HospitalInspections.org

23021




25052

Based on observation and interview, the hospital failed to ensure that the ED intravenous nursing cart was free of contamination when RN 11 closed the bottom drawer using the bottom of his shoe.

Findings:

On 3/4/10 at 1018 hours, RN 11 was observed opening the bottom drawer of the intravenous nursing cart located outside Trauma Room B in the ED. RN 12 stated several large volume intravenous solutions were stored in the drawer. RN 11 removed a product from the drawer and then was observed to close the drawer using the bottom of his shoe. Using the bottom of his shoe can potentially contaminate the handle of the drawer when other nurses use the handle to open the drawer to retrieve a product inside.

Based on staff interview, observations, and administrative document reviews, the hospital failed to set priorities for its performance improvement in high-risk and problem-prone areas. This occurred when the inability of registered nurses to accurately determine and prepare doses of emergency medications for pediatric patients was previously identified by the California Department of Public Health (CDPH) as a problem area and the problem had not been corrected at the time of this survey. This failure potentially placed pediatric patients at risk for avoidable medication errors. In addition, the hospital failed to focus on high risk drugs that carry a Black Box Warning (BBW) to ensure the safety of patients who received them. A Black Box Warning indicates that the drug carries a significant risk of serious or even life-threatening adverse effects. It is the U.S. Food and Drug Administration's (FDA) strongest required warning. The hospital administered droperidol, a BBW drug, without following the FDA warning to monitor ECGs (test to determine how the heart is functioning) in 8 of 18 patients reviewed over the last three months (Patients 5, 6, 11, 12, 13, 14, 15, and 16).

Findings:

1. The previous full Medicare validation survey which was completed on 10/16/09 cited the hospital for a deficiency involving the preparation of doses of emergency medications for pediatric patients. The deficiency occurred when an emergency department registered nurse was unable to accurately draw a dose of epinephrine into a syringe for a theoretical pediatric patient of known length (height). The nurse used a Broselow tape to determine the dose. The Broselow tape provided doses of emergency medications for pediatric patients based on the patient's length when weight was unknown. The dose the nurse calculated was 100 times the dose recommended for the patient by the Broselow tape. The plan of correction submitted by the hospital read, "The Director of Emergency Services is auditing staff knowledge during weekly rounds and ongoing." Also, "All Emergency department staff were re-educated on the use of the Broselow tape system in the department staff meeting."

The following reflected the actions taken after the validation survey on 10/16/09. The minutes of the ED staff meeting on 1/6/10 at 0630 hours, under the subject: Broselow Tape read, "CMS sighted [sic] the ED for not being able to correctly use the Broselow tape for medication administration. Please take the time to review the Broselow tape and the medication dosages." The staff meeting minutes on 2/3/10 at 0630 hours, under CMS:Broselow tape//One Legacy read, "We then explained we use the pediatric pharmacy calculations found on the greaseboard and in the binder on the pediatric crash cart. This information contains the dosage in mg and ml for resuscitative drugs and can be printed off the greaseboard ... or pulled out of binder for keeping with the patient during their stay in ED."

On 3/2/10 from 1040 hours to 1115 hours, RN 5 and RN 7 in the emergency department were asked to draw into a syringe pediatric doses of emergency medications for theoretical pediatric patients. They were not able to demonstrate drawing up accurate doses of the medications. RN 6, the nurse educator, was present during the observation of RN 5.

At 1050 hours on 3/2/10, RN 6 said, "We should not use the Broselow tape." She said she did not know what the hospital's policy and procedure was regarding the determination of doses of emergency medications for emergency pediatric patients.

At 1340 hours on 3/2/10, the ED Director was asked what the policy and procedure was for use in the emergency department for pediatric emergencies. The ED Director stated the emergency department used the policy and procedure titled, Emergency Response to Cardiac/Respiratory Arrest (Code White) for pediatric emergencies. The policy, under III Policy on page 2, read, "The Code Teams provide 24 hour a day support to all inpatient care areas ...except for the Emergency Department and Neonatal Intensive Care Unit which manage their own code calls. Refer to Department specific procedure manuals for code procedures in those areas." At 1500 hours, the CMO stated the hospital did not have a specific pediatric code policy and procedures for the emergency department.

The hospital failed to correct the cited deficiency from the previous validation survey, completed on 10/16/09, regarding emergency drug calculations. There was no documentation that the hospital followed through with nurse training which would also include a return demonstration by the nurse. The failure to correctly prepare and administer doses of emergency medications placed patients at risk for adverse effects up to and including death from medication errors. See A500.



25052


2. On 3/2/10 at 1405 hours, review of the hospital' s Policy on Procedure (P&P) titled, "Medication Management: Black Box Warning (BBW)" and dated as written 2/10/10 revealed the guidelines the hospital followed when droperidol was ordered. According to the P&P, there were no hospital restrictions and no ECG (test to determine how the heart is functioning) or monitoring required before or after administering droperidol.

The hospital stored droperidol in ADCs (automated drug cabinets) on nursing stations throughout the hospital. Nurses were able to override this medication (override means they can remove a medication without review by a pharmacist) and administer to patients without following the FDA mandated BBW requirements. The American Society of Health-Systems Pharmacists (ASHP) has published standards of practice for ADCs. ASHP has pointed out (Am J Health-System Pharmacists. 1998;55: 1403-7) that ADCs should, "ensure safe medication storage, distribution, access, and use ..." Further, ASHP recommends that the ADC should "Provide for prospective, timely review of medication orders by a pharmacist at all appropriate decision points in the medication-use process, especially before administration of the first dose." This was not routinely done since nursing staff could override the pharmacist review and remove droperidol without a pharmacist check.


On 3/2/10 at 1415, the DOP stated droperidol is an override medication stored in the ADCs. He stated nurses have access to obtaining this medication without pharmacist review and without following BBW requirements. The hospital failed to take action and develop a plan to monitor the quality of care and ensure patient safety when droperidol was admininister without regard for the FDA's Black Box Warning. See A500.

23014

Based on observations, interviews, medical record reviews, and administrative document reviews, the medical staff failed to be accountable for the quality of care provided to pediatric patients during medical emergencies. Two of two RNs observed were not able to draw up accurate doses of pediatric emergency medications (RN 5 and 7). This failure potentially placed pediatric patients at risk for avoidable medication errors which could have contributed to adverse effects up to and including death.

In addition, the medical staff failed to ensure the safety of patients by not identifying and documenting polices and procedures to protect patients from adverse drug consequences of high risk drugs that contain Black Box Warnings (BBW- indicate that the drug carries a significant risk of serious or even life-threatening adverse effects.) It is the U.S. Food and Drug Administration's (FDA) strongest required warning. The hospital administered droperidol, a BBW drug, without following the FDA warning to monitor ECGs (test to determine how the heart is functioning) in 8 of 18 patients reviewed over the last three months (Patients 5, 6, 11, 12, 13, 14, 15 and 16).

