72311 Nursing Service - General (a) Nursing service shall include, but not be limited to, the following: (1) Planning of patient care, which shall include at least the following: (A) Identification of care needs based upon an initial written and continuing assessment of the patient's needs with input, as necessary, from health professionals involved in the care of the patient. Initial assessments shall commence at the time of admission of the patient and be completed within seven days after admission.
72311 Nursing Service - General (a) Nursing service shall include, but not be limited to, the following: (3) Notifying the attending physician promptly of: (B) Any sudden and/or marked adverse change in signs, symptoms or behavior exhibited by a patient.
72523 Patient Care Policies and Procedures (a) Written patient care policies and procedures shall be established and implemented to ensure that patient related goals and facility objectives are achieved.
The following citation was written as a result of unannounced visits to the facility on 10/19/05, 11/15/05, and 03/21/06 for the investigation of complaint #CA00050742 related to quality of care and treatment.
The Department determined the facility failed to:
1. Provide continuing assessments of care needs of Patient A by obtaining orders for treatment of a urinary infection between 03/19/05 and 03/30/05 and provide continuing assessments of care needs by assessing the intake and output to determine adequate fluid balance. 2. Implement the physician order of 03/19/05 to obtain a urine culture and sensitivity lab test that would have identified the type of bacteria present in order to provide effective antibiotic treatment. 3. Implement the physician order dated 01/26/05 to change the indwelling urinary catheter monthly when nursing staff did not change Patient A's catheter until 3/24/05 (57 days after original placement on 1/26/05). 4. Notify the attending physician promptly when Patient A had a urinalysis on 03/19/05 that was positive for an infection. 5. Implement their Significant Change of Condition policy and procedure, dated January 1997, by not notifying the physician when the urinalysis results were abnormal and suggestive of a urinary tract infection. 6. Implement their Intake and Output Measurement policy and procedure, undated, by not evaluating the intake and output values weekly to determine adequacy of fluid balance and hydration. These failures resulted in Patient A not receiving appropriate antibiotic treatment for a urinary tract infection for 11 days, from 03/19/05 through 03/30/05. This led to her transfer to the Acute Care Hospital Emergency Room (ER) on 03/30/05 at 7:15 p.m. and admission to the Intensive Care Unit of the Acute Care Hospital with diagnoses including urinary tract infection, sepsis (infection in the blood), respiratory failure, and electrolyte disturbance. Patient A was admitted to the intensive care unit of the acute care hospital where she was treated for the multiple medical conditions for ten days. She expired on 04/09/05 due to complications of the urosepsis (infection in the urinary tract resulting in a generalized blood stream infection).
Patient A was a 71 year old female admitted to the skilled nursing facility on 11/21/03. She had diagnoses including congestive heart failure, Hepatitis C, cirrhosis of the liver, difficulty swallowing, advanced dementia, Alzheimer's disease and depression.
A review was conducted of a quarterly Minimum Data Set (MDS) assessment dated 12/24/04. The MDS is an interdisciplinary assessment tool that describes the patient's physical and psychosocial status and is used to develop a plan of care. Patient A was assessed to have short-term memory problems and moderately impaired decision making ability. She was independent with bed mobility and eating. She required limited assistance for transfers, ambulation, dressing, and personal hygiene. She required extensive assistance for bathing. She was continent of both bowel and bladder. She was 5'4" and weighed 196 pounds.
JANUARY Review of the Dietary Progress Notes dated 01/11/05 revealed Patient A required 2522 cc (cubic centimeters, a measurement of volume) of fluid intake daily. Her diet provided approximately 2000 cc. She was consuming approximately 20% of her meals. The dietary note indicated Patient A "only nibbles on food and husband gives her Ensure or snacks."
Nurse's Notes dated 01/23/05 at 10:00 a.m. documented Patient A fell in the bathroom. The notes documented Patient A "started shivering and [oxygen] saturations 84-86%. [Oxygen] given at 2 liters. Received new orders for STAT labs, [oxygen], and straight cath" for a UA C&S (urinalysis, with culture and sensitivity).
A laboratory report and Physician's Orders dated 01/23/05 revealed that Patient A was positive for a urinary tract infection and orders were received for antibiotics to treat the infection.
A Nurse's Note dated 01/26/05 at 4:10 p.m. documented the licensed nurse (LN) contacted Patient A's physician reporting that Patient A "doesn't urinate for two days." Physician's Orders dated 01/26/05 (no time) revealed "insert F/C (Foley catheter)" and to "change the urinary catheter monthly on the 27th and as necessary."
