HospitalInspections.org

Based on observation, interview, record review and policy review, the hospital failed to ensure that:
- The Labor and Delivery Unit (L&D) in the Women's Center was appropriately staffed to prevent unsafe nurse-to-patient ratios for seven patients (#29, #42, #43, #44, #45, #46 and #47) of seven discharged patients reviewed, which contributed to a sentinel event (actual events that could or did cause patient harm) and grave outcome for Patient #29. (A-0392)
- Nursing staff performed dressing changes according to hospital policy for one patient (#36) of two patients observed. (A-395)
- Nursing staff adequately supervised L&D high-risk patients and recognized the potentially serious complications of hypertension (high blood pressure) during pregnancy for two patients (#1 and #29) of two patients reviewed. (A-0395)
- Nursing staff administered medications according to physicians' orders and hospital policy for four patients (#11, #16, #29, and #35) of 10 patients reviewed. (A-0405)

These failed practices resulted in a systemic failure and noncompliance with 42 CFR 482.23 Condition of Participation: Nursing Services. The hospital census was 143.

The severity and cumulative effect of these practices had the potential to place all patients at risk for their health and safety, also known as Immediate Jeopardy (IJ).

By the survey exit date of 10/28/22, the hospital provided an acceptable plan of correction (POC) to remove the risk of harm to patients, and the IJ was removed.

Based on interview, record review and policy review, the hospital failed to ensure that staffing adequately met the needs of patients on the Labor and Delivery (L&D) Unit, to prevent unsafe nurse-to-patient ratios for seven patients (#29, #42, #43, #44, #45, #46 and #47) of seven discharged patients reviewed, which contributed to a sentinel event (actual events that could or did cause patient harm) and grave outcome for Patient #29. This failed practice placed all patients admitted to L&D at risk for their health and safety. The hospital census was 143.

The severity and cumulative effects of these practices had the potential to place all patients at risk for their health and safety, also known as Immediate Jeopardy (IJ).

By the survey exit date, 10/28/22 at 5:00 PM, the hospital had provided an acceptable plan of correction (POC) to remove the risk of harm to patients, and the IJ was removed.

Findings included:

Although requested, the hospital failed to provide a policy and procedure that directed L&D staffing.

1. Review of the undated hospital document provided by Staff L, Risk Management Director, titled, "Summary of Current Staffing and Gaps (identified as the Association of Women's Health, Obstetric [OB, the branch of medical science concerned with childbirth and caring for and treating women in or in connection with childbirth] and Neonatal Nurses [AWHONN] Staffing Standards, revised 06/2022)," showed nurse-to-patient ratios should be one-to-one (1:1, continuous visual contact with close physical proximity) for the following patient types and clinical situations:
- Women that presented for initial OB triage (process of determining the priority of a patient's treatment based on the severity of their condition).
- Women with antepartum (the time between conception and the onset of labor) complications who were unstable.
- Women with medical or obstetric complications such as preeclampsia (a disorder of pregnancy characterized by the onset of high blood pressure [BP, normal is approximately 90/60 to 120/80] which increases the risk of the mother and the baby), hypertensive (high blood pressure) crisis and all abnormal fetal heart rate (FHR, measure of the heart rate and rhythm of the fetus) patterns during labor.
- Women who were receiving oxytocin (a hormone that can cause or strengthen labor contractions during childbirth) during labor.
- Women laboring with minimal to no pain relief or medical intervention.
- Continuous bedside nursing attendance to women receiving intravenous (IV, in the vein) magnesium sulfate (a medication used to prevent seizure in women with pre-eclampsia for the first hour of administration; 1:1 ratio during labor and until at least two hours postpartum.
- Continuous bedside nursing attendance to women during the active pushing phase of second-stage labor.

Review of the hospital's OB triage log dated 10/14/22, showed:
- Patient #29 arrived at 2:08 AM with contractions;
- Patient #43 arrived at 5:13 AM for a scheduled induction (use of medications or other methods to bring on [induce] labor);
- Patient #46 arrived at 7:41 AM in labor with vaginal bleeding;
- Patient #47 arrived at 8:45 AM for BP monitoring;
- Patient #42, #44, and #45 were being monitored for labor as well as patient #42 having fetal
monitoring issues; and
-Patient #44 and #45 had begun the process of induction.

