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Based on medical record review, document review, and interview, the Governing Body of the hospital failed to ensure that contract nursing staff provided services performed in a safe and effective manner. Agency nurses being used by the hospital during the period 04/10 through 09/10 failed to follow current standards of practice in providing care to hospital patients, and the agency nurses, by their own testimony, were unable to use the Emergency Department medical records software to accurately document the physical status of the patients and treatments being provided. The findings are:

A. RN #1's assessment of Pt #1 on 04/17/10 at 4:00 am indicates the following: Patient's behavior is inappropriate and appears agitated; parents are with patient and providing restraint; pupil response is pinpoint; large tremors of extremities and body; heart rate is 210; cardiac monitor is attached to patient; skin temperature is hot, clammy, diaphoretic. As a result of this assessment RN #1 placed Pt #1 in restraints but failed to inform ER Physician #1 of his extremely high heart rate or increasing temperature.

It should be noted that no temperature had been taken on Pt #1 since admission vitals on 04/17/10 at 3:47 am.

B. Pt #1's medical record reveals the following entries by RN #1 on 04/17/10: (1) At 4:10 am a "brief reassessment" was done and states twice, "skin hot and diaphoretic"; (2) at 4:43 am a " brief reassessment " was done and states, "status unchanged, dr. notified"; (3) at 5:00 am a "brief reassessment" was done and indicates, "physical status unchanged, hallucinating, dr. notified." The medical record contains no documentation that RN #1 took an objective temperature reading following any of these 3 assessments.

There were no further entries in the medical record by RN #1 between 5:00 am and 6:05 am.

C. According to Pt #1's medical record, at 6:05 am on 04/17/10 the mother called RN #1 to treatment room #6, due to Pt #1 having no respirations and no pulse. A code was called and cardiopulmonary resuscitation (CPR) was started. Defib [defibrillation] monitor was placed on the patient. Emergency Department Physician #1 attempted to intubate, patient rigid. Vecuronium (a neuromuscular blocker that facilitates endotracheal intubation) intravenous (IV) was given at 6:08 am and intubation was performed by ED Physician #1. CPR measures were taken, including the administration of atropine (an anticholinergic cardiac drug) IV and amiodarone (an antiarrhythmic cardiac drug) IV. The patient did not respond to the defibrillation. At 6:34 am, CPR was stopped per physician order.

While CPR was being done, RN #1 took Pt #1's rectal temperature at 6:22 am and the temperature was 107.7.

D. It should again be noted that Pt #1's temperature had not been taken between 3:47 am and 6:22 am. The patient went for a period of two hours and 34 minutes without any temperature being taken even though nursing reassessments clearly document that the patient's skin was hot and diaphoretic to touch.

E. The medical record of Pt #3 revealed that once Pt #3 was in treatment room #10, RN #4 started an IV, lab work was drawn, ADT immunization was given intramuscular (IM) and Toradol (a nonsteroidal anti-inflammatory drug) 60 mg was given IV push even though NP #1 had ordered it given IM.

F. Nurse Practitioner #1 (NP #1) confirmed that the hospital policy is that if a nurse makes a mistake on a medication order that the practitioner should be immediately notified. However, RN #4 did not inform her that he had given the 60 mg Toradol IV push rather than IM as she ordered. She also stated that she had to ask RN #4 directly how he had given the injection to find out that he had not followed her orders.


G. RN #1 was an agency nurse working under contract in the Emergency Department (ED). During interview on 12/16/10 at 1:00 pm, she was asked why there was no documentation of reassessment or attempts to take temperature on Pt #1. She stated that once she got Pt #1 in treatment room #6, started the IV and gave the physician ordered medications, she had to take care of another patient with chest pains and also had to start an IV on yet a third patient. She was asked how long it took to start the IV, and she replied, "I was tied up for about 15 to 20 minutes." She also stated that she was unfamiliar with the medical records charting software and was unable to do some of the required documentation.


H. During interview on 12/16/10 at 1:00 pm, RN #1 was asked how much time she had spent learning the medical records software used in the ED. She stated, "I did a tutorial on the software that took about one and a half hours." At 4:00 pm on 12/16/10 the ED Nurse Manager was interviewed and asked how much time the hospital allowed for agency nurses to learn the medical records software used in the ED. She replied that 4 hours was allowed for the software tutorial. She was then told that RN #1 had stated that she only spent one and a half hours on the tutorial. The ED Nurse Manager said that she was not aware of how much time RN #1 had spent learning the software.

I. On 12/16/10 at 1:00 pm, during interview, RN #4, an agency nurse who was the primary nurse for Pt #3, was asked to explain some omissions and errors in the medical records charting for Pt #3. RN #4 stated, "When I was trying to use the ED Medical records software to chart in this case, I realized that I didn't really understand how to use it very well." He went on to state that he recognized that he needed more training on the ED medical records software.

Based on medical record review, documentation review and interview, the hospital failed to ensure that patients were provided care in a safe setting. The hospital failed to provide services consistent with the patients' condition and results of periodic assessments by staff. The hospital also failed to notify the Centers for Medicare & Medicaid Services (CMS) Dallas Regional Office within the allowed time frame that a patient had died in restraints. The findings are:

A. Based on medical record review, document review and interview, the hospital failed to ensure that patients receive care in a safe setting. The hospital failed to provide services consistent with the patients' condition and results of periodic assessments by staff. Pt #1 was seen in the Emergency Department (ED) on 04/17/10. The hospital did not deliver care to Pt #1 that was consistent with current standards of practice for possible drug toxicity, interventions that included frequent neurological assessments, continuous monitoring of vital signs (including the temperature for hyperthermia/hypothermia) and preventing or minimizing absorption by administering activated charcoal. Nursing management did not correctly assess the capabilities of agency nurses and did not provide enough qualified, competent and knowledgeable staff to care for the patients in the ED. Pt #1 subsequently died. (Refer to A 144)

B. Based on record review, interview and confirmation with CMS-Dallas, the hospital failed to ensure that CMS-Dallas was notified of a death of a patient while in restraints. The death occurred on 04/17/10 and was never reported to CMS-Dallas. Federal regulations require that notification of death in restraints be made to CMS Regional Office by the close of business on the next business day. (Refer to A 214)

Based on medical record review, document review and interview, the hospital failed to ensure that patients receive care in a safe setting. The hospital failed to provide services consistent with the patients' condition and results of periodic assessments by staff. (1) Pt #1 was seen in the Emergency Department (ED) on 04/17/10. The hospital did not deliver care to Pt #1 that was consistent with current standards of practice for possible drug toxicity, interventions that included frequent neurological assessments, continuous monitoring of vital signs (including the temperature for hyperthermia/hypothermia) and preventing or minimizing absorption by administering activated charcoal. Nursing management did not correctly assess the capabilities of agency nurses and did not provide enough qualified, competent and knowledgeable staff to care for the patients in the ED. Pt #1 subsequently died. (2) Pt #2, a 28-year-old female who came into the hospital on the Labor & Delivery (L&D) floor for the delivery of her baby, developed postpartum hemorrhage following the delivery of her baby by cesarean section. She underwent an emergent abdominal hysterectomy during which she coded on the operating table two times during the surgery. Following the surgery she went to the Intensive Care Unit with ischemic damages and proceeded to code again while being transported to another hospital out of state. As of 12/17/10, the patient was on DNR ("Do Not Resuscitate") status on a ventilator, in a nursing home. Nursing management failed to correctly assess the training and experience of nursing staff and agency nurses and to provide enough nursing staff to care for the patients in the L&D unit and ED. The findings are:

A. Pt #1 was a 22-year-old college student. The medical record reveals that Pt #1 presented to the Emergency Department (ED) on 04/17/10 at 3:47 am. He was brought in by both of his parents and stated that he was suffering from an accidental overdose of methamphetamine. Pt #1 further stated that he had used 1 gram of methamphetamine after not using the drug for over a year and was afraid that he had "overdosed." Pt #1 was seen at 3:50 am by ED Physician #1, who evaluated the patient and completed a history and physical. At this time it was documented that Pt #1 had a temperature of 98.5 and respiratory rate of 28 "unlabored."

B. ED Physician #1 ordered the following: (1) electrocardiogram, (2) laboratory tests to verify that methamphetamines were present in Pt #1 system, (3) a Complete Blood Count with differential, (4) an intravenous line (IV) bolus of 1000 cc normal saline which was instilled at 4:00 am and (5) normal saline 1000 bolus. The following medications were given on the orders of ED physician #1: IV Ativan 1 mg @ 4:10 am; IV Metoprolol 5 mg given @ 4:13 am; IV Metoprolol 5 mg given @ 4:22 am; IV Metoprolol 5 mg given @ 4:35 am; IV Ativan 1 mg @ 4:55 am; IV Ativan 1 mg @ 5:10 am; and IV Metoprolol 5 mg given @ 5:10 am. ED Physician #1 also ordered that Pt #1 be put in two-point restraints due to his extreme physical agitation and flailing of arms and legs. The reason for the two-point restraints was to protect the IV that had been placed and to keep Pt #1 on the table. Restraints were first applied at 5:15 am. Although the documentation in the medical record does not indicate when, the patient was eventually placed in 4-point restraints.

C. On 12/20/10 at 8:30 am, during interview via phone, ED Physician #1 was asked why no additional help was summoned while the ED was trying to deal with a number of urgent cases. He stated, "At that time we were extremely busy, there were three or four patients with chest pain, one of which we were giving cardiolytics to. We were insanely busy at the time." He also stated, "There was a high level of chaos at that time." The ED Physician #1 was asked why the ED charge nurse did not call for assistance during this period. He replied, "Calling additional help was actively discouraged by the Administration." He further stated that he wasn't sure if there were any other nurses available at the time. He added, "RN #2 and RN #3 were experienced emergency room nurses. RN #1 is not as experienced as the other two." His final comment was, "There was only one of me and I had no one to call in."

D. RN #1's assessment of Pt #1 at 4:00 am indicated the following: Patient's behavior is inappropriate and appears agitated; parents are with patient and providing restraint; pupil response is pinpoint; large tremors of extremities and body; heart rate is 210; cardiac monitor is attached to patient; skin temperature is hot, clammy and diaphoretic.
It should be noted that no temperature and vital signs had been taken on Pt #1 since admission vital signs at 3:47 am on 04/17/10.

E. Pt #1's medical record revealed the following entries by RN #1: (1) at 4:10 am, a "brief reassessment" was done and the assessment indicates twice, "skin hot and diaphoretic"; (2) at 4:43 am, a "brief reassessment" was done and the assessment indicates, "status unchanged, dr. notified"; (3) at 5:00 am, a "brief reassessment" was done and the assessment indicates, "physical status unchanged, hallucinating, dr. notified."
There were no further entries in the medical record including vital signs or mental status by RN #1 between 5:00 am and 6:05 am. Other than the parents, who were in the exam room with Pt #1, there is no documentation that any ED staff assessed him during this period.

F. According to Pt #1's medical record, at 6:05 am on 04/17/10 the mother called RN #1 to treatment room #6 because Pt #1 had no respirations and no pulse. A code was called and cardiopulmonary resuscitation (CPR) was started. Defib (defibrillation) monitor was placed on the patient. Emergency Department Physician #1 attempted to intubate, patient rigid. Vecuronium IV was given at 6:08 am and intubation was performed by ED Physician #1. CPR measures were taken, including the administration of atropine IV and amiodarone IV. The patient did not respond to the defibrillation. At 6:34 am, CPR was stopped per physician order. On 12/20/10 at 8:30 am, during interview via phone, ED Physician #1 was asked, "Did RN #1 ever notify you that Pt #1 was running a very high temperature or having any other medical problems?" He responded by saying, "No, I had no idea anything was wrong with this case until I heard the code being called." He was also asked if he saw any evidence that ice packs had been applied to Pt #1 when he came into treatment room #6 to assist with the code. He stated, "No, I saw no signs of any ice or other method of cooling being applied. In fact, after a few minutes of CPR, I ordered that ice bags be put around Pt #1's extremities in an effort to bring down his temperature."

G. While CPR was in progress, RN #1 took Pt #1's rectal temperature at 6:22 am and the temperature was 107.7.

H. Pt #1's temperature was not taken between 3:47 am and 6:22 am. The patient went for a period of two hours and 34 minutes without any temperature being taken even though nursing reassessments clearly document that the patient's skin was hot and diaphoretic to touch.

I. RN #1, who was taking care of Pt #1, did add an addendum to the medical record on 05/14/10, almost a month after the adverse patient event. In the addendum, RN #1 documents, "Unable to take temp orally or rectal without harming oral mucosa due combativeness. Unable to temporal temp accurately due to heavy diaphoresis. 5:50 ice pack to head, neck, and extremities. Unable to maintain ice packs on extremities due to combativeness and throwing body around." On 12/16/10 at 1:00 pm, during interview, RN #1, an agency nurse who was the primary nurse for Patient #1, was asked to explain what prompted her to write an addendum on 05/14/10 to her original nursing notes (of 04/17/10) on Pt #1. She stated, "I realized that I did not document the amount of IV fluids that the patient had received. I also realized that I had not charted the ice packs that I applied or the restraints." She was asked if she was requested to go back and chart on this patient by the Director of Nursing. She replied, "No." On 12/20/10 at 8:30 am, during interview via phone, ED Physician #1 was asked, "Did RN#1 ever notify you that Pt #1 was running a very high temperature or having any other medical problems?" He responded by saying, "No, I had no idea anything was wrong with this case until I heard the code being called." He was also asked if he saw any evidence that ice packs had been applied to Pt #1 when he came into treatment room #6 to assist with the code. He stated, "No, I saw no signs of any ice or other method of cooling being applied. In fact, after a few minutes of CPR, I ordered that ice bags be put around Pt #1's extremities in an effort to bring down his temperature."

J. On 12/15/10 at 2:20 pm, during phone interview, the mother of Pt #1 was contacted by surveyors. She verified that she and Pt #1's father brought him to the ED and stayed with him in treatment room #6 from the time he went into the treatment room until the code was called. She stated repeatedly, in response to questions from surveyors, that at no time during his care in treatment room #6 were any ice packs or any other method to cool Pt #1 provided by RN #1 or any other ED staff. She further stated, "I had to fight with them just to get a cool washcloth for his head."

K. An autopsy was performed on 04/18/10 by the Office of the Medical Investigator (OMI) at 8:30 am, which revealed under the section Pathologic Diagnoses, "Upon his arrival to the hospital, he was treated but was noted to have a markedly elevated temperature and when [went] into cardiac arrest. Resuscitation efforts were unsuccessful." The OMI indicated that Pt #1 died of a methamphetamine toxicity.

L. On 12/16/10 at 1:00 pm, during interview, RN #1, an agency nurse working under contract in the ED, was asked why there was no documentation of reassessment or attempts to take temperature on Pt #1. She stated that once she got Pt #1 in treatment room #6, started the IV and gave the physician ordered medications, she had to take care of another patient with chest pains and also had to start an IV on yet a third patient. She was asked how long it took to start the IV. She replied, "I was tied up for about 15 to 20 minutes." She also stated that she was unfamiliar with the medical records charting software and was unable to do some of the required documentation. She was asked where the ED charge nurse was during this period. She stated that he had spent a considerable amount of time at the nursing station talking to the Poison Control Center about methamphetamine overdose and that he was also taking care of other patients.


