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Based on observation, interview, and record review, the facility failed to ensure Patient Rights were protected by:

1. Failing to ensure three sampled patients (Patients 404, 106, and 107) were provided the right to formulate advance directives and have hospital staff and practitioners who provided care in the hospital comply with those directives (A132);

2. Failing to ensure care was provided in a safe setting by ensuring involuntarily confined (5150) patients were under constant observation and admitted to environments that were designed (with adequate bathrooms and ability to regulate temperature), equipped (with bedside monitors, medications ordered for the patients, and bedside phones to order dietary preferences), and staffed (with nurses at the same ratios to provide the level of care they would receive on inpatient units) (A144); and

3. Failing to ensure one sampled patient's injury of unknown origin (potential abuse) was reported and investigated and the patient was protected from further abuse during an investigation (A145).

The cumulative effect of these systemic problems resulted in failure of the facility to ensure patients rights were promoted and protected in a safe and effective manner.

Based on interview and record review, the facility failed to obtain, communicate, or assist three sampled patients (Patients 404, 106, and 107) with advance directives. This failed practice resulted in the potential for delay and/or denial of the patient's right to make legal decisions, including their right to accept or refuse medical or surgical treatment, and the right to have written instruction, such as a living will or durable power of attorney for healthcare while hospitalized.

(An advance directive is a written instruction, such as a living will or durable power of attorney for health care, that gives directions to the healthcare team, in advance, regarding procedures/treatments the patient wants or doesn't want to have done in the event they become incapacitated).


Findings:

1. The electronic health record (EHR) was reviewed for Patient 404 on February 26, 2015. Patient 404 was admitted to the facility on February 22, 2015. Patient 404's admission diagnoses included altered level of consciousness, acute renal failure, and shortness of breath.

The EHR nursing admission assessment indicated Patient 404's advance directive was documented as "UNK" or unknown. The EHR indicated if the nurse's response was "N" or "U" the nurse should explain the entry. There was no further documentation in the EHR which indicated an updated status for Patient 404's advance directive.

Record review of Patient 404's chart indicated Patient 404 had an updated advance directive dated, January 27, 2015, signed by a surrogate decision maker. The form titled, "Advance Healthcare Directive Preferred Intensity of Care Documentation," indicated, "Resuscitate-no, Medication restriction-no, Treatment Restriction-no, Tube Feeding-yes, and Intravenous solutions-yes."

An interview was conducted with the Medical Intensive Care Unit Manager (MICUM) on February 26, 2015, at 11:30 a.m. The MICUM stated that day, the status of patient (404's) advance directive was unclear. The MICUM stated, "The nurse needs to clarify with the physician the advance directive of this patient."

An interview was conducted with Patient 404's Nurse, Nurse 6, on February 26, 2015, at 11:15 a.m. Nurse 6 stated she did not have enough time to update the status of the advance directive in the EHR but she was aware of the written advance directive (located in the chart). Nurse 6 stated, "We (nursing) need to clarify with the family (the advance directive)."

Record review of the facility policy titled, "Advance Directive," dated with revision on January 2012, indicated, "...Any person who becomes aware during the patient's hospitalization that the patient has formulated or revoked an Advance Directive(s) shall notify the patient's attending physician. The attending physician is responsible for the new information and updating the patient's treatment plan..." The policy further indicated,"If a patient is incapacitated at the time of admission, the hospital may give advance directive information to a family member or surrogate. If the patient is unaccompanied, information on advance directives and inquiry into the existence of an advance directive shall be directed to the patient's surrogate decision maker by the nursing staff responsible for the patient, once a surrogate decision maker has been identified by the attending physician with the assistance of social services."



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2. The electronic medical record (EMR) for Patient 106 was reviewed on February 24, 2015. Patient 106 was admitted to the facility on February 21, 2015, with a diagnosis of left hip fracture requiring surgical correction.

The advance directive (AD) section of the EMR, displaying previous and current admitting information, indicated the following:

a. On November 27, 2014, she indicated she had not executed (completed) an advance directive;

b. On January 19, 2015, Patient 106 indicated she had executed an advance directive. There was no evidence a copy was requested. There was no evidence a copy was placed in the chart. There was no information regarding her wishes according to her advance directive;

c. On January 20, 2015, her daughter indicated she had executed an advance directive, and she wanted all life saving measures done if she suffered a cardiac or respiratory arrest. Her daughter was asked to provide a copy of the AD at 8:59 a.m., and the Case Management (CM) notes indicated Patient 106 had an AD on file at 11:30 a.m. There was no evidence a copy of the AD was placed in the chart. There was no information regarding her wishes according to her advance directive; and,

d. On February 22, 2015, Patient 106 indicated she had executed an advance directive (AD) and was asked to provide a copy of it, but no copy was in the chart. There was no information regarding her wishes according to her advance directive.

The paper chart for Patient 106 was reviewed on February 24, 2015. The record did not contain a copy of Patient 106's advance directive.

During an interview with Registered Nurse (RN) 4 on February 24, 2015, at 4 p.m., the RN stated she did not know whether Patient 106 had an AD. RN 4 stated she had not asked the patient or checked in the EMR or the paper chart to see if there was an AD. She stated she could, "look into it."

During an interview with the Vice President of Quality (VPQ) on February 25, 2015, at 2:30 p.m., the VPQ stated when a patient was admitted, if they indicated they had executed an AD, the staff would request a copy of it. According to the VPQ, when a copy of the AD was received, it would be scanned into the computer, then placed into the paper chart. The VPQ stated the AD information would not be available for use on the next admit because, "it might change."

The facility policy titled, "Advance Directive," was reviewed on February 25, 2015. According to the policy, if a patient indicated they had an AD, but did not bring a copy with them, they would be asked if they provided one on the previous admission, and a copy would be obtained from the medical record and placed on the current chart. When the copy was received on the unit, the nurse would have the AD reviewed by the patient or their surrogate and verify if it still reflected the patient's wishes.

3. The electronic medical record (EMR) for Patient 107 was reviewed on February 25, 2015. Patient 107 was being seen in the Radiation Oncology Clinic for treatment of lung cancer.

The advance directive (AD) section of the EMR indicated Patient 107 had executed (completed) an AD, and there was a copy in the chart. No copy was located after searching the EMR. There was no information regarding the contents of the AD or the patient's wishes according to the AD in the EMR.

The paper chart for Patient 107 was reviewed on February 25, 2015. The paper chart contained a copy of the AD executed by Patient 107 that indicated she did not want to be kept on life support if she suffered from an irreversible condition and could only be kept alive with the use of life support.

During an interview with the Radiation Oncology Administrative Assistant (AA) on February 25, 2015, at 8:10 a.m., the AA stated she asked every patient she registered to receive services at the clinic, if they executed an AD. The AA stated if the patient told her they had executed an AD, she asked them for a copy, and placed the copy in the paper chart. The AA stated the EMR could be accessed from the clinic or from the hospital, and the people in the hospital could see that Patient 107 had executed an AD, but they could not see what the patient's wishes were according to the AD because the copy was located in the paper record inside the clinic.

The facility policy titled, "Advance Directive," was reviewed on February 25, 2015. According to the policy, all adult inpatients and outpatients would be queried about whether or not they had an advance directive, and would be asked to provide a copy if they had one, but they would be informed that if they had an AD, it would not be honored.

Based on observation, interview, and record review, the facility failed to ensure:

1. A Certified Nursing Assistant (CNA) prevented one 5150 patient (Patient 102) from locking herself in the bathroom each time she used it, resulting in the potential for a suicide attempt, harm, or death to the patient;

2. A security officer working for a contracted security service received training on monitoring of 5150 (involuntarily confined) patients before he was assigned to do so, resulting in the potential for psychiatric patients with suicidal or homicidal tendencies to injure themselves, other patients, visitors, or staff;

(A 5150 patient is a patient who has been involuntarily confined by a peace officer or qualified clinician because they are suspected to have a mental disorder that makes them a danger to themselves, a danger to others, or gravely disabled.

Patients who are a danger to themselves must remain in an environment that prevents them from getting to objects that they may use to cause self harm.

Patients who are a danger to others must remain in a calm environment where visitors and outside stimulation are monitored and controlled to prevent escalation of behavior and threat or injury to others);

and,

3. Four patients (Patients 109, 110, 111, and 204) were admitted to appropriate environments that were designed (with adequate bathrooms and ability to regulate temperature), equipped (with bedside monitors, medications that had been ordered for the patients, and bedside phones to order dietary preferences), and staffed (with the same nurses at the same ratios to provide the level of care they would receive on inpatient units) to promote quality of care, comfort, and dignity of the patients, resulting in the potential for emotional and physical harm to the patients.

Findings:

During a tour of the Emergency Department (ED) on February 24, 2015, at 11 a.m., the following was observed:

1. A certified nursing assistant (CNA) was standing outside of room M (a room that had a 5150 patient in it).

During an interview with the CNA on February 24, 2015, at 11:05 a.m., the CNA stated the patient in the room (Patient 102) was there on a 5150 because she tried to drown herself.

When asked how the patient used the bathroom (a female patient with a male CNA), he pointed to a bathroom door at the end of the hallway, and stated he walked to the door with her and waited outside of the door while she went to the bathroom. The CNA stated the patient was able to lock the door while she was in the bathroom. He stated at times a female would go into the bathroom with the patient, but not always. He stated if she locked herself in and he was concerned about her, or she would not or did not come out, he would call security. He stated she could hurt herself in there, but that was the reason he stood by the door.

2. A security officer was sitting in a chair outside of room N (a room that had a 5150 patient in it). Activity was observed taking place down the hall (approximately 100 feet away) involving a patient laying on the ground and screaming. The officer left the doorway of the 5150 patient to check on the activity down the hall. As he walked away, the officer said to a male employee that was nearby, "Will you watch him?" He walked away without waiting for a response from the other male employee, or telling the other male employee anything about the 5150 patient.

During an interview with the officer on February 24, 2015, at 11:10 a.m., the officer stated he was, "watching," a 5150 patient who hit a wall with his fist. The officer stated he did not know what the 5150 was issued for (a danger to himself or a danger to others), but, "I would go with a danger to self since he hit a wall." The officer stated it would not matter if the patient was being held as a danger to himself or a danger to others, because he would, "just watch him and react accordingly."

The employee file for the security officer was reviewed on February 26, 2015. There was no evidence in the file the security officer was trained or demonstrated competency in monitoring/sitting with 5150 patients.

During an interview with the Manager of Public Safety on February 26, 2015, at 11:20 a.m., the manager stated there was no specific training done for the security officers regarding monitoring/sitting with 5150 patients.

3. A review of the facility census on February 24, 2015, indicated there were 267 admitted patients with 249 licensed general acute care beds. Admitted patients were located in the medical surgical/telemetry/cardiovascular (general acute care) units, as well as 25 admitted patients in the Emergency Department (ED), 14 admitted patients in the Outpatient Surgery/Observation Unit, and four adult patients admitted to the Pediatric Unit.

During a facility tour on February 25, 2015, at 10:50 a.m., a sign on the wall in the hallway indicated the facility had a newly labeled, "Observation Unit (OBS)." Upon entering the unit, it was observed to be an aisle with a door to the main hallway at one end, and a nurse's station at the other end. Beds lined the walls on both sides of the aisle, separated by privacy curtains, 15 beds in total. The lights in the unit were on, all controlled by one switch so they could never be turned off for patients to have darkness for sleep. There were no bedside telephones for patients to make phone calls, including calls to the dietary department to report their meal choices. A sign on the wall in the nurse's station read,"Call daily for breakfast, lunch, and dinner."

During the tour of the OBS Unit, two patients, one male and one female, were observed wearing hospital gowns, while walking from their curtained beds, to the unit's bathrooms. The patient bathrooms were located in the same unit, but around the corner and about 40 feet from the bed at the end of the hall. There were two bathrooms total, one male bathroom and one female bathroom, to be shared between the 15 patients. There were no showers available for patients to use.

