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1700 MEDICAL WAY

SNELLVILLE, GA 30078

GOVERNING BODY

Tag No.: A0043

Based on record review, and staff interview, the Governing Body failed to effectively oversee the Medical Staff, Pharmacy, Administration of Drugs and Nursing Staff for one (1) patient #2 of the ten (10) sampled, who received Succinylcholine (a muscle relaxant medication that is used in surgery or emergency situations for insertion of an endotracheal tube (tube to help them breath), which was an erroneous order and the patient became apneic for almost two (2) minutes and a CODE Blue (rapid response of healthcare professionals and treatment to prevent death) to be performed..

Cross refer for specific details to:

482.21 Qapi;
482.22 Medical Staff;
482.23 Nursing Services and;
482.25 Pharmaceutical Services.

MEDICAL STAFF - ACCOUNTABILITY

Tag No.: A0049

Based on medical record review, and staff interview, the Medical Staff failed to have effective policies and procedures that minimize drug errors for one (1) patient #2, of the ten (10) sampled, who received Succinylcholine (a muscle relaxant medication that is used in surgery or emergency situations for insertion of an endotracheal tube (tube to help them breath), which was an erroneous order and the patient became apneic for almost two (2) minutes and a Code Blue (rapid response of healthcare professionals and treatment to prevent death) to be performed.

Findings include:

On April 12, 2014:

at 11;35 p.m.;
Record review for patient #2, revealed the patient presented to the Emergency Department (ED) as a walk-in patient, the Registered Nurse (RN) triaged (assessment by a nurse to determine the patient's medical needs and the priority in which the patient will be seen) with complaints of chest tightness with nausea, shortness of breath, and dizziness.

at 12:00 a.m.;
The Emergency Department (ED) physician (#4) completed an medical history as follows:
? Cardiac categorization (insertion of a thin flexible tube through an extremity artery and threaded into the vessels of the heart to determine whether there is any blockage);-sick sinus syndrome (group of heart rhythm problems in which the heart ' s sinus node or natural pacemaker does not function properly);
? Atrial fibrillation (abnormal heart rhythm);
? Insertion of a pacemaker;
? High blood pressure;
? Gall bladder surgery;
? Hysterectomy; and
? That the patient was a smoker.

Continued review of the ED physician notes revealed patient #2 reported having chest tightness for eight (8) hours, palpitations, nausea, dizziness and that the last time the patient felt like this her potassium was low. The ED #4 physical examination the patient was short of breath but had no cough or wheezing and that the patient had bilateral irregular pulses.

Review of the labortory assessment completed in the ED revealed patient #2, potassium level to be 3.0 (normal reference range of 3.5-5.1). The ED physican treatment plan included continuous cardiac monitoring, insertion of an intravenous line (IV-vein access for the administration of fluids, medications, and/or blood products), and oxygen administered at three (3) liters by nasal cannula.

In the ED, patient #2, completed an electrocardiogram assessing the cardiac rhythm as atrial fibrillation. Review of ED #4, physician orders revealed to administer IV fluids, Aspirin by mouth, Diltiazem HCL (used to treat high blood pressure) by mouth, Cardizem (used to treat abnormal heart rhythm), and a potassium supplement by mouth.

at 12:05 a.m.:
Review of the ED Nursing Notes revealed that patient #2 reported the symptoms had subsided. The ED physician #4, encouraged the patient to be admitted and examined by cardiology (specialist who deals with heart disorders) and the patient agreed to be admitted.

at 3:10 a.m.;
Review of the nursing notes revealed that patient #2 was transferred to a unit in the hospital from the ED. The ED nurse and the unit RN assessed the vital signs. The unit RN completed the initial nursing assessment at 3:38 a.m. The RN also initiated the patient ' s plan of care at this time.

at 3:37 a.m.:
Review of ED physician #4, admission orders revealed the following:
? Etomidate (a sedative) ten (10) milligram (mg) to be administered intravenously as directed; and
? Succinylcholine (paralyzing agent) one-hundred and sixty (160) mg IV push to be administered once.

at 3:52 a.m.:
Review of the Medication Administration Record (MAR) revealed Succinylcholine 160 mg IV push was signed as being administered by the Licensed Practical Nurse (LPN #3). Per review of the MAR the side effects had been discussed with patient #2. The side effects included muscle weakness, dry mouth, and difficulty speaking.