M. On 12/16/10 at 1:00 pm, during interview, RN #1 was asked how much time she had spent learning the computer medical records software used in the ED. She stated, "I did a tutorial on the software that took about one and a half hours." On 12/16/10 at 4:00 pm, during interview, the Director of ED was asked how much time the hospital allowed for agency nurses to learn the computer medical records software used in the ED. She replied that 4 hours was allowed for the software tutorial. She was then told that RN #1 had stated that she only spent one and a half hours on the tutorial. The Director of ED said that she was not aware of how much time RN #1 had spent learning the software.

N. Review of Pt #2's medical record revealed that the primary Labor & Delivery (L&D) RN (Registered Nurse) #5 was taking care of this patient from the day shift which started at 7:00 am. Pt #2 came into the hospital at 8:38 am, the morning of 06/25/10. The treatment included the patient's labor process through the cesarean section (c-section) delivery at 2245 (10:45 pm). RN #5 was the recovery nurse following the c-section at 2325 (11:25 am). RN #5 was also involved in the patient's case when she (RN #5) was transferred to the main OR (operating room) at 0139 (1:39 am on 06/26/10). RN #5 remained with Pt #2 throughout the emergent hysterectomy surgery, until Pt #2 was transferred to the Intensive Care Unit (ICU) at 0415 (4:15 am).

O. On 12/15/10 at 10:40 am, during interview, the Director of Women's Services (DWS) confirmed the following actions by the hospital staff were not in accordance with acceptable current standards of practice while reviewing Pt #2's chart with the surveyor:
a. That RN #5 was the primary nurse for Pt #2, who was also emotionally connected to Pt #2 (being her sister-in-law).
b. That RN #5 had worked her 7 am to 7 pm shift and was still on the clock until Pt #2 was transferred to the Intensive Care Unit (ICU) at 4:15 am. RN #5 had worked a total of 20 hours without relief.
c. That RN #5 should have notified providers sooner by calling the CRNA (Certified Registered Nurse Anesthetist) for the placement of the epidural catheter, notifying the primary provider regarding the non-reassuring fetal heart tones during the labor phase and also notifying the provider of the patient's excessive bleeding following the c-section in the recovery room.
d. That there was a delay of approximately 15 minutes of relaying information to the physician regarding the excessive bleeding of the patient in the recovery room, which prevented the patient from receiving blood products in an expedient manner.
e. That there was a lack of documentation on the part of the provider with respect to medication orders and physician progress notes.
f. That there was a lack of nursing documentation throughout the duration of the labor phase, including vital signs which were on the fetal heart monitor strips but were not transferred into the chart.
g. That there was a lack of nursing documentation during the recovery of the patient following the c-section as to the taking and recording of the vital signs at least every 15 minutes. The DWS also confirmed that there was a problem with the blood pressure monitor in the recovery room, that did not print strips following each vital sign cycle. This equipment is used for every c-section occurring in the hospital.
h. That there is no evidence in the medical record of the recovery room notes, including the recorded vital signs from the machine. There was also lack of documentation on the amount, color, odor, clots if any of the lochia (drainage), height and firmness of the uterus as per hospital policy.
i. That the Labor & Delivery nursing staff failed to communicate information to the house supervisor as the events were progressing.

2. On 12/16/10 at 10:00 am, during interview, the House Supervisor for the 7 p to 7 a shift on 06/26/10 was questioned about RN #5 taking care of a family member and working longer than her 12-hour shift. He responded, "I was aware that [name of RN #5] was still working, even though I know that she was still there from the day shift...I was aware she was still in the hospital with a family member, but I did not know that she was still on the clock...She should have been aware that she should not have been taking care of her family member...When I looked into the main OR later that night, I saw her scrubbed in for the case." He stated," None of the L&D nursing staff were informing me of the events on the floor." He further stated, "As the night house supervisor, I am a glorified errand boy who runs around the hospital getting things for everyone."

3. On 12/16/10 at 12:00 pm, during interview, the primary Obstetrician provider for Pt #2 stated the following: "With reviewing the chart now, the nursing documentation is very poor...I know that I gave orders that were not documented. The [name of RN #5] did things not documented when ordered... Yes, I was aware that [name of RN #5] was her sister-in-law. I was introduced after the c-section to the patient's husband as the nurse's brother... I feel that [name of RN #5] was forced into her decision to stay with her sister-in-law, as she was the most experienced nurse there that day and night...The unit secretary who usually works the floor was not there that night. Another unit secretary was pulled to the floor from the mental health unit. She was not familiar with where the phone numbers were of who to contact for main surgery or even where paper chart supplies were kept...There was a lack of education of the staff, lack of experienced or critical nursing/physician judgment, there should have been a quicker decision for going to the OR...I depend on the nurses to write my orders. That particular night there were a lot of challenges...for the circumstances. For instance, there was a lack of resources, it was a hard situation...one nurse on the floor was inexperienced and the other nurse I felt was emotionally unstable, from a phone conversation that I overheard earlier in the evening...I remember that [name of RN #5] was in the operating room, acting as a circulating nurse..."

Based on record review, interview and confirmation with the CMS Dallas office, the hospital failed to ensure that the CMS Dallas office was notified of a death of a patient while in restraints. The death occurred on April 17, 2010 and was not reported to the CMS Dallas office. Federal regulations require that notification of death in restraints be made to the CMS Regional Office by the close of business on the next business day. The findings are:

A. During a complaint investigation, the medical record of Patient (Pt) #1 was reviewed as the record of one of the patients listed in the complaint. The medical record revealed that Pt #1 died in the Emergency Department while in restraints at 6:34 am on Saturday, 04/17/10.

B. The medical record of Pt #1 contained a "Hospital Restraint/Seclusion Death Report Worksheet" which is submitted to the CMS Regional Office at any time a patient dies in restraints. The worksheet indicated a date of Monday, 05/24/10, as the date that CMS-Dallas was notified of the death in restraints.

C. On 12/16/10 at 3:45 pm, the Chief Nursing Officer (CNO) was interviewed concerning the late notification of CMS-Dallas in the case of Pt #1. She stated that the hospital failed to identify the case of Pt #1 as a death in restraints and the death was not identified until 05/24/10, at which point the worksheet was faxed to CMS-Dallas. She was unable to explain why the death in restraints was not identified and reported in a timely manner.

D. On 01/07/11 Clerk #1 in the CMS Dallas office verified that they had no record of ever receiving a "Hospital Restraint/Seclusion Death Report Worksheet" from the hospital on this death in restraints by Pt #1.

Based on record review, Quality Assessment & Performance Improvement (QAPI) data, Quality Improvement Committee (QIC) minutes, medical record reviews, and interviews, the hospital failed to ensure that the QAPI program focused on indicators related to improving health outcomes and the prevention and reduction of medical errors. The findings are:

A. Based on Quality Assessment and Performance Improvement (QAPI) data,
Quality Improvement Committee (QIC) minutes and interview, the hospital's QAPI program failed to identify and analyze adverse patient events, and other aspects of performance that assess processes of care, hospital services and operation (refer to A 267).

B. Based on Quality Assessment and Performance Improvement (QAPI) data, Quality Improvement Council (QIC) minutes, medical record review and interview, the hospital failed to ensure that the QAPI program activities tracked medical errors and adverse patient events, analyzed their causes and implement preventive actions and mechanism that include feedback and learning throughout the hospital (refer to A 288).

C. Based on Quality Assessment and Performance Improvement (QAPI) data, Quality Improvement Council (QIC) minutes, medical record review and interviews, the hospital failed to ensure that the hospital-wide QAPI efforts addressed priorities for improved quality of care and that all improvement actions were evaluated (refer to A 312).

Based on Quality Assessment and Performance Improvement (QAPI) data, the Quality Improvement Committee (QIC) minutes and interview, the hospital's QAPI program failed to identify and analyze adverse patient events, and other aspects of performance that assess processes of care, hospital services and operation. The findings are:

A. Based on review of QAPI documents titled "Event Occurrence Log" for the months of June 2010 through November 2010, surveyors were able to identify two areas of adverse patient outcomes: "Perinatal - Unattended Delivery; Delayed response" and "Medication Variance" that had been identified by the data collection system as significant problems. There was no evidence that the QAPI program had made any effort to analyze these significant patient care problems.

B. Review of the Event Occurrence Log for the months of June 2010 through November 2010, the data documented the following frequency of Perinatal - Unattended Delivery; Delayed Response:
06/10 - 2
07/10 - 0
08/10 - 1
09/10 - 2
10/10 - 0
11/10 - 4
1. This is a total of 9 Perinatal - Unattended Delivery; Delayed Response occurring in a six-month period. It should also be noted that in November 2010 there were four (4) Perinatal-Unattended Delivery; Delayed Response.

C. On 12/16/10 at 9:15 am, during interview, the Quality Director/FOC was asked to explain the meaning of the phrase "Perinatal - Unattended Delivery; Delayed Response." She stated that it meant that the patient had been admitted to the Labor & Delivery unit because the birth of a child was imminent. She further explained, "Although the patient was in an L&D bed, when her birth process started there was no physician available to assist with the birth." She was asked what the point would be of being admitted to a hospital to have a physician assisted birth, and delivering the child without the assistance of a physician. She replied that the hospital was having problems communicating with the physicians to let them know that they needed to be in the Labor & Delivery unit when the birth process started. The Quality Director/FOC was then asked to explain what the QAPI program and the designated QA committee had done about these unattended births. She replied, "Nothing has been done about this through the QA program."

D. Review of the Event Occurrence Log for the months of June 2010 through November 2010, the data documented the following frequency of a Medication Variance:
06/10 - 1 medication error that did reach the patient
07/10 - 10 medication errors of which, 8 reached the patient
08/10 - 7 medication errors that did reach the patient
09/10 - 2 medication errors that did reach the patient
10/10 - 2 medication errors that did reach the patient
11/10 - 6 medication errors that did reach the patient
1. This means that in a six-month period there were 26 reported medication errors in which the medication was given to a patient before an error was discovered.

E. On 12/16/10 at 9:15 am, during interview, the Quality Director/FOC was asked to explain what the QAPI program and designated QA committee, the Quality Improvement Committee (QIC), had done about this pattern of medication errors where in most cases the medication was given to the patient before the error was discovered. In response she stated that nothing had been done through the QAPI program or the QIC. She was then asked if these multiple medication errors had been reported to any other committees. She stated that the QAPI data on medication errors was reported to the Infection and Therapeutics Committee and that the Infection and Therapeutics Committee reported its findings to the Medical Executive Committee. The Quality Director/FOC was asked to provide the surveyor with copies of the meeting minutes where the Medication Error Reports were discussed.

F. On 12/16/10 at 2:30 pm, the hospital provided minutes of the Infection and Therapeutics Committee for the months of August which covered Medication Error Reports from March through July 2010 and the month of December for the Medication Error Reports for August through September 2010. The hospital also provided minutes of the Medical Executive Committee for the month of September which indicated that a summary of the Infection and Therapeutics Committee Summary for August 27, 2010 was on the agenda.

G. Review of the Infection and Therapeutics Committee minutes for August 27, 2010 indicated under Pharmacy Reports, item #1 - Medication Error Reports - March through July 2010. This revealed that any medication errors occurring in the hospital between the first day of March 2010 and the last day of July 2010 would not be reviewed until August 27, 2010. If a serious medication error occurred during the first week of March 2010, it would not be reviewed by the Infection and Therapeutics Committee until the end of August 2010. This is a period of at least five months before any review of a medication error -- including an error which may have resulted in an adverse patient outcome -- was conducted.

H. On 12/16/10 at 4:00 pm, during interview, the Chief Nursing Officer (CNO) was asked about the five-month delay before medication errors were reviewed by the Infection and Therapeutics Committee. She stated, "I see what you are saying, it shouldn't take that long to review medication errors." She was also asked if any actions were taken by the Infection and Therapeutics Committee after receiving the Medication Error Report for March through July. She stated that she was not aware of any action being taken by the committee.

I. Review of the Medical Executive Committee Agenda for September 8, 2010 revealed item A -5 "Infection and Therapeutics Committee Summary for August 27, 2010 (information)." There was no indication in the information provided by the hospital on this meeting to indicate that the committee did anything but look at a numerical summary of medication errors among other data being reported by the Infection and Therapeutics Committee.

J. Review of the Quality Improvement Council/Patient Safety Committee minutes for August 24, 2010, did not indicate any mention of either the ongoing problems with Perinatal - Unattended Delivery or Medication Errors as an agenda item or that any identification of these two problem areas had occurred.

K. Based on the complaint investigation it was determined that within a six-month period between 06/01/10 and 09/30/10, Pt #1 and Pt #3 died during treatment in the Emergency Department and Pt #2 has a major permanent disability, which confines her to a nursing home in a vegetative state on a ventilator as the result of giving birth followed by complications. On 12/16/10 at 9:15 am, during interview, the Quality Director/FOC(QD) was asked if the QAPI program considered the outcome for these three patients to be an "adverse patient event." The surveyor was asked to define adverse patient event for the QD, and following the explanation of the term, the QD stated that, "Yes, we considered these three cases to be adverse patient events." The QD was then asked, given that one of the primary responsibilities of the QAPI program is to identify adverse patient events and take action, what the QAPI program had done about these three adverse patient events. She replied, "Nothing was done about these three cases by the QAPI program." The QD was then asked if peer review had been done on these three cases. She responded that the case of Pt #1 had both internal and external peer review done, Pt #2 had an internal and external peer review done, and Pt #3 had an internal peer review done. The QD was asked to make copies of the internal and external peer reviews available so that the surveyor could verify that the peer reviews had been done. The QD was also told that the information in the peer reviews would not be used in the deficiency documentation, but was just to verify that they had been done.

L. On 12/16/10 at 4:40 pm, during the daily briefing, the Chief Nursing Officer (CNO) was asked when the peer reviews would be provided, since they had been requested at 9:30 am, and had not yet been provided. The CNO stated, "Oh, we talked with our corporate office and they told us that the peer reviews would not be provided to you." Therefore the surveyors were unable to determine if the hospital did peer reviews in these three cases of adverse patient outcomes.

Based on Quality Assessment and Performance Improvement
(QAPI) data, Quality Improvement Council (QIC) minutes, medical record review and interview, the hospital failed to ensure that the QAPI program activities tracked medical errors and adverse patient events, analyze their causes and implement preventive actions and mechanisms that include feedback and learning throughout the hospital. The findings are:

A. From review of the QAPI documents titled "Event Occurrence Log" for the months of June 2010 through November 2010, surveyors were able to identify two areas of adverse patient outcomes: "Perinatal - Unattended Delivery; Delayed response" and "Medication Variance" that had been indicated by the data collection system as significant problems. There was no evidence that the QAPI program had made any effort to analyze these significant patient care problems or implement preventive actions and mechanisms that included feedback and learning throughout the hospital.