Further observation revealed there were no bedside monitors, and a sign on the wall in the nurse's station read, "Please call tele room to verify patient can be seen on monitor and get rhythm."

During a concurrent interview with the Manager of the Observation and Cardiovascular Units, the manager stated the unit was licensed as an outpatient surgery unit, but was now used for admitting observation patients. She stated there were 14 patients in the unit with 15 beds. She stated the unit was staffed,"mostly," with float nurses or travelers, at a medical surgical or telemetry ratio. According to the manager, there were currently four registered nurses (RNs) working in the unit. The manager stated patients admitted to the unit should have an expected length of stay of greater than six hours, but they should not be there for more than 24 hours. The manager stated there were four patients in the unit who had been there for two days (Patients 109, 110, 111, and 113), and she did not know who authorized their admission to the unit. The manager stated they were not observation patients, they were higher acuity patients who required inpatient care.

A review of the census indicated 10 patients were admitted to the unit on February 24, 2015, (the previous day), and four patients were admitted to the unit on February 23, 2015 (two days earlier).

Record reviews were conducted and indicated the following:

a. Patient 109 presented to the Emergency Department (ED) on February 23, 2015, with complaints of right sided headaches and weakness for the past few days. She had a history of thyroid disease and hypertension (HTN - high blood pressure). Her heart rate in the ED was 129 (normal 60-100). According to the ED physician's report, she was admitted to the facility at the request of her primary care physician due to concerns about her fast heart rate and headaches associated with right arm weakness (signs of a possible stroke).

The admitting history and physical (H&P) indicated the patient had a history of HTN, hypothyroidism (low thyroid functioning), and anxiety, and had been having severe headaches associated with right sided numbness and blurred vision for three days.

Patient 109 was admitted to the observation unit with diagnoses that included severe headaches (complex migraines versus other pathology [abnormality], HTN, hypothyroidism, and anxiety. The plan included treatment of the headaches with oral and intravenous pain medications, a neurology consult, blood pressure medications, thyroid labs and medications, medication for anxiety, medication to decrease the acid content in the stomach caused by stress, and medication to prevent development of clots in the legs caused by prolonged time in the bed.

She was still in the unit two days later.

b. Patient 110 was accepted as a transfer to the facility (at a time when the facility had no empty general acute care beds available) from a different facility on February 23, 2015, after being treated there for complaints of Bell's Palsy (paralysis of one side of the face) and feeling like his heart was skipping a beat. The examination at the other facility indicated Patient 110 had bradycardia (a slow heart rate) and an elevated troponin level (a lab value that is indicative of injury to the heart muscle).

The ED physician's record indicated his heart rate was 57 and 52 respectively (normal 60-100), his electrocardiogram (EKG) showed changes in the inferior wall of his heart that was indicative of possible damage to the heart muscle, and his care was being transitioned to inpatient service for further evaluation and care.

The admitting H&P indicated he was being admitted for observation for acute coronary syndrome and placed on telemetry, an echocardiogram would be ordered, and a consult would be done with a cardiologist.

According to the record, Patient 110 had a lexiscan procedure (intravenous (IV) cardiac and nuclear medication injection with a heart scan to determine if reversible damage has occurred in the heart muscle) done on February 24, 2015 (the day after he was admitted to the observation unit), that showed reversible damage to the heart muscle with abnormal pumping of the heart. He was sent back to the observation unit following the test, and scheduled to have a cardiac catheterization (injecting contrast into the coronary arteries and the left ventricle to assess the blood flow to the heart and the pumping function of the ventricle) the following day.

He was still in the unit two days later.

A review of the census on February 26, 2015, indicated Patient 110 was still in the observation unit (three days after admission).

c. Patient 111 presented to the ED on February 23, 2015, complaining of feeling dizzy and unsteady on his feet for one day, with diplopia (double vision). The ED physician's report indicated the patient had a history of diabetes and HTN, and the computerized axial tomography (CT) scan of his brain showed a one centimeter area of concern that appeared as if there was blood in the brain. The record indicated Patient 111 was being transitioned to the inpatient service for further care.

The admitting H&P indicated Patient 111 was admitted to the observation unit with a diagnosis of intracerebral hemmorhage (bleeding into the brain), with a plan to obtain a magnetic resonance imaging (MRI) of his brain and a neuro (neurology/neurosurgery) consult.

He was still in the unit two days later.

A review of the census on February 26, 2015, indicated Patient 111 was still in the observation unit (three days after admission).

d. Patient 204 was accepted as a transfer to the facility (at at time the facility had no empty general acute care beds available) from a different facility on February 24, 2015, at 9:02 a.m., due to Non-ST elevation myocardial infarction (heart attack) and pneumonia. Physician's orders for Patient 204 included telemetry (heart monitoring) and vital signs every 2 hours. Patient 204 was also receiving the antibiotic Zosysn every eight hours to treat pneumonia (infection of the lungs).

The admitting H&P indicated Patient 204 was being admitted for coronary angiography (injecting contrast into the coronary arteries and the left ventricle to assess the blood flow to the heart and the pumping function of the ventricle).

According to the record, Patient 204 was admitted to the observation unit at 9:02 a.m., and was transferred to the cath lab at 3:10 p.m. Patient 204 was sent back to the observation unit, on February 24, 2015, at 4:40 p.m.

Patient 204's angiogram findings indicated the patient had significant blockage and the physician would be discussing coronary angioplasty (minimally invasive procedure to open blocked arteries) or bypass graft (open heart surgery) with the patient's son.

Patient 204 remained in the observation unit until February 25, 2015, at 2:30 p.m., when she was transferred to the cardiovascular unit (29 hours and 28 minutes after she was admitted to the observation unit).

During a tour of the telemetry room on February 25, 2015, at 11:30 a.m., three monitor technicians (MTs) were observed sitting in a room with three banks of telemetry monitoring screens.

During a concurrent interview with MT 1, the MT stated each of them was responsible for monitoring up to 48 heart rhythms, and the total number of patients that could be monitored in the room was 144. The MT stated they did not know the baseline rhythms for all of the patients they were monitoring, and would not necessarily know when a patient's rhythm changed unless it was a, "dangerous," rhythm. He stated they were monitoring for and reporting, "dangerous," rhythms only. MT 1 had the patients in the Observation unit in his bank of monitors, and stated he saw only 11 observation patient rhythms, not 14.

The rhythm for Patient 110 was observed to be a normal sinus rhythm with frequent premature atrial contractions (PACs) (a usually benign, early beat of the heart that can be described by the patient as a skipped beat or a jolt in the chest - as Patient 111 had complained of).

On February 26, 2015, at 9:30 a.m., RN 3 was observed providing care in the "Observation Unit." RN 3 stated she had to get Patient 206's medication from the pharmacy as it was not in the unit.

During an interview with the Observation Unit Manager, on February 26, 2015, at 10:10 a.m., the Manager stated they did not have a pyxis refrigerator in the unit, so they had to obtain medications from the pharmacy. In addition, the Manager stated as the patient's were transient (short stay or transfers), daily medications were not sent to the unit. The Manager stated the patient's nurse would call the pharmacy about an hour before the patient's medication was due, to receive the medication.

During an observation of the OBS unit on February 26, 2015, between 9:30 and 10:15 a.m., there were 15 patients in the unit with each privacy curtain closed around the respective bed. A 68 year old female, admitted the previous day for complaints of chest pain, was heard yelling through the curtain, "it's hot in here." Staff opened the curtains, and exposed the patient to the other patients, staff, and visitors in the unit.

The facility policy titled, "Plan for the Provision of Patient Care - Scope of Service," was reviewed on February 26, 2015. The policy indicated the following:

A. The observation unit was used to care for patients requiring further management, specifically to determine the need for inpatient admission, who met criteria for medical, surgical, and telemetry level of care up to a 24 hour stay;

B. The observation unit was for patients where diagnosis, treatment, stabilization, and discharge could reasonably be expected within 24 hours;

C. Acceptable diagnoses for the Observation unit included diagnoses such as non-specific chest pain (chest pain without an identified cause), anemia, non-titrated IV medications (not needing to increase and decrease rates to manage symptoms), cardiac arrhythmias (abnormal heart rhythms), elective angiograms, interventional radiology procedures, and same day surgery;

D. Acceptable diagnoses for the Cardiovascular unit (CVU) included acute myocardial infarction (heart attack) (the diagnosis Patient 204 had), cardiac dysrhythmias (abnormal heart rhythms), and stroke (the type of diagnoses Patients 109 and 111 had). Staffing in the unit was one nurse for every three patients, and the nursing staff provided continuous cardiac monitoring; and,

E. The Progressive Care Unit (PCU) was for patients who were stable with the potential for becoming unstable. Acceptable diagnoses for the PCU included stable myocardial infarction and acute coronary syndrome (the diagnosis Patient 110 had). Staffing in the unit was one nurse for every three patients, and the nursing staff provided continuous cardiac monitoring.

During an interview with the Vice President (VPQ) of Quality on February 25, 2015, at 2:30 p.m., the VP stated Patients 109, 110, 111, and 204 should have been admitted to the inpatient areas, but there were no rooms available for them.

Based on interview and record review, the facility failed for one sampled patient (Patient 208) to follow their policy and procedure titled, "Abuse Assessment and Reporting," after staff reported a new onset of vaginal/groin bruising to Patient 208. Facility staff failed to report the injury to the Risk Manager, and the Social Services personnel failed to report the incident to the appropriate entities. In addition, the facility failed to follow their policy and procedure titled, "Assault Abuse within the Hospital," by failing to conduct an investigation, as soon as possible after Patient 208 was observed with a new onset of vaginal/groin bruising. This failure resulted in a delay in determining the cause of Patient 208's bruising and the failure to protect Patient 208 from further injury.

Findings:

On February 5, 2015, APS (Adult Protective Services) sent a "Report of Suspected Dependent Adult/Elder Abuse," to the California Department of Public Health. The report indicated it was completed on February 5, 2015, at 9:27 a.m. The report indicated Patient 208 was a victim and "suspected abuser," was unknown. The following was documented: "RP (Reporting Party) is hospital SW (Social Worker) reporting that client (Patient 208) was admitted on 1/22/15...RP said that sometime after that the CNA (Certified Nurse Assistant) noticed some bruising around client's vaginal area...RP said as far as known, this incident was not reported to law enforcement, APS or any other agency and no pictures were taken of the bruising...Client was discharged from the hospital on February 3, 2015..."

On February 12, 2015, at 2:40 p.m., SW 1 was interviewed. SW 1 stated on February 2, 2015, she received a call from a case manager about a possible "APS (Adult Protective Services) Case." SW 1 stated the facility had identified medical changes to Patient 208 that could be abuse related. SW 1 stated she instructed staff how to contact APS and to complete paperwork. SW 1 stated, when she returned to work on February 5, 2015, she followed up with unit staff and found the incident had not been reported to APS. SW 1 stated she notified APS on February 5, 2015 (three days after the initial report).

The facility's policy and procedure titled, "Abuse Assessment and Reporting," with a last revised date of March 2013, was reviewed. The policy indicated:

a. It applied to all hospital and medical staff practitioners;

b. Staff who have knowledge of suspected cases of abuse/neglect of the elderly or dependent adults will report to the proper authorities;

c. For adult abuse/neglect-reports should made as soon as possible by telephone to the (county of residence of the victim) Adult Protective Services (APS);

d. Hospital personnel must complete the required abuse reporting forms, with the original being attached to the patient's record;

e. Depending upon the severity of the injuries of the possible victim, APS may also recommend Law enforcement be notified;

f. The patient's medical record documentation should include all pertinent observations; (i.e., physical injuries, patient and family behavior during visits), and all actions taken by staff;

g. Indicators of possible sexual abuse included bruises or bleeding in external genitalia; and

h. Documentation shall be completed in the medical record reflecting the initial concern and the agency contact information where the report was filed. This will include the name, contact person, phone number, date and time of the report, and the outcome expected (i.e. whether agency staff will be coming to the hospital to see the patient, any time frames given by the agency intervention).