There was no evidence that the Etomidate was administered.

at 3:56 a.m.:
the Hospitalist/physician dictated patient #2 History and Physical Examination

at 4:17 a.m.:
" CODE Blue Sheet " was completed, (there was no evidence of any other nurse's notes prior to the Code Blue) revealed the following:

The CODE team arrived, the recorder of the report was staff member #9;
The event was witnessed and patient #2 was unconscious at the onset of the code;
A hospital wide code announced;
Patient #2 was apneic (temporary suspension of breathing) and oxygen four (4) liters applied by nasal cannula;
Chest compressions;
Sinus rhythm / paced recorded by monitor;
Prior to the CODE, patient #2 received Succinylcholine 160 mg IV push;

at 4:19 a.m.:
Patient #2, is now alert and oriented, breathing easy with pink color. Nursing notes revealed the patient remained stable, that the patient notified his/her family himself/herself, and that the patient was transferred to the Progressive Care Unit for monitoring.

at 5:32 a.m.:
The Hospitalist/physician completed the " Post CODE Blue " including the following:
--Patient #2, received Succinylcholine which was an erroneous order, the patient had become apneic and unconscious.
--Patient #2 had not required intubation and had not required chest compressions and had maintained a pulse and blood pressure but had experienced apnea and respiratory depression for almost 2 minutes.
Patient #2 was breathing but was moved to the Progressive Care unit for closer monitoring.

Review of facility policy titled Ordering and Transcribing Medications, review date 2/13, revealed that the facility's policy is to develop, implement, and maintain policies and procedures to support ordering of drugs and the transcription of drug orders which ensure the safe and appropriate use of these medications; that only medications needed to treat the patient's condition were ordered; that it is the ordering physician's responsibility to ensure that there is a documented diagnosis, condition, or indication for use of each medication ordered; and, that this may be documented in the history and physical, in consultation reports, or progress notes, unless specifically required with the type of medication ordered.

Review of patient #2 record revealed no supporting diagnosis nor condition for the use of Succinylcholine.

Interview on 4/17/2014 at 3:45 p.m. via telephone revealed the patient complained of being in pain related to recieving CPR during the CODE. The patient stated that when the nurse came to administer the medication, the patient told the nurse I am not suppose to get that, I am here for low potassium in a pill. The patient stated that the nurse would not listen and continued to administer the medication.


Review of facility policy titled Pharmacist Order Verification, review date 8/13, revealed the following
? The pharmacist would review each prescription or order for medication before administration
? Exception is made for situations in which a licensed independent practitioner (LIP) with appropriate clinical privileges controls ordering, preparation and administration of the medication, as in endoscopies or cardiac catheterization laboratories, surgery, during cardiorespiratory arrest, or in the Emergency Department
? Excepts also include urgent situations when the resulting delay would harm the patient, including situations in which the patient experiences a sudden change in clinical status
? All concerns, issues or questions regarding a medication order would be discussed and clarified with the prescribe before verification.

Review of facility policy titled, " Pharmacy Essentials of Patient Information for Medication Dispensing and Administration", review date 04/13, revealed that the pharmacy department would obtain and review patient information when preparing and dispensing medications, in order to allow for the safe and effective administration of medications.

Review of facility policy titled Medication Preparation, effective 7/10, review date 12/13, revealed the following:
? The patient's profile would be screened to detect dosage problems, potential contraindications, drug-drug interactions, drug-disease interactions, drug-laboratory interactions and therapeutic duplication
? Relevant patient-specific information would be readily available to the pharmacist
? A review of all clinically significant warnings generated by the pharmacy computer system during order entry would be conducted
? The Pharmacy computer system includes special alerts/staff reminders identifying problematic drugs such as high-alert medications, look-alike and sound-alike drug names or medications with complicated/problematic packaging or labeling


Review of facility policy titled Medication Administration, effective date 11/79, last reviewed 07/13, revealed that:
? Patients would be given medications in a safe manner reducing potential errors
? Prior to the first doses, a licensed nurse would discuss the purpose of the medication with patient and would have reviewed pertinent lab data
? Patient and/or family member would be advised, as appropriate, about any potentially significant adverse reaction or concerns
? Patient would be observed taking medication
? If the patient had an adverse reaction to the drug, the drug would be stopped, and the licensed nurse would document reaction in Meditech nurses notes, and the physician would be notified
? An occurrence report would be generated by the licensed nurse, and would be reviewed by a pharmacist

Interview with the Pharmacy Director on 4/21/2014 at 10:50 a.m. revealed that Succinylcholine may be sent to the floor if the patient was crashing and the anesthesia physician requests; it would be assumed that the patient is in critical condition and needs it now; and, that he/she received notifications, printed reports, and worked with the nursing managers to resolve problems.

Interview on 4/22/2014 at 10:00 a.m. the pharmacy director stated that a warning system which warned nurses that a high risk drug was being removed was recently added; that regarding drug order verification, not all orders entered into the computer system (CPOE) by an ED physician went to the pharmacy, most went to the Pyxis system in the ED for a nurse to obtain; that when a label printed in the pharmacy, it meant the drug was not available on that floor; that it was very unusual for an ED physician to order medication for a patient on the nursing unit, but could be due to an emergency up there; that it was not unusual for a physician to order a paralytic medication without ordering a sedative medication because if the anesthesia department staff (in house 24/7) had arrived on the scene, they would have anesthetic/sedative medications with them; that it would be unusual to get a label for needed in the ED because the ED and ICU had the medication stocked in their rapid sequence intubation kit stored in the Pyxis, and could obtain it by overriding the system in an emergency.

