1375 University Ave Healdsburg, CA 95448
Citation Number: 110009753
Citation Date: 1/24/2014
Violation Date: 6/5/2012
Class: AA
Penalty: $50,000

F281 483.20(k)(3)(i) Services Provided Meet Professional Standards The services provided or arranged by the facility must meet professional standards of quality.

The facility failed to ensure that, Resident 9 (one of the three abbreviated survey sample), who was fed by a gastric tube (G tube: a tube inserted directly into the stomach through an abdominal incision for the administration of food, fluids, and medications), received appropriate treatment and services to prevent gastric tube replacement complications; failed to identify signs and symptoms of sepsis (sepsis is a serious medical condition caused by an overwhelming immune response to infection); and failed to ensure that all staff were trained to replace feeding tubes.

This presented imminent danger to Resident 9, as a result of the misplacement of the gastric tube outside of the stomach, which led to sepsis, kidney failure and death.

During a review of the clinical record, on 8/3/12 at 11 a.m., Resident 9 was admitted to the facility on 6/25/09 with diagnoses that included persistent vegetative state due to a stroke with brain hemorrhage, high blood pressure, and a seizure disorder. Resident 9 had a gastric tube for feeding, fluids, and medications. Resident 9's Minimum Data Set (MDS), an evaluation tool, revealed that Resident 9 could not understand others or be understood and was totally dependent for all activities of daily living. (Merck Manual - persistent vegetative state is a chronic condition that preserves the ability to maintain blood pressure, respiration, and cardiac function, but not cognitive function. The patient has no awareness of self and interacts with the environment only via reflexes and cannot interact with people. Purposeful responses to external stimuli are absent, as are language comprehension and expression. Treatment is supportive only).

Nurses notes, dated 6/8/12, as a late entry for 6/5/12, revealed that at 10 a.m., Licensed Nurse (LN) D went into Resident 9's room to turn on the tube feeding after it had been turned off for one hour after medication was administered. The gastric tube was lying on Resident 9's stomach with the balloon deflated. A moist Q-tip was inserted to keep the tract open and another gastric tube was inserted, with some difficulty. Placement was checked by injecting air into the gastric tube and listening for air. The notes indicated that air was heard to the left of the gastric tube insertion site, and that there was no residual fluid, as the tube feeding had been off for one hour following a medication. A second nurse checked placement. Further record review revealed that there were no notations on the care plan about the reinsertion.

During an interview, on 8/7/12 at 11:30 a.m., when asked to explain the note of passing the gastric tube with difficulty, LN D stated that she could not get it to, "follow the line," and tried three or four attempts to get it in, then finally felt a pop as the gastric tube was placed and felt that the pop meant that it was in the tract of the stomach. LN D did inject air into the tube to listen for air in the stomach and heard it to the left, not where it had normally been heard before (on the right). LN D asked another nurse to check placement but was not in the room when this occurred. LN D stated that the second nurse, who checked placement, reported that Resident 9's color was gray two hours after the gastric tube was replaced. Resident 9 was suctioned through the tracheostomy, and there was no sputum, and it was decided to just continue monitoring.

LN D stated that this resident could not tell you what was wrong, so observation skills were critical. LN D stated that the physician was not notified at the time, as she felt the tube pop into the tract. LN D also stated that an X-ray should have been done, to check placement, after the difficult placement and that it was standard orders when something did not seem right. During an interview, on 8/7/12 at 11 a.m., LN H stated that LN D had requested that he check placement of the gastric tube after it was reinserted. LN H was not in the room when LN D reinserted the tube. LN H stated that the tube feeding had been held for one hour after medication so there was only a small amount of residual fluid in the tube when checked for fluid, and that air was heard on the left side and none on the right side, where it had been previously heard. LN H stated that he had not attended any in-services for gastric tubes.

During an interview, on 8/7/12 at 10:20 a.m., LN G, the nurse who cared for Resident 9 during the evening (3 p.m. to 11 p.m.) shift, was asked if gastric tube residual and placement had been verified. LN G stated that it had been reported that the gastric tube was replaced, but the report had not indicated that it was a difficult replacement. LN G did state that air was heard when the gastric tube placement was checked. When asked if there was residual fluid, and where the residual was recorded, LN G stated that residuals were not recorded, and could not remember if there was any residual fluid in the tube or stomach, and that residuals were never recorded. LN G stated that as the evening progressed Resident 9's condition worsened. The nursing assistants had reported that Resident 9 was very diaphoretic (profuse sweating) while sitting up in a chair. LN G asked the nursing assistants to put Resident 9 back to bed and turn on a fan. Later the nursing assistants reported that Resident 9 was again very diaphoretic and asked LN G to re-evaluate. LN G stated that Resident 9's blood pressure was low, and it seemed like something was going on, and thought that Resident 9 was possibly getting a urinary tract infection. Resident 9's temperature and pulse were not taken. When asked what the policy was for reporting a low blood pressure or for required nursing documentation, LN G did not know, and stated that the policy manuals that were at the nursing station, and were not very user friendly, so they were not used very often. LN G also stated that the above findings were not recorded in the record, but should have been.