Review of the hospital-provided document titled, "OB Patient Assignment," dated 10/14/22, showed the following:
- There were two Registered Nurses (RNs), Staff KKK and Staff TTT, scheduled from 7:00 AM to 7:00 PM.
- One additional RN, Staff VVV, was scheduled to work from 10:30 AM to 2:30 PM.
- Staff KKK, RN, was assigned three patients, Patient #29, #44 and #45.
- Staff TTT, RN, was assigned three patients, Patient #42, #43 and #46, plus Patient #47, who arrived at 8:45 AM for high BP monitoring in triage.
- Staff VVV, RN, was reassigned Patient #46 from Staff TTT when she arrived at 10:30 AM.

Review of Patient #29's medical record showed the following:
- She was a 29-year-old pregnant female who was dropped off at the hospital by a family member on 10/14/22, with the chief complaint of uterine contractions.
- She spoke Spanish and did not understand English.
- At 2:08 AM, she arrived to the L&D triage area for observation. Her initial BP was elevated at 154/107.
- At 2:35 AM, Staff OOO, OB Physician, was notified of the patient's arrival and results of her initial exam. New orders were received to obtain stat (immediately) laboratory (labs) tests; a stat ultrasound to determine gestational age (a measure of the age of a pregnancy, full-term is defined as approximately 40 weeks), fetal wellbeing and presentation (specifies which part of the fetus's body leads the way out through the birth canal); and the patient was placed in observation status. A computer table translator was requested from the House Supervisor.
- At 5:35 AM, the patient's BP was 166/109.
- At 5:59 AM, Staff OOO, was noted to be present on the L&D unit and she was made aware of the patient's lab results, ultrasound results, and assessment.
- At 6:08 AM, the patient was fully admitted to inpatient status on L&D with the admission diagnosis of severe pre-eclampsia. The physician order sets for OB Hypertensive Urgency-Severe Pre-Eclampsia, No IV Access-Oral Antihypertensive Meds and Antihypertensive Meds-IV Access Established were ordered.
- At 6:09 AM, the physician order sets for Labor Admission Orders, Labor Epidural (anesthesia [a state of controlled, temporary loss of sensation] injected into the space around the spinal cord to reduce pain) Orders and OB Induction Orders were ordered. The patient's BP was 170/107.
- At 6:21 AM, IV access was obtained per admission orders and at 6:30 AM, the patient received IV blood pressure medication (labetalol).
- At 6:33 AM and 6:34 AM, respectively, Staff JJJ, RN, noted (indicates the staff member acknowledged and took the correct actions) the OB Hypertensive Urgency-Severe Pre-Eclampsia order set.
- At 6:43 AM, Staff OOO was notified of follow-up BPs and nursing notes indicated that no new orders were received.
- At 6:59 AM, Staff JJJ, RN, provided shift-to-shift report to Staff KKK, RN, oncoming day shift nurse who assumed Patient #29's care.
- At 9:48 AM, the patient had an elevated BP of 189/102.
- At 10:04 AM, the patient had an elevated BP of 181/111.
- At 10:18 AM, the patient had an elevated BP of 182/110.
- At 10:48 AM, the patient had an elevated BP of 217/142.
- At 11:10, the translator computer tablet was set-up for the patient; however, the patient repeatedly shook her head no. A staff member's personal cellular phone was utilized and the patient would read the translation and shake her head yes or no to questions presented.
- At 11:26 AM, Staff WWW, Certified Registered Nurse Anesthetist (CRNA), noted that the epidural procedure was uneventful.
- At 11:40 AM, Staff WWW noted that the patient was tachycardic (abnormally rapid heart rate, greater than 100 beats per minute), anxious (a feeling of fear, dread, and uneasiness), with normal BP, decreased oxygen saturation (O2 sats, measure of how much oxygen is in blood) of 88%-92%, and bilateral breath sounds were tight. The OB Physician and Respiratory Therapy were called to the patient's room.
- At 11:49 AM, the patient's BP was 176/104.
- At 11:51 AM, Staff KKK, RN, attempted to keep the patient in bed and noted that she was diaphoretic (excessive, abnormal sweating) and kept shaking her head no.
- At 11:54 AM, a rapid response (a changing situation that requires more staff to address the current needs of the patient) was called. The patient received oxygen by mask; however, she was cyanotic (blue to purplish discoloration of the skin due to low oxygen presence in the blood) with O2 sats in the low 80s. Staff NNN, OB Physician, arrived and performed an exam. The fetus was confirmed bradycardic (slow heart rate) and the decision was made to intubate (process where a healthcare provider inserts a tube through a person's mouth or nose down into their windpipe when a person is not breathing on their own) the patient in the labor room and prep for emergent cesarean section (C-section, surgical delivery of a baby through an incision made in the mother's abdomen and uterus). The emergent scenario was further complicated by the inability to communicate effectively, there were no family members present and no prenatal records available for review.
- The patient was moved to the OR, an emergent c-section was performed, and the baby was delivered at 12:08 PM. Following closure of the uterus, surgery was stopped as the patient had cardiac arrest (when the heart suddenly and unexpectedly stops pumping) and became pulseless.
- At 12:13 PM, a Code Blue (emergency situation where a patient's heart or breathing has stopped, and staff quickly respond to attempt to restore the heartbeat or breathing) was called and cardiopulmonary resuscitation (CPR, emergency life-saving procedure performed when a person's breathing or heartbeat has stopped) was initiated. The patient was revived and surgery continued. The patient remained intubated and was transferred to the ICU.
- The Consultation Report completed by Staff YYY, ICU Physician, showed that given the patient's critical condition and the need to be evaluated at a tertiary (a higher level of specialized care) center, contact was made with Hospital B. The patient was accepted by the maternal-fetal medicine team. An air ambulance was contacted and the patient was airlifted to Hospital B at approximately 3:30 PM.