Observation with the pharmacy director revealed the Succinylcholine bottle cap was red, and had "Warning: Paralyzing Agent" printed in white letters on it; the label on the bottle read: "Succinylcholine Chloride is a potent drug which may cause respiratory depression. Facilities must be immediately available for artificial respirations."

Observation of two (2) different medication administration records (MARs), revealed one order for Succinylcholine included: "Warning: Paralyzing Agent **(for intubation only)**" printed under the medication name, and one did not. Both MAR orders had the drug side effects printed to the top right of the record. The pharmacy director explained that the automatic warning message was recently added in the system for all high risk drugs, and that (second) warning labels had been ordered and expected to arrive this day, which would be placed across the medication caps when dispensed.

During an interview with the night pharmacist (employee #10) on 4/22/2014 at 9:00 a.m. in the conference room, he/she stated that he/she had worked in the facility for approximately twenty-five years, currently employed as part time status on evening and night shifts; he/she recalled the patient, stating the label came up on the printer in the main pharmacy, which showed the patient's location; that he/she had already completed the patient's MAR, and never verified the Succinylcholine order; that he/she had heard a "code blue" overhead announcement, then received a call from a floor nurse requesting the medication; that the physician had entered the order for the Etomidate (sedative) differently, that he/she was unaware of the order at the time, the nurse had not mentioned it, and no label had printed for it, so the medication had been obtained, labeled, and sent up by the tube system to the nursing unit; that he/she didn't think about who was up there, and was expecting to get a phone call. The pharmacist went on to explain that all special instructions for medications come up on the computer automatically, that he/she had not entered any; that warnings did come up on some medications, but he/she was unsure of why a warning had not come up for this medication on the patient's MAR, and did not recall if it ever had; that normal pharmacy practice was to only verify the orders that came through the computer (not for medication labels only which print in the pharmacy).

Review of Quality Review Log for April 2014 failed to reveal evidence that a complaint had been received regarding this patient's care.

Medication Discharge Summary: two examples of medication orders on the medication administration record, second order shows a newly added ***Warning: Paralyzing Agent (for intubation ONLY)*** under drug name and dosage.

QAPI

Tag No.: A0263

Based on record review, staff interview, Supervisor's Report, Reported Adverse Drug Reactions, the Quality Assurance/Performance Improvemnt (Qapi) failed to effectively maintain a process to assure that the Medical Staff, Pharmacy /Administration of Drugs and Nursing Staff identified, processed, dispensed and administered Succinylcholine (a muscle relaxant medication that is used in surgery or emergency situations for insertion of an endotracheal tube (tube to help them breath), which was an erroneous order and the patient became apneic for almost two (2) minutes and a Code Blue (rapid response of healthcare professionals and treatment to prevent death) to be performed for one (1) patient (#2) of the ten (10) sampled patients.

Cross refer for specific details to:

482.22 Medical Staff;
482.23 Nursing Services and;
482.25 Pharmaceutical Services

PATIENT SAFETY

Tag No.: A0286

Based on record review and interview the facility failed to assure that a high risk medication Succinylcholine (paralyzing agent) was ordered and administered to the right patient which caused and Immediate Jeopardy (IJ) event for one (1) patient #2 of the ten (10) sampled.

Findings include:

On April 12, 2014:

at 11;35 p.m.;
Record review for patient #2, revealed the patient presented to the Emergency Department (ED) as a walk-in patient, the Registered Nurse (RN) triaged (assessment by a nurse to determine the patient's medical needs and the priority in which the patient will be seen) with complaints of chest tightness with nausea, shortness of breath, and dizziness.

at 12:00 a.m.;
The Emergency Department (ED) physician (#4) completed an medical history as follows:
? Cardiac categorization (insertion of a thin flexible tube through an extremity artery and threaded into the vessels of the heart to determine whether there is any blockage);-sick sinus syndrome (group of heart rhythm problems in which the heart ' s sinus node or natural pacemaker does not function properly);
? Atrial fibrillation (abnormal heart rhythm);
? Insertion of a pacemaker;
? High blood pressure;
? Gall bladder surgery;
? Hysterectomy; and
? That the patient was a smoker.

Continued review of the ED physician notes revealed patient #2 reported having chest tightness for eight (8) hours, palpitations, nausea, dizziness and that the last time the patient felt like this her potassium was low. The ED #4 physical examination the patient was short of breath but had no cough or wheezing and that the patient had bilateral irregular pulses.

Review of the labortory assessment completed in the ED revealed patient #2, potassium level to be 3.0 (normal reference range of 3.5-5.1). The ED physician treatment plan included continuous cardiac monitoring, insertion of an intravenous line (IV-vein access for the administration of fluids, medications, and/or blood products), and oxygen administered at three (3) liters by nasal cannula.