B. From review of the Event Occurrence Log for the months of June 2010 through November 2010, the data documented the following frequency of Perinatal - Unattended Delivery; Delayed Response:
06/10 - 2
07/10 - 0
08/10 - 1
09/10 - 2
10/10 - 0
11/10 - 4
1. This is a total of 9 Perinatal - Unattended Delivery; Delayed Response occurring in a six-month period. It should also be noted that in November 2010 there were four (4) Perinatal - Unattended Delivery; Delayed Response.

C. On 12/16/10 at 9:15 am, during interview, the Quality Director/FOC was asked what the phrase "Perinatal - Unattended Delivery; Delayed Response" meant. She stated that it meant that the patient had been admitted to the Labor & Delivery unit because the birth of a baby was imminent. She further explained, "Although the patient was in an L&D bed, when her birth process started there was no physician available to assist with the birth." She was asked what the point would be of being admitted to a hospital to have a physician assisted birth, and then having to deliver the baby without the presence of a physician. She replied that the hospital was having problems communicating with the physicians to let them know that they needed to be in Labor & Delivery unit when the birth process started. The Quality Director/FOC was then asked to explain what the QAPI program and the designated QA committee had done about these unattended births. She replied, "Nothing has been done about this through the QA program."

D. Review of the Event Occurrence Log for the months of June 2010 through November 2010, the data documented the following frequency of a Medication Variance:
06/10 - 1 medication error that did reach the patient
07/10 - 10 medication errors of which, 8 reached the patient
08/10 - 7 medication errors that did reach the patient
09/10 - 2 medication errors that did reach the patient
10/10 - 2 medication errors that did reach the patient
11/10 - 6 medication errors that did reach the patient
1. This means that in a six-month period there were 26 reported medication errors in which the medication was given to a patient before an error was discovered.

E. On 12/16/10 at 9:15 am, during interview, the Quality Director/FOC was asked to explain what the QAPI program and designated QA committee, the Quality Improvement Committee (QIC), had done about this pattern of medication errors occurring in most of the cases, the medication was given to the patient before the error was discovered. In response, she stated that nothing had been done through the QAPI program or the QIC. She was then asked if these multiple medication errors had been reported to any other committees. She stated that the QAPI data on medication errors was reported to the Infection and Therapeutics Committee and that the Infection and Therapeutics Committee reported their findings to the Medical Executive Committee. The Quality Director/FOC was asked to provide surveyor with copies of the meeting minutes indicating that the Medication Error Reports were discussed.

F. On 12/16/10 at 2:30 pm, the hospital provided minutes to the Infection and Therapeutics Committee for the months of August which covered Medication Error Reports from March through July 2010 and the month of December for the Medication Error Reports for August through September 2010. The hospital also provided minutes of the Medical Executive Committee for the month of September which indicated that a summary of the Infection and Therapeutics Committee Summary for August 27, 2010 was on the agenda.

G. Review of the Infection and Therapeutics Committee minutes for August 27, 2010 indicated under Pharmacy Reports, item #1 - Medication Error Reports - March through July 2010. This revealed that any medication errors occurring in the hospital between the first day of March 2010 and the last day of July 2010 would not be reviewed until August 27, 2010. If a serious medication error occurred during the first week of March 2010, it would not be reviewed by the Infection and Therapeutics Committee until the end of August. This is a period of at least five months before any review of a medication error -- including an error which may have resulted in an adverse patient outcome -- was conducted.

H. On 12/16/10 at 4:00 pm, during interview, the Chief Nursing Officer (CNO) was asked about the five-month delay before medication errors were reviewed by the Infection and Therapeutics Committee. She stated, "I see what you are saying, it shouldn't take that long to review medication errors." She was also asked if any actions were taken by the Infection and Therapeutics Committee after receiving the Medication Error Report for March through July 2010. She stated that she was not aware of any action being taken by the committee.

I. Review of the Medical Executive Committee Agenda for September 8, 2010 revealed item A -5 "Infection and Therapeutics Committee Summary for August 27, 2010 (information)." There is no indication in the information provided by the hospital on this meeting to indicate that the committee did anything but look at a numerical summary of medication errors among other data being reported by the Infection and Therapeutics Committee.

J. Review of the Quality Improvement Council/Patient Safety Committee minutes for August 24, 2010 did not indicate any mention of either the ongoing problems with Perinatal - Unattended Delivery or Medication Errors as an agenda item or that any identification of these two problem areas had occurred.

K. In the case of Pt #2, there was a significant delay in beginning the emergency hysterectomy on 06/26/10 at 1:40 am, because the unit secretary was unable to find the Operating Room (OR) on-call list and had to hunt in different departments of the hospital to find a copy of the current on-call list. The attending physician stated during interview on 12/16/10 at 12:00 pm that there was a significant delay in being able to take Pt #2, who was in a crisis, to the OR for the emergent hysterectomy because of the delay in being able to notify the main OR on-call staff that they were needed. In fact, he stated that the delay took so long that he left Labor & Delivery on the second floor and walked down to the OR, on the first floor, to see if the OR staff were ready; he found that all required staff were not yet present.

L. Although the failure of the hospital to have a well functioning system to allow unit secretaries to notify the OR on-call team contributed to the adverse patient outcome for Pt #2, there was no documented evidence in any QAPI minutes that indicated that in the period following the event on 06/26/10 that the QAPI program identified, analyzed or implemented preventive actions and mechanisms in the hospital.

Based on Quality Assessment and Performance Improvement (QAPI) data, Quality Improvement Council (QIC) minutes, medical record review and interviews, the hospital failed to ensure that the hospital-wide QAPI efforts addressed priorities for improved quality of care and that all improvement actions are evaluated. The findings are:

A. From review of the QAPI documents titled "Event Occurrence Log" for the months of June 2010 through November 2010, surveyors were able to identify two areas of adverse patient outcomes: "Perinatal - Unattended Delivery; Delayed response" and "Medication Variance" that had been indicated by the data collection system as significant problems. There was no evidence that the QAPI program had made any effort to analyze these significant patient care problems or implement preventive actions and mechanisms that included feedback and learning throughout the hospital. In addition the QAPI program did not address the failure of the hospital Operating Staff on-call system that resulted in a significant delay in starting an emergency hysterectomy on Pt #2 on 06/26/10 with an adverse patient outcome for Pt #2.

B. Review of the Event Occurrence Log for the months of June 2010 through November 2010, the data indicated the following frequency of Perinatal - Unattended Delivery; Delayed Response:
06/10 - 2
07/10 - 0
08/10 - 1
09/10 - 2
10/10 - 0
11/10 - 4
1. This is a total of 9 Perinatal - Unattended Delivery; Delayed Response occurring in a six-month period. It should also be noted that in November 2010 there were four (4) Perinatal - Unattended Delivery; Delayed Response.

C. On 12/16/10 at 9:15 am, during interview, the Quality Director/FOC was asked what did the phrase "Perinatal - Unattended Delivery; Delayed Response" meant. She stated that it meant that the patient had been admitted to the Labor & Delivery unit because the birth of a baby was imminent. She further explained, "Although the patient was in an L&D bed, when her birth process started there was no physician available to assist with the birth." She was asked what the point would be of being admitted to a hospital to have a physician assisted birth, and then have to deliver the baby without the presence of a physician. She replied that the hospital was having problems communicating with the physicians to let them know that they needed to be in Labor & Delivery unit when the birth process started. The Quality Director/FOC was then asked to explain what the QAPI program and the designated QA committee had done about these unattended births. She replied, "Nothing has been done about this through the QA program."

D. Review of the Event Occurrence Log for the months of June 2010 through November 2010, the data indicated the following frequency of a Medication Variance:
06/10 - 1 medication error that did reach the patient
07/10 - 10 medication errors of which, 8 reached the patient
08/10 - 7 medication errors that did reach the patient
09/10 - 2 medication errors that did reach the patient
10/10 - 2 medication errors that did reach the patient
11/10 - 6 medication errors that did reach the patient
1. This indicates that in a six-month period there were 26 medication errors where the medication was given to the patient.

E. On 12/16/10 at 9:15 am, during interview, the Quality Director/FOC was asked to explain what the QAPI program and designated QA committee, the Quality Improvement Committee (QIC), had done about the pattern of medication errors, where in most cases the medication was given to the patient before the error was discovered. In response she stated that nothing had been done through the QAPI program or the QIC. She was then asked if these multiple medication errors had been reported to any other committees. She stated that the QAPI data on medication errors was reported to the Infection and Therapeutics Committee and that the Infection and Therapeutics Committee reported their findings to the Medical Executive Committee. The Quality Director/FOC was asked to provide surveyor with copies of the meeting minutes where the Medication Error Reports were discussed.

F. On 12/16/10 at 2:30 pm the hospital provided minutes to the Infection and Therapeutics Committee for the months of August which covered Medication Error Reports from March through July 2010 and the month of December for the Medication Error Reports for August through September 2010. The hospital also provided minutes of the Medical Executive Committee for the month of September which indicated that a summary of the Infection and Therapeutics Committee Summary for August 27, 2010 was on the agenda.

G. Review of the Infection and Therapeutics Committee minutes for August 27, 2010 indicated under Pharmacy Reports, item #1 - Medication Error Reports - March through July 2010. This revealed that any medication errors occurring in the hospital between the first day of March 2010 and the last day of July 2010 would not be reviewed until August 27, 2010. If a serious medication error occurred during the first week of March 2010, it would not be reviewed by the Infection and Therapeutics Committee until the end of August. This is a period of at least five months before any review of a medication error -- including an error which may have resulted in an adverse patient outcome -- was conducted.

H. On 12/16/10 at 4:00 pm the Chief Nursing Officer (CNO) was interviewed about the five plus month delay before medication errors were reviewed by the Infection and Therapeutics Committee. She stated, " I see what you are saying, it shouldn't take that long to review medication errors." She was also asked if any actions were taken by the Infection and Therapeutics Committee after receiving the Medication Error Report for March through July 2010. She stated that she was not aware of any action being taken by the committee.

I. Review of the Medical Executive Committee Agenda for September 8, 2010 revealed item A -5 "Infection and Therapeutics Committee Summary for August 27, 2010 (information)." There is no indication in the information provided by the hospital on this meeting to indicate that the committee did anything but look at a numerical summary of medication errors among other data being reported by the Infection and Therapeutics Committee.

J. Review of the Quality Improvement Council/Patient Safety Committee minutes for August 24, 2010 did not reveal any mention of either the ongoing problems with Perinatal - Unattended Delivery or Medication Errors as an agenda item or that any identification of these two problem areas had occurred.

K. In the case of Pt #2, there was a significant delay in beginning the emergency hysterectomy on 06/26/10 at 1:40 am, because the unit secretary was unable to find the Operating Room (OR) on-call list and had to hunt in different departments of the hospital to find a copy of the current on-call list. The attending physician stated during interview on 12/16/10 at 12:00 pm that there was a significant delay in being able to take Pt #2 who was in a crisis, to the OR for the emergent hysterectomy because of the delay in being able to notify the main OR on-call staff that they were needed. In fact, he stated that the delay took so long that he left Labor & Delivery on the second floor and walked down to the OR, on the first floor, to see if the OR staff were ready; he found that all required staff were not yet present.

L. Although the failure of the hospital to have a well functioning system to allow unit secretaries to notify the OR on-call team contributed to the adverse patient outcome for Pt #2, there was no documented evidence in any QAPI minutes indicating that in the period following the event on 06/26/10 that the QAPI program identified, analyzed or implemented preventive actions and mechanisms in the hospital.

Based on record review, staff interviews and facility policy, nursing services and the hospital failed to ensure: (1) that nursing personnel with the appropriate education, experience, licensure, competence and specialized qualifications were assigned to provide nursing care for each patient in accordance with the individual needs of each patient throughout the facility (refer to A 397); (2) that the Director of Nursing provided adequate supervision and evaluation of the clinical activities of the non-employee nursing personnel during the period between 04/10 and 09/10 (refer to A 398); (3) that there were physician orders for medications that were administered to a patient by a Registered Nurse (refer to A 406); and (4) that the nursing staff personnel complete the blood transfusion records in accordance with the facility policy records (refer to A 409). The cumulative effect of these systemic practices resulted in the hospital nursing services' inability to ensure that patients' needs could be met.

Based on record review, staff interviews and facility policies, nursing services and the hospital failed to ensure that nursing personnel with the appropriate education, experience, licensure, competence and specialized qualifications were assigned to provide nursing care for each patient in accordance with the individual needs of each patient throughout the facility for 3 of 16 sampled patients (Patient #'s 1, 2 and 3). The findings are:

A. Record review of Pt #2 revealed that the primary RN (Registered Nurse) #5 was taking care of this patient from the day shift which started at 7:00 am. Pt #2 came into the hospital at 8:38 am, the morning of 06/25/10. The treatment included the patient's labor process through the cesarean section (c-section) delivery at 2245 (10:45 pm). RN #5 was the recovery nurse following the c-section at 2325 (11:25 am). RN #5 was also involved in the patient's case when she (RN #5) was transferred to the main OR (operating room) at 0139 (1:39 am on 06/26/10). RN #5 remained with Pt #2 throughout the emergent hysterectomy surgery, until Pt #2 was transferred to the Intensive Care Unit (ICU) at 0415 (4:15 am) on 06/26/10.

B. On 12/15/10 at 10:40 am, during interview, the Director of Women's Services (DWS) confirmed that the following actions by the hospital staff were not in accordance with acceptable current standards of practice while reviewing Pt #2's chart with the surveyor:
a. That RN #5, who was the primary nurse for Pt #2, was also emotionally connected to Pt #2 (being her sister-in-law).
b. That RN #5 had worked her 7 am to 7 pm shift and was still on the clock until Patient #2 was transferred to the ICU at 4:15 am. RN #5 had worked a total of 20 hours without relief.
c. That RN #5 should have called the CRNA (Certified Registered Nurse Anesthetist) for the placement of the epidural catheter, notifying the primary provider for Pt #2 regarding the non-reassuring fetal heart tones during the labor phase and also notifying the provider of the patient's excessive bleeding following the c-section in the recovery room.
d. That there was a delay of approximately 15 minutes of relaying information to the physician regarding the excessive bleeding of the patient in the recovery room, which prevented the patient from receiving blood products in an expedient manner.
e. That there was a lack of documentation on the part of the provider with respect to medication orders and and physician progress notes.
f. That there was a lack of nursing documentation throughout the duration of the labor phase, including vital signs which were on the fetal heart monitor strips but were not transferred into the chart.
g. That there was a lack of the nursing documentation during the recovery of the patient following the c-section as to the taking and recording of the vital signs at least every 15 minutes. The DWS also confirmed that there was a problem with the blood pressure monitor in the recovery room, that did not print strips following each vital sign cycle. This equipment is used for every c-section occurring in the hospital.
h. That there is no evidence in the medical record of the recovery room notes, including the recorded vital signs from the machine. There was also lack of documentation on the amount, color and odor of the lochia (drainage), presence or absence of clots in the lochia, and the height and firmness of the uterus. Such documentation was required per hospital policy.
i. The Labor & Delivery nursing staff failed to communicate information to the house supervisor as the events were progressing.