Findings:

1. On 3/2/10 between 1040 hours and 1115 hours, RN 5 and 7 in the emergency department were asked to draw into a syringe pediatric doses of emergency medications for theoretical pediatric patients. Both RNs were not able to accurately and quickly draw up the appropriate dose of medications for the pediatric patients.

The hospital's previous validation survey which was completed on 10/16/09 cited the hospital for a similar deficiency. The deficiency occurred when an ED staff nurse was unable to accurately draw a dose of epinephrine into a syringe for a theoretical pediatric patient of known length (height). The nurse used a Broselow tape to determine the dose. The dose she calculated was 100 times the dose recommended for the patient by the Broselow tape. The plan of correction submitted by the hospital read, "The Director of Emergency Services is auditing staff knowledge during weekly rounds and ongoing." Also, "All Emergency department staff were re-educated on the use of the Broselow tape system in the department staff meeting."

The minutes of the ED staff meeting, on 1/6/10 at 0630 hours, under the subject: Broselow Tape read, "CMS (Center for Medicare and Medicaid Services) sighted the ED for not being able to correctly use the Broselow tape for medication administration. Please take the time to review the Broselow tape and the medication dosages." The minutes of the staff meeting on 2/3/10 at 0630 hours, under CMS:Broselow tape//One Legacy read, "We then explained we use the pediatric pharmacy calculations found on the greaseboard and in the binder on the pediatric crash cart. This information contains the dosage in mg and ml (milliliters) for resuscitative drugs and can be printed off the greaseboard ... or pulled out of binder for keeping with the patient during their stay in ED."

The medical staff Pharmacy and Therapeutics Committee failed to ensure correction of the cited deficiency from the previous validation survey regarding emergency drug calculations. The failure to correctly prepare and administer doses of emergency medications placed patients at risk for adverse effects up to and including death from medication errors. See A500.



25052

2. On 3/3/10 and 3/4/10, review of 18 medical records revealed that eight patients (Patients 5, 6, 11, 12, 13, 14, 15 and 16) received droperidol injection without ECG monitoring. According to the BBW for droperidol, patients should be followed on a ECG for 2-3 hours after the injection to monitor for arrhythmias.

Droperidol's Black Box Warning states, "Due to droperidol's potential for serious cardiac arrhythmias (irregular heartbeats), it should be reserved for use in the treatment of patients who failed to show an acceptable response to other adequate treatments, either because of insufficient effectiveness or the intolerable adverse-effects from those drugs. All patients should undergo a 12 lead ECG prior to the administration of Droperidol to determine if a cardiac arrhythmia was present. For patients in whom the potential benefit of droperidol treatment was felt to outweigh the risks, ECG monitoring should be performed prior to treatment and continued 2-3 hours after completing treatment to monitor for arrhythmias."

There was no documentation in the medical records of these eight patients that ECG monitoring was performed following droperidol injections. The Risk Manager on 3/4/10 at 1152 hours stated that there was one patient (Patient 15) who did not receive an ECG prior to or following the three doses of droperidol he received on 2/18/10.

On 3/2/10 at 1405 hours, review of the hospital's Policy on Procedure (P&P) titled, "Medication Management: Black Box Warning (BBW)" and dated as written 2/10/10 revealed the guidelines the hospital followed when droperidol was ordered. According to the P&P, there were no hospital restrictions and no ECG (test to determine how the heart is functioning) or monitoring required before or after administering droperidol. Document review and interview with the DOP failed to reveal the reason why the medical staff's Pharmacy and Therapeutics committee had not incorporated the ECG monitoring recommended by the FDA BBW.

Based on observation, record review and staff interview, the hospital failed to ensure nursing services:

1. Implemented the plan of correction from the previous survey on 10/16/09, and ensure the ED nursing staff were competent to accurately calculate and draw up emergency medications for the pediatric population. See A397, A500 #1.

2. Implemented the plan of correction from the previous survey on 10/16/09, to monitor refrigerator temperatures to ensure that vaccines and other medications were safely stored in the ED refrigerator in accordance with the manufacturer's recommendations, regulatory requirements, and hospital's P&P. See A505, A1104.

3. One of one nurse observed administered medications via stomach tube without a water flush to ensure the medications reached the stomach for absorption. See A405.

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Based on staff interviews, observations, and administrative document reviews, the hospital failed to assign competent nursing personnel to the emergency department according to patients' needs. This occurred when three of four ED nurses, randomlt selected, were unable to accurately and quickly prepare doses of emergency medications for pediatric patients (RN 5, 7 and 11). Ten randonly selected nursing competency files failed to show 10 of 10 ED nurses' competencies to draw up and adminster emergency medication had been tested since 2006 or 2007 (RN 5, 7, 16, 17, 18, 19, 20, 21, 22, 23). This failure had the potential to cause avoidable medication errors that could cause adverse consequences up to, and including, death.

Findings:

1. The previous full Medicare validation survey which was completed on 10/16/09 cited the hospital for a deficiency involving the preparation of doses of emergency medications for pediatric patients. The deficiency occurred when an ED staff nurse was unable to accurately draw a dose of epinephrine into a syringe for a theoretical pediatric patient of known length (height). The dose the nurse calculated was 100 times the dose recommended for the patient. The plan of correction submitted by the hospital read, "The Director of Emergency Services is auditing staff knowledge during weekly rounds and ongoing." Also, "All Emergency department staff were re-educated on the use of the Broselow tape system in the department staff meeting." The hospital's written plan of correction was to re-educate all ED staff on the use of the Broselow tape system with the Director of the ED auditing staff knowledge during weekly rounds.

The following reflected the actions taken after the validation survey on 10/16/09. The minutes of the ED staff meeting on 1/6/10 at 0630 hours, under the subject: Broselow Tape read, "CMS sighted [sic] the ED for not being able to correctly use the Broselow tape for medication administration. Please take the time to review the Broselow tape and the medication dosages." The staff meeting minutes on 2/3/10 at 0630 hours, under CMS:Broselow tape//One Legacy read, "We then explained we use the pediatric pharmacy calculations found on the greaseboard and in the binder on the ped's crash cart (emergency cart). This information contains the dosage in mg and ml for resuscitative drugs and can be printed off the greaseboard ... or pulled out of binder for keeping with the patient during their stay in ED."

On 3/2/10 at 1040 hours, RN 5 was asked to draw up two emergency medications for a theoretical pediatric patient in the emergency department. She was unable to draw up the correct dose of atropine (to increase heart rate) in the syringe. The correct dose was 0.13 mg but RN 5 drew into a syringe a dose of 0.065 mg which was incorrect.

