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2701 S BRISTOL ST

SANTA ANA, CA 92704

NURSING SERVICES

Tag No.: A0385

Based on observation, interview, and record review, the hospital failed to ensure the nursing staff provided the necessary care and services to ensure the health and safety of the patients as evidenced by:

1. The hospital failed to ensure the nursing staff were maintained at all times for the CCU as required. Cross reference to A392.

2. The hospital failed to ensure the nursing staff provided the necessary care and services to three of 22 sampled patients (Patients 2, 3, and 22). Cross reference to A395.

3. The hospital failed to ensure the nursing staff administered the heparin (blood thinner) IV drip medication to one of 22 patients (Patient 9) as per the physician's order. Cross reference to A405.

4. The hospital failed to ensure the nursing staff administered the blood transfusion to two of 22 sampled patients (Patients 2 and 8) as per the hospital's P&P and physician's order. Cross reference to A410.

The cumulative effect of these systemic practices resulted in the hospital's inability to provide safe and effective nursing services.

STAFFING AND DELIVERY OF CARE

Tag No.: A0392

Based on interview and record review, the hospital failed to ensure the nursing staff were maintained at all times for the CCU as required. This failure created the risk for substandard health outcomes to the patients.

Findings:

Review of the hospital's 2023 Plan for Provision of Patient Care showed for CCU, the CCU nurses required special skills and advanced education or experience in the care of critically ill patients. The CN acts as a resource person to staff that are floated to the unit to provide patient care. Nursing staff in the CCU includes a department director, CN, and staff nurses (RNs). Staffing ratios are 1:1 and 1:2 depending on acuity criteria. A nurse is assigned to monitoring of telemetry or cardiac monitors. The Department Director or designee will classify patients and forecast staffing needs daily for the next 24 hours. The Staffing Coordinator or Administrative Supervisor will collaborate with the Director or designee to adjust staffing up or down according to the census and patient acuity to each shift. The Department Director and Staffing Coordinator or Administrative Supervisor will make arrangement to meet changing increased patient census.

Review of the hospital's P&P titled Telemetry/Cardiac Monitoring dated June 2024 showed in part:

* Policy: All patients admitted to CCU will be monitored via hard wire monitoring or telemetry. All patients admitted to other nursing units with a physician ' s order for "Telemetry or Cardiac Monitoring" will have the cardiac rate and rhythm monitored by CCU team members as per procedure below.

* Designated Team Members: RN and LVN.

* Procedure: CCU team members will

- Observe monitor rate or rhythm at central station in CCU and document on telemetry log every four hours.

- Obtain ECG strip on initiation or admission, every shift and with rhythm changes.

- Interpret strip for rhythm, rate presence and configuration of P waves, length of PR interval, QRS complexes, T waves, length of Q-T intervals, and presence of dysrhythmias.

- Set the alarms on the basis of the patient's current clinical status and heart rate.

- Notify the patient's nurse of any rate or rhythm changes.

- Document on rhythm strip any reported signs or symptoms, timing of drugs or other treatments that may have affected or cause change in patient rate or rhythm. All symptomatic tachy-or brady arrhythmia and all rhythms that require immediate treatment will be documented in the patient's medical record.

- Mount rhythm strips on patient medical record. It is not acceptable to substitute written diagnostic statements for the tracing themselves.

Review of the hospital's P&P tilted Staffing Intensive Care Unit: 1:1 Acuity Patient - Nurse Ratio dated September 2023 showed in part:

* Policy: A 1:1 status work sheet will be used to identify patients whose acuity required continuous non-interrupted nursing care by Intensive Care RN.

* Procedure: The CN or Assigned Nurse will determine acuity of all ICU patients each shift. The CN will determine those patients requiring status using the status scale worksheet. A score of greater than five determines that the patient's condition is appropriate for 1:1 status.

On 3/10/25 at 1500 hours, a tour of the ICU was conducted with Director 1 and Director 3. RN 9 was asked about the nurse-to-patient ratios in the ICU. RN 9 stated when they were short of staff and mostly happened during the night shifts, the M/S/telemetry nurses or LVNs from the subacute unit would float to the ICU, have their own patients, team up with the CN like the team nursing where the M/S/telemetry RNs or LVNs would administer the medications through GT, FT, or PO and medication drips, and the patient assessments were left for the CN to do. RN 9 was asked about the ICU acuity assessments. RN 9 stated the RNs filled out the acuity forms and the CN endorsed the acuity to the incoming CN including the procedures for the day. RN 9 was asked about the Monitor Technician. RN 9 stated at times, if there was no MT, the CN became the MT and would have their own patients.

On 3/10/24 at 1600 hours, review of the CCU Staff Assignments was conducted with Director 1 and showed the following:

- For 11/24/24 7 A to 7 P shift, four RNs were assigned to care for eight patients; one RN assignment was for "helping hands" and there was a MT. One RN had two patients from the 1000 to 7 P shift. There were eight telemetry patients in the M/S Telemetry unit. There was no assigned CN and a nurse was assigned to monitor the telemetry or cardiac monitors. The patient acuity was left blank.

- For 11/24/24 7 P to 7 A shift, two RNs were assigned to care for six patients and there was a MT. One RN was assigned to three patients on ventilator. There were eight telemetry patients in the M/S Telemetry unit. There was no assigned CN and a nurse was assigned to monitor the telemetry or cardiac monitors. The patient acuity was left blank.

- For 12/14/24 7 A to 7 P shift, two RNs were assigned to care for three patients and there was a MT. There were eight telemetry patients in the M/S/Telemetry unit. One RN was assigned to care for one patient and also functioned as the CN. One RN was assigned to care for two CCU patients. There was no nurse assigned to monitor the telemetry or cardiac monitors. The patient acuity was left blank.

- For 12/14/24 7 P to 7 A shift, two RNs were assigned to care for three patients and a MT. There were eight telemetry patients in the M/S/Telemetry unit. One RN was assigned to care for one patient and also functioned as the CN. One RN was assigned to care for two CCU patients. There was no nurse assigned to monitor the telemetry or cardiac monitors. The patient acuity was left blank.

- For 12/21/24 7 A to 7 P shift, one RN was assigned as the CN and aslo to monitor the telemetry or cardiac monitors. There were nine telemetry patients in the M/S/Telemetry unit. One RN was assigned to care for one CCU patient. There was no MT. The patient acuity was left blank.

- For 12/21/24 7 P to 7 A shift, one RN was assigned as the Resource RN and also to monitor the telemetry or cardiac monitors. There were eight telemetry patients in the M/S/Telemetry unit. One RN was assigned to care for one CCU patient. There was no MT. The patient acuity was left blank.

- For 12/22/24 at 7 A to 7 P shift, one RN was assigned to care for one CCU patient, functioned as the CN, and also monitored the telemetry or cardiac monitors. There were 10 telemetry patients in the M/S/Telemetry unit. One RN was assigned to care for two CCU patients. There was one RN on orientation. There was a MT. The patient acuity was left blank.

- For 12/22/24 at 7 P to 7 A shift, one RN was assigned as the Resource RN. There were 10 telemetry patients in the M/S/Telemetry unit. One RN was assigned to care for one CCU patient and the first patient to be admitted to the CCU. One RN was assigned to care for two CCU patients. There was a MT. The patient acuity was left blank.

- For 1/17/25 at 7 A to 7 P shift, one RN was assigned as the CN and also to monitor the telemetry or cardiac monitors. The CCU had three patients. One RN was assigned to care for two patients and one RN was assigned to care for one patient. One RN was on orientation. There was no MT. The patient acuity was left blank.

- For 1/17/25 at 7 P to 7 A shift, The CCU had six patients with 3 RNs. Two patients were on ventilators. There was no RN assigned as the CN and there was nurse assigned no monitor the telemetry or cardiac monitors. Each RN was assigned to care for two patients. There was a MT. There were five patients on telemetry.

- For 1/18/25 at 7 A to 7 P shift, the CCU had six patients with 5 RNs. One of the 5 RNs was assigned to monitor the telemetry or cardiac monitors for both CCU (for six patients) and Telemetry Unit (for 10 patients). There was no RN assigned as the CN for the CCU. There was no RN assigned for the code blue and RRT for this shift.

