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Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.13 PATIENT'S RIGHTS was out of compliance.

A-0144 - The patient has the right to receive care in a safe setting. Based on observations, document reviews, and interviews, the facility failed to ensure patients received care in a safe setting. Specifically, the facility failed to ensure telemetry monitoring was provided in accordance with the provider's orders, facility policies, and facility-adopted educational references in five of six telemetry patients' medical records reviewed. (Patient #1, #3, #4, #5, and #6)

Based on observations, document reviews, and interviews, the facility failed to ensure patients received care in a safe setting. Specifically, the facility failed to ensure telemetry monitoring was provided in accordance with the provider's orders, facility policies, and facility-adopted educational references in five of six telemetry patients' medical records reviewed. (Patient #1, #3, #4, #5, and #6)

Findings include:

Facility policies:

The Cardiac and Pulse Oximetry Monitoring read, purpose: to outline safe practices for adult patients requiring continuous cardiac (heart) monitoring, promote the safety of patients, and recommend the efficient utilization of resources. The procedure of initiation of cardiac monitoring: obtain an order for continuous cardiac monitoring from the licensed independent practitioner (LIP) and ensure that the order is in the electronic health record (EHR): ensure the availability of monitoring equipment prior to receiving the patient on the unit. Communication chain of command response to alarm: assigned nurse's aide, RN, charge RN, house supervisor or hospital-specific Rapid Response Team or Code Blue process

The Telemetry Monitoring Alarm Notification and Escalation Process policy read, in an emergent situation (e.g. pulse ox less than or equal to 80%, SPO2 probe off or not reading, lethal arrhythmias, telemetry box with a dead battery, or all of the telemetry leads off) the telemetry technician must immediately notify the patient's nurse or charge nurse. The RN must immediately put eyes on the patient while on the phone with the telemetry technician. If the telemetry technician can not reach the nurse or charge nurse, the telemetry technician will follow the hospital-specific Response Team or Code Blue notification process.

Reference:

The Elsevier Procedures - Cardiac Monitor Setup and Lead Placement guideline provided by the facility read, continuous cardiac electrophysiologic monitoring is performed routinely for most acute and critically ill patients. A key component of such monitoring is the electrocardiogram (ECG), which provides a continuous graphic picture of electrical activity generated by the depolarization and repolarization of cardiac tissue. These images may be used for diagnostic, documentation, and treatment purposes. The basic goals of ECG monitoring are to monitor patients for rate or rhythm changes, myocardial ischemia (cardiac tissue death) and injury, and to monitor the QT or QTC interval (measurement of the electrical activity in the heart) in patients at risk of torsades de pointes (a lethal heart rhythm). Alterations in electrode position may distort the appearance of the waveform significantly, leading to misdiagnosis or mistreatment.

1. The facility failed to ensure an adequate number of telemetry monitor equipment to ensure continuous cardiac monitoring occurred as ordered in a patient who experienced an unexpected death. Additionally, the facility failed to provide continuous cardiac monitoring for patients, including continuous observation of a patient's heart rate and rhythm, as ordered by their physicians, to detect any changes in condition.

A. Observations

i. On 10/30/23 at 12:16 p.m., observations were conducted in the intensive care unit (ICU). Observations revealed a continuous alarm sounding from Patient #3's room. Further observation revealed the cardiac monitor leads were hanging at the bedside, and the patient's bed was empty without staff present. During the observation, the charge nurse stated the nursing staff walked patients around the unit on a portable monitor. At 12:19 p.m., the patient was located with the nurse on the intermediate care (IMC) unit without receiving continuous cardiac monitoring.

ii. On 10/30/23 at 12:38 p.m., observations conducted in the 6W surgical and trauma unit revealed three of the 17 patients with telemetry orders were off of telemetry monitoring according to the display screen at the nurse's station. (Patient #4, #5, and #6)

At 12:54 p.m., observations conducted in the 6W surgical and trauma unit revealed Patient #4 was off of telemetry monitoring in her room without nursing staff present. Patient #4's nurse and charge nurse stated they were unaware Patient #4 was off of cardiac monitoring and that they did not receive a notification from the telemetry technician informing them that the patient's leads were off.