Nurse's Notes dated 01/31/05 at 11:05 a.m. documented Patient A's family was "concerned with dark color urine and (decreased) appetite and (decreased) fluid intake. Family request (sic) IV (intravenous - directly into a blood vessel) therapy. Call to [physician]." A Nurse's Notes dated 01/31/05 at 11:30 a.m. documented the LN spoke with the physician who told her "IV therapy not indicated at this time. MD states continue to monitor and encourage [oral] fluids."
Review of the Intake and Output Records for January 2005 revealed Patient A's average daily intake for January 2005 was 1264 cc/day (50% of the recommended amount).
FEBRUARY The last Physician's Progress Note in Patient A's medical record was dated 02/09/05. There was no further documentation by Patient A's physician. All subsequent orders from Patient A's physician were telephone orders transcribed by the LN's.
Review of the Dietary Progress Notes dated 02/15/05 revealed Patient A "intake (approximately) 2% meal, refused 14 - 17 meals. I&O 1267 cc, not meeting estimated needs." The Registered Dietician (RD) noted "MD informed today. He said...encourage fluids. Will alert [nursing] and monitor."
The Intake and Output Records for Patient A for February 2005 were reviewed. The section of the Intake and Output Record titled Evaluation of Intake and Output for the week ending 02/04/05, indicated the "Intake ranged from 620 to 1580 (cc)" and the "Output ranged from 400 to 1200 (cc)". The "Clinical Evaluation" section on the form ending with the date of 02/04/05, revealed "increase fluid intake." For the weeks ending 02/11/05, 02/18/05, and 02/25/05, the Evaluation of Intake and Output sections were left blank which did not provide an accurate assessment of fluid balance.
Review of the Intake and Output Records for February 2005 revealed Patient A's average daily intake (for the days that had documentation) for February 2005 was 1172 cc/day (46% of the recommended amount). Patient A never achieved the required daily fluid intake of 2522 cc as recommended in the Dietary Progress Notes dated 01/11/05. The documented data collected and/or omitted on the Intake and Output Records for February 2005 could not be effectively evaluated to continually assess Patient A's intake and output to determine adequacy. Lack of the documentation on the Evaluation of Intake and Output summaries for 02/11/05, 02/18/05, and 02/25/05 indicated no assessment of the intake and output for Patient A during that time.
Nurse's Notes during the month of February 2005 documented 14 of 28 days (50%) when fluids were encouraged by staff. They documented 9 of 28 days (32%) when Patient A refused meals. They documented 18 of 28 days (64%) when the urine was described as "dark yellow" or "amber" colored. The dark color of urine "can be caused by...not drinking enough water or fluids...concentrated urine appears dark yellow." (Reference - Medline Plus, Medical Encyclopedia: Dehydration, 06/13/06).
The facility policy titled Intake and Output Measurement (undated) was reviewed. The policy indicated, "The following residents require measurement and general documentation guidelines of intake and output every eight hours, including a 24-hour total and weekly evaluation: 1. All residents with indwelling catheter for a minimum of the first 30 days." Under the section titled Procedure, the policy indicated "the intake and output is to be evaluated weekly to determine adequacy. If not adequate or if output is more than intake, the physician is to be notified and corrective action taken."
The facility failed to implement their policy titled Intake and Output Measurement when they did not ensure Patient A's intake and output were accurately documented each shift and evaluated weekly for the month of February 2005 to determine adequacy of Patient A's fluid status.
MARCH The Intake and Output Records for Patient A for March 2005 were reviewed. In the section of the Intake and Output Record titled Evaluation of Intake and Output for the week ending 03/07/05, the daily intake range was "1120 to 1850" cc and the daily output range was "1050 to 1275" cc. For 10 of 89 opportunities to measure urine output in March, no values were recorded.
Review of the Intake and Output Records for March 2005 revealed Patient A's average daily intake for March was 1417 cc/day (56% of the recommended amount). Patient A never achieved the required daily fluid intake of 2522 cc as recommended in the Dietary Progress Notes dated 01/11/05. Patient A failed to meet her required daily fluid intake for 28 of the possible 28 days (100%) in March (two days only had partial data).
Nurse's Notes during the month of March 2005 documented 14 of 30 days (46%) when fluids were encouraged by staff. They documented 5 of 30 days (16%) when Patient A refused meals. They documented 6 of 30 days (20%) when the urine was described as "dark yellow" or "amber" colored.
