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METHODIST FREMONT HEALTH 450 EAST 23RD ST FREMONT, NE 68025 March 17, 2011
VIOLATION: PATIENT RIGHTS Tag No: A0115
Based on interviews of administrative staff, nursing staff; the review of 5 medical records for 4 sampled patients (Patients 4, 5A, 5B, 12 and13) that had received interventional cardiac catheterizations, the review of facility policies/procedures that confirmed the facility did not have a policy for transport of patients from the cardiac catheterization [cath] lab to the inpatient room; the observation of the cardiac cath lab revealing there was no portable monitor present resulting in the determination that the facility failed to ensure patients had cardiac monitoring from the time they were disconnected from the monitor on the procedure table until they reached the inpatient room and were reconnected to the floor monitoring equipment putting the patients at risk of delay in awareness and treatment of potentially fatal cardiac arrthymias.

Centers for Medicare & Medicaid Services (CMS) Regional Office was contacted on 3/17/2011 at 3:00 PM with the determination that the seriousness of this failure and the risk to cardiac patients post catheterization resulted in a finding of Immediate Jeopardy and placed the facility out of compliance with the Condition of Participation of Patient Rights for failure to provide care in a safe setting (as written at A-0144).

The Administrator was informed of the Immediate Jeopardy determination at 3:20 PM on 3/17/2011.

The facility provided evidence of a portable cardiac monitor to be utilized in the cardiac cath lab on 3/17/2011 at 3:50 PM. The facility also provided a written policy that ensures all patients being transferred from the cath lab to other inpatient areas will have cardiac monitoring services provided. The facility produced evidence and documentation of education regarding these changes to cath lab staff. The facility administration assured quality improvement monitoring will be implemented to ensure continued compliance. This resulted in the abatement of the Immediate Jeopardy as of 4:00 PM on 3/17/2011. The facility census was 47. Refer to specific findings at A-0144.
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on staff interviews, patient care observations, the review of patient medical records, facility provided record reviews and facility policies, the facility failed to ensure 4 of 4 post cardiac catheterization patients (Patients 4, 5A and B, 12, and 13) being transferred to the inpatient floors following interventional cardiac catheterization were under continual cardiac monitoring. Failure to provide continual cardiac monitoring places patients at risk of serious harm, as serious cardiac complications could go undetected and without immediate treatment to prevent or treat potentially deadly disturbances in cardiac rhythm. The findings were of such a serious nature that a determination was made that the cardiac catheterization patients had been put in Immediate Jeopardy. Facility provided records showed that the facility had performed 75 interventional cardiac catheterizations in fiscal year 2010 and 52 so far in fiscal year 2011. Facility census was 47. Total patient sample reviewed was 14. Findings are:

A. Review of the medical record for Patient 4 found an admission date of [DATE]. Review of the History and Physical dated 2/9/11 noted diagnoses of [DIAGNOSES REDACTED][DIAGNOSES REDACTED] (condition where there is an elevation of lipids, or fats, in the blood) and microcytic anemia (the presence of smaller than normal red blood cells in the blood). The report noted that the patient had been admitted with chest pain. The record also documented that the patient had a cardiac catheterization [cath] procedure following the myocardial infarction (heart attack) in 2008. At that time the patient had been given a beta blocker ( a class of drugs used for various indications, but particularly for the management of cardiac arrhythmias (a problem with the rate or rhythm of the heartbeat))that resulted in severe bradycardia (slow heartbeat) and asystole (absence of heartbeat) requiring resuscitation. The patient had beta blockers listed as an allergy in multiple areas of the record.
The medical record contained documentation of a cardiac cath that was completed on 2/11/11. The Cardiac Cath Report noted the preoperative diagnosis was unstable angina (chest pain) and noted the same for the post operative diagnosis. The documentation of the cardiac catheterization revealed Patient 4 had required cardiac interventions including provision of a beta blocker medication to decrease the heart rate to allow balloon angioplasty (procedure for elimination of areas of narrowing in the blood vessels) of the right coronary artery and placement of a stent. After completion of the angioplasty of the right coronary artery, angioplasty of the obtuse marginal branch artery was performed. The patient had stable vital signs during and after the completion of the procedure. The lowest heart rate was 67. The cardiologist and cath lab staff were aware of patient's history of response to beta blockers. The report noted giving very small amounts very slowly and watching for any signs of bradycardia.