This was in contrast to the Telemetry Monitoring Alarm Notification and Escalation Process policy, which instructed the telemetry technician to immediately notify the patient's nurse or charge nurse that the patient's leads were off. If the telemetry technician could not reach the nurse or charge nurse, the telemetry technician was then expected to follow the hospital-specific Response Team or Code Blue notification process.

B. Review of Medical Records and Telemetry Records

i. Review of Patient #1's medical record revealed on 9/27/23 at 2:17 a.m., the patient was directly admitted from an outside facility to 6W for alcohol withdrawal. At 3:54 a.m., Provider #6 ordered continuous telemetry monitoring for 48 hours. Further review of the medical record revealed that RN #4 documented the patient had a telemetry order for continuous cardiac monitoring, however, the equipment was unavailable, and she would place the cardiac monitor on the patient when a telemetry box was found. The medical record showed at 11:25 a.m., approximately seven and a half hours after the patient arrived at the facility, the CNA notified RN #12 that the patient did not look well. Provider #6's note indicated the patient was found unresponsive and without a pulse at 11:28 a.m., a code blue (a code used to indicate a patient requiring resuscitation) was called, and CPR (cardiopulmonary resuscitation) was initiated. Provider #6 terminated CPR at 12:10 p.m., and the patient subsequently died. There was no evidence in the medical record of Patient #1 on continuous telemetry monitoring throughout the patient's stay.

ii. Review of Patient #5's medical record revealed on 10/29/23 at 7:07 p.m., the patient presented to the emergency department (ED) with shortness of breath. Patient #5's medical record indicated the patient was admitted to the facility with a diagnosis of pneumonia (an infection in the lungs) and placed on 6W. On 10/29/23 at 10:03 p.m., Provider #7 ordered continuous telemetry monitoring for 48 hours.

Patient #5's telemetry record revealed on 10/30/23 at 2:05 a.m., the telemetry flowsheet documentation showed the patient's cardiac rhythm was sinus tachycardia (a regular cardiac rhythm in which the heart beat faster than normal). At 5:59 a.m., the patient was noted to be off telemetry monitoring per the Full Disclosure documentation. Further review of the telemetry record revealed Patient #5's nurse was not notified that the patient's cardiac leads were off until 10:55 a.m. (four hours and 56 minutes after the patient was noted to be off of telemetry monitoring) and again at 12:41 p.m. The telemetry record showed the notification was escalated to the charge nurse at 12:41 p.m. At 12:56 p.m., six hours and 57 minutes after the patient was noted to be off continuous telemetry monitoring, the Full Disclosure documentation revealed the patient was placed back on cardiac monitoring.

iii. Review of Patient #4's medical record revealed on 10/29/23 at 1:49 p.m., the patient presented to the ED with severe abdominal pain. On 10/29/23 at 1:57 p.m., Provider #8 ordered an EKG (a test where a snapshot recording of the electrical signals in the heart) that showed the patient had a left bundle branch block (a condition in which there was a delay or blockage along the pathway that electrical impulses traveled to make the heart beat) cardiac rhythm. On 10/29/23 at 5:31 p.m., Provider #7 ordered continuous telemetry monitoring for 48 hours. Patient #5's medical record indicated the patient was admitted to the hospital with a diagnosis of a splenic infarct (occurred when blood flow to the spleen was compromised, causing tissue damage) and placed on 6W.

Review of Patient #4's telemetry record revealed on 10/30/23 at 3:50 a.m., the telemetry flowsheet documentation showed the patient's cardiac rhythm was atrial fibrillation with a rapid ventricular rate (an irregular and very rapid heart rhythm). At 6:05 a.m., the telemetry flowsheet documentation showed the patient's cardiac rhythm was atrial fibrillation (irregular heartbeat) with a heart block (when the electrical signal that controls the heartbeat was partially or completely blocked).