Review of Patient #29's Physician Orders dated 10/14/22, showed the following for the OB Hypertensive Urgency-Severe Pre-Eclampsia order set:
- At 6:08 AM, Staff OOO, OB Physician, ordered and electronically signed the order set.
- It was to be implemented for OB patients with a blood pressure greater than or equal to 160/110. Two BP measurements within 15-60 minutes; values did not have to be consecutive.
- Directed nursing staff to start an IV and if BP was not controlled (greater than 160/110), to initiate the Anti-Hypertensive Medication Orders. The goal was to begin treatment immediately if severe elevation of BP persisted for 15 minutes or more.
- Directed nursing staff to obtain specific diagnostic labs.
- Directed nursing staff to initiate a magnesium sulfate IV infusion.

At 6:33 AM and 6:34 AM, respectively, Staff JJJ, RN, noted the OB Hypertensive Urgency-Severe Pre-Eclampsia order set; however, from 9:48 AM to 10:48 AM, Patient #29 had four elevated BP readings that met criteria for the OB Hypertensive Urgency-Severe Pre-Eclampsia order set to be implemented. Nursing staff failed to initiate the Anti-Hypertensive Medication orders and administer additional IV BP medication (labetalol) and failed to initiate the magnesium sulfate IV infusion, as ordered by the physician.

Review of Patient #29's Fetal Heart Monitoring (FHM, electronic tracing of a fetal heart rate during pregnancy, where nurses document timed details, such as the mother's blood pressure and medication administration) strip, dated 10/14/22 from 5:31 AM to 6:09 AM, showed the patient's BP was 166/109 and 170/107.

On 10/14/22 at 6:30 AM, Patient #29 received labetalol 20 mg IV as ordered, but Staff JJJ, OB RN failed to concurrently initiate the magnesium sulfate IV infusion, also ordered by Staff OOO, OB Physician.

Review of Patient #29's FHM strip, dated 10/14/22 from 9:48 AM to 10:48 AM, showed the patient's BP was 189/102, 181/111, 182/110 and 217/142.