Nurse's Notes dated 03/19/05 at 12:00 p.m. documented Patient A had "decreased [urinary] output...Slept most of a.m. shift. Refused meals and meds." The LN further documented Patient A's "[physician] called no new orders. Want (sic) LVN to talk to family about to either change code or decide to put IV and/or feeding tube. Discuss (sic) [with] daughter and family will let us know decision." Nurse's Notes dated 03/19/05 at 2:00 p.m. documented "received phone call from family to 'do everything we can.' [Physician] notified received [new order] to start IV and get appointment for G-tube."
A review was completed of the Nurse's Notes dated 3/19/05. At 3:00 p.m. it was documented that intravenous fluids were started as ordered. At 3:30 p.m. it was documented that "abdomen distended [Foley catheter] no output. Irrigated [Foley catheter]...with thick yellowish mucousy (sic) return 1,000 cc clamped out at 450 cc." At 6:30 p.m. it was documented "informed [physician] of [Patient A's] urine appearance, obtained order for STAT (immediate) UA C&S (urinalysis/culture and sensitivity)."
Nurse's Notes dated 03/19/05 at 8:00 p.m. documented "UA sent out to lab at 8 p.m. Urine yellowish in color with [small amount] of sediment." The urinalysis report dated 03/19/05 for Patient A documented the following:
* blood 3+ (normal 0) * protein 2+ (normal 0) * leukocyte esterase positive (presence of enzymes in specific white blood cells normal negative) * white blood cells greater than 100 with many clumps (normal 0-5) * red blood cells 50-100 (normal 0-2) * bacteria 2+ (normal 0)
These values were consistent with a urinary tract infection. There was no documentation that a culture and sensitivity test was performed as ordered by the physician on 03/19/05.
The urinalysis was performed at a local satellite laboratory on 03/19/05. A preliminary report of Patient A's urinalysis findings was faxed to the facility on 03/19/05 at 10:12 p.m. There was no documented evidence the physician was faxed or made aware of the results of the urinalysis. No new orders were obtained for the treatment of Patient A's urinary tract infection.
Nurse's Notes dated 03/20/05 at 6:26 a.m. documented "Foley cath with amber color urine in bag, [Patient A] more alert...responds appropriately, but doesn't want to wake up...turgor fair, slept all shift."
Nurse's Notes dated 03/21/05 (no time) documented Patient A's temperature was 99.5 and her blood pressure was 140/80. The LN documented Patient A was "alert and confusion (sic)."
An MDS dated 03/21/05 was initiated due to a change in Patient A's condition. The MDS documented Patient A had the following changes: 1. Long term memory problems (previously no long term memory problems). 2. Extensive assistance for bed mobility (previously independent). 3. Extensive assistance for transfers (previously limited assistance). 4. Total assistance for dressing, toileting, personal hygiene (previously limited assistance). 5. Total assistance for bathing (previously extensive assistance). 6. Limited range of motion with partial loss of voluntary movement in one arm (previously no limitations). 7. No ambulation (previously ambulated with limited assistance). 8. Placement of an indwelling urinary catheter (previously continent).
Nurse's Notes dated 03/22/05 at 5:50 a.m. documented Patient A's blood pressure was 150/90 and "had a slight temp of 100.7 (axillary - under the arm). Gave pain med (Vicodin, which contains Acetaminophen) and brought it back down to 97.1 (axillary)."
A second copy of the urinalysis results was faxed to the facility by the main laboratory on 03/22/05 at 1:55 a.m. There was no documented evidence the physician was faxed or made aware of the results of the second faxed urinalysis report. No new orders were obtained for the treatment of Patient A's urinary tract infection.
The facility Policy/Procedure for Significant Change of Condition dated January 1997 indicated "the resident's primary physician or designated alternate will be notified immediately of any change in a resident's physical or mental condition." Under the section titled Guidelines, the policy indicated "leaving a message on the physician's answering machine is not adequate for notification of a significant change of condition. If the staff nurse is unable to reach the primary physician, then it is expected that the alternate physician be notified." The policy gave examples of factors to be considered in making a change of condition determination, which included "lab values."
The facility failed to implement the Policy/Procedure for Significant Change of Condition when they did not ensure Patient A's physician immediately received the faxed laboratory report indicating a urinary tract infection. No follow-up call was made to the physician and no alternate physician was contacted. This resulted in no treatment orders being obtained.