A review of Patient 208's record was conducted on February 24, 2015. Patient 208 was admitted to the facility on January 22, 2015, with diagnosis that included urinary tract infection (UTI). Patient 208's "History and Physical (H&P)," indicated the patient was an 80 year old female, with a history of frequent urinary tract infections. According to the H&P, Patient 208 suffered from dementia, anxiety and depression and became more confused when she had an UTI.

The following notes were documented in Patient 208's record:

February 1, 2015, at 3:33 a.m., "Pt family visited, updated on POC (plan of care)...skin kept c/d/i (Clean, dry and intact) turned q2h (every 2 hours) and PRN (as needed)..."

February 3, 2015, at 5:42 p.m., "MD visited Pt and spoke to pt's son...Pt repositioned q2 hrs..."

February 3, 2015, at 9:36 a.m., "...Pt (patient) with back bruises...Pt non verbal but groaning, Social Worker involved with Pt..."

February 4, 2015, at 7:04 a.m., "...Bruises noted to Groin and Bilat (Bilateral) hip bone Green/Purple-incont (incontinent) of urine-Pt cleaned before transport-Pt only moans in response to movement..."

On February 5, 2015, at 7:19 p.m., the RN who had been caring for Patient 208 on February 2, 2015, documented the following: "Late Entry, Monday 2/2/15: 1800 (6 p.m.) Pt found this morning with dark ecchymosis at left inner thigh, radiating to pt vagina by CNA (Certified Nursing Assistant)...CNA stated that she had the same patient last week and pt did not have any ecchymosis in that area. Called MD (physician)...in AM, MD stated not to give Lovenox (blood thinner) if ordered and he will come by in the afternoon to see patient. Reported new bruise to Social Worker...Advised CNA to fill out APS (Adult Protective Services) worksheet and explain her concerns. MD arrived in afternoon, reported to Dr...about the ecchymosis, ...MD glanced over Pt and sat down in nursing station, ...Stated 'I wouldn't worry about it.' Pt was in no distress, vitals stable."

Patient 208's electronic medical record had documentation of the patient's assessments in the "Meditech," system. On February 1, 2015, at 8 p.m., the nurse documented bruising to the patient's left groin and hip. On February 2, 2015, at 5:22 p.m., the nurse documented bruising to the patient's left groin and hip.

A review of the "Case Management Report," revealed an entry dated February 5, 2015, at 10:17 a.m. The entry indicated it was a Social Worker (SW) note for February 2, 2015. The SW indicated she had received a call from the case manager about a possible APS referral. The SW spoke with the patient's nurse who reported "CNA had observed medical changes in pt that could be abuse related." The SW provided contact information and education to CNA on how to fill out APS form. According to the documentation by the SW, the CNA was unable to fill out the form at that time and reported she (the CNA) would follow up with call to APS. On February 5, 2015, at 10:23 a.m., the SW documented "Filed APS report...spoke with intake specialist..."

The "Report of Suspected Dependent Adult/Elder Abuse," form completed on February 5, 2015, was reviewed. The form indicated Patient 208 was in an acute care hospital and prior to February 2, 2015, the patient may have been physically assaulted. According to documentation, "CNA and RN (Registered Nurse) reported pt has bruises around vaginal area that was not present on Friday 1/20/15..."

An interview was conducted CNA 1, on February 24, 2015, 2:45 p.m. CNA 1 stated she was providing care for Patient 208, on February 2, 2015, when she asked family members to step outside while she was bathing the patient. CNA 1 stated family members were reluctant to go outside, but eventually did. CNA 1 stated while changing Patient 208, she observed bruising to the patient's groin area. CNA 1 stated she did not know what caused the patient's bruising, but prior to February 2, 2015, "Patient 208's skin was perfect, she did not have any bruising." CNA 1 stated she immediately informed the patient's nurse, about the bruising and about the visitors behavior. CNA 1 stated the nurse evaluated the patient's condition and contacted the charge nurse and the facility's Social Worker. CNA 1 stated she helped position the patient when photographs were taken. CNA 1 stated the SW explained to her (the CNA) that she was a mandated reporter and the APS paperwork would need to be completed. CNA 1 stated she did not have time to complete the document on February 2, 2015, and she did not complete the form prior to leaving for the day.

An interview was conducted with D2 Manager (Manager), on February 24, 2015, at 3:15 p.m. The Manager stated when CNA 1 called her, she immediately went to Patient 208's bedside. The Manager stated it did not look like the patient had been battered, "it looked like she had a bleed and it had migrated when the patient was lying on her side." The Manager stated the SW was called but "we did not call the Risk Manager."

On February 24, 2015, at 3;45 p.m., the Director of D2/Transplant was interviewed. The Director stated staff reported the incident to the Social Worker and the Director believed the SW would report the incident as needed. The Director stated the abuse policy did not get specific as to time frame for reporting, but she would expect an allegation of abuse to be reported the same day. The Director stated staff were unaware the Risk Manager (RM) needed to be notified about the incident. The Director stated the RM was eventually contacted and did interview some of the assigned staff.

An interview was conducted with the Risk Manager (RM) on February 25, 2015, at 1:30 p.m. The RM stated she was not immediately notified about Patient 208's new onset of bruising. The RM stated she was notified by the CN on February 5, 2015, three days after the incident and two days after the patient was discharged to a Board and Care. The RM stated she needed to be notified immediately, as she needed to begin interviewing staff and visitors, to ensure the patient's safety. The RM stated the delay in notifying her, delayed the investigation. The RM stated if the injuries were as a result of abuse, she would contact law enforcement, but after speaking with Manager, they did not believe the injuries were a result of abuse. The RM stated she began to interview staff on February 5, 2015. The RM stated one CNA interviewed indicated there was no care rendered that would cause that type of bruising.

Patient 208's record was re-reviewed. There was no photographic evidence of Patient 208's bruising.

On February 26, 2015, at 10:40 a.m., an interview was conducted with the D2 Manager. The Manager stated she spoke with Patient 208's registered nurse (RN), who stated she never thought the patient's injury was due to abuse.

A review of the training module completed by the facility employees on an annual basis included a section titled "Rapid Regulatory Compliance: Clinical: Part 1." The training module included the following:

a. Patient Assault and Abuse: Protecting Patients: to help protect patient from assault: be aware of the warning signs of abuse;

b. Identifying and Assessing Victims of Abuse and Neglect- As a healthcare provider, you are in a unique position to identify victims of abuse;

c. With regard to victims of abuse and neglect, The Joint Commission requires that accredited facilities: Identify victims of abuse or neglect; Educate healthcare staff; Assess and refer victims to available resources and report abuse and neglect.

The facility policy and procedure titled, "Assault Abuse within the Hospital," with an originated date of April 2011, indicated patients had the right to be free from abuse or any mistreatment by anyone, "including, but not limited to, staff, other patients, consultants, volunteers, staff of other agencies serving the patient, family members, legal guardians, friends or other individuals." Procedures included:

a. The hospital will conduct an investigation in a confidential manner as soon as possible, consistent with the needs of the situation. The investigation will include the person(s) who have potential knowledge of the situation;

b. Any allegation of abuse, assault/battery will be immediately reported to the Director of Risk Management;

c. Conduct a thorough investigation into the allegations;

d. Maintain a record of the allegation, results of the investigation, and any corrective action taken; and

e. Risk Management will keep investigation documentation as it related to the patient's allegation and investigation.

After being notified by CNA 1, that Patient 208 had injuries that could be indicative of abuse, the RN and Social Worker, failed to notify the facility Risk Manager, APS, and/or Law Enforcement, and concluded without investigation that no further intervention and patient protection was required.

Based on observation, interview, and record review, the facility failed to:

1. Develop, measure, analyze, and track quality indicator data from their newly developed observation unit (where patients with multiple diagnoses and needs were being admitted) to determine the appropriateness of admission and delivery of safe and effective care. This failed practice resulted in admissions to the unit that were not consistent with the expected diagnoses and length of stay, and the potential for lack of safe and effective services (nursing, dietary, pharmacy, patient rights) (A273);

2. Ensure a monitoring system was in place to assure patients were opiod tolerant prior to receiving fentanyl transdermal patches for pain control, resulting in the potential for respiratory arrest and death in patients (A273);

3. Ensure actions were taken to prevent further medication errors after an investigation into a medication error resulting in cardiac arrest was carried out, and necessary preventative actions were identified, resulting in the potential for further medication errors that could lead to patient harm or death (A286); and,

4. Ensure an adverse event related to failure to medicate a patient as ordered, and a subsequent fall resulting in a fatal head injury, was appropriately investigated and analyzed, and preventative actions were planned and implemented, resulting in the potential for further medication errors that could lead to patient harm or death (A286).

The cumulative effect of these systemic problems resulted in failure to ensure an effective quality assessment and performance improvement program, focused on prevention of errors and adverse outcomes, and improvement of processes, was implemented and maintained.

Based on observation, interview, and record review, the facility failed:

1. To develop, measure, analyze, and track quality indicator data from their newly developed observation unit (where patients with multiple diagnoses and needs were being admitted) to determine the appropriateness of admission and delivery of safe and effective care. This failed practice resulted in admissions to the unit that were not consistent with the expected diagnoses and length of stay, and the potential for lack of safe and effective services (nursing, dietary, pharmacy, patient rights); and,

2. To ensure a monitoring system was in place to assure patients were opiod tolerant prior to receiving fentanyl transdermal patches for pain control, resulting in the potential for respiratory arrest and death in patients.


Findings:

1. The Performance Improvement and Patient Safety Plan, with an approval date of September 2014, was reviewed on February 24, 2015. The plan indicated performance expectations and measurements would be identified and established during the design of a new system, process, or service.

A review of the facility census on February 24, 2015, indicated there were 267 admitted patients with 249 licensed general acute care beds. Admitted patients were located in the medical surgical/telemetry/cardiovascular (general acute care) units, as well as 25 admitted patients in the Emergency Department (ED), 14 admitted patients in the Outpatient Surgery/Observation Unit, and four adult patients admitted to the Pediatric Unit.

During a facility tour on February 25, 2015, at 10:50 a.m., a sign on the wall in the hallway indicated the facility had a newly labeled, "Observation Unit (OBS)." Upon entering the unit, it was observed to be an aisle with a door to the main hallway at one end, and a nurse's station at the other end. Beds lined the walls on both sides of the aisle, separated by privacy curtains, 15 beds in total. The lights in the unit were on, all controlled by one switch so they could never be turned off for patients to have darkness for sleep. There were no bedside telephones for patients to make phone calls, including to the dietary department to report their meal choices. A sign on the wall in the nurse's station read,"Call daily for breakfast, lunch, and dinner."

During the tour of the OBS Unit, two patients, one male and one female, were observed wearing hospital gowns, while walking from their curtained beds, to the unit's bathrooms. The patient bathrooms were located in the same unit, but around the corner and about 40 feet from the bed at the end of the hall. There were two bathrooms total, one male bathroom and one female bathroom, to be shared between the 15 patients. There were no showers available for patients to use.

Further observation revealed there were no bedside monitors, and a sign on the wall in the nurse's station read, "Please call tele room to verify patient can be seen on monitor and get rhythm."

During a concurrent interview with the Manager of the Observation and Cardiovascular Units, the manager stated the unit was licensed for outpatient surgery patients, but was now used for admitting observation patients. She stated there were 14 patients in the unit with 15 beds. She stated the unit was staffed,"mostly," with float nurses or travelers, at a medical surgical or telemetry ratio. According to the manager, there were currently four registered nurses (RNs) working in the unit. The manager stated patients admitted to the unit should have an expected length of stay of greater than six hours, but they should not be there for more than 24 hours. The manager stated there were four patients in the unit who had been there for two days (Patients 109, 110, 111, and 113), and she did not know who authorized their admission to the unit. The manager stated they were not observation patients, they were higher acuity patients who required inpatient care.