Staff KKK, OB RN failed to recognize the elevation in the patient's BP and follow the physician's orders to implement treatment and repeat the labetalol order.

Review of Patient #29's FHM strip, dated 10/14/22 at 11:16 AM, showed an epidural was started and a BP was not taken prior to the procedure and every five minutes for 30 minutes as ordered by the physician. A BP was not taken from 10:48 AM to 11:49 AM, at which time the BP was then elevated above the threshold at 176/104 and she had an O2 sat of 82%.

Review of Patient #29's Operative Note, dated 10/14/22 at 1:36 PM, showed that Staff NNN, OB Physician, performed an emergency C-section after the fetus was found in distress and the patient's condition was deteriorating quickly. The physician's review of the patient's admission records noted multiple severe range blood pressures, although laboratory values were within normal range for pre-eclampsia. The patient had reportedly received labetalol, but did not receive magnesium sulfate, as ordered, despite having severe pregnancy-induced high BP.

Review of Hospital B's medical record showed that Patient #29 was airlifted from Poplar Bluff Regional Medical Center and taken to the ICU of Hospital B. The patient was intubated (process where a healthcare provider inserts a tube through a person's mouth or nose down into their windpipe when a person is not breathing on their own), on a ventilator (a machine that supports breathing) and unresponsive to stimuli (something which causes a response). From 10/14/22 to 10/24/22, radiology imaging showed that Patient #29 had suffered a collapsed lung with pulmonary edema (an abnormal buildup of fluid in the lungs), a possible stroke (a medical emergency that occurs when the blood supply to part of the brain is interrupted or reduced, preventing brain tissue from getting oxygen and nutrients), brief seizures (sudden, uncontrolled electrical disturbances in the brain which causes changes in behavior, movements, and/or in levels of consciousness). The electroencephalography (EEG, a recording of brain activity often used to evaluate presence of seizure activity) showed that there was generalized periodic discharges and moderate to severe slowing which commonly occurs with severe encephalopathy (inflammation of the brain), which was caused by hypoxia or anoxia (low oxygen). The plan was to place a percutaneous endoscopic gastrostomy (PEG, a tube inserted through a person's abdomen directly into the stomach to provide a means of feeding when oral intake is not possible) tube and perform a tracheostomy (an opening created in the neck in order to place a tube into a person's windpipe that allows air to enter the lungs). The prognosis (the likely course of a disease or ailment) was indeterminate at the time of review.

During an interview on 10/26/22 at 5:10 PM, Staff JJJ, RN, stated that she had worked as a night shift nurse when Patient #29 arrived. She stayed over in the morning to assist the day nurses due to the high acuity on the unit. She stated that vital signs were normally checked every 15-30 minutes, depending on what was going on with the patient. Patient #29 came in with high blood pressure and no prenatal care. Staff OOO, OB Physician, wrote Hypertension Protocol Orders. She "thought" the doctor had said, "We may have to mag her," but that she should have clarified the doctor's order. The day shift nurse, Staff KKK, RN, was given report at 7:00 AM and it was reported that labetalol was given for high BP.

During an interview on 10/27/22 at 4:20 PM, Staff KKK, RN, stated that she was the nurse assigned to Patient #29 on the day of the incident. She had four patients that morning: one ready to deliver, one in pre-term labor, one in active labor and Patient #29 with hypertension issues. She had been told that Patient #29 had received BP medication and her pressure was stable, but not that magnesium sulfate was ordered. Due to high acuity, Patient #29 should have been a 1:1 patient. Patient #29 began to have respiratory issues when the anesthesia nurse was at the bedside to insert her epidural. She kept saying that she couldn't breathe. That was when she ended up being intubated. The normal process for the Hypertensive Protocol would have been to give labetalol and then start the magnesium sulfate infusion. She stated that she had not given any medications for the patient's BP. The patient acuity on the unit was overwhelming and they could have used additional nursing staff. She was told that the nursing supervisor tried to call in additional staff, but she was only aware of two other staff that received texts asking for assistance. Staff had voiced on numerous occasions that the staffing ratios on L&D were unsafe. She stated that the physicians had even voiced concerns, but no changes had been made by hospital administration.