On 3/2/10 at 1100 hours, RN 7 was asked to draw up a dose of sodium bicarbonate (to decrease acid in the blood) for a theoretical pediatric patient in the emergency department. for the patient. RN 7 first used the Broselow tape to determine the dose; then she used two computers, one in the patient room and one outside the room in attempts to determine the correct dose. After 14 minutes she never returned to the room to prepare the medication.


21262


2. On 3/3/10 at 1000 hours, review of the ED staff meeting minutes conducted on 1/6/10 showed that "CMS sighted [sic] the ED for not being able to correctly use the Broselow tape for medication administration. Please take the time to review the Broselow tape and the medication dosages." However, the ED staff meeting conducted on 2/3/10, showed contradicting messages. It stated that, "We then explained we use the pediatric pharmacy calculations found on the greaseboard and in the binder on the ped's crash cart (emergency cart). This information contains the dosage in mg and ml for resuscitative drugs and can be printed off the greaseboard ... or pulled out of binder for keeping with the patient during their stay in ED."

On 3/3/10 at 1600 hours, per the hospital's request, a mock code was conducted with RN 9 and 11 to verify re-education of the nursing staff on emergency drug calculation. RN 12, the ED Director was also in attendance.

RN 9 was observed to accurately calculate and draw three emergency medications. The second nurse, RN 11, was observed to accurately draw the first of three emergency medications, however, the second pediatric dose was miscalculated twice.

On 3/4/10, review of competencies for ten ED nursing staff, randomly picked, showed the latest nursing skills test on safe medication administration were dated 11/06 to 7/07 (Ten randonly selected nursing competency files failed to show 10 of 10 ED nurses' competencies to draw up and administer emergency medication had been tested since 2006 or 2007 (RN 5, 7, 16, 17, 18, 19, 20, 21, 22, 23).

3. At 1500 hours on 3/4/10 the Director of Emergency Services was unable to provide documentation that nursing staff received educatio about pediatric emergency medication calculations, drawing up and admistration of the medications and that each nurse successfully passed a return demonstration. She was unable to provide documented evidence of the weekly monitoring of the ED nursing staff's ability to accurately administer emergency medications to pediatric patients. See A500 #1.

Based on observation, staff interview and record review, one of one RNs failed to follow the hospital's policy on administering medications through a nasogastric tube. This had the potential for the medication to not be administered into the patient's bodily system.

Findings:

Review of the hospital's computer resource entitled Medication Administration: Nasogastric Tube or Enteral Tube, undated, showed that 30 to 60 ml of water would be given after the last dose of medication was administered through the nasogastric tube.

On 3/3/10 at 1300 hours, during a medication pass with RN 1, she was observed to give a medication through Patient 10's nasogastric tube and not flush the tube after the medication was given. When RN 1 was asked about flushing the tube after administering the medication through it, she stated that normally nasogastric tubes were flushed after medications were given and that she intended to go back into the room to flush the tube.

On 3/4/10 at 0930 hours, during an interview with the Risk Manager, she stated that although the hospital's P&P did not cover everything regarding proper administration of drugs through nasogastric tubes, the nurses had a computer resource they could go to for guidance for administering drugs through nasogastric tubes.




25447

22781




17108

Based on interviews, and a review of six open medical records selected randomly from the Neuropsychiatric Center, the hospital failed to ensure the provision of a complete and accurate record for six of six patients (Patients 19, 20, 21, 22, 23 and 24). This resulted in the potential for important information to be missing for clinical care of the patients.

Findings:

1. Patient 19 came to the MHA (Mental Health Adolescent) unit of the hospital for the treatment of escalating agitation and threats to others on 2/20/10 at 0350 hours. A review of the "Interdisciplinary Treatment Plan Problem List" was done during an onsite visit to the unit on 3/1/10 at approximately 1000 hours. When reviewed, there was no documentation that the boxes for "Nutrition/Diet, Skin integrity/Wounds, Self-care deficit, Fall risk, Cultural & Spiritual Needs or Treatment Non-compliance" had been evaluated. When interviewed concurrently RNs 13 and 14 stated that "blank entries were considered normal". However, when requested, staff were unable to produce a policy and procedure for "normal entries."

2. Patient 20 came to the MHA unit of the hospital on 2/26/10, for the treatment of depression and suicidal thoughts with a plan. A review of the "Interdisciplinary Treatment Plan Problem List" was done during an onsite visit to the unit on 3/1/10 at approximately 1000 hours. When reviewed, there was no documentation that the boxes for "Nutrition/Diet, Skin integrity/Wounds, Self-care deficit, Fall risk, Cultural & Spiritual Needs or Treatment Non-compliance" had been evaluated. When interviewed concurrently, RNs 13 and 14 stated that "blank entries were considered normal." However, when requested, staff were unable to produce a policy and procedure for "normal entries." When reviewed on 3/2/10, the areas on the medical record left blank on 3//1/10 were filled in with a zero (0).

3. Patient 21 was admitted to the MHA unit of the hospital on 2/20/10 for the treatment of combative behavior and threats of physical abuse to others. A review of the "Interdisciplinary Treatment Plan Problem List" was done during an onsite visit to the unit on 3/1/10 at approximately 1000 hours. When reviewed, there was no documentation that the boxes for "Nutrition/Diet, Skin integrity/Wounds, Self-care deficit, Fall risk, Cultural & Spiritual Needs or Treatment Non-compliance" had been evaluated. The entries for short term and long term goals had been filled out with a zero(0). When interviewed concurrently, RNs 13 and 14 stated that "blank entries were considered normal." However, when requested, staff were unable to produce a policy and procedure for "normal entries."

4. Patient 22 came to the MHA unit of the hospital on 2/24/10 for the treatment of suicidal thoughts and anxiety. A review of the "Interdisciplinary Treatment Plan Problem List" was done during an onsite visit to the unit on 3/1/10 at approximately 1000 hours. This revealed that the areas on the medical record for Substance Abuse/Dependence, Cultural & Spiritual, Communication, Medical, Nutrition/Diet, Skin integrity, Self-care Deficit, and Fall risk had been left blank. When interviewed concurrently, RNs 13 and 14 stated that "blank entries were considered normal. However, when requested, staff were unable to produce a policy and procedure for "normal entries."

5. Patient 23 came to the MHA unit of the hospital on 2/26/10 for the treatment of depression and suicidal thoughts. A review of the "Interdisciplinary Treatment Plan Problem List" was done during an onsite visit to the unit on 3/1/10 at approximately 1000 hours. The area on the medical record for "Thought disorder, Cultural & Spiritual Needs, Treatment non-compliance, Nutrition/diet, Skin integrity/wounds, and Self-care deficit" had been left blank. When interviewed concurrently, RNs 13 and 14 stated that "blank entries were considered normal". However, when requested, staff were unable to produce a policy and procedure for "normal entries."