In the ED, patient #2, completed an electrocardiogram assessing the cardiac rhythm as atrial fibrillation. Review of ED #4, physician orders revealed to administer IV fluids, Aspirin by mouth, Diltiazem HCL (used to treat high blood pressure) by mouth, Cardizem (used to treat abnormal heart rhythm), and a potassium supplement by mouth.

at 12:05 a.m.:
Review of the ED Nursing Notes revealed that patient #2 reported the symptoms had subsided. The ED physician #4, encouraged the patient to be admitted and examined by cardiology (specialist who deals with heart disorders) and the patient agreed to be admitted.

at 3:10 a.m.;
Review of the nursing notes revealed that patient #2 was transferred to a unit in the hospital from the ED. The ED nurse and the unit RN assessed the vital signs. The unit RN completed the initial nursing assessment at 3:38 a.m. The RN also initiated the patient ' s plan of care at this time.

at 3:37 a.m.:
Review of ED physician #4, admission orders revealed the following:
? Etomidate (a sedative) ten (10) milligram (mg) to be administered intravenously as directed; and
? Succinylcholine (paralyzing agent) one-hundred and sixty (160) mg IV push to be administered once.

at 3:52 a.m.:
Review of the Medication Administration Record (MAR) revealed Succinylcholine 160 mg IV push was signed as being administered by the Licensed Practical Nurse (LPN #3). Per review of the MAR the side effects had been discussed with patient #2. The side effects included muscle weakness, dry mouth, and difficulty speaking.

There was no evidence that the Etomidate was administered.

at 3:56 a.m.:
the Hospitalist/physician dictated patient #2 History and Physical Examination

at 4:17 a.m.:
" CODE Blue Sheet " was completed, (there was no evidence of any other nurse's notes prior to the Code Blue) revealed the following:

The CODE team arrived, the recorder of the report was staff member #9;
The event was witnessed and patient #2 was unconscious at the onset of the code;
A hospital wide code announced;
Patient #2 was apneic (temporary suspension of breathing) and oxygen four (4) liters applied by nasal cannula;
Chest compressions;
Sinus rhythm / paced recorded by monitor;
Prior to the CODE, patient #2 received Succinylcholine 160 mg IV push;

at 4:19 a.m.:
Patient #2, is now alert and oriented, breathing easy with pink color. Nursing notes revealed the patient remained stable, that the patient notified his/her family himself/herself, and that the patient was transferred to the Progressive Care Unit for monitoring.

at 5:32 a.m.:
The Hospitalist/physician completed the " Post CODE Blue " including the following:
--Patient #2, received Succinylcholine which was an erroneous order, the patient had become apneic and unconscious.
--Patient #2 had not required intubation and had not required chest compressions and had maintained a pulse and blood pressure but had experienced apnea and respiratory depression for almost 2 minutes.
Patient #2 was breathing but was moved to the Progressive Care unit for closer monitoring.

Review of facility policy titled Ordering and Transcribing Medications, review date 2/13, revealed that the facility's policy is to develop, implement, and maintain policies and procedures to support ordering of drugs and the transcription of drug orders which ensure the safe and appropriate use of these medications; that only medications needed to treat the patient's condition were ordered; that it is the ordering physician's responsibility to ensure that there is a documented diagnosis, condition, or indication for use of each medication ordered; and, that this may be documented in the history and physical, in consultation reports, or progress notes, unless specifically required with the type of medication ordered.

Review of facility policy titled Pharmacist Order Verification, review date 8/13, revealed that:
? The pharmacist would review each prescription or order for medication before administration
? All concerns, issues or questions regarding a medication order would be discussed and clarified with the prescribe before verification


Review of facility policy titled Labeling Standards, effective 7/10, review date 12/13, revealed that:
? All drug containers would be labeled
? Drug labels would be clear, consistent, legible and in compliance with state and federal requirements
? There would be a standard method for appropriately and safely labeling medications dispensed to both inpatients and outpatients
? Label requirements would be in general compliance with the current ASHP Technical Assistance Bulletin on Singe Unit and Unit Dose Packages of Drugs


Review of facility policy titled Medication Administration, effective date 11/79, last reviewed 07/13, revealed that:
? Patients would be given medications in a safe manner reducing potential errors
? Medications would have the "5 rights" checked prior to administration
? All medication would have bar code and medication scanned prior to administration
? All medications would have bar code and patient armband scanned prior to administration
? Prior to the first doses, a licensed nurse would discuss the purpose of the medication with patient and would have reviewed pertinent lab data
? Patient and/or family member would be advised, as appropriate, about any potentially significant adverse reaction or concerns
? Patient would be observed taking medication
? Patient's response to medication would be monitored by asking patient's perceptions regarding side effects and/or perceived efficacy
? Scheduled medications are kept in Automated Dispensing Cabinet or patient specific folder/drawer in med room
? Automated medication storage systems were available for prn and controlled substances
? Medication vials and ampules would be taken to the bedside and drawn up in a syringe, or syringe must be labeled with the drug and dosage
? Allergy armband would be checked prior to administration and would be checked against those listed on MAR
? If the patient had an adverse reaction to the drug, the drug would be stopped, and the licensed nurse would document reaction in Meditech-nurses notes, and the physician would be notified
? An occurrence report would be generated by the licensed nurse, and would be reviewed by a pharmacist
? All staff involved in the medication process would demonstrate competence upon hire, on an annual basis, and as needed with the introduction of new medications, equipment, and systems. To include: Pharmacists, Registered nurses, and Licensed Practical nurses

