical record showed that on 10/19/14, the patient had left heart catheterization with coronary angiogram and percutaneous intervention to the right coronary artery. Review of the patient's event log showed that there was only one cath lab RN present during the procedure.

Review of the time cards showed that there was only one Cardiac cath lab RN (Staff E) on call on 10/19/14.

3. Review of SP#14's medical record showed that on 10/19/14, the patient had left heart catheterization with coronary angiogram and percutaneous intervention. Review of the patient ' s event log showed that there was only one cath lab RN present during the procedure.

Review of the time cards showed that there was only one Cardiac cath lab RN (Staff E) on call on 10/19/14.

On 02/20/15 at 4:30PM, the Associate Administrator of Quality stated that the cath lab schedule and the "on call " was not tracked as a quality indicator. She stated that the " on call " schedule was recognized after SP#1 incident and will be monitored based on the action plan submitted by the Risk Manager.

Review of the facilty record showed that the incident with SP #1 was not investigated and analyzed by the risk manager at the time of survey.

Based on interview and record review, the facility failed to ensure that the "on call" nursing staff was available in the cardiac catheterization lab to meet the needs in 3 of 10 sampled patients (SP) #1, # 13, and #14), and that the nursing staff had the required training in catheterization laboratory procedures .




The findings:

1. Review of sampled patient (SP)#1 medical record showed that the patient presented to the emergency room on 12/20/14 at 5:15P M for syncope, weakness and dizziness. The electrocardiogram (EKG) results reported the patient had ST segment elevations in the anterior lead which was consistent with an acute anterior wall myocardial infarction (heart attack). The recommendation was to take the patient to the Cardiac Catheterization Laboratory and perform a diagnostic procedure with possible intervention.

Staff A (The Registered Nurse from the post anesthesia care unit (PACU) cardiac catheterization nursing documentation showed that the patient arrived in the CCL (Cardiac Catheterization Laboratory (Cath Lab) on 12/20/14 at 7:01 PM.

According to SP#1 surgical event log on 12/20/14: At 7:11 PM, a bolus of the drug Angiomax (use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI)), was given by Staff A. The log further recorded that at 7:42 PM; the Angiomax I.V. was not connected, and was noted by the M.D. (medical doctor). At 7:44 PM, the Angiomax I.V. was connected by Staff B -the ICU (intensive care unit) nurse. The log then note that at 8:40 PM, Staff B -the ICU nurse then left the case and the CCL nurse arrived. At 9:15 PM, the case ended and the patient was transported to ICU.

The Operative Report on 12/20/14 showed that the sampled patient #1 had a cardiac catheter procedure. The operative report further reported that the patient had a totally occluded LAD (left anterior descending). The report then showed the Angiomax I.V. bolus was ordered and the Angiomax drip was also ordered and " supposedly started". The operative report further documents the guide-wire became stuck at the midlevel of the LAD and there was moderate degree of difficulty advancing the guide-wire and coronary flow was not achieved. The report further state that after inflation was performed the patient ' s became hypotensive with significant bradycardia. The heart rate was normalized with insertion of a pacemaker. However, the patient remained hypotensive. Then aspiration to the guiding catheter was performed, and significant amount of red blood clots were obtained, which was dampening the blood pressure. At that point, it was investigated and realized that the line that was not running Angiomax was not connected to the patient. This was corrected. The surgery continued. However, the patient continued to be hypotensive, in shock and respiratory distress. The patient was intubated.

The consultation notes on 12/26/2014 reported that the patient remained comatose and was developing multisystem organ failure. Consideration of withholding, and withdrawing life support was being made.

Review of the patient's medical record then showed that on 12/26/14 at 6:45 PM, the patient was admitted to a hospice. Expiration notification showed that on 12/26/14, the patient expired after withdrawal of life support.

Review of the Cardiac Catheterization Laboratory staff work schedule showed that on Saturday, December 20, 2014, there were(2) Registered Nurses (RN) on call, including Staff C.

Review of the "Unit Specific Selection Criteria of Job Specifics for Clinical Staff Nurse for Cardiac Catheterization Lab" showed that a minimum of 500 hours of documented experience in a dedicated cardiac interventional laboratory at a hospital with a level II adult cardiovascular services program , a Minimum of 1 (one) year of ICU, CCU, or cardiac cath lab experience meeting the above 500 hours requirement, and experience in coronary angioplasty(open narrowed or blocked blood vessels), coronary stenting (tube placed in a coronary artery to keep the grafted vessel open), IVUS (Intravascular Coronary Ultrasound) , FFR( Fraction Flow Reserve (measures blood pressure through the coronary artery) , pacemakers, device implants, and pericardiocentesis ( a removal of fluid from the pericardial sac) is required. Experience in circulating, monitoring and scrub assist with physician., and preparation of all equipment and supplies necessary to perform cardiac diagnostic and cardiac interventional procedures is required and appropriate documentation for all the above.


