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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.

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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 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.




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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.