Nurse's Notes dated 03/24/05 at 8:00 p.m. documented "Foley cath intact, new one put in by [treatment] nurse, flowing with gravity, yellow/urine with pus noted. Will continue to monitor." This was five days after the laboratory results were available indicating Patient A had a urinary tract infection. There was no documented evidence Patient A's physician was notified of the appearance of her urine when the catheter was changed. This was the first documented time Patient A's catheter had been changed (57 days after original placement), despite the Physician Order dated 01/26/05 to "change the urinary catheter monthly on the 27th and as necessary." There were no new physician's orders for treatment of the urinary tract infection.
Nurse's Notes dated 03/30/05 at 6:30 p.m. documented Patient A was "shivering" and "lethargic" (less alert). Her temperature was 99.2 and blood pressure 105/70. Her heart rate was 120 beats per minute and respirations were 28 breaths per minute. The LN "notified [physician] - ordered to send out to hospital E.R." Continuing notes documented that at 6:40 p.m. "1st Responder Transportation called, arrived at 7:05 p.m. and at 7:15, transferred to [hospital]. [Foley catheter] intact with no urine noted."
From 03/19/05 through 03/30/05, a total of 11 days, Patient A had a urinary tract infection. The facility failed to ensure the physician was aware of the laboratory results and failed to obtain the culture and sensitivity as ordered on 03/19/05. As a result of these failures, Resident A's urinary tract infection went untreated.
Patient A arrived at the ER on 03/30/05 at 7:40 p.m. The Emergency Room Admission Report dated 03/30/05 documented Patient A's "initial vital signs are blood pressure 116/61, pulse 108, respiratory rate 22, temperature 98.5, and her pulse oximetry (oxygen saturation in the blood) 96% on room air (normal)." ER Physician 1 documented, "The patient is depressed in her level of consciousness. She is looking around the room. She is not making any appropriate answers to questions. She is not following commands. Her mucous membranes are slightly dry. Her throat is clear. She also has a diminished gag reflex...She has diminished air movement...3+ pitting edema bilaterally in her upper extremities...mild edema in her lower extremities. But her skin is overall in fairly good condition."
ER Physician 1 further documented "In the emergency department an IV was established, blood cultures were done and laboratory work was sent. The patient did have a Foley catheter in and the drainage of urine was slightly cloudy. This Foley catheter was removed and a new Foley catheter was placed. Upon replacement of the new Foley catheter the patient diuresed (drained) approximately one liter (1000 cc) of a dark orange-ish color urine that was fairly clear. After the drainage of the urine there has been drainage of some significantly purulent fluid (urine containing pus), followed by blood. This became concerning and this is likely the source of infection."
While in the ER, Patient A had an IV started and received 1 gm (gram, a measurement of mass) of Rocephin (antibiotic) through the IV after the blood cultures were sent. ER Physician 1 documented Patient A "had an episode of emesis (vomiting) and therefore was treated with a NG tube to drain her stomach, however, the patient continued to vomit, her level of consciousness was depressed, and her gag response was depressed, and therefore the patient was electively orally intubated (placed on a breathing machine)." ER Physician 1 documented Patient A was "admitted to the [Intensive Care Unit] in critical condition."
The urinalysis report dated 03/30/05 (from a sample taken after the new catheter was inserted) documented Patient A's urine contained the following:
White Blood Cells 50-100 (normal 0-5) Leukocyte Esterase 2+ (normal negative) bacteria 3+ (normal 0)
The urine culture report documented greater than 100,000 colonies/ml of mixed flora. The urinalysis confirmed the presence of a urinary tract infection.
The blood test dated 03/30/05 revealed Patient A had a white blood cell count of 18.3 (normal less than 10). This was consistent with an infection in the blood system. A blood culture was drawn that revealed growth of Proteus mirabilis and Enterococcus faecalis.
Patient A's 03/31/05 History and Physical listed diagnoses including probable sepsis, probable pneumonia, and urinary tract infection. Patient A expired ten days later on 04/09/05 at 4:50 p.m. The Death Summary dated 05/03/05 documented "the patient was admitted and was started on broad spectrum antibiotics after cultures were taken. It was thought that she probably had urosepsis (infection that began in the urinary tract)." The Summary indicated the attending physician discussed Patient A's prognosis with the family indicating "the chance of significant recovery was 'close to zero.' The family ultimately wished to withdraw care...She may be extubated (breathing machine removed) and placed on comfort care. This was done and the patient did expire." The Death Summary documented the final diagnosis as "death as a consequence of sepsis due to gram negative bacteremia/sepsis."
