HospitalInspections.org

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Based on observation, interviews, review of the hospital's policies and procedures, and, patient clinical records, the hospital failed:

1. To ensure the safe use of droperidol (medication used for nausea and vomiting) according to the hospital policy and the FDA (Food and Drug Administration) boxed warning. (A500)

2. To provide pharmaceutical services that would ensure patient safety by providing pharmacy oversight of scheduled medications removed from the ED (Emergency Department) Pyxis (Automated Dispensing Cabinets). (A494)

The cumulative effects of these systematic problems resulted in the hospital's inability to ensure the provisions of quality health care in a safe environment.

Based on interview and clinical record review, the hospital failed to ensure pharmacy monitoring and oversight of scheduled medication in the ED (Emergency Department). This failure had the potential to cause the incorrect dosing of patients and/or the diversion of medications to go un-noted.

Findings:

On 7/11/12 at 9:10 AM, during the discussion with the Director of Pharmacy (DPH) regarding oversight of the scheduled medications in the ED pyxis (automatic dispensing cabinet), a list of scheduled medications removed by staff from the ED pyxis was requested for review for the period between 7/7/12 and 7/8/12. Review of the medication list provided by the DPH revealed numerous narcotic medications including morphine, hydromorphone and fentanyl, etc. were removed for patients receiving pain treatment in the ED.

The clinical records for Patient 19 and Patient 20 were concurrently reviewed with the DPH on 7/11/12. The clinical record for Patient 19 indicated that on 7/7/12 at 3 AM and again at 3:20 PM, 6 milligrams (mg) of morphine were ordered to be administered via intravenous (IV) push. Review of the pyxis records for Patient 19 indicated 8 mg of morphine were removed for each of those times. The clinical record for Patient 20 indicated that on 7/7/12 at 8:30 PM, hydromorphone 1 mg IV was ordered and 2 mg of the medication was removed from the ED pyxis. There was no record of any wastage of morphine and hydromorphone by staff for each of these two patients.

In the interview with the DPH on 7/11/12 at 10:53 AM, she acknowledged that any excess narcotic medications that were not administered to patients would need to be wasted and documented during the medication removal process. During the discussion with the DPH and Pharmacist (Pharm) 1 they were asked to provide documented evidence that the hospital has revised processes to reduce access to medication prior to pharmacy reviews and to allow the pharmacy department to have the ability to review medications in the ED and to provide oversight in accordance to their plan of correction.

Review of the information provided by Pharm 1 on 7/11/12 revealed the hospital had started reviewing for ED medication orders on 6/25/12 and currently about one out of every ten ED patients was chosen for review according to Pharm 1. In addition, no review of withdrawal of the scheduled medications by a pharmacist to determine whether the dose ordered by the prescriber and the dose removed from the ADC (Automatic Dispensing Cabinet) and administered to patients were the same. This process provided no oversight and accountability that narcotics and other addictive and potent medications were given as prescribed. Medication adverse events would not be identified and could potentially place patients at risk of receiving inappropriate medications leading to serious harm and injury.

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Based on interviews, and clinical record reviews, the hospital failed to follow the FDA (Food and Drug Administration) boxed warning and facility policy for the safe use of droperidol (medication used for nausea and vomiting) for four of 21 sampled patients (16, 17, 18, and 21). This failure exposed patients to potentially avoidable life-threatening adverse effects of medication.

Findings:

The clinical records of patients who received droperidol for the most recent three months period were provided by the Director of Pharmacy (DPH) on 7/10/12. The clinical records of four patients who received the medication from 5/9/12 through 7/6/12 were randomly selected from the list for review. Review of Patient 16, Patient 17 and Patient 18's clinical records with the DPH and Quality Assurance Coordinator (QA) 1 revealed these patients were given droperidol on 5/20/12, 6/17/12 and 5/25/12 respectively while they were in the ED (Emergency Department) for treatment. Further review of their clinical records did not provide evidence that the required EKGs (electrocardiogram, test to determine heart function) were conducted according to hospital policy and the FDA boxed warning.