6. Patient 24 came to the MHA unit of the hospital on 2/28/10 for the treatment of an eating disorder and end stage renal disease. A review of the "Interdisciplinary Treatment Plan Problem List" was done during an onsite visit to the unit on 3/1/10 at approximately 1000 hours. The area on the medical record for "Thought disorder, substance abuse/dependence, Cultural & Spiritual, Communication, High risk behavior had been left blank and not filled in or evaluated. When interviewed concurrently, RNs 13 and 14 stated that "blank entries were considered normal". However, when requested, staff were unable to produce a policy and procedure for "normal entries."

Based on observation, interview, and medical record, document review, and P&P review, the hospital failed to ensure that pharmaceutical services carried out its full and complete oversight that meets the needs of the patients in the hospital.

Findings:

1. Pharmaceutical Services failed to ensure tetanus and diphtheria vaccines were stored in the refrigerator at temperatures recommended by the manufacturer. The vaccines were stored while temperatures registered in the freezing range (as low as 23 degrees Fahrenheit) from 1/28/10 to 2/24/10. This resulted in potentially ineffective vaccines being administered to 101 patients in the Emergency Department.

An immediate jeopardy (IJ) was called on 3/3/10 at 1526 hours. The immediate jeopardy had not been abated at the time of exit on 3/4/10 at 1530 hours because all 101 patients had not been notified of the potential ineffective vaccination they had received. See A505, A724.

A revisit to the hospital on 3/10/10 showed the patient who had been vaccinated with the potentially ineffective vaccines had been notified and a system was in place for follow-up immunization of the patient. At 1530 hours on 3/10/10, the Administrator was notified the Immediate Jeopardy situation was abated.

2. Pharmaceutical Services failed to ensure they provided for patient safety when two of two nurses in the ED (Emergency Department) were unable to quickly and accurately draw up doses of pediatric emergency medications. This resulted in the potential failure to ensure pediatric patients would receive drugs in appropriate doses during a pediatric emergency.

An immediate jeopardy was called on 3/2/10 at 1330 hours as a result of the inability of ED nurses to accurately and quickly prepare doses of emergency medications for pediatric patients. The immediate jeopardy had not been abated at the time of exit on 3/4/10 at 1530 hours because nurses were not able to draw up accurate doses during a mock pediatric code conducted on 3/4/10 at 1600 hours. See A500 #1, A285, A347, A397.

On a revisit to the hospital on 3/10/10, three randomly selected ED nurses were observed to be able to accurately draw up emergency medications during a pediatric mock code in the ED. At 1530 hours on 3/10/10, the Administrator was notified the Immediate Jeopardy situation was abated.

3. Pharmaceutical Services failed to ensure patient safety by failing to recognize a medication, droperidol (a medication to treat nausea and vomiting), as a high risk medication that contained a Black Box Warning (BBW - Black Box Warning means that medical studies indicate that the drug carries a significant risk of serious or even life-threatening adverse effects. It is the U.S. Food and Drug Administration's strongest required warning). The hospital placed no restrictions on the use of droperidol and continued to administer the drug without regard for the FDA's concerns or reasons for incorporating a BBW for this medication. See A500 #3, A285 #2, A347.

4. Pharmaceutical Services failed to ensure that "override" medications removed from an ADC (Automated Drug Cabinet) and administered to patients without a pharmacist review were followed up on to determine whether the medications accessed by override were ordered by a prescriber and were appropriate and safe for the patient. See A500 #2.

5. Pharmaceutical Services failed to ensure that two vials of vaccines, H1N1 (swine flu) and Purified Protein Derivative (an extract of tuberculosis bacilli), were not available for patient use after they were left open for more than 30 days. See A505 #2.

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.





25447

Based on interviews, observations, medical record reviews and administrative document review, the hospital failed to provide for patient safety in the control of drugs and biologicals in accordance with standards of practice and Federal and State laws. These factors created unsafe conditions which had the potential to adversely affect patients when two of two nurses in the ED were unable to quickly and accurately draw up doses of emergency medications (RN 5 and RN 7). This resulted in the potential failure to ensure patients would receive drugs in appropriate doses during a pediatric emergency. The hospital failed to ensure new medication orders were reviewed by pharmacists prior to administration to patients in the ED, Labor and Delivery, and Post Anesthesia Care Units In addition, the hospital failed to ensure patient safety by failing to recognize a medication, droperidol (a medication to treat nausea and vomiting), as a high risk medication that contained a black box warning (a black box warning means that medical studies indicate that the drug carries a significant risk of serious or even life-threatening adverse effects. It is the U.S. Food and Drug Administration's strongest required warning) while treating eight of 18 patients reviewed over the last three months (Patients 5, 6, 11, 12, 13, 14, 15 and 16).

An immediate jeopardy was called on 3/2/10 at 1330 hours, as a result of the inability of ED nurses to accurately and quickly prepare doses of emergency medications for pediatric patients. The immediate jeopardy had not been abated at the time of exit on 3/4/10 at 1530 hours, because nurses were not able to draw up accurate doses during a mock pediatric code conducted on 3/4/10 at 1600 hours.

A revisit to the hospital on 3/10/10 observation of a mock pediatric code in the ED showed the ED nurses were able to accurately draw up emergency medications. At 1530 hours on 3/10/10, the Administrator was notified the Immediate Jeopardy situations were abated.

Findings:

1. On 3/2/10 at 1040 hours, RN 5 in the ED was asked to draw into a syringe pediatric doses of two emergency medications for theoretical pediatric patients. RN 6 was present as an observer. RN 5 was given a height for a theoretical patient. The first medication she was asked to draw into a syringe was epinephrine (to increase heart rate and blood pressure). She used a Broselow tape to determine the weight of the patient. Broselow tapes provide weights which correspond to a patient's height. The Broselow tapes also provide doses of emergency medications which correspond to each of the weights. She also used the Broselow tape to determine the dose of the medication. RN 5 drew into a syringe the correct dose of epinephrine. RN 5 subsequently was asked to prepare a dose of atropine (to increase heart rate) for the same theoretical patient. She again used the Broselow tape to determine the dose which corresponded to the patient's height. The correct dose was 0.13 mg but RN 5 drew into a syringe a dose of 0.065 mg which was 1/2 the dose needed.

At 1050 hours on 3/2/10, RN 6, the nurse educator said, "We should not use the Broselow tape." However, she said she did not know what the hospital's policy and procedure was regarding the determination of doses of emergency medications for emergency pediatric patients.

At 1100 hours on 3/2/10, RN 7 was asked to determine a dose of atropine for a theoretical patient in the ED. She was given the height of the patient. RN 7 used the Broselow tape to correctly determine the dose of atropine for the patient. She said nurses used the Broselow tape for every single patient that comes into the ED. She subsequently was asked to determine a dose of sodium bicarbonate (to decrease acid in the blood) for the patient. RN 7 first used the Broselow tape to determine the dose, then she used two computers, one in the patient room and one outside the room, in attempts to determine the correct dose. After 14 minutes she never returned to the room to prepare the medication.