During an interview on 10/28/22 at 9:05 AM, Staff TTT, RN, stated that she worked the day shift when the incident with Patient #29 occurred. The acuity on the unit had been very high with three patients in labor, two about to deliver, and two other high-risk patients. When a patient underwent a C-section, it could tie a nurse up for up to three hours. The L&D nurses were responsible for recovery of patients following c-sections. She had texted the OB Director regarding the need for additional staff around 9:45 AM. Another nurse arrived at 10:30 AM. There were not enough staff to care for the number of high acuity patients. The physicians had voiced concerns with administration numerous times. They always responded with, "We're working on it." There was not an on-call nursing schedule to assist with fluctuating acuity and numbers. On weekends, nurses could be on voluntary call for 10 cents an hour. Not much assistance had been generated by this approach. Staff TTT stated that there were actually two Hypertension Protocols, one that used labetalol only, and another that utilized a magnesium sulfate infusion. If the order set had magnesium sulfate on it, the expectation was that the nurse would have started that infusion.

During an interview on 10/26/22 at 4:50 PM, Staff NNN, OB Physician, stated that Patient #29 began to have respiratory issues, she became hypoxic (not enough oxygen reaching the cells and tissues in the body) and thrashed around. Initially, they thought that maybe her epidural had gone too high. Staff placed a fetal scalp lead on the baby which showed a terminal bradycardia. Patient #29 was emergently intubated due to respiratory arrest (absence of breathing). She stated that they moved her into the operating room for an emergency C-section. The infant was delivered, they hadn't closed Patient #29's incision when she suffered cardiac arrest. Staff were able to revive her and she was placed on a ventilator and transferred to Intensive Care Unit (ICU, a unit where critically ill patients are cared for). She stated that when the documentation was reviewed after delivery, it was noted that the day shift nurse and the night shift nurse both failed to start the magnesium sulfate, and the day shift nurse failed to report or treat the continued high BPs. Staff NNN received an update from Patient #29's physician at hospital B that indicated the patient had suffered a stroke from high BP and lack of oxygen. She also stated that the patient had just received a PEG tube and a tracheostomy. The patient's outcome was grave.

During an interview on 10/26/22 at 5:30 PM, Staff OOO, OB Physician, stated that she had been on-call the night that Patient #29 arrived to L&D. She ordered some lab work and an ultrasound to date the fetus. In the morning of 10/14/22 around 5:30 AM, when she arrived on the unit, Staff JJJ, RN, was too busy at that time to give an update. In review of the documentation, it was found that the patient had three elevated BPs that were not reported or treated. She told Staff JJJ that the patient needed medications immediately. The protocol included the use of Magnesium Sulfate, placement of a urinary catheter, and other blood pressure medications. Staff OOO expected that labetalol was given and then the magnesium sulfate to have been started, per her orders. She then signed out to Staff PPP, OB Physician, at 6:00 AM. Based on Patient #29's BP, she should have been a 1:1 patient.

During an interview on 10/26/22 at 5:50 PM, Staff PPP, OB Physician, stated that she had taken care of Patient #29. She had received the patient from Staff OOO, OB Physician. She received report that the patient had started on magnesium sulfate and started the Hypertension Protocol. She stated that she was never told the patient had spikes in BP that morning and she expected that the magnesium sulfate was started. She stated that it had been very busy on L&D, she delivered two patients, then briefly checked on Patient #29. Patient #29 appeared comfortable and her BP was reasonable. She had not been notified of any changes in Patient #29's blood pressure. She then left L&D for the Operating Room (OR). While in the OR, she received a call that Patient #29 was having a "panic attack" (specific periods of sudden onset of intense apprehension, fearfulness, or terror, often associated with feelings of impending doom) and she was instructed to return to the patient's room immediately. Upon her arrival, Patient #29 had pulled out her IV and was uncooperative with staff. She assisted in holding the patient down for reinsertion of an IV and a urinary catheter. At that point, Patient #29 experienced respiratory distress and became unresponsive to commands. A rapid response was called overhead and an intensivist (a physician experienced in treating critically ill patients) responded along with additional staff. Staff had difficulty intubating the patient. Once she was intubated, tons of pink frothy secretions poured from the endotracheal tube (ET-tube, a tube inserted through the mouth or nose that extends into the lungs, to maintain an open passageway for oxygen). They took Patient #29 directly to the OR to deliver the infant via emergency C-section. During the closure of the incision, Patient #29 went into cardiac arrest. Staff were successful in the resuscitation. She was then transferred to the ICU.