A review of the census indicated 10 patients were admitted to the unit on February 24, 2015, (the previous day), and four patients were admitted to the unit on February 23, 2015 (two days earlier).

Record reviews were conducted and indicated the following:

a. Patient 109 presented to the Emergency Department (ED) on February 23, 2015, with complaints of right sided headaches and weakness for the past few days. She had a history of thyroid disease and hypertension (HTN - high blood pressure). Her heart rate in the ED was 129 (normal 60-100). According to the ED physician's report, she was admitted to the facility at the request of her primary care physician due to concerns about her fast heart rate and headaches associated with right arm weakness (signs of a possible stroke).

The admitting history and physical (H&P) indicated the patient had a history of HTN, hypothyroidism (low thyroid functioning), and anxiety, and had been having severe headaches associated with right sided numbness and blurred vision for three days.

Patient 109 was admitted to the observation unit with diagnoses that included severe headaches (complex migraines versus other pathology [abnormality], HTN, hypothyroidism, and anxiety. The plan included treatment of the headaches with oral and intravenous pain medications, a neurology consult, blood pressure medications, thyroid labs and medications, medication for anxiety, medication to decrease the acid content in the stomach caused by stress, and medication to prevent development of clots in the legs caused by prolonged time in the bed.

She was still in the unit two days later.

b. Patient 110 was accepted as a transfer to the facility (at at time when the facility had no empty general acute care beds available) from a different facility on February 23, 2015, after being treated there for complaints of Bell's Palsy (paralysis of one side of the face) and feeling like his heart was skipping a beat. The examination at the other facility indicated Patient 110 had bradycardia (a slow heart rate) and an elevated troponin level (a lab value that is indicative of injury to the heart muscle).

The ED physician's record indicated his heart rate was 57 and 52 respectively (normal 60-100), his electrocardiogram (EKG) showed changes in the inferior wall of his heart that was indicative of possible damage to the heart muscle, and his care was being transitioned to inpatient service for further evaluation and care.

The admitting H&P indicated he was being admitted for observation for acute coronary syndrome and placed on telemetry, an echocardiogram would be ordered, and a consult would be done with a cardiologist.

Patient 110 had a lexiscan procedure (intravenous (IV) cardiac and nuclear medication injection with a heart scan to determine if reversible damage has occurred in the heart muscle) done on February 24, 2015 (the day after he was admitted to the observation unit), that showed reversible damage to the heart muscle with abnormal pumping of the heart. He was sent back to the observation unit following the test, and scheduled to have a cardiac catheterization (injecting contrast into the coronary arteries and the left ventricle to assess the blood flow to the heart and the pumping function of the ventricle) the following day.

He was still in the unit two days later.

A review of the census on February 26, 2015, indicated Patient 110 was still in the observation unit (three days after admission).

c. Patient 111 presented to the ED on February 23, 2015, complaining of feeling dizzy and unsteady on his feet for one day, with diplopia (double vision). The ED physician's report indicated the patient had a history of diabetes and HTN, and the computerized axial tomography (CT) scan of his brain showed a one centimeter area of concern that appeared as if there was blood in the brain. The record indicated Patient 111 was being transitioned to the inpatient service for further care.

The admitting H&P indicated Patient 111 was admitted to the observation unit with a diagnosis of intracerebral hemmorhage (bleeding into the brain), with a plan to obtain a magnetic resonance imaging (MRI) of his brain and a neuro (neurology/neurosurgery) consult.

He was still in the unit two days later.

A review of the census on February 26, 2015, indicated Patient 111 was still in the observation unit (three days after admission).

d. Patient 204 was accepted as a transfer to the facility (with no empty general acute care beds available) from a different facility on February 24, 2015, at 9:02 a.m., due to Non-ST elevation myocardial infarction (heart attack) and pneumonia. Physician's orders for Patient 204 included telemetry (heart monitoring) and vital signs every 2 hours. Patient 204 was also receiving the antibiotic Zosysn every eight hours to treat pneumonia (infection of the lungs).

The admitting H&P indicated Patient 204 was being admitted for coronary angiography (injecting contrast into the coronary arteries and the left ventricle to assess the blood flow to the heart and the pumping function of the ventricle).

Patient 204 was admitted to the observation unit at 9:02 a.m., and was transferred to the cath lab at 3:10 p.m. Patient 204 was sent back to the observation unit, on February 24, 2015, at 4:40 p.m.

Patient 204's angiogram findings indicated the patient had significant blockage and the physician would be discussing coronary angioplasty (minimally invasive procedure to open blocked arteries) or bypass graft (open heart surgery) with the patient's son.

Patient 204 remained in the observation unit until February 25, 2015, at 2:30 p.m., when she was transferred to the cardiovascular unit (29 hours and 28 minutes after she was admitted to the observation unit).

During a tour of the telemetry room on February 25, 2015, at 11:30 a.m., three monitor technicians (MTs) were observed sitting in a room with three banks of telemetry monitoring screens.

During a concurrent interview with MT 1, the MT stated each of them was responsible for monitoring up to 48 heart rhythms, and the total number of patients that could be monitored in the room was 144. The MT stated they did not know the baseline rhythms for all of the patients they were monitoring, and would not necessarily know when a patient's rhythm changed unless it was a "dangerous" rhythm. He stated they were monitoring for and reporting "dangerous" rhythms only. MT 1 had the patients in the Observation unit in his bank of monitors, and stated he saw only 11 observation patient rhythms, not 14.

The rhythm for Patient 110 was observed to be a normal sinus rhythm with frequent premature atrial contractions (PACs) (a usually benign, early beat of the heart that can be described by the patient as a skipped beat or a jolt in the chest - as Patient 111 complained of).

On February 26, 2015, at 9:30 a.m., RN 3 was observed providing care in the "Observation Unit." RN 3 stated she had to get Patient 206's medication from the pharmacy as it was not in the unit.

During an interview with the Observation Unit Manager, on February 26, 2015, at 10:10 a.m., the Manager stated they did not have a pyxis refrigerator in the unit, so they had to obtain medications from the pharmacy. In addition, the Manager stated as the patient's were transient (short stay or transfers), daily medications were not sent to the unit. The Manager stated the patient's nurse would call the pharmacy about an hour before the patient's medication was due, to receive the medication.

During an observation of the OBS unit on February 26, 2015, between 9:30 and 10:15 a.m., there were 15 patients in the unit with each privacy curtain closed around the respective bed. A 68 year old female, admitted the previous day for complaints of chest pain, was heard yelling through the curtain, "it's hot in here." Staff opened the curtains, and exposed the patient to the other patients, staff, and visitors in the unit.

The facility policy titled, "Plan for the Provision of Patient Care - Scope of Service," was reviewed on February 26, 2015. The policy indicated the following:

A. The observation unit was used to care for patients requiring further management, specifically to determine the need for inpatient admission, who met criteria for medical, surgical, and telemetry level of care up to a 24 hour stay;

B. The observation unit was for patients where diagnosis, treatment, stabilization, and discharge could reasonably be expected within 24 hours;

C. Acceptable diagnoses for the Observation unit included diagnoses such as non-specific chest pain (chest pain without an identified cause), anemia, non-titrated IV medications (not needing to increase and decrease rates to manage symptoms), cardiac arrhythmias (abnormal heart rhythms), elective angiograms, interventional radiology procedures, and same day surgery;

D. Acceptable diagnoses for the Cardiovascular unit (CVU) included acute myocardial infarction (heart attack) (the diagnosis Patient 204 had), cardiac dysrhythmias (abnormal heart rhythms), and stroke (the type of diagnoses Patients 109 and 111 had). Staffing in the unit was one nurse for every three patients, and the nursing staff provided continuous cardiac monitoring; and,

E. The Progressive Care unit (PCU) was for patients who were stable with the potential for becoming unstable. Acceptable diagnoses for the PCU included stable myocardial infarction and acute coronary syndrome (the diagnosis Patient 110 had). Staffing in the unit was one nurse for every three patients, and the nursing staff provided continuous cardiac monitoring.

During an interview with the Vice President (VP) of Quality on February 25, 2015, at 2:30 p.m., the VP stated Patients 109, 110, 111, and 204 should have been admitted to the inpatient areas, but there were no rooms available for them.

During an interview with the VP of Quality on February 26, 2015, at 1:55 p.m., the VP stated there was no data being collected or analyzed to determine the appropriateness of the diagnoses, length of stay, or care needs of the patients being admitted to the observation unit.

2. Review of the clinical record for Patient 501 on February 26, 2015, with the clinical pharmacy manager (CPM) and Director of Pharmacy (DPH), revealed that he was admitted to the hospital on January 31, 2015, for complaints of worsening shortness of breath. Patient 501 was diagnosed with stage four lung cancer in December 2014, and had a history of tobacco use and chronic obstructive pulmonary disease (COPD). The following narcotic (opioid) pain medications were prescribed for pain relief during his hospital stay:

1. January 31, 2015, Morphine Sulfate 4mg (milligrams) intravenously (IV) every six hours as needed for severe pain;

2. January 31, 2015, Norco 5/325 mg; two tablets by mouth every four hours as needed for moderate pain;

3. February 3, 2015, Morphine Sulfate 15 mg tablet by mouth every 12 hours; and,

4. February 4, 2015, Fentanyl patch 25 mcg (micrograms)/hour; apply one patch every 72 hours.

Review of the medication administration record (MAR) with the CPM showed the above opioid medications were administered on the following dates and times:

Norco 5 mg was given on February 2, 2015, at 2:54 p.m., and February 3, 2015, at 11:35 a.m.;

Morphine sulfate 4mg intravenous (IV) was given on February 3, 2015, 7:28 p.m., and on February 4, 2015, at 12:03 p.m., and at 12:45 p.m. hours;

Morphine sulfate 15mg tablet was given on February 3, 2015 at 9:45 a.m., and on February 4, 2015 at 8:58 a.m.

Further review of his medication administration record (MAR) also revealed fentanyl 25 mcg/hour transdermal patch (topical narcotic pain relief patch) was later administered on February 4, 2015, at 3:49 p.m., by his nurse.

According to the hospital medication reconciliation record dated January 31, 2015, there was no documented evidence that Patient 501 was on any form of opioid pain medication prior to hospital admission. Based on the duration and the amount of opioid exposure prior to administration of the fentanyl patch, Patient 501 was improperly prescribed and subsequently administered a fentanyl patch according to the Food and Drug Adminisration (FDA) boxed warning.

The boxed warning for transdermal Duragesic (topical narcotic type pain relief medication; also called fentanyl patches), which the FDA required to be included with all containers of the drug, read, "Duragesic (brand name for transdermal fentanyl) is ONLY for use in patients who are already tolerant to opioid (narcotic type pain relief medications) therapy of comparable potency. Use in non-opioid tolerant patients may lead to fatal respiratory depression."

Also included in the warning was, "Duragesic should ONLY be used in patients who already are receiving opioid therapy who have demonstrated opioid tolerance, and who require a total daily dose at least equivalent to Duragesic 25 mcg/hour. Patients who are considered opioid-tolerant are those who have been taking, for a week or longer, at least 60 mg of morphine (an opioid) daily, or at least 30 mg of oral oxycodone (an opioid) daily, or at least 8 mg of oral hydromorphone (an opioid) daily or an equianalgesic dose of another opioid."


During an interview with the CPM and the DPH on February 26, 2015, at 11:43 a.m., they both acknowledged that Patient 501 had not been on the opioid pain medications long enough to be considered opioid tolerant according to the FDA's boxed warning definition. They also confirmed there was currently no hospital guideline or procedure for prescribing or reviewing a fentanyl patch order to ensure that the patient was opioid tolerant prior to receiving any fentanyl patch.