1. Review of the hospital policy titled "Post Partum Recovery in Labor & Delivery," last revised on 07/2000, revealed the following:
"I. Recover patient in LDR:
A. Take vital signs and record. Blood pressure, pulse, respirations, temperature.
Fundus, height and firmness, massage where indicated.
Perineum - condition of episiotomy, color, amount of edema.
Lochia - amount , color, odor, clots if any.
Bladder - extent of filling.
B. Notify attending physician of significant changes in any of the observations of the patient.
II. Treatment during recovery period:
A. Vital signs and observations taken and recorded at least every 15 minutes.
B. Medications, Intravenous fluids, and treatments given as physician orders.
C. Provide for patient safety..."

2. Review of the hospital policy titled "Amnio-Infusion Protocol," last revised on 10/2003, revealed the following:
"Procedure:
Maternal consent.
Insertion of intrauterine pressure catheter by OB/GYN physician.
Infusion of 600 cc of normal saline at room temperature over the first hour (10 cc/minute).
Maintenance rate of infusion 180 cc/hr (3 cc/min). Infusion is to be done by an IV pump.
Continuous fetal monitoring and monitoring of uterine pressure.
Monitor return of fluid and notify OB/GYN physician if no fluid returns..."

3. On 12/16/10 at 10:00 am, during interview, the House Supervisor for the 7 p to 7 a shift on 06/26/10 was questioned about RN #5 taking care of a family member and working longer than her 12-hour shift. He responded, "I was aware that [name of RN #5] was still working, even though I knew she was still there from the day shift...I was aware she was still in the hospital with a family member, but I did not know that she was still on the clock...She should have been aware that she should not have been taking care of her family member...When I looked into the main OR later that night, I saw her scrubbed in for the case." He stated, "None of the L&D nursing staff were informing me of the events on the floor." He further stated, "As the night house supervisor, I am a glorified errand boy, who runs around the hospital getting things for everyone."

4. On 12/16/10 at 12:00 pm, during interview, the primary Obstetrician provider for Pt #2 stated the following: "With reviewing the chart now, the nursing documentation is very poor...I know that I gave orders that were not documented. The [name of RN #5] did things not documented or ordered... Yes, I was aware that [name of RN #5] was her sister-in-law. I was introduced after the c-section to the patient's husband as the nurse's brother... I feel that [name of RN #5] was forced into her decision to stay with her sister-in-law, as she was the most experienced nurse there that day and night...The unit secretary who usually works on the floor was not there that night. Another unit secretary was pulled to the floor from the mental health unit. She was not familiar with where the phone numbers were of who to contact for main surgery or even where paper chart supplies were kept...There was a lack of education of the staff, lack of experienced or critical nursing/physician judgment, there should have been a quicker decision for going to the OR...I depend on the nurses to write my orders. That particular night there were a lot of challenges...for the circumstances. For instance, there was a lack of resources, it was a hard situation...one nurse on the floor was inexperienced and the other nurse I felt was emotionally unstable, from a phone conversation that I overheard earlier in the evening...I remember that [name of RN #5] was in the operating room, acting as a circulating nurse..."

C. Review of Patient #1's medical record revealed the following:
1. RN #1's assessment of Pt #1 on 04/17/10 at 4:00 am indicated the following: Patient's behavior is inappropriate and appears agitated; parents are with patient and providing restraint; pupil response is pinpoint; large tremors of extremities and body; heart rate is 210; cardiac monitor is attached to patient; skin temperature is hot, clammy and diaphoretic.
a. It should be noted that no temperature and vital signs had been taken on Pt #1 since admission vital signs at 3:47 am on 04/17/10.
2. Pt #1's medical record revealed the following entries by RN #1: (1) at 4:10 am, a "brief reassessment" was done and the assessment indicates twice, "skin hot and diaphoretic"; (2) at 4:43 am, a "brief reassessment" was done and the assessment indicates, "status unchanged, dr. notified"; (3) at 5:00 am, a "brief reassessment" was done and the assessment indicates, "physical status unchanged, hallucinating, dr. notified."
a. There were no further entries in the medical record including vital signs or mental status by RN #1 between 5:00 am and 6:05 am. Other than the parents, who were in the exam room with Pt #1, there is no documentation that any ED staff assessed him during this period.

3. According to Pt #1's medical record, at 6:05 am on 04/17/10, the mother called RN #1 to treatment room #6 because Pt #1 had no respirations and no pulse. A code was called and cardiopulmonary resuscitation (CPR) was started. Defib (defibrillation) monitor was placed on the patient. Emergency Department Physician #1 attempted to intubate, patient rigid. Vecuronium IV was given at 6:08 am and intubation was performed by ED Physician #1. CPR measures were taken, including the administration of atropine IV and amiodarone IV. The patient did not respond to the defibrillation. At 6:34 am, CPR was stopped per physician order. On 12/20/10 at 8:30 am, during interview via phone, ED Physician #1 was asked, "Did RN #1 ever notify you that Pt #1 was running a very high temperature or having any other medical problems?" He responded by saying, "No, I had no idea anything was wrong with this case until I heard the code being called." He was also asked if he saw any evidence that ice packs had been applied to Pt #1 when he came into treatment room #6 to assist with the code. He stated, "No, I saw no signs of any ice or other method of cooling being applied. In fact, after a few minutes of CPR, I ordered that ice bags be put around Pt #1's extremities in an effort to bring down his temperature."
4. While CPR was in progress, RN #1 took Pt #1's rectal temperature at 6:22 am and the temperature was 107.7.
a. Pt #1's temperature had not been taken between 3:47 am and 6:22 am. The patient went for a period of two hours and 34 minutes without any temperature being taken even though nursing reassessments clearly document that the patient's skin was hot and diaphoretic to touch.
b. On 12/16/10 at 1:00 pm, during interview, RN #1, who was an agency nurse working under contract in the Emergency Department (ED), was asked why there was no documentation of reassessment or attempts to take the temperature on Pt #1. She stated that once she got Pt #1 in treatment room #6, started the IV and gave the physician ordered medications, she had to take care of another patient with chest pains and also had to start an IV on yet a third patient. She was asked how long it took to start the IV. She replied, "I was tied up for about 15 to 20 minutes." She also stated that she was unfamiliar with the computer medical records charting software and was unable to do some of the required documentation. She was then asked how much time she had spent learning the computer medical records software charting used in ED. She stated, "I did a tutorial on the software that took about one and a half hours."


D. Review of Patient #3's medical record revealed the following:
1. Once Pt #3 was in treatment room #10 in the ED, RN #4 started an IV, lab work was drawn, ADT immunization was given intramuscular (IM) and Toradol 60 mg was given IV push even though Nurse Practitioner (#1) had ordered it to be given IM.

2. NP #1 confirmed that the hospital policy is that if a nurse makes a mistake on a medication order, the practitioner should be immediately notified. However, RN #4 did not inform her that he had given the 60 mg of Toradol IV push rather than IM as she had ordered. She also stated that she had to ask RN #4 directly how he had administered the medication, only to find out that he had not followed her orders.

3. On 12/16/10 at 4:00 pm, the Director of ED was interviewed and asked how much time the hospital allowed for agency nurses to learn the computer medical records charting software that is used in the ED. She replied that 4 hours was allowed for the software tutorial. She was then told that RN #1 had stated that she only spent one and a half hours on the tutorial. The Director of ED said that she was not aware of how much time RN #1 had spent learning the software.

4. On 12/16/10 at 1:00 pm, during interview, RN #4, an agency nurse who was the primary nurse for Pt #3, was asked to explain some omissions and errors in the medical records charting for Pt #3. RN #4 stated, "When I was trying to use the ED Medical records software to chart in this case, I realized that I didn't really understand how to use it very well." He went on to state that he recognized that he needed more training on the ED medical records charting software.

E. On 12/15/10 between 5:00 pm and 10:00 pm, interviews were conducted outside of the hospital with several employees that wanted to remain anonymous. The employees stated that were fearful for their jobs if they were to meet with the surveyor inside of the hospital. The employees expressed their concerns regarding the nursing staff who were being floated to units in the hospital in which they had no training or experience. The units included the Intensive Care Unit and the Labor & Delivery Unit. One anonymous interviewee stated, "I'm scared for the safety of our patients who come into the hospital, who believe that they are being taken care of by an experienced, competent nurse, who know what he or she is doing, to give them the best possible care that they deserve."

Based on medical record review, document review and interview, the hospital failed to ensure that the Director of Nursing provided adequate supervision and evaluation of the clinical activities of the non-employee nursing personnel during the period between 04/10 and 09/10, resulting in adverse patient outcomes for 2 of 16 sampled patients (Patient #'s 1 & 3). The findings are:

A. RN #1's assessment of Pt #1 at 4:00 am on 04/17/10 indicated the following: Patient's behavior was inappropriate and appears agitated; parents were with patient and providing restraint; pupil response was pinpoint; large tremors of extremities and body; heart rate was 210; cardiac monitor was attached to patient; skin temperature was hot, clammy and diaphoretic.
a. It should be noted that no temperature and vital signs had been taken on Pt #1 since admission vital signs at 3:47 am on 04/17/10.

B. Pt #1's medical record revealed the following entries by RN #1: (1) at 4:10 am, a "brief reassessment" was done and the assessment indicates twice, "skin hot and diaphoretic"; (2) at 4:43 am, a "brief reassessment" was done and the assessment indicates, "status unchanged, dr. notified"; (3) at 5:00 am, a "brief reassessment" was done and the assessment indicates, "physical status unchanged, hallucinating, dr. notified."
1. There were no further entries in the medical record including vital signs or mental status by RN #1 between 5:00 am and 6:05 am. Other than the parents, who were in the exam room with Pt #1, there is no documentation that any ED staff assessed him during this period.

C. According to Pt #1's medical record, at 6:05 am on 04/17/10 the mother called RN #1 to treatment room #6 because Pt #1 had no respirations and no pulse. A code was called and cardiopulmonary resuscitation (CPR) was started. Defib (defibrillation) monitor was placed on the patient. Emergency Department Physician #1 attempted to intubate, patient rigid. Vecuronium IV was given at 6:08 am and intubation was performed by ED Physician #1. CPR measures were taken, including the administration of atropine IV and amiodarone IV. The patient did not respond to the defibrillation. At 6:34 am, CPR was stopped per physician order. On 12/20/10 at 8:30 am, surveyors interviewed ED Physician #1 via phone, he was asked, "Did RN#1 ever notify you that Pt #1 was running a very high temperature or having any other medical problem?" He responded by saying, "No, I had no idea anything was wrong with this case until I heard the code being called." He was also asked if he saw any evidence that ice packs had been applied to Pt #1 when he came into treatment room #6 to assist with the code. He stated, "No, I saw no signs of any ice or other method of cooling being applied. In fact, after a few minutes of CPR, I ordered that ice bags be put around Pt #1's extremities in an effort to bring down his temperature."
a. While CPR was in progress, RN #1 took Pt #1's rectal temperature at 6:22 am and the temperature was 107.7.

D. Pt #1's temperature was not taken between 3:47 am and 6:22 am. The patient went for a period of two hours and 34 minutes without any temperature being taken even though nursing reassessments clearly document that the patient's skin was hot and diaphoretic to touch.

E. On 12/16/10 at 1:00 pm, during interview, RN #1, who was an agency nurse working under contract in the ED, was asked why there was no documentation of reassessment or attempts to take temperature on Pt #1. She stated that once she got Pt #1 in treatment room #6, started the IV and gave the physician ordered medications, she had to take care of another patient with chest pains and also had to start an IV on yet a third patient. She was asked how long it took to start the IV. She replied, "I was tied up for about 15 to 20 minutes." She also stated that she was unfamiliar with the medical records charting software and was unable to do some of the required documentation.


F. On 12/16/10 at 1:00 pm, during interview, RN #1 was asked how much time she had spent learning the medical records charting computer software used in ED. She stated, "I did a tutorial on the software that took about one and a half hours." On 12/16/10 at 4:00 pm, during interview, the Director of the ED was asked how much time the hospital allowed for agency nurses to learn the medical records charting computer software that is used in the ED. She replied that 4 hours was allowed for the software tutorial. She was then told that RN #1 had stated that she only spent one and a half hours on the tutorial. The Director of the ED said that she was not aware of how much time RN #1 had spent learning the software.
1. RN #1, who was taking care of Pt #1, did add an addendum to the medical record on 05/14/10, almost a month after the adverse patient event. In the addendum, RN #1 documents, "Unable to take temp orally or rectal without harming oral mucosa due to combativeness. Unable to temporal temp accurately due to heavy diaphoresis. 5:50 ice pack to head, neck, and extremities. Unable to maintain ice packs on extremities due to combativeness and throwing body around."
2. On 12/16/10 at 1:00 pm, during interview, RN #1, an agency nurse who was the primary nurse for Pt #1, was asked to explain what prompted her to write an addendum on 05/14/10 to her original nursing notes (of 04/17/10) on Pt #1. She stated, "I realized that I did not document the amount of IV fluids that the patient had received. I also realized that I had not charted the ice packs that I applied or the restraints." She was asked if she was requested to go back and chart on this patient by the Director of Nursing. She replied, "No."



G. Pt #3 was a 54-year-old man. The medical record reveals that Pt #3 was transported to the ED by ambulance on 09/30/10 at 13:06 (1:06 pm) and his presenting complaint was a cat bite that had occurred 6 days earlier and was infected. Pt #3 stated that he had "lanced" the wound with his pocket knife and drained some pus. The finger was red and swollen as well as the hand.

H. Pt #3 was seen by Nurse Practitioner (NP) #1, who was a contract employee working for a contract emergency room physician service, at 14:08 (2:08 pm). NP #1 evaluated the patient, took a medical history and completed the physical examination. The examination revealed that Pt #3 was in "no acute distress." The exam did note that Pt #3 was intoxicated at the time.

I. NP #1's evaluation of his right hand was as follows: "Index Finger (2nd Digit)-Extensive erythema noted at radial, ulnar, volar, dorsal aspect(s). Severe tenderness to palpation. Diffusely tender over the entire finger. Neurovascular exam intact. Moderate warmth appreciated dorsal, volar aspect(s). Three areas of apparent animal bite or scratch."

J. At 13:57 (1:57 pm) NP #1 consulted with ED Physician #2 about Pt #3. ED Physician #2 determined that Pt #3 should be admitted to the medical/surgical floor and be given a course of IV antibiotic therapy.

K. NP #1 gave the following orders: (1) ED level 5; (2)Complete Blood Count @ 14:16 (2:16 pm);(3) CMP Complete Metabolic Panel @ 14:16; (4) IV insertion 13:55 (1:55 pm); (5) IM immunization ADT 0.5 mg IM @ 13:55; and (6) IV Toradol 60 mg@ 14:05 (2:05 pm) (Note NP #1 states she gave an order for Toradol 60 mg to be given IM rather than as documented by RN #4 as IV push).

L. At 13:34 (1:34 pm) Pt #3 was moved to treatment room #10. An "Adult Assessment" was done on Pt #3. No significant findings other than pain from the right finger being at a 5 on a scale of one-to-ten. Other findings of the Adult Assessment were: Heart rate is 86. Monitor shows normal sinus rhythm. An electronic non-invasive blood pressure monitor was attached to Pt #3 at this point.

