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Based on observation, interview, and record review, nursing failed to supervise and evaluate care for one of 29 sampled patients (8). Patient 8 was severely ill admitted to the hospital's telemetry unit with a physician's order for continuous cardiac (heart) monitoring. Patient 8's primary nurse (RN A) failed to ensure Patient 8 was connected to the cardiac monitor. Patient 8 subsequently suffered cardiopulmonary arrest and died on the unit while not connected to a cardiac monitor. Failure to connect the patient to the cardiac monitor adversely affects nursing staff ability to supervise and evaluate severely ill patients. Findings:

Patient 8's record was reviewed on 8/26/15. The record indicated Patient 8 was admitted to the hospital on 8/8/15 for medical care of increasing abdominal pain and shortness of breath. Diagnoses on admission included a history of diabetes mellitus, coronary artery disease, hyperlipidemia, hypertension, acute renal disease, and colon cancer with additional tumor growth in the liver.

The Discharge Summary dated 8/9/15 indicated Patient 8 presented to the Emergency Department (ED) on 8/7/15 with complaints of worsening abdominal distention, pain in the right upper abdomen area, and difficulty breathing over the past one week. Patient 8 was alert and in mild distress from pain when seen in the ED. Blood tests performed in the ED indicated Patient 8 had an abnormally high potassium level at 7.1 (normal 3.5 - 5). Additional blood tests indicated abnormal function of the liver and kidneys. Patient 8's electrocardiogram (EKG, a test of the electrical signals from the heart) indicated normal sinus rhythm (NSR) at 100 beats per minute. Patient 8's high potassium level was treated with intravenous calcium gluconate, insulin and dextrose (sugar). A follow-up blood test indicated at 11:18 p.m. the potassium level had decreased to 6.1.

Review of physician orders dated 8/8/15 at 12:34 a.m. indicated the patient was admitted to the Transitional Care Neurosurgery Unit (TCNU) Stepdown for care. Admission physician orders included an order for "cardiac monitoring," and full code (perform cardiopulmonary resuscitation, if needed).

During an interview with Patient 8's telemetry primary nurse (RN A) on 8/19/15 at 9 a.m. (during the licensing investigation of the incident), RN A stated he received Patient 8 on the TCNU from the ED at 12:20 a.m. on 8/8/15. He stated he spoke with the patient and did a physical assessment, then checked the physician orders on Patient 8's electronic health record. RN A stated he noted the order for cardiac monitoring. At 12:50 a.m. he left the patient and went to the the "control room" (area on the TCNU where patient cardiac rhythms are displayed and observed on monitor screens) and obtained a telemetry box (a medical device connected to the patient which monitors cardiac rhythm) along with lead wires (attaches the telemetry box to electrodes on the patient's body) from the monitor technician (MT, a staff member who sits in the control room and continuously observes the monitors). RN A stated he requested assistance from RN B to help with the admission procedures.

RN A stated he returned to Patient 8's room. He stated he handed the telemetry monitor box and lead wires to RN B and asked RN B to put it on the patient. He stated he left RN B and Patient 8 to provide care to other patients. He stated after caring for other patients he returned to Patient 8's room at 3:34 a.m. and gave medications including 10 units of intravenous insulin. He stated he saw the telemetry box connected to the patient but had not yet verified the patient's cardiac rhythm. At this time the patient was alert and oriented. RN A stated he offered the patient a urinal in case he needed to urinate due to receiving intravenous fluids, and counseled the patient to stay by the bedside to use the urinal. He stated he left the room and went to check Patient 8's "strip" (a narrow paper print-out documenting the patient's heart rhythm, kept in the control room).

RN A stated on the way to the control room he heard the "code button" and immediately went to the code. RN A stated Patient 8 was in cardiopulmonary arrest and assisted other staff with an attempt to resuscitate the patient. He stated the code lasted until 4:10 a.m., and he stated Patient 8 expired. RN A stated after Patient 8 was pronounced dead he went to check on Patient 8's strip. The monitor technician (a staff member who observes patient heart rhythms and prints the strips) stated a strip was not recorded. RN A stated at this time he realized Patient 8's telemetry box had not been connected to the monitor and Patient 8 had not been on the monitor since his admission to the TCNU. RN A stated around 7 a.m. on 8/8/15 he notified Patient 8's admitting physician (MD A), and the charge nurse (CN) the patient had not been connected to the monitor. He documented the incident using the PSN (Patient Safety Network) tool on the computer. RN A stated he assumed Patient 8's cardiac monitor was connected by RN B. RN A stated in hindsight he should have communicated with RN B regarding the status of Patient 8's cardiac monitor.