At 1340 hours on 3/2/10, the ED Director was asked what policy and procedure the ED used for pediatric emergencies. The ED Director stated the ED used the P&P titled, Emergency Response to Cardiac/Respiratory Arrest (Code White) for pediatric emergencies. The policy, under III Policy on page two read, "The Code Teams provide 24 hour a day support to all inpatient care areas ...except for the ED and Neonatal Intensive Care Unit which manage their own code calls. Refer to Department specific procedure manuals for code procedures in those areas." The policy on page two read, "Personnel competent to provide ACLS or PALS assume charge of the code situation until relieved by an ACLS or PALS certified physician or by the physician on the Code Team, as appropriate." Page 4 read, "Critical Care RN: May act as code team leader following ACLS guidelines until a physician arrives" and, on page 5 of the document, "Prepares and or administers prescribed medications as ordered." At 1500 hours on 3/2/10, the CMO stated the hospital did not have a specific pediatric code P&P for the ED. The lack of a P&P failed to ensure guidance for the ED nursing staff to follow.

The policy on page 5 read, "Clinical Pharmacist or designee prepares all necessary medications as needed." The ED Director stated pharmacists did not attend codes (emergencies) in the ED.

The minutes of the ED staff meeting on 1/6/10 at 0630 hours, under the subject Broselow Tape read, "CMS (Center for Medicare and Medicaid Services) sighted the ED for not being able to correctly use the Broselow tape for medication administration. Please take the time to review the Broselow tape and the medication dosages." This action item failed to ensure ED staff actually reviewed the Broselow tape to educate themselves and correct the deficiency.

The minutes of the staff meeting on 2/3/10 at 0630 hours, about CMS: Broselow tape//One Legacy read, "We then explained we used the pediatric pharmacy calculations found on the greaseboard and in the binder on the pediatric crash cart. This information contains the dosage in mg and ml for resuscitative drugs, and can be printed off the greaseboard...or pulled out of binder for keeping with the patient during their stay in ED." This directive was in conflict with the directions to the ED staff given during the meeting on 1/6/10.

2. On 3/1/10 at 1405 hours, RPh 1 stated several areas in the hospital which had automated medication dispensing cabinets (ADCs) were not profiled. Being "profiled" meant medication could not be removed for new medication orders until after a pharmacist's review of the order (except in override, below). Pharmacists reviewed each new order for safety considerations such as drug interactions, proper doses, appropriate indications, and potential medication errors. ADCs which were not profiled did not ensure that a pharmacist reviewed each new order before the drug was administered. ADCs were not profiled in the labor and delivery area, post anesthesia recovery, and ED.

The hospital provided override reports for their ADCs from 2/10 to 3/1/10. These "override" reports documented each time a medication was removed from a profiled ADC before a pharmacist had reviewed the medication for patient safety considerations. There were 555 reports of overrides for the month of February 2010. The medications ranged from non-prescription drugs (for example, acetaminophen, for pain relief) to drugs which were potentially lethal if used improperly (for example, propofol, a sedative). RPh 2, on 3/1/10 at 1445 hours, stated pharmacists did not follow-up on all overrides. This meant that no one followed-up to determine whether the medications accessed by overrides were ordered by a prescriber and were appropriate and safe for the patient. She stated that the number of overrides which were not followed-up was "not a small number."

RPh 2 on 3/1/10 at 1445 hours, also commented on "discrepancies" recorded for the ADCs for the month of February, 2010. A discrepancy occurred when the number of doses (count) for a medication was either over or under the count which was listed in the computer attached to the ADC. Nurses were required to record the number of doses removed and to acknowledge the correct count at the time of removal. A discrepancy was recorded each time the count was over or under the number of doses of the medication which were supposed to be present. The hospital provided a discrepancy report which documented that there were 1,170 discrepancies for February, 2010. Potential reasons for discrepancies included incorrect count by the nurse, administration of too many or two few doses to a patient, drug diversion, and administration to a patient in the absence of a prescriber's order (for example, the wrong patient). Some of the potential reasons for the discrepancies such as administration to the wrong patient would have denied a review by the pharmacist before administration. At 1445 hours on 3/1/10, RPh 2 stated, "to be honest, we don't follow-up on all discrepancies." She stated there was no time to follow-up on all the discrepancies in an attempt to determine why the discrepancies occurred.

The American Society of Health-Systems Pharmacists (ASHP) has published standards of practice for automated storage and distribution devices (ADCs). ASHP pointed out (Am J Health-Syst Pharm. 1998;55: 1403-7) that ADCs should, "ensure safe medication storage, distribution, access, and use..." ASHP cautions hospitals to ensure that "Vulnerabilities to medication errors are minimized, and those that remain are identified, documented, and modified." Furthermore, ASHP recommends that the ADC should "Provide for prospective, timely review of medication orders by a pharmacist at all appropriate decision points in the medication-use process, especially before administration of the first dose..."


25052


3. On 3/2/10 at 1405 hours, review of the hospital's P&P titled, "Medication Management: Black Box Warning (BBW)" and dated as written 2/10/10, revealed the guidelines the hospital followed when droperidol was ordered. According to the P&P, there were no hospital restrictions and no ECG (test to determine how the heart is functioning) or monitoring required before or after administering droperidol.

Due to the potential of serious adverse consequences, including death, droperidol has a special warning (BBW) issued by the Food and Drug Administration (FDA) and published in the manufacturer's package insert and drug information references to ensure it is used safely. The following is the BBW for droperidol:

"Due to droperidol's potential for serious cardiac arrhythmias, it should be reserved for use in the treatment of patients who fail to show an acceptable response to other adequate treatments, either because of insufficient effectiveness, or the intolerable adverse-effects from those drugs. The BBW states, all patients should undergo a 12 lead ECG prior to the administration of droperidol, to determine if a cardiac arrhythmia is present. For patients in whom the potential benefit of droperidol treatment is felt to outweigh the risks, ECG monitoring should be performed prior to treatment and continued 2-3 hours after completing treatment to monitor for arrhythmias."

The hospital stored droperidol in ADCs on nursing stations throughout the hospital. Nurses were able to override this medication without review by a pharmacist and administer to patients without following the FDA mandated BBW requirements.

The following eight patients received droperidol without appropriate ECG monitoring:

* On 3/2/10 at 1450 hours, RN 8 stated that Patient 11 received droperidol without ECG monitoring following the dose and as described in the BBW. Review of Patient 11's medication administration record (MAR) revealed he received a dose of droperidol 0.625 milligrams (mg) by intravenous (IV) push on 2/11/10 at 0100 hours, without follow up ECG monitoring.