M. Once Pt #3 was in treatment room #10, RN #4 started an IV, lab work was drawn, ADT immunization was given IM and Toradol 60 mg was given IV push even though NP #1 had ordered it to be given IM. Pt #3 was resting on the gurney in the room with the blood pressure monitor attached. At 13:55 (1:55 pm) Pt #3 was reassessed by NP #1 and NP #1 advised him of the plan to have him be seen by a hospitalist, and then to be admitted to the hospital for IV antibiotic therapy. A few minutes later Pt #3 came out of treatment room #10 and was talking on a cell phone. Pt #3's departure from the treatment room was observed by NP #1 who was sitting at the nursing station doing charting directly across from treatment room #10. Pt #3 finished his cell phone call and went back into treatment room #10 and lay down on the gurney.

N. At approximately 14:25 (2:25 pm) a housekeeper walking by treatment room #10 stated to nurses at the nursing station that Pt #3 "did not look good." NP #1 went into the room and found the patient unresponsive. A code was called and CPR was started. CPR with usual medical interventions was performed for about 30 minutes and Pt #3 was pronounced dead.
1. The medical record for Pt #3 indicates that the first pharmacological intervention of IV Epinephrine 1 amp was given at 14:26 (2:26 pm). The Cardiopulmonary Arrest record for Pt #3 reveals that ED Physician #2 started an intubation at 14:28 (2:28 pm). The medical record revealed the reason for death as: "Cardiopulmonary Arrest/Code Blue/Expire."

O. According to Pt #3's medical record, an electronic non-invasive blood pressure monitor was attached to Pt #3 at 13:34 (1:34 pm). However, the medical record does not indicate that any blood pressure readings were taken from the monitor at anytime during Pt #3's treatment. If the blood pressure monitor was working, it should have given staff at the nurse's station a warning that the blood pressure was dropping when Pt #3 was beginning to code.
1. It should also be noted that the period between Unit Secretary's note stating that Pt #3 was re-evaluated at 14:07 (2:07 pm) and 14:25 (2:25 pm) when Pt #3 was discovered to be unresponsive. This is a period of eighteen (18) minutes with no documented monitoring of Pt #3.


P. On 12/20/10 at 2:15 pm, a phone interview was done with NP #1 who was on vacation in Louisiana. NP #1 stated the following:
1. She did the initial workup of Pt #3 including initial assessment and history & physical.
2. She asked ED Physician #2 to look at Pt #3. ED Physician #2 examined Pt #3 and gave orders for the hospitalist to evaluate Pt #3 and admit to the hospital for IV antibiotic therapy. ED Physician #2 reasoned that because Pt #3, based on his intoxication, would not be a reliable person to take medications and perform treatments at home, Pt #3 should be admitted to the hospital for the treatment.
3. Pt #3 had a bad case of cellulitis that was affecting his whole right hand and up the arm. She also noted that Pt #3 was intoxicated.
4. She ordered lab work and the ED plan was to get Pt #3 ready to be admitted after to the hospital after he had been seen by the hospitalist.
5. After Pt #3 was in treatment room #10 and had received the tetanus and Toradol, she went on to see other patients.
6. Some minutes later she passed by the room and told Pt #3, who was on the phone, that he would be seen by the hospitalist and admitted for IV antibiotic therapy.
7. She went to the nursing station and was sitting directly across from treatment room #10 while doing some charting.
8. A housekeeper was standing in front of treatment room #10 and stated to NP #1,"he doesn't look very good." NP #1 immediately went into the room and determined that he had arrested.
9. She confirmed that the hospital policy is that if a nurse makes a mistake on a medication order that the practitioner should be immediately notified. However, RN #4 did not inform her that he had given the 60 mg of Toradol IV push rather than IM as she ordered. She also stated that she had to ask RN #4 directly, how he had given the injection to Pt #3, only to find out that he had not followed her orders.
10. She was advised earlier by RN #4, after he had started the IV on Pt #3, that Pt #3 had admitted to polydrug abuse.
11. She had no idea why Pt #3 died and is hoping the autopsy report will explain why he died.

Q. On 12/16/10 at 11:00 am, RN #4 was interviewed and made the following statements:
1. He has been an RN for three years.
2. The ED was very busy at the time Pt #3 presented for care.
3. Pt #3 presented with a pain in his hand, had been drinking but appeared to be oriented and stated that he was "feeling goofy."
4. Pt #3's right hand was red, swollen, tender & radial pulses were present.
5. Pt #3 denied drug use during triage.
6. While trying to start Pt #3's IV, Pt #3 volunteered that he had been using a variety of drugs but appeared to be "evasive" when asked other questions.
7. Pt #3 complained of pain in his hand at a 5 on a one-to-ten scale. RN #4 reported to NP #1 that Pt #3 was experiencing pain and was requesting pain medication.
8. Toradol 60 mg was ordered IM by NP #1 and so documented in chart.
9. He felt "rushed" because there were "so many sick people" and he gave the 60 mg of Toradol as an IVP.
10. RN #4 then went on to take care of other patients until he heard code blue being called. When he got to treatment room #10, a nurse, a respiratory therapist, and a housekeeper were already in the room starting CPR.

Based on record review, interview and hospital policy, the hospital failed to ensure that there were doctor's orders for medications that were administered to 1 of 16 sampled patients (#2). The findings are:

A. Review of Patient #2's medical record revealed the following:

1. The pre-printed MAR dated 06/25/10 indicated that the Registered Nurse #5 (RN #5) administered to Pt #2 a Pitocin or Oxytocin (to help with labor contractions) IV (intravenous) drip, and Methergine and Hemabate (medications to prevent and treat postpartum hemorrhage caused by uterine atony). Further review of Patient #2's MAR indicated that the Methergine and Hemabate were documented as being administered x 4 doses, with no times as to when they were administered by the RN.
2. There is no evidence of physician orders for the Pitocin drip, or the Methergine and Hemabate in the chart.
3. Cytotec (to promote cervical ripening) 1000 mcg was administered per rectum at 12:35 am on 06/26/10. There is neither evidence of a physician order for this medication nor is the medication documented in the MAR.

B. On 12/15/10 at 10:40 am, during interview, the Director of Women's Services (DWS) reviewed Patient (Pt) #2's medical chart with the surveyor. She stated that during the time when Pt #2 was on the floor, the labor was uneventful. The Maternal Review of Systems and Medication Administration Record dated 06/25/10 revealed the following:
"0832 Patient to L&D [Labor & Delivery] dept via wheelchair accompanied by family and staff. Patient to room and to bathroom and changed into gown and urine sample obtained. To bed and the External Fetal Monitor (EFM) applied to soft nontender abdomen after Leopold's maneuver. Assessment done and vitals taken. Pt states that she has been contracting for a while and at 0500 this am she felt like she started leaking fluid. Pt states that pain on scale of 0 -10 is a 8. Bed low call bell in reach. Will continue to monitor. Dr to be called."
A review of the LD-Flowsheets indicated the following:
At 10:08 am, an 18-gauge IV catheter is started in the left hand.
At 10:32 am, Pitocin (given to induce or stimulate labor and to reduce postpartum bleeding after expulsion of placenta) infusion drip (Pitocin 20 units in 1000 cc of D5LR - Titrate 2 MU q [every] 20 min prn) is started at 4.0 milliunits (mu)/hour (hr)
At 11:00 am, Pitocin drip is increased to 6.0 mu/hr.
At 11:26 am, Pitocin drip is increased to 8.0 mu/hr.
At 11:44 am, Pitocin drip is increased to 10.0 mu/hr.
At 12:00 pm, MD at bedside and examined the patient.
At 12:04 pm, Pitocin drip is increased to 12.0 mu/hr.
At 12:23 pm, Pitocin drip is increased to 14.0 mu/hr.
At 12:45 pm, Pitocin drip is increased to 16.0 mu/hr.
At 1:02 pm, Pitocin drip is increased to 18.0 mu/hr.
At 1:38 pm, Pitocin drip is increased to 20.0 mu/hr .
At 1:44 pm, the patient's membranes rupture spontaneously, the fluid is clear.
At 2:03 pm, Pitocin drip is increased to 22.0 mu/hr.
At 2:30 pm, Pitocin drip is increased to 24.0 mu/hr. Internal Uterine Activity (IUA) monitor is indicated as being placed without reflecting the presence of a physician. Uterine contractions occurs 1-1.5 minutes lasting 60-80 seconds, contraction quality is strong.
At 3:00 pm, Pitocin drip is increased to 26.0 mu/hr,
At 3:41 pm, Pitocin drip is increased to 28.0 mu/hr.
At 4:30 pm, Pitocin drip is increased to 30.0 mu/hr.
At 4:38 pm, patient is given Stadol IV for pain at a 9 on the pain scale.
At 5:10 pm, patient's pain is at 6 on the pain scale.
At 6:10 pm, patient's pain is at 10 on the pain scale.
At 6:30 pm, patient is requesting an epidural.
At 6:47 pm, the CRNA is called for the request of the epidural.
At 6:59 pm, IV bolus of 500 cc of Lactated Ringers given.
At 7:02 pm, the epidural catheter is placed by the CRNA.
At 7:36 pm, patient is placed on her left side, the fetal heart tones (FHT) indicate a late decelerate.

During this review of the medical record the DWS stated that the baby was stressed at this time. The LD-Flowsheets show that at 8:06 pm, the baseline of the FHT is 140's. Commenting about the baseline entry in the medical record, the DWS stated that MD should be called at this time.

The LD-Flowsheets further indicate the following:
At 8:23 pm, FHT indicates deceleration lasting 120 seconds down to 75.
At 8:26 pm, patient's heart rate 100 and oxygen saturation 97%.
At 8:37 pm, patient's blood pressure 90/40 and heart rate 112. Pitocin drip is indicated at 20.0 mu/hr.
At 8:54 pm, patient's blood pressure is 154/109 and heart rate 126.
At 8:57 pm, an Amnioinfusion is completed, with no documentation of amount infused or return from the vagina.
At 9:01 pm, primary Obstetrician (OB) provider is called and report is given.
At 9:14 pm, primary OB provider is at bedside.
At 9:42 pm, Pitocin drip is off, FHT are increased, in the 185's. Primary OB provider is called to come and evaluate patient.
At 9:45 pm, patient is having hypertonic contractions.

In reviewing the entry in the medical record about the hypertonic contractions, the DWS remarked that the fetus was in distress at this point.

Additionally, the LD-Flowsheets reveal the following:
At 10:34 pm, primary OB provider is at bedside, and performed a fetal scalp stimulation.
At 10:41 pm, an emergent cesarean section is called.
At 10:49 pm, patient is leaving via stretcher to the operating room.

C. Review of hospital policy titled "Induction/Augmentation of Labor [Indications/Contraindications/Procedure(s)]," last reviewed on 5/10, revealed the following information:
"Oxytocin Infusion: Oxytocin infusion may be started and maintained by a qualified nurse as long as a physician can respond within fifteen (15) minutes, if needed.
1. There shall be a written/verbal order by the physician for the Oxytocin to be used, the initial rate of infusion, frequency and rate of increasing. These orders should be clear and concise.
2. The infusion will be administered via an infusion pump monitor IVPB.
3. Oxytocin shall be increased per physician's orders until an adequate labor pattern is established with a reassuring FHR pattern and adequate recovery time between contractions, or until 20-25 m/u Oxytocin is reached without order of MD (upon physician preference) to increase Oxytocin higher.
a. Registered Nurses will be allowed to lower, stop or increase the Pitocin drip as indicated. If Pitocin is turned off, notify physician. Order must be received for amount of Pitocin to be infused when restarted.
b. There must be no uterine hyperstimulation.
c. There must be a fetal heart rate and uterine contraction tracing. If necessary, a fetal scalp electrode and/or an intrauterine pressure catheter should be placed to achieve this goal.
d. The nurse is to notify the doctor if monitoring of fetal maternal unit is inadequate. If notified, the doctor must return for evaluation of the patient's status. Oxytocin administration will be done only if the patient has electronic fetal monitoring.
e. Nurses who monitor the Oxytocin infusions will be trained by an experienced Labor & Delivery nurse during the orientation phase of employment.
Augmentation is terminated for the following indications:
a. Precipitous labor progress
b. Tetanic or prolonged IUPC monitored UC's greater than 2 minutes
c. Unusual vaginal bleeding
d. Possible over-dosage (decreasing uterine activity with increasing doses)
e. Fetal distress (late, prolonged or severe variable decelerations or the sudden onset of meconium stained fluid)
f. Pelvic structural deformities

D. On 12/15/10 at 10:40 am, during interview, the DWS confirmed while reviewing the chart that there was a lack of physician orders for medications and patient treatments/interventions in the chart.

E. On 12/16/10 at 12:00 pm, during interview, the primary Obstetrician provider for Patient #2 was asked about the lack of physician orders for medications or patient interventions in the chart. He replied, "I depend on the nurses to write my orders."

Based on record review, facility policy and interview, the hospital failed to ensure that the nursing staff personnel completed the blood transfusion records in accordance with the facility policy for 1 of 16 sampled patient (Patient #2) records. The findings are:
A. Review of Patient #2's medical record revealed that during the events following the c-section, a total of 7 units of packed red blood cells (PRBC) and 6 units of fresh frozen plasma (FFP) were given to Patient #2. The blood transfusion record documentation revealed the following:
1. The blood transfusion record indicated that the first unit of PRBC was issued on 06/26/10 at 0021 (12:21 am) and was given stat. There was no further documentation indicating what time the blood was started or stopped and the vital signs (VS) (including the blood pressure, pulse, temperature and respirations). The patient received the blood which included pre-transfusion; however, the VS were not taken at 15 minutes, 30 minutes, and 1 hour, etc. The record was completed at 0057 (12:57 am). The amount of time it took to transfuse the blood cannot be determined from this record.
2. The blood transfusion record indicated that the second unit of PRBC was issued on 06/26/10 at 0021 hours (12:21 am) and was given stat. There is no further documentation indicating what time the blood was started or stopped, and the VS were not taken at 15 minutes, 30 minutes, and 1 hour, etc. The record was completed at 0109 (1:09 am). The amount of time it took to transfuse the blood cannot be determined on this record.
3. The blood transfusion record indicated that the third unit of PRBC was issued on 06/26/10 at 0216 hours (2:16 am) and started at 0226 (2:26 am) and stopped at 0336 (3:36 am). This indicates that the unit of blood transfused in approximately 1 hour and 10 minutes. The blood pressure, pulse and respiration rate is documented for the pre-transfusion set of VS, excluding the blood pressure and temperature. The pulse and respiration rate is documented at the 15-minute interval and the blood pressure, pulse and respiration rate is documented for the post-transfusion time.
4. The blood transfusion record indicated that the fourth unit of PRBC was issued on 06/26/10 at 0226 hours (2:26 am) and started at 0250 (2:50 am) and stopped at 0320 (3:20 am).
This indicates that the unit of blood transfused in approximately 30 minutes.
The pulse and respiration rate is documented for the pre-transfusion set of VS, excluding the blood pressure and temperature. The blood pressure, pulse and respiration rate is documented for the post-transfusion set. There is no documentation of VS being monitored at the 15-minute interval and 30-minute interval.
5. The blood transfusion record indicated that the fifth unit of PRBC was issued on 06/26/10 at 0226 hours (2:26 am) and started at 0236 (2:36 am) and stopped at 0246 (2:46 am).
This indicates that the unit of blood transfused in approximately 10 minutes. The pulse and respiration rate is documented for the pre-transfusion set of VS, excluding the blood pressure and temperature. The pulse and respiration rate is documented at the post-transfusion time.
6. The blood transfusion record indicated that the sixth unit of PRBC was issued on 06/26/10 at 0226 hours (2:26 am) and started at 0250 (2:50 am) and stopped at 0300 (3:00 am). This indicates that the unit of blood transfused in approximately 10 minutes. The pulse and respiration rate is documented for the pre-transfusion set of VS, excluding the blood pressure and temperature. The blood pressure, pulse and respiration rate is documented, excluding the temperature as the post-transfusion time.
7. The blood transfusion records of 5 of 6 units of FFP were reviewed as completed properly. The sixth unit of FFP did not indicate who completed the form, on what date or the time.
8. The blood transfusion record indicated that the seventh unit of PRBC was issued on 06/26/10 at 0458 hours (4:58 am) and started at 0645 (6:45 am) and stopped at 0812 (8:12 am). This indicates that the unit of blood transfused in approximately 1 hour and 33 minutes. The seventh unit of PRBC did not indicate who completed the form, on what date or the time.