- For 1/18/25 at 7 P to 7 A shift, the CCU had four patients. There was no RN assigned as the CN for the CCU. There was no RN assigned to monitor the telemetry or cardiac monitors for both CCU (for four patients) and Telemetry Unit (for 10 patients). There was a MT. There was no RN assigned for code blue and RRT for this shift.

On 3/10/25 at 1600 hours, an interview and concurrent record review was conducted with Interim CNO and Director 1. Director 1 was asked who the Director for CCU was. Director 1 stated he and the Interim CNO had been overseeing the ED and CCU since December 2024 when the Director was on leave. Director 1 verified the ICU staffing on 11/24/24, for the 7 P - 7A shift was out of ratio. The Interim CNO was asked about the M/S nurse who had floated to the CCU. The Interim CNO stated the M/S nurses were trained with ACLS and would monitor the patients on telemetry. The Interim CNO was asked who had monitored the cardiac monitors for telemetry patients if there was no assigned MT. The Interim CNO stated there was a central monitor in the telemetry nursing station and the telemetry CN could monitor the patients and alert the nurses. The EKG strips were run and interpreted by the ICU nurses. If there was a MT, the MT could run the EKG strips and interpret. The CCU CN looked at it and initialed the EKG strips. The Interim CNO was asked about the RN who was assigned as "helping hands" in the ICU. The Interim CNO stated the RN, who was assigned as "helping hands," was the M/S/Telemetry nurses to help admininster the PO, FT, and IV medications but not the medication drips. The Interim CNO was asked about the patient acuity in the CCU. The Interim CNO stated she did not see the acuity was done for the patients, but if the ratio was 1:1, the nurses would do the acuity. However, as per the hospital's P&P, the acuity would be done on all patients in ICU.

The findings were shared with the Interim CNO.

RN SUPERVISION OF NURSING CARE

Tag No.: A0395

Based on observation, interview, and record review, the hospital failed to ensure the nursing staff provided the necessary care and services to three of 22 sampled patients (Patients 2, 3, and 22) as evidenced by:

1. For Patient 2,

a. The oxygen was administered to Patient 2 without a physician's order as per the hospital's P&P.

b. Patient 2 was not monitored every two hours while on Bi-PAP as per the hospital's P&P.

c. The physician was not informed of the patient's change in condition when the oxygen was changed from the nasal cannula to NRM for Patient 2.

d. The MT failed to accurately interpret Patient 2's EKG rhythm strips and inform the CCU or telemetry nurses for the change in cardiac rate and rhythm for 29 minutes, prompting the telemetry nurse to call a code blue after finding the patient was unresponsive and not breathing with dilated pupils.

e. The code blue record did not document the medication doses administered during the code blue for Patient 2.

2. Failure to ensure the alarm of central telemetry monitor was set at the default level or audible to be heard for Patient 22.

3. Failure to collect the urine sample for Streptococcus Pneumoniae Ag laboratory test for Patient 3 as per the physician's order.

These failures created the increased risk of poor health outcomes to the patients receiving services in the hospital.

Findings:

1. On 3/11/25, Patient 2's closed medical record was reviewed and showed Patient 2 was admitted to the hospital on 1/15/25 at 0856 hours, with the chief complaint of syncope.

Review of the ED Provider Aware Note dated 1/15/25 at 0956 hours, showed on 1/15/25 at 0930 hours, Patient 2's SpO2 was 88% on room air. The patient was placed on NRM. The patient had hypoxia. The patient was admitted to the Telemetry at 1440 hours.

a. Review of the hospital's P&P titled Oxygen Therapy dated September 2023 showed the following:

* Policy:

- All free flow oxygen will be delivered via a compensated flowmeter at the exact liter flow as ordered by the physician.

- All oxygen delivered that is more than three liter per cannula or 6 liters per mask will be humidified via the approved humidification equipment.

- RCP's will be responsible for setting up patients/residents on oxygen. Nursing may also start patients/residents on oxygen and will notify the RCP immediately after initiation (except in ER, PACU, and L&D).

* Procedure: Verify the physician's order.

On 3/11/25 at 1505 hours, an interview and concurrent review of Patient 2's closed medical record review was conducted with LVN 1.

Review of Patient 2's oxygen therapy dated 1/18/25, showed the following:

- At 0030 hours, the patient was receiving FIO2 60% via BiPAP. The patient's SPO2 was 96% and the patient's RR was 20 breaths per minute.

- At 0428 hours, the patient was receiving FIO2 60% via BiPAP. The patient's SPO2 was 95 % and the patient's RR was 23 breaths per minute.

- At 0716 hours, the patient was receiving 8 L/min oxygen via nasal cannula with humidification. The patient's SPO2 was 94 % and the patient's RR was 20 breaths per minute.

- At 1110 hours, the patient was receiving 8 L/min oxygen via nasal annual with humidification. The patient's SPO2 was 95 % and the patient's RR was 18 breaths per minute.

- At 1506 hours, the patient was receiving 8 L/min oxygen via nasal annual with humidification. The patient's SPO2 was 94 % and the patient's RR was 18 breaths per minute.

- At 2020 hours, the patient was receiving 15 L/min or FIO2 100 % oxygen via NRM. The patient's SPO2 was 96 % and the patient's RR was 18 breaths per minute.

- At 2350 hours, "CODE BLUE," the patient was receiving 15 L/min or FIO2 100% oxygen via bag valve mask.

However, there was no documented evidence to show the physician's order was obtained for the use of oxygen via nasal cannula and NRM for Patient 2.

On 3/12/25 at 1510 hours, an interview and concurrent review of Patient 2's medical record was conducted with RN 7. RN 7 was asked for Patient 2's physician's order for the use of oxygen. RN 7 stated the physician ordered on 1/16/25 at 0636 hours, BiPAP at bedtime, IPAP 12 cm H2O, EPAP 5 cm H2O, back up rate 15, FIO2 80%, and RT adjust settings for patient's comfort. However, there was no physician's order for oxygen therapy via NRM and nasal cannula for Patient 2.

On 3/13/25 at 1606 hours, an interview and concurrent review of Patient 2's medical record was conducted with Manager 2. Manager 2 was asked about Patient 2's oxygen therapy with 8 L/min via nasal cannula. Manager 2 stated there was no physician's order for the supplemental oxygen and the oxygen could not be given via nasal cannula at 8 L/min, it would not be effective.

b. Review of hospital's P&P titled Bi-PAP, Non-Invasive Ventilatory Support dated April 2024 showed in part:

* Initiation of therapy will be based upon a valid physician's order which must include:

- FIO2: supplemental oxygen will be administered based upon the patient's needs as determined by ABG analysis and/or pulse oximetry.

* Clinical monitoring: all patients receiving non-invasive ventilation must continuously monitored a minimum of every two hours and should include but not limited to

- Cardiac and respiratory rate.

- Use of accessory muscles.

- Auscultation.

- Pulse oximetry.

On 3/12/25 at 1510 hours, an interview and concurrent review of Patient 2's medical record was conducted with RN 7. RN 7 was asked for Patient 2's physician's order for the use of oxygen. RN 7 stated the physician ordered on 1/16/25 at 0636 hours, BiPAP at bedtime, IPAP 12 cm H2O, EPAP 5 cm H2O, back up rate 15, FIO2 80%, and RT adjust settings for patient's comfort.

Review of Patient 2's oxygen therapy dated 1/18/25, showed Patient 2 was receiving FIO2 60% via BiPAP at 0030 and 0428 hours. At 0716 hours, the patient was receiving 8 L/min oxygen via nasal cannula with humidification.

Review of RN's assessment and reassessment showed Patient 2's respiratory assessment was conducted once a shift or on 1/17/25 at 2000 hours and 1/18/25 at 0800 hours. The section of Respiratory Assessment showed Patient 2 ' s breath sounds were crackles on all lung fields on 1/17/25 at 2000 hours and 1/18/25 at 0800 hours. There was no documented evidence to show the auscultation of the patient's lungs was performed when the patient was receiving the BiPAP on 1/18/25 from 0030 to 0428 hours, as per the hospital's P&P.

Review of the oxygen therapy showed Patient 2's SPO2 levels were assessed on 1/18/25 at 0030 and 0428 hours. However, there was no documented evidence to show the patient's SPO2 levels were assessed every two hours when the patient was receiving the BiPAP on 1/18/25 from 0030 to 0428 hours, as per the hospital's P&P.