Based on interview and record review, the facility failed to ensure:

1. Actions were taken to prevent further medication errors after an investigation into a medication error resulting in cardiac arrest was carried out, and necessary preventative actions were identified; and,

2. An adverse event related to failure to medicate a patient as ordered, and a subsequent fall resulting in a fatal head injury, was appropriately investigated and analyzed, and preventative actions were planned and implemented.

These failed practices resulted in the potential for further medication errors that could lead to patient harm or death.

Findings:

The Performance Improvement and Patient Safety Plan, with an approval date of September 2014, was reviewed on February 24, 2015. The plan indicated the following:

a. Goals included reducing medical/health system errors by identifying and managing risks to patient safety;

b. Objectives included facilitating an environment that encouraged recognition and acknowledgement of risks to patient safety and medical errors, and initiating action to reduce those risks;

c. Information from data analysis would be used to implement change that would improve the quality of care and patient safety; and,

d. After necessary actions were determined and implemented, they would be monitored and evaluated to assure effective change.

1. During the investigation of an entity reported incident on January 7, 2015, the following was revealed:

Patient 100 was admitted to the facility on December 3, 2014, with diagnoses that included diabetes, hypertension (HTN), hyperlipidemia (high levels of fat in the blood - such as cholesterol), left bundle branch block (LBBB - cardiac rhythm abnormality), and worsening of previously diagnosed congestive heart failure (CHF).

According to the record, Patient 100 was taken to the cardiac cath lab on December 5, 2014, for a right and left heart catheterization (using catheters and contrast to measure pressures in the heart, view the coronary arteries and assess for blockages, and determine the pumping effectiveness of the ventricle).

The cath lab progress notes indicated the following:

a. Patient 100 was placed on the cath lab table at 8:41 a.m.;

b. The procedure was started at 8:54 a.m., and completed at 9:17 a.m. During the procedure, a blockage was seen in the middle portion of the left anterior descending (LAD) coronary artery, and the cardiologist decided to perform a fractional flow reserve (FFR - an elective procedure, not an emergency) test to determine how significant the blockage was;

c. At 9:17 a.m., the patient's blood pressure (BP) was normal at 121/79 (normal 120/80), with a normal heart rate of 64 (normal 60-100);

d. At 9:18 a.m., an angiomax bolus was administered intravenous (IV) (to prevent blood clots from forming during the procedure), and the catheter for the procedure was inserted;

e. At 9:21 a.m., a continuous infusion of angiomax was started;

f. At 9:22 a.m., the patient's BP was 131/86 (normal), and his heart rate was 61 (normal). The guidewire for the procedure was inserted;

e. At 9:27 a.m., adenosine (a medication that causes a fast acting/short lasting vasodilation [arteries open bigger and wider] and slowing of the heart to determine how big the vessel is and how adequate the flow is distal to [past] the blockage) was started IV at a fast rate (646 ml [milliliters] per hour);

f. At 9:27 a.m. (the same time), the nurse realized that an error had occurred, and adrenaline (epinephrine - a medication that causes a sudden onset of vasoconstriction [arteries become smaller] and increase in heart rate and blood pressure) was started instead of adenosine, at the same rate, and given for a duration of 15 seconds for a total of 0.99 mg of epinephrine IV;

g. At 9:27 a.m. (seconds later), the patient's blood pressure (BP) increased to 254/149;

h. At 9:28 a.m., Patient 100 was complaining of difficulty breathing, and a code blue was called;

i. At 9:29 a.m., the code team arrived and cardiopulmonary resuscitation (CPR) was started.

According to the record, the patient's heart rate increased to 175, but CPR was continued due to inability to obtain a BP until 9:35 a.m. (for six minutes). Patient 100 was intubated (a tube was inserted into his mouth, past his vocal chords, and into his trachea to assist in giving him artificial breathing). One hour later he was stabilized and transferred to the intensive care unit (ICU).

The Code Blue Report, dictated December 5, 2014, at 12:08 p.m., indicated a blockage was seen in the middle portion of the left anterior descending (LAD) coronary artery, and the cardiologist decided to perform a fractional flow reserve (FFR) test to determine how significant the blockage was. According to the report, instead of receiving adenosine (as ordered and planned) (a medication that causes a fast acting/short lasting vasodilation [arteries open bigger and wider] and slowing of the heart to determine how big the vessel is and how adequate the flow is distal to [past] the blockage), the patient received received adrenaline (epinephrine - a medication that causes a sudden onset of vasoconstriction [arteries become smaller] and increase in heart rate and blood pressure [BP]).

The patient complained of severe chest pain, his BP increased to approximately 300 systolic (top number - normal 120), then he started having shortness of breath and was coughing up copious (extremely large) amounts of blood. A code blue was called, and cardiopulmonary resuscitation (CPR) was started and continued for approximately five minutes until a pulse was felt. The patient was intubated (a tube was inserted into his mouth, past his vocal chords, and into his trachea to assist in giving him artificial breathing), stabilized, and transferred to the intensive care unit (ICU).

The facility reference titled, "ADENOSINE PREPARATIONS," was reviewed on February 26, 2015. The reference indicated intravenous (IV) adenosine for use in the cath lab FFR procedure was to be mixed as follows:

A. Remove 40 cc (milliliters) of normal saline from a 100 cc bag;

B. Add one vial (90 mg/30 cc [milligrams/milliliters]) of adenosine;

C. Result is (1 mg/cc) 90 mg adenosine in 90 cc normal saline;

D. Dosage to be infused is 140 mcg/kg/min (micrograms per kilogram per minute); and,

E. Drip rate to be used is 8.4 X pt weight (kg) (times the patient's weight in kilograms).

During an interview with the Cath Lab Director (CLD) on January 7, 2015, at 10:20 a.m., and on February 26, 2015, at 12:40 p.m., the director stated Patient 100 had a heart cath done in mid December. The director stated a blockage was identified, and the cardiologist wanted to perform an FFR to determine the severity of the blockage and the possible need for intervention to open the vessel. The director stated the physician ordered Cath Lab Registered Nurse (CLRN) 1 to proceed with preparation of angiomax and adenosine infusions.

The director stated CLRN 1 removed angiomax from the pyxis station (automated dispensing cabinet), and handed it to her colleague (CLRN 2) to prepare. The director stated CLRN 1 then removed adenosine from the pyxis station, prepared an infusion, then handed it to CLRN 2 to prime the tubing and set the infusion rate on the pump. The infusion was readied and started by CLRN 2.

According to the director, after the adenosine infusion was started, CLRN 1 went to scan the medication and label the bag, and realized she had mixed an adrenaline infusion instead of an adenosine infusion. CLRN 1 notified the physician, the infusion was stopped, and the patient began to decompensate, requiring intubation, CPR, and a transfer to ICU.

The director stated the facility investigation revealed CLRN 1 removed adrenoline from the pyxis instead of adenosine, assumed it was the correct medication, and did not check the vial. The director stated CLRN 1 did not scan the medication until after she mixed the infusion, and did not label the bag until after the infusion was started.

In order for the incorrect medication to be infused, the following failures occurred:

a. CLRN 1 removed the wrong medication from the pyxis station, not verifying the medication when she removed it;

b. CLRN 1 failed to scan the medication vial when she removed it;

c. CLRN 1 mixed the infusion, using the wrong medication vial;

d. CLRN 1 failed to label the medication infusion bag until after it was started;

e. CLRN 1 handed an unlabeled medication bag to CLRN 2 for the infusion to be started; and,

f. CLRN 2 accepted an unlabeled IV medication bag and started an infusion.

The facility investigation was reviewed on January 7 and again on February 26, 2015, with the Vice President (VP) of Quality. The investigation identified actions that needed to be taken to prevent reoccurrence of the error as follows:

a. Registered Nurses (RNs) to follow medication administration policy;

b. Review/research for competencies for RNs mixing/preparing medications;

c. Review procedure for medication administration (including handing off medications to other nurses); and,

d. Consider having pharmacy mix/prepare all intravenous (IV) infusions.

During an interview, the VP stated the nurses would continue to mix/prepare IV infusions in the specialty areas, and they had a reference to use if they had questions. The VP stated she did not know whether competency verification had been done for the nurses who mixed/prepared IV infusions (a requirement according to the medication administration policy, and a necessary action item according to the facility investigation). She stated the cath lab director would know.

During an interview with CLRN 3 on February 24, 2015, the RN stated the nurses in the cath lab currently prepared/mixed four different medications for infusion; angiomax, adenosine, neosynephrine (for blood pressure support), and levophed (for blood pressure support).

The facility policy titled, "Medication Administration," was reviewed on Janaury 7 and February 26, 2015. The policy indicated all staff administering medications at the facility would have their competence validated prior to administering medications and periodically thereafter.

A review of cath lab education records indicated in January 2012 (three years earlier) 10 of 19 nurses from the cath lab demonstrated competency in mixing IV infusions. The list did not include CLRN 1. There was no evidence the facility ever verified CLRN 1 was competent to mix IV infusions. There was no evidence CLRN 2 had demonstrated competence in mixing IV infusions for the past three years.

During an interview with the CLD on February 26, 2015, at 12:40 p.m., the director stated the department had not done competency verification for nurses preparing IV infusions since he started working there (for two years).

2. During the investigation of an adverse event on December 9, 2014, the record for Patient 112 was reviewed with the Director of Quality (DQ), and the Emergency Department (ED) Manager. Patient 112, a 52 year old male, was admitted to the facility on November 24, 2014, at 11:33 p.m., with diagnoses that included hypertensive urgency (abnormally high blood pressure that must be lowered).

The History and Physical dated November 25, 2014, indicated "Assessment and plan: The patient presented to outside hospital with a systolic blood pressure 245 over a diastolic of 100. He had accompanying shortness of breath...on exam he does have bibasilar lung sounds (abnormal) and his blood pressure is markedly elevated...the patient will benefit most from a nephrology (kidney) consult for dialysis as well as titration (to continuously measure) of blood pressure medications..."

(Normal blood pressure range is less than 120 mm systolic, and less than 80 mm diastolic. Reference from American Heart Association).

The nurse's notes indicated on November 25, 2014, at 7:28 a.m., RN 1 notified the physician that Patient 112's blood pressure was 219/110, and received an order to give Patient 112 the medication Hydralazine (a medication used to lower/control elevated blood pressure).

The nurse's note entry for 7:34 a.m., indicated "Pt (patient) report given to...RN 5. Pt care transferred...RN 5 aware of new order for Hydralazine IVP (intravenous push - given into a vein)."

The admission assessment dated November 25, 2014, at 7:30 a.m., indicated "...awaiting Hydralizine for elevated B/P (blood pressure)."

The nurse's notes (late) entry dated November 25, 2014, at 4:40 p.m., indicated "09:58 a.m....Found Patient 112 lying on floor with obvious bleeding...SBP 255/168..."

The medication administration record indicated Patient 112 received the medication to lower his elevated blood pressure at 10:36 a.m., three hours and eight minutes after the RN received the order, and 28 minutes after Patient 112 was found on the floor with a head injury.

Patient 112 was admitted with diagnoses to include elevated blood pressure. There was a physician's order to give medication to lower Patient 112's blood pressure.The RN did not administer the medication ordered to control Patient 112's blood pressure in a timely manner. Patient 112 was found on the ED bathroom floor with a blood pressure of 255/168.

The Coroner's investigation report indicated Patient 112 died on December 7, 2014, from a brain hemorrhage which resulted from blunt force head trauma following the fall in the ED on November 25, 2014.


During an interview with the Director of Risk Management (DRM), on December 9, 2014, at 12:45 p.m., the DRM stated the facility had completed an investigation of the incident and determined Patient 112 was stable prior to his fall and able to ambulate to the bathroom without assistance. The DRM stated the facility determined Patient 112's fall was an unavoidable accident.