B. Review of the facility policy titled "Blood Transfusion: General Nursing Procedures," last revised on 02/10, revealed the following:
"Take vital signs, pre transfusion, and record on the patient's clinical record: temperature, pulse, respiration, blood pressure...Start blood or blood components...Check vital signs at first 15 minutes, then 30 minutes, then at 1 hour and post transfusion and record..."

C. On 12/15/10 at 10:40 am, during interview, the Director of Women's Services confirmed that the blood transfusion records were not completed as required by hospital policy.

Based on medical record review, document review and interview the hospital failed to ensure that the Medical Record Service took administrative responsibility for ensuring the completeness and accuracy of medical records of patient being seen in the hospital. Failures by nursing and medical staff to accurately document what treatments and procedures were being provided to patients make it very difficult for outside reviewers to determine if patients received care and treatment that was in accordance with acceptable standards of practice. The findings are:


A. Based on medical record review and interview, the hospital failed to ensure that nursing staff, both employed and contracted, were accurately documenting and promptly completing medical record entries for Pt #'s 1, 2, & 3. Failure to document care and procedures being done on these three patients resulted in surveyors being unable to determine if care and treatment had been provided in accordance with currents standards of practice (refer to A 438).

Based on medical record review and interview, the hospital failed to ensure that nursing staff, both employed and contracted, were accurately documenting and promptly completing medical record entries for Pt #'s 1, 2, & 3. Failure to document care and procedures being done on these three patients resulted in surveyors being unable to determine if care and treatment had been provided in accordance with current standards of practice.
The findings are:

A. RN #1's assessment of Pt #1 at 4:00 am indicates the following: Patient's behavior is inappropriate and appears agitated; parents are with patient and providing restraint; pupil response is pinpoint; large tremors of extremities and body; heart rate is 210; cardiac monitor is attached to patient; skin temperature is hot, clammy and diaphoretic.
It should be noted that no temperature and vital signs had been taken on Pt #1 since admission vital signs at 03:47 am on 04/17/10.
B. Pt #1's medical record revealed the following entries by RN #1: (1) At 4:10 am, a "brief reassessment" was done and the assessment indicates that twice, "skin hot and diaphoretic"; (2) at 4:43 am, a "brief reassessment" was done and the assessment indicates, "status unchanged, dr. notified"; (3) at 5:00 am, a "brief reassessment" was done and the assessment indicates, "physical status unchanged, hallucinating, dr. notified."
There were no further entries in the medical record including vital signs or mental status by RN #1 between 5:00 am and 6:05 am. Other than the parents, who were in the exam room with Pt #1, there is no documentation that any ED staff assessed him during this period.

C. At 6:05 am, the mother called RN#1 to treatment room #6 because Pt #1 had no respirations and no pulse. A code was called and cardiopulmonary resuscitation (CPR) was started. Defib (defibrillation) monitor was placed on the patient. Emergency Department Physician #1 attempted to intubate, patient rigid. Vecuronium IV was given at 6:08 am and intubation was performed by ED physician #1. CPR measures were taken, including the administration of atropine IV and amiodarone IV. The patient did not respond to the defibrillation. At 6:34 am, CPR stopped per physician order.
1. While CPR was in progress, RN #1 took Pt #1's rectal temperature at 6:22 am and the temperature was 107.7.

D. Pt #1's temperature was not taken between 3:47 am and 6:22 am. The patient went for a period of two hours and 34 minutes without any temperature being taken even though nursing reassessments clearly document that the patient's skin was hot and diaphoretic to touch.

E. On 12/16/10 at 1:00 pm, during interview, RN #1, an agency nurse who was the primary nurse for Patient #1, did add an addendum to the medical record on 05/14/10, almost a month after the adverse patient event. In the addendum, RN#1 documents, "Unable to take temp orally or rectal without harming oral mucosa due combativeness. Unable to temporal temp accurately due to heavy diaphoresis. 5:50 ice pack to head, neck, and extremities. Unable to maintain ice packs on extremities due to combativeness and throwing body around." RN #1 was asked to explain what prompted her to write an addendum to her original nursing notes (of 04/17/10) on Pt #1. She stated, "I realized that I did not document the amount of IV fluids that the patient had received. I also realized that I had not charted the ice packs that I applied or the restraints." She was asked if she was requested to go back and chart on this patient by the Director of Nursing. She replied, "No."

F. On 12/15/10 at 2:20 pm, during phone interview, the mother of Patient #1 was asked if she recalled if her son had ice packs to his body. She replied, "No ma'am. My son did not have any ice or even a cold rag to wipe his face. We [my ex-husband and I] asked the nurse several times if we could have any ice chips or a cold wash cloth to wipe his face, but she said no...My son was hot and sweaty even when he got into the bed. I do not recall that his temperature was taken at all...The monitor above his head was going off all the time and nobody came in to silence it. I kept on resetting the machine...At one time, my ex-husband wanted to cut off the gown. We did take off my son's socks and shoes."

G. On 12/16/10 at 10:45 am, the Director of Health Information Management was interviewed and asked about the hospital policy on addendum's to medical records that was in effect in May 2010. She stated that in May 2010 there was no policy, but that she arrived in late September and on the first of October 2010 put a policy in place that only allowed staff and physicians to make an addendum within 3 days of the event. She added that addendum's to medical records were always considered to be "suspect" and that it was not a recommended practice.

H. On 12/16/10 at 1:00 pm, during interview, RN #4, an agency nurse who was the primary nurse for Patient #3, was asked to explain some omissions and errors in the medical records charting for Pt. #3. RN #4 stated, "When I was trying to use the ED Medical records software to chart in this case, I realized that I didn't really understand how to use it very well." He went on to state that he recognized that he needed more training on the ED medical records software.

I. Review of Patient #2's medical record revealed the following information:
a. That there was a lack of documentation on the part of the provider with respect to medication orders and physician progress notes.
b. That there was a lack of nursing documentation throughout the duration of the labor phase, including vital signs which were on the fetal heart monitor strips but were not transferred into the chart.
c. That there was a lack of nursing documentation during the recovery of the patient following the c-section as to taking and recording of the vital signs at least every 15 minutes.
d. During the events following the c-section, a total of 7 units of packed red blood cells (PRBC) and 6 units of fresh frozen plasma (FFP) were given to Pt #2. The blood transfusion record documentation revealed the following:
1. The blood transfusion record indicated that the first unit of PRBC was issued on 06/26/10 at 0021 (12:21 am) and was given stat. There was no further documentation indicating what time the blood was started or stopped and the vital signs (VS) (including the blood pressure, pulse, temperature and respirations). The patient received the blood which included pre-transfusion; however, the VS were not taken at 15 minutes, 30 minutes, and 1 hour, etc. The record was completed at 0057 (12:57 am). The amount of time it took to transfuse the blood cannot be determined from this record.
2. The blood transfusion record indicated that the second unit of PRBC was issued on 06/26/10 at 0021 hours (12:21 am) and was given stat. There is no further documentation indicating what time the blood was started or stopped, and the VS were not taken at 15 minutes, 30 minutes, and 1 hour, etc. The record was completed at 0109 (1:09 am). The amount of time it took to transfuse the blood cannot be determined on this record.
3. The blood transfusion record indicated that the third unit of PRBC was issued on 06/26/10 at 0216 hours (2:16 am) and started at 0226 (2:26 am) and stopped at 0336 (3:36 am). This indicates that the unit of blood transfused in approximately 1 hour and 10 minutes. The blood pressure, pulse and respiration rate is documented for the pre-transfusion set of VS, excluding the blood pressure and temperature. The pulse and respiration rate is documented at the 15-minute interval and the blood pressure, pulse and respiration rate is documented for the post-transfusion time.
4. The blood transfusion record indicated that the fourth unit of PRBC was issued on 06/26/10 at 0226 hours (2:26 am) and started at 0250 (2:50 am) and stopped at 0320 (3:20 am). This indicates that the unit of blood transfused in approximately 30 minutes. The pulse and respiration rate is documented for the pre-transfusion set of VS, excluding the blood pressure and temperature. The blood pressure, pulse and respiration rate is documented for the post-transfusion set. There is no documentation of VS being monitored at the 15-minute interval and 30-minute interval.
5. The blood transfusion record indicated that the fifth unit of PRBC was issued on 06/26/10 at 0226 hours (2:26 am) and started at 0236 (2:36 am) and stopped at 0246 (2:46 am). This indicates that the unit of blood transfused in approximately 10 minutes. The pulse and respiration rate is documented for the pre-transfusion set of VS, excluding the blood pressure and temperature. The pulse and respiration rate is documented at the post-transfusion time.
6. The blood transfusion record indicated that the sixth unit of PRBC was issued on 06/26/10 at 0226 hours (2:26 am) and started at 0250 (2:50 am) and stopped at 0300 (3:00 am). This indicates that the unit of blood transfused in approximately 10 minutes. The pulse and respiration rate is documented for the pre-transfusion set of VS, excluding the blood pressure and temperature. The blood pressure, pulse and respiration rate is documented, excluding the temperature as the post-transfusion time.
7. The blood transfusion records of 5 of 6 units of FFP were reviewed as completed properly. The sixth unit of FFP did not indicate who completed the form, on what date or the time.
8. The blood transfusion record indicated that the seventh unit of PRBC was issued on 06/26/10 at 0458 hours (4:58 am) and started at 0645 (6:45 am) and stopped at 0812 (8:12 am). This indicates that the unit of blood transfused in approximately 1 hour and 33 minutes. The seventh unit of PRBC did not indicate who completed the form, on what date or the time.

J. On 12/15/10 at 10:40 am, during interview, the Director of Women's Services confirmed that the blood transfusion records were not completed as required by hospital policy.

K. Review of the facility policy titled "Blood Transfusion: General Nursing Procedures," last revised on 02/10, revealed the following: "Take vital signs, pre transfusion, and record on the patient's clinical record: temperature, pulse, respiration, blood pressure...Start blood or blood components...Check vital signs at first 15 minutes, then 30 minutes, then at 1 hour and post transfusion and record..."

L. Pt #3 was a 54-year-old man. The medical record reveals that Pt #3 was transported to the ED by ambulance on 09/30/10 at 13:06 (1:06 pm) and his presenting complaint was a cat bite that had occurred 6 days earlier and was infected. Pt #3 stated that he had "lanced" the wound with his pocket knife and drained some pus. The finger was red and swollen as well as the hand.

M. Pt #3 was seen by Nurse Practitioner (NP) #1, who was a contract employee working for a contract emergency room physician service, at 14:08 (2:08 pm). NP #1 evaluated the patient, took a medical history and completed the physical examination. The examination revealed that Pt #3 was in "no acute distress." The exam did note that Pt #3 was intoxicated at the time.

N. NP #1's evaluation of his right hand was as follows: "Index Finger (2nd Digit)-Extensive erythema noted at radial, ulnar, volar, dorsal aspect(s). Severe tenderness to palpation. Diffusely tender over the entire finger. Neurovascular exam intact. Moderate warmth appreciated dorsal, volar aspect(s). Three areas of apparent animal bite or scratch."

O. At 13:57 (1:57 pm) NP #1 consulted with ED Physician #2 about Pt #3. ED Physician #2 determined that Pt #3 should be admitted to the medical/surgical floor and be given a course of IV antibiotic therapy.

P. NP #1 gave the following orders: (1) ED level 5; (2)Complete Blood Count @ 14:16 (2:16 pm);(3) CMP Complete Metabolic Panel @ 14:16; (4) IV insertion 13:55 (1:55 pm); (5) IM immunization ADT 0.5 mg IM @ 13:55; and (6) IV Toradol 60 mg@ 14:05 (2:05 pm) (Note NP #1 states she gave an order for Toradol 60 mg to be given IM rather than as documented by RN #4 as IV push).

Q. At 13:34 (1:34 pm) Pt #3 was moved to treatment room #10. An "Adult Assessment" was done on Pt #3. No significant findings other than pain from the right finger being at a 5 on a scale of one-to-ten. Other findings of the Adult Assessment were: Heart rate is 86. Monitor shows normal sinus rhythm. An electronic non-invasive blood pressure monitor was attached to Pt #3 at this point.

R. Once Pt #3 was in treatment room #10, RN #4 started an IV, lab work was drawn, ADT immunization was given IM and Toradol 60 mg was given IV push even though NP #1 had ordered it to be given IM. Pt #3 was resting on the gurney in the room with the blood pressure monitor attached. At 13:55 (1:55 pm) Pt #3 was reassessed by NP #1 and NP #1 advised him of the plan to have him be seen by a hospitalist, and then to be admitted to the hospital for IV antibiotic therapy. A few minutes later Pt #3 came out of treatment room #10 and was talking on a cell phone. Pt #3's departure from the treatment room was observed by NP #1 who was sitting at the nursing station doing charting directly across from treatment room #10. Pt #3 finished his cell phone call and went back into treatment room #10 and lay down on the gurney.

S. At approximately 14:25 (2:25 pm) a housekeeper walking by treatment room #10 stated to nurses at the nursing station that Pt #3 "did not look good." NP #1 went into the room and found the patient unresponsive. A code was called and CPR was started. CPR with usual medical interventions was performed for about 30 minutes and Pt #3 was pronounced dead.
1. The medical record for Pt #3 indicates that the first pharmacological intervention of IV epinephrine 1 amp was given at 14:26 (2:26 pm). The Cardiopulmonary Arrest record for Pt #3 reveals that ED Physician #2 started an intubation at 14:28 (2:28 pm). The medical record revealed the reason for death as: "Cardiopulmonary Arrest/Code Blue/Expire."

