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Based on observation, interview and record review the hospital's governing body failed to assume full responsibility for determining, implementing, and monitoring policies governing the facility's total operation when:

1. For Patient 1, the facility failed to ensure a comprehensive operative report was completed immediately after a surgery in accordance with the facility's policy and procedure (P&P) (Refer to A0047).

2. For Patients 4 and 7, the facility staff failed to ensure interventions were implemented timely when the patients experienced multiple episodes of low heart rate (Refer to A0083).

The cumulative effect of these systemic problems resulted in the facility failure to ensure the governing body was effective in carrying out its responsibilities for the conduct of the facility which resulted in substandard care and death.

Based on interview and record review the facility failed to ensure a comprehensive operative report was completed immediately after a surgery, in accordance with the facility's policy and procedure (P&P), for one of 30 sampled patients, Patient (1).

This failure had the potential to cause a delay of treatment for patients.

Findings:

On May 8, 2024, at 12:30 p.m., an interview and concurrent record review were conducted with the Cardiac Manager (CM).

The facility document titled, "History and Physical (H&P)," indicated Patient 1 was admitted to the facility on April 28, 2024, for shortness of breath and STEMI (a heart attack).

Review of a facility document titled, "AUTHORIZATION FOR AND CONSENT TO SURGERY OR SPECIAL DIAGNOSTIC OR THERAPEUTIC PROCEDURES," dated April 29, 2024, at 7:15 a.m., indicated, "...Coronary Artery Bypass Grafting...Endoscopic vein harvest..."

Further review of Patient 1's record indicated there was no documented evidence an Operative Report was completed for Patient 1, this report was not in the Electronic Medical Record (EMR).

An interview was conducted on May 08, 2024, at 12:49 p.m., with the CM. The CM stated there is no Post Operative Report in the chart, the surgery was performed on April 29, 2024, there should have been an Operative Report per hospital policy.

An interview and concurrent record review were conducted on May 08, 2024, at 2:40 p.m., with the Director of Health Information Manager (DHIM). The DHIM stated she does not see a Post Operative Report in the chart. The DHIM further stated the expectation would be for the surgeon to have completed the report within 24 hours, or before the patient goes to the next level of care, when the provider is no longer with the patient.

An interview and concurrent record review were conducted on May 08, 2024, at 2:51 p.m., with the Director of Medical Staff (DMS). The DMS stated the expectation would be for the surgeon to complete the Operative Report within 24 hours, this chart did not have it. The DMS further stated the Rules and Regulations for documentation post-surgery were not followed in this specific case.

A review of facility document titled, "[Name of the facility] Medical Staff General Rules & [and] Regulations," dated June 10, 2019, was conducted. The document indicated, "...Operative and invasive procedure reports shall be written or dictated within twenty-four (24) hours following the procedure for outpatients as well as inpatients. The report is promptly authenticated by the practitioner and made a part of the patient's current medical record. An operative/invasive procedure progress note is required to be entered in the medical record immediately after the procedure to provide pertinent information for any individual required to attend the patient..."

Based on observation, interview and record review, the facility failed to ensure the facility followed their policy and procedures, for two of 30 sampled patients (Patient 4, and 7) when the facility staff failed to ensure interventions were implemented timely when Patients 4 and 7 experienced multiple episodes of low heart rate.

These failures had the potential to delay patient care, and cause harm or death to the patients.

a. A review of Patient 4's record was conducted with the Senior Clinical Effectiveness Coordinator (SCEC) on May 10, 2024, at 12:40 p.m. The History and Physical (H&P), dated April 7, 2024, indicated Patient 4 was admitted to the facility on April 7, 2024, for anemia (low red blood cell count) and gastrointestinal bleed (bleeding that occurs in the large intestines).

The facility document titled, "Progress Note-Physician," dated April 7, 2024, indicated, "...Discussed in detail with the patient in case of emergency in which his heart stops or he is unable to breath the methods of which he would take in order to preserve life...The patient is in full understanding of the risk of benefits of life saving/heroic measures and would like to have DNR/DNI [Do Not Resuscitate] in the event of incapacitation for any reason while in the hospital..."

The facility document titled, "Progress Note-Physician," dated April 8, 2024, at 1741 (5:41 p.m.), authored by Resident (R 1) indicated, "...CODE BLUE was activated on 04/08/2024 [April 8, 2024] at 1521 [3:21 p.m.]. Upon arrival, patient was found laying on the floor of his room with noticeable urinary incontinence and stool. Nursing staff advised that the patient was pulseless and unresponsive and CPR [life saving procedure performed when the heart stops] was in progress at the time of arrival. Had reviewed patient's CODE STATUS prior to arrival and called off all heroic measures as patient was DNI/DNR. Patient was pronounced at 1522 [3:22 p.m.]. Non responsive to painful stimulus, no initiation of breaths, absent pulse, asystole on monitor, absent heart & breath sounds on auscultation, no pupillary reflex. Updated the wife and daughter at bedside..."

The facility document titled, "Progress Note-Physician," dated April 9, 2024, at 12:24 p.m., authored by, Physician (P 1) indicated, "...Spoke with wife...over the phone today giving our condolences to her and her family and also reached out to see if there is anything that we can do to help. In addition I also disclosed to [name of wife] that there was a period of approximately 25 minutes where her husband's heart rate gradually declined and stated that in these types of circumstances typically the physician would have been notified but due to unforeseen reasons we were not..."

The facility document titled, "Progress Note-Nurse," dated April 8, 2024, at 1932 (7:32 p.m.), authored by Registered Nurse (RN 1) indicated, "...At approx [approximately] 1520 [3:20 p.m.] tele monitor alerted asystole. Went to check on pt [patient] who was found on the floor unresponsive...Checked for pt pulse not (sic) was found initiated code blue and began chest compression..."

The facility document titled, "Telemetry Specific Details," dated April 8, 2024, at 1517 (3:17 p.m.) indicated, "...at 1517 [3:17 p.m.]...Tele Alert Notification Reason...Bradycardia [slow heart beat], other informational didn't alarm...at 1521 [3:21 p.m.]...Asystole [hearts electrical system fails and causes heart to stop beating]...Flag Comments by [name of telemetry monitor tech (MT 1)], on April 8, 2024, 1539 [3:39 p.m.] attempted to contact RN, CODE blue called after..."

A review of the facility's EKG (electrocardiogram, test for heart rate and rhythm) strips, dated April 8, 2024, indicated the following:

- At 14:59:12 (2:59 and 12 seconds p.m.), Patient 4's heart rate was 50 beats per minute;

- At 14:59:20 (2:59 and 20 seconds p.m.), Patient 4's heart rate was 41 beats per minute;

- At 14:59:29 (2:59 and 29 seconds p.m.), Patient 4's heart rate was 37 beats per minute;

- At 14:59:38 (2:59 and 38 seconds p.m.), Patient 4's heart rate was 43 beats per minute;

- At 15:09:49 (3:09 and 49 seconds p.m.), Patient 4's heart rate was 46 beats per minute;

- At 15:09:58 (3:09 and 58 seconds p.m.), Patient 4's heart rate was 48 beats per minute;

- At 15:14:32 (3:14 and 32 seconds p.m.), Patient 4's heart rate was 44 beats per minute;

- At 15:14:40 (3:14 and 40 seconds p.m.), Patient 4's heart rate was 50 beats per minute;

- At 15:19:38 (3:19 and 38 seconds p.m.), Patient 4's heart rate was 30 beats per minute;

- At 15:19:46 (3:19 and 46 seconds p.m.), Patient 4's heart rate was 29 beats per minute;

- At 15:21:26 (3:21 and 26 seconds p.m.), Patient 4's heart rate was 20 beats per minute;

- At 15:21:28 (3:21 and 28 seconds p.m.), Patient 4's heart rate was 20 beats per minute;

- At 15:21:34 (3:21 and 34 seconds p.m.), Patient 4's heart rate was 0 beats per minute; and

- At 15:21:36 (3:21 and 36 seconds p.m.), Patient 4's heart rate was 0 beats per minute.

An interview and concurrent record review were conducted with the Director of Medsurg/Tele PCU (progressive care unit) (DMTPCU) on May 10, 2024, at 12:55 p.m. The DMTPCU stated there were three level alarms for heart rate parameters and defaulted at heart rate of 50 bpm. The DMTPCU stated alarms gets louder and louder based on the level. The DMTPCU stated the tele machine at 2:59:20 (2:59 and 20 seconds p.m.) started to alarm and the patient was at 41 beats per minute and there was no evidence MT 1 (Monitor-Tech, staff responsible to observe and interpret heart rate and rhythm from the remote monitor) notified RN 1. The DMTPCU stated MT 1 was busy interpreting a tele strip for a newly admitted patient. The DMTPCU stated MT 1 was monitoring 48 patients and at this time there were multiple alarms going off. The DMTPCU stated the alarm was set at 10%, which is deemed low for the day shift due to ambient noise. The DMTPCU stated MT 1 stated Patient 4's decline in heart rate was an oversight as he did not hear the alarm.

There was no documented evidence MT 1 notified RN 1of Patient 4's low heart rate on April 8, 2024, from 2:59 and 12 seconds p.m., to 3:21 and 36 seconds p.m., (22 minutes and 44 seconds).

There was no documented evidence Patient 4 was assessed for physical symptoms related to severe changes in heart rate and rhythm on April 8, 2024, from 2:59 and 12 seconds p.m. to 3:21 and 36 seconds p.m., (22 minutes and 44 seconds), when the patient's heart rate was low.

b. On May 8, 2024, at 1 p.m., an interview and concurrent record review was conducted with the Stroke Program Manager (SPM).

A review of Patient 7's record was conducted. The H&P dated May 2, 2024, indicated Patient 7 was admitted to the facility for dizziness, double vision, and UTI (urinary tract infection).

The facility document titled, "Cardiac Rhythm," dated May 1, 2024, through May 7, 2024, indicated, "...Sinus Bradycardia...05/02/2024 [May 2, 2024]...07:54:00 [7:54 a.m.]..." There was no documented evidence the Monitor Tech [MT 2] notified the RN.

The facility document titled, "Communication Log," dated May 1, 2024, through May 8, 2024, was reviewed. There was no documented evidence a notification was made to the RN on May 2, 2024, for the bradycardic episode of Patient 7.

An interview was conducted on May 8, 2024, at 1:25 p.m., with the Director of Medsurg/Tele/PCU (DMTPCU). The DMTPCU stated he was not able to find any communication from MT 2 to the RN for the bradycardia on May 2, 2024. He stated the MT 2 should have called the RN when the heart rate fell below the parameters. The DMTPCU further stated MT 2 should have documented the notification in the EMR. The DMTPCU stated the bradycardia telemetry strip was not in the EMR and it should have been printed and placed in the patient chart.

