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Based on observation, interview and record review, the hospital failed to perform conscious sedation (a drug-induced depression of consciousness during which patients respond purposefully to verbal commands and/or light touching), under the direction of a qualified Doctor of Medicine or osteopathy.

Refer to Tag A-1002; 482.52(b) Standard: Delivery of Services.

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

Based on observation,interview and record review,the hospital failed to administer conscious sedation (a drug-induced depression of consciousness during which patients respond purposefully to verbal commands and/or light touching), medications in a safe manner when facility did not:

1. Ensure a qualified physician was present during the nurses administration of a restricted medication in a non-approved area and medications used for conscious sedation.

2. Provide cardiac monitoring during administration of a restricted medication and medication resulting in sedation.

3. Assess and document blood pressure, heart rate, respiration, and oxygen saturation prior to the patient receiving sedation medication and every 15 minutes during sedation.

This resulted in respiratory failure (is when oxygen level in the blood becomes too low or the carbon dioxide level becomes too high) in one patient (Patient 1) and eventual death.

Findings:

Patient 1 was a 36 year old, admitted to the intensive care unit (ICU) after a motor vehicle accident in which she received multiple injuries. She had bilateral (on each side) chest tubes, (tubes next to the lungs to remove fluids and/or air surrounding the lungs), splints on her legs, a feeding tube, (a tube in the nose through which a liquid formula would be given for food), a c-spine (neck)collar, (a collar to prevent bending of the neck), and was being mechanically ventilated with a machine that takes over a person's breathing.

On February 22, 2010 at 10:35 AM, an unannounced visit was made to the hospital following an entity-reported incident involving Patient 1, who suffered respiratory failure during an MRI (magnetic resonance imaging procedure, used to obtain highly detailed images of the body's interior) with conscious sedation which contributed to the patient's death on February 26, 2010.

The clinical record for Patient 1 was reviewed on February 22, 2010 at 11:30 AM. The Trauma History and Physical dated January 27, 2010 indicated Patient 1 was admitted after a motor vehicle accident in which she suffered a right clavicle fracture, multiple right rib fractures, fractures to both lower legs and feet, facial lacerations, a spleen laceration, a head injury, and bilateral pleural effusions (excess fluid accumulating around the lungs). Patient 1 underwent surgery for these injuries and then was transferred to the ICU where she was placed on a ventilator, (a machine that takes over a person's breathing).

Review of the Nursing Flow Sheets on March 4, 2010 at 2:07 PM, indicated immediately following her motor vehicle accident and upon her admission to ICU January 27, 2010, Patient 1 did not move or open her eyes to any stimulus. Patient 1 demonstrated neurologic improvement over time and was beginning to be able to follow commands with spontaneous movement, opening her eyes, and verbally responding with a cry. After the February 12, 2010 event, Patient 1 had decreased neurologic functioning and did not respond to stimuli, (such as shaking, pinching, or otherwise trying to get the patient to respond). Nursing Flow Sheets dated after February 12, 2010 indicated Patient 1's neurological status as pupils size 4 and fixed and dilated (no reactive to light), does not respond to commands or painful stimuli.


On February 22, 2010 at 11:20 AM the physician orders dated February 12, 2010 included an order for an MRI of the C-spine. Physician 1 ordered vecuronium (used for muscle relaxing with possible side effects of muscle weakness to muscle paralysis resulting in respiratory difficulty or apnea) (breathing has prolonged pause or stops), 10 mg IV(intravenously, or into the vein), fentanyl 100 mcg IV (used for anesthesia and pain), and Versed 2 mg IV (sedation for anesthesia induction and procedures), one time for the MRI procedure.

The Medication Administration Record for Patient 1, dated February 12, 2010, indicated that Registered Nurse (RN) 1 administered the following medications IV, as ordered for the MRI at 7:05 PM: vecuronium 10 mg, fentanyl 100 Mcg, and Versed 2 mg.

During an interview with RN 1 on February 22, 2010 at 11:20 AM, she described that on February 12, 2010 at 6:30 PM she accompanied Patient 1 to the MRI suite with a portable cardiac monitor and portable ventilator. During the MRI, Patient 1 was hooked up to the pulse oximeter (a device measuring the oxygen in arterial blood) that provided the heart rate and oxygenation level; but the patient was not hooked up to the cardiac monitor. RN 1 stated she administered the following medications IV as ordered by the physician: vecuronium 10 mg fentanyl 100 mcg and Versed 2 mg. After the procedure, RN 1 entered the MRI room and discovered the patient was cyanotic (bluish skin resulting from not enough oxygen in the blood). RN 1 stated she called for help from the respiratory technician (RT) 1 and asked the MRI Tech (Tech 1) to call for backup from the ICU. She checked for a pulse and felt a slight pulse. She attached the portable cardiac monitor to Patient 1 and thought she saw a pulse. Help arrived from ICU and Respiratory and they transported Patient 1 to the unit. Upon arrival at the unit Patient 1 had no pulse and a Code Blue (indicating a patient requires immediate resuscitation) was called.