On 02/02/15 at 12:33 PM, Staff A, RN, stated that she worked in the Recovery Room/PACU. She stated that she does not work in the Cardiac Catheterization Laboratory. She stated that she was asked to come in for SP#1's emergency catheterization (cath) lab procedure. She stated that there was an on -call RN who was not able to come in. Staff A stated that she lived close by. However, she did not work in the cath lab and had no cath lab experience. She stated that she gave Neo-Synephrine and atropine and that she had previous experience giving these medications. Staff A stated that the patient was stable when the case was finished and was transported to ICU by the Assistant Director of Perioperative Services, and Staff C. On 02/02/15 at 3:00 PM, Staff A stated that the Angiomax drip was started in the ER and that the ER calculated the dose. She stated that the Angiomax drip was based on the patient ' s weight and that there was no titration. She stated that the Nitroglycerin drip was discontinued by the surgeon.

Review of Staff A personnel file showed that she was the Associate Nurse Manager of Recovery and was hired 07/2001. Staff A previous experience was in PACU and ICU. She did not have experience in circulating, monitoring and scrub assist with a physician. She did not have training in preparation of all equipment and supplies necessary to perform cardiac diagnostic and cardiac interventional procedures with the appropriate documentation.

On 02/02/15 at 12:52PM, Staff B, a Registered Nurse, stated that he worked in the ICU. He stated that the House Supervisor asked him to come to CCL to assist with SP#1's cath. He stated that when he went into the room to assist that there was confusion with the Angiomax IV (intravenous) drip and he went to make sure that the drip was connected, and that the rate was correct. However, the drip was not connected to the patient. He stated that it was disconnected. The medication Angiomax opens up blood vessels that have blot clots. Staff B also stated that upon his arrival to the room, the patient was not getting perfusion. He stated that he had to go up to the maximum dose on the Nitroglycerin drip because it was going at half the dose. He stated that after he had double the dose, the patient started perfusing. Staff B also stated that he left the Cardiac Catheterization Laboratory because the patient was intubated and stable and another nurse had come in to help. He stated that he had been called down to CCL before to help with drug calculation and to give medications. Staff B stated that he had not worked in a Cardiac Catheterization Laboratory before.

Review of Staff B personnel filed showed that he was the Associate Nurse Manager of ICU. He was hired in 11/1984. Staff B had previous experience in the OR. He did not have training in preparation of all equipment and supplies necessary to perform cardiac diagnostic and cardiac interventional procedures with the appropriate documentation.

On 02/02/15 at 11:00 AM, the Assistant Director of Perioperative Services stated that she helped out in Cardiac Catheterization Lab in emergencies. However, she did not assume patient care. On 02/02/15 at 12:35 PM, the Assistant Director of Perioperative Services stated that the "on call" nurse (on 12/20/14) had a problem getting to the facility quickly. She stated that she lived minutes away from the facility and that she asked Staff A to help. Assistant Director of Perioperative Services further stated that no other RNs were available to come in. She stated that Staff A was the primary nurse in the cath lab (on 12/20/14). The Assistant Director of Perioperative Services stated that in an emergency, she is qualified to help cath lab. She stated that Staff A was more qualified to be in the cath lab and that was why Staff A gave medications to SP#1. Assistant Director of Perioperative Services stated that one medication got disconnected from SP#1 and as soon as it was discovered, the medication was reconnected. She stated that the medication that was disconnected was Angiomax which was an anticoagulant. She stated that a bolus of Angiomax was given and the patient was also on continuous Angiomax drip which got dislodged. She stated that Staff B, an ICU nurse discovered the disconnected medication. She stated that Staff C, a CCL nurse came in during the case.

Review of the Assistant Director of Perioperative Services personnel file showed that she was hired in 08/2012. She had 20 years of experience in the Operating Room. She did not have training in preparation of all equipment and supplies necessary to perform cardiac diagnostic and cardiac interventional procedures with the appropriate documentation.


On 02/02/15 at 2:55 PM, Staff C, RN (CCL Nurse), stated that he was not on-call on 12/20/14. He stated that the schedule was altered to reflect that he was on- call. Staff C stated that he was asked to come in and he came in. He stated that he assisted with the patient's balloon pump procedure and transfer to ICU. Staff C stated that there always has to be someone "on call" in the CCL. He stated that during procedures, the RN documents medications given and vital signs in the medical record. He stated that a technician also documents the Cardiac Catheterization Lab procedure on the event log. Staff C stated there was no staffing problem at this time.

On 02/02/15 at 10:30 AM, the Nursing Interim Director of Cardiac Catheterization Lab stated that there are two RNs and four technicians in CCL at all times. He stated that all RNs are qualified to assist with all procedures. He stated that after CCL procedures, patients go to PACU or ICU.


2. Review of SP#13's medical record showed that on 10/19/14, the patient had left heart catheterization with coronary angiogram and percutaneous intervention to the right coronary artery. Review of the patient's event log showed that there was only one cath lab RN present during the procedure.

Review of the time cards showed that there was only one Cardiac cath lab RN (Staff E) on call on 10/19/14.

3. Review of SP#14's medical record showed that on 10/19/14, the patient had left heart catheterization with coronary angiogram and percutaneous intervention. Review of the patient ' s event log showed that there was only one cath lab RN present during the procedure.