According to the procedure log, this procedure was completed at 12:22 PM. At 12:36 PM the patient was removed from the cath lab monitor and transferred to a cart in preparation for taking the patient to a room on the 4th floor telemetry unit. Patient 4's last set of vital signs in the cath lab room included a blood pressure of 117/79 and pulse of 88. The patient's level of consciousness throughout the procedure had been noted as fully awake other than one time in which the patient was noted to be arousable on calling.

Review of the Physician's Orders for post cath care revealed direction that the patient was to have telemetry (continuous heart monitoring).

The next documentation reviewed was of the patient arriving at the inpatient room on 4th floor at 1:00 PM. Upon arrival to the inpatient room on the 4th floor, the vital signs were noted to include a blood pressure of 100/72, and a pulse of 72. Continued review of the vital signs record revealed that at 1:15 PM the blood pressure was 71/42 and the pulse was 45. During this time the patient did not have any cardiac monitoring. The telemetry was hooked up to Patient 4 and the first telemetry strip was printed at 1:33 PM (note this is 57 minutes after being disconnected from the monitor in the cath lab), showing bradycardia with a pulse of 38. The patient required transfer to the intensive care unit as a result of the bradycardia (slow heart rate) and the low blood pressure. The immediate interventions that were then initiated including administration of Atropine by intravenous [IV] route (a drug that increases the heart rate), followed by a Dopamine IV drip (a medication that increases blood pressure and kidney profusion) that did resolve the bradycardia and the low blood pressure for this patient.

An interview was completed on 3/15/11 at 3:45 PM with a Registered Nurse (RN)-C that worked in the Intensive Care Unit (ICU) when Patient 4 returned to ICU from the Telemetry Unit on the 4th floor. RN-C was not sure of the time that Patient 4 was brought to the unit, she had returned from lunch to find them "flying" back to the unit with the patient. RN-C stated the patient was ashen, diaphoretic, very lethargic, but able to answer questions. She stated the patient's heart rate was in the low 40s. They opened up the IV and gave a bolus of fluid and hooked him up to their equipment (cardiac monitor, oxygen, etc,). The cardiology Physician's Assistant (PA) was on the floor and gave immediate directions. The cardiologist that performed the heart cath was called and came to the unit. Medications and fluids were ordered and given with resolution of the complications that the cardiologist thought to be from the sedation and the medication given during the heart cath. The cardiologist told RN-C that it would just take time for the medications to wear off. RN-C did not know if the patient had been on a heart monitor before arriving back in the ICU. RN-C said the patient had been in ICU prior to the cath and had been monitored on the unit and had a heart monitor during transfer to the cath lab. She referenced their policy that cardiac patients are always to be on a heart monitor while on the unit and when taken to and from any tests or procedures off of the unit.

An interview with Patient 4's Cardiologist was completed on 3/16/11 at 10:15 AM. The Cardiologist said the patient required the cardiac cath procedure because of ongoing chest pain that had not responded to medication. He said it was necessary to intervene in the ongoing coronary ischemia (medical term for not having enough blood through the coronary arteries) the patient was having. During the cath he was not able to adequately visualize the blood vessels due to the tight stenosis (a condition where a blood vessel has become abnormally narrowed) and inability to get the contrast material (dye) through the arteries. The patient was given small doses of a beta blocker that slowed the heart rate sufficiently to allow the contrast material to be in the vessels long enough to complete the angioplasty and put a stent in place. The patient tolerated the procedure well and had stable vital signs. The Cardiologist said the bradycardia and low blood pressure that evolved later may have been a vagal response or may have been due to the beta blocker given. He said there is no way to know what really caused it. The patient has done well since the procedure with relief of the ischemia that had been causing the symptoms. The Cardiologist stated there wasn't any other type of drug that he could have given to the patient besides a beta blocker to produce the effect he needed to allow him to perform the interventions needed.