A review of the facility's policy and procedure (P&P) titled, "Cardiac/Telemetry Monitoring in the Telemetry Units," dated May 9, 2022, was conducted. The P&P indicated, "...To provide skilled cardiac monitoring to patients who require continuous telemetry...An evaluation of the patient will occur by the RN...with any changes in rhythm, heart rate, or conduction. The physician will be notified as appropriate...All life-threatening rhythms require physician notification...The Telemetry Monitor Technician will notify the RN...any time there is a change in rhythm or concern about the patient. The Telemetry Monitor Technician will also document these changes in the EMR (electronic medical record)...The Telemetry Monitor Technician will log the call to the RN...in the EMR...The Telemetry Monitor Technician will maintain a report on all telemetry monitored patients...Heart rate alarms and the arrhythmia analysis function must be turned ON at all times..."

Based on interview and record review, the facility failed to ensure patients or their representative, were informed in advance of their rights to appeal discharge, for three of 30 sampled patients (Patient 2, 9, and 18).

These failures had the potential to result in the patient not being informed of their rights to appeal discharge.

Findings:

1. On May 9, 2024, at 10:29 a.m., a concurrent interview and record review were conducted with the Cardiac Manager (CM).

A review of Patient 2's record was conducted. The "History and Physical (H&P)," dated May 3, 2024, at 7:27 p.m., indicated, Patient 2 was admitted to the facility for a NSTEMI (heart attack).

The facility document titled, "Discharge Request," dated May 8, 2024, at 9:22 a.m., indicated Patient was discharged on May 8, 2024.

There was no documented evidence that an Important Message from Medicare (IMM) was given and signed by Patient 2, 48 hours prior to discharge.

An interview was conducted with the CM on May 9, 2024, at 10:48 a.m. The CM stated "I can not find an Important Message from Medicare in (computer program name) or the physical chart." The CM further stated the patient should have been given the IMM 48 hours before discharge.

2. On May 9, 2024, at 9:30 a.m., a concurrent interview and record review with Clinical Supervisor (CS) was conducted.

A review of Patient 9's record was conducted. The "H&P," dated April 19, 2024, indicated, Patient 9 was admitted to the facility on April 19, 2024, for weakness and UTI (urinary tract infection).

The facility document titled, "Discharge Summary," dated May 7, 2024, at 12:38 p.m., was reviewed. The document indicated Patient 9 was discharged home on May 7, 2024.

The facility document titled, "IMM," dated April 23, 2024, was reviewed. The document indicated, "PT [patient] medically unable to sign 04/23/24 [April 23, 2024] 2:06 p.m." There was no documented evidence the IMM was provided to Patient 9 or Patient 9's representative prior to discharge.

An interview with the CS was conducted on May 9, 2024, at 10:15 a.m. The CS stated the IMM was only presented to Patient 9 on April 23, 2024. The CS stated the IMM should have been presented to the patient or the patient's family 48 hours prior to the discharge date of May 7, 2024.

3. A review of Patient 18's chart was conducted on May 9, 2024, at 9:37 a.m., with the Wound Care Program Manager (WCPM).

A review of the facility's document titled, "H&P," dated, May 4, 2024, indicated, Patient 18 was admitted on May 4, 2024, with a diagnosis of respiratory failure and Renal failure (Acute Kidney Injury).

There was no documented evidence that an IMM was given and signed by Patient 18 on admission.

A review of the facility's policy and procedure (P&P) titled, "Important Message from Medicare," dated February 13, 2023, was conducted. The P&P indicated, "...In the event the patient or the patient [sic] representative did not sign the IMM, it becomes the responsibility of the PAS (Patient Access Staff) Department to attempt to obtain a signature prior to discharge...Attempts will be made daily until a signature has been obtained...Completing the IMM...Upon admission to an impatient status...If not delivered on inpatient admission, must be delivered within 2 calendar days of admission...PAS staff must explain the form and ensure that the beneficiary or responsible party comprehends...The form must be signed and dated by beneficiary or responsible party...Care Coordination staff or their designee must deliver a follow-up copy of the Important Message (IMM) as far in advance as possible before discharge, but no more than 2 calendar days before the day of discharge..."

Based on observation, interview and record review, the facility failed to ensure the facility followed their policy and procedures, for 15 of 30 sampled patients (Patient 1, 4, 5, 7, 8, 9, 10, 11, 12, 18, 24, 27, 28, 29, and 30) when:

1. For Patient 9, 10, 29, and 30 the facility failed to ensure pain was reassessed after medication administration (refer to A398).

2. For Patient 1, 24, and 27 patients did not receive an initial assessment and reassessment by a case manager and social services during hospitalization (refer to A398).

3. For Patient 4, 12 and 30 critical lab values were not reported in a timely manner (refer to A398).

4. For Patients 8, 11, 27, 28, 29, and 30 the facility did not review, sign, date, time and/or place the telemetry strips in the patient's physical chart (refer to A398).

5. For Patient 5 the facility did not complete a wound consult per physician's order (refer to A398).

6. For Patient 4 and 7 the facility staff failed to ensure interventions were implemented timely when Patient 4 and 7 had multiple episodes of low heart rate which were not addressed timely (refer to A398).

7. An intravenous contrast was inappropriately stored in the Radiology Department (refer to A398).

8. Two bottles of anesthetics were inappropriately stored in the Minor Procedure Room (refer to A398).

9. For Patient 18, a procedural time out was not performed before an arterial line (a thin, flexible tube that is placed into an artery) placement (refer to A398).

10. For patient 24, 27, 28, and 29 the facility failed to ensure an individualized plan of care was completed (refer to A396).

11. The facility failed to ensure a Registered Nurse (RN) completed yearly required competencies (refer to A397).

The cumulative effect of these systemic failures resulted in the patients to not be provided safe and quality care to meet the patient needs and had the potential to delay provision of care and treatment.

Based on interview and record review, the facility failed to ensure an individualized plan of care were completed, for four of 30 sampled patients (Patient 24, 27, 28, and 29).

This failures had the potential to delay patient care, patient services, and cause patient harm.

Findings:

a. A concurrent interview and record review were conducted with the Clinical Effective Coordinator (CEC) on May 8, 2024, at 3:20 p.m.

A review of Patient 24's record was conducted. The facility document titled, "History and Physical (H&P)," indicated, Patient 24 was admitted to the facility on May 8, 2024, for right hip pain and a right total hip replacement.

During an interview with the CEC on May 8, 2024, at 3:20 p.m., the CEC stated she was unable to find a patient specific care plans for risk for infection and skin integrity relating to the post-surgical patient that were developed and implemented for the patient in the EMR (electronic medical record). She stated the patient should have had an individualized care plan started with in 24 hours of admission.

b. A concurrent interview and record review were conducted with the CEC on May 9, 2024, at 1:06 p.m.

A review of Patient 27's record was conducted. The facility document titled, "H&P," indicated, Patient 27 was admitted to the facility on May 5, 2024, for worsening chest pain, NSTEMI (non ST elevated myocardial infarction) heart attack.

A review of the facility document titled, "Document In Plan," dated May 9, 2024, indicated there was no evidence of a care plan for pain documented in the Patient 27's electronic medical record (EMR).

An interview was conducted with the CEC on May 9, 2024, at 1:47 p.m. The CEC stated there was no documented individualized care plans for pain in the Patient 27's EMR. She stated Patient 27 should have had a care plan for pain.

c. A concurrent interview and record review were conducted with the CEC on May 9, 2024, at 2:09 p.m.

A review of Patient 28's record was conducted. The facility document titled, "H&P," indicated, Patient 28 was admitted to the facility on May 5, 2024, for blood in stools.

A review of the facility document titled, "Document In Plan," dated May 9, 2024, indicated there was no evidence an individualized care plan was developed or implemented in Patient 28's EMR.

An interview was conducted with the CEC on May 9, 2024, at 2:24 p.m. The CEC stated there was no individualized care plans in Patient 28's EMR. She stated Patient 28 should have had a care plan developed and implemented.

An interview was conducted with the Emergency Room Manager (ERM) on May 9, 2024, at 2:28 p.m. The ERM stated Patient 28 should have had care plans implemented. The ERM stated the "Quality Team" helps review the care plans, helps make sure the care plans are completed, and assists to complete the care plans when needed.

d. A concurrent interview and record review were conducted with the CEC on May 10, 2024, at 9:50 a.m.

A review of Patient 29's record was conducted. The facility document titled, "H&P," indicated, Patient 29 was admitted to the facility on May 3, 2024, for cough, generalized weakness, and urinary tract (bladder) infection.

A review of the facility document titled, "Document In Plan," dated May 9, 2024, indicated, Patient 29's care plans were not reviewed each shift after implementation. The individualized care plans were missing risk for urinary tract infection, and sepsis.

An interview was conducted with the CEC on May 10, 2024, at 10:12 a.m. The CEC stated there was no individualized care plan for sepsis and urinary tract infection. The CEC stated it would be expected for the patient to have had an individualized care plan for sepsis and urinary tract infection. She stated based on her understanding of the policy, nurses should address the patient's care plan every shift per policy.

A review of the facility's Policy and Procedure (P&P) titled, "Assessment-Reassessment of the Patient," dated November 28, 2021, was conducted. The document indicated, "...The Registered Nurse will develop an Individualized Plan of Care this will be implemented and documented with target dates on all inpatients...Within 24 hours of admission...Each shift by addressing goals..."

Based on interview and record review the facility failed to ensure a Registered Nurse (RN) completed yearly required competencies.

This failure had the potential to cause harm to patients by an unqualified RN providing the care and treatment.

Findings:

A review of the facility document titled, "Student Assignment Completion Report," was conducted. The document indicated, "...DELINQUENT...Cardiac Rhythms and Dysrhythmias...12/31/2023 [December 31, 2023]...PAST DUE...Cardiac Rhythms and Dysrhythmias...4/30/2024 [April 30, 2024]..."

A review of the facility document titled, "ANNUAL PERFORMANCE EVALUATION - STAFF," dated 2024, was conducted. The document indicated, "...Able to interpret cardiac arrhythmia's, intervene as appropriate and alert physician of any significant changes..."

An interview and record review were conducted with the Director of Medical /Surgical /Telemetry and Infection Preventionist (DMST&IP) on May 10, 2024, at 9:30 a.m. The DMST&IP stated Registered Nurse (RN 1) did not complete her competencies per requirements.

An interview and record review were conducted with the Chief Nursing Officer (CNO) on May 10, 2024, at 9:49 a.m. The CNO stated the nurse did not complete her required competencies and she was not disciplined per facility policy.

A review of the facility Policy and Procedure (P&P), titled, "Competency Assessment," dated February 12, 2024, was conducted. The document indicated, "...Competency assessment occurs upon hire during the orientation period, on an ongoing basis, and at a minimum, annually..."

A review of the facility P&P titled, "Performance Evaluation," dated February 12, 2024, was conducted. The document indicated, "...Employees are required to complete each of the following items during the year as scheduled; however, no later than May 31st...Annual Self-Paced Orientation/Post Tests (LMS assignments)...The annual evaluation is not finalized until each of the following requirements have been completed...Annual Self-Paced Orientation / Post Test LMS Transcript..."

A review of the P&P titled, "Corrective Action Process," dated February 13, 2024, was conducted. The document indicated, "...Corrective action may be initiated for many reasons, including, but not limited to, violations of [Name of the Facility] work rules or policies, poor job performance, attendance, unauthorized disclosure of patient and/or employee health information, etc. The severity of the action generally depends on the nature of the offence and the employee's work record. Corrective action may range from a preventative counseling session to immediate employment termination. The usual process for the corrective action process is...Preventive Counseling...Written Warning...Final Written Warning...Employment Termination...The counseling process should be timely and follow the incident requiring the corrective action as closely as possible..."