On 3/12/25 at 1530 hours, an interview and concurrent review of Patient 2's closed medical record was conducted with RT 1 and RN 7. RT 1 was asked about Patient 2's oxygen delivered via nasal cannula and NRM, BiPAP orders, and monitoring with BiPAP use. RT 1 stated the patient's oxygen could be changed from nasal cannula or mask as per the patient's comfort based on the physician's order. The oxygen delivered via nasal cannula could only be at maximum of 6 L/min humidified, the patient was monitored every four hours when the patient was on BiPAP on M/S/Telemetry unit. The RT was asked about Patient 2's ABG, RT 1 stated the patient's oxygen level was low. When asked about how he would maintain and adjust Patient 2's FIO2, RT 1 stated he would titrate the FIO2 as long as the SPO2 was kept above 92%. However, there was no physician's order to titrate FIO2 to maintain SPO2 level above 92%.

On 3/17/25 at 1515 hours, interview was conducted with Interim CNO and Director 3 about Patient 2's assessment and monitoring while the patient was on Bi-PAP. The Interim CNO stated the RNs had the pulse oximeter to check for the SPO2. However, the nursing documentation did not show the SPO2 was monitored every two hours. The findings were shared with the Interim CNO and Director 3.

c. Review of the hospital's P&P titled Assessment and Reassessment dated September 2023 showed in part:

* Policy: Each patient is reassessed every shift by a RN (or as unit specific policies dictate) or more frequently as warranted by the patient's condition. The RN may delegate basic assessment and data collection to the LVN to perform as long as it is within the LVN's scope of practice. The scope and intensity of any further assessment is based on the patient's diagnosis, the care setting, the patient's desire for care, and the patient's response to any previous care.

* Reassessment: Complete daily assessment and reassessment will be done every shift and/or change of condition or per unit policy. The RN must reassess the patient when there is a significant change in condition or diagnosis (example: change in respiratory condition, pain, change of level of consciousness).

* Documentation: Nursing is to document patient's condition and findings, action plan, and how patient responds to treatment, communication with the physician and other disciplines pertinent to the patient's plan of care.

On 3/11/25 at 1505 hours, an interview and concurrent review of Patient 2's medical record was conducted with LVN 1.

Review of RN's documentation for Patient 2 showed on 1/18/25 at 0800 hours, Patient 2 was on 6 L/min oxygen via nasal cannula. At 2000 hours, the RN documented Patient 2 received 11 L/min oxygen via NRM. There was no documented evidence the reason why the patient's oxygen therapy was changed to 11 L/min oxygen via NRM at 2000 hours. There was no documented evidence to show the physician was notified when the patient ' s condition was changed.

LVN 1 was asked for the RN's documentation of Patient 2's change in condition. LVN 1 showed the RN's progress note; however, the RN progress note did not show the physician was notified and communication with other discipline such as the RT about the change in condition when Patient 2's oxygen was increased from 6 L/min humidified oxygen via nasal cannula to 11 L/min via NRM.

The findings were shared with the Interim CNO.

d. Review of the hospital's P&P titled Telemetry/Cardiac Monitoring dated June 2024 showed the following:

* Policy: All patients admitted to CCU will be monitored via hard wire monitoring or telemetry. All patients admitted to other nursing units with physician order for "Telemetry Cardiac Monitoring" will have the cardiac rate and rhythm monitored by CCU team members as per P&P.

* Designated Team Members: RN and LVN

* Telemetry Monitoring on General Nursing Unit:

- Verify order for telemetry.

- Assess the patient history for cardiac dysrhythmias or other cardiac problems and send telemetry request to CCU with the following information: patient's name (addressograph), diagnoses, medications, and other pertinent information such as potassium level or cardiac history.

- If contacted by CCU nurse of any change in patient rate or rhythm, go to the patient's bedside, call CCU nurse from patient bedside at ext. 5522 and report patient condition and any changes made (battery change, electrode change etc.); report any significant changes to patient's physician.

* CCU Team Members will

- Observe monitor rate/rhythm at central station in CCU and document on telemetry log every 4 hours.

- Obtain EKG strips on initiation or admission, every shift, and with rhythm changes.

- Interpret strips for rhythm, rate, presence, and configuration of P waves, length of PR interval, length of QRS complexes, T waves, length of QT intervals, and presence of dysrhythmias.

- Set the alarms on the basis of patient's clinical status and heart rate.

- Notify patient's nurse of any rate or rhythm changes.

- Document on the strip any reported signs and symptoms, timing of drugs or other treatments that may have effects or cause change in patient rate or rhythm. All symptomatic tachy or brady arrhythmias and all rhythms that require immediate treatment will be documented in the patient's medical record.

- Mount rhythm strips on patient medical record. It is not acceptable to substitute written diagnosis statements for the tracings themselves.

- If any significant changes in patient rate or rhythm, call rapid response or code blue as appropriate and notify patient's nurse and physician.

* Points of emphasis: Place the strips of significant changes in center page with strips of before and after the event. Do not fold or wind rolls of ECG strips onto the chart as data is lost when chart is copied or scanned.

Review of the CCU Staff Assignment for 1/18/25, for the 7P to 7A shift showed two CCU RNs were assigned to care for four CCU patients, one M/S RN was assigned for "helping hands", one sitter was assigned for a 1:1 patient, and one MT to monitor the CCU and Telemetry Unit's cardiac monitors. There was no RN assigned as the CCU CN. There was no RN assigned for code blue and RRT.

On 3/10/25 at 1610 hours, interview with the Interim CNO was conducted. The Interim CNO was asked who monitored the patients' telemetry if there was no assigned CN and/or MT in the CCU. The interim CNO stated the CN in M/S unit could monitor the patients who were on telemetry. There was a central monitor in the nursing station and could alert the nurses if there was arrhythmia. The CCU nurses ran and interpreted the telemetry EKG strips. If there was a MT, the MT ran and interpreted the EKG strips, and the CCU CN looked at it and verified the interpretation.

Review of Patient 2's EKG strips showed the following:

- On 1/16/25 at 0701 hours, the patient's heart rate was 80 bpm and the patient's had SR. And at 1927 hours, the patient's heart rate was 83 bpm, and the patient had SR.

- On 1/17/25 at 0854 hours, the patient's heart rate was 86 bpm, and the patient had SR. And at 2125 hours, the patient's heart rate was 83 bpm, and the patient had SR.

- On 1/18/25 7A to 7P shift, there was no documentation of the EKG strip.

- On 1/18/25 at 1900 hours, the patient's heart rate was 82 bpm, and the patient had SR. At 2316 hours, the patient's heart rate was 58 bpm, and the patient had "SB/pacemaker not firing." At 2326 hours, the patient's heart rate was 47 bpm, and the patient had "Brady" and "pacemaker starts." At 2344 hours, the patient's heart rate was 61 bpm, and the patient had "paced/PEA?" At 2345 hours, the EKG strip showed "CPR"; however, there was no rhythm interpretation. There was no documented evidence to show the CCU nurse or Patient 2's primary nurse was notified of the change in the patient's cardiac rate and rhythm on 1/18/25 at 2316, 2326, 2344, and 2345 hours. There was no documented evidence to show the patient's cardiac rhythm was interpreted by the CCU nurse on 1/18/25 at 2316, 2326, 2344, and 2345 hours as per the hospital's P&P.

On 3/11/25 at 1330 hours, interview and concurrent review of Patient 2's closed medical record was conducted with the Interim CNO. The Interim CNO verified MT 2 ran the recorded EKG strips for 1/18/25, for the 7P to 7A shift, and there was no documented evidence the nurse in CCU or Telemetry was notified when the patient's rate and rhythm had changed. Patient 2 had changes in the cardiac rate and rhythm from 2316 hours to 2345 hours (29 minutes), the MT was noting the patient had pacemaker or having PEA without notifying the nurse to verify of the condition change prompting the telemetry nurse to call a code blue at 2350 hours when RN 6 and the RT found the patient unresponsive and not breathing with dilated pupils. The Interim CNO was asked about the hospital's P&P for Telemetry or Cardiac Monitoring did not include the MT as one of the CCU's Team Members. The Interim CNO stated the MT stayed in CCU to monitor the Telemetry. The Chief Quality and Patient Safety Officer stated there was another hospital's P&P that she could provide.