On 7/11/12, a review of Patient 21's clinical record with DPH and QA 1 identified this patient who also received droperidol on 6/22/12 in the ED without appropriate EKG monitoring post administration of the medication.

The boxed warning for droperidol which was required by the FDA to be published with each container of the drug provided the following information: "Cases of QT prolongation and/or torsade de pointes (Tdp- heart rhythm disturbances) have been reported in patients receiving Inapsine (droperidol brand name) at doses at or below recommended doses. Some cases have occurred in patients with no known risk factors for QT prolongation and some cases have been fatal." The boxed warning also cautioned that, "Based on these reports, all patients should undergo a 12-lead EKG (electrocardiogram) prior to administration of Inapsine to determine if a prolonged QT interval (that is, QT greater than 440 milliseconds for males or 450 milliseconds for females) is present." Also, "Inapsine is contraindicated in patients with known or suspected QT prolongation...".

During the interview with the Emergency Department Manager (EDM) and the ED Director (DIR ED) on 7/11/12 at 11:20 AM, they both acknowledged they were not familiar with the hospital's plan of correction on monitoring the use of droperidol in the ED and they were unable to provide evidence that the monitoring aspect of the hospital plan of correction was followed up by any authorized individual to ensure all doses of this medication administered in the ED comply with the new hospital policy and procedure.

Review of the hospital plan of correction dated 5/31/12, on page 19 under A500, it stated "The clinical directors of ICU (Intensive Care Unit) and ED or their designees will complete 15 charts per month for a period of 90 days ... to ensure all doses of this medication comply with policy." Review of the hospital policy entitled "Droperidol for Intravenous (IV) Use" on page 2 under Monitoring Considerations, it stated, "1. When IV droperidol is used, pre-treatment EKG, calculation of QTc, and ongoing cardiac monitoring for development of Tdp throughout the course of treatment for a minimum of two (2) hours after the last IV dose is indicated."

Based on observation, interview, and record review, the hospital failed to implement infection control practices in accordance with hospital policy and nationally-recognized infection control guidelines as evidenced by:

1. The hospital staff failed to use appropriate personal protection equipment and maintaining a sanitary environment when handling laboratory specimens.
2. The hospital staff failed to use appropriate hand hygiene.
3. The hospital failed to to properly and completely document on two maintenance logs.

These failures had the potential to result in spread of infectious diseases to patients and staff.

Findings:

1. During a concurrent observation with the Director of Emergency Services (DIR ED), on 7/10/12 at 11:30 AM, Registered Nurse (RN) A was observed coming out from behind the pulled curtain of Emergency Department (ED) Bed 6 holding a laboratory specimen cup filled with a yellow fluid with ungloved hands. He proceeded to the nursing station, set the laboratory specimen on the counter, entered data into the computer, labelled the container, placed the container in a biohazard bag and put it in the laboratory outbox then washed his hands.

During an interview with DIR ED, on 7/10/12 at 11:35 AM, she stated RN A did not follow hospital policy and procedure for appropriate hand hygiene, should not have used the computer prior to washing his hands or set the specimen container on the counter prior to placing it a biohazard bag.

The employee education file was reviewed on 7/11/12. RN A received training on infection control prevention and proper hand hygiene on 6/27/12.

The hospital policy and procedure titled "Isolation Precautions-Standards" dated 6/10, indicated "C. All Patients 2.b. Wear gloves (clean, non sterile) to enter the room of a patient on contact precautions, for contact with potentially infective material and surfaces." The policy further indicated that hand hygiene must be performed "promptly between patient contacts and after contact with blood, bodily fluids, secretions, and equipment or article contaminated by them."