During an interview on March 5, 2010 at 9:36 AM, RN 1 stated that she was aware of the procedural sedation policy and that a cardiac monitor was required. She stated "I should not have given the medication without the monitor or the doctor. At the time, I was exhausted and had another patient not doing well. I should have told the charge nurse to let the next shift give the meds." RN 1 did not call a code or emergency response because,"I kind of felt a pulse at her groin so we ran to the unit." She further stated she was not aware the MRI suite had a cardiac monitor that could have been used during the procedure.

During a telephone interview with RT 1 on February 24, 2010 at 2:56 PM, RT 1 stated that at about 10 minutes into the procedure, Tech 1 stopped and said that Patient 1 had to be repositioned, because she moved. The ventilator alarm sounded and RT 1 found that the ventilator tubing had disconnected from the patient. She described Patient 1 looked fine at that time. After repositioning the patient, RN 1 gave the medications (vecuronium 10 mg, fentanyl 100 mcg, and Versed 2 mg), and they left the magnet room. Tech 1 began the MRI again and informed RN 1 and RT 1 it would be 20 minutes (until the procedure was completed). The oxygen level of the patient ranged 90 to 96 percent but would drop to the 80s then go back up. When the MRI was completed, RN 1 entered the room and she called out for help. RT 1 described Patient 1 as having a blue face and hands. She disconnected the ventilator and began mechanical bagging (pushing air into the patient's lungs with a hand held bag). Help arrived from the ICU and from the respiratory department and the patient was taken back to the unit. She stated it took approximately two minutes to reach the unit.

During a telephone interview with Tech 1 on March 3, 2010 at 10:40 AM, she said that RN 1 and RT 1 arrived (at the MRI unit) with the patient on a gurney. RT 1 was receiving readings from the ventilator, but an alarm kept going off. Tech 1 also described having difficulty getting the pulse rate and oxygen saturation readings from the pulse ox monitor. Tech 1 described RN 1 and RT 1 worked with the pulse ox monitor and was able to obtain heart rate and oxygen saturation but the alarm would not stop, so the MRI turned off the alarm. Tech 1 stated she did not put Patient 1 on a cardiac monitor because she was informed during orientation that they did not do cardiac monitoring during MRIs. She was not asked to put the patient on the monitor. She stated that a few minutes into the procedure they had to stop because the ventilator equipment was not working and the patient needed repositioning. Tech 1 noted a drop in Patient 1's heart rate and asked what was normal. RN 1 said, "I don't know." Tech 1 described that during the last few minutes of the procedure the heart rate and oxygen saturation were at a steady decline and RN 1 was very anxious and kept asking how much longer. RN 1 rushed into the room at the end of the procedure and called for help. RT 1 began bagging the patient and told Tech 1 to call their units for additional help. Tech 1 stated, "I asked if we should call a code and was told just to call the units."

During observation of the MRI suite on February 22,2010 at 10:45 AM, it was noted that the location of the suite was outside the hospital in a trailer unit. A crash cart, (cart of emergency equipment and medications), was not observed in the unit. During observations on March 4, 2010 at 2:30 PM, it was noted the nearest crash cart to the MRI suite was in the Physical Therapy Department next to Room 11445 (approximately 50-70 yards from the MRI suite).

An interview was conducted with Physician 1 on March 4, 2010 at 2:40 PM. When asked about the policy for procedural sedation requiring a physician to be present Physician 1 responded; "You need to discuss the policies with the DON." When Physician 1 was asked if Patient 1 had made progress since admission to the unit Physician 1 responded; "She was doing good, responding to staff but still fragile." When asked if the event during the MRI contributed to the death of Patient 1 on February 26, 2010 Physician 1 said; "Most definitely."

