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670 STONELEIGH AVENUE

CARMEL, NY 10512

DATA COLLECTION & ANALYSIS

Tag No.: A0273

Based on document review and interview, the facility did not utilize its quality assurance and performance improvement program to ensure that surgical incidents were investigated and analyzed to ensure improved patient outcome and safety.

Findings include:

The facility's Quality, Performance Improvement and Patient Safety Plan for 2017 states, "the overall goal of the Quality, Performance Improvement and Patient Safety/Satisfaction Plan is to design processes well and systematically measure, analyze and improve performance to improve patient outcomes, and to improve patient safety."

Review of medical record #1 revealed the patient underwent a partial removal of a bladder tumor on 11/17/16. Postoperatively the patient developed respiratory failure and puncture of the bladder with additional complications as a result of the bladder irrigation fluid leaking into the pelvis and abdomen. The patient died on 11/26/16.

The facility's peer review of the care provided to Patient #1 determined "optimal level of care met." There was no evidence that the facility identified the delay in addressing the patient's respiratory failure, the delay in recognizing the puncture of the bladder, the complications as a consequence of the bladder irrigation fluid leaking into the pelvis and the discrepancy with the bladder irrigation intake and output.

A sample of 24 surgical incidents for 11/2016 to 11/2017 were reviewed. These incidents included but was not limited to equipment failures, returns to surgery within 24 hours and a patient who became agitated and verbally threatening after he awoke in the operating room. Only 2 incidents had documented investigations and analyses in the Quality Assessment Performance and Improvement (QAPI) data.

There was no documented evidence in the quality minutes for 11/2016 - 11/2017 that these incidents were analyzed and that corrective measures were implemented to prevent reoccurrence.

This finding was shared with Staff A, the Director of Quality on 12/1/17 at 3:15 PM.

RN SUPERVISION OF NURSING CARE

Tag No.: A0395

Based on medical record review, document review and interview, in one (1) of 19 medical records reviewed, it was determined the nursing staff failed to (a) measure and monitor a patient's fluid output and (b) assess a patient's edema. This was evident for Patient #1.

Findings include:

Review of Patient #1's medical record identified the following: the patient underwent a partial removal of a bladder tumor on 11/17/16 and a Continuous Bladder Irrigation (CBI) was started at the end of the procedure in the operating room.

Nursing documentation revealed the patient was admitted to the Post Anesthesia Care Unit (PACU).

The surgeon ordered to "run CBI (continuous bladder irrigation) fast enough to keep urine pink to clear."

There was no nursing documentation of the output of the continuous bladder irrigation throughout the patient's stay in the post anesthesia care unit (PACU-recovery unit).

Staff B, the PACU registered nurse who provided care for the patient on 11/17/16 stated on 11/30/17 at 10:40 AM, that she does not measure the output of patients that have a continuous bladder irrigation.

The patient was transferred from the PACU on 11/17/16 to a surgical unit.

The patient was transferred to the intensive care unit at 7:15 PM.

Nursing documentation indicates at 10:00 PM there was a mismatch in the volume of fluid instilled and the fluid output. The output is much lesser than the infused volume. The patient's abdomen was noted to be more swollen and a physician was informed.

Nursing documentation on 11/17/16 at 11:30 PM revealed the intensivist (critical care physician) gave an order to stop the continuous bladder irrigation due to the perforation of the bladder.

The total fluid input was 19,408 milliliters (ml) and the output was documented as 5,400 ml on 11/17/16.

This represents a significant discrepancy with the intake and output monitoring.

Nursing documentation revealed the nurses on the night shift documented that the patient developed edema (swelling) on 11/17/16 and it persisted throughout her hospitalization.

A physician documented on 11/18/16 that he noted the patient had significant edema (swelling).

There was no documentation by the day shift nurses that the patient had swelling during her hospitalization.

These findings were shared with Staff A, the Director of Quality on 12/11/7 at 3:10 PM.

VENTILATION, LIGHT, TEMPERATURE CONTROLS

Tag No.: A0726

Based on document review and interview, it was determined the facility failed to maintain temperature and humidity in operating rooms within accepted standards of practice.

Findings:

Review of facility's policy titled "Temperature & Humidity in Controlled Environments" (Approved 03/2016), revealed that the temperature in operating rooms shall be between 65 F - 75 F with a humidity between 20%-60%.