Record review, on 8/4/12 at 11 a.m., revealed nurses notes for the night shift (11 p.m. to 7 a.m.), with a time recorded as 3 a.m., that Resident 9's blood pressure was 89/52: "Gave patient rest of water via G tube, stopped feeding for 30 minutes, re-checked BP (blood pressure), it had gone up to 90/54, restarted feeding." A second note, timed also as 3 a.m., indicated, "Second time BP was checked, it was 75/47. After giving rest of water and elevating feet re-checked, it was 90/54." During an interview, on 8/7/12 at 11:35 a.m., LN I stated that the concern on the night shift was the low blood pressure. LN I also stated that sometime during the night Resident 9 was shaking, so a warm blanket was applied. When asked what the pulse was when the blood pressure was checked, LN I did not know. When asked if a temperature was taken when Resident 9 was shaking, LN I replied, "no." LN I stated that the other Licensed Nurse on that night (LN P) and she had been concerned with the low blood pressure. LN I did check gastric tube placement, but did not recall if there was any residual, did hear air, but was not sure which side it was heard. When asked about the no urine output for the entire night shift, LN I responded that sometimes the residents did not have urine output on the night shift and would make up for it on the day shift. When asked to list the symptoms of sepsis, LN I did not know them.

During an interview, on 9/4/12 at 11 a.m.., when asked what the signs and symptoms of sepsis were, LN P, the second nurse on the night shift caring for Resident 9, indicated she did not know them that night.

(Sepsis Fact Sheet - National Institute of General Medical Sciences: Common symptoms of sepsis are fever, chills, rapid breathing and heart rate, rash, confusion and disorientation. Sepsis is a serious medical condition caused by an overwhelming immune response to infection. Immune chemicals released into the blood to combat the infection trigger widespread inflammation, which leads to blood clots and leaky vessels. This results in impaired blood flow, which damages the body's organs by depriving them of nutrients and blood. In the worst cases, blood pressure drops, the heart weakens and the patient spirals toward septic shock. Once this happens, multiple organs - lungs, kidneys, liver - may quickly fail and the patient can die. Sepsis does not arise on its own. It stems from another medical condition such as an infection in the lungs, urinary tract, skin, abdomen or other part of the body.) Record review, on 8/3/12 at 10 a.m., of the 6/6/12, day shift nurses notes (7 a.m. to 3 p.m.), revealed that at 8 a.m. the vital signs were: Temperature 38.2 axillary, Pulse 132, Respirations 43, Blood Pressure 122/82. Resident 9 was diaphoretic and cold, his toes and feet were gray, his hands were cold, and he was cyanotic (a bluish discoloration of the skin and mucous membranes; a sign that oxygen in the blood is dangerously diminished). The notes indicated that the physician was notified immediately, and laboratory studies, EKG and chest x-ray were ordered. At 9 a.m. Resident 9's heart rate was in the 40's, his blood pressure was 81/56, his oxygen saturations were in the 70's (normal = 96-99), and the hospital Rapid Response Team was called.

During an interview, on 8/10/12 at 3:15 p.m., LN E, the hospital intensive care nurse who responded to the rapid response team page, stated that Resident 9's abdomen was very distended, his color was gray, his skin was cold, and that it was obvious that Resident 9 was in full-blown septic shock. LN E stated that the rapid response team should have been called much earlier. Resident 9 was transferred to the hospital intensive care unit with a diagnosis of septic shock.