Interview on 04/21/14 at 3:15 p.m., the LPN (#3) stated the portable computer contains an access status board which included a list of assigned patients names, medications ordered, admitting physicians, and whether any medications were due. The nurse said that the status board indicated patient #2 was receiving intravenous fluids and that a dose of the potassium supplement was due at 3:15 a.m. The nurse stated the electronic system then identified that a dose of Succinylcholine was now due. The Succinylcholine came up to the nursing station via the tube system, the medication was in a bottle (vial), I got a 10 cc (cubic centimeter) syringe, went to the patient ' s room, scanned the medication and patient ' s armband, and drew up 160 mg or 8 cc of the medication. The patient did not question what the medication was or refuse it; I already knew that the patient was a nurse that worked at a rehabilitation center, so I did explain the side effects of the drug. I don ' t recall whether I told the patient what I was administering. I was not 100% familiar with this medication. I called pharmacy and I relied on the pharmacist and the entered side effects on the electronic MAR which popped in automatically for a general idea of what the medication was but I did not look it up. After I administered 2-3 cc by slow intravenous push of the medication the patient began to flail his/her arm and could not speak but was mouthing something. I stopped and did not administer any more of the medication. When the patient began to flail, I stopped and went to the door and called for the Rapid Response Team. I called and confirmed that the patient ' s monitor was showing that the patient ' s heart rate was sinus rhythm (normal). My co-workers arrived and the patient ' s lips were turning blue, we applied oxygen by nasal cannula and I pushed the Code Blue button. The patient retained a pulse during the episode, did not require intubation, and there were no medications administered. The patient only required supportive care did not require any type breathing assistance.

The pharmacy failed to provide the oversight of a high risk medication, and the nurse failed to assure knowledge of the medication causing patient #2 to have a life threatening event.

NURSING SERVICES

Tag No.: A0385

Based on medical record review, the facility failed to assure that nursing care and services was administered in a safe effective manner for one (1) patient (#2) which cause a life threatening event of the ten (10) sampled patients.

Findings include:

On April 12, 2014:

at 11;35 p.m.;
Record review for patient #2, revealed the patient presented to the Emergency Department (ED) as a walk-in patient, the Registered Nurse (RN) triaged (assessment by a nurse to determine the patient's medical needs and the priority in which the patient will be seen) with complaints of chest tightness with nausea, shortness of breath, and dizziness.

at 12:00 a.m.;
The Emergency Department (ED) physician (#4) completed an medical history. Continued review of the ED physician notes revealed patient #2 reported having chest tightness for eight (8) hours, palpitations, nausea, dizziness and that the last time the patient felt like this her potassium was low. The ED #4 physical examination the patient was short of breath but had no cough or wheezing and that the patient had bilateral irregular pulses.

Review of the labortory assessment completed in the ED revealed patient #2, potassium level to be 3.0 (normal reference range of 3.5-5.1). The ED physician treatment plan included continuous cardiac monitoring, insertion of an intravenous line (IV-vein access for the administration of fluids, medications, and/or blood products), and oxygen administered at three (3) liters by nasal cannula.

In the ED, patient #2, completed an electrocardiogram assessing the cardiac rhythm as atrial fibrillation. Review of ED #4, physician orders revealed to administer IV fluids, Aspirin by mouth, Diltiazem HCL (used to treat high blood pressure) by mouth, Cardizem (used to treat abnormal heart rhythm), and a potassium supplement by mouth.

at 12:05 a.m.:
Review of the ED Nursing Notes revealed that patient #2 reported the symptoms had subsided. The ED physician #4, encouraged the patient to be admitted and examined by cardiology (specialist who deals with heart disorders) and the patient agreed to be admitted.

at 3:10 a.m.;
Review of the nursing notes revealed that patient #2 was transferred to a unit in the hospital from the ED. The ED nurse and the unit RN assessed the vital signs. The unit RN completed the initial nursing assessment at 3:38 a.m. The RN also initiated the patient ' s plan of care at this time.

at 3:37 a.m.:
Review of ED physician #4, admission orders revealed the following:
? Etomidate (a sedative) ten (10) milligram (mg) to be administered intravenously as directed and;
? Succinylcholine (paralyzing agent) one-hundred and sixty (160) mg IV push to be administered once.

at 3:52 a.m.:
Review of the Medication Administration Record (MAR) revealed Succinylcholine 160 mg IV push was signed as being administered by the Licensed Practical Nurse (LPN #3). Per review of the MAR the side effects had been discussed with patient #2. The side effects included muscle weakness, dry mouth, and difficulty speaking.