At 9:20 a.m., the patient was noted to be off telemetry monitoring per the Full Disclosure documentation. Further review of the telemetry record revealed Patient #4's nurse was notified that the patient's cardiac leads were off at 10:55 a.m. (one hour and 35 minutes after the patient was noted to be off of telemetry monitoring) and again at 12:41 p.m. At 12:44 p.m., three hours and 24 minutes after the patient was noted to be off of continuous telemetry monitoring the Full Disclosure documentation revealed the patient was placed back on cardiac monitoring. At 2:12 p.m., the telemetry flowsheet documentation shows a four-beat run of ventricular tachycardia (a potentially lethal fast heart rhythm).

iv. Review of Patient #6's medical record revealed on 10/29/23 at 2:05 a.m., the patient presented to the ED with weakness and confusion. At 6:15 a.m., Provider #9 ordered an EKG test that showed the patient's cardiac rhythm was sinus tachycardia. At 6:15 a.m., Provider #10 ordered continuous telemetry monitoring for 48 hours. Patient #6's medical record indicated the patient was admitted to the hospital with a diagnosis of sepsis (a serious condition in which the body responds improperly to an infection) and placed on 6W.

Review of Patient #6's telemetry record revealed on 10/30/23 at 7:08 a.m., the telemetry flowsheet documentation showed the patient's cardiac rhythm was normal sinus (a normal heart rhythm). At 9:49 a.m., the patient was noted to be off telemetry monitoring per the Full Disclosure documentation. Further review of the telemetry record revealed Patient #6's nurse was notified that the patient's cardiac leads were off at 12:41 p.m. (two hours and 52 minutes after the patient was noted to be off of telemetry monitoring). At 12:47 p.m., two hours and 58 minutes after the patient was noted to be off continuous telemetry monitoring, the Full Disclosure documentation revealed the patient was placed back on cardiac monitoring.

v. Review of Patient #3's medical record revealed on 10/24/23 at 8:54 p.m., the patient presented to the ED with alcohol intoxication and stated he had a seizure before coming to the hospital. Further review of Patient #3's medical record revealed he was admitted to 6W on 10/25/23 at 2:59 a.m. for altered mental status and tachycardia. The medical record indicated Patient #3 was transferred to the ICU on 10/27/23 at 6:57 a.m. for alcohol withdrawal. The medical record review further revealed on 10/28/23, Provider #11 wrote that the patient should be on continuous cardiac monitoring due to hypokalemia (low potassium level in the blood).

This was in contrast with the observation conducted on 10/30/23 at 12:16 p.m., which showed Patient #3 was observed in the ICU without being on continuous cardiac monitoring.

C. Interviews

i. On 10/30/23 at 1:40 p.m., an interview was conducted with telemetry technician (Tech) #1. Tech #1 stated telemetry monitoring allowed staff to monitor a patient's cardiac rhythm and alert the nurse of any changes. Tech #1 stated she was responsible for monitoring up to 48 patients at any given time. Upon review of Patient #4, who was observed on 6W at 12:54 p.m. without telemetry monitoring, Tech #1 said she notified Patient #4's nurse that the cardiac leads were off at 10:55 a.m and 12:41 p.m. Tech #1 said that when a patient's cardiac leads were off, it was considered an urgent matter and required the telemetry technician to call the nurse immediately and if the nurse or charge nurse did not answer she would call the Rapid Response to check on the patient. Tech #1 stated that she missed that Patient #4 was off of the telemetry monitor because she was analyzing cardiac rhythms for other patients. Tech #1 stated if a patient was not on continuous cardiac monitoring, the staff could miss a cardiac event, and the patient could go into a lethal rhythm and die.

This was in contrast to the Telemetry Monitoring Alarm Notification and Escalation Process which read, in an emergent situation (e.g., pulse ox less than or equal to 80%, SPO2 probe off or not reading, lethal arrhythmias, telemetry box with a dead battery, or all of the telemetry leads off) the telemetry technician should have notified the patient's nurse or charge nurse and the nurse should have immediately put eyes on the patient while on the phone with the telemetry technician.

ii. On 10/30/23 at 12:20 p.m., an interview was conducted with RN #2. RN #2 stated when a patient was admitted to the ICU, the patient would be placed on a cardiac monitor. RN #2 stated all patients admitted to the ICU would be placed on continuous cardiac monitoring unless they had discharge orders to the general floor without telemetry orders and were waiting for a bed. RN #2 stated that if the patient was off cardiac monitoring, the nursing staff could miss a change in the patient's condition, and the patient could code.