During an interview on 8/31/15 at 8:30 a.m. (during the licensing investigation of the incident), RN B stated she was working as a "team leader" nurse, helping other nurses on the TCNU on 8/8/15. RN B stated RN A asked for assistance in admitting Patient 8. RN B stated she went to Patient 8's room. RN B stated she began asking the patient questions needed for the admission process. She stated while talking to the patient RN A handed her a cardiac monitor telemetry box and lead wires. RN B stated RN A stated "can you put it on when you finish?" She stated she opened the box, checked to see if there were two AA batteries inside, and then "snapped" the lead wires to electrodes on Patient 8's body in the chest area. She stated she placed the telemetry box on the left side of the patient on the surface of the bed. RN B stated she did not notify the MT the patient had been connected.

RN B stated usually the nurse calls the MT to verify the telemetry monitor box was sending a rhythm to the control room. RN B stated she assumed RN A would promptly return to the room to verify the telemetry monitor was connected with the MT. RN B stated RN A had "only asked me to put on the box." RN B stated immediately after placing the telemetry monitor box, two other nurses requested help so she left Patient 8's room to start an IV for another patient. RN B stated she then heard and observed a team trying to resuscitate Patient 8. RN B stated after Patient 8 passed away, RN A told her "the batteries were dead, it never monitored." RN B stated she felt very bad over the incident. She stated "it was a big lesson to learn." She stated "things happen quick. It is very important to monitor the patient."

On 8/26/15 review of Patient 8's 8/8/15 "Cardio-pulmonary Arrest Sheet," resuscitation attempts began at 3:45 a.m. with Patient 8's rhythm on the crash cart portable monitor documented as "VTach" (ventricular tachycardia, an abnormally fast heart rate). The sheet indicated the resuscitation attempt ended at 4:10 a.m. with Patient 8's rhythm documented as "asystole" (no heart beat).

On 8/26/15 review of Patient 8's 8/8/15 "Death Certificate Worksheet" indicated the cause of death was "Severe sepsis and anion gap metabolic acidosis" due to "Metastatic colon cancer."

During an interview on 8/31/15 at 7:30 a.m. (during the licensing investigation of the incident), monitor technician A (MT A) stated he was working on the TCNU on the 8/8/15 night shift (11 p.m. to 7:30 a.m.). MT A stated at the beginning of the shift he was notified Patient 8 was coming to the unit, but was not told when to expect his arrival. MT A stated he made an entry in the computer which created an area for Patient 8 on the monitor screen. MT A stated the screen typically displayed a blue background with straight lines until the telemetry monitor box was connected. MT A stated RN A came to the control room and checked out a telemetry monitor box, but did not notify MT A the patient had arrived on the unit. MT A stated the usual procedure was the nurse would notify the MT when the patient arrived, hook the patient to the telemetry monitor box, and verify connection to the monitor with the MT. MT A stated as time went by he checked the screen about every 15 minutes to see if a rhythm for Patient 8 was available, but he saw only the blue screen and never saw any rhythm for Patient 8, and was not aware the patient had been admitted to the unit.

A tour of the TCNU department was conducted on 8/25/15 at 9:30 a.m. The TCNU provided continuous cardiac monitoring to patients in the unit. The continuous cardiac monitoring in TCNU was performed by an MT. During the tour it was noted an MT was stationed in a private room approximately 10 to 15 feet around the corner from the TCNU nurses stations. The MT was observed sitting in front of screens which displayed the cardiac rhythms for the TCNU patients. The room included a microphone system the MT could use to page staff, and call light system which allowed the MT to make voice contact with patients in their rooms. The MT could also contact nurses via Vocera (a personal communication device carried by nurses).

During an interview on 8/26/15 at 11:50 a.m., the director of inpatient nursing (DIN) stated when admitting a patient the primary RN was responsible for ensuring the patient was properly connected to the telemetry monitor if ordered. The connection should be verified very shortly after the patient arrived to the unit, and no more than one hour should elapse before the primary RN reads and signs a strip.