Based on observation, interview and record review, the facility failed to ensure the facility followed their policy and procedures (P&P), for 15 of 30 sampled patients (Patient 1, 4, 5, 7, 8, 9, 10, 11, 12, 18, 24, 27, 28, 29, and 30) when:

1. For Patient 9, 10, 29, and 30 the facility failed to ensure pain was reassessed after medication administration.

2. For Patient 1, 24, and 27, patients did not receive an initial assessment and reassessment by a case manager and social services during hospitalization.

3. For Patient 4, 12 and 30, critical lab values were not reported in a timely manner.

4. For Patient 8, 11, 22, 27, 28, 29, and 30, the facility did not review, sign, date, time and/or place the telemetry strips in the patients physical chart.

5. For Patient 5, the facility did not complete a wound consult per physician's order.

6. For Patient 4 and 7, the facility staff failed to ensure interventions were implemented timely when Patients 4 and 7 experienced multiple episodes of low heart rate.

7. An intravenous contrast was inappropriately stored in the Radiology Department.

8. Two bottles of anesthetics were inappropriately stored in the Minor Procedure Room.

9. For Patient 18, a procedural time out was not performed before an arterial line (a thin, flexible tube that is placed into an artery) placement.

These failures had the potential to delay patient care, cause harm, medical errors such as wrong-site or wrong-procedure, or death to the patients.

Findings:

1a. On May 9, 2024, at 9:30 a.m., a concurrent interview and record review with the Clinical Supervisor (CS) were conducted.

A review of Patient 9's record was conducted. The "History and Physical (H&P)," dated April 19, 2024, indicated Patient 9 was admitted to the facility on April 19, 2024, for weakness and UTI (urinary tract infection).

Review of an untitled document, dated April 26, 2024, at 0:40 (12:40 a.m.), indicated, "...hydrocodone-acetaminophen [Norco 5 mg, unit of measurement]-325 mg oral tablet...Frequency...q4h [every four hours]...PRN [as needed]...Pain 4-6 [Moderate]..."

The facility document titled, "Medications," indicated Patient 9 was administered Norco on the following dates:

-May 2, 2024, at 11:30 a.m.;
-May 4, 2024, at 6:38 a.m.; and
-May 4, 2024, at 11:44 a.m.

There was no documented evidence Patient 9's pain was reassessed after the pain medication Norco was administered on the above dates.

1b. On May 9, 2024, at 11 a.m., a concurrent interview and record review with the Clinical Supervisor (CS) were conducted.

A review of Patient 10's record was conducted. The "H&P," dated May 5, 2024, indicated Patient 10 was admitted to the facility on May 6, 2024, for chest discomfort, bilateral shoulder pain, numbness to left hand, dizziness, and weakness.

Review of an untitled document, dated May 5, 2024, at 4:18 a.m., indicated, "...oxyCODONE...10 mg...Frequency...q6H [every six hours]...PRN [as needed]..."

The facility document titled, "Medications," indicated Patient 10 was administered OxyCODONE on May 5, 2024, at 22:59 (10:59 p.m.). There was no documented evidence Patient 10's pain was reassessed after the pain medication oxyCODONE was administered.

An interview with the CS was conducted on May 9, 2024, at 11:10 a.m. The CS stated there was no documented evidence Patients 9 and 10's pain was reassessed after pain medication was given on the above dates and times. The CS further stated the registered nurse (RN) should have reassessed Patients 9 and 10's pain one hour after the medication was given. The CS stated the RN should have documented the patient's pain in the EMR (Electronic Medical Record) to ensure the pain medication was effective.

1c. On May 10, 2024, at 10:40 a.m., a concurrent interview and record review with Clinical Effective Coordinator (CEC) were conducted.

A review of Patient 29's record was conducted. The facility document titled "H&P," indicated Patient 29 was admitted to the facility on May 3, 2024, for cough, generalized weakness, and urinary tract (bladder) infection.

The facility document titled, "Patient Flow Sheet ," indicated Patient 29's pain was assessed on the following dates:

-May 5, 2024, at 2016 (8:16 p.m.) numeric scale 6/10.
-May 6, 2024, at 5:28 p.m., numeric scale 4/10 (pain screening tool using 0-10);

Review of an untitled document, dated May 4, 2024, at 1:04 p.m., indicated, "...acetaminophen [Tylenol] 650 mg oral tablet...Frequency...q6h...PRN...Fever/Pain 1-3 (Mild)..."

The facility document titled, "Medications," indicated Patient 29 was administered Acetaminophen on the following dates:

-May 4, 2024, at 0117 (1:17 a.m.);
-May 5, 2024, at 2017 (8:17 p.m.);
-May 5, 2024, at 0529 (5:29 a.m.); and
-May 6, 2024, at 1550 (3:50 p.m.).

There was no documented evidence Patient 29's pain was reassessed after the pain medication Tylenol was administered.

An interview was conducted with the CEC on May 10, 2024, at 9:50 a.m. The CEC stated there was no documentation the nurse notified the physician about the pain being greater than 3. The nurse gave the Acetaminophen for pain greater than 1-3/10. The CEC stated the nurse did not follow the physician's orders. The CEC stated the nurse should have requested medication for the pain and the assessed level. She further stated there was no documentation that the pain was reassessed.

1d. On May 9, 2024, at 10:40 a.m., a concurrent interview and record review with Clinical Effective Coordinator (CEC) were conducted.

A review of Patient 30's record was conducted. The facility document titled "H&P," indicated Patient 30 was admitted on May 5, 2024, for seizure like activity, confusion, and fell out of the bed.

The facility document titled, "Patient Flow Sheet," indicated Patient 30's pain was assessed on the following dates:

-February 5, 2024, at 0730 (7:30 a.m.), FLACC (Face, Legs, Activity, Cry, Consolability) pain scale 6/10;
-February 5, 2024, at 0830 (8:30 a.m.), FLACC pain scale 6/10;
-February 5, 2024, at 1030 (10:30 a.m.), FLACC pain scale 2/10;
-February 5, 2024, at 1523 (3:23 p.m.), FLACC pain scale 5/10; and
-February 5, 2024, at 2100 (9:00 p.m.), FLACC pain scale 2/10.

The facility untitled document, dated February 5, 2024, at 12:34 p.m., indicated, "...acetaminophen 650 mg OG-Tube [thin soft tubed placed through the mouth and into the stomach]...Frequency...q4h...PRN... /Pain 1-3...Fever..."

The facility untitled document, dated February 5, 2024, at 12:34 p.m., indicated, "...acetaminophen 650 mg Supp [suppository] Rectal Frequency...q4h...Once PRN... /Pain 1-3...Fever..."

The facility document titled, "Medications," indicated Patient 30 was administered Acetaminophen on the following dates:

- February 5, 2024, at 0155 (1:55 a.m.), OG-Tube; and
- February 5, 2024, at 1259 (12:59 p.m.), supp/Rectal.

There was no documented evidence Patient 30's pain was reassessed after the pain medication Tylenol was administered.

An interview was conducted with the CEC on May 10, 2024, at 11:44 a.m. The CEC stated based on the assessment the patient should have been given pain medication. The medication given was not an appropriate medication to be given based on the physician's order. The nurses used the FLACC pain scale to assess the patient's pain.

A review of the P&P titled, "Medication Administration and Monitoring," dated April 8, 2024, was conducted. The P&P indicated, "...Medications will be administered in safe, accurate, and consistent manner...Medications Not Eligible for Scheduled Dosing Times include...PRN medications...The response of the patient to medication will be monitored by the administering nurse...according to the clinical needs of the patient...The patient's own perceptions of the efficacy...will be gathered...Relevant information in the medical record will be taken into consideration, such as relevant...clinical response, and medication profile..."

2a. A review of Patient 1's record was reviewed with the Cardiac Manager (CM) on May 8, 2024, at 12:30 p.m.

Patient 1's H&P indicated, Patient 1 was admitted to the facility on April 28, 2024, for shortness of breath and STEMI (a heart attack).

The facility document titled, "Consult to Case Management (Case Management Consult)," was reviewed. There was no documented evidence an initial case management assessment was completed during Patient 1's hospitalization.

An interview and record review were conducted with the Case Management Manager (CMM) on May 8, 2024, at 3:13 p.m. The CMM stated this patient should have had an initial assessment and then a reassessment prior to discharge and it was not done.

2b. A concurrent interview and record review were conducted with the CEC on May 9, 2024, at 9:59 a.m.

A review of Patient 24's record was conducted. The facility document titled, "H&P," indicated Patient 24 was admitted to the facility on May 7, 2024, for right hip pain and had a right total hip replacement.

A review of the facility document titled, "Orders," was reviewed. The document indicated a case management referral was ordered May 7, 2024 at 10:10 a.m. There was no documented evidence an initial case management assessment was completed during Patient 24's hospitalization.

An interview and record review were conducted with the CMM on May 9, 2024, at 9:59 a.m. The CMM stated a case manager was working on the discharge assessment, currently there was no admissions assessment in the electronic health record.

2c. A concurrent interview and record review were conducted with the CEC on May 9, 2024, at 1:06 p.m.

A review of Patient 27's record was conducted. The facility document titled, "H&P," indicated Patient 27 was admitted to the facility on May 5, 2024, for worsening chest pain, NSTEMI (non ST elevated myocardial infarction) heart attack.

A review of a document titled, "Orders," indicated a case management referral was ordered May 9, 2024, at 12:19 p.m. There was no documented evidence an initial case management assessment was completed during Patient 27's hospitalization.

An interview and record review were conducted with the CMM on May 9, 2024, at 9:59 a.m. The CMM stated there was no documentation a case management initial assessment was completed as ordered by the physician.

A review of the P&P titled, "[Facility Name] Physician's Orders," undated, was reviewed. The documented indicated, "...Licensed personnel may carry out orders for which there is a hospital Policy/Procedure and for which they have been trained...Provider orders will be accurately processed and promptly followed..."

3a. On May 9, 2024, at 9:17 a.m., a record review and concurrent interview were conducted with the CM.

A review of Patient 4's record was conducted. The H&P, dated April 7, 2024, indicated Patient 4 was admitted to the facility on April 7, 2024, for anemia (low red blood cell count) and gastrointestinal (inside the intestine) bleed.

A review of Patient 4's labs indicated, CO2 (Carbon dioxide) 48 mEq/L (unit of measurement) (critical) (Normal Range 23-29 mEq/L) on April 8, 2024, at 8:08 a.m. The pharmacy documented Registered Nurse (RN 1), was notified at 9:48 a.m. There was no documented evidence RN 1 called the physician to give the critical lab results.

An interview was conducted with the CM on May 9, 2024, at 9:32 a.m. The CM stated if there were critical lab values the nurse was supposed to notify the provider within 30 minutes, and if there was no response, the nurse should have followed the escalation process. The CM further stated there was no notification in the chart per policy.

3b. On May 9, 2024, at 3:15 p.m., a record review and concurrent interview were conducted with the CS. The CS stated Patient 12 was admitted on May 3, 2024, for chest pain and shortness of breath.