This interview was in contrast with the observation conducted on 10/30/23 at 12:16 p.m., which showed Patient #3 was observed in the ICU without being on continuous cardiac monitoring.

iii. On 10/30/23 at 12:20 p.m., an interview was conducted with RN #4, who provided care to Patient #1. RN #4 stated Patient #1 was transferred from an outside facility's Emergency Room to 6W as a direct admit for severe alcohol withdrawal. RN #4 said an order for a telemetry monitor for continuous cardiac monitoring was placed; however, the floor lacked telemetry leads. RN #4 stated she notified the charge nurse of the lack of telemetry equipment and documented the concern in the patient's chart. RN #4 stated Patient #1 did not receive a telemetry monitor due to the lack of telemetry supplies.

RN #4 stated nursing staff would triage those who needed telemetry monitoring and write orders under a provider's name to discontinue telemetry monitoring from patients they felt were stable enough not to be monitored. RN #4 said providers were not notified of the discontinuation of telemetry orders as there was only one provider on nights, and they were busy with attending codes, rapid responses, and admitting patients.

This was in contrast to the Cardiac and Pulse Oximetry Monitoring, which read the procedure of initiation of cardiac monitoring was to ensure the availability of monitoring equipment prior to receiving the patient on the unit.

iv. On 11/08/23 at 8:01 a.m., an interview was conducted with the clinical nurse manager (Manager) #5. Manager #5 stated staff from 6W would sometimes borrow telemetry equipment from another department if needed. Manager #5 said the nurse would notify the charge nurse of the equipment shortage, and the charge nurse would then escalate the need to the house supervisor. Manager #5 stated if staff was unable to locate equipment, such as telemetry boxes, the nurse would notify the provider to triage the patients and determine which patients could be removed from continuous cardiac monitoring.

Manager #5 stated Patient #1 was a direct admit to 6W with telemetry orders; however, the patient was not placed on continuous cardiac monitoring due to lack of equipment. Manager #5 said at the time of Patient #1's admission, staff was not able to pull telemetry boxes from other floors as staff was not trained on how to assign the telemetry boxes to their floor in the computer system, and the telemetry box would not read appropriately.

v. On 11/08/23 at 1:13 p.m., an interview was conducted with Provider #6. Provider #6 stated continuous telemetry monitoring was defined as the ability of nursing staff to view and monitor a patient's heart rhythm. Provider #6 stated it was the expectation that after the provider placed the telemetry monitor order, the patient would be placed on continuous cardiac monitoring. Provider #6 stated the provider was expected to be notified of any pulse oximetry or cardiac rhythm changes. Provider #6 said that a lack of cardiac monitoring could have resulted in missing significant cardiac changes, and the patient could die.

Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.23 NURSING SERVICES was out of compliance.

A-395 - A registered nurse must supervise and evaluate the nursing care for each patient. Based on interviews and document review, the facility failed to provide nursing services in accordance with facility protocol, policy, and national guidelines. Specifically, the facility failed to ensure registered nurses (RN) assessed detox patients on Clinical Institute Withdrawal Assessment (CIWA) protocols (clinical assessment used to diagnose the severity of alcohol withdrawal) in four of eight medical records reviewed (Patients #1, #11, #13, and #15). Additionally, nursing staff failed to assess patients after the administration of as needed (PRN) medications and scheduled medications in three of eight medical records reviewed (Patient #1, #11, and #15).

Based on interviews and document review, the facility failed to provide nursing services in accordance with facility protocol, policy, and national guidelines. Specifically, the facility failed to ensure registered nurses (RNs) assessed detox patients on Clinical Institute Withdrawal Assessment (CIWA) protocols (clinical assessment used to diagnose the severity of alcohol withdrawal) in four of eight medical records reviewed (Patients #1, #11, #13, and #15). Additionally, nursing staff failed to assess patients after the administration of as needed (PRN) medications and scheduled medications in three of eight medical records reviewed (Patient #1, #11, and #15).