Review of the hospital's P&P titled Telemetry Criteria: Standardized Procedure dated May 2024 showed the following:

* Purpose: To provide evidenced based guidelines for implementation of cardiac telemetry monitoring including criteria for initiation and discontinuation based on Medical Staff approval of the American Heart Association Practice Standards for Electrocardiographic Monitoring in the hospital setting.

* Policy: RN and MT who have met the required education requirements may access and interpret cardiac rhythms for patients on cardiac monitoring.

On 3/11/25 at 1505 hours, an interview and concurrent record review for Patient 2 was conducted with LVN 1.

Review of the ED Provider Aware Note dated 1/15/25 at 0956 hours, showed Patient 2 came to the ED from home complaining of syncopal episode. Patient 2 had the history of ESRD, on HD, DM, HTN, and five stents placed 4 years ago. Patient 2's EKG showed normal sinus rhythm. The patient's disposition was to admit to the telemetry unit. Patient 2 did not have a history of pacemaker; however, on 1/18/25, the EKG strips showed the MT documented "paced" or "pacemaker starts".

On 3/11/25 at 1605 hours, a tour and observation at telemetry nursing unit was conducted with LVN 1. RN 4 was asked about the telemetry monitoring at the nursing station and how she would know or be notified if the patient was having arrhythmia. RN 4 stated the telemetry monitor in their nursing station did not alarm, it would only flash, the MT would notify them when the MT identified arrhythmia. They always had a MT that was in CCU.

On 3/12/25 at 1025 hours, interview and record review for Patient 2 was conducted with RN 3, the Interim CNO and MT 1. RN 3 was asked about the monitoring of telemetry patients. RN 3 stated when she had patients, she did not have time and could not sit and keep an eye on the monitor for the telemetry patients. When asked how she would know if the telemetry patient had change in rhythm or arrythmia that needed attention. RN 3 stated the MT would inform her. RN 3 was asked about the EKG logbook. RN 3 showed the logbook documentation for every 4 hours monitoring of the patient ' s heart rate and rhythm; however, the log for Patient 2 on 1/18/25 from 0800 hours to 2000 hours were left blank.

e. Review of hospital's P&P titled Code Blue dated April 2024 showed in part:

*Post Code Procedures: the following are duties of the primary nurse; however, may be delegated as needed:

- Ensure complete documentation, including code blue form completed and a copy to be sent to Pharmacy and copies of the EKG strips.

On 3/12/25 at 0800 hours, interview and concurrent review of Patient 2's medical record was conducted with Director 1.

Review of the Code Blue Record for Patient 2 showed a code blue was called on 1/18/25 at 2350 hours, due to cardiopulmonary arrest. Patient 2 was found unconscious, not breathing, pulseless, and pupils were dilated. An intraosseous was inserted on the left and right knee for ACLS medication administration. Epinephrine (an emergency medication used during the code blue) was administered three times; however, the dose of epinephrine was not documented each time that the medication was administered. Calcium (an emergency medication used during the code blue) was administered; however, the dose of calcium and completed name of calcium was not accurately documented. Sodium Bicarb (an emergency medication used during the code blue) was administered at 2355 hours and 0003 hours; however, there were no doses of the medications (epinephrine, calcium, and sodium bicarb) each time it was given. Director 1 was asked to clarify the medications administered during the code blue. Director 1 verified the medication doses given were not documented.

On 3/12/25 at 1505 hours, the Interim CNO was asked to show the EKG strips recorded when Patient 2 had cardiopulmonary arrest and expiration after performing the code blue measures. The Interim CNO stated she would ask and look for it; however, there was no EKG strip documentation provided for the code blue and at the time the patient was pronounced dead on 1/19/25 at 0008 hours.

2. Review of the hospital's P&P titled Clinical Alarms dated April 2024 showed in part:

* Definition: Clinical alarm - a patient generated physiologic monitoring and diagnostic system that contains audible and/or visual alarms designed to alert staff to life-threatening or critical changes in a patient's condition. Equipment with clinical alarm systems include but not limited to defibrillators, ventilators, infusion pumps, ECG monitors, blood pressure monitors, bedside telemetry, central station monitors, anesthesia machines, bed alarms, feeding pumps, and laboratory analyzers.

* Policy:

- All hospital and medical staff who use medical equipment will check alarm settings prior to device use to ensure that they are appropriate and that audible alarms will be clearly discernable relative to ambient and competing noise.

- At no time will hospital staff bypass, shut off or adjust medical equipment alarm volumes to a level that cannot be readily heard when the alarm activates.

On 3/17/25 at 1248 hours, an observation at the telemetry unit was conducted with RN 7. The central telemetry monitor was observed to have a patient's heart rate of more than 176 bpm and flashing red tachy. The patient was Patient 22 assigned on Telemetry 6. The monitor alarm sound was not audible. When being very near the telemetry monitor, the alarm sound was very soft and short. RN 4 was asked to show the alarm setting for Patient 22's telemetry. The alarm setting sound was at level 2; however, the default alarm sound was at level 6. RN 7 stated the setting of the central telemetry monitor was controlled in CCU by the MT. A telephone interview with MT 3 and RN 7 was conducted. MT 3 was asked about the alarm level for Patient 22. MT 3 stated Patient 22 had high heart rate which was up to 170s for two hours and was about to be transferred to ICU. MT 3 stated he silenced the monitor alarm on his side at the CCU.


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3. On 3/11/25, review of Patient 3's closed medical record was initiated with LVN 1. Patient 3's closed medical record showed the patient was admitted to the hospital on 2/2/25, with a diagnosis of pneumonia and influenza.

Review of the physician's order dated 2/5/25, showed to collect urine sample for Streptococcus pneumonia antigen laboratory test for Patient 3.

Further review of Patient 3' s medical record showed the urine sample was not collected for Streptococcus pneumonia Ag testing as ordered by the physician, and did not show the reason the urine was not collected. The findings were verified with LVN 1.

ADMINISTRATION OF DRUGS

Tag No.: A0405

Based on interview and record review, the nursing staff failed to ensure the heparin IV drip medication was administered as per physician's order for one of 22 patients (Patient 9). This failure created the risk of substandard health outcomes to the patient.

Findings:

Review of the hospital's P&P titled Anticoagulation, Therapeutic Heparin dated November 2023 showed the nursing department responsibilities include verification (documented) must be done for initial and any changes to therapy by a second nurse. If there is difficulty in determining the change in rate, the nurse may contact the on-call pharmacist for assistance.

Review of the heparin protocol for AMI/ACS showed the APTT goal is between 59 to 96 seconds and the first APTT was scheduled 6 hours after the bolus (loading dose). When the APTT level is between 50 - 59 seconds, the rate will be changed by increasing 1 unit per kg per hour. When the APTT level is between 60 - 85 seconds, there will be no change in the rate.

On 3/13/ 25 at 1430 hours, an interview and concurrent review of Patient 9's medical record was conducted with RN 7.

Patient 9's medical record showed Patient 9 was admitted to the hospital on 3/7/25.

Further review of Patient 9's medical record showed on 3/7/25 1506 hours, the physician ordered for heparin drip 25,000 units in 250 ml D5W (Dextrose 5% in Water, an IV solution) with the initial dose of 15 units per kg per hour, IV rate of 10 ml per hour for chest pain. The baseline PTT was 29.1 seconds (the normal range is between 25.1 to 36.5 seconds).

Review of Patient 9's eMAR showed on 3/7/25 at 1720 hours, a bolus of 3000 units IV was administered and the drip was started at 1723 hours with the rate of 9 ml per hour. However, the physician's order for the IV rate was 10 ml per hour.

Further review of Patient 9's medical record showed the APTT level was drawn at midnight of 3/8/25 and resulted at 0100 hours with the level of 61.9 seconds. At 0600 hours, the APTT was drawn and resulted at 0712 hours with the level of 56.2 seconds. At 0748 hours, the heparin drip was stopped. However, according to the heparin protocol, for the APTT level between 50 to 59 seconds, the rate should be changed by increasing 1 unit per kg per hour.

RN 7 stated there was a physician's order on 3/8/25 at 0826 hours, to administer heparin 1900 units IV once, then increase the drip to 10 ml or 1000 units per hour. When asked for the reason of stopping the heparin drip at 0748 hours, RN 7 verified it was not as per protocol and could not find documentation to show the reason why the heparin drip was stopped.