A review of Patient 12's labs indicated his white blood cell count was critically low on the following dates:

-May 3, 2024, at 1.8 g/dL (unit of measurement) (normal white blood cell count between 4.5 - 11.0 g/dL); and
-May 6, 2024, at 1.8 g/dL.

There was no documented evidence the critical values were reported to the physician.

An interview was conducted with the CS on May 9, 2024, at 3:45 p.m. The CS stated there was no documented evidence the lab values above were reported to the physician. The CS stated any lab values that are critical should have been reported to the physician right away.

3c. A concurrent interview and record review were conducted with the CEC on May 9, 2024, at 1:06 p.m.

A review of Patient 30's record was conducted. The facility document titled, "H&P," indicated Patient 30 was admitted on May 5, 2024, for seizure like activity and confusion, following a fall out of the bed.

A review of Patient 30's labs indicated Troponin (protein in heart cells) 1,514.5 ng/mL (unit of measurement) (critical) (Normal Range 0 and 0.04 ng/mL) on February 5, 2024, at 3.33 a.m. There was no documented evidence the RN called the physician to give the critical results.

An interview was conducted with the CEC on May 10, 2024, at 11:11 a.m. The CEC stated the labs were not reported to the physician.

A review of the P&P titled, "Critical Results," dated April 8, 2024, was conducted. The document indicated, "...All Registered Nurses...in clinical departments that report critical results...Critical results apply to all diagnostic tests, including...laboratory tests...Critical results are those that fall significantly outside the normal range and may present life-threatening values...The results may reflect a pathological state which, if left untreated, poses an imminent threat to life...The time frame for communicating critical results to a physician is to be within sixty (60) minutes...Carbon dioxide...Critical Low < 10 mmol/L...Critical High...> (greater than)...40 mmol/L...Troponin...female....>51.4 ng/L (unit of measurement)...Hemoglobin...Critical Low...<(less than) 10.0 g/dL...When the reporting department calls the physician, the first and last name of the patient should be used...Documentation...The reporting clinician (i.e., nurse...) will document physician notification in the patient's medical record..."

4a. On May 8, 2024, at 1 p.m., an interview and concurrent record review with the Stroke Program Manager (SPM) were conducted.

A review of Patient 8's record was conducted. The "H&P," dated May 6, 2024, indicated Patient 8 was admitted to the facility on May 6, 2024, for left sided facial tingling and numbness.

A review of the facility's document titled, "Vitals Quick View," dated May 6, 2024, was reviewed. The document indicated Patient 8 was on telemetry (continuous tracking of your heartbeat). The document further indicated Patient 8's telemetry strip interpretation on May 6, 2024, at 1800 (6 p.m.) was missing. There was no documented evidence Patient 8's telemetry strip was placed in his chart.

An interview and concurrent record review was conducted on May 8, 2024, with the Stroke Program Manager (SPM). The SPM stated at a minimum, one telemetry strip should be interpreted, printed, signed, and dated every shift. She further stated Patient 8's May 6, 2024, strip interpretation was incomplete, and the strip was missing from the patient's chart.

4b. On May 9, 2024, at 1:30 p.m., an interview and concurrent record review with the CS were conducted.

Patient 11's H&P indicated he was admitted to the facility on May 2, 2024, for shortness of breath (SOB), increased cough and rhonchi (coarse rattling lung sounds).

A review of the facility's document titled, "Vitals Quick View," dated May 4, 2024, was conducted. The document indicated Patient 11 was on telemetry. The document further indicated Patient 11's telemetry strip interpretation on May 4, 2024, was missing. There was no documented evidence Patient 11's telemetry strip was placed in his chart.

An interview and concurrent record review was conducted on May 9, 2024, at 1:30 p.m., with the CS. The CS stated a telemetry strip should have been printed every shift when a patient was on telemetry. She stated the telemetry strip for May 4, 2024, was missing and not in the chart. She further stated there was no documented evidence in the EMR a May 4, 2024, telemetry strip was interpreted, printed, signed and dated.

4c. A concurrent interview and record review were conducted with the Wound Care Program Manager (WCPM) on May 9, 2024, at 2:45 p.m.

A review of Patient 22's record was conducted. The facility document titled, "H&P, " indicated, Patient 22 was admitted to the facility on November 26, 2023, for transaminitis (high levels of a particular type of enzyme in your blood, called a transaminase) and proctitis (inflammation of the rectum and anus).

During a review of Patient 22's record, the following telemetry strips were reviewed:

-November 27, 2023, at 4:33 a.m., there was no documented evidence of time, date, printed name, and signature of RN or monitor tech (MT) documented on the strip;

-November 27, 2023, at 8:20 a.m., there was no documented evidence of time, date, printed name and signature of RN or MT was documented on the strip;

-November 27, 2023, at 7:09 p.m., there was no documented evidence of time, date, printed name and signature of RN or MT was documented on the strip;

-November 28, 2023, day shift (7 a.m. to 7 p.m.), there was no documented evidence a telemetry strip was printed and interpreted;

-November 28, 2023, at 10:14 p.m., there was no documented evidence of time, date, printed name and signature of RN or MT was documented on the strip;

-November 29, 2023, day shift, there was no documented evidence a telemetry strip was printed and interpreted;

-November 29, 2023, at 8:45 p.m., there was no documented evidence of time, date, printed name and signature of RN or MT was documented on the strip;

-November 30, 2023, at 12:16 a.m., there was no documented evidence of time, date, printed name and signature of RN or MT was documented on the strip; and

-November 30, 2023, at 7:23 a.m., there was no documented evidence of time, date, printed name and signature of RN or MT was documented on the strip.

An interview on May 9, 2024, at 3:45 p.m., with the WCPM was conducted. The WCPM stated the policy for telemetry strip documentation was changed to reflect the new process, however, when the policy was received from the hospital, the WCPM stated the policy was not followed.

4d. A concurrent interview and record review were conducted with the Clinical Effective Coordinator (CEC) on May 9, 2024, at 1:06 p.m.

A review of Patient 27's record was conducted. The facility document titled, "H&P," indicated, Patient 27 was admitted to the facility on May 5, 2024, for worsening chest pain, NSTEMI (non ST elevated myocardial infarction) heart attack.

A review of facility documents titled, "Caliper Measurement," was conducted. There was no documented evidence the six second telemetry strips were completed with full printed, signed name, date, and time of interpretation on the following dates:

-May 4, 2024, day shift (7 a.m. to 7 p.m.) or night shift (7 p.m. to 7 a.m.);
-May 5, 2024, day shift or night shift;
-May 6, 2024, day shift or night shift;
-May 7, 2024, day shift or night shift;
-May 8, 2024, day shift or night shift; and
-May 9, 2024, day shift.

An interview and record review were conducted with the CEC on May 9, 2024, at 2 p.m. The CEC stated she was aware of the policy for the telemetry strips to include the nurse's full printed and signed name, date, and time of interpretation and to place the strips in the patient's chart.

An interview and record review were conducted with the Director of Medsurg/Tele PCU (DMTPCU) on May 9, 2024, at 2:10 p.m. The DMTPCU stated the policy was to run the six second telemetry strip, interpret the strip, and sign. The DMTPCU stated the strips were incomplete and the nurses were not following their policy.

4e. A concurrent interview and record review were conducted with the CEC on May 9, 2024, at 3:09 p.m.

A review of Patient 28's record was conducted. The facility document titled, "H&P," indicated, Patient 28 was admitted to the facility on May 5, 2024, for blood in stools for months.

A review of facility documents tilted, "Caliper Measurement," was conducted. There was no documented evidence the six second telemetry strips were completed with full printed, signed name, date, and time of interpretation on the following dates:

-May 4, 2024, night shift;
-May 5, 2024, day shift, missing strip in the medical record;
-May 5, 2024, night shift; and
-May 6, 2024, day shift.

An interview and record review were conducted with the CEC on May 9, 2024, at 3:51 p.m. The CEC stated she was unable to find the telemetry strip for May 5, 2024 a.m. shift. The CEC also stated that the telemetry strips were not printed, signed and dated.

4f. A concurrent interview and record review were conducted with the CEC on May 10, 2024, at 8:40 a.m.

A review of Patient 29's record was conducted. The facility document titled, "H&P," indicated, Patient 29 was admitted to the facility on May 3, 2024, for cough, generalized weakness, and urinary tract (bladder) infection.

A review of the facility documents tilted, "Caliper Measurement," was conducted. There was no documented evidence the six second telemetry strips were completed with full printed, signed name, date, and time of interpretation on the following dates:

-May 3, 2024, night shift;
-May 4, 2024, day shift or night shift;
-May 5, 2024, day shift or night shift;
-May 6, 2024, day shift or night shift;
-May 7, 2024, day shift or night shift; and
-May 8, 2024, day shift or night shift.

An interview and record review were conducted with the CEC on May 10, 2024, at 9:39 a.m. The CEC stated the telemetry strips were not complete as per policy.

4g. A concurrent interview and record review were conducted with the CEC on May 8, 2024, at 3:20 p.m.

A review of Patient 30's record was conducted. The facility document titled, "H&P," indicated, Patient 30 was admitted on May 5, 2024, for seizure like activity, confusion, and fell out of the bed.

A review of the facility documents tilted, "Caliper Measurement," was conducted. There was no documented evidence the six second telemetry strips were complete with full printed, signed name, date, and time of interpretation on the following dates:

-February 5, 2024, 1550 (3:50 p.m.);
-February 5, 2024, 2112 (9:12 p.m.);
-February 5, 2024, 2145 (9:45 p.m.);
-February 6, 2024, 1200 (12:00 a.m.);
-February 6, 2024, 0200 (2:00 a.m.);
-February 6, 2024, 0227 (2:27 a.m.); and
-February 6, 2024, 0246 (2:46 a.m.).

An interview and record review were conducted with the CEC on May 10, 2024, at 10:50 a.m. The CEC stated the telemetry strips were not complete as per policy.

A review of the facility's P&P titled, "Cardiac/Telemetry Monitoring in the Telemetry Units," dated May 09, 2022, was conducted. The P&P indicated, "...To provide skilled cardiac monitoring to patients who require continuous telemetry...A six second (minimum) telemetry strip will be run a minimum of once per shift...A strip will also be run anytime dysrhythmias are noted...The strip (s) will be placed into the patient's Chart after evaluation/documentation has been completed...Telemetry Monitor Technician responsibility for strip documentation...Documentation is to include a complete strip interpretation...PR, QRS, QT, rhythm type, heart rate...It is the endorsed Nurse's responsibility to chart the Rhythm interpretation in the EMR...Strip evaluation and documentation on the strip for telemetry monitored patient in the Telemetry Units is done by the designated Telemetry Monitor Technician...The strip will include the nurse's Full Printed and Signed name, Date, and Time of interpretation and place the strip in the patient's chart..."

5. On May 10, 2024, at 9:19 a.m., an interview and concurrent record review was conducted with the Senior Clinical Effectiveness Coordinator (SCEC).

Patient 5's H&P indicated she was admitted to the facility on May 4, 2024, for pneumonia (lung inflammation caused by bacterial or viral infection).