During an interview on 9/1/15 (during the state investigation) at 8:02 a.m., MD A stated she was assigned to care for Patient 8. MD A stated she ordered continuous cardiac monitoring for Patient 8 while on the TCNU, as Patient 8 was seriously ill, and had abnormal laboratory tests. MD A stated of particular concern was Patient 8's elevated potassium level, as the elevated potassium level put Patient 8 at risk for developing an abnormal hearth rhythm. MD A stated an example would be ventricular tachycardia (V-tach). MD A stated V-tach could "be serious if it persists," and cardiac monitoring would not have prevented Patient 8's death. MD A stated based on Patient 8's laboratory results, including a "lactate level of 22, low bicarb, and anion gap, he had metabolic acidosis. We discussed the case afterward and thought he had part of his bowel dead, and that was the reason for metabolic acidosis." MD A stated "we didn't realize this until the labs came back,." and "the code resulted from the metabolic acidosis and organ failure." MD A stated even maximum treatment would not have prevented death.

On 8/26/15 review of the 11/2013 hospital policy and procedure "Telemetry Procedures" indicated "Cardiac rhythm is observed continuously by a trained telemetry monitor technician." The policy indicated the purpose was "to ensure timely identification of changes in cardiac rhythm and patient condition" and "facilitate early identification of cardiac conditions requiring a higher level of care." The procedure indicated to admit a patient, "Advise monitor tech of admission." The procedure indicated "bedside nurse will obtain strip, review and initial."

Based on observation, interview, and record review, the hospital failed to maintain equipment to ensure an acceptable level of safety when six of 29 sampled patients (Patients 2, 3, 4, 5, 6, and 7) were exposed to possible infection during endoscopy procedures at an outpatient gatroenterology clinic. One particular endoscope used at the clinic for the procedures involving Patients 2, 3, 4, 5, 6, and 7 harbored a potential source of infection in the form of a medical device called a stent (a small tubular device placed in the patient to keep a duct open). The stent had been exposed to body fluids from a source patient (Patient 1). The stent was retained inside the endoscope after Patient 1's procedure and was not detected by the hospital despite multiple procedures and cleaning and disinfection between procedures. Failure to ensure the sterility of the endoscope carried the potential to transmit infections. Findings:

An endoscope (a duodenoscope is a type of endoscope) is a flexible fiber-optic tube with a camera at the end. The endoscope is inserted through the mouth and into the digestive tract by a physician and used to diagnose and treat gastrointestinal (GI) disease. Instruments are passed through the endoscope to take tissue samples, open narrowed ducts and remove stones.

On 8/6/15 the California Department of Public Health received a faxed report from the hospital indicating a foreign object was protruding from an endoscope used on a patient during a procedure on 7/31/15. The foreign object was determined to be a plastic stent (a small tubular medical device) used on a patient during a prior procedure on 7/16/15. The hospital determined the stent had been lodged undetected inside the endoscope during six procedures after the source patient, resulting in six potential exposures to infection. The endoscope had been cleaned and sterilized according to manufacturer's instructions between patients.

On 8/19/15 (during the licensing investigation of the incident), review of Patient 1's procedure note dated 7/16/15 indicated the patient was undergoing an endoscopic retrograde choleangiography (ERCP) procedure. The note indicated "during the placement of the 5 Fr 3 cm. stent with no internal barbs the wire came out of the pancreatic duct." The note indicated "Of note on both occasions the stent had not gone out of the scope but on the second occasion it was not possible to find the stent in the scope nor on the floor following removal of the wire. It had not visually gone out of the scope and the stent could not be located in the duodenum nor on the x-ray."

On 8/19/15 (during the licensing investigation of the incident), review of Patient 7's ERCP procedure note dated 8/4/15 indicated "When the...stone extraction balloon catheter was advanced across the duodenoscope elevator channel, a possible foreign object was seen emerging from the elevator channel out of the duodenoscope but still within the scope. Views were poor and it could not be determined what this object was-it was removed via snare."

During an interview with the hospital infection control officer (ICO) on 8/19/15 at 2:15 p.m. (during the licensing investigation of the incident), the ICO stated the object removed from the duodenoscope during Patient 7's procedure was the stent lost during Patient 1's procedure. The ICO stated there were six patient exposures (Patients 2, 3, 4, 5, 6, and 7). The ICO stated the stent never went into any of the patients. The ICO stated despite cleaning and sterilization between each use for other patients, the stent had somehow remained in the duodenoscope. The ICO stated there was a chance the cleaning and the sterilization may not have destroyed all micro-organisms on the stent, and there was a very low risk of infection. The ICO stated each exposed patient would be tested periodically for infection for six months to monitor the outcome.