Findings include:

Facility order set:

The Provider Order Set: Alcohol Withdrawal CIWA Less Than 19 read, vital signs are to be completed routinely until discontinued. Vital signs should be completed at the following time period based on the patient's CIWA Score. If the CIWA is greater than 19, vital signs should be completed every 30 minutes. For CIWA between 8-19, vital signs should be completed every 2 hours times 2 then every 4 hours. Patients must be awakened for vital signs when CIWA score is 8 or above. CIWA nursing assessments should be completed as follows: For CIWA greater than 19, every 30 minutes times 2, then every 2 hours. For CIWA between 8-19, every 2 hours times 2 then every 4 hours. For CIWA less than 8, every 4 hours. Always check CIWA within 1 hour after medications. Notify the provider if CIWA does not decrease by at least 3 points after medication administration. The provider should be notified if the CIWA score is greater than 19, if there is any seizure activity, and/or if there is new onset delirium and/or hallucinations.

Reference:

The Elsevier Clinical Skills - Alcohol Withdrawal reference provided by the facility read, delirium tremens (DTs) is a potentially fatal condition occurring 24 to 72 hours after cessation or reduction of prolonged and heavy alcohol use. Reassess signs and symptoms of alcohol withdrawal symptoms (AWS) including assessing for DTs using standardized assessment tools such as CIWA. Assess the patient's response to medications and other treatments or interventions. Monitor the patient's vital signs, orientation, sleep, and emotional status, including suicidal thoughts. Monitor a patient receiving pharmacotherapy for signs of oversedation and respiratory depression. Continue to reassess the patient's condition until an assessment is no longer clinically indicated per the organization's practice regarding alcohol withdrawal.

1. The facility failed to ensure patients who were detoxing from alcohol were assessed per facility protocol, policy, and national guidelines.

A. Record Review

i. A review of Patient #1's medical record revealed on 9/27/23 at 2:17 a.m., the patient was directly admitted to 6W for alcohol withdrawal. Further review of the record revealed the provider ordered CIWA monitoring and vital sign assessments.

a. A review of Patient #1's flowsheets revealed at 3:04 a.m., Patient #1's CIWA score was 7. Patient #1's vital signs assessments revealed a blood pressure of 138/79, heart rate of 134, and respirations of 20. At 7:56 a.m., the patient's vital signs assessments revealed a blood pressure of 144/89, heart rate of 109, and respirations of 20 breaths per minute, however, there was no indication of a CIWA at this time. Patient #1's next CIWA was assessed at 9:00 a.m. at which time Patient #1's score was 9. The CIWA assessment performed at 9:00 a.m. was five hours and 56 minutes after the initial CIWA had been assessed for Patient #1.

This was in contrast to the CIWA order set which read, patients with a CIWA score of less than 8 should have been assessed every four hours.

b. The next CIWA assessment for Patient #1 was due at 11:00 a.m. according to the facility order set (protocol), however, there were no further CIWA assessments documented in the medical record. At 11:25 a.m., the CNA notified RN #12 that the patient did not look well. Provider #6's note indicated the patient was found unresponsive and without a pulse at 11:28 a.m. A code blue (a code used to indicate a patient requiring resuscitation) was called and CPR (cardiopulmonary resuscitation) was initiated. CPR was terminated at 12:10 p.m., and the patient subsequently died.

ii. A review of Patient #11's medical record revealed on 9/27/23 at 6:45 a.m. Patient #11 arrived at the emergency department (ED). According to Patient #11's medical record, Patient #11 had abdominal pain, alcohol problems, and a blood alcohol level (BAL) of 297. At 7:59 a.m., Patient #11's physician ordered CIWAs to be conducted for Patient #11.

a. A review of the CIWAs performed for Patient #11 revealed at 9:30 a.m., Patient #11's CIWA score was 8. Further record review revealed another CIWA was initiated at 12:57 p.m., however, the CIWA was not completed and as a result, the CIWA score was not calculated for Patient #11 at that time.

At 3:46 p.m., six hours and 16 minutes after Patient #11's CIWA score was 8, Patient #11 was discharged home. The facility was unable to provide evidence a second CIWA had been completed for Patient #11 prior to being discharged home.