A review of the facility's document titled, "Wound Care Consult," dated May 5, 2024, at 6:18 a.m., was conducted. The documented indicated, "...Reason for Consult...Stage 4 pressure on sacral [tail bone] area...Special instructions...Eval and Treat..."

There was no documented evidence that a wound consult was completed for Patient 5.

An interview and concurrent record review was conducted on May 10, 2024, at 9:53 a.m., with the SCEC. The SCEC stated there was no documented evidence in the chart a wound consult was completed per physican order.

An interview and concurrent record review were conducted on May 10, 2024, at 9:58 a.m., with the WCPM. The WCPM stated she did not see any evidence the wound consult was done. The WCPM further stated, "I did not do it, I was assisting with the survey". The WCPM stated she was the only wound care nurse at this time.

A review of the P&P titled, "[Facility Name] Physician's Orders," undated, was conducted. The documented indicated, "...Licensed personnel may carry out orders for which there is a hospital Policy/Procedure and for which they have been trained...Provider orders will be accurately processed and promptly followed..."

6a. A review of Patient 4's record was conducted. The History and Physical (H&P), dated April 7, 2024, indicated Patient 4 was admitted to the facility on April 7, 2024, for anemia and gastrointestinal bleed.

The facility document titled, "Progress Note-Physician," dated April 7, 2024, indicated, "...Discussed in detail with the patient in case of emergency in which his heart stops or he is unable to breath the methods of which he would take in order to preserve life...The patient is in full understanding of the risk of benefits of life saving/heroic measures and would like to have DNR/DNI [do not resuscitate/do not intubate] in the event of incapacitation for any reason while in the hospital..."

The facility document titled, "Progress Note-Physician," dated April 8, 2024, at 1741 (5:41 p.m.), authored by Resident (R 1) was reviewed. The document indicated, "...CODE BLUE was activated on 04/08/2024 [April 8, 2024] at 1521 [3:21 p.m.]. Upon arrival, patient was found laying on the floor of his room with noticeable urinary incontinence and stool. Nursing staff advised that the patient was pulseless and unresponsive and CPR [life saving procedure performed when the heart stops] was in progress at the time of arrival. Had reviewed patient's CODE STATUS prior to arrival and called off all heroic measures as patient was DNI/DNR. Patient was pronounced at 1522 [3:22 p.m.]. Non responsive to painful stimulus, no initiation of breaths, absent pulse, asystole on monitor, absent heart & breath sounds on auscultation, no pupillary reflex. Updated the wife and daughter at bedside..."

The facility document titled, "Progress Note-Physician," dated April 9, 2024, at 12:24 p.m., authored by, Physician (P 1) was reviewed. The document indicated, "...Spoke with wife...over the phone today giving our condolences to her and her family and also reached out to see if there is anything that we can do to help. In addition I also disclosed to [name of wife] that there was a period of approximately 25 minutes where her husband's heart rate gradually declined and stated that in these types of circumstances typically the physician would have been notified but due to unforeseen reasons we were not..."

The facility document titled, "Progress Note-Nurse," dated April 8, 2024, at 1932 (7:32 p.m.), authored by RN 1 was reviewed. The document indicated, "...At approx.[approximately] 1520 [3:20 p.m.] tele [telemetry] monitor alerted asystole [heart ceases to beat]. Went to check on pt [patient] who was found on the floor unresponsive...Checked for pt pulse not (sic) was found initiated code blue and began chest compression..."

The facility document titled, "Telemetry Specific Details," dated April 8, 2024, at 1517 (3:17 p.m.) was reviewed. The document indicated, "...at 1517 [3:17 p.m.]...Tele Alert Notification Reason...Bradycardia, other informational didn't alarm...at 1521 [3:21 p.m.]...Asystole...Flag Comments by [name of telemetry monitor tech, MT 1], on April 8, 2024, 1539 [3:39 p.m.] attempted to contact RN, CODE blue called after..."

Review of the facility's EKG (electrocardiogram, [test for heart rate and rhythm]) strips, dated April 8, 2024, indicated the following:

- At 14:59:12 (2:59 and 12 seconds p.m.), Patient 4's heart rate was 50 beats per minute;

- At 14:59:20 (2:59 and 20 seconds p.m.), Patient 4's heart rate was 41 beats per minute;

- At 14:59:29 (2:59 and 29 seconds p.m.), Patient 4's heart rate was 37 beats per minute;

-At 14:59:38 (2:59 and 38 seconds p.m.), Patient 4's heart rate was 43 beats per minute;

- At 15:09:49 (3:09 and 49 seconds p.m.), Patient 4's heart rate was 46 beats per minute;

- At 15:09:58 (3:09 and 58 seconds p.m.), Patient 4's heart rate was 48 beats per minute;

-At 15:14:32 (3:14 and 32 seconds p.m.), Patient 4's heart rate was 44 beats per minute;

- At 15:14:40 (3:14 and 40 seconds p.m.), Patient 4's heart rate was 50 beats per minute;

- At 15:19:38 (3:19 and 38 seconds p.m.), Patient 4's heart rate was 30 beats per minute;

- At 15:19:46 (3:19 and 46 seconds p.m.), Patient 4's heart rate was 29 beats per minute;

- At 15:21:26 (3:21 and 26 seconds p.m.), Patient 4's heart rate was 20 beats per minute;

- At 15:21:28 (3:21 and 28 seconds p.m.), Patient 4's heart rate was 20 beats per minute;

- At 15:21:34 (3:21 and 34 seconds p.m.), Patient 4's heart rate was 0 beats per minute; and

- At 15:21:36 (3:21 and 36 seconds p.m.), Patient 4's heart rate was 0 beats per minute.

An interview and concurrent record review were conducted with the DMTPCU on May 10, 2024, at 12:55 p.m. The DMTPCU stated there were three level alarms for heart rate parameters and defaulted at heart rate of 50. The DMTPCU stated alarms get louder and louder based on the level. The DMTPCU stated the tele machine at 2:59:20 (2:59 and 20 seconds p.m.) started to alarm and the patient was at 41 beats per minute and there was no evidence MT 1 notified RN 1. The DMTPCU stated MT 1 was busy interpreting a tele strip for a newly admitted patient. The DMTPCU stated MT 1 was monitoring 48 patients and at this time there were multiple alarms going off. The DMTPCU stated the alarm was set at 10% volume, which is deemed low for the day shift due to ambient noise. The DMTPCU stated MT 1 stated Patient 4's decline in heart rate was an oversight as he did not hear the alarm.

There was no documented evidence MT 1 notified RN 1 of Patient 4's low heart rate on April 8, 2024, from 2:59 and 12 seconds p.m. to 3:21 and 36 seconds p.m., (22 minutes and 44 seconds).

There was no documented evidence Patient 4 was assessed for physical symptoms related to severe changes in heart rate and rhythm on April 8, 2024, from 2:59 and 12 seconds p.m. to 3:21 and 36 seconds p.m., (22 minutes and 44 seconds), when the patient's heart rate was low.

6b. On May 8, 2024, at 1 p.m., an interview and concurrent record review were conducted with the SPM.

A review of Patient 7's record was conducted. The H&P dated May 2, 2024, indicated, Patient 7 was admitted to the facility for dizziness, double vision, and UTI (urinary tract infection).

The facility document titled, "Cardiac Rhythm," dated May 1, 2024, through May 7, 2024, was reviewed. The document indicated, "...Sinus Bradycardia...05/02/2024 [May 2, 2024]...07:54:00 [7:54 a.m.]..." There was no documented evidence the Monitor Tech (MT 2) notified the RN.

The facility document titled, "Communication Log," dated May 1, 2024, through May 8, 2024, was reviewed. There was no documented evidence a notification was made to the RN on May 2, 2024, for the bradycardic episode of Patient 7.

An interview was conducted on May 8, 2024, at 1:25 p.m., with the DMTPCU. The DMTPCU stated he was not able to find any communication from MT 2 to the RN for Patient 7's bradycardia on May 2, 2024. He stated the MT 2 should have called the RN when the heart rate fell below the parameters. The DMTPCU further stated MT 2 should have documented the notification in the EMR. The DMTPCU stated the bradycardia telemetry strip was not in the EMR and it should have been printed and placed in the patient's chart.

A review of the P&P titled, "Cardiac/Telemetry Monitoring in the Telemetry Units," dated May 9, 2022, was conducted. The P&P indicated, "...To provide skilled cardiac monitoring to patients who require continuous telemetry...An evaluation of the patient will occur by the RN...

Based on observation, interview, and record review, the facility failed to ensure for seven of 30 sampled patients (Patient 1, 3, 11, 22, 23, 26, and 27) an effective and active system-wide infection control program for the prevention, control, and investigation of infections and communicable diseases, including meeting the needs of all patients requiring gastrointestinal services (the study, diagnosis, and treatment of disorders that deal with the digestive system) and the use of flexible endoscopes (a reusable instrument used to inspect and treat interior portions of the body) was implemented when:

1. Operating room temperatures were not maintained per Association of Operating Room Nurses (AORN) guidelines (Refer to A0749).

2. Temperature and humidity were not monitored in the gastrointestinal (GI, related to the stomach and intestines) lab decontamination and clean room (Refer to A0749).

3. Surgical tables and mats in Operating Rooms (OR) 2 and 4 were left wet after cleaning (Refer to A0749).

4. Two IV (intravenous, within the vein) poles were found with chipped paint and rusty color at the base in Operating Rooms 2 and 4 (Refer to A0749).

5. Multiple equipment in the Radiology Department (RD, medical speciality using medical imaging to diagnose diseases and guide treatment) were not appropriately cleaned (Refer to A0749).

6. For Patients 1, 3, 11, 22, 23, 26, and 27 were not provided a CHG (Chlorhexidine gluconate, skin cleaning to help reduce the spread of infections in the hospital especially in intensive care units) bath (Refer to A0750).

7. Management and staff of the GI department were unaware of the standards or guidelines to follow for the processing and storage of flexible scopes (Refer to A772).

8. ANSI/AAMI (American National Standards Institute/ Association for the Advancement of Medical Instrumentation) guidelines were not followed when there was not a two or three compartment sink for processing/cleaning the flexible scopes (Refer to A772).

9. The endoscope storage cabinet did not contain a HEPA (high efficiency particulate air [filter]). This type of air filter can remove dust, pollen, mold, bacteria, and any airborne particles with a size of 0.3 microns (µm - unit of measurement) filter, and preventive maintenance were not performed in accordance with ANSI/AAMI guidelines (Refer to A772).

10. Gray and black particles, and debris were observed scattered at the bottom of the endoscope storage cabinet (Refer to A772).

11. The facility did not have a policy and procedure in place to guide staff on how to process and store the flexible scopes (Refer to A772).

12. Gastrointestinal Technician (GI Tech) staff did not have the certification needed to process endoscopes in accordance with ANSI/AAMI guidelines (Refer to A772).

The cumulative effects of these systemic problems resulted in the facility's inability to provide an effective hospital wide infection control program and to provide patient care in a safe and effective manner.