On 3/16/11 at 11:20 AM, an interview was completed with RN-D that had received the patient from the cath lab on the telemetry unit on the 4th floor. RN-D stated that on 2/11/11 she had been working on the "tele" unit. She was called into the room when Patient 4 arrived from the cath lab. She went to the room and obtained a report from the cath lab RN. They assessed the patient together and a set of vital signs were obtained. The patient did not have a heart monitor on. The patient was lethargic but gave appropriate responses to questions. The groin wound was assessed as well as the pedal pulses. The cath lab nurse was very thorough in describing the procedure, medications the patient had been given, and the patient's tolerance of the procedure. A nurse aide stayed with the patient when RN-D left to go to the nurse's station. RN-D said when she was in the nurse's station she realized the patient was not hooked up to a cardiac monitor. RN-D went to obtain the telemetry pack to hook the patient up. She said she was going to the patient's room when the patient's significant other came from the room concerned about the patient's status. RN-D said Patient 4 was responsive but they had difficulty getting a blood pressure. RN-D hooked the patient up to telemetry and went to the nurse's station to obtain a strip. The cardiology PA was nearby and was called over. Patient's pulse was low, in the 30s. They all went into the patient's room, the PA determined the patient had a significant change in condition, and they proceeded to transfer him to ICU.

An interview by telephone was completed on 3/17/11 at 11:10 AM with RN-B that had transferred Patient 4 from the cath lab to the 4th floor Telemetry bed. RN-B said that following a cardiac cath, the patient remains on the table with monitoring of heart rate, oxygen saturation, and blood pressure until they make sure the patient is at baseline. They finish the paperwork and then the patient is removed from the monitor, and assisted to transfer to a cart to be transported to the floor. While the patient is there in the cath lab someone is standing by them checking the groin wound site, and the patient's alertness. The circulating nurse is the one who transports the patient, puts the patient on the monitor, connects them to telemetry and makes sure the patient is still stable. RN-B stated she has worked in the cath lab since June of 2010 and has never taken a patient from the cath lab with a cardiac monitor on.

This patient had an interventional cardiac catheterization with increased risk of complications from the administration of a beta blocker, and did not have cardiac monitoring from the time the patient was transferred from the cardiac cath procedure table to a cart at 12:36 PM until connected to telemetry, when at 1:33 PM a strip was run. The patient did have complications from the procedure, and a delay in needed treatment as a result of the lack of cardiac monitoring. This had the potential to result in permanent and severe harm to the patient.

B. Review of the medical record of Patient 13 revealed an admission date of [DATE]. Patient 13 had listed diagnoses of [DIAGNOSES REDACTED]. The report indicated this patient had previously had a cardiac cath on 2/7/11 (just 15days earlier) following a myocardial infarction addressing stenosis of the right coronary artery. For this cath the cardiac cath log documented the patient was removed from the monitor and placed on a cart in preparation for admission and transport to the 4th floor telemetry unit. The last documented blood pressure was 157/95 and the pulse was 118 at 12:27 PM. Review of the Rhythm Strip Record showed the first strip run after arriving on the telemetry unit had a noted time of 12:57 PM (30 minutes following the end of monitoring in the cath lab). The strip showed the patient had a heart rate of 47, bradycardia, that was significantly different from the pulse of 118 noted on the cardiac cath log. There was a noted change in pulse rate to bradycardia during the period of time the patient did not have cardiac monitoring.

A tour of the cardiac cath lab was completed on 3/17/11 at 11:30 AM. Observation showed the procedure table and equipment was set up and prepared so that it was ready when needed. The department manager was present as well as a tech. The department did not have a portable monitor that could be utilized during transport to the floor. The only thing they could use according to the manager would be the defibrillator monitor from the crash cart. It was heavy and awkward to use. She said it could be used if a patient was not stable, but normally the patients were transported without cardiac monitoring when leaving the cath lab. It was also reported that they did not have a policy for transporting patients from the cardiac cath lab to inpatient beds.





C. Medical record review of Patient 5 revealed the patient had 2 interventional heart catheterizations on 2 different dates. Record 5 A documents the patient was admitted on [DATE] for a recent myocardial infarction and coronary artery disease. Record review of document titled Cardiac Catheterization Report dated 3/15/11 notes Patient 5 had an interventional cardiac catheterization procedure performed with placement of a drug eluting stent (a drug-eluting stent is coated with a medicine that helps further prevent the arteries from re-closing) at 9:25 AM. At 9:55 AM Registered Nurse (RN)-A documented "Pt [Patient] transported to 410 (telemetry floor) via bed. VSS [vital signs stable]. Report given to RN." Review of document titled Rhythm Strip Record has the first cardiac monitoring rhythm strip on telemetry dated 3/15/11 at 10:00 AM. The rhythm is noted to be sinus bradycardia with first degree atrioventricular block (a disease of the electrical conduction system of the heart) with a rate of 49 beats per minute. Sinus bradycardia is an abnormal slow heart rhythm (below 60 beats per minute). The patient had the same rhythm during the procedure. The record lacks evidence the patient had continual cardiac monitoring when transferred from the catheterization lab to the telemetry floor. Review of physician orders for admission written on 3/15/11 at 9:46 AM noted the physician ordered the patient to have "telemetry" (continual cardiac monitoring).