T. According to Pt #3's medical record, an electronic non-invasive blood pressure monitor was attached to Pt #3 at 13:34 (1:34 pm). However, the medical record does not indicate that any blood pressure readings were taken from the monitor at anytime during Pt #3's treatment. If the blood pressure monitor was working, it should have given staff at the nurse's station a warning that the blood pressure was dropping when Pt #3 was beginning to code.
1. It should also be noted that the period between Unit Secretary's note stating that Pt #3 was re-evaluated at 14:07 (2:07 pm) and 14:25 (2:25 pm) when Pt #3 was discovered to be unresponsive. This is a period of eighteen (18) minutes with no documented monitoring of Pt #3.


U. On 12/20/10 at 2:15 pm, a phone interview was done with NP #1 who was on vacation in Louisiana. NP #1 stated the following:
1. She did the initial workup of Pt #3 including initial assessment and history & physical.
2. She asked ED Physician #2 to look at Pt #3. ED Physician #2 examined Pt #3 and gave orders for the hospitalist to evaluate Pt #3 and admit to the hospital for IV antibiotic therapy. ED Physician #2 reasoned that because Pt #3, based on his intoxication, would not be a reliable person to take medications and perform treatments at home, Pt #3 should be admitted to the hospital for the treatment.
3. Pt #3 had a bad case of cellulitis that was affecting his whole right hand and up the arm. She also noted that Pt #3 was intoxicated.
4. She ordered lab work and the ED plan was to get Pt #3 ready to be admitted after to the hospital after he had been seen by the hospitalist.
5. After Pt #3 was in treatment room #10 and had received the tetanus and Toradol, she went on to see other patients.
6. Some minutes later she passed by the room and told Pt #3, who was on the phone, that he would be seen by the hospitalist and admitted for IV antibiotic therapy.
7. She went to the nursing station and was sitting directly across from treatment room #10 while doing some charting.
8. A housekeeper was standing in front of treatment room #10 and stated to NP #1,"he doesn't look very good." NP #1 immediately went into the room and determined that he had arrested.
9. She confirmed that the hospital policy is that if a nurse makes a mistake on a medication order that the practitioner should be immediately notified. However, RN #4 did not inform her that he had given the 60 mg of Toradol IV push rather than IM as she ordered. She also stated that she had to ask RN #4 directly how he had given the injection to Pt #3, only to find out that he had not followed her orders.
10. She was advised earlier by RN #4, after he had started the IV on Pt #3, that Pt #3 had admitted to polydrug abuse.
11. She had no idea why Pt #3 died and is hoping the autopsy report will explain why he died.

V. On 12/16/10 at 11:00 am, RN #4 was interviewed and made the following statements:
1. He has been an RN for three years.
2. The ED was very busy at the time Pt #3 presented for care.
3. Pt #3 presented with a pain in his hand, had been drinking but appeared to be oriented and stated that he was "feeling goofy."
4. Pt #3's right hand was red, swollen, tender & radial pulses were present.
5. Pt #3 denied drug use during triage.
6. While trying to start Pt #3's IV, Pt #3 volunteered that he had been using a variety of drugs but appeared to be "evasive" when asked other questions.
7. Pt #3 complained of pain in his hand at a 5 on a one-to-ten scale. RN #4 reported to NP #1 that Pt #3 was experiencing pain and was requesting pain medication.
8. Toradol 60 mg was ordered IM by NP #1 and so documented in chart.
9. He felt "rushed" because there were "so many sick people" and he gave the 60 mg of Toradol as an IVP.
10. RN #4 then went on to take care of other patients until he heard code blue being called. When he got to treatment room #10, a nurse, a respiratory therapist, and a housekeeper were already in the room starting CPR.

Based on record review, hospital policy and staff interview, the facility failed to ensure that all patient medical record entries were completed and that physician order entries were either dated, timed or authenticated in written form within the 72-hour time frame in accordance with state law for 1 of 16 sampled patients (Patient # 2). The findings are:

A. Review of the medical record for Patient #2 revealed the following:
1. The lack of documentation by the nurse during the Pt #2's labor phase and the recovery of the Pt #2 following the c-section regarding taking and recording of the vital signs. It was confirmed by nursing administration that there was a problem with the blood pressure monitor in the recovery room, that did not print strips following each vital sign cycle. This equipment is used for every c-section occurring in the hospital.
2. The c-section recovery room notes were not in evidence in the chart. There was also lack of documentation on the amount, color, odor, clots if any of the lochia (drainage), height and firmness of the uterus as per hospital policy.

B. Review of the Medication Administration Record (MAR) indicated the following:
1. The pre-printed MAR dated 06/25/10 indicated that the Registered Nurse #5 (RN #5) administered to Pt #2 a Pitocin or Oxytocin (to help with labor contractions) IV (intravenous) drip, Methergine and Hemabate (medications given to prevent and treat postpartum hemorrhage caused by uterine atony). Further review of Patient #2's MAR indicated that the Methergine and Hemabate were documented as being administered x 4 doses, with no times as to when they were administered by the RN.
a. There is no evidence of physician orders for the Pitocin drip or the Methergine and Hemabate in the chart.
b. Cytotec (to promote cervical ripening) 1000 mcg was administered per rectum at 12:35 am on 06/26/10, according to the L&D Flowsheet. There is neither evidence of a physician order for this medication nor is the medication documented in the MAR.
Review of Patient #2's medical record revealed that during the events following the c-section, a total of 7 units of packed red blood cells (PRBC) and 6 units of fresh frozen plasma (FFP) were given to Patient #2. The blood transfusion record documentation revealed the following:
1. The blood transfusion record indicated that the first unit of PRBC was issued on 06/26/10 at 0021 (12:21 am) and was given stat. There was no further documentation indicating what time the blood was started or stopped and the vital signs (VS) (including the blood pressure, pulse, temperature and respirations). The patient received the blood which included pre-transfusion; however, the VS were not taken at 15 minutes, 30 minutes, and 1 hour, etc. The record was completed at 0057 (12:57 am). The amount of time it took to transfuse the blood cannot be determined from this record.
2. The blood transfusion record indicated that the second unit of PRBC was issued on 06/26/10 at 0021 hours (12:21 am) and was given stat. There is no further documentation indicating what time the blood was started or stopped, and the VS were not taken at 15 minutes, 30 minutes, and 1 hour, etc. The record was completed at 0109 (1:09 am). The amount of time it took to transfuse the blood cannot be determined on this record.
3. The blood transfusion record indicated that the third unit of PRBC was issued on 06/26/10 at 0216 hours (2:16 am) and started at 0226 (2:26 am) and stopped at 0336 (3:36 am). This indicates that the unit of blood transfused in approximately 1 hour and 10 minutes. The blood pressure, pulse and respiration rate is documented for the pre-transfusion set of VS, excluding the blood pressure and temperature. The pulse and respiration rate is documented at the 15-minute interval and the blood pressure, pulse and respiration rate is documented for the post-transfusion time.
4. The blood transfusion record indicated that the fourth unit of PRBC was issued on 06/26/10 at 0226 hours (2:26 am) and started at 0250 (2:50 am) and stopped at 0320 (3:20 am). This indicates that the unit of blood transfused in approximately 30 minutes. The pulse and respiration rate is documented for the pre-transfusion set of VS, excluding the blood pressure and temperature. The blood pressure, pulse and respiration rate is documented for the post-transfusion set. There is no documentation of VS being monitored at the 15-minute interval and 30-minute interval.
5. The blood transfusion record indicated that the fifth unit of PRBC was issued on 06/26/10 at 0226 hours (2:26 am) and started at 0236 (2:36 am) and stopped at 0246 (2:46 am). This indicates that the unit of blood transfused in approximately 10 minutes. The pulse and respiration rate is documented for the pre-transfusion set of VS, excluding the blood pressure and temperature. The pulse and respiration rate is documented at the post-transfusion time.
6. The blood transfusion record indicated that the sixth unit of PRBC was issued on 06/26/10 at 0226 hours (2:26 am) and started at 0250 (2:50 am) and stopped at 0300 (3:00 am). This indicates that the unit of blood transfused in approximately 10 minutes. The pulse and respiration rate is documented for the pre-transfusion set of VS, excluding the blood pressure and temperature. The blood pressure, pulse and respiration rate is documented, excluding the temperature as the post-transfusion time.
7. The blood transfusion records of 5 of 6 units of FFP were reviewed as completed properly. The sixth unit of FFP did not indicate who completed the form, on what date or the time.
8. The blood transfusion record indicated that the seventh unit of PRBC was issued on 06/26/10 at 0458 hours (4:58 am) and started at 0645 (6:45 am) and stopped at 0812 (8:12 am). This indicates that the unit of blood transfused in approximately 1 hour and 33 minutes. The seventh unit of PRBC did not indicate who completed the form, on what date or the time.

C. Review of the facility policy titled, "Blood Transfusion: General Nursing Procedures," last revised on 02/10, revealed the following:
"Take vital signs, pre transfusion, and record on the patient's clinical record: temperature, pulse, respiration, blood pressure...Start blood or blood components...Check vital signs at first 15 minutes, then 30 minutes, then at 1 hour and post transfusion and record.. Document what you have done in the clinical record and complete transfusion lab slip. Identify the unit number by using the blood stickers attached to the back of the unit of blood and the start and stop times for the blood transfusion on the nurses notes."

D. On 12/15/10 at 10:40 am, during interview, the Director of Women's Services confirmed that the blood transfusion records were not completed as required by hospital policy.
1. Review of Patient #2's physician order entries indicates:
a. A verbal order entry to Type & Screen for units & transfuse now and Hemoglobin and Hematocrit stat, dated 06/25/10, was not authenticated by the MD responsible for the service provided until 07/16/10. This is 21 days from the verbal order date.
b. A verbal order entry for four units of FFP - transfuse now, dated 06/26/10, was never authenticated by the MD responsible for the service provided.
c. A verbal order entry for 2 units FFP - transfuse now, dated 06/26/10, was not authenticated by the MD responsible for the service provided until 08/24/10. This is 59 days from the verbal order date.
d. A verbal order entry Stat Complete Blood Count, Comprehensive Metabolic Panel, Prothrombin Time & Partial Thromboplastin Time, Cardiac Enzymes and Chest x-ray portable, dated 06/26/10, was not authenticated by the MD responsible for the service provided until 07/20/10. This is 24 days from the verbal order date.
e. A verbal order entry Lactic Acid stat, dated 06/26/10, was not authenticated by the MD responsible for the service provided until 07/20/10. This is 24 days from the verbal order date.
f. A telephone order entry for Cardizem 10 mg IV x 1 now, dated 06/26/10, was not authenticated by the MD responsible for the service provided until 07/23/10. This is 27 days from the verbal order date.
g. A telephone order entry for Versed 1 mg IVP x 1 now, call if not effective, dated 06/26/10, was not authenticated by the MD responsible for the
service provided until 07/20/10. This is 24 days from the verbal order date.
h. A telephone order entry for " Versed 1 mg IV bolus every hour prn jerking spasms and continue drip @ 2 mg/hr; maintain SBP above 90 mmHg," dated 06/26/10, was not authenticated by the MD responsible for the service provided until 07/20/10. This is 24 days from the verbal order date.
i. A verbal order entry for Cardizem 20 mg IVP now, dated 06/26/10, was not authenticated by the MD responsible for the service provided until 07/20/10. This is 24 days from the verbal order date.
j. A telephone order entry for ABG's now, dated 06/27/10, was not authenticated by the MD responsible for the service provided until 07/20/10. This is 23 days from the verbal order date.
k. A telephone order entry to decrease PEEP to 5, FiO2 to 40 %, dated 06/26/10, was not authenticated by the MD responsible for the service provided until 07/20/10. This is 24 days from the verbal order date.

E. Review of the hospital's policy titled "Verbal Orders," last revised 12/2002 revealed the following:
"...The ordering physician shall be responsible for signing such orders. Verbal/telephone orders for new admissions, re-admissions, new orders or changes to current orders should be used infrequently...Orders that are not written by the prescriber will be subsequently authenticated and countersigned by the prescribing practitioner or other responsible practitioner within 72 hours of receipt..."
"[Name of hospital] strongly discourages routine (non-emergent) face to face verbal orders issued while the physician resides on the same floor as the intended receiving patient."

F. On 12/15/10 at 10:40 am, during interview, the Director of Women's Services confirmed that physician order entries were not authenticated by a countersignature in a timely manner for Patient #2.

G. On 12/16/10 at 12:00 pm, during interview, the primary Obstetrician provider for Pt #2 stated the following: "...I know I gave orders that were not documented...I depend on the nurses to write my orders."

Based on medical record review, document review, and interview, the hospital failed to ensure that the Emergency Department (ED) met the emergency needs of patients in accordance with the acceptable standards of practice. The hospital failed to provide services consistent with the patient's condition and results of periodic assessments by staff. The hospital did not deliver care to Pt #1 that was consistent with current standards of practice for possible drug toxicity, interventions that included frequent neurological assessments, continuous monitoring of vital signs (including the temperature for hyperthermia/hypothermia) and preventing or minimizing absorption by administering activated charcoal. Nursing management did not correctly assess the capabilities of agency nurses and did not provide enough qualified, competent and knowledgeable staff to care for the patients in the ED. Pt #1 subsequently died. Also contributing to the neglect was a failure on the part of nursing management to supervise and correctly assess the capabilities of agency nurses and to provide enough staff to care for the patients in the ED. The findings are:

A. Based on medical record review, document review and interview the hospital's ED failed to ensure that there was adequate medical and nursing personnel qualified in emergency care of patients to meet the written emergency procedures and needs anticipated by the facility. Agency nurses working in the ED were not satisfactorily oriented to the ED and did not have the knowledge and training to use the medical records charting computer software used in the ED. The agency nurses also did not provide care to patients in accordance with acceptable standards of practice (refer to A 1112).

Based on medical record review, document review and interview the hospital's Emergency Department (ED) failed to ensure that there was adequate medical and nursing personnel qualified, competent and knowledgeable in emergency care to meet the written emergency procedures and needs anticipated by the facility. Agency nurses working in the ED were not satisfactorily oriented to the ED and did not have the knowledge and training to use the medical records software used in the ED. The agency nurses also did not provide care that was consistent with acceptable current standards of practice for possible drug toxicity, interventions that included frequent neurological assessments, continuous monitoring of vital signs (including the temperature for hypothermia/hyperthermia) and preventing or minimizing absorption by administering activated charcoal. The findings are:

A. Pt #1 was a 22-year-old college student. The medical record reveals that Pt #1 presented to the Emergency Department (ED) on 04/17/10 at 3:47 am. He was brought in by both of his parents and stated that he was suffering from an accidental overdose of methamphetamine. Pt #1 further stated that he had used 1 gram of methamphetamine after not using the drug for over a year and was afraid that he had "overdosed."
1. Pt #1 was seen at 3:50 am by ED Physician #1, who evaluated the patient and completed a history and physical. At this time it was documented that Pt #1 had a temperature of 98.5 and a respiratory rate of 28 "unlabored."