Due to the failure of the GI Techs not being aware of the standards or guidelines to follow for the processing and storage of flexible scopes, the endoscope storage cabinet not containing a HEPA filter, gray and black debris being observed at the bottom of the endoscope storage cabinet, not having policy and procedures in place to guide staff on how to process and store the flexible scopes, and GI Techs did not have certification needed to process endoscopes in accordance with ANSI/AAMI guidelines, the team determined that an IJ (immediate jeopardy) situation existed on May 7, 2024, at 5 p.m., and was communicated to the hospital staff which included the Chief Nursing Officer (CNO), Director of Education (DE), Chief Operating Officer (COO), and the Senior Clinical Effectiveness Coordinator (SCEC).

On May 9, 2024, at 4 p.m., the facility provided an acceptable removal plan of immediate action that included the following:

1. Current staff (two GI Techs), and new hires, will follow the AAMI scope cleaning and reprocessing guidelines. The facility developed and published a new policy that follows AAMI guidelines as of May 8, 2024. (2) Staff will be educated to the new endoscopy cleaning and reprocessing policy for processing and storing scopes by May 8, 2024. (3) 1:1 training will be provided by competent staff on how to process and store flexible scopes according to the new policy by May 8, 2024. (4) Employees on a leave of absence will be educated and trained on the date of return to work and prior to cleaning and processing scopes independently. (5) The facility will monitor compliance by conducting weekly audits for three months to achieve a goal of 95% compliance.

2. Facility has approved and published a new scope cleaning and reprocessing policy that follows AAMI guidelines as of May 8, 2024.

3. Facility will ensure all staff responsible for cleaning and reprocessing scopes have been made aware of the process. Education and training will be completed by May 8, 2024.

4. Facility will create and assign education in the Learning Management System (LMS) that includes a copy of the policy, quarterly, and any updates to evidence-based practices by May 9, 2024.

5. Staff will perform an annual competency on scope cleaning and reprocessing.

On May 9, 2024, at 5 p.m., the implementation of the removal plan was verified onsite through observation, interview, and record review. The CNO was notified that the immediate jeopardy was removed.

Based on observation, interview and record review, the facility did not follow the infection control plan to maintain the cleanliness of the facility environment when:

1. Operating room temperatures were not maintained per Association of Operating Room Nurses (AORN) guidelines.

2. Temperature and humidity were not monitored in the gastrointestinal (GI, related to the stomach and intestines) lab decontamination and clean room.

3. Surgical tables and mats in Operating Rooms (OR) 2 and 4 were left wet after cleaning.

4. Two IV (intravenous, within the vein)) poles were found with chipped paint and rusty color at the base in Operating Rooms 2 and 4.

5. Multiple equipment in the Radiology Department (RD, medical speciality using medical imaging to diagnose diseases and guide treatment) were not appropriately cleaned.

These failures placed all patients receiving services in these areas, at risk for infection and to not receive quality health care.

Findings:

1. On May 6, 2024, at 1:23 p.m., a tour of Operating Rooms 1, 2, 3, 4, and 5 was conducted with the Interim Operating Room Manager (IORD) and the Clinical Effective Coordinator (CEC).

During the tour in Operating Room (OR) 4, the temperature monitor mounted on the back wall was observed at 65.5 degrees Fahrenheit.

A review of facility document titled, "OR DAILY REPORT," indicated, the temperatures in the Operating Rooms were as followed:

-May 6, 2024, at 65 degrees Fahrenheit in Operating Room 1;

-May 5, 2024, at 65 degrees Fahrenheit in Operating Room 1;

-May 4, 2024, at 64.9 degrees Fahrenheit in Operating Room 1;

-May 3, 2024, at 65 degrees Fahrenheit in Operating Room 1;

-May 2, 2024, at 65.4 degrees Fahrenheit in Operating Room 1;

-May 1, 2024, at 64.9 degrees Fahrenheit in Operating Room 1;

-April 30, 2024, at 65.4 degrees Fahrenheit in Operating Room 1;

-April 29, 2024, at 67.0 degrees Fahrenheit in Operating Room 1;

-May 6, 2024, at 67.7 degrees Fahrenheit in Operating Room 2;

-May 4, 2024, at 67.9 degrees Fahrenheit in Operating Room 2;

-May 2, 2024, at 67.7 degrees Fahrenheit in Operating Room 2;

-May 1, 2024, at 67.8 degrees Fahrenheit in Operating Room 2;

-May 6, 2024, at 67.8 degrees Fahrenheit in Operating Room 3;

-May 4, 2024, at 67.3 degrees Fahrenheit in Operating Room 3;

-May 3, 2024, at 67.7 degrees Fahrenheit in Operating Room 3;

-May 2, 2024, at 67 degrees Fahrenheit in Operating Room 3;

-May 1, 2024, at 67.2 degrees Fahrenheit in Operating Room 3;

-April 30, 2024, at 67.4 degrees Fahrenheit in Operating Room 3;

-April 29, 2024, at 67.6 degrees Fahrenheit in Operating Room 3;

-May 6, 2024, at 66.5 degrees Fahrenheit in Operating Room 4;

-May 5, 2024, at 65.8 degrees Fahrenheit in Operating Room 4;

-May 4, 2024, at 66.2 degrees Fahrenheit in Operating Room 4;

-May 3, 2024, at 65.1 degrees Fahrenheit in Operating Room 4;

-May 1, 2024, at 65.7 degrees Fahrenheit in Operating Room 4;

-April 30, 2024, at 65.2 degrees Fahrenheit in Operating Room 4;

-April 29, 2024, at 66.3 degrees Fahrenheit in Operating Room 4;

-May 6, 2024, at 64.8 degrees Fahrenheit in Operating Room 5;

-May 5, 2024, at 65.3 degrees Fahrenheit in Operating Room 5;

-May 4, 2024, at 65.1 degrees Fahrenheit in Operating Room 5;

-May 3, 2024, at 64.9 degrees Fahrenheit in Operating Room 5;

-May 2, 2024, at 65.7 degrees Fahrenheit in Operating Room 5;

-May 1, 2024, at 64.5 degrees Fahrenheit in Operating Room 5;

-April 30, 2024, at 64.7 degrees Fahrenheit in Operating Room 5; and

-April 29, 2024, at 64.9 degrees Fahrenheit in Operating Room 5.

An interview and concurrent record review were conducted on May 7, 2024, at 1:23 p.m., with the Director of Plant Operations (DPO). The DPO stated he reviewed the temperature and humidity policy, and it indicated OR temperature should be between 64-75 degrees Fahrenheit. The DPO stated the information was from the AORN guidelines they follow however, he was unable to state which version of the guidelines they were following.

A follow up interview was conducted on May 8, 2024, at 11:15 a.m., with the DPO. The DPO stated they follow the 2021 AORN guidelines that indicated the OR room temperature should be between 68-75 degrees Fahrenheit. He stated they were not meeting the guidelines.

On May 8, 2024, a review of the document titled, "AORN eGUIDELINES," dated 2024, was conducted. The document indicated "...Temperature...OR's should be designed to maintain space temperature between 68-75 degrees Fahrenheit..."

2. A tour of the GI decontamination room was conducted on May 7, 2024, at 9:45 a.m., with the IORD, GI technician (GI tech) and Wound Care Program Manager (WCPM).

During a tour of the GI decontamination room on May 7, 2024, at 9:54 a.m., a thermostat mounted on the wall was observed.

During an interview on May 7, 2024, at 10:02 a.m., with the GI tech, the GI Tech stated the room temperature and humidity was not being monitored.

On May 7, 2024, at 10:02 a.m., the facility was unable to provide the requested temperature and humidity logs for the GI decontamination and clean room. There was no documented evidence the temperature and humidity was being monitored in the GI decontamination and clean rooms.

A review of the AORN eGuideline titled, "AORN Guidelines Summary: Processing Flexible Endoscopes [an instrument which can be introduced into the body to view internal parts]," undated, indicated, "...Maintain relative humidity and temperature within the heating, ventilation, and air conditioning (HVAC) design parameters. Processing flexible endoscopes in an area where temperature, humidity, environmental cleaning, surgical attire, traffic patterns, and security are managed may improve efficiency, help maintain functionality of flexible endoscopes, reduce the risk of cross contamination, and provide a safe work environment..."

3. On May 6, 2024, at 2:30 p.m., a tour of OR 2 and 4 was conducted with the IORD and the CEC.

During the tour on May 6, 2024, at 2:30 p.m., in Operating Room 2, the underside of the mats and the surgical table were observed to be wet.

An interview was conducted on May 6, 2024, at 3:15 p.m,. with the IORD. The IORD stated the table and mats were wet and they should not have been wet. The mats and table should have been dry depending on the dwell time. The mats should have been dried before they were placed on the surgical table.

During the tour on May 6, 2024, at 3:25 p.m., in Operating Room 4, the underside of the mats and the surgical table were observed to be wet.

An interview was conducted on May 6, 2024, at 3:25 p.m., with the Environmental Services (EVS) 1. The EVS 1 stated the underside of the mats and table were wet. EVS 1 stated the mats should not have been wet. EVS 1 stated the turnover of the room was quick and there was no time to wait for it to dry. EVS 1 stated they cleaned with VIREX Plus (a cleaning solution). EVS 1 stated the VIREX Plus was to stay on the surface for two minutes. EVS 1 stated the rag might have been too wet when cleaning the table. EVS 1 further stated the table should have only been wet for 2 (two) minutes.

An interview was conducted on May 7, 2024, at 1:36 p.m., with the Environmental Services (EVS) 2. The EVS 2 stated the process was to take the bucket to the Doverseu Quattroselect (dispenser used to mix the Virex Plus and water) and choose the type of cleaner, Virex Plus or the Crew Na SC (cleaning solution). The EVS 2 stated the cleaner that was used in the OR was the Virex Plus. The EVS 2 stated the dispenser would automatically mix the solution with the water. EVS 2 further stated she changed the soap solution at least two or three times in eight hours. The EVS 2 stated they were to leave the solution on the surgical table and mats for 2-3 minutes.

An interview was conducted on May 8, 2024, at 10:56 a.m., with the Environmental Services Supervisor (EVSS). The EVSS stated the carts were set up with the Virex Plus in the buckets. The EVSS stated the rag should be wet enough to stay wet for the duration of the dwell time. The EVSS stated the dwell time was three minutes. If the equipment was still wet, they were to dry with another rag. The EVSS stated the room turn over time was 10-15 minutes depending on the type of surgical case. The EVSS stated competencies were done every year and placed in the employee's file. The EVSS stated two minutes was not the correct dwell time. EVSS stated the correct dwell time was three minutes. The EVSS reviewed the picture of OR 4 surgical table, and mats, and stated the table was wet and should not be. EVSS further stated that either the rag was too wet, or the staff did not allow for dry time.

A review of the undated, Virex Plus instructions, was conducted on May 8, 2024, at 1:38 p.m. The instructions indicated, "...Directions for use...Contact Time: Leave surface wet for 1 minute for HIV-1(Human Immunodeficiency Virus, a virus that attacks calls that help the body fight infection) and three minutes for HBV (Hepatitis B Virus, an infection of the liver) and HCV (Hepatitis C Virus, viral infection that causes liver inflammation, or swelling) with a 1/2 ounce per gallon use-solution use contact time indicated on the label for disinfection against all other viruses bacteria and fungi..."