* On 3/3/10, review of Patient 16's medical record revealed that he had "Nonspecific intraventricular conduction delay" on his ECG dated 11/16/09. He received droperidol 0.625 mg IV push on 2/22/10. There was no post ECG monitoring following the droperidol dose.

* On 3/3/10, review of Patient 6's medical record revealed that there was no ECG prior to the dose of droperidol and no ECG monitoring following the dose. The patient received droperidol 0.625 mg IV push on 1/28/10 at 2120 hours.

* On 3/3/10, review of Patient #12's medical record revealed an ECG dated 1/20/10 which showed a borderline ECG (right ventricular conduction delay). The patient was admitted to the hospital for a radical prostatectomy which was performed on 1/28/10. On 1/29/10, he received droperidol 0.625 mg IV push at 0640 hours without ECG monitoring following the dose.

* On 3/3/10, review of Patient 5's medical record revealed she received droperidol 0.625 mg IV push on 1/26/10 at 0830 hours without ECG monitoring following the dose.

* On 3/3/10, review of Patient 13's medical record revealed he received droperidol 0.625 mg IV push for nausea status post radical prostatectomy on 2/3/10 at 1520 hours, without ECG monitoring following the dose.

* On 3/3/10, review of Patient 14's medical record revealed a dose of droperidol 0.625 mg IV push administered on 2/17/10 at 1845 hours, without ECG monitoring following the dose.

* On 3/4/10, review of Patient 15's medical record revealed doses of droperidol 0.625 mg IV push administered on 2/18/10 at 1331, 1600 and 2117 hours. The Risk Manager on 3/4/10 at 1152 hours, stated that there was no ECG monitoring prior to the first dose or following the three doses of droperidol.

All eight patients above received droperidol injections without ECG monitoring 2-3 hours after the dose as defined in the FDA BBW. According to the hospital's P&P titled, "Medication Management: Black Box Warning (BBW)," and dated as written 2/10/10, stated that, "Black Box Warnings, generally include certain contraindications or serious warnings, particularly those that may lead to death or serious injury." The hospital continued to administer droperidol without regard for the FDA's concerns or reasons for not incorporating a BBW for this medication.






25447

2. On 3/2/10 at 1030 hours, during a tour of the Neurosurgical unit's medication room conducted with the CMO and the Infection Control Nurse (RN10), two opened vaccine vials available for patient use were found in the medication refrigerator. The H1N1 (swine flu) vaccine vial was dated as opened on 1/19/10. The Purified Protein Derivative (an extract of tuberculosis bacilli) was dated as opened on 1/29/10.

The Charge Nurse for the Neurosurgical unit was shown the two opened vaccine vials. The Infection Control Nurse stated that opened vials were to be kept not more than 30 days per hospital policy. The CMO stated that those vials should not be in the medication refrigerator for patient use. The Charge Nurse disposed of the two opened vials.


25052

Based on observation, interviews, and policy and document review, the hospital failed to:
* ensure that potentially inactivated tetanus and diphtheria vaccines were not available for patient use. Tetanus is an infection of the nervous system by Clostridium tetani, a potentially deadly bacteria. Diphtheria is an infection leading to breathing problems, paralysis, heart failure and even death. The tetanus and diphtheria vaccines were stored at freezing temperatures which compromised their integrity (as low as 23 degrees Fahrenheit) from 1/28/10 to 2/24/10. During this time, 101 patients were administered these potentially ineffective vaccines. The violation has caused or is likely to cause serious injury or death to patients. An immediate jeopardy (IJ) was called on 3/3/10 at 1526 hours. The immediate jeopardy had not been abated at the time of exit on 3/4/10 at 1530 hours, because all 101 patients had not been notified of the potential ineffective vaccination they had received. A revisit to the hospital on 3/10/10 showed the patients who had been vaccinated with the potentially ineffective vaccines had been notified and a system was in place for follow-up immunization of the patient. At 1530 hours on 3/10/10, the Administrator was notified the Immediate Jeopardy situations were abated.
* ensure two opened vaccine vials found in the medication refrigerator of the Neurosurgical unit were not available for patient use after they were opened for more than 30 days.

Findings:

1. On 3/2/10 at 1100 hours, during a tour of the ED, it was discovered that the ED's medication refrigerator temperature log revealed recorded temperatures dating back to 1/28/10, which were below freezing (freezing = 32 degrees Fahrenheit or less). These temperatures were recorded as low as 25 degrees Fahrenheit for days in a row. During the period of 1/28/10 to 2/24/10, the refrigerator was out of range for 22 of the 28 days with nine days in the freezing range. The second to last column of the temperature log states, if temperatures were not in range, list corrective action. There was no action documented on the temperature log to report the defect until 2/24/10. On 3/2/10 at 1110 hours, according to RN 8, no action was taken by the nursing staff to report these temperatures to the pharmacy department. She stated the ED needed a new refrigerator and could not answer why it had not arrived. According to the hospital's P&P titled Medication Management: Refrigerator and freezer drug storage requirements, written 9/94, and last reviewed 1/10, "If after the first adjustment of the thermostat, the temperature remains out of the acceptable range, contact pharmacy to relocate the drugs and facilities to repair/replace the unit."

Stored in the refrigerator were 26 vials of tetanus and diphtheria vaccines. The manufacturer of the vaccine was contacted by the hospital the morning of 3/3/10. The manufacturer related it could not guarantee the potency of the vaccine if stored outside of package insert recommendations. The package insert advised that the vaccine be stored between 36 - 46 degrees Fahrenheit, and "DO NOT FREEZE."

In addition to the vaccines, there were nine other medications including insulin (medication to treat diabetic patients with high blood sugars) stored in the refrigerator. The American Diabetes Association recommends to never store insulin in freezing temperatures and to discard the bottle if they become frozen.

On 3/3/10 at 0935 hours, RPh1 stated that a pharmacist performed monthly floor stock inspections which included reviewing temperature logs for all refrigerators in the hospital. If temperatures were documented out of range on a regular basis, they would be either fixed or replaced. On 3/3/10 at 1515 hours, review of the monthly floor stock inspection report submitted 2/8/10, revealed the pharmacist documented that, "All medication refrigerators have current version log sheets, are completely filled out per policy, and log sheets have documented action for out of bounds (too high or too low) temperatures."

On 3/3/10 at 1700 hours, the hospital presented a plan of correction that included contacting by telephone all 101 patients who received the potentially ineffective vaccine and sending registered letters to their homes to notify them that the vaccine administered in the ED may not have been effective. On 3/4/10 at 1215 hours, the CMO indicated that the letters were mailed on 3/4/10 at noon.