There was no evidence that the Etomidate was administered.

at 4:17 a.m.:
" CODE Blue Sheet " was completed, (there was no evidence of any other nurse's notes prior to the Code Blue) revealed the following:

The CODE team arrived, the recorder of the report was staff member #9;
The event was witnessed and patient #2 was unconscious at the onset of the code;
A hospital wide code announced;
Patient #2 was apneic (temporary suspension of breathing) and oxygen four (4) liters applied by nasal cannula;
Chest compressions;
Sinus rhythm / paced recorded by monitor;
Prior to the CODE, patient #2 received Succinylcholine 160 mg IV push;

at 4:19 a.m.:
Patient #2, is now alert and oriented, breathing easy with pink color. Nursing notes revealed the patient remained stable, that the patient notified his/her family himself/herself, and that the patient was transferred to the Progressive Care Unit for monitoring.

at 5:32 a.m.:
The Hospitalist/physician completed the " Post CODE Blue " including the following:
--Patient #2, received Succinylcholine which was an erroneous order, the patient had become apneic and unconscious.
--Patient #2 had not required intubation and had not required chest compressions and had maintained a pulse and blood pressure but had experienced apnea and respiratory depression for almost 2 minutes.
Patient #2 was breathing but was moved to the Progressive Care unit for closer monitoring.

Review of facility policy titled Medication Administration, effective date 11/79, last reviewed 07/13, revealed that:
? Patients would be given medications in a safe manner reducing potential errors
? Prior to the first doses, a licensed nurse would discuss the purpose of the medication with patient and would have reviewed pertinent lab data
? Patient and/or family member would be advised, as appropriate, about any potentially significant adverse reaction or concerns
? Patient would be observed taking medication
? Patient's response to medication would be monitored by asking patient's perceptions regarding side effects and/or perceived efficacy

Interview on 04/21/14 at 3:15 p.m., the LPN (#3) stated the portable computer contains an access status board which included a list of assigned patients names, medications ordered, admitting physicians, and whether any medications were due. The nurse said that the status board indicated patient #2 was receiving intravenous fluids and that a dose of the potassium supplement was due at 3:15 a.m. The nurse stated the electronic system then identified that a dose of Succinylcholine was now due. The Succinylcholine came up to the nursing station via the tube system, the medication was in a bottle (vial), I got a 10 cc (cubic centimeter) syringe, went to the patient ' s room, scanned the medication and patient ' s armband, and drew up 160 mg or 8 cc of the medication. The patient did not question what the medication was or refuse it; I already knew that the patient was a nurse that worked at a rehabilitation center, so I did explain the side effects of the drug. I don ' t recall whether I told the patient what I was administering. I was not 100% familiar with this medication. I called pharmacy and I relied on the pharmacist and the entered side effects on the electronic MAR which popped in automatically for a general idea of what the medication was but I did not look it up. After I administered 2-3 cc by slow intravenous push of the medication the patient began to flail his/her arm and could not speak but was mouthing something. I stopped and did not administer any more of the medication. When the patient began to flail, I stopped and went to the door and called for the Rapid Response Team. I called and confirmed that the patient ' s monitor was showing that the patient ' s heart rate was sinus rhythm (normal). My co-workers arrived and the patient ' s lips were turning blue, we applied oxygen by nasal cannula and I pushed the Code Blue button. The patient retained a pulse during the episode, did not require intubation, and there were no medications administered. The patient only required supportive care did not require any type breathing assistance.

ADMINISTRATION OF DRUGS

Tag No.: A0405

Based on record review and interview the facility failed to administer medication in a safe manner which cause a life threatening event for one (1) patient #2 of the ten (10) sampled patients.

Findings include:

Cross refer to A 286 Patient Safety and A 385 for specific details.

The Emergency Department physician order a high risk medication on the wrong patient.
The Pharmacy dispensed a high risk medication without oversight.
Nursing administered a high risk medication without fully understanding the potential life threatening side affects of the medication.

Standard-level Tag for Pharmaceutical Service

Tag No.: A0490

Based on record review, staff interview, the facility failed to prevent a high risk medication to be administered causing a life threatenting event to one (1) patient (#2) of the ten (10) sampled patients.

Findings include:

On April 12, 2014:

at 11;35 p.m.;
Record review for patient #2, revealed the patient presented to the Emergency Department (ED) as a walk-in patient, the Registered Nurse (RN) triaged (assessment by a nurse to determine the patient's medical needs and the priority in which the patient will be seen) with complaints of chest tightness with nausea, shortness of breath, and dizziness.

at 12:00 a.m.;
The Emergency Department (ED) physician (#4) completed an medical history as follows:
? Cardiac categorization (insertion of a thin flexible tube through an extremity artery and threaded into the vessels of the heart to determine whether there is any blockage);-sick sinus syndrome (group of heart rhythm problems in which the heart ' s sinus node or natural pacemaker does not function properly);
? Atrial fibrillation (abnormal heart rhythm);
? Insertion of a pacemaker;
? High blood pressure;
? Gall bladder surgery;
? Hysterectomy; and
? That the patient was a smoker.