During an observation on 8/18/15 (during the licensing investigation of the incident), at 3 p.m. the actual stent in question was a hollow, slightly curved blue tube about 1 and 1/4 inches long and about 1/10 of an inch in diameter, with two holes in the sides, inside a clear plastic bag.

During an observation on 8/19/15 at 11:40 a.m., (during the licensing investigation of the incident), duodenoscope serial #2802486 was approximately 6 feet long, black colored tapered tube with hand controls controls at the large end and a small opening about 1/4 inch wide at the tip. The tip could be flexed using a button on the control end.

During an interview on 8/25/15 at 9:45 a.m., Physician B stated all endoscopes reprocessed in the ambulatory clinic and main hospital were processed according to very specific guidelines provided by the endoscope manufacturer. Physician B stated a log was kept which indicated the patient's name medical record number, scope name/type, serial number, the name of the procedure, date/time of the procedure, the name of the provider performing the procedure and the date and time of the reprocessing cycle.

Physician B stated when the retention of the stent (plastic tube to relieve narrowing of a duct) in the scope was identified during Patient 7's procedure, the log allowed the hospital to determine which patients had been exposed to the endoscope used in Patient 1's procedure. Physician B further stated the endoscope was identified as #2486 and was immediately taken out of service and the patients exposed were identified. Physician B explained the endoscope reprocessing procedure consists of a multiple step protocol conducted by staff members with specific competencies to do so. Physician B stated the initial steps in endoscope reprocessing begin in the procedure room immediately after the procedure was complete. The endoscope is then brought to the reprocessing area to complete the reprocessing procedure.

During an observation and interview on 8/25/15 at 10 a.m., GI Staff B stated he was trained to reprocess the scopes and follow the manufacturer's guidelines for endoscope cleaning. GI Staff B wore personal protective equipment, including an impervious gown, face shield, gloves, and a mask and submersed the scope in the sink. He then proceeded to follow the manufacturer's recommendations to test for leaks and the manual cleaning of the endoscope. GI Staff B manually washed the endoscope inside and out using disposable brushes and cloths. All removable parts were also cleaned in the same manner. GI Staff B stated the brushes were discarded after use and not used to clean a different scope. GI Staff B then used an endoscope flushing aid to flush detergent solution and then water into the channels of the endoscope for the recommended amount of time. GI Staff B placed the endoscope in the automated reprocessing machine and tested the disinfecting solution with test tape to ensure the solution would provide the correct strength for high level disinfection. GI Staff B determined the solution was at the correct strength and continued with the final step of the reprocessing protocol.

During interview and record review on 8/26/15 at 8:45 a.m., Physician B stated the following: Patient 1 had a GI procedure on 7/16/15 which was uneventful and successful. Patient 2 had a GI procedure on 7/20/15. Physician B stated there was no resistance when inserting instruments though the endoscope and the procedure was completely successful. Patient 3 had a GI procedure on 7/20/15. Physician B stated a stent was placed in the bile duct, tissue biopsies were taken, no resistance was met and the procedure was completely successful. Patient 4 had a GI procedure on 7/21/15. Physician B stated the physician who performed the procedure made multiple passes through the endoscope, placed a stent and the procedure was completely successful.

Patient 5 had a GI procedure on 7/24/15. Physician B stated a balloon was passed through the endoscope to dilate the bile duct, no resistance was met and the procedure was completely successful. Patient 6 had a GI procedure on 7/31/15. Physician B stated stones were removed successfully from the bile duct through the endoscope and there was no resistance when inserting instruments through the endoscope. Patient 7 had a GI procedure on 8/4/15. Physician B stated as an instrument was passed through the endoscope, a foreign object was identified and removed from the endoscope. Physician B stated the object was determined to be the stent from Patient 1's procedure.

During an interview and record review on 8/26/15 at 11:10 a.m. the director of quality reviewed the reprocessing logs which indicated the procedures for Patients 1 to 7 were performed with the use of endoscope #2486. The logs indicated the endoscopes had passed the reprocessing procedure. The director of quality stated all scopes are logged for identification and tracking.

On 8/26/15 a review of the manufacturer's recommendations for cleaning and sterilization of the duodenoscope of the same model as #2802486 indicated hospital procedure for cleaning and sterilization was in accordance with the manufacturer's recommendations.