Review of the facility's temperature and humidity logs for 09/2017, 10/2017, and 11/2017 revealed that the temperature and humidity for the reviewed months were not consistently maintained within accepted standards of practice (temperature 68-75 degrees F, and humidity 20%-60%). For example, for the month of November 2017, temperature and humidity were not consistently maintained in all operating rooms for the duration of the month. This includes, but is not limited to operating room (OR) #1 the temperature was 60 F, OR #2 the temperature was 62 F, and OR #6 the temperature was 63 F on 11/ 01/2017;
Operating rooms # 1 the temperature was 61 F; humidity was 12 %, OR # 5 the temperature was 63 F; humidity was 15%, OR #6 the temperature was 60 F; humidity was 15 %), OR #7 the temperature was 64 F; humidity was 22 %), OR #9 the temperature was 63 F; humidity was 15 %, OR # 10 the temperature was 62 F; humidity was 16 %), and OR #11 the temperature was 64 F; humidity was 13 % on 11/11/2017.

On 11/28/2017, at 02:50 PM, during an interview with staff F, the Facility Manager, stated that the low temperatures in the operating rooms are related to preferences of surgeons. Staff F showed two (2) work requests for 11/10/2017 and 11/11/2017 aimed at addressing low humidity levels in the operating rooms, but requests were placed for OR #s 1 - 4 of the 12 operating rooms. Low humidity levels were noted to be present in all operating rooms. Low humidity levels continued throughout the operating rooms beyond the dates indicated. This was brought to the attention of Staff F who verbalized understanding.

OPERATING ROOM POLICIES

Tag No.: A0951

Based on medical record review, document review and interview, in one (1) of 19 medical records reviewed, it was determined the facility failed to conduct timely assessment and treatment of a post surgical patient. Specifically, the facility failed to (a) recognize and treat the patient's deteriorating breathing condition and (b) monitor the output of a continuous bladder irrigation. This was evident for Patient #1.

Findings include:

a) Review of Patient #1's medical record identified the following: this seventy-nine year old patient was admitted to the facility on 11/17/16 for a removal of a bladder tumor. The patient had a previous medical history of Anxiety and severe respiratory compromise. The procedures were completed at 1:17 PM and the patient was taken to the post-anesthesia care unit (PACU) at 1:21 PM.

At 1:23 PM the surgeon ordered to run a continuous bladder irrigation (CBI) fast enough to keep the urine from pink to clear.

There was no physician's order to monitor the patient's intake and output.

Nursing documentation revealed at 1:45 PM the patient's breathing had increased. Nursing documentation at 2:00 PM revealed the "patient was very anxious, asking for her inhaler, given Albuterol nebulizer per" the anesthesiologist "who is at bedside. Patient asking for something to calm her down. Patient shaking, complained of feeling very anxious." Oxygen 3 liters per minute via nasal cannula was administered continuously.

Nursing documentation also revealed the following findings:

At 2:30 PM the patient's breathing increased further.
At 3:00 PM the heart rate had increased.

At 3:38 PM the patient was squirming, shifting back and forth, moans, or whimpers, she continued to have difficulty breathing and she was lethargic. The patient also had fatigue and an irregular and a rapid heart rate.

At 5:12 PM the patient's respiration continued to increase.

A nursing note at 5:14 PM revealed a physician was informed of the patient's increasing pace of breathing.

There was no documentation in the medical record that the anesthesiologist or the surgeon reassessed and monitored the patient when the patient's breathing and heart rate increased after 1:45 PM.

The surgeon reassessed the patient on 11/18/16 at 9:03 AM, more than 18 hours after the patient developed severe breathing problems.

A test performed at 10:21 AM on 11/18/16 revealed the catheter's tip appeared to have punctured through the bladder and had extended into the pelvic cavity (lower abdomen).

The patient developed breathing complications, shock and an acute kidney injury.

The patient was placed on hospice care on 11/25/16 and she died on 11/26/16 at 7:05 AM.

These findings were shared with Staff A, the Director of Quality on 12/11/7 at 3:10 PM.

INTRAOPERATIVE ANESTHESIA RECORD

Tag No.: A1004

Based on medical record review and interview, in one (1) of 19 medical records reviewed, it was determined the intraoperative anesthesia record did not include the regional anesthesia that was administered. This was evident for Patient #1.

Findings include:

Review of Patient #1's medical record identified the following: the patient underwent a partial removal of a bladder tumor on 11/17/16 in the operating room.

There was no documentation in the anesthesia record that any anesthetic was given.

Staff C, the anesthesiologist who cared for the patient stated during an interview conducted on 11/29/17 at 11:52 AM, that he probably gave medication in the spine. He confirmed that he had not documented the administration of the medication.

This finding was shared with the Director of Quality on 12/1/17 at 3:10 PM.