Continued review of the ED physician notes revealed patient #2 reported having chest tightness for eight (8) hours, palpitations, nausea, dizziness and that the last time the patient felt like this her potassium was low. The ED #4 physical examination the patient was short of breath but had no cough or wheezing and that the patient had bilateral irregular pulses.

Review of the labortory assessment completed in the ED revealed patient #2, potassium level to be 3.0 (normal reference range of 3.5-5.1). The ED physican treatment plan included continuous cardiac monitoring, insertion of an intravenous line (IV-vein access for the administration of fluids, medications, and/or blood products), and oxygen administered at three (3) liters by nasal cannula.

In the ED, patient #2, completed an electrocardiogram assessing the cardiac rhythm as atrial fibrillation. Review of ED #4, physician orders revealed to administer IV fluids, Aspirin by mouth, Diltiazem HCL (used to treat high blood pressure) by mouth, Cardizem (used to treat abnormal heart rhythm), and a potassium supplement by mouth.

at 12:05 a.m.:
Review of the ED Nursing Notes revealed that patient #2 reported the symptoms had subsided. The ED physician #4, encouraged the patient to be admitted and examined by cardiology (specialist who deals with heart disorders) and the patient agreed to be admitted.

at 3:10 a.m.;
Review of the nursing notes revealed that patient #2 was transferred to a unit in the hospital from the ED. The ED nurse and the unit RN assessed the vital signs. The unit RN completed the initial nursing assessment at 3:38 a.m. The RN also initiated the patient ' s plan of care at this time.

at 3:37 a.m.:
Review of ED physician #4, admission orders revealed the following:
? Etomidate (a sedative) ten (10) milligram (mg) to be administered intravenously as directed; and
? Succinylcholine (paralyzing agent) one-hundred and sixty (160) mg IV push to be administered once.

at 3:52 a.m.:
Review of the Medication Administration Record (MAR) revealed Succinylcholine 160 mg IV push was signed as being administered by the Licensed Practical Nurse (LPN #3). Per review of the MAR the side effects had been discussed with patient #2. The side effects included muscle weakness, dry mouth, and difficulty speaking.

There was no evidence that the Etomidate was administered.

at 3:56 a.m.:
the Hospitalist/physician dictated patient #2 History and Physical Examination

at 4:17 a.m.:
" CODE Blue Sheet " was completed, (there was no evidence of any other nurse's notes prior to the Code Blue) revealed the following:

The CODE team arrived, the recorder of the report was staff member #9;
The event was witnessed and patient #2 was unconscious at the onset of the code;
A hospital wide code announced;
Patient #2 was apneic (temporary suspension of breathing) and oxygen four (4) liters applied by nasal cannula;
Chest compressions;
Sinus rhythm / paced recorded by monitor;
Prior to the CODE, patient #2 received Succinylcholine 160 mg IV push;

at 4:19 a.m.:
Patient #2, is now alert and oriented, breathing easy with pink color. Nursing notes revealed the patient remained stable, that the patient notified his/her family himself/herself, and that the patient was transferred to the Progressive Care Unit for monitoring.

at 5:32 a.m.:
The Hospitalist/physician completed the " Post CODE Blue " including the following:
--Patient #2, received Succinylcholine which was an erroneous order, the patient had become apneic and unconscious.
--Patient #2 had not required intubation and had not required chest compressions and had maintained a pulse and blood pressure but had experienced apnea and respiratory depression for almost 2 minutes.
Patient #2 was breathing but was moved to the Progressive Care unit for closer monitoring.

Review of facility policy titled Ordering and Transcribing Medications, review date 2/13, revealed that the facility's policy is to develop, implement, and maintain policies and procedures to support ordering of drugs and the transcription of drug orders which ensure the safe and appropriate use of these medications; that only medications needed to treat the patient's condition were ordered; that it is the ordering physician's responsibility to ensure that there is a documented diagnosis, condition, or indication for use of each medication ordered; and, that this may be documented in the history and physical, in consultation reports, or progress notes, unless specifically required with the type of medication ordered.

Review of patient #2 record revealed no supporting diagnosis nor condition for the use of Succinylcholine.

Interview on 4/17/2014 at 3:45 p.m. via telephone revealed the patient complained of being in pain related to recieving CPR during the CODE. The patient stated that when the nurse came to administer the medication, the patient told the nurse I am not suppose to get that, I am here for low potassium in a pill. The patient stated that the nurse would not listen and continued to administer the medication.


