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Based on interviews and documentation review the Hospital failed to ensure that corrective actions were developed and/or implemented for all areas identified as in need of improvement.

Findings included:

Review of medical record indicated Patient #1 had a past medical history of high blood pressure, coronary artery disease, a myocardial infarction (heart attack) with stent placement, congestive heart failure, and a ventricular arrhythmia (irregular heart rate that can be serious or life threatening) managed with Amiodarone therapy (medication used to treat certain types of ventricular arrhythmias; side effects include lung damage). On 1/18/11 Patient #1 was hospitalized and was diagnosed with interstitial lung disease thought to be associated with Amiodarone therapy.

Medical record documentation indicated on 1/27/11 Patient #1 was re-admitted to the Hospital's Pulmonary Care Unit (PCU) following an episode of rapid respirations), rapid heart rate, confusion, and a decrease in his/her oxygen saturation level (SpO2) to 50% (normal range is 95% to 100%) on 4 liters of oxygen. Patient #1 was placed on a Do Not Resuscitate (DNR)/Do Not Intubate (DNI) status. Patient #1 was given a pureed diet for energy consumption which he/she did not like and was given supplements but either ate poorly or refused. Discharge was planned for 1/29/11 to a skilled nursing facility.

Medical record documentation dated 1/29/11 Patient #1's oral intake continued to be poor. The discharge order was canceled and a family meeting was to be scheduled regarding duotube insertion.

The Pulmonologist assigned to Patient #1 on 1/29/11 (Pulmonologist #1) was interviewed on 3/9/11 at 11:45 A.M. with the Director of Risk Management present. Pulmonologist #1 said Patient #1's poor nutritional intake needed to be addressed prior to discharge Pulmonologist #1 said a meeting was held with Patient #1 and his/her family and the decision was made to insert a duotube. Pulmonologist #1 said one family member questioned whether the procedure was painful and when told it was uncomfortable he/she wanted Patient #1 to sleep through the procedure. Pulmonologist #1 said sedation and the risks involved were discussed. Pulmonologist #1 said it was unusual but not unheard of to use moderate sedation to insert a duotube. Pulmonologist #1 said he/she considered Patient #1's age and condition and ordering the medications and doses.

Physician Orders dated 1/29/11 indicated Versed (a Benzodiazepine; peak action is 5-7 minutes and duration of action is 20-60 minutes depending on the amount infused; adverse effects include respiratory depression) and Fentanyl (opioid analgesic; peak action is 10-15 minutes and duration of action is 30-60 minutes depending on the amount infused; adverse effects include slowed heart rate and respiratory depression) were ordered for sedation.

Medical record documentation dated 1/29/11 indicated that the procedure was started at approximately 2:30 P.M. Present and involved were: PCU Nurse #1, Pulmonologist #1, and Resident #1.

Interviews with Pulmonologist #1, PCU Nurse #1 (interviewed on 3/10/11 at 8:25 A.M.), and Resident #1 (interviewed on 3/9/11 at 2:00 P.M.) regarding the procedure and review of medical record documentation indicated that: Patient #1 was properly positioned; the duotube insertion was attempted once with only the numbing spray and was unsuccessful; Versed 1 mg and Fentanyl 25 mcg were ordered by Pulmonologist #1 and administered by PCU Nurse #1 and there was approximately a 5 minute wait for the medication to take effect; Pulmonologist #1 attempted to insert again but Patient #1, was still uncomfortable and pushed Pulmonologist #1 away; Pulmonologist #1 ordered Versed 1 mg and Fentanyl 25 mcg repeated which was administered by PCU Nurse #1, and after a few minutes Resident #1 inserted the duotube with the assistance of Pulmonologist #1. Documentation indicated Patient #1 was nonresponsive, his/her extremities were flaccid, and his/her vital signs were stable. Patient #1 was placed in the high fowler position.

Medical record documentation regarding post-procedure monitoring dated 1/29/11 from 2:30 P.M. (the start of the procedure) until 4:00 P.M. indicated that Patient #1's vital signs were recorded as: blood pressures (normal range is 90-140/60-90) were: 135/51 (2:28 P.M.); 108/51 (2:29 P.M.); 142/51 (2:33 P.M.); 143/51 (2:44 P.M.); 149/72 (2:48 P.M.); 159/94 (2:53 P.M.); 147/84 (2:58 P.M.); 147/53 (3:03 P.M.); 114/52 (3:19 P.M.); 109/36 (3:33 P.M.); 90/44 (3:49 P.M.); 87/24 (4:04 P.M.); respirations ranged from 14 to 21 breaths per minute until approximately 4:00 P.M. when they were recorded as labored, and SpO2's ranged from 94% to 98% on oxygen.

Medical record documentation dated 1/29/11 indicated Patient #1's blood pressure was taken manually to confirm accuracy, he/she was placed in Trendelenburg position, the physician was notified, and Resident #1 assessed Patient #1. Patient #1 was administered 3 boluses of intravenous fluids, 3 doses of Flumazenil (antagonist used to reverse the effect of Benzodiazepines), and 2 doses of Narcan (antagonist used to reverse the effects of opioids).

Medical record documentation dated 1/29/11 indicated a central line was inserted, bi-level positive airway pressure (breathing apparatus that helps get more oxygen to the lungs via a mask attached to the apparatus) was applied (because Patient #1 was a DNI), vasopressors (medication to increase blood pressure) were ordered and started, the ICU was called and accepted Patient #1, and Patient #1's family was informed of his/her condition. Patient #1 expired on 1/30/11.

The Director of Risk Management was interviewed throughout the survey. The Risk Manager said an investigation was conducted that included a multidisciplinary review.

The Anesthesiologist who reviewed Patient #1's medical record was interviewed on 3/10/11 at 12:45 P.M. The Anesthesiologist said based on his/her review it was his/her opinion that although administration of moderate sedation was an unusual scenario; the doses of medication used were reasonable. The Anesthesiologist said he/she felt Patient #1 was frail and had an underlying issue that contributed to the event.

Corrective Actions were developed, were in various stages of implementation and included: 1. implementation of the revision of the Moderate Sedation Policy (implemented; to be completed 4/1/11); 2. Development of an algorithm regarding approaches to moderate sedation (in draft form); 2. counseling for Pulmonologist #1 (completed 2/1/11); Counseling for Resident #1 (completed 2/14/11 and again 3/4/11); counseling for the Resource Nurse and PCU Nurse #1 (completed); 3. Education: presentation of this case during Patient Safety Rounds by Resident #1 and Anesthesiology (scheduled 3/23/11); Moderate Sedation Policy to PCU staff (completed 2/3/11); Rapid Response (started 3/4/11 and ongoing); Moderate Sedation Policy and Rescue Interventions to Residents (to be completed 3/11/11); 4. Quality Committee Reviews: Medical Peer Review (scheduled 3/16/11); Mortality and Morbidity review (scheduled 3/24/11); 5. addition of a specific moderate sedation tab was added in the nursing section of the electronic medical record (completed), and 6. continued random observation and record auditing regarding universal protocol and informed consents monthly (confirmed through review of audits).

The Corrective Action plan and supporting documentation did not address: the absence of Health Care Proxy information; consider re-education of parties involved regarding the improperly executed Informed Consent; consider re-education of parties involved regarding the time-out process; lack of documentation by Pulmonologist #1 (family meeting, procedure note, transfer summary); education for all nursing staff regarding chain of command; use of central lines prior to verification of placement in emergencies, and there was no evidence that Pulmonologist #1's was being quality monitored until this case went to peer review.