BLOOD TRANSFUSIONS AND IV MEDICATIONS

Tag No.: A0410

Based on interview and record review, the hospital failed to ensure the nursing staff administered the blood transfusion to two of 22 sampled patients (Patients 2 and 8) as evidenced by:

1. For Patient 2, the blood transfusion was not administered in the morning as per the physician's order.

2. For Patient 8, the blood transfusion was not started and monitored as per the hospital's P&P.

These failures increased the risk of substandard care for the patients receiving care in the hospital.

Findings:

1. Patient 2's closed medical record was reviewed and showed Patient 2 was admitted to the hospital on 1/15/25.

Review of Patient 2's laboratory result showed on 1/18/25 at 0126 hours, Patient 2's platelet level was critical low or was 14 K/uL (normal range: 152 - 348 K/uL).

Review of the physician's order dated 1/18/25 at 0209 hours, showed the order to transfuse one unit of platelet over one hour in the morning for the platelet level of 14 K/uL.

Review of the nurses' notes dated 1/18/25 at 0800 hours, showed Patient 2 was waiting for the unit of platelet from the blook bank.

Review of the blood bank documentation showed the blood bank received one unit of platelet on 1/18/25 at 1014 hours, from Vendor 1 and the unit of platelet was issued to the nurse at 1306 hours.

Review of Patient 2's medical record showed on 1/18/25, the platelet transfusion was started at 1322 hour and stopped at 1352 hours.

On 3/17/25 at 1200 hours, an interview and concurrent review of Patient 2's closed medical record was conducted with Director 7, CLS 1, and the Interim CNO. When asked if the blood bank staff had notified the nurse when the platelet was ready for transfusion, CLS 1 confirmed there was no documented evidence to show the blood bank staff had called the nurse when the platelet was received from Vendor 1 at 1014 hours. Closed medical record review showed Patient 2 did not receive the platelet transfusion in the morning as per the physician's order. The findings were verified with the Interim CNO.




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2. Review of the hospital's P&P titled Blood Administration and Transfusion Reactions dated February 2024 showed in part:

* Prior to blood and blood product transfusion, vital signs will be taken with 15 to 30 minutes before transfusion begins.

* Record date or time the transfusion was started (when blood hits the vein) as the time the blood entered the patient venous access on the blood transfusion form or in the patient's electronic record.

- Note: It is critical to correctly document this time as the first 15 - 30 minutes of a transfusion is when many reactions occur. Perform vital signs 15 minutes after the product hits the vein. A nurse must remain with the patient for the first 15 minutes of every blood and blood products transfusion.

* Administer blood or component slowly for the first 15 minutes at a rate between 60 to 120 ml/hour (1-2 ml/min).

* Vital signs must be taken at the following intervals:

- 15 to 30 mins prior to start of transfusion time.

- 15 minutes after start of transfusion (the time the blood entered the patient venous access).

- 30 minutes

- One hour

- Two hours

- Three hours

- Completion time

- 15 to 30 mins after completion

On 3/12/25 at 1335 hours, interview and concurrent review of Patient 8's closed medical record was conducted with LVN 1 and RN 7.

Patient 8's closed medical record showed the patient was admitted to the hospital on 2/17/25 and discharged on 3/9/25.

Review of Patient 8's order for blood transfusion showed on 2/27/25 at 1316 hours, an order to transfuse one unit PRBC over three hours.

Review of Patient 8's blood transfusion vital signs record showed on 2/27/25, the vital signs were taken as follows:

- At 1529 hours, the pre vital signs prior to the blood transfusion.

- At 1545 hours, the vital signs for the start of the blood transfusion.

- At 1615 hours, the vital signs for 30 minutes after the start of the blood transfusion.

- At 1715 hours, the vital signs for one hour after the start of the blood transfusion.

- At 1815 hours, the vital signs for two hours after the start of the blood transfusion.

RN 7 was asked for the completion time of Patient 8's blood transfusion. RN 7 stated the completion time was at 1815 hours. RN 7 was asked for the vital signs that would be taken 15 to 30 minutes after the blood transfusion was completed. RN 7 could not show documentation of the vital signs was taken 15 to 30 minutes after the blood transfusion was completed. RN 7 was asked for the documentation of the blood flow rate of 60 to 120 ml/hour for the first 15 minutes of the blood transfusion. RN 7 stated there was no documentation to show the rate was documented in Patient 8's medical record.

ADEQUACY OF LABORATORY SERVICES

Tag No.: A0582

Based on interview and record review, the hospital failed to maintain the adequate blood product inventory levels to meet the patient needs. This failure posed the risk of substandard care to the patients.

Findings:

Review of the hospital's P&P titled Inventory Control - Ordering, Stocking and Returning Blood Products dated January 2018, showed the following:

* It is the responsibility of the Transfusion Service Technologist on all shift to maintain adequate blood product inventory levels to meet the needs of our patients.

* All routine stock orders will be delivered the same day between 1600-1800.

* Inventory: Par levels that should be maintained daily

- O positive: 12 PRBC and 4 FFP.
- A positive: 10 PRBC and 3 FFP.
- B positive: 6 PRBC and 6 FFP.
- AB positive: 2 PRBC and 2 FFP.
- O negative: 2 PRBC and 2 FFP.
- A negative: 2 PRBC
- B negative: 2 PRBC

If Vendor 1 is low in inventory in times of blood shortage, Vendor 1 will stock at only 50% of this inventory. Call the secondary provider for units not met by Vendor 1.

Review of the Daily Blood Product Inventory Management showed the following:

* Liquid Plasma minimum of one for Group A and one for Group AB based on availability from the supplier.

* These amounts are minimum requirement to have in the laboratory at all times.

* A negative: a minimum of 2 RBC.

* A positive: a minimum of 3 RBC.

* B negative: a minimum of 2 RBC.

* B positive: a minimum of 2 RBC.

* O negative: a minimum of 4 RBC.

* O positive: a minimum of 12 RBC.

On 3/11/25 at 0900, an observation of the laboratory service area was conducted with Manager 1 and LVN 1. The blood bank refrigerator was observed to not have the minimum requirement of blood products in their blood bank inventory. Manager 1 stated the CLS called Vendor 1 every morning and determined how much blood products the hospital might need. The CLS could get the blood products from the sister hospitals or could use the O negative blood type (universal blood type) for A negative and B negative blood type patients.

Review of the Daily Blood Product Inventory Management forms dated 1/17 and 1/18/25, showed the hospital's blood bank had the following blood products:

* A positive: 2 RBC
* B positive: 2 RBC
* O negative: 2 RBC
* O positive: 7 RBC

Review of the Daily Blood Product Inventory Management forms dated 3/1 and 3/4/25, showed the hospital's blood bank had the following blood products:

* A positive: 4 RBC
* B positive: 2 RBC
* O negative: 2 RBC
* O positive: 6 RBC

Review of the Daily Blood Product Inventory Management form dated 3/2/25, showed the hospital's blood bank had the following blood products:

* A negative: 1 RBC
* A positive: 4 RBC
* B positive: 2 RBC
* O negative: 1 RBC
* O positive: 6 RBC
* A negative and A positive: 2 cryoprecipitate
* B negative and B positive: 2 cryoprecipitate
* O negative and O positive: 1 cryoprecipitate
* AB negative: 2 FFP
* AB positive: 3 FFP

Review of the Daily Blood Product Inventory Management form dated 3/3/25, showed the hospital's blood bank had the following blood products:

* A negative: 1 RBC
* A positive: 4 RBC
* B positive: 2 RBC
* O negative: 2 RBC
* O positive: 6 RBC
* A negative and A positive: 2 cryoprecipitate
* B negative and B positive: 2 cryoprecipitate
* O negative and O positive: 1 cryoprecipitate
* AB negative: 2 FFP
* AB positive: 3 FFP

Review of the Daily Blood Product Inventory Management form dated 3/5/25, showed the hospital's blood bank had the following blood products:

* A positive: 4 RBC
* B positive: 2 RBC
* O negative: 1 RBC
* O positive: 6 RBC
* A negative and A positive: 2 cryoprecipitate
* B negative and B positive: 2 cryoprecipitate
* O negative and O positive: 1 cryoprecipitate
* AB negative: 2 FFP
* AB positive: 3 FFP.