This was in contrast to the CIWA order set which read, CIWAs should have been performed every two hours for patients whose CIWA score was between 8 and 19.

iii. A review of Patient #13's medical record revealed Patient #13 arrived at the ED on 10/28/23 at 1:15 a.m. due to a fall.

a. A review of Patient #13's orders revealed on 10/28/23 at 7:35 a.m., an order was placed for CIWAs. A review of Patient #13's medical record revealed her first CIWA was conducted at 8:22 a.m. with a score of 1. The next assessment was performed at 11:24 a.m. with a score of 0. A third assessment with a score of 1 was completed at 8:00 p.m., eight hours and 36 minutes later. The next CIWA was assessed on 10/29/23 at 11:33 a.m., Patient #13's CIWA score was 3. The next CIWA was not performed until 8:33 p.m., eight hours later.

This was in contrast to the CIWA order set which read, for a CIWA score less than 8, the patient should be assessed every four hours.

B. Interviews

i. On 11/2/23 at 2:48 p.m., an interview was conducted with the 6 West charge RN (RN) #16. RN #16 stated for a patient with CIWA orders, the assessment should have been done every four hours or more often based on the CIWA score. RN #16 stated if a CIWA patient was not assessed or treated with medication, there was a risk for the patient would have a seizure or possible death.

ii. On 11/8/23 at 1:13 p.m., an interview was conducted with Provider #6. Provider #6 stated the CIWA assessment was used to identify the severity of a patient's alcohol withdrawal symptoms. Provider #6 stated patients with CIWA scores of 8 or more were actively experiencing alcohol withdrawal. Provider #6 stated CIWA assessments were performed to prevent the patient from worsening and to decrease the body's physical reaction to alcohol withdrawal. Provider #6 stated the physical symptoms of alcohol withdrawal were vomiting and aspirating, life-threatening seizures, and even death of the patient.

2. The facility failed to ensure patients were assessed after medication was administered.

A. Medical Record Reviews

i. A review of Patient #1's record revealed Librium (a medication used to treat alcohol withdrawal symptoms) was ordered to be administered four times a day.

Review of Patient #1's Medication Administration Record (MAR) revealed Librium was administered to the patient on 9/27/23 at 4:08 a.m. There was no indication the patient was reassessed after medication administration to ensure efficacy. Librium was administered again at 9:06 a.m., however, there was no evidence the patient was reassessed after medication administration.

This was in contrast to the CIWA order set which read, always check CIWA within one hour after medication administration. Notify the provider if the CIWA score does not decrease by three points.

ii. A review of Patient #11's medical record revealed Phenobarbital (a medication used to prevent seizures and for alcohol withdrawal treatment) was ordered at 1:40 p.m. on 9/27/23.

Review of Patient #11's MAR revealed Phenobarbital was administered at 2:52 p.m. There was no evidence the patient was reassessed after medication administration to ensure effectiveness.

iii. A review of Patient #15's medical record revealed the patient arrived at the facility on 10/28/23 at 3:56 p.m. for alcohol problems and suicidal ideation (SI). At 4:06 p.m., an order was placed for CIWA assessments.

At 9:58 p.m., an order was placed for Patient #15 to be administered 2 milligrams (mg) of Lorazepam (a medication often used to treat alcohol withdrawal) for CIWA scores between 8 and 14.

According to the MAR for Patient #15, at 10:48 p.m. Patient #15 was administered 2 mg of Lorazepam. The patient's next CIWA assessment was conducted at 12:56 a.m. on 10/29/23. This was over two hours after the medication was administered.

B. Interviews

i. On 11/7/23 at 2:25 p.m., an interview was conducted with RN #13. RN #13 stated it was important to follow CIWA protocol to prevent seizures and possible death. RN #13 stated it was important to reassess patients after medication administration to ensure the medication was working to treat the patient's symptoms. She further stated if the medication was not effective, she would notify the provider.

ii. On 11/2/23 at 2:48 p.m., an interview was conducted with the 6 West charge RN (RN) #16. RN #16 stated Lorazepam was often used to treat withdrawal symptoms. She further stated the patient needed to be assessed one hour after medication administration. RN #16 stated if a CIWA patient was not assessed or treated with medication, there was a risk that the patient would have a seizure or possible death.

iii. On 11/8/23 at 1:13 p.m., an interview was conducted with Provider #6. Provider #6 stated it was important to reassess a patient after medication administration to ensure the medication was working and to ensure the patient was not going through withdrawal. Provider #6 stated he would expect to be notified if a patient's CIWA score increased despite medication being administered.

Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation: §485.640 Infection Prevention and Control and Antibiotic Stewardship Programs, was out of compliance.

A-0750- The infection prevention and control program includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and addresses any infection control issues identified by public health authorities. Based on document reviews and interviews, the facility failed to ensure the infection prevention and control program investigated and implemented preventative measures to avoid sources and transmission of surgical site infections (SSI).

Based on document reviews and interviews, the facility failed to ensure the infection prevention and control program investigated and implemented preventative measures to avoid sources and transmission of surgical site infections (SSI).

Findings include:

Facility policies:

The Infection Prevention and Control Plan policy read, the Infection Prevention and Control program and its surveillance activities are part of a plan of action designed to reduce the risk of acquisition and transmission of infections among patients. The goals and objectives for the Infection Prevention and Control (IPCC) program is to identify and minimize or eliminate the risk of acquiring or transmitting infections that pose the most threat to any person within our facilities. The surveillance data will be collected, reviewed and analyzed to: Improve outcomes, obtain "baseline" data, identify problems/trends, investigate perceived problems, evaluate control interventions, and monitor quality of care (current practices). The infection prevention program manager oversees and investigates outbreaks, unusual clusters of infections, risk management issues or patient safety concerns, and institutes appropriate corrective actions.

The Adverse Clinical Event Reporting, Analysis, Disclosure, and Non-Payment policy read, the facility Patient Safety and Quality Department will assemble an internal multidisciplinary team with representatives from Quality, Patient Safety, Administration, and the department involved in the incident as soon as possible to stabilize the situation, determine next steps including the need for a Root Cause Analysis (RCA) or Critical Event Analysis (CEA), and assign an executive sponsor and team leader. Events requiring a RCA or CEA will utilize a standardized event analysis process. The cause analysis process should begin within 72 hours of awareness of the event and be completed no later than 45 days post-event, dependent on event severity and outcome.

Reference:

The How SSIs Are Identified document read, when a SSI is identified, infection prevention will enter it into Midas (safety event system) and identify any potential deviation in care. If unable to identify an obvious deviation, infection prevention will ask the operating room (OR) director to investigate the case for any potential deviation in care. If no deviation in care is identified, infection prevention will enter results into Midas for Patient Safety to score as appropriate for a SSE (Serious Safety Event). If an obvious deviation in care is identified, infection prevention will set up a CEA with the OR Director and send to Patient Safety to Score as an SSE as appropriate.

1. The facility failed to ensure the infection prevention and control program investigated and implemented preventative measures to avoid sources and transmission of surgical site infections related to cesarean sections (surgery to deliver a baby through a cut in the mother's abdomen).

A. Document Review

i. Review of the SSI log revealed Patient A had a cesarean section on 6/12/23. Patient A's SSI was identified on 6/23/23. A CEA for Patient A was completed on 7/27/23. Upon request, the facility was unable to provide evidence of any preventative measures implemented to prevent the recurrence of SSIs related to cesarean sections.

ii. Review of the SSI log revealed Patient B had a cesarean section on 6/30/23. Patient B's SSI was identified on 7/28/23. Review of safety event documentation provided by the facility revealed on 8/8/23, a CEA was to be scheduled within two weeks (8/22/23). A CEA for Patient B was completed on 10/6/23, 70 days after the SSI was identified. Upon request, the facility was unable to provide evidence of any preventative measures implemented to prevent the recurrence of SSIs related to cesarean sections.

iii. Review of the SSI log revealed Patient C had a cesarean section on 8/8/23. Patient C's SSI was identified on 8/17/23. Review of safety event documentation provided by the facility revealed on 9/1/23, a CEA was to be scheduled within 2 weeks (9/15/23). The CEA for Patient C had not been completed prior to the start of the survey on 10/30/23, 74 days after the SSI was identified. Upon request, the facility was unable to provide evidence of any preventative measures implemented to prevent the recurrence of SSIs related to cesarean sections.

iv. Review of the SSI log revealed Patient D had a cesarean section on 8/13/23. Patient D's SSI was identified on 8/24/23. Safety event documentation in Midas (the facility's safety event documentation system) and a CEA had not been completed for Patient D prior to the start of the survey on 10/30/23, 67 days after the SSI was identified. Upon request, the facility was unable to provide evidence of any preventative measures implemented to prevent the recurrence of SSI related to cesarean sections.