Staff interview with heart catheterization lab Manager on 3/16/11 at 3:25 PM revealed the patient was not transported with cardiac monitoring to the telemetry floor and confirmed the patient had first degree heart block both before and after the procedure. First degree heart block is also known as first degree atrioventricular block.

D. Medical record review of Patient 5's prior heart catheterization performed on 2/22/11 is identified as Record #5 B. The patient was admitted on [DATE] for diagnosis of [DIAGNOSES REDACTED]"Unstable angina and Non STEMI ". Non STEMI is a myocardial infarction in which a clot only partially occludes the coronary artery and as a result only a portion of the heart muscle supplied by that artery is damaged. The interventional procedure included balloon angioplasty and placement of a stent. RN-B documentation at 8:44 PM states "Patient removed from monitor, transferred to cart in preparation for return to Room ICU [Intensive Care Unit]." Post heart catheterization physician orders written at 8:38 PM on 2/22/11 note the patient is to be on telemetry. Review of Rhythm Strip Record has the first rhythm strip documented on return to ICU dated 2/22/11 at 9:50 PM noting the patient was in normal sinus rhythm with a heart rate of 72. The patient was discharged on [DATE].

During a telephone Interview with RN-B on 3/17/11 at 11:08 AM the nurse stated "I have never transported a patient on a monitor to ICU or telemetry since I came 6/28/10." RN-B works full time in the heart catheterization lab.

Interview with the Director of Nursing (DON) on 3/17/11 at 11:20 AM stated "transporting a patient to ICU without a monitor is not what I expect. An ICU patient is to be monitored unless we have a physician order that there is no need to monitor."

E. Medical record review for Patient 12 revealed the patient went directly from the Emergency Department to the heart catheterization lab on 3/15/11. Review of the Cardiac Catheterization Report dated 3/15/11 notes the patient was having the procedure for an STEMI (myocardial infarction with occlusion of coronary artery blood flow causing heart muscle to die). The patient arrived in the lab at 5:08 PM. Balloon angioplasty was performed with placement of 2 stents. One drug eluting stent was placed in the 1st Diagonal Coronary Artery and the second placed in the Mid Left Anterior Descending Artery. RN-B documented at 7:30 PM "Pt [patient] transported to 411 [telemetry floor] via bed. Report given to RN." Review of Rhythm Strip Record on telemetry shows the first strip recorded is dated 3/15/11 at 7:43 PM (13 minutes after arrival to the floor). The telemetry nurse initialed the strip documenting the patient was in normal sinus rhythm with a heart rate of 88. RN-B did not initial the strip as per hospital policy. Review of physician orders post procedure 3/15/11 at 7:10 PM noted the patient was to be admitted to an inpatient bed on telemetry.

Interview with RN-B on 3/17/11 at 1:45 PM confirmed Patient 12 with a recent myocardial infarction and interventional heart catheterization was not transported to the floor on a cardiac monitor. RN-B further stated that the 7:30 PM time was the time of arrival to telemetry floor and they had left the lab about 5 -15 minutes prior to that. RN-B could recall only 1 time taking a patient to ICU on a monitor stating it had not been "a common practice."

The facility failed to provide a safe environment of care which included continual cardiac monitoring post interventional cardiology. This patient potentially was unmonitored for up to 28 minutes during which time a cardiac arrhythmia could have gone undetected and untreated placing the patient at risk of serious harm or death.

F. On 3/17/11 the facility implemented sufficient measures to ensure all cardiac catheterization patients requiring transfer to inpatient areas would be provided continual cardiac monitoring. A portable cardiac monitor was assigned for use in the cardiac catheterization lab. All staff transporting patients from the catheterization lab were oriented on a new policy requiring cardiac monitoring during transport post interventional catheterization This was verified by observation, review of policy and interviews with staff. This abated the finding of Immediate Jeopardy on 3/17/11.