The DRM stated she was unaware of Patient 112's elevated blood pressure, the delay in physician call back , and the delay in the treatment for an elevated blood pressure. She stated these issues did not come during the investigation.

The DRM stated the incident involving Patient 112 would be reviewed again with Department heads.

Based on interview and record review, the facility failed to ensure it provided an organized nursing service to all patients by failing to ensure:

1. An initial skin assessment and interventions were implemented for one sampled patient (Patient 406) according to the facility policy. (A396);

2. Implementation and documentation for tracheostomy care was performed per facility policy for one sampled patient (Patient 408). (A396);

3. Registered Nurses (RNs) in the cardiac cath lab demonstrated competency in mixing critical intravenous (IV) medications for infusion during cardiac procedures prior to assigning them the task, resulting in a significant medication error and cardiac arrest of one patient (Patient 100) (A397);

4. Labor and Delivery (L&D) registered nurses (RNs) were qualified to perform a Medical Screening Exam (MSE), as per policy. The RNs did not have their competency to perform an MSE validated by an Obstetrician on staff, and MSE was not part of the L&D RN's annual competencies, resulting in RNs performing MSEs (a standardized procedure) without validated competencies (A397);

5. Intravenous (IV) medications were prepared and administered correctly and by competent individuals when the wrong IV medication was prepared and infused to one patient (Patient 100), resulting in cardiac arrest requiring resuscitation (A405);

6. One patient (Patient 112) received medication to lower his blood pressure in a timely manner. This failed practice may have resulted in the death of Patient 112. (A405); and

7. Medications were prepared in the pharmacy and sent to the observation unit to be administered to patients prior to the time they were due to be given, resulting in medications being administered late. (A405).

The cumulative effects of these systemic problems resulted in failure of the nursing department to ensure care was being provided in a safe and effective manner.

Based on interview and record review the facility failed to:

1. Ensure an initial skin assessment and interventions were implemented for one sampled patient, (Patient 406) per facility policy; and

2. Ensure implementation and documentation for tracheostomy care was performed per facility policy for one sampled patient, (Patient 408).

These failed interventions had the potential to delay the necessary care and treatment of Patients 406 and 408's skin conditions which had the potential to decrease wound healing and prolong hospital stay.

Findings:

1. According to the National Pressure Ulcer Advisory Panel, an unstageable pressure ulcer is a full thickness skin or tissue loss - depth unknown. (Full thickness tissue loss in which actual depth of the ulcer is completely obscured by slough (yellow, tan, gray, green or brown) and/or eschar (tan, brown or black) in the wound bed). Until enough slough and/or eschar are removed to expose the base of the wound, the true depth cannot be determined.

Record review was conducted for Patient 406's on February 26, 2015. The record indicated Patient 406 was admitted to the facility with an unstageable coccyx (low back) pressure wound on February 19, 2015. The admission assessment Braden score (risk for skin breakdown) for Patient 406 was 19 (high risk). The facility's first measurement of the coccyx wound was on February 22, 2015, three days after Patient 406's admission. The unstageable coccyx wound measured 2 centimeters (cm) long by 2 cm wide, with no depth.

An interview was conducted with the Surgical Intensive Care Unit Manager (SICM) on February 26, 2015, at 11:45 a.m. The SICM stated," The admitting nurse who documented the unstageable skin issue on February 19, 2015, should have documented the measurements." Record review was conducted with the SICM present. The SICM stated "The nurses should have followed up and requested a physician order for a Wound Consult."

As of February 26, 2015, a wound consult was not ordered for Patient 406, seven days after admission with an unstageable pressure ulcer and a Braden score of 19 (which indicated high risk for further skin breakdown).

Record review of the facility policy titled, "Photography of Skin Conditions," revised October 2014, indicated, "...A full wound assessment should minimally include: wound type, stage, (if pressure ulcer related) measurements, drainage type and amount, odor, wound base tissue, types and percentages, periwound surrounding skin,...any other findings as well as how the affected area was cleaned, prepped, and type of dressing applied." The policy further indicated,"Consults can be requested for the at risk patient when there is an identified need...wound debridement or wound care specialist consultation with difficult to manage wounds or high risk for skin breakdown."

2. Patient 408 was admitted to the facility on February 23, 2015, with the diagnosis of multiple facial lacerations post motor vehicle accident which required placement of a tracheostomy (temporary or permanent airway surgically placed in the lower neck). Patient 408's tracheostomy was placed on February 23, 2015.

Record review was conducted for Patient 408 on February 26, 2015. The record indicated Patient 408 had two documented entries for a twenty four hour period regarding post operative care (dressing change and assessment) of her tracheostomy; one entry documented at 4 a.m. and one entry documented at 8 p.m., both on February 24, 2015.

An interview was conducted with the Surgical Intensive Care Unit Manager (SICM) on February 26, 2015 at 11:50 a.m. The SICM stated, "The facility policy post tracheostomy was for nursing to assess, administer (skin care), and document the skin status of a new tracheostomy every four hours post placement (for twenty four hours)."

Documentation on Patient 408's record indicated the nurses did not document their assessment and interventions per facility policy every four hours post tracheostomy placement.

A record review of the facility policy titled, "Tracheostomy Care," revised September 2012, indicated,"...Patients with less than twenty four hours (24) post-op tracheostomy will receive trach care every four hours."

Based on interview and record review, the facility failed to ensure:

1. Registered Nurses (RNs) in the cardiac cath lab demonstrated competency in mixing critical intravenous (IV) medications for infusion during cardiac procedures prior to assigning them the task, resulting in a significant medication error and cardiac arrest of one patient (Patient 100); and,

2. Labor and Delivery (L&D) registered nurses (RNs) were qualified to perform a Medical Screening Exam (MSE), as per policy. The RNs did not have their competency to perform an MSE validated by an Obstetrician on staff, and MSE was not part of the L&D RN's annual competencies, resulting in RNs performing MSEs (a standardized procedure) without validated competencies.

Findings:

1. During the investigation of an entity reported incident on January 7, 2015, the following was revealed:

Patient 100 was admitted to the facility on December 3, 2014, with diagnoses that included diabetes, hypertension (HTN), hyperlipidemia (high levels of fat in the blood - such as cholesterol), left bundle branch block (LBBB - cardiac rhythm abnormality), and worsening of previously diagnosed congestive heart failure (CHF).


Patient 100 was taken to the cardiac cath lab on December 5, 2014, for a right and left heart catheterization (using catheters and contrast to measure pressures in the heart, view the coronary arteries and assess for blockages, and determine the pumping effectiveness of the ventricle).

A Code Blue Report, dictated December 5, 2014, at 12:08 p.m., indicated a blockage was seen in the middle portion of the left anterior descending (LAD) coronary artery, and the cardiologist decided to perform a fractional flow reserve (FFR - an elective procedure, not an emergency) test to determine how significant the blockage was. According to the report, instead of receiving adenosine (a medication that causes a fast acting/short lasting vasodilation [arteries open bigger and wider] and slowing of the heart to determine how big the vessel is and how adequate the flow is past the blockage) as ordered, the patient received adrenaline (epinephrine - a medication that causes a sudden onset of vasoconstriction [arteries become smaller] and increase in heart rate and blood pressure [BP]).

The facility reference titled, "ADENOSINE PREPARATIONS," was reviewed on February 26, 2015. The reference indicated intravenous (IV) adenosine for use in the cath lab FFR procedure was to be mixed as follows:

A. Remove 40 cc (milliliters) of normal saline from a 100 cc bag;

B. Add one vial (90 mg/30 cc [milligrams/milliliters]) of adenosine;

C. Result is (1 mg/cc) 90 mg adenosine in 90 cc normal saline;

D. Dosage to be infused is 140 mcg/kg/min (micrograms per kilogram per minute); and,

E. Drip rate to be used is 8.4 X pt weight (kg) (times the patient's weight in kilograms).

According to the code blue record, the patient complained of severe chest pain, his BP increased to approximately 300 systolic (top number - normal 120), then he started having shortness of breath and was coughing up copious (extremely large) amounts of blood. A code blue was called, and cardiopulmonary resuscitation (CPR) was started and continued for approximately five minutes until a pulse was felt. The patient was intubated (a tube was inserted into his mouth, past his vocal chords, and into his trachea to assist in giving him artificial breathing), stabilized, and transferred to the intensive care unit (ICU).

During an interview with the Cath Lab Director (CLD) on January 7, 2015, at 10:20 a.m., and on February 26, 2015, at 12:40 p.m., the director stated Patient 100 had a heart cath done in mid December. The director stated a blockage was identified, and the cardiologist wanted to perform an FFR to determine the severity of the blockage and the possible need for intervention to open the vessel. The director stated the physician ordered Cath Lab Registered Nurse (CLRN) 1 to proceed with preparation of angiomax (to prevent blood from clotting) and adenosine infusions.

The director stated CLRN 1 removed angiomax from the pyxis station (automated dispensing cabinet), and handed it to her colleague (CLRN 2) to prepare. The director stated CLRN 1 then removed adenosine from the pyxis station, prepared an infusion, then handed it to CLRN 2 to prime the tubing and set the infusion rate on the pump. The infusion was readied and started by CLRN 2.

According to the director, after the adenosine infusion was started, CLRN 1 went to scan the medication and label the bag, and realized she had mixed an adrenaline infusion instead of an adenosine infusion. CLRN 1 notified the physician, the infusion was stopped, and the patient began to decompensate, requiring intubation, CPR, and a transfer to ICU.

The director stated the facility investigation revealed CLRN 1 removed adrenoline from the pyxis instead of adenosine, assumed it was the correct medication, and did not check the vial. The director stated CLRN 1 did not scan the medication until after she mixed the infusion, and did not label the bag until after the infusion was started.

In order for the incorrect medication to be infused, the following failures occurred:

a. CLRN 1 removed the wrong medication from the pyxis station, not verifying the medication when she removed it;

b. CLRN 1 failed to scan the medication vial when she removed it;

c. CLRN 1 mixed the infusion, using the wrong medication vial;

d. CLRN 1 failed to label the medication infusion bag until after it was started;

e. CLRN 1 handed an unlabeled medication bag to CLRN 2 for the infusion to be started; and,

f. CLRN 2 accepted an unlabeled IV medication bag and started an infusion.

During an interview with CLRN 3 on February 24, 2015, the RN stated the nurses in the cath lab currently prepared/mixed four different medications for infusion; angiomax, adenosine, neosynephrine (for blood pressure support), and levophed (for blood pressure support).

The facility policy titled, "Medication Administration," was reviewed on January 7 and February 26, 2015. The policy indicated all staff administering medications at the facility would have their competence validated prior to administering medications and periodically thereafter.

A review of cath lab education records indicated in January 2012 (three years earlier) 10 of 19 nurses from the cath lab demonstrated competency in mixing/preparing IV infusions. The list did not include CLRN 1. There was no evidence the facility ever verified CLRN 1 was competent to mix/prepare IV infusions. There was no evidence CLRN 2 (or any other cath lab nurses) had demonstrated competence in mixing/preparing IV infusions for the past three years.

The employee file for CLRN 1 was reviewed on February 26, 2015. The file indicated on July 2, 2014, CLRN 1 received a final written warning after she administered an incorrect medication to a patient. The recommended action for CLRN 1 was to administer correct patient medications as ordered by the physician. There was no evidence of action taken to determine the cause of the July 2014 error, determine the need for education or training, or monitor the nurse for competence in medication administration.

During an interview with the CLD on February 26, 2015, at 12:40 p.m., the director stated the department had not done competency verification for nurses preparing IV infusions since he started working there (for two years). The director stated CLRN 1 had been disciplined in July for a medication error, and there was no remediation or monitoring done after the discipline was completed.