During the previous full Medicare validation survey dated 10/16/09, it was found that medications were not stored in accordance with state requirements, and hospital P&Ps for seven of eleven medication refrigerators observed. The hospital's plan of correction was as follows:
"Pharmacy staff was re-educated on monitoring temperatures. Random audits are conducted on two units per week by pharmacy to assure 100% compliance is achieved and sustained for three consecutive months. An automated temperature monitoring system was implemented in UCI's Douglas Hospital Pharmacy and on Douglas Hospital nursing unit medication refrigerators. Audits of manually recorded refrigerators is being conducted by pharmacy. On going real time monitoring and alarming of automated refrigerators is being conducted by the Director, Pharmacy Services or designee."

The hospital failed to implement their plan of correction from the previous survey on 10/16/09, and continued to fail to ensure that vaccines and other medications were safely and stored in the ED refrigerator in accordance with the manufacturer's recommendations, regulatory requirements, and hospital's P&P.

Based on record review and staff interview, the hospital failed to ensure the ED medication refrigerator was maintained in an acceptable level of safety and quality. Consequently, vaccine supplies, rendered potentially ineffective for being stored under freezing temperature, were administered to 101 patients.

Findings:

On 3/4/10, review of the hospital's P&P on Medication Management: Refrigerator and Freezer Drug Storage Requirements, revised on 1/10, showed that all personnel dispensing or administering medications were responsible for assuring the integrity of these medications including assuring proper storage.

The procedure included that drug storage refrigerators, freezers and warmers would be inspected daily by unit staff and the daily temperature would be recorded on the appropriate log sheet. If the the temperature was outside the appropriate range, the unit staff would adjust the thermostat and check the temperature again in 60 minutes. If the temperature remained out of the acceptable range after the first adjustment, the pharmacy should be notified immediately to relocate the drugs and contact facility's personnel to fix/replace the refrigeration unit. All actions should be documented on the back of the log sheet.

On item No. 4, it stated, if the unit experienced any "out of bounds" conditions during the previous time period, the pharmacy should be contacted to provide guidance on whether the drugs should be replaced or were safe to use.

During the previous full Medicare validation survey dated 10/16/09, medications were found not stored in accordance with state requirements, and hospital P&Ps for seven of eleven medication refrigerators inspected. The hospital's plan of correction was as follows:

"Pharmacy staff was re-educated on monitoring temperatures. Random audits were conducted on two units per week by pharmacy to assure 100% compliance was achieved and sustained for three consecutive months. An automated temperature monitoring system was implemented in UCI's Douglas Hospital Pharmacy and on Douglas Hospital nursing unit medication refrigerators. Audits of manually recorded refrigerators were being conducted by pharmacy. On going real time monitoring and alarming of automated refrigerators were being conducted by the Director, Pharmacy Services or designee."

In additon, the hospital's deficiencies from the previous survey included failure to maintain proper temperature ranges on nourishment refrigerators. The approved plan of corrections submitted by the hospital stated that corrective actions had been implemented since 11/12/09. A few of the hospital's corrective actions were to have Clinical Engineering conduct routine maintenance and monitor other medical equipment to ensure preventive maintenance. The Facilities Department would conduct weekly inspections which would include verifying refrigerator logs to ensure refrigeration units were functioning properly. It also showed that the Facilities Department was to replace refrigeration units in the event that these units were not able to function within the range specified.

On 3/1/10 at 1300 hours, a follow-up validation survey was conducted to verify the hospital's correction of deficiencies from the previous survey of 10/16/09. On 3/2/10 at 1100 hours, during a tour of the ED, it was discovered that the ED's medication refrigerator temperature log had recorded temperatures which were below freezing (freezing = 32 degrees Fahrenheit or less) temperatures. During the period of 1/28/10 to 2/24/10, the refrigerator was out of range for 22 of the 28 days with nine days in the freezing range. There was no action documented on the temperature log to report the defect to facilities or pharmacy personnel until 2/24/10.

On 3/2/10 at 1110 hours, according to RN 8, no action was taken by the nursing staff to report these temperatures to the pharmacy department. She stated the ED needed a new refrigerator and could not answer why it had not arrived. There was no other action documented by the nurses to contact pharmacy to relocate the vaccines and Facilities Department to repair/replace the refrigeration unit in accordance to the hospital's P&P.

The hospital failed to implement their plan of correction from the previous survey on 10/16/09, by not conducting and monitoring routine preventative maintenance of medical equipment. Vaccines and other medications were not safely and properly stored in the ED refrigerator in accordance with the manufacturer's recommendations and regulatory requirements.




22553



25052

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

* Provide for patient safety in the control of drugs and biologicals in accordance with standards of practice, and Federal and State laws. These factors created the potential to adversely affect patients when two of two nurses in the emergency department were unable to quickly and accurately draw up doses of emergency medications for pediatric patients. See A500 #1 and A1112.

* Ensure vaccines were stored within temperatures recommended by the manufacturer to preserve effectiveness. See A505.

* Ensure oversight on revision of P&Ps so they reflected current practice and gave clear guidance to ED practitioners during pediatric emergencies. See A1104.

* Demonstrate that emergency services were integrated and coordinated as to the maintenenance of refrigeration equipment in order to ensure medications and biologicals were stored in a manner to provide for their continued effectiveness. See A724.

The cumulative effects of these systemic practices resulted in the hospital's inability to ensure quality care in a safe setting.

Based on interview and record review, the hospital failed to assess, evaluate and update existing departmental P&Ps regarding emergency medical services on an ongoing basis. The hospital failed to ensure oversight on revision of P&Ps so they reflected current practice and gave clear guidance to ED practitioners during pediatric emergencies. The hospital failed to ensure medical staff oversight and correction of previous deficiencies concerning the delivery of pharmaceutical services. As a result, medication-related devices, such as refrigerators that were used to store vaccines for patient use, were not properly maintained. There was also a lack of oversight in re-educating the ED nursing staff on drug calculations and the use of Broselow tape which could lead to wrong dose medication errors.

Findings:

1. On 3/4/10, the hospital's P&P on Medication Management: Refrigerator and Freezer Drug Storage Requirements, revised on 1/10, was reviewed. The policy showed that all personnel dispensing or administering medications were responsible for assuring the integrity of these medications including assuring proper storage.

The procedure included that drug storage refrigerators, freezers and warmers would be inspected daily by unit staff and the daily temperature would be recorded on the appropriate log sheet. If the the temperature was outside the appropriate range, the unit staff would adjust the thermostat and check the temperature again in 60 minutes. If the temperature remained out of the acceptable range after the first adjustment, the pharmacy should be notified immediately to relocate the drugs and contact the facilities to fix/replace the refrigeration unit. All actions should be documented on the back of the log sheet.

On Procedure No. 4, it showed, if the unit experienced any "out of bounds" conditions during the previous time period, the pharmacy should be contacted to provide guidance on whether the drugs ought to be replaced or were safe to use.