A review of Policy and Procedure titled, "Equipment- Cleaning Schedule," dated May 9, 2022, was conducted. The policy indicated "...Equipment will be cleaned with hospital approved germicide after each patient use on a regular schedule...The manufacture's recommendation for use will be followed...Equipment cleaning responsibilities are listed in the table that follows...EQUIPMENT...Beds (all hospitals owned)...WHO...EVS...HOW...Hospital-approved disinfectant...WHEN...All surfaces upon patient discharge..."

4. On May 6, 2024, at 2:35 p.m., a tour of OR 2 was conducted with the IORD and the CEC.

During the tour on May 6, 2024, at 2:35 p.m., in Operating Room 2, an IV pole was observed to have chipped paint and a rusty color at the base of the pole.

During the tour on May 6, 2024, at 3:45 p.m., in Operating Room 4, an IV pole was observed to have chipped paint and a rusty color at the base of the pole.

An interview was conducted on May 7, 2024, at 1:43 p.m., with the Clinical Supervisor (CS). The CS stated the IV poles were removed from OR 2 and OR 4 due to equipment being damaged. The CS further stated that sometimes the equipment will come from other units and the damage was missed when in the OR.

An interview was conducted on May 7, 2024, at 2:16 p.m., with the Senior Clinical Effective Coordinator (SCEC). The SCEC stated upon review of the picture of the IV pole from the OR, the pole would be considered damaged equipment and should have been removed from the OR.

A review of Policy and Procedure titled, "Mechanical Safety," dated August 7, 2021, was conducted. The policy indicated, "...All mechanical devices shall be inspected and approved prior to use in patient care areas...Staff members are to report any malfunctioning or damaged equipment to their supervisor immediately...Check all...broken platforms...Report any malfunction to your Supervisor or Director, placing an out of order red ticket on the device..."

5. A tour of the Radiology Department was conducted on May 6, 2024, at 2:15 p.m., with the Radiology Director (Rad Dir), Radiology Supervisor (Rad Sup) and WCPM.

During a concurrent observation and interview on May 6, 2024, at 2:52 p.m., with the Rad Dir, Rad Sup, and WCPM, in the Fluoroscopy (medical imaging procedure that uses an X-ray beam to create a continuous X-ray image on a monitor in real time) room, a dried brown smear on the black pad attached to the panel beside the MBS (Modified Barium Swallow, a non-invasive, quick, radiographic procedure that allows a doctor to examine a patient's swallowing anatomy) chair was observed. The Rad Sup wiped down the smear and stated it was dirt or possible body fluid from the last patient that was in this room. The Rad Dir stated the panel should have been wiped down after each patient use.

During an interview on May 6, 2024, at 3:08 p.m., with the Environmental Services Supervisor (EVSS 2), the EVSS 2 stated the room is terminally cleaned (a thorough cleaning and disinfection procedure used in healthcare facilities) when requested and daily at night. The EVSS 2 further stated cleaning included high dusting, removal of trash, and mopping the floors.

During a tour on May 6, 2024, at 3:10 p.m., in the Fluoroscopy room, gray fuzzy matter was observed all over the [Equipment Name] cart, and the [Equipment Name] device.

During an interview on May 6, 2024, at 3:12 p.m., with the EVSS 2, the EVSS 2 stated the device, and the cart should have been cleaned and dusted daily but were not.

During a concurrent observation and interview on May 6, 2024, at 3:15 p.m., with the Rad Dir, Rad Sup and WCPM, in the X-Ray room, gray and black particles on the surfaces of the X-ray tube and "Wall Bucky" were observed. The Rad Dir stated it should have been dusted by EVS when they cleaned at night.

During a concurrent observation and interview on May 6, 2024, at 3:26 p.m., with the Rad Dir, the Rad Sup and WCPM, in the Computed Tomography Room (CT#1, computerized X-ray imaging procedure in which a narrow beam of X-rays is aimed at the patient and quickly rotated around the body), accumulated gray, black and fuzzy particles on top of the suction canister at the side of the crash cart and on the surface and screen of the defibrillator were observed. The Rad Dir stated it should have been dusted by EVS when they cleaned at night.

A review of the facility's policy and procedure titled, "Imaging Rooms," dated October 10, 2022, indicated, "...Procedure...Perform the Standard 7 Step Process...Complete the High Dust process...Inspection Standards 1. Ceilings, ledges, countertops, furniture, and cabinets are clean and free of dust..."

Based on interview, and record review, the facility failed to ensure the facility's infection control program was maintained or methods to prevent the transmission of infections were implemented within the facility when patients were not provided a Chlorhexidine Gluconate (CHG, bathing product that kills germs and reduces the spread of infections in hospitals) bath, in accordance with the facility's Policy and Procedure (P&P), for seven of 30 sampled patients (Patient 1, 3, 11, 22, 23, 26, and 27).

These failures had the potential to result in the transmission and spread of pathogens (bacteria, virus, or other microorganism) which could cause disease/s to the patients receiving care in the facility.

Findings:

a. A concurrent interview and record review were conducted with the Cardiac Manager (CM) on May 8, 2024, at 1:13 p.m.

Patient 1's History and Physical (H&P) indicated Patient 1 was admitted to the facility on April 28, 2024, for shortness of breath and STEMI (a heart attack). There was no documented evidence Patient 1 was allergic to CHG.

A facility document titled, "Order," dated April 28, 2024, at 2:33 a.m., was reviewed. The document indicated, "...Level of Care...Critical Care..."

The Central Line flow sheet dated April 28, 2024, at 5:06 p.m., was reviewed. The document indicated a central line was inserted.

The Function and Safety flow sheets, from April 28, 2024, to May 8, 2024, were reviewed.
There was no documented evidence Patient 1 was provided a CHG bath on May 1, 2024, May 4, 2024, and May 6, 2024.

An interview was conducted with the CM on May 8, 2024, at 1:47 p.m. The CM stated the three days listed above were missing CHG baths. The CM further stated the patient had a central line and was admitted to Critical Care level of care and should have had a daily CHG bath per facility policy.

b. Patient 3's H&P indicated he was admitted to the facility on April 2, 2024, for syncope (fainting) and pneumonia (bacterial or viral infection in the lungs). There was no documented evidence Patient 3 was allergic to CHG.

The Central Line flow sheet dated April 15, 2024, at 10:02 a.m., was reviewed. The document indicated a central line was inserted.

The Function and Safety flow sheets, from April 15, 2024, to May 8, 2024, were reviewed.
There was no documented evidence Patient 3 was provided a CHG bath on April 26, 2024, May 1, 2024, May 4, 2024, May 5, 2024, and May 6, 2024.

An interview was conducted with the CM on May 8, 2024, at 1:58 p.m. The CM stated the five days listed above were missing CHG baths. The CM further stated the patient had a central line in place and should have had a daily CHG bath per policy.

c. An interview and record review were conducted with the Clinical Supervisor (CS) on May 9, 2024, at 9:45 a.m. The following records were reviewed:

Patient 11's H&P indicated he was admitted to the facility on May 2, 2024, for shortness of breath (SOB), increased cough and rhonchi (low pitched and rattling breath sounds). There was no documented evidence Patient 11 was allergic to CHG.

The Urinary Catheter (Foley Protocol) sheet dated May 4, 2024, was reviewed. The document indicated Patient 11 had a Foley Catheter (a semi flexible plastic tube that is inserted into the bladder to drain urine).

There was no documented evidence Patient 11 was provided a CHG bath on May 4, 2024, May 5, 2024, and May 6, 2024.

An interview was conducted with the CS on May 9, 2024, at 2:55 p.m. The CS stated Patient 11 had a Foley catheter and should have had a CHG bath daily. The CS stated there was no documented evidence Patient 11 received a CHG bath on May 4, 2024, through May 6, 2024.

d. An interview and record review were conducted with the Wound Care Program Manager (WCPM) on May 9, 2024, at 2:45 p.m. The following records were reviewed:

A review of Patient 22's record was conducted. The facility document titled, "H&P," indicated, Patient 22 was admitted to the facility on November 26, 2023, for Transaminitis (high levels of a particular type of enzyme in your blood, called a transaminase) and Proctitis (inflammation of the rectum and anus). This document further indicated Patient 22 had a foley catheter on admission. There was no documented evidence Patient 22 was allergic to CHG.

The Function and Safety flow sheets, from November 26, 2023, through November 31, 2023, were reviewed. There was no documented evidence Patient 22 was provided a CHG bath from November 26, 2023, through November 31, 2023.

An interview was conducted with the WCPM on May 9, 2024, at 3:04 p.m. The WCPM stated the patient should have had a CHG bath per the hospital CAUTI (Catheter Associated Urinary Tract Infection) protocol.

e. An interview and record review were conducted with the Clinical Effective Coordinator (CEC) on May 8, 2024, at 12:30 p.m. The following records were reviewed:

A review of Patient 23's record was conducted. The facility document titled, "H&P," indicated, Patient 23 was admitted to the facility on May 1, 2024, for painless abdominal cramping. There was no documented evidence Patient 23 was allergic to CHG.

A facility document titled, "Preprocedural Checklist," dated May 6, 2024, was reviewed. The document indicated, "...Chlorhexidine Bath...Completed...NO...Chlorhexidine Shower completed...NO...Chlorhexidine wipes completed...NO...Chlorhexidine 2% wipe of surgical site Completed...NO..."

An interview was conducted with the CEC on May 8, 2024, at 1:10 p.m. The CEC stated she was unable to find documentation the CHG bath was given prior to the surgical procedure. The CEC stated if unable to find in the documentation in the Electronic Medical Record (EMR) then one can assume the CHG bath was not given.

f. An interview and record review were conducted with the CEC on May 9, 2024, at 10 a.m. The following records were reviewed:

A review of Patient 26's record was conducted. The facility document titled, "H&P," indicated, Patient 26 was admitted to the facility on May 7, 2024, for cardioversion (procedure to return heartbeat to normal rhythm). There was no documented evidence Patient 26 was allergic to CHG.

A facility document titled, "Preprocedural Checklist," dated May 7, 2024, was reviewed. The document indicated, "...Chlorhexidine Bath...Completed...Blank...Chlorhexidine Shower completed...Blank...Chlorhexidine wipes completed...Blank..."

An interview was conducted with the CEC on May 9, 2024, at 10:57 a.m. The CEC stated the patient should have had a CHG bath prior to the procedure. The CEC stated the CHG bath was not documented in the preprocedural check list or the EMR.

g. An interview and record review were conducted with the CEC on May 9, 2024, at 10 a.m. The following records were reviewed:

A review of Patient 27's record was conducted. The facility document titled, "H&P," indicated, Patient 27 was admitted to the facility on May 5, 2024, for worsening chest pain, NSTEMI (non ST elevated myocardial infarction) heart attack. There was no documented evidence Patient 27 was allergic to CHG.

The Function and Safety flow sheets, from May 4, 2024, to May 9, 2024, were reviewed. There was no documented evidence Patient 26 was provided a CHG bath on May 4, 2024, May 5, 2024, May 6, 2024, May 7, 2024, May 8, 2024, and May 9, 2024.