On February 22, 2010 at 12 PM the hospital's policy for Medications Restricted to Approved Units or Personnel was reviewed and indicated the following:

1. "Restricted medication will be administered only in the approved units. Vecuronium is identified as a restricted medication to approved units or personnel. The ICU was identified as an approved unit." The MRI suite was not listed as an approved unit for this medication to be administered.
2. "If the physician orders a medication listed in Addendum A for a non-approved unit the physician will order the medication to be given with bedside monitoring to include continuous cardiac monitoring and pulse oximetry and blood pressures every 15 minutes and must be administered under direct supervision of the ordering physician" There were no orders found for the above on the physician order forms or in nursing documentation during the record review conducted on February 22, 2010 or March 4, 2010.

On March 4, 2010 at 3 PM the hospital's policy and procedure on Procedural Sedation Minimal/Moderate/Deep was reviewed and indicated following:

1. "Minimal Staffing Requirements of a physician and Registered Nurse and additional staffing required based on patient's acuity, procedure and potential response to the medications administered." A physician was not present, this is verified during the March 5, 2010 at 9:36 AM interview with RN 1, the February 24, 2010 at 2:56 PM interview with RT 1, and the March 3, 2010 at 10:40 AM interview with Tech 1.
2. "Nursing qualifications for minimal/moderate sedation requires documented completion of the RN Sedation Learning Module and EKG certification." Review of the "Personnel Continuing Education Report" provided by the hospital, indicated RN 1 had not completed the Sedation Learning Module.
3. "RN responsibilities pre procedure are to validate the presence of suctioning equipment, easily accessible crash cart, attach pulse oximeter and automatic blood pressure." RN 1 did not use the cardiac monitor in the MRI room (March 5, 2010 9:36 PM RN interview, the crash cart was not located in the MRI trailer but in the hospital near Physical Therapy,observation on March 4, 2010 at 2:30 PM of MRI area), This allowed the patient's condition to deteriorate.
4. "Physician responsibilities intra-procedure delivers or directs the RN to deliver minimal/moderate sedation medications." RN 1 administered restricted medication and conscious sedation medications without the presence of a physician, this was verified during the March 5, 2010 at 9:36 AM interview with RN 1, the February 24, 2010 at 2:56 PM interview with RT 1, and the March 3, 2010 at 10:40 AM interview with Tech 1.
5. "RN responsibilities intra-procedure assess and document blood pressure, heart rate, respiration and oxygen saturation (vitals) at least every 15 minutes during minimal/moderate sedation." Interview on February 22, 2010 at 11:20 AM, RN 1 stated she did not record the vitals pre or intra-procedure, and documentation was not found in medical records of Patient 1. This allowed the patient's condition to deteriorate without the staff being aware.
6. "RN to document Pre, Intra and Post assessments on a Nursing Sedation Record." This form was not found in the medical records of Patient 1 and RN 1 stated she did not complete one and verified by the DON on February 22, 2010.

Review of the hospital's policy and procedure on Patient Transport on March 4, 2010 at 3 PM, indicated all "patients on mechanical ventilation would have a cardiac monitor and a blood pressure monitor. It further indicated that transport would be documented on a ventilator flow sheet to include time of departure, any complications during the procedure and vital signs before, during and after transport." This sheet was not found during the review of Patient 1's medication records. RN 1 interviewed on February 22, 2010 and RT 1 interviewed on February 24, 2010 indicated they did not document Patient 1's vitals before or during the procedure. The DON was unable to find flow sheets or records of vitals.

Special considerations were noted in the policy that the "RT may request immediate return to the ICU if it is thought that the patient's cardiopulmonary status has deteriorated or is likely to deteriorate into a potential code status." RT 1 failed to stop procedure when it was identified the ventilator equipment was not working properly as stated by Tech 1 interviewed on March 3, 2010 at 10:40 AM.

Review of the California Board of Registered Nursing, scope of practice for "Conscious Sedation" indicated: As of 1995, safety considerations for conscious sedation include continuous monitoring of oxygen saturation, cardiac rate and rhythm, blood pressure, respiratory rate, and level of consciousness as specified in national guidelines or standards. Immediate availability of an emergency cart which contains resuscitative (to restore life) and antagonist (reversing the effects of a medication) medications, airway and ventilatory adjunct (other supporting) equipment, defibrillator (a machine that shocks the heart to stop a deadly rhythm), suction, and a source for administration of 100% oxygen are commonly included in national standards for inducing conscious sedation." RN 1 failed to meet these standards by not ensuring the monitoring equipment, resuscitative equipment and emergency medications were in place and the ordering physician was present prior to administration of restrictive medications and sedating medications. RN 1 also failed to provide proper monitoring before and during procedure and documentation of same.

The cumulative effect of these systemic practices resulted in the hospital's inability to safely perform anesthesia.