This was in contrast to the How SSI Are Identified documentation provided by the facility which read, when a SSI was identified, infection prevention would enter it into Midas and identify any potential deviation in care.

v. Review of the SSI log revealed Patient E had a cesarean section on 8/15/23. Patient E's SSI was identified on 8/30/23. Review of safety event documentation provided by the facility revealed a CEA was to be scheduled with infection prevention by 9/14/23. A CEA for Patient E was completed on 10/6/23. Upon request, the facility was unable to provide evidence of any preventative measures implemented to prevent the recurrence of SSIs related to cesarean sections.

vi. Review of the SSI log revealed Patient F had a cesarean section on 8/29/23. Patient F's SSI was identified on 9/12/23. Review of safety event documentation provided by the facility revealed a CEA was scheduled for 10/27/23 with infection prevention. A CEA for Patient F had not been completed prior to the start of the survey on 10/30/23, 48 days after the SSI was identified. Upon request, the facility was unable to provide evidence of any preventative measures implemented to prevent the recurrence of SSI related to cesarean sections.

Patients B-D & F were in contrast to the Adverse Clinical Event Reporting, Analysis, Disclosure, and Non-Payment policy which read, the cause analysis process should have begun within 72 hours of awareness of the event and be completed no later than 45 days post-event, dependent on event severity and outcome.

Patients A-F were also in contrast to the Infection Prevention and Control Plan policy which read, the surveillance data would be collected, reviewed and analyzed to: Improve outcomes, obtain "baseline" data, identify problems/trends, investigate perceived problems, evaluate control interventions, and monitor quality of care (current practices). The infection prevention program manager oversaw and investigated outbreaks, unusual clusters of infections, risk management issues or patient safety concerns, and instituted appropriate corrective actions.

B. Interviews

i. On 11/7/23 at 11:19 a.m., an interview was conducted with the operating room director (Director) #14. Director #14 stated she investigated SSIs. Director #14 stated she spoke with staff who were involved in patients' surgical procedures, performed medical record reviews, filled out gap analysis templates (used to identify gaps in infection prevention), and reviewed safety events to determine if issues were identified with contaminated surgical instruments when she conducted SSI investigations. Director #14 also stated SSIs were investigated to determine if any deviations or gaps were identified to see how the facility could improve.

Director #14 stated in June and August, there were SSIs with cesarean sections and the action plan identified for improvement was to have patients complete nose-to-toes disinfection (used to reduce bacteria on the skin before surgery). Director #14 stated she was unable to speak with the obstetrics and gynecology department providers about the proposed process change because she had missed the last two month's meetings. Additionally, Director #14 stated no one had gone to the labor and delivery department to observe cesarean sections and there had been no further discussions related to process changes. Furthermore, Director #14 stated SSIs could ruin patients' lives and cause the need for additional procedures.

ii. On 11/7/23 at 3:23 p.m. and 11/8/23 at 9:48 a.m., interviews were conducted with infection preventionist (IP) #15. IP #15 stated her role as IP was to facilitate and oversee the investigation of SSIs. IP #15 stated the managers and directors were the experts in their field and she relied on the experts to recognize gaps in care. IP #15 stated IPs needed to be able to observe the units to determine if there were deviations in care. IP #15 also stated observations had not been conducted in labor and delivery in response to the cesarean section SSIs.

Additionally, IP #15 stated the root cause of the cesarean section SSIs had not been identified. IP #15 stated she was concerned due to a recognized trend of three cesarean section SSIs with the same provider who performed patients' surgical skin preps (cleaning and disinfecting the skin). Additionally, IP #15 stated Director #14 had not yet talked with the provider or observed his prepping technique.