On 11/15/05 at 2:40 p.m., the Director of Nurses 2 (DON 2) at the facility was interviewed. She stated she would expect the LNs to call the physician if they received no response to a faxed report within 24 hours.
Urine specimens collected at the facility were processed at an outside laboratory. On 12/15/05 at 4:13 p.m., Technician 3 at the outside laboratory was interviewed. She stated no culture and sensitivity had been ordered or completed for Patient A. Only the urinalysis had been ordered and completed on 03/19/05.
On 01/04/06 at 4:35 p.m., Physician 4 (Patient A's attending physician) was interviewed. During the interview, the results of Patient A's urinalysis were reviewed with the physician. He stated the test results (i.e., white blood cells and leukocyte esterase) were "significant." When asked if he would have treated the patient based on the test results, he stated he would "probably have treated the infection."
There was no documentation from the physician that indicated he was aware of the abnormal laboratory results for Patient A. There was no documentation of a licensed nurse's follow-up with the physician to assure he had received the faxed report as directed in the Policy/Procedure for Significant Change of Condition dated January 1997.
On 03/21/06 at 3:40 p.m., LVN 5 was interviewed. He stated he would call the physician if there was a large discrepancy between intake and output. He defined large discrepancy as "50-100 cc" during the shift.
On 03/21/06 at 3:45 p.m., DON 6 (interim DON who started at the facility in January 2006) was interviewed. She stated if there was no physician response to a call or fax within two hours, the LN should call the physician. She stated that all reports containing "critical" lab values should be called to the physician. She stated the physician should be notified of any discrepancies in the intake and output. She stated her expectation of nursing staff is to complete the weekly Evaluation of Intake and Output. She stated it was the facility policy "to change the [collection] bag weekly and the catheter monthly."
On 03/21/06 at 3:50 p.m., RN 7 was interviewed. She stated she would normally call the physician with any lab results. However, one physician (Patient A's physician) wanted all reports faxed to him. She stated she would expect a response by the next shift and follow-up if none was received.
On 02/28/07 at 4:50 p.m., Family Member 8 was interviewed. She stated that she had visited Patient A daily since her admission to the facility. She stated Patient A's husband visited Patient A at the facility every day from 11:00 a.m. until 7:00 p.m. About two weeks before Patient A died, the husband became too ill to go to the facility. At that time Family Member 8 visited twice a day. She stated they would take in Ensure and puddings and were able to coax Patient A to take them. Patient A's son also visited twice a week.
Family Member 8 stated Patient A began to "really decline" after Patient A's fall at the facility on 01/23/05. Family Member 8 stated the facility did not take proper care of Patient A's catheter after it was inserted. She further stated family members had to tell the staff on "multiple occasions" to check on the catheter and that the "room had a foul odor" from the catheter. Family Member 8 stated "many times the urine 'looked pusey' and 'sometimes bloody looking'." When the family members would complain to staff, staff responded by emptying the collection bag. Family Member 8 stated she could not remember if the family was told about her urinalysis reports.
The Department determined the facility failed to:
1. Provide continuing assessments of care needs of Patient A by obtaining orders for treatment of a urinary infection between 03/19/05 and 03/30/05 and provide continuing assessments of care needs by assessing the intake and output to determine adequate fluid balance. 2. Implement the physician order of 03/19/05 to obtain a urine culture and sensitivity lab test that would have identified the type of bacteria present in order to provide effective antibiotic treatment. 3. Implement the physician order dated 01/26/05 to change the indwelling urinary catheter monthly when nursing staff did not change Patient A's catheter until 3/24/05 (57 days after original placement on 1/26/05). 4. Notify the attending physician promptly when Patient A had a urinalysis on 03/19/05 that was positive for an infection. 5. Implement their Significant Change of Condition policy and procedure, dated January 1997, by not notifying the physician when the urinalysis results were abnormal and suggestive of a urinary tract infection. 6. Implement their Intake and Output Measurement policy and procedure, undated, by not evaluating the intake and output values weekly to determine adequacy of fluid balance and hydration.
These violations presented either imminent danger that death or serious harm would result or a substantial probability that death or serious physical harm would result and were a direct proximate cause of death of the patient.