Record review, on 8/3/12 at 10 a.m., revealed a CT scan of the abdomen/pelvis, dated 6/8/12, with the conclusion: "The gastrostomy tube is outside the stomach. Fluid and air are present in the abdominal wall." Resident 9 was transferred to another local hospital intensive care unit on 6/9/12, for consideration of dialysis (process of cleansing the blood by passing it through a special machine. Dialysis is necessary when the kidneys are not able to filter the blood) due to renal insufficiency (kidney function failure) with anuria (failure of the kidneys to produce urine). A CT scan of the abdomen/pelvis, dated 6/11/12, was done with the impression: Feeding tube in musculature of the left abdominal wall, air in the left anterior abdominal wall crossing the midline to the right, intra-abdominal air also present, primarily against the left anterior abdominal wall, with associated fluid. Resident 9 died on 6/17/12, with final discharge diagnosis that included septic shock secondary to intra-abdominal (inside abdominal cavity) sepsis, and acute kidney injury. Review, on 8/3/12 at 1 p.m., of the facility policy titled: Gastrostomy Tube Changing or Reinsertion of (excluding Jejunostomy tubes), dated 7/11, included the policy statement: "...if a gastrostomy tube falls out, a replacement tube should be inserted as soon as possible, within a few minutes at most..." Documentation required: "1. 24 hour nursing assessment notes, 2. Nurse's progress notes, 3. Kardex, and 4. Care Plan." Review of the facility policy titled: Notification of Resident Changes, dated 7/11, included: "Procedure: The physician shall be notified promptly of: a. Any sudden and marked change in signs, symptoms or behavior exhibited by a resident, b. Any unusual occurrence involving a resident,... d. Any untoward response or reaction by a resident to a medication or treatment..." During a review, on 8/14/12 at 5 p.m., the facility policy Titled: Contacting the physician for changes in patient's condition, revised 1/11, included: "1. The nurse will notify the attending physician when the following circumstances arise, unless otherwise modified by the physician: a. Systolic B/P below 80 or above 180 mm Mercury - new onset, b. Pulse below 50 or above 110, new onset....2. When any of the above conditions occur, the Lead Nurse or Staff nurse will: 1. Contact the physician by office phone, Tiger Text or overhead paging if in the hospital. B. Contact the ICU for possible admission to that unit (consider calling a Rapid Response Team to evaluate the patient) ..." During a review, on 1/24/13 at 11 a.m., the manufacturer instructions (BARD) for the gastric tube, included in Warnings "... Be certain that the balloon has passed through the fistulous tract and is completely in the stomach prior to inflation of the balloon. Placement or slippage of the device into the peritoneal cavity will result in serious consequences including peritonitis, sepsis and potentially, death..." During an interview, on 8/3/12 at 10 a.m., when asked about the specific staff training for gastric tubes, Administrative Staff C stated that there was no formal training. Nursing staff, who had previous experience, trained new staff who, after inserting a G tube, could then train the next nurse. There were no skills competency evaluations, and the yearly Licensed Nurse performance evaluations were not specific to skills with gastric tubes. Administrative Staff C stated that all 13 residents in the distinct part skilled nursing unit had gastric tubes, and that all residents had traumatic brain injuries requiring feeding, fluids, and medications through gastric tubes.

During a review, on 8/3/12 at 11 a.m., the performance evaluation for LN D indicated that all criteria were met, but that there was a need to strengthen critical thinking skills. The licensed nurse performance evaluation did not include an evaluation of skills with gastric tubes.

Safe Practices in Patient Care: Enteral Nutrition and Hydration in Long-Term Care (Continuing Education for Nurses), indicated...Tube Displacement...The auscultation method of listening for insufflative air over the epigastrium to check for tube placement is not always reliable...If there is any question of tube migration or displacement or if the nurse is unable to determine tube placement, an X-ray should be requested..." http://emedicene.medscape.com/article/14589-overview: G-tube replacements:..."If G-tube replacement does not occur easily, abort the procedure and contact the provider who placed the tube..." American Society for Parenteral and Enteral Nutrition (ASPEN) Standards of Practice: Standard 11: 11.1 Appropriate access devices (tubes placed for the delivery of nutrients or drugs) shall be placed by or under the supervision of a physician, nurse or specially trained healthcare professional who is competent and knowledgeable in recognizing and managing complications associated with the placement and management of the device...11.3 Proper placement of vascular (into a blood vessel) and enteral devices (into the gastrointestinal tract) shall be appropriately confirmed and documented before use...11.4 complications related to an access device and outcome of actions to manage the complication shall be clearly documented in the medical record.

The facility violated the regulation by failing to ensure that all staff were trained and competent to replace gastrostomy tubes, failed to obtain an x-ray to check placement of the gastric tube after difficulty in passing the tube, and failed to recognize signs and symptoms of sepsis.

These failures resulted in Resident 9's gastric tube placement outside of the stomach which resulted in septic shock with kidney failure and was the direct proximate cause of death.

The above violation presented an imminent danger to the patient and was a direct proximate cause of the death of the patient.