Review of the time cards showed that there was only one Cardiac cath lab RN (Staff E) on call on 10/19/14.

On 02/20/15 at 4:30PM, the Associate Administrator of Quality stated that the cath lab schedule and the on-call was not tracked as a quality indicator. She stated that the on-call schedule was recognized after SP#1 incident and will be monitored based on the action plan submitted by the Risk Manager.

Review of the facility record showed that the incident with SP #1 was not investigated and analyzed by the risk manager at the time of survey.
Review of the "Cardiac Alert/ STEMI Response" policy, dated 02/13 state that there is a Cardiac Cath team that will respond to STEMI emergencies Monday-Friday, 7am to 3:30 pm The Cardiac Alert team ( Cardiac Cath on-call) will respond from 3:30pm to 7 am Monday through Friday and 24 hours on weekends and holidays within 30 minutes of STEMI activation.

Based on interview and record review the facility failed to administer the Intravenous drugs Angiomax and Nitroglycerin in accordance with the orders of the practitioner and according to accepted standards of practice in 1 of 10 sampled patients (SP) #1.

The findings:

Review of the facility's policy titled, " Medication Administration, " dated 05/14, showed that the individual who is administering a medication should check the patency of IV (intravenous) tubing before giving the medication.


Review of sampled patient (SP)#1 medical record showed that the patient presented to the emergency room on 12/20/14 at 5:15P M for syncope, weakness and dizziness. The electrocardiogram (EKG) results reported the patient had ST segment elevations in the anterior lead which was consistent with an acute anterior wall myocardial infarction (heart attack). The recommendation was to take the patient to the Cardiac Catheterization Laboratory and perform a diagnostic procedure with possible intervention.

Staff A (The Registered Nurse from the post anesthesia care unit (PACU) cardiac catheterization nursing documentation showed that the patient arrived in the CCL (Cardiac Catheterization Laboratory (Cath Lab) on 12/20/14 at 7:01 PM.

According to SP#1 surgical event log on 12/20/14: At 7:11 PM, a bolus of the drug Angiomax (use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI)), was given by Staff A. The log further recorded that at 7:42 PM; the Angiomax I.V. was not connected, and was noted by the M.D. (medical doctor). At 7:44 PM, the Angiomax I.V. was connected by Staff B -the ICU (intensive care unit) nurse. The log then note that at 8:40 PM, Staff B -the ICU nurse then left the case and the CCL nurse arrived. At 9:15 PM, the case ended and the patient was transported to ICU.

The Operative Report on 12/20/14 showed that the sampled patient #1 had a cardiac catheter procedure. The report then showed the Angiomax I.V. bolus was ordered and the Angiomax drip was also ordered and " supposedly started". The operative report further documents the guide-wire became stuck at the midlevel of the LAD and there was moderate degree of difficulty advancing the guide-wire and coronary flow was not achieved. The report further state that after inflation was performed the patient ' s became hypotensive with significant bradycardia. The heart rate was normalized with insertion of a pacemaker. However, the patient remained hypotensive. Then aspiration to the guiding catheter was performed, and significant amount of red blood clots were obtained, which was dampening the blood pressure. At that point, it was investigated and realized that the line that was not running Angiomax was not connected to the patient. This was corrected. The surgery continued. However, the patient continued to be hypotensive, in shock and respiratory distress. The patient was intubated.


On 02/02/15 at 3:00 PM, Staff A stated that the Angiomax drip was started in the ER and that the ER calculated the dose. She stated that the Angiomax drip was based on the patient ' s weight and that there was no titration.


On 02/02/15 at 12:52PM, Staff B, a Registered Nurse, stated that he worked in the ICU. He stated that the House Supervisor asked him to come to CCL to assist with SP#1 ' s cath. He stated that when he went into the room to assist that there was confusion with the Angiomax IV (intravenous) drip and he went to make sure that the drip was connected, and that the rate was correct. However, the drip was not connected to the patient. He stated that it was disconnected. The medication Angiomax opens up blood vessels that have blot clots. Staff B also stated that upon his arrival to the room, the patient was not getting perfusion. He stated that he had to go up to the maximum dose on the Nitroglycerin drip because it was going at half the dose. He stated that after he had double the dose, the patient started perfusing. Staff B also stated that he left the Cardiac Catheterization Laboratory because the patient was intubated and stable and another nurse had come in to help. He stated that he had been called down to CCL before to help with drug calculation and to give medications. Staff B stated that he had not worked in a Cardiac Catheterization Laboratory before.

On 02/02/15 at 11:00 AM, the Assistant Director of Perioperative Services stated that one medication got disconnected from SP#1 and as soon as it was discovered, the medication was reconnected. She stated that the medication that was disconnected was Angiomax which was an anticoagulant. She stated that a bolus of Angiomax was given and the patient was also on continuous Angiomax drip which got dislodged. She stated that Staff B, an ICU nurse discovered the disconnected medication. She stated that Staff C, a CCL nurse came in during the case.

On 02/20/15 at 1:56PM, the Surgeon stated that the Angiomax was not running for about 10 to 15 minutes.