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2. On February 25, 2015, at 10 a.m., Registered Nurse 10 was interviewed. RN 10 stated she worked in L&D, and was able to perform MSEs. RN 10 stated she was "checked off" and was competent to perform an MSE. RN 10 stated an RN has to have worked in the department "awhile" before being allowed to perform an MSE.

On February 26, 2015, at 1:30 p.m., the "Obstetric Medical Screening Competency Report," was reviewed with the Labor and Delivery Manager (LDM). RN 10's name did not appear on the report. The LDM stated the report was old, and she did not have a current report to list all nurses that were checked off. The LDM further stated all nurses currently working in L&D were considered competent to perform MSEs.

On February 26, 2015, the employee file for RN 11 was reviewed. There was no documented evidence of an initial competency to perform an MSE. In addition, MSEs were not part of the annual competencies for 2014.

On February 26, 2015, at 1:30 p.m., the Labor and Delivery Manager (LDM) was interviewed. The LDM stated RN 11's name appeared on the "Obstetric Medical Screening Competency Report," dated August 2010, but was unable to find the documented evidence of the initial competency being validated by an obstetrician (OB). The LDM stated all the RNs were "checked off" by another RN (not by an OB doctor), and required to take an exam, to verify competency to perform an MSE. The LDM further stated, the standardized procedure for an MSE was not part of annual competencies for L&D RNs.

The policy and procedure titled, "Standardized Procedure --SP-18 Medical Screening Exam (MSE) Process," dated June 2013, was reviewed. The policy indicated, "Qualified to perform... A Qualified Registered Nurse who has been competency validated for the Labor and Delivery Medical Screening Exam." The policy defined competency validated as:

"i. Qualifications for Registered Nurses: Completes competency for Medical Screening Exam, validated by medical staff with privileges in Obstetrics...
ii. Evaluations: Initial evaluation at completion of orientation and then annually from date of hire... Annual employee evaluation will include core competencies.
iii. Written Record: A list of person authorized to perform the standardized function will be kept on file with Nursing Administration and in the Labor and Delivery Department and will be updated concurrently..."

Based on interview and record review, the facility failed to ensure:

1. Intravenous (IV) medications were prepared and administered correctly and by competent individuals when the wrong IV medication was prepared and infused to one patient (Patient 100), resulting in cardiac arrest requiring resuscitation;

2. One patient (Patient 112) received medication to lower his blood pressure in a timely manner. This failed practice may have resulted in the death of Patient 112; and,

3. Medications were prepared in the pharmacy and sent to the observation unit to be administered to patients prior to the time they were due to be given, resulting in medications being administered late.

Findings:

1. During the investigation of an entity reported incident on January 7, 2015, the following was revealed:

Patient 100 was admitted to the facility on December 3, 2014, with diagnoses that included diabetes, hypertension (HTN), hyperlipidemia (high levels of fat in the blood - such as cholesterol), left bundle branch block (LBBB - cardiac rhythm abnormality), and worsening of previously diagnosed congestive heart failure (CHF).

According to the record, Patient 100 was taken to the cardiac cath lab on December 5, 2014, for a right and left heart catheterization (using catheters and contrast to measure pressures in the heart, view the coronary arteries and assess for blockages, and determine the pumping effectiveness of the ventricle).

The cath lab progress notes indicated the following:

a. Patient 100 was placed on the cath lab table at 8:41 a.m.;

b. The procedure was started at 8:54 a.m., and completed at 9:17 a.m. During the procedure, a blockage was seen in the middle portion of the left anterior descending (LAD) coronary artery, and the cardiologist decided to perform a fractional flow reserve (FFR - an elective procedure, not an emergency) test to determine how significant the blockage was;

c. At 9:17 a.m., the patient's blood pressure (BP) was normal at 121/79 (normal 120/80), with a normal heart rate of 64 (normal 60-100);

d. At 9:18 a.m., an angiomax bolus was administered intravenous (IV) (to prevent blood clots from forming during the procedure), and the catheter for the procedure was inserted;

e. At 9:21 a.m., a continuous infusion of angiomax was started;

f. At 9:22 a.m., the patient's BP was 131/86 (normal), and his heart rate was 61 (normal). The guidewire for the procedure was inserted;

e. At 9:27 a.m., adenosine (a medication that causes a fast acting/short lasting vasodilation [arteries open bigger and wider] and slowing of the heart to determine how big the vessel is and how adequate the flow is distal to [past] the blockage) was started IV at a fast rate (646 ml [milliliters] per hour);

f. At 9:27 a.m. (the same time), the nurse realized that an error had occurred, and adrenaline (epinephrine - a medication that causes a sudden onset of vasoconstriction [arteries become smaller] and increase in heart rate and blood pressure) was started instead of adenosine, at the same rate, and given for a duration of 15 seconds for a total of 0.99 mg of epinephrine IV;

g. At 9:27 a.m. (seconds later), the patient's blood pressure (BP) increased to 254/149;

h. At 9:28 a.m., Patient 100 was complaining of difficulty breathing, and a code blue was called;

i. At 9:29 a.m., the code team arrived and cardiopulmonary resuscitation (CPR) was started.

According to the record, the patient's heart rate increased to 175, but CPR was continued due to inability to obtain a BP until 9:35 a.m. (for six minutes). Patient 100 was intubated (a tube was inserted into his mouth, past his vocal chords, and into his trachea to assist in giving him artificial breathing). One hour later he was stabilized and transferred to the intensive care unit (ICU).

The Code Blue Report, dictated December 5, 2014, at 12:08 p.m., indicated a blockage was seen in the middle portion of the left anterior descending (LAD) coronary artery, and the cardiologist decided to perform a fractional flow reserve (FFR) test to determine how significant the blockage was. According to the report, instead of receiving adenosine (as ordered and planned) (a medication that causes a fast acting/short lasting vasodilation [arteries open bigger and wider] and slowing of the heart to determine how big the vessel is and how adequate the flow is distal to [past] the blockage), the patient received received adrenaline (epinephrine - a medication that causes a sudden onset of vasoconstriction [arteries become smaller] and increase in heart rate and blood pressure [BP]).

The patient complained of severe chest pain, his BP increased to approximately 300 systolic (top number - normal 120), then he started having shortness of breath and was coughing up copious (extremely large) amounts of blood. A code blue was called, and cardiopulmonary resuscitation (CPR) was started and continued for approximately five minutes until a pulse was felt. The patient was intubated (a tube was inserted into his mouth, past his vocal chords, and into his trachea to assist in giving him artificial breathing), stabilized, and transferred to the intensive care unit (ICU).

The facility reference titled, "ADENOSINE PREPARATIONS," was reviewed on February 26, 2015. The reference indicated intravenous (IV) adenosine for use in the cath lab FFR procedure was to be mixed as follows:

A. Remove 40 cc (milliliters) of normal saline from a 100 cc bag;

B. Add one vial (90 mg/30 cc [milligrams/milliliters]) of adenosine;

C. Result is (1 mg/cc) 90 mg adenosine in 90 cc normal saline;

D. Dosage to be infused is 140 mcg/kg/min (micrograms per kilogram per minute); and,

E. Drip rate to be used is 8.4 X pt weight (kg) (times the patient's weight in kilograms).

During an interview with the Cath Lab Director (CLD) on January 7, 2015, at 10:20 a.m., and on February 26, 2015, at 12:40 p.m., the director stated Patient 100 had a heart cath done in mid December. The director stated a blockage was identified, and the cardiologist wanted to perform an FFR to determine the severity of the blockage and the possible need for intervention to open the vessel. The director stated the physician ordered Cath Lab Registered Nurse (CLRN) 1 to proceed with preparation of angiomax and adenosine infusions.

The director stated CLRN 1 removed angiomax from the pyxis station (automated dispensing cabinet), and handed it to her colleague (CLRN 2) to prepare. The director stated CLRN 1 then removed adenosine from the pyxis station, prepared an infusion, then handed it to CLRN 2 to prime the tubing and set the infusion rate on the pump. The infusion was readied and started by CLRN 2.

According to the director, after the adenosine infusion was started, CLRN 1 went to scan the medication and label the bag, and realized she had mixed an adrenaline infusion instead of an adenosine infusion. CLRN 1 notified the physician, the infusion was stopped, and the patient began to decompensate, requiring intubation, CPR, and a transfer to ICU.

The director stated the facility investigation revealed CLRN 1 removed adrenoline from the pyxis instead of adenosine, assumed it was the correct medication, and did not check the vial. The director stated CLRN 1 did not scan the medication until after she mixed the infusion, and did not label the bag until after the infusion was started.

In order for the incorrect medication to be infused, the following failures occurred:

a. CLRN 1 removed the wrong medication from the pyxis station, not verifying the medication when she removed it;

b. CLRN 1 failed to scan the medication vial when she removed it;

c. CLRN 1 mixed the infusion, using the wrong medication vial;

d. CLRN 1 failed to label the medication infusion bag until after it was started;

e. CLRN 1 handed an unlabeled medication bag to CLRN 2 for the infusion to be started; and,

f. CLRN 2 accepted an unlabeled IV medication bag and started an infusion.

During an interview with CLRN 3 on February 24, 2015, the RN stated the nurses in the cath lab currently prepared/mixed four different medications for infusion; angiomax, adenosine, neosynephrine (for blood pressure support), and levophed (for blood pressure support).

The facility policy titled, "Medication Administration," was reviewed on Janaury 7 and February 26, 2015. The policy indicated all staff administering medications at the facility would have their competence validated prior to administering medications and periodically thereafter.

A review of cath lab education records indicated in January 2012 (three years earlier) 10 of 19 nurses from the cath lab demonstrated competency in mixing IV infusions. The list did not include CLRN 1. There was no evidence the facility ever verified CLRN 1 was competent to mix IV infusions. There was no evidence CLRN 2 had demonstrated competence in mixing IV infusions for the past three years.

The employee file for CLRN 1 was reviewed on February 26, 2015. The file indicated on July 2, 2014, CLRN 1 received a final written warning after she administered an incorrect medication to a patient. The recommended action for CLRN 1 was to administer correct patient medications as ordered by the physician. There was no evidence of action taken to determine the cause of the July 2014 error, determine the need for education or training, or monitor the nurse for competence in medication administration.

During an interview with the CLD on February 26, 2015, at 12:40 p.m., the director stated the department had not done competency verification for nurses preparing IV infusions since he started working there (for two years). The director stated CLRN 1 had been disciplined in July for a medication error, and there was no remediation or monitoring done after the discipline was completed.



29542

2. The record for Patient 112 was reviewed. Patient 112 was transferred from another facility to the Emergency Department (ED), on November 24, 2014, at 11:33 pm., with the chief complaint of hypertensive urgency (unusually high blood pressure that must be lowered).

The History and Physical dated November 25, 2014, indicated "Assessment and plan: The patient presented to outside hospital with a systolic blood pressure 245 over a diastolic of 100. He had accompanying shortness of breath...on exam he does have bibasilar lung sounds (abnormal) and his blood pressure is markedly elevated...the patient will benefit most from a nephrology (kidney) consult for dialysis as well as titration (to continuously measure) of blood pressure medications..."

(Normal blood pressure range is less than 120 mm systolic, and less than 80 mm diastolic. Reference from American Heart Association).

The nurse's notes indicated on November 25, 2014, at 7:28 a.m., RN 1 notified the physician that Patient 112's blood pressure was 219/110, and received an order to give Patient 112 the medication Hydralazine (a medication used to lower/control elevated blood pressure).

The nurse's note entry for 7:34 a.m., indicated "Pt (patient) report given to...RN 5. Pt care transferred...RN 5 aware of new order for Hydralazine IVP (intravenous push - given into a vein)."

The admission assessment dated November 25, 2014, at 7:30 a.m., indicated "...awaiting Hydralizine for elevated B/P (blood pressure)."