An interview was conducted with the CEC on May 9, 2024, at 1:20 p.m. The CEC stated there was no documentation that the patient had a CHG bath in the EMR. The CEC stated the patient should have had a CHG bath once per shift.

The review of the facility's P&P titled, "Central Venous Catheters- Insertion, Care, Maintenance and Removal," dated July 13, 2020, was conducted. The document indicated, "...Ongoing documentation for the patient with a central venous catheter should include the location of the catheter, number of lumens and catheter size, type of dressing, site assessment, presence of any complications, and any actions taken...Daily CHG bath..."

The review of the facility's P&P titled, "Preventing Catheter Associated Urinary Tract Infections (CAUTI)," dated May 10, 2021, was conducted. The document indicated, "...To reduce the incidence of hospital acquired, catheter associated urinary tract infections...Urinary tract infections can result in sepsis, prolonged hospitalization and mortality...Perineal/meatal care should be performed at least every shift and the patient will receive a daily CHG bath as needed utilizing hospital approved peri-wash products and bath wipes..."

The review of the facility's P&P titled, "Prevention of Surgical Site Infections," dated October 10, 2022, was conducted. The document indicated "...Patient will be bathed preoperatively with an antimicrobial product (Chlorhexidine gluconate preferred) the evening before and the morning of surgery..."

Based on observation, interview, and record review, the facility failed to ensure the needs of all patients requiring gastrointestinal (GI) services (the study, diagnosis and treatment of disorders that deal with the digestive system) including the use of flexible endoscopes (a reusable instrument used to inspect and treat the interior portions of the body) were met when:

1. Management and staff of the GI department were unaware of the standards or guidelines to follow for the processing and storing of flexible scopes.

2. ANSI/AAMI (American National Standards Institute/ Association for the Advancement of Medical Instrumentation) guidelines were not followed when there were not a two or three compartment sink for processing/cleaning the flexible scopes.

3. The endoscope storage cabinet did not contain a HEPA (high efficiency particulate air [filter]). This type of air filter can remove dust, pollen, mold, bacteria, and any airborne particles with a size of 0.3 microns (µm - unit of measurement) filter and preventive maintenance were not performed in accordance with ANSI/AAMI guidelines.

4. Gray and black particles, and debris were observed scattered at the bottom of the endoscope scope storage cabinet.

5. The facility did not have a policy and procedure in place to guide staff on how to process and store the flexible scopes.

6. Gastrointestinal Technicians (GI Techs) did not have the certification needed to process endoscopes in accordance with ANSI/AAMI guidelines.

These failures placed all patients receiving services in these areas, at risk for infection and to not receive quality health care.

Findings:

1. A tour of the GI decontamination room was conducted on May 7, 2024, at 9:45 a.m., with the Interim Operating Room Director (IORD), GI technician (GI tech) and Wound Care Program Manager (WCPM).

During an interview on May 7, 2024, at 9:54 a.m., with the IORD and GI tech, both were unable to articulate the standards or guidelines they follow for the processing and storage of the facility's endoscopes.

2. During a concurrent observation and interview on May 7, 2024, at 9:55 a.m., with the GI Tech, in the GI Decontamination room, one compartment sink was observed being used to process scopes. The GI tech stated, this was the set up in place when he started in April 2023, and has been using one sink to process and clean all the endoscopes used in the GI department.

During an interview with the IORD on May 7, 2024, at 12:51 p.m., in the conference room, the IORD stated the hospital followed the following nationally recognized guidelines: ANSI/AAMI ST91:2021 (2022) (American National Standards/Association for the Advancement of Medical Instrument, standards development organizations) Flexible and Semi Rigid endoscope processing in healthcare facilities.

During a concurrent interview and record review on May 7, 2024 at 12:51 p.m., with the IORD, the facility document titled, "ANSI/AAMI ST91 flexible and semi-rigid endoscope processing health care facilities," dated 2022, was reviewed. The ANSI/AAMI ST91 flexible and semi-rigid endoscope processing health care facilities indicated, "...Design of endoscope processing area...Physical Facilities...General space requirements...Space requirements in the decontamination area...decontamination sink for manual cleaning...sink...for leak testing...if the facility anticipates for manual high-level-disinfection or manual liquid chemical sterilization [a two-part process that uses a liquid chemical germicide to sterilize reusable medical devices that are sensitive to heat]...separate sink for rinsing..." The IORD stated they did not follow these guidelines.

During an interview on May 9,2023, at 10:30 a.m., with the Respiratory Therapy Director (RTD). The RTD stated they processed and clean their bronchoscopes (a thin tube-like instrument with a light and lens that allows a medical professional to examine the insides of the lungs, trachea, and bronchi) in the GI Department.

3. During a concurrent observation and interview on May 7, 2024, at 10:05 a.m., with the IORD, GI tech and WCPM, in the GI clean room, the scope storage cabinet containing 20 scopes, did not have a HEPA filter. The IORD stated she did not know if the cabinet had a HEPA filter or if Biomed (a facility department) was monitoring this storage cabinet. The GI Tech stated the cabinet was a regular storage cabinet that did not have a HEPA filter and was not being monitored by the Biomed department.

During an interview on May 7, 2024, at 10:14 a.m., the Biomed Engineer stated the endoscope storage cabinet in the GI clean room did not have a HEPA filter and was not being monitored by their department.

During a record review on May 7, 2024, at 12:57 p.m., with the IORD, the facility document titled, "ANSI/AAMI ST91:2021 flexible and semi-rigid endoscope processing health care facilities", dated 2022, indicated, "...Endoscope drying cabinets. Endoscope drying cabinets are closed cabinets designed for storage of flexible endoscopes that circulate HEPA-filtered or instrument air through the cabinet and each endoscope channel at continuous positive pressure...Conventional drying cabinets. Conventional cabinets are closed cabinets that enable circulation of HEPA-filtered or instrument air through the cabinet at passively or via continuous positive pressure, but do not include forced air through endoscope channels..."

4. During a concurrent observation and interview on May 7, 2024, at 10:05 a.m., with the IORD, and GI tech, in the GI clean room, 20 scopes were observed hanging freely in the cabinet and were labeled, "Clean". Gray and black particles, and debris were observed scattered throughout the bottom of the cabinet where the scopes were stored. The IORD stated the expectation is for the cabinet to be cleaned daily but it was not. The GI tech stated he oversaw the cleaning of the storage cabinet daily however, he stated he had not done it daily as expected.

During a concurrent interview and record review on May 7, 2024, at 12:55 p.m., with the IORD, the facility document titled, "ANSI/AAMI ST91:2021 flexible and semi-rigid endoscope processing health care facilities," dated 2022, was reviewed. The ANSI/AAMI ST91:2021 flexible and semi-rigid endoscope processing health care facilities indicated, "...Storage of processed endoscopes...Storage of high level disinfected or liquid chemical sterilized endoscopes...Endoscopes are to be stored in an area that is clean, well-ventilated, and dust-free in order to keep the endoscopes dry and prevent exposure to potentially hazardous microbial contamination..."

A review of the ANSI/AAMI guidelines, titled, "ANSI/AAMI ST91:2021 flexible and semi-rigid endoscope processing health care facilities," dated 2022, indicated, "...Environmental Cleaning...Other surfaces, such as walls, storage shelves, endoscope storage cabinets, and registers and duct diffusers, should be cleaned and disinfected on a regularly scheduled basis and more often if needed..."

5. During the tour of the GI area on May 7, 2024, at 9:45 a.m., with the IORD, GI tech and WCPM, the policies and procedure for processing flexible scopes were requested. The IORD stated the facility did not have a policy in place to provide guidance to staff specific to processing flexible scopes.

The review of ANSI/AAMI guidelines, titled, "ANSI/AAMI ST91:2021 flexible and semi-rigid endoscope processing health care facilities," dated 2022, indicated, "...Quality control...General considerations...This section covers aspects of establishing policy and procedures, product identification and traceability, documentation and record-keeping, verification, and monitoring of the cleaning process, monitoring of high-level disinfection and sterilization processes, product recalls, and quality process improvement...Establishing policy and procedures for quality assurance and safety program. The health care facility should establish a multidisciplinary, comprehensive, written quality assurance and safety program for all aspects of endoscope processing..."

6. A review of the GI tech's employee file was conducted on May 10, 2024, at 9:44 a.m., with the Human Resources Director (HRD). The HRD stated there was no documented evidence the GI tech was certified to process flexible scopes according to the guidelines.

An interview was conducted on May 9, 2024, at 10 a.m., with the GI Tech. The GI Tech stated, Bronchoscopes used by the Respiratory Department are processed and cleaned in the GI area. The GI Tech further stated on occasion a staff member from the Respiratory Department will process the bronchoscopes when they (GI techs) are not working.

An interview was conducted on May 10, 2023, at 10:30 a.m., with the RTD. The RTD stated, GI techs did the processing of their bronchoscopes but sometimes a designated Respiratory Therapist (RT) who served as a back up would process the scopes. The RTD was unsure if the RT was certified in processing flexible scopes. The RTD further stated her department followed AAMI - ST 91 for processing scopes.

A review of the ANSI/ AAMI guidelines, titled, "ANSI/AAMI ST91:2021 flexible and semi-rigid endoscope processing health care facilities," dated 2022, was conducted with the RTD. It indicated, "...Education, training, and competency verification...General considerations...All personnel performing processing of endoscopes should be certified in flexible endoscope processing within two years of employment and should maintain that certification throughout their employment..."

A review of RT's employee file was conducted on May 10, 2024, at 12:40 p.m. with the HRD. The HRD stated there was no documented evidence the RT was certified to process flexible scopes according to the guidelines.

Due to the failures of the GI lab staff not being aware of the standards or guidelines to follow for the processing and storage of flexible scopes, the endoscope storage cabinet not containing a HEPA filter, gray and black debris being observed at the bottom of the endoscope storage cabinet, the facility not having a policy and procedures in place to guide staff on how to process and store the flexible scopes, and two GI Techs did not have certification needed to process endoscopes in accordance with the ANSI/AAMI guidelines, the survey team determined that an IJ (immediate jeopardy) situation existed on May 7, 2024, at 5 p.m., and was communicated to the hospital staff which included the Chief Nursing Officer (CNO), Director of Education (DE), Chief Operating Officer (COO), and the Senior Clinical Effectiveness Coordinator (SCEC).

On May 9, 2024, at 4 p.m., the facility provided an acceptable removal plan of immediate action that included the following:

1. The facility approved and published a new scope cleaning and reprocessing policy as of May 8, 2024.

2. The facility will ensure all staff responsible for cleaning and reprocessing scopes have been made aware of the process. Education and training will be completed by May 8, 2024.

3. The facility will create and assign education in the Learning Management System (LMS) that includes a copy of the policy quarterly, and any updates to evidence-based practices.

4. Staff will perform an annual competency on scope cleaning and reprocessing.

5. A second sink will be installed on May 8, 2024.

6. A drying cabinet with a HEPA filter will be installed on May 8, 2024.

On May 9, 2024, at 5 p.m., the implementation of the removal plan was verified onsite through observation, interview, and record review. The CNO was notified that the immediate jeopardy was removed.