Review of the Daily Blood Product Inventory Management form dated 3/6/25, showed the hospital's blood bank had the following blood products:

* A positive: 4 RBC
* B positive: 2 RBC
* O negative: 1 RBC
* O positive: 4 RBC
* A negative and A positive: 2 cryoprecipitate
* B negative and B positive: 2 cryoprecipitate
* O negative and O positive: 1 cryoprecipitate
* AB negative: 2 FFP
* AB positive: 3 FFP.

The number of blood products ordered and received were left blank in the Daily Blood Product Inventory Management forms on the above days.

An interview and concurrent review of the Daily Blood Product Inventory Management forms was conducted with CLS 1 and the Chief Quality and Patient Safety Officer on 3/12/25 at 1351 hours. CLS 1 stated the CLS called Vendor 1 in the morning and documented the blood products ordered and received in the Daily Blood Product Inventory Management forms. CLS 1 confirmed the above Daily Blood Product Inventory Management forms did not document the blood products which were ordered and received by the hospital's blood bank and the reason why they did not meet the required minimum blood product inventory. CLS 1 verified the amount of blood products inventory of hospital's P&P titled Inventory Control - Ordering, Stocking and Returning Blood Products and the Daily Blood Product Inventory Management form did not match. CLS 1 stated they would change the hospital's P&P to reflect the blood product requirement in the hospital. The Chief Quality and Patient Safety Officer verified the above findings.

FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE

Tag No.: A0724

Based on observation, interview, and record review, the hospital failed to ensure the facilities, supplies, and equipment were maintained in multiple patient care areas to assure the safety and quality for patient care. This failure posed the increased risk of substandard health outcomes to the patients.

Findings:

Review of the hospital's P&P titled Preventative Maintenance Verification System dated 4/12/17, showed the following:

* Policy: Biomedical Engineering is to use a color-coded sticker system to identify equipment's preventive maintenance due date, performance verification indication, and functional status.

* Procedure:

- Preventive Maintenance color-coded stickers will be used based on the month or year that the service is due and frequency of service (Reference, "Preventive Maintenance and Performance Sticker Chart," attached)

- Preventive maintenance stickers must have the following information by the biomedical technician: date of service; serviced by initials; next inspection due date, month and year minimum; and service performed indicated.

Review of the hospital's P&P titled Equipment Testing dated 4/12/17, showed the following:

- Scope: Biomedical Engineering

- Purpose: To establish specific guidelines for the testing and inspection of all Clinical Equipment, defined as follows: "any device whose use is therapeutic or diagnostic in nature."

- Policy: Preventive and corrective maintenance actions shall be made in accordance with manufacturer's specifications and accepted industry standards.

* Procedure:

- All hospital owned clinical equipment will be tested for safety, proper operation and proper function: before initial use; after major repairs or upgrades; as indicated in the Quality Assurance or Risk Assessment Policy; after any accident or damage, real or suspected; before a unit is removed from temporary storage and placed in service.

- Preventive maintenance shall be performed in accordance with the manufacturer specifications, accepted industry standards, or by application of the alternate equipment management (AEM) program allowed by CMS.

- An electrical safety inspection shall be completed at least annually on equipment powered by greater than pr equal to 110 VAC.

Review of the hospital's P&P titled Clinical Alarms dated April 2024 showed in part:

* Definition: Clinical alarm - a patient generated physiologic monitoring and diagnostic system that contains audible and or visual alarms designed to alert staff to life-threatening or critical changes in a patient's condition. Equipment with clinical alarm systems include, but not limited to defibrillators, ventilators, pumps, ECG monitors, blood pressure monitors, bedside telemetry, central station monitors, anesthesia machines, bed alarms, feeding pumps, and laboratory analyzers.

* Policy:

- The biomedical engineering will ensure that all clinical alarms are functional at the appropriate settings and are sufficiently audible with respect to distances and competing noises within the unit.

* Procedure: The Biomedical Engineer will inspect all medical equipment prior to use. The evaluation of equipment includes a determination of the processes that will be used to test, inspect, and maintain the equipment. These strategies include:

- Inspections based on the manufacturer's specifications.

- Equipment with clinical alarm systems on a regular preventive maintenance schedule. Biomedical Engineer tracks the inspection, testing, and maintenance of the medical equipment.

- Biomedical Engineer shall be responsible for maintaining a master inventory listing which includes all devices with design incorporated clinical alarm features.

- Biomedical Engineer shall test and document the proper function of clinical alarms on all applicable equipment as a component of scheduled inspections. Inspections are performed as defined in the Medical Equipment Management Plan.

Review of hospital's P&P titled Safety Maintenance Plan dated November 2023 showed in part:

* Safety Risk Management: The Safety Officer is designated to manage risk, coordinate risk reduction activities in physical environment, collect deficiency information, and disseminate summaries of actions and results. The Safety Officer assures that compliance with applicable codes and regulations, as applied to the buildings and services are provided at the hospital.

1.a. On 3/17 45 at 1045 hours, an observation of the ED was conducted with LVN 1. The following critical equipment was observed to have the PM with its expiration dates:

- One ETCO2 channel

- One IV pump channel

- One portable vital sign machine

b. On 3/18/25 at 0840 hours, an observation at the cardiology room with Biomedical Technician 1 and Lead Technician Echocardiology. A thermometer was observed to have PM with its past due date.

c. On 3/18/25 at 0930 hours, an observation of the ICU was conducted with RN 7. The following equipment was observed:

- One cardiac monitor in Room 9 did not have a PM sticker.

- One portable doppler had the overdue PM.

- One Hoyer lift had no PM stickers.

d. On 3/18/25 at 1010 hours, observation of the central supply room next to ICU was conducted with RN 7. The following equipment was observed:

* Ventilators showed the PM sticker dated 2023.

* One hypothermia blanket had no PM sticker.

* One TF machine had overdue for PM.

e. On 3/18/25 at 1010 hours, an observation of the Telemetry Unit was conducted with RN 7. The following equipment was observed:

* Central Telemetry Monitor, Eye scope, and Otoscope had no PM stickers.

f. On 3/18/25 at 1050 hours, during the observation in the ICU with RN 3 and RN 7, the following equipment was observed with its expiration dates:

- Two Thora-Para French 8 catheter drainage trays

g. On 3/18/25 at 1122 hours, during an observation in Radiology Room 3 with RN 7 and the Radiology Technician, the following equipment was observed with its expiration dates:

- One 2-lumen hemodialysis catheter.

- Five 2-lumen PICC lines.

- Nine midline 2- lumen.

- One Thora Para 8-french catheter drainage.

- Three soft tissue biopsy trays.

2. On 3/18/25 at 0930 hours, an observation of the ICU was conducted with RN 7. The following was observed:

* In ICU 7, wall vacuum for wall suction outlet was inoperable

An interview with RN 3 and RN 7 was conducted regarding the note posted by the door of ICU 7 dated 2/19/25. RN 3 stated the vacuum has not been working since 2024. The date posted on the door was the last date RN had communicated with engineering department staff.

On 3/18/25 at 1220 hours, interview with Director 6 was conducted. When asked about the vacuum at the ICU 7. Director 6 stated he had not received any approval from the corporate office for the vendor to repair.

3. Review of the hospital's P&P titled Medical Radiation Physicist dated September 2023 showed in part:

* Policy:

- Radiology Services retains a Qualified Physicist (QMP) for the performance of surveys of imaging equipment on an annual basis for proper operation.

- The QMP works collaboratively with the Radiologist and Technologists to ensure that all radiation producing, and related equipment remains safe and suitably calibrated, that radiation dose determinations are accurate, and that all imaging modalities are functioning at their optimal levels. The QMP ensures that all such equipment, policies and procedures are in compliance with state and federal regulations and in keeping with published standards. The QMP's primary professional responsibility is to the staff and patient's safety and welfare.

On 3/17/25 at 1158 hours, an observation of the radiology service area and concurrent interview was conducted with RN 7 and Director 8. A portable x-ray machine showed the quality assurance sticker with the date of 10/2023. Director 8 was asked for the annual medical physicist report. Director 8 stated the portable x-ray machine needed the battery change to be done in December 2024; however, the battery was changed on 1/15/25, and he did not call the physicist before the machine was put in service again.

4. On 3/18/25 at 1132 hours, observation of the L&D and Newborn unit was conducted with RN 7, RN 11, and RN 12. RN 12 was asked about the central bedside fetal monitoring at the nursing station. RN 12 stated it had not worked for years. RN 12 stated the nurses would go back and forth to the room to monitor the baby. It was also observed to have a leaking faucet in the hearing test room for the neonates.