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2. During an observation and interview on 7/10/12 at 12:45 PM, RN B was caring for Patient 10 in the Diagnostic Treatment Center. Patient 10 was on contact precaution (isolation for bacteria that can be spread by direct contact). RN B removed her gloves and exited the room. RN B did not utilize the hand sanitizer at the doorway, choosing to wash her hands at a small kitchenette approximately 25 feet from the doorway. The very small staff kitchen contained empty cafeteria trays immediately adjacent to the sink. Clean dishes were on the counter next to the cafeteria trays. RN B was asked why she chose to wash her hands in the kitchenette, she replied, "I should have used the sanitizer at the doorway."

On 7/11/12, at 4:30 P.M., the Procedure, "Hand Hygiene" was reviewed. The Policy Statement read: "It is the policy that staff will practice correct hand hygiene for the prevention and control of transmission of microorganisms that may cause infections in patients and personnel....." The Procedure read: "....2. Hand hygiene is practiced: a. Before: 1) direct patient contact....b. After 1) direct patient contact....4) removing gloves...."

3. During an interview on 7/11/12, at 9:50 AM, the director of surgical services (DIR OR) was asked for the terminal cleaning log for the GI laboratory and the operating room. The DIR OR stated Environmental Services documented the cleaning and kept the log. The Director of Environmental Services (DIR ES) was interviewed at 9:55 A.M. He defined terminal cleaning as: "top to bottom cleaning, washing walls, mopping, moving equipment to clean everything. It is done nightly. There is one person who works 10 P.M. to 6:30 A.M. every night whose job it is to terminally clean each OR (operating room)." The terminal cleaning log was reviewed at 2:25 P.M. with the DIR OR and DIR ES. For the first 11 days of July 2012, the log documented:

Operating Room 1 was terminally cleaned on 7/7/12.
Operating Room 2 was terminally cleaned on 7/2/12, 7/7/12.
Operating Room 3 was terminally cleaned on 7/2/12, 7/7/12.
Operating Room 4 was terminally cleaned on 7/8/12.
Operating Room 5 was terminally cleaned on 7/5/12.
Operating Room 6 was terminally cleaned on 7/3/12.
Operating Room 7 was not terminally cleaned 7/1-11/12.
Operating Room 8 was terminally cleaned 7/2/12.

The DIR ES stated, "There should be documentation we cleaned each room every night. In addition, we terminally clean each operating room when there's a trauma with a lot of blood on the floor but obviously we aren't documenting our work."

On 7/11/12, the AORN (Associated of periOperative Registered Nurses) practice recommendations and the OR cleaning policies were reviewed with DIR OR at 3 PM. The recommendations indicated terminal cleaning was to be done every 24 hours. DIR OR stated he was unaware of any issue with the terminal cleaning process or the lack of documentation. The cleaning policy of "All horizontal surfaces in the OR should be damp dusted before the first scheduled surgical procedure of the day," was discussed with the DIR OR. He stated, "We don't do that."

During an interview with the director of Respiratory Therapy (DIR RESP) on 7/11/12 at 1:30 P.M., the Soak Station Log was reviewed. This log documents the cleaning and soaking of respiratory therapy equipment and the EEG caps (device used to monitor electrical activity of the brain) in the high-level cold disinfectant (CIDEX). The dates on the log are from 6/26/2012 to 7/11/2012. Each line identified the employee who was cleaning the equipment, identified the piece of equipment to be cleaned, a soak time in and a soak time out. Out of 36 pieces of equipment that were cleaned during these 15 days, there were only nine times the 'soak time out' was filled in. DIR RESP agreed the time the equipment was removed from the Cidex should have been documented.

The Policy and Procedure, "Cleaning of Respiratory Therapy Equipment" was reviewed with DIR RESP. It indicated: "5. Equipment must be completely submerged in Cidex and remain there for a minimum of 1 hour." DIR RESP was asked how he could be assured the respiratory therapy equipment had been soaked for an hour. He stated, "By looking at the log, you can't."



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