During a previous validation survey dated 10/16/09, medications were not stored in accordance with state requirements and the hospital's P&Ps for seven of eleven medication refrigerators inspected. The hospital's plan of correction was to re-educate the pharmacy and nursing staff on monitoring temperatures. Random audits were to be conducted on two units per week by pharmacy to assure 100% compliance for three months. An automated temperature monitoring system was implemented in UCI's Douglas Hospital Pharmacy and on Douglas Hospital nursing unit medication refrigerators. On going real time monitoring and alarming of automated refrigerators were being conducted by the Director, Pharmacy Services or designee.

On 3/2/10 at 1100 hours, during a tour of the ED, the ED medication refrigerator temperature log revealed recorded freezing (below 32 degrees Fahrenheit) temperatures dating back to 1/28/10. During the period of 1/28/10 to 2/24/10, the refrigerator was out of range for 22 of the 28 days with nine days in the freezing range. There was no action documented on the temperature log to report the defect to Pharmacy Department or Engineering Department according to the hospital's P&P. As a result, vaccines and other refrigerated medications were stored in freezing temperatures, and administered to patients when potency could not be guaranteed.

2. In addition to the above plan of correction submitted for the validation survey on 10/16/09, regarding refrigerators, it was stated that both the Clinical Engineering and Facilities Department would monitor, on an ongoing basis, other medical equipment to ensure that these medical equipment were appropriately tagged and the preventative maintenance was up to date. The Facilities Department added that replacement refrigerators were available in the event that unit was not able to function within the range specified.

Review of the hospital's P&P for Code White, revised on 2/09, showed that the Clinical Engineering Department was mainly focused on inspection, routine and additional maintenance of pacemakers, suction equipment and defibrillators only semi-annually. The P&P did not reflect the additional responsibility of the Engineering Department to monitor other medical equipment to ensure patient safety by preventive maintenance.

3. On 3/2/10 at 1215 and 1340 hours, during meetings with the CMO, CEO, ER Medical Director, ER Nursing Director, ER Nurse Educator and the CNO, the hospital representatives stated that Code Blue (adult resuscitation cases) and Code White (pediatric resuscitation cases) were not being announced in ED because the ED physician and nurses were always present in the ED. The pharmacists also were not involved in ED emergency cases. The ED physicians were expected to determine the medications and calculate the dosages while the nurses were expected to draw the dosage amount and administer the medications.

On 3/4/10, review of the hospital's P&P on Emergency Response to Code White, authored by the Code Blue Committee, effective on 2/09, showed that, "Clinical Pharmacist or designee prepares all necessary medications as needed. Assists with code documentation as needed. Senior pharmacist or specialist pharmacist in a specialty area may assume the responsibilities of the code team pharmacist."

The hospital failed to update and revise existing P&Ps to reflect current ED practice.

Based on observation, staff interview and record review, the hospital failed to demonstrate that the three of four ED nursing staff had the necessary qualifications to meet the patient needs presented in the emergency room, especially the pediatric population (RN 5, 7 and 11). The hospital failed to ensure 10 of 10 nurses' competnecies files contained evidence of current competney to accurately draw up and administer emergency medications to pediatric patients (RN 5, 7, 16, 17, 18, 19, 20, 21, 22, 23). The hospital's failure had the potential to cause wrong dose medication errors (overdose or under dose) in the preparation of emergency drugs for patients in the ED.

Findings:

1. On 3/1/10, review of the previous hospital's validation survey, completed on 10/16/09, revealed several discrepancies in administration of drugs. One of the medication discrepancies was regarding competency of a nursing staff in the ED on preparation of an epinephrine dose for a pediatric patient in a simulated emergency situation. The nursing staff and an ER physician were queried about the same epinephrine dose using the same hospital system which was the Broselow system, a pediatric drug delivery system which allowed staff to calculate medication doses based on a zone using a child's weight or length. The scenario revealed an under dose of the medication by the RN secondary to inaccurate medication calculation.

The hospital's written plan of correction was to re-educate all ED staff on the use of the Broselow tape system with the Director of the ED auditing staff knowledge during weekly rounds.

On 3/1/10 at 1300 hours, a follow-up validation survey was conducted to verify the hospital's plan of correction.

On 3/2/10 at 1040 hours, a "mock code" (simulated emergency situation) was conducted by a pharmacist surveyor to verify competency of ED nursing staff on emergency drug calculations. RN 5 was observed using the Broselow tape without any hint from the pharmacist surveyor. The first pediatric dose of epinephrine was drawn accurately, but RN 5 failed to accurately calculate the second pediatric dose of atropine.

At this point, the ED nurse educator, RN 6, stated that the ED was not using the Broselow tape for drug calculation. However, RN 5 affirmatively responded to the use of the Broselow system. When the two staff were asked by the pharmacist surveyor regarding instruction according to the hospital's P&P, RN 6 responded that she did not know what their policy stated.

The pharmacist surveyor observed a second nurse, RN 7. RN 7 was also observed to use the Broselow tape system, without hint from the pharmacist surveyor, to calculate the first pediatric dose of atropine. On the second pediatric dose of sodium bicarbonate, RN 7 initially used the Broselow system then decided to use two computers to verify her calculations. RN 7 decided to use a third computer by the ED nurse station and did not return after 14 minutes.

On 3/3/10 at 1000 hours, review of the ED staff meeting minutes conducted on 1/6/10 showed that "CMS cited the ED for not being able to correctly use the Broselow tape for medication administration. Please take the time to review the Broselow tape and the medication dosages." However, the ED staff meeting conducted on 2/3/10, showed contradicting messages. It stated that, "CMS requested demonstration on the use of the Broselow tape. We had a return demonstration on how we determined the patients' weight based on length. We then explained we use the pediatric pharmacy calculations found on the greaseboard."

On 3/3/10 at 1600 hours, per the hospital's request, another mock code was conducted to verify re-education of the nursing staff on emergency drug calculation. A different pharmacist surveyor conducted the second mock code with a different witness, RN 12, the ED director.

RN 9 was observed to accurately calculate and draw three emergency medications. The second nurse, RN 11, was observed to accurately draw the first of three emergency medications, however, the second pediatric dose was miscalculated twice.

On 3/4/10, review of competencies for ten ED nursing staff, randomly picked, revealed the latest nursing skills test on safe medication administration for RN 5, 7, 16, 17, 18, 19, 20, 21, 22, and 23 were dated 11/06 to 7/07.

The hospital failed to implement their plan of correction from the previous survey on 10/16/09, and to ensure nursing staff were able to accurately calculate and draw emergency medications for pediatric patients as demonstrated by the two mock codes conducted. The hospital's failure had the potential to cause wrong dose medication errors (overdose or under dose) in the preparation of emergency drugs for patients in the ED. See A397, A500.