C. ED Physician #1 ordered the following: (1) EKG, (2) laboratory tests to verify that methamphetamines were present in Pt #1's system, (3) a Complete Blood Count with differential, (4) an intravenous line (IV) that was inserted at 4:00 am, and (5) normal saline 1000 cc bolus.
1. The following medications were given on the orders of ED Physician #1: IV Ativan 1 mg @ 4:10 am; IV Metoprolol 5 mg given @ 4:13 am; IV Metoprolol 5 mg @ 4:22 am; IV Metoprolol 5 mg @ 4:35 am; IV Ativan 1 mg @ 4:55 am; IV Ativan 1 mg @ 5:10 am; and IV Metoprolol 5 mg @ 5:10 am.
2. ED Physician #1 also ordered that Pt #1 be put in two-point restraints due to his extreme physical agitation and flailing of arms and legs. The reason for the two-point restraint was to protect the IV that had been placed and to keep Pt #1 on the table. Restraints were first applied at 5:15 am. Although the documentation in the medical record does not indicate when, the patient was eventually placed in 4-point restraints.

D. RN#1's assessment of Pt #1 at 4:00 am indicates the following: Patient's behavior is inappropriate and appears agitated; parents are with patient and providing restraint; pupil response is pinpoint; large tremors of extremities and body; heart rate is 210; cardiac monitor is attached to patient; skin temperature is hot, clammy and diaphoretic.
1. It should be noted that no temperature had been taken on the Pt.#1 since admission vitals at 3:47 am.

E. Pt #1's medical record revealed the following entries by RN #1: (1) at 4:10 am, a "brief reassessment" was done and the assessment indicates twice, "skin hot and diaphoretic"; (2) at 4:43 am, a "brief reassessment" was done and the assessment indicates, "status unchanged, dr. notified"; (3) at 5:00 am, a "brief reassessment" was done and the assessment states, "physical status unchanged, hallucinating, dr. notified."
There were no further entries in the medical record including vital signs or mental status by RN #1 between 5:00 am and 6:05 am. Other than the parents, who were in the exam room with Pt #1, there is no documentation that any ED staff assessed him during this period.
1. There were no further entries in the medical record by RN #1 between 5:00 am and 6:05 am.

F. According to Pt #1's medical record, at 6:05 am on 04/17/10 the mother called RN #1 to treatment room #6 because Pt #1 had no respirations and no pulse. A code was called and cardiopulmonary resuscitation (CPR) was started. Defib (defibrillation) monitor was placed on the patient. Emergency Department physician #1 attempted to intubate, patient rigid. Vecuronium IV was given at 6:08 am and intubation was performed by ED physician #1. CPR measures were taken, including the administration of atropine IV and amiodarone IV. The patient did not respond to the defibrillation. At 6:34 am, CPR was stopped per physician order. On 12/20/10 at 8:30 am, surveyors interviewed ED Physician #1 by phone as he was out of state on vacation. ED Physician #1 was asked, "Did RN#1 ever notify you that Pt #1 was running a very high temperature or having any other medical problem?" He responded by saying, "No, I had no idea anything was wrong with this case until I heard the code being called." He was also asked if he saw any evidence that ice packs had been applied to Pt #1 when he came into treatment room #6 to assist with the code. He stated, "No, I saw no signs of any ice or other method of cooling being applied. In fact, after a few minutes of CPR, I ordered that ice bags be put around Pt #1's extremities in an effort to bring down his temperature."

G. While CPR was in progress, RN #1 took Pt #1's rectal temperature at 6:22 am and the temperature was 107.7.

H. It should again be noted that the Pt #1's temperature had not been taken between 3:47 am and 6:22 am. The patient went for a period of two hours and 34 minutes without any temperature being taken even though nursing reassessments clearly documents that the patient's skin was hot and diaphoretic to touch.

I. RN #1, who was taking care of Pt #1, did add an addendum to the medical record on 05/14/10, almost a month after the adverse patient event. In the addendum, RN #1 documents, "Unable to take temp orally or rectal without harming oral mucosa due combativeness. Unable to temporal temp accurately due to heavy diaphoresis. 5:50 ice pack to head, neck, and extremities. Unable to maintain ice packs on extremities due to combativeness and throwing body around." On 12/16/10 at 1:00 pm, during interview, RN #1, an agency nurse who was the primary nurse for Patient #1, was asked to explain what prompted her to write an addendum on 05/14/10 to her original nursing notes (of 04/17/10) on Pt #1. She stated, "I realized that I did not document the amount of IV fluids that the patient had received. I also realized that I had not charted the ice packs that I applied or the restraints." She was requested if she was asked to go back and chart on this patient by the Director of Nursing. She replied, "No." On 12/20/10 at 8:30 am, surveyors interviewed ED Physician #1 by phone. ED Physician #1 was asked, "Did RN#1 ever notify you that Pt #1 was running a very high temperature or having any other medical problem?" He responded by saying, "No, I had no idea anything was wrong with this case until I heard the code being called." He was also asked if he saw any evidence that ice packs had been applied to Pt #1 when he came into treatment room #6 to assist with the code. He stated, "No, I saw no signs of any ice or other method of cooling being applied. In fact, after a few minutes of CPR, I ordered that ice bags be put around Pt #1's extremities in an effort to bring down his temperature."

J. On 12/15/10 at 2:20 pm, during interview, the mother of Pt #1 was contacted by surveyors. She verified that she and Pt #1's father brought him to the ED and stayed with him in treatment room #6 from the time he went into the treatment room until the code was called. She stated repeatedly, in response to questions from surveyors, that at no time during his care in treatment room #6 were any ice packs or any other method to cool Pt #1 provided by RN #1 or any other ED staff. She further stated, "I had to fight with them just to get a cool washcloth for his head."

K. An autopsy done on 04/18/10 by the Office of the Medical Investigator (OMI) at 8:30 am revealed under the section, Pathologic Diagnoses, "Upon his arrival to the hospital, he was treated but was noted to have a markedly elevated temperature and when [went] into cardiac arrest. Resuscitation efforts were unsuccessful." It should be noted that in this section of the autopsy report, the OMI indicates that Pt#1 died of methamphetamine toxicity.

L. On 12/16/10 at 1:00 pm, RN #1, an agency nurse working under contract in the ED, was asked why there was no documentation of reassessment or attempts to take the temperature on Pt #1. She stated that once she got Pt #1 in treatment room #6, started the IV and gave the physician ordered medications, she had to take care of another patient with chest pains and also had to start an IV on yet a third patient. She was asked how long it took to start the IV, and replied, "I was tied up for about 15 to 20 minutes." She also stated that she was unfamiliar with the medical records computer charting software and was unable to do some of the required documentation. She was asked where the ED charge nurse was during this period. She stated that he had spent considerable time at the nursing station talking to the Poison Control Center about methamphetamine overdose and that he was also taking care of other patients.


M. On 12/20/10 at 8:30 am, surveyors interviewed ED Physician #1 by phone as he was out of state on vacation. ED Physician #1 was asked why no additional help was summoned while the ED was trying to deal with a number of urgent cases. He stated, "At that time we were extremely busy, there were three or four patients with chest pain, one of which we were giving cardiolytics to. We were insanely busy at the time." He also stated, "There was a high level of chaos at that time." ED Physician #1 was asked why the ED charge nurse did not call for assistance during this period. He replied, "Calling for additional help was actively discouraged by the Administration." He further stated that he wasn't sure if there were any other nurses available at the time. He added, "[RN #2] and [RN #3] are experienced emergency room nurses. [RN #1] is not as experienced as the other two." His final comment was, "There was only one of me, I had no one to call in."


N. On 12/16/10 at 1:00 pm, during interview, RN #1 was asked how much time she had spent learning the medical records computer charting software used in the ED. She stated, "I did a tutorial on the software that took about one and a half hours." On 12/16/10 at 4:00 pm, during interview, the Director of ED was asked how much time the hospital allowed for agency nurses to learn the medical records computer charting software used in the ED. She replied that 4 hours was allowed for the software tutorial. She was then told that RN #1 had stated that she only spent one and a half hours on the tutorial. The Director of ED said that she was not aware of how much time RN #1 had spent learning the software.


O. Pt #3 was a 54-year-old man. The medical record reveals that Pt #3 was transported to the ED by ambulance on 09/30/10 at 13:06 (1:06 pm) and his presenting complaint was a cat bite that had occurred 6 days earlier and was infected. Pt #3 stated that he had "lanced" the wound with his pocket knife and drained some pus. The finger was red and swollen as well as the hand.

P. Pt #3 was seen by Nurse Practitioner (NP) #1, who was a contract employee working for a contract emergency room physician service, at 14:08 (2:08 pm). NP #1 evaluated the patient, took a medical history and completed the physical examination. The examination revealed that Pt #3 was in "no acute distress." The exam did note that Pt #3 was intoxicated at the time.

Q. NP #1's evaluation of his right hand was as follows: "Index Finger (2nd Digit)-Extensive erythema noted at radial, ulnar, volar, dorsal aspect(s). Severe tenderness to palpation. Diffusely tender over the entire finger. Neurovascular exam intact. Moderate warmth appreciated dorsal, volar aspect(s). Three areas of apparent animal bite or scratch."

R. At 13:57 (1:57 pm) NP #1 consulted with ED Physician #2 about Pt #3. ED Physician #2 determined that Pt #3 should be admitted to the medical/surgical floor and be given a course of IV antibiotic therapy.

S. NP #1 gave the following orders: (1) ED level 5; (2)Complete Blood Count @ 14:16 (2:16 pm);(3) CMP Complete Metabolic Panel @ 14:16; (4) IV insertion 13:55 (1:55 pm); (5) IM immunization ADT 0.5 mg IM @ 13:55; and (6) IV Toradol 60 mg@ 14:05 (2:05 pm) (Note NP #1 states she gave an order for Toradol 60 mg to be given IM rather than as documented by RN #4 as IV push).

T. At 13:34 (1:34 pm) Pt #3 was moved to treatment room #10. An "Adult Assessment" was done on Pt #3. No significant findings other than pain from the right finger being at a 5 on a scale of one-to-ten. Other findings of the Adult Assessment were: Heart rate is 86. Monitor shows normal sinus rhythm. An electronic non-invasive blood pressure monitor was attached to Pt #3 at this point.

U. Once Pt #3 was in treatment room #10, RN #4 started an IV, lab work was drawn, ADT immunization was given IM and Toradol 60 mg was given IV push even though NP #1 had ordered it to be given IM. Pt #3 was resting on the gurney in the room with the blood pressure monitor attached. At 13:55 (1:55 pm) Pt #3 was reassessed by NP #1 and NP #1 advised him of the plan to have him be seen by a hospitalist, and then to be admitted to the hospital for IV antibiotic therapy. A few minutes later Pt #3 came out of treatment room #10 and was talking on a cell phone. Pt #3's departure from the treatment room was observed by NP #1 who was sitting at the nursing station doing charting directly across from treatment room #10. Pt #3 finished his cell phone call and went back into treatment room #10 and lay down on the gurney.

V. At approximately 14:25 (2:25 pm) a housekeeper walking by treatment room #10 stated to nurses at the nursing station that Pt #3 "did not look good." NP #1 went into the room and found the patient unresponsive. A code was called and CPR was started. CPR with usual medical interventions was performed for about 30 minutes and Pt #3 was pronounced dead.
1. The medical record for Pt #3 indicates that the first pharmacological intervention of IV Epinephrine 1 amp was given at 14:26 (2:26 pm). The Cardiopulmonary Arrest record for Pt #3 reveals that ED Physician #2 started an intubation at 14:28 (2:28 pm). The medical record revealed the reason for death as: "Cardiopulmonary Arrest/Code Blue/Expire."

W. According to Pt #3's medical record, an electronic non-invasive blood pressure monitor was attached to Pt #3 at 13:34 (1:34 pm). However, the medical record does not indicate that any blood pressure readings were taken from the monitor at anytime during Pt #3's treatment. If the blood pressure monitor was working, it should have given staff at the nurse's station a warning that the blood pressure was dropping when Pt #3 was beginning to code.
1. It should also be noted that the period between Unit Secretary's note stating that Pt #3 was re-evaluated at 14:07 (2:07 pm) and 14:25 (2:25 pm) when Pt #3 was discovered to be unresponsive. This is a period of eighteen (18) minutes with no documented monitoring of Pt #3.


X. On 12/20/10 at 2:15 pm, a phone interview was done with NP #1 who was on vacation in Louisiana. NP #1 stated the following:
1. She did the initial workup of Pt #3 including initial assessment and history & physical.
2. She asked ED Physician #2 to look at Pt #3. ED Physician #2 examined Pt #3 and gave orders for the hospitalist to evaluate Pt #3 and admit to the hospital for IV antibiotic therapy. ED Physician #2 reasoned that because Pt #3, based on his intoxication, would not be a reliable person to take medications and perform treatments at home, Pt #3 should be admitted to the hospital for the treatment.
3. Pt #3 had a bad case of cellulitis that was affecting his whole right hand and up the arm. She also noted that Pt #3 was intoxicated.
4. She ordered lab work and the ED plan was to get Pt #3 ready to be admitted after to the hospital after he had been seen by the hospitalist.
5. After Pt #3 was in treatment room #10 and had received the tetanus and Toradol, she went on to see other patients.
6. Some minutes later she passed by the room and told Pt #3, who was on the phone, that he would be seen by the hospitalist and admitted for IV antibiotic therapy.
7. She went to the nursing station and was sitting directly across from treatment room #10 while doing some charting.
8. A housekeeper was standing in front of treatment room #10 and stated to NP #1,"he doesn't look very good." NP #1 immediately went into the room and determined that he had arrested.
9. She confirmed that the hospital policy is that if a nurse makes a mistake on a medication order that the practitioner should be immediately notified. However, RN #4 did not inform her that he had given the 60 mg of Toradol IV push rather than IM as she ordered. She also stated that she had to ask RN #4 directly how he had given the injection to Pt #3, only to find out that he had not followed her orders.
10. She was advised earlier by RN #4, after he had started the IV on Pt #3, that Pt #3 had admitted to polydrug abuse.
11. She had no idea why Pt #3 died and is hoping the autopsy report will explain why he died.

Y. On 12/16/10 at 11:00 am, RN #4 was interviewed and made the following statements:
1. He has been an RN for three years.
2. The ED was very busy at the time Pt #3 presented for care.
3. Pt #3 presented with a pain in his hand, had been drinking but appeared to be oriented and stated that he was "feeling goofy."
4. Pt #3's right hand was red, swollen, tender & radial pulses were present.
5. Pt #3 denied drug use during triage.
6. While trying to start Pt #3's IV, Pt #3 volunteered that he had been using a variety of drugs but appeared to be "evasive" when asked other questions.
7. Pt #3 complained of pain in his hand at a 5 on a one-to-ten scale. RN #4 reported to NP #1 that Pt #3 was experiencing pain and was requesting pain medication.
8. Toradol 60 mg was ordered IM by NP #1 and so documented in chart.
9. He felt "rushed" because there were "so many sick people" and he gave the 60 mg of Toradol as an IVP.
10. RN #4 then went on to take care of other patients until he heard code blue being called. When he got to treatment room #10, a nurse, a respiratory therapist, and a housekeeper were already in the room starting CPR.