On 3/18/25 at 1310 hours, interview was conducted with Biomedical Technician 1. Biomedical Technician 1 was asked about the central monitor at the L&D. Biomedical Technician 1 stated the PC of the central monitor was not working, it needed a new PC, and he informed the CEO and CNO at that time. Biomedical Technician 1 showed the work order dated 10/4/23, showing the L&D central bedside monitor computer had crashed and could not be repaired.

5. On 3/17/25 at 1500 hours, interview was conducted with the Biomedical Technician 1 about the PM. Biomedical Technician 1 stated after checking the machines he changed the PM sticker. When asked about the color-coded sticker system to identify equipment's PM, the Biomedical Technician 1 stated we ran out of the stickers.

a. On 3/17/25 at 1045 hours, an observation of the ED was conducted with LVN 1. The following equipment's PM stickers were observed to have the current due dates; however, the these PM stickers were in white color (which was not following the hospital's P&P):

- One Pediatric Zoll defibrillator

- One adult defibrillator

- Cardiac monitors

- Thermometers

- IV pumps (pump and channel)

- One portable vital signs machine

- One EKG machine

b. On 3/17/25 at 1158 hours, an observation of the radiology service area was conducted with RN 7 and Director 8. The following equipment's PM stickers were observed to have the current due dates; however, the these PM stickers were in white color (which was not following the hospital's P&P):

- One portable x-ray #2

- One C-arm and monitor

c. On 3/18/25 at 0840 hours, an observation at the cardiology room with Biomedical Technician 1 and Lead Technician Echocardiology. The following equipment's PM stickers were observed to have the current due dates; however, the these PM stickers were in white color (which was not following the hospital's P&P):

- One echocardiogram machine

- One treadmill and EKG

- One vital signs machine

d. On 3/18/25 at 0930 hours, an observation of the ICU was conducted with RN 7. The following equipment's PM stickers were observed to have the current due dates; however, the these PM stickers were in white color (which was not following the hospital's P&P):

- IV pumps and channel

- Bedside cardiac monitors

- TF pumps

- Ventilators

- SCD machines

- Thermometers

e. On 3/18/25 at 1008 hours, an observation of the respiratory therapy room was conducted with RN 7. The following equipment's PM stickers were observed to have the current due dates; however, the these PM stickers were in white color (which was not following the hospital's P&P):

- One ABG analysis machine

- One high flow oxygen therapy device

f. On 3/18/25 at 1010 hours, an observation of the central supply room next to ICU was conducted with RN 7. The following equipment's PM stickers were observed to have the current due dates; however, the these PM stickers were in white color (which was not following the hospital's P&P):

- Ventilators

- Telemetry boxes

- One TF machine

- IV pumps

f. On 3/18/25 at 1010 hours, an observation of the Telemetry Unit was conducted with RN 7. The following equipment's PM stickers were observed to have the current due dates; however, the these PM stickers were in white color (which was not following the hospital's P&P):

- One vital sign machine

6. On 3/18/25 at 0830 hours, an observation of the radiology service hallway area was conducted was with Biomedical Technician 1. The middle hallway was observed to have a garbage can with cloth under.

On 3/18/25 at 1220 hours, an interview was conducted with Director 6. Director 6 was asked about the garbage can at the radiology service hallway area. Director 6 stated the hospital requested for a crane to remove the AC from the roof to repair the leaking roof.


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7. On 3/18/25 at 1000 hours, a tour of the kitchen was conducted with the Clinical Dietitian and Dietary Clerk. The following was observed:

* Ice buildup on the ceiling and black pipe in the ceiling of the walk-in refrigerator.

* Multiple trays used to serve food were chipped.

* The floor was broken in multiple area and was unable to be cleaned.

On 3/18/25 at 1122 hours, Director 6 was informed the findings.

8. On 3/12/25 at 0813 hours, a tour of the OR was conducted with RN 2. One of four hand washing sinks was observed being leaked. RN 2 confirmed the findings.

VENTILATION, LIGHT, TEMPERATURE CONTROLS

Tag No.: A0726

Based on observation, interview, and record review, the hospital failed to ensure the temperature and humidity was maintained in ICU, Radiology, and the OR. These failures created a potential risk for an unsafe environment.

Findings:

Review of the hospital P&P titled Climate Control dated August 2023 showed in part:

* Purpose: to ensure a comfortable and safe environment for all patients, visitors, and staff members.

* Policy: The facilities department is responsible for maintaining comfort ambient temperatures throughout all buildings.

* Normal temperature ranges will be maintained between 68- and 74-degrees F excluding the L&D and OR where the temperatures may be selected to a lower temperature.

Review of the hospital's titled Humidity Readings dated August 2023 showed in part:

* Policy: Humidity readings for the operating rooms, delivery rooms, and nurseries will be recorded by the individual departments. Calibration of the indicating equipment will be performed by the Facilities Department.

* Procedure: Humidity readings will be recorded by those departments needing to maintain a record of humidity levels. The documents will remain with the recording department for as long as necessary.

1. On 3/17/25 at 1203 hours, an observation of Radiology Room 3 was conducted with RN 7 and Director 8. Director 8 stated Radiology Room 3 had not been used for years and used now for storage of other machines and supplies. The room was observed to have packs of PICC lines, hemodialysis catheters that contained 1% lidocaine (a local anesthetic, a numbing medication) 5 ml to be kept between 20 to 25 degrees C (68 - 77 degrees F). The air condition thermostat was observed not working. When asked for the temperature monitoring for this room, Director 8 could not show documented evidence showing the room temperature was monitored.

On 3/18/25 at 1220 hours, an interview was conducted with Director 6. Director 6 was asked about the non-working thermostat at Radiology Room 3. Director 6 stated he would check.

2. On 3/18/25 at 1050 hours, an observation of the ICU clean utility room was conducted with RN 7 and RN 3. The portable thermometer showed the temperature level was less than 20 degrees C (or less than 68 degrees F). When asked what was stored in the clean utility room, RN 3 showed the following sterile packs that contained 1% lidocaine 5 ml to be kept between 20 to 25 degrees C (68 - 77 degrees F).

- Arterial Line

- TLC

- Lumbar puncture trays

- Soft tissue biopsy trays

- 2 Lumen CVC trays

RN 3 verified the findings.


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3. Review of the hospital's P&P titled Temperature and Humidity Monitoring - OR dated September 2023 showed the temperature and humidity in the surgical services are assessed twice a day during every day of operation by the assigned personnel who is competent of the procedure. The temperature and humidity readings are recorded, including decimal points, on the designated log and kept in the department. If the temperature and humidity is out of range, wait for 30 minutes and repeat the reading. If it is still out of range, notify Engineering for correction. For humidity measurements higher than the targeted range of 60%, engineering will assess the situation and determine if the humidity can be brought down with any adjustments to the temperature control or HVAC system. The temperature and humidity levels will be in accordance with the AORN.

According to the AORN's Guidelines for Design and Maintenance dated 7/20/23, the design parameters for HVAC are as following:

* For OR and Cesarean Delivery Room:

- The temperature level will be between 68 and 75 degrees F.

- The relative humidity level will be between 20 to 60%.

* For Sterile Processing Clean Assembly Workroom:

- The temperature level will be between 68 and 73 degrees F.

- The maximum relative humidity level will be 60%.

a. Review of the Temperature & Humidity form showed if temperature and/or humidity is out of range, wait for 30 minutes and repeat the reading, if it is still out of range, follow these steps:

* Immediately notify engineering.

* Document on the Temperature & Humidity follow-up and correction log any correction action taken to correct temperature and/or humidity.

* If still unable to maintain appropriate temperature and humidity in required area, notify nursing supervisor, infection control, affected department manager and senior management immediately.

* The temperature range for OR and L&D will be between 68 and 75 degrees F.

* The relative humidity range for OR and L&D will be between 20 to 60 %.

* The temperature range for SPD will be between 68 and 73 degrees F.

* The maximum relative humidity level for SPD will be 60%.

Further review of the Temperature & Humidity forms for February and March 2025 showed there was no documented evidence any correction actions were taken to correct the temperature levels when they were out of ranges. For example,

* On 2/1/25, the temperature levels of OR 1, OR 2, and L&D 1 were 61.3, 64.8, 65.4 degrees F, respectively.