The nurse's notes (late) entry dated November 25, 2014, at 4:40 p.m., indicated "09:58 a.m....Found Patient 112 lying on floor with obvious bleeding...SBP 255/168..."

The medication administration record indicated Patient 112 received the medication to lower his elevated blood pressure at 10:36 a.m., three hours and eight minutes after the RN received the order, and 28 minutes after Patient 112 was found on the floor with a head injury.

Patient 112 was admitted with diagnoses to include elevated blood pressure. There was a physician's order to give medication to lower Patient 112's blood pressure.The RN did not administer the medication ordered to control Patient 112's blood pressure in a timely manner. Patient 112 was found on the ED bathroom floor with a blood pressure of 255/168.

The Coroner's investigation report indicated Patient 112 died on December 7, 2014, from a brain hemorrhage which resulted from blunt force head trauma following the fall in the ED on November 25, 2014.



18918

3. On February 25, 2015, at 10:45 a.m., Registered Nurse (RN) 2 was observed providing care to patients in the "Observation Unit." RN 2 was assigned Patient 204, a 58 year old transfer from another facility who had undergone a cardiac catheterization on February 24, 2015. RN 2 stated Patient 204 was receiving intravenous antibiotics for treatment of pneumonia.

RN 2 administered the medication, then documented in the electronic medical record. RN 2 stated the medication was late, so a note would need to be added to the record.

4. On February 26, 2015, at 9:30 a.m., RN 3 was observed providing care in the "Observation Unit." RN 3 stated she had to get Patient 206's medication from the pharmacy as it was not in the unit. RN 3 took the medication to the patient's bedside, scanned the patient's armband, then scanned the medication. As the electronic record did not include instructions for reconstituting the medication, RN 3 called the pharmacy for directions. RN 3 gave the medication as instructed and documented in the medication record.

During an interview with the Observation Unit Manager, on February 26, 2015, at 10:10 a.m., the Manager stated they did not have a pyxis refrigerator in the unit, so they had to obtain medications from the pharmacy. In addition, the Manager stated as the patient's were transient (short stay or transfers), daily medications were not sent to the unit. The Manager stated the patient's nurse would call the pharmacy about an hour before the patient's medication was due, to receive the medication.

Based on observation and interview, the facility failed to monitor and store medication in a freezer at the appropriate temperature as specified by the manufacture storage instruction. Temperatures registering outside the manufacturer's storage range and duration could result in the loss of integrity of the medication and potentially harm patients by not providing the expected therapeutic effect.

Findings

On February 24, 2015, at 3:46 p.m. during an inspection visit to the inpatient pharmacy with the Pharmacy Operations Manager (POM) and the Director of Pharmacy (DPH), the February 2015 temperature log for a freezer in the pharmacy was found posted on its left side. The temperature of the freezer was at -16.8 degree Celsius (C). When first review of the temperature log with the POM, it was noted that there was no temperature recorded for this freezer over the past two days. Further review of the temperature log revealed that the temperature of this freezer was between the ranges of -16 Celsius to -15 C for the first 21 days of this month (February 2015).

One of the medications found inside the freezer was Prostin E2 (vaginal suppository medication to help dilate the opening of the uterus (cervix) in a pregnant woman) 20mg. The medication labeling on the box indicated, "Store in a freezer not above -20 C."

In the interview with the POM and DPH on February 24, 2015, at 3:58 p.m., they acknowledged the temperature of the freezer was improperly set and maintained at a level above the storage condition required by the drug manufacturer.

Review of the hospital policy titled, "Medication Procurement Storage and Security," on page 2 under Medication Storage," indicated, " 2. Medications are stored according to the manufacturer's recommendations ...5. Medication contained in refrigerators, freezers and warming Cabinets must be monitored with a functional thermometer and temperatures documented."

Based on interview and record review, the facility failed to ensure the safe use of fentanyl (opioid pain medication) transdermal patch in accordance with the FDA boxed warning. This failure could potentially expose patients to avoidable life threatening adverse effects of the medication.

Findings:

Review of the clinical record for Patient 501 on February 26, 2015, with the clinical pharmacy manager (CPM) and Director of Pharmacy (DPH), revealed that he was admitted to the hospital on January 31, 2015, for complaint of worsening shortness of breath. Patient 501 was diagnosed with stage four lung cancer in December 2014, and had a history of tobacco use and chronic obstructive pulmonary disease (COPD). The following narcotic (opioid) pain medications were prescribed for pain relief during his hospital stay:

1. January 31, 2015, Morphine Sulfate 4mg (milligrams) intravenously (IV) every six hours as needed for severe pain;

2. January 31, 2015, Norco 5/325 mg; two tablets by mouth every four hours as needed for moderate pain;

3. February 3, 2015, Morphine Sulfate 15 mg tablet by mouth every 12 hours; and,

4. February 4, 2015, Fentanyl patch 25 mcg (micrograms)/hour; apply one patch every 72 hours.

Review of the medication administration record (MAR) with the CPM showed the above opioid medications were administered on the following dates and times:

Norco 5 mg was given on February 2, 2015, at 2:54 p.m., and February 3, 2015, at 11:35 a.m.;

Morphine sulfate 4mg intravenous (IV) was given on February 3, 2015, 7:28 p.m., and on February 4, 2015, at 12:03 p.m., and at 12:45 p.m. hours;

Morphine sulfate 15mg tablet was given on February 3, 2015 at 9:45 a.m., and on February 4, 2015 at 8:58 a.m.

Further review of his medication administration record (MAR) also revealed fentanyl 25 mcg/hour transdermal patch (topical narcotic pain relief patch) was later administered on February 4, 2015, at 3:49 p.m., by his nurse.

According to the hospital medication reconciliation record dated January 31, 2015, there was no documented evidence that Patient 501 was on any form of opioid pain medication prior to hospital admission. Based on the duration and the amount of opioid exposure prior to administration of the fentanyl patch, Patient 501 was improperly prescribed and subsequently administered a fentanyl patch according to the Food and Drug Adminisration (FDA) boxed warning.

The boxed warning for transdermal Duragesic (topical narcotic type pain relief medication; also called fentanyl patches), which the FDA required to be included with all containers of the drug, read, "Duragesic (brand name for transdermal fentanyl) is ONLY for use in patients who are already tolerant to opioid (narcotic type pain relief medications) therapy of comparable potency. Use in non-opioid tolerant patients may lead to fatal respiratory depression."

Also included in the warning was, "Duragesic should ONLY be used in patients who already are receiving opioid therapy who have demonstrated opioid tolerance, and who require a total daily dose at least equivalent to Duragesic 25 mcg/hour. Patients who are considered opioid-tolerant are those who have been taking, for a week or longer, at least 60 mg of morphine (an opioid) daily, or at least 30 mg of oral oxycodone (an opioid) daily, or at least 8 mg of oral hydromorphone (an opioid) daily or an equianalgesic dose of another opioid."

During an interview with the CPM and the DPH on February 26, 2015, at 11:43 a.m., they both acknowledged that Patient 501 had not been on the opioid pain medications long enough to be considered opioid tolerant according to the FDA's boxed warning definition.

Based on observation, interview, and record review, the facility failed to ensure potentially deteriorated medication was not available for patient use in the hospital and was stored in accordance with the manufacturer's recommendations. This failure could place patients at risk for treatment failure during episodes of angina (chest pain).

Findings:

On February 25, 2015, at 2:35 p.m., during an inspection of the medication stocked in Room 3 of the catheterization laboratory (Cath Lab) with the Pharmacy Operations Manager (POM) and Director of Pharmacy (DPH), eleven bottles of the Baxter brand intravenous (IV) Nitroglycerin (medication to treat episodes of angina [chest pain] in people who have coronary artery disease [narrowing of the blood vessels that supply the heart]) were stored in a lighted pyxis (automated medication dispensing cabinet) tower, exposed to the light and the heat generated by the lights. The bottles did not have an expiration date other than the manufacturers' date, and the POM was unable to determine if the medication was deteriorated.

According to the manufacturer recommendations for nitroglycerin, exposure of the product to heat should be minimized, and it should be protected from light until it's time of use.

During an interview with POM on February 25, 2015, at 2:43 p.m., the POM confirmed the IV nitroglycerin bottles in Room 3 of the Cath Lab were not adequately protected from light after reading the medication label on one of the bottles. He also acknowledged the potency of the medication could have been adversely affected as a result.

Based on observation, interview, and record review, the facility failed to ensure proper hand hygiene was demonstrated by a nurse during the medication pass. This failed practice had the potential to spread infection to patients, visitors, and staff in the hospital.

Findings:

During a medication pass observation on the north fifth floor medical/surgical unit with Registered Nurse (RN) 500 and the Infection Control Manager (ICM) on February 25, 2015, at 9:55 a.m., RN 500 retrieved the medications and supplies for Patient 504 from the medication room, proceeded directly to the patient's room, and gave the medications without first washing his hands or using any antimicrobial hand gel.

In addition, during the process of administering the two oral medications (Lisinopril 10 mg and Amlodipine 5 mg [for blood pressure]) to Patient 504, after RN 500 had verified the medication orders on the computer in the patient's room with his gloved hands, he picked up one pill after the other from a pill cup with his gloved fingers, and put them into the patient's mouth.

Review of the hospital policy titled, "Hand Hygiene," on page 2 under the procedure, the policy indicated, "B. When to decontaminate hands: decontaminate hands means using soap and water or waterless hand sanitizer depending on the level of soilage on hands. Prior to entry into a patient's room ...after contact with inanimate objects (including medical equipment) in the patient's room. "

During an interview with the ICM on February 25, 2015, at 10:25 a.m., the ICM acknowledged she made the same observation and agreed that RN 500 should have washed his hands or used hand sanitizer prior to administering medications to the patient.

Based on interview and record review, the facility failed to ensure consents for breast localization procedures (inserting a needle to mark the exact location of an abnormality in the breast), performed in the Breast Center, included the side of the intended procedure (which breast). This failed practice resulted in the potential for the localization and subsequent biopsy of the tissue to be performed on the wrong breast, continued growth of abnormal or cancerous breast tissue, and harm or death to the patient.

Findings:

During a tour of the Breast Center on February 25, 2015, at 10:05 a.m., accompanied by the Regulatory Complaince Manager and the Breast Center Director, the director stated the center performed mammograms and needle localization procedures.

The record for Patient 108 was reviewed. Patient 108 underwent a needle localization procedure earlier that morning in preparation for a lumpectomy (removal of a lump) following chemotherapy for right breast cancer.

According to the record, Patient 108 had the following history:

1. December 2013, the patient had a bilateral (both sides) mammogram that showed emtremely dense breast tissue with no evidence of malignancy (cancer);

2. June 2014, a right breast mammogram showed extremely dense tissue with a large ill-defined mass. A right breast ultrasound indicated the mass was a suspicious abnormality, and a needle biopsy was recommended;

3. December 2014, a left breast mammogram showed a suspicious abnormality. The radiologist recommended a biopsy of a calcification in the upper outer quadrant of the left breast to rule out malignancy.

A left breast ultrasound showed no abnormalities.

An addendum to the report indicated the left breast mammogram was compared to previous studies, and the calcifications in the left breast were stable and were likely benign (not cancerous). The radiologist noted that the patient last had a right screening mammogram in June 2014, and recommended she get, "back on schedule," for bilateral annual screening. There was no mention of the right breast lump or cancer treatment.

The record indicated on February 25, 2015, Patient 108 signed a, "Consent To Perform Localization Procedure." The consent did not indicate which breast the procedure would be performed on.

During an interview with the Mammography Technician, the technician stated she witnessed the patient signing the consent, and prior to the procedure the consent was compared to the intended procedure. The technician stated the consent form was pre-printed, and did not include which breast the procedure was being performed on for any of the patients who underwent needle localizations in the clinic.

The facility policy titled, "Consent for Procedures," was reviewed. The policy indicated the consent form must include the name of the procedure, to include the side when indicated.