Review of facility policy titled Pharmacist Order Verification, review date 8/13, revealed the following
? The pharmacist would review each prescription or order for medication before administration
? Exception is made for situations in which a licensed independent practitioner (LIP) with appropriate clinical privileges controls ordering, preparation and administration of the medication, as in endoscopies or cardiac catheterization laboratories, surgery, during cardiorespiratory arrest, or in the Emergency Department
? Excepts also include urgent situations when the resulting delay would harm the patient, including situations in which the patient experiences a sudden change in clinical status
? All concerns, issues or questions regarding a medication order would be discussed and clarified with the prescribe before verification.

Review of facility policy titled, " Pharmacy Essentials of Patient Information for Medication Dispensing and Administration", review date 04/13, revealed that the pharmacy department would obtain and review patient information when preparing and dispensing medications, in order to allow for the safe and effective administration of medications.

Review of facility policy titled Medication Preparation, effective 7/10, review date 12/13, revealed the following:
? The patient's profile would be screened to detect dosage problems, potential contraindications, drug-drug interactions, drug-disease interactions, drug-laboratory interactions and therapeutic duplication
? Relevant patient-specific information would be readily available to the pharmacist
? A review of all clinically significant warnings generated by the pharmacy computer system during order entry would be conducted
? The Pharmacy computer system includes special alerts/staff reminders identifying problematic drugs such as high-alert medications, look-alike and sound-alike drug names or medications with complicated/problematic packaging or labeling


Review of facility policy titled Medication Administration, effective date 11/79, last reviewed 07/13, revealed that:
? Patients would be given medications in a safe manner reducing potential errors
? Prior to the first doses, a licensed nurse would discuss the purpose of the medication with patient and would have reviewed pertinent lab data
? Patient and/or family member would be advised, as appropriate, about any potentially significant adverse reaction or concerns
? Patient would be observed taking medication
? If the patient had an adverse reaction to the drug, the drug would be stopped, and the licensed nurse would document reaction in Meditech nurses notes, and the physician would be notified
? An occurrence report would be generated by the licensed nurse, and would be reviewed by a pharmacist

Interview with the Pharmacy Director on 4/21/2014 at 10:50 a.m. revealed that Succinylcholine may be sent to the floor if the patient was crashing and the anesthesia physician requests; it would be assumed that the patient is in critical condition and needs it now; and, that he/she received notifications, printed reports, and worked with the nursing managers to resolve problems.

Interview on 4/22/2014 at 10:00 a.m. the pharmacy director stated that a warning system which warned nurses that a high risk drug was being removed was recently added; that regarding drug order verification, not all orders entered into the computer system (CPOE) by an ED physician went to the pharmacy, most went to the Pyxis system in the ED for a nurse to obtain; that when a label printed in the pharmacy, it meant the drug was not available on that floor; that it was very unusual for an ED physician to order medication for a patient on the nursing unit, but could be due to an emergency up there; that it was not unusual for a physician to order a paralytic medication without ordering a sedative medication because if the anesthesia department staff (in house 24/7) had arrived on the scene, they would have anesthetic/sedative medications with them; that it would be unusual to get a label for needed in the ED because the ED and ICU had the medication stocked in their rapid sequence intubation kit stored in the Pyxis, and could obtain it by overriding the system in an emergency.

Observation with the pharmacy director revealed the Succinylcholine bottle cap was red, and had "Warning: Paralyzing Agent" printed in white letters on it; the label on the bottle read: "Succinylcholine Chloride is a potent drug which may cause respiratory depression. Facilities must be immediately available for artificial respirations."

Observation of two (2) different medication administration records (MARs), revealed one order for Succinylcholine included: "Warning: Paralyzing Agent **(for intubation only)**" printed under the medication name, and one did not. Both MAR orders had the drug side effects printed to the top right of the record. The pharmacy director explained that the automatic warning message was recently added in the system for all high risk drugs, and that (second) warning labels had been ordered and expected to arrive this day, which would be placed across the medication caps when dispensed.

Interview on 4/22/2014 at 9:00 a.m. with the night pharmacist (#10) recalled the patient, stating the label came up on the printer in the main pharmacy, which showed the patient's location; that he/she had already completed the patient's MAR, and never verified the Succinylcholine order; that he/she had heard a "code blue" overhead announcement, then received a call from a floor nurse requesting the medication; that the physician had entered the order for the Etomidate (sedative) differently, that he/she was unaware of the order at the time, the nurse had not mentioned it, and no label had printed for it, so the medication had been obtained, labeled, and sent up by the tube system to the nursing unit; that he/she didn't think about who was up there, and was expecting to get a phone call. The pharmacist went on to explain that all special instructions for medications come up on the computer automatically, that he/she had not entered any; that warnings did come up on some medications, but he/she was unsure of why a warning had not come up for this medication on the patient's MAR, and did not recall if it ever had; that normal pharmacy practice was to only verify the orders that came through the computer (not for medication labels only which print in the pharmacy).