* On 2/3/25, the temperature level of OR 1 was 63.2 degrees F.

* On 2/5/25, the temperature level of OR 1 was 66.8 degrees F.

* On 2/8/25, the temperature levels of OR 1 and L&D 1 were 61.6 and 64.9 degrees F, respectively.

* On 2/16/25, the temperature levels of OR 1, OR 2, OR 3, and L&D 1 were 59.6, 67, 61.5, 64.5 degrees F, respectively.

* On 2/22/25, the temperature levels of OR 1, OR 2, OR 3, and OR 5 were 64.2, 64.3, 66.4, and 66.3 degrees F, respectively.

* On 2/27/25, the temperature levels of OR 1, OR 3, and L&D 1 were 67, 65, and 66.5 degrees F, respectively.

* On 3/4/25, the temperature levels of OR 1, OR 3, and L&D 1 were 66.2, 64.3, and 67 degrees F, respectively.

* On 3/8/25, the temperature levels of OR 1, OR 2, OR 3, and L&D 1 were 67, 67.7, 67.8, and 65.1 degrees F, respectively.

* On 3/9/325, the temperature levels of OR 1, OR 2, and L&D 1 were 66.2, 67.4, and 66.3 degrees F, respectively.

* On 3/10/25, the temperature levels of OR 1, OR 3, and L&D 1 were 65.5, 67, and 66.5 degrees F, respectively.

* On 3/11/25, the temperature levels of OR 1, OR 3, SPD, and L&D 1 were 65.5, 64.1, 74, 67.2 degrees F, respectively.

b. On 3/12/25 at 0813 hours, a tour of the OR was conducted with RN 2. The following was observed:

* OR 1, the temperature level was 65 degrees F, and the relative humidity level was 65%.

* OR 2, the relative humidity level was 61%.

* OR 3, the temperature level was 63.8 degrees F.

RN 2 stated the engineering checked the temperature level every day; and today, the temperature levels was 66.6 degrees F, 67.8 degrees F, and 67.3 degrees F for ORs 1, 2, and 3. The humidity level for OR 2 was 67%. The surgical cases were delayed until the OR's temperature level reached the temperature and humidity ranges.

During an observation on 3/12/25 at 0930 hours, the scheduled surgical cases were observed not being started.

Review of the Surgery Schedule dated 3/12/25, showed the following:

* Patient 5's surgery was scheduled on 3/12/25, from 1000 to 1100 hours.

* Patient 6's surgery was scheduled on 3/12/25, from 1100 to 1200 hours.

* Patient 7's surgery was scheduled on 3/12/25, from 0900 to 1000 hours.

However, review of medical records for Patients 5, 6, and 7 showed the surgeries were not started for Patients 5, 6, and 7 as scheduled.

* Patient 5's medical record showed on 3/12/25, Patient 5's surgery was started at 1156 hours and ended at 1215 hours.

* Patient 6's medical record showed on 3/12/25, Patient 6's surgery was started at 1238 hours and ended at 1305 hours.

* Patient 7's medical record showed on 3/12/25, Patient 7's surgery was started at 1114 hours and ended at 1129 hours.

On 3/13/25 at 1400 hours, an interview was conducted with the Quality Coordinator, the Chief Quality and Patient Safety Officer, Director 3, and RN 2. They verified that the issues related to the temperature and/or humidity levels was not reported or tracked by QAPI.

On 3/13/25 at 1427 hours, an interview was conducted with the Administrator Assistant and the Lead Engineer. They were informed about the above temperature levels which were outside the acceptable ranges.

EMERGENCY SERVICES POLICIES

Tag No.: A1104

Based on interview and record review, the hospital failed to ensure the hospital's P&Ps were implemented for two of 22 sampled patients (Patients 16 and 17) as evidenced by:

1. The ED nursing staff did not assess Patient 16 every two hours as per the hospital's P&P.

2. The ED nursing staff did not notify the ED physician and did not implement the hospital's P&P related to leaving the hospital AMA for Patient 17.

These failures created the unsafe care environment for the patients.

Findings:

1. Review of the hospital's P&P titled Triage and Assessments of Patients Using the Emergency Severity Index (ESI) dated September 2023 showed in part:

* Purpose: To ensure that every patient receives efficient and appropriate medical care based on his or her ESI level, an evidenced based triage tool.

* Policy:

- The patient's level of urgency is indicated using the ESI.

- Triage is used to determine the patient's clinical urgency and to assess patient acuity based on their presentation in the ED and the expected level of care they will require.

* Responsibility of the Triage RN:

- Respond upon notification of a patient requesting medical treatment.

- Perform an overview of the patients waiting to be seen to determine if any patients appear to require priority triage and categorization. If any patients appear to require priority triage and categorization. If priority triage is not indicated, triage will be conducted based on the patient's time of arrival.

- ESI Methodology: After a triage assessment is completed, the triage RN will categorize the patient with ESI level of 1 (most urgent) to 5 (least urgent).

- ESI level 3 (Urgent): patient is stable with multiple types of resources needed to investigate or treat (such as laboratory test and X-ray imaging). Conditions that require prompt but not immediate care, utilizing two or more resources. The patient presents with a condition that could progress to a serious problem requiring emergency interventions. The vital signs of a Level 3 patient may or may not be outside normal limits (danger zone).

- Periodically reassess the triage status of registered ED patients waiting for emergency care.

- Patients should be reassessed upon change in status. For levels 3, 4, and 5, patients should be reassessed every two 2 hours and with significant change in status.

- Communicate with the Charge RN/designee and ED physician about the number of patients waiting at triage, triage categories, and other problems affecting patients care.

On 3/13/25 at 1207 hours, an interview and concurrent review of Patient 16's closed medical record was conducted with RN 7.

Patient 16's closed medical record showed Patient 16 arrived to ED on 2/24/25 at 1944 hours, and complained of vomiting of blood. Patient 16 was triaged at 2010 hours. The Triage RN determined Patient 3 had ESI level 3. After triage, Patient 16 was sent to the ED waiting area.

RN 7 was asked when the ED physician had seen Patient 16 for MSE. RN 7 stated the patient left the ED and had not seen by the ED physician. When asked for the RN's documentation to show when the patient had left the ED, RN 7 stated there was no RN's documentation to show when the patient had left the ED. However, the Registration Report showed the procedure and treatment were not carried out due to patient leaving prior to being seen by the health care provider. The patient was discharged on 2/25/25 at 0010 hours (four hours after the patient was triaged).

2. Review of the hospital's P&P titled Leaving Hospital Against Medical Advice dated September 2023 showed in part:

* Policy: An adult with capacity to make health care decisions has the right to leave the hospital even against the advice of the physician. If the patient lacks capacity to make health care decisions, the patient has the right to have a legal representative make the decision to stay or leave for him or her. The "Leaving Hospital Against Medical Advice" release form will be completed whenever a patient decides to leave the hospital before treatment is completed and this decision is contrary to the advice of the physician.

* Procedure:

- Notify the physician as soon as the patient states he or she wants to leave the hospital before a discharge order is written.

- Request the patient to stay until they have the opportunity to talk to the physician (in person or per phone) who will explain the risk and consequences of leaving.

- Notify the Department Manager or Administrative Supervisor.

- Ensure the patient leaves the hospital in a safe manner. Arrange transportation (example: family member, taxi, ambulance). Do not attempt to accompany the patient once he or she leaves the hospital campus.

* Documentation:

- Document the facts surrounding the patient's departure and all actions taken to assure safety.

- Present release form to patient and request he or she to sign it, in the presence of a witness.

- Record "patient refused to sign" if indeed he or she refused to sign the form.

- Note the date and time and witness on the form.

On 3/13/25 at 1207 hours, interview and concurrent review of Patient 17's closed medical record was conducted with RN 7.

Review of ED Triage Aware Note dated 1/22/25 at 2317 hours, showed the triage time was 2130 hours. RN 7 was asked for the RN's triage assessment. RN 7 stated there was no RN's triage assessment documentation. However, the Triage RN documented Patient 17's chief complaint was that the patient had left before being triaged in the stretcher, the patient did not to want to go on a chair, and no bed was available at that time. RN 7 was asked for Patient 17's AMA documentation. RN 7 stated there was no other documentation for Patient 17 regarding the AMA. RN 7 verified the ED physician was not informed when the patient left.