During an interview on 10/27/22 at 3:45 PM, Staff M, CNO, stated that he was concerned that the patient had elevated BP without treatment and the elevated BP was not communicated to the physician. He also stated that it was expected that the nurse would have treated and reported the elevated BP to the physician. Staff M stated that staff had to have been in the room to have seen the results of the vital signs.

During an interview on 10/26/22 at 12:50 PM, Staff L, Risk Management Director, stated that the hospital had not completed a RCA for the incident related to Patient #29. The hospital had their first meeting to obtain background information on 10/24/22.

During an interview on 10/27/22 at 11:00 AM, Staff AAA, Chief Executive Officer (CEO), stated that administrative staff had not had time to complete a RCA related to the sentinel event of Patient #29 that occurred on 10/14/22. He stated that administrative staff had just held their first meeting on 10/24/22, and initiated the timeline of events, 10 days post event, and that the survey team probably knew more about what had occurred than they did.

Review of Patient #42's medical record showed that she was admitted to L&D on 10/12/22 at 9:48 AM, for induction. The fetal heart tracings (FHT, measure the fetal heart rate and rhythm) showed that the fetus was having decelerations (a decrease in the fetal heart rate below the baseline heart rate). She was in active labor, on Oxytocin (a hormone that can cause or strengthen labor contractions during childbirth) and the fetus was having difficulties. She delivered a male infant on 10/14/22 at 9:08 AM.

Review of Patient #43's medical record showed that she was admitted to L&D on 10/14/22 at 5:05 AM, for induction.

Review of Patient #44's medical record showed that she was admitted to L&D on 10/13/22 at 9:30 PM, for induction. Her membranes (a fluid-filled bag [amniotic sac] that surrounds and protects the fetus) ruptured at 9:47 PM, and she received Oxytocin during her labor period. The FHTs showed that the fetus was having difficulties.

Review of Patient #45's medical record showed that she was admitted to L&D on 10/13/22 at 1:12 PM, for fetal monitoring. She was changed to an induction and had an epidural placed as a result of fetal decelerations and ruptured membranes. She was admitted on 10/14/22 at 7:22 AM, in active labor.

Review of Patient #46's medical record showed that she was admitted to L&D on 10/14/22 at 9:51 AM, for contractions and vaginal bleeding, 35.3 weeks gestational age. She had previously suffered fetal demise (fetal death) of twins, one at 12 weeks and the second at 21 weeks. At 10:30 AM, her membranes ruptured and the FHTs showed decelerations. At 11:36 AM, a male infant was delivered. At 4:58 PM, Patient #46 was discharged to travel to be with her infant son that had been transferred to higher level of care.

Review of Patient #47's medical record showed that she was admitted to L&D on 10/14/22 at 8:34 AM, for observation and monitoring. She had a history of elevated blood pressures and had experienced swelling in her lower extremities. Her blood pressure had been a concern since 19 weeks, when she had been started on blood pressure medications. Due to the swelling and continued blood pressure elevations, there was concern of preeclampsia.

Five of these patients, Patient #42, #44, #45, #46, and #47 met criteria to have 1:1 staffing ratios due to their level of acuity (the severity of a patient's illness and the level of service needed).

During an interview on 10/28/22 at 1:20 PM, Staff L, Risk Management Director, stated that the hospital had difficulty managing the acuity on L&D due to the fact that some of the Obstetrics providers refused to call ahead to place their elective induction patients on the schedule and to determine staff availability.

During an interview on 10/26/22 at 1:45 PM, Staff LLL, OB Unit Manager, stated that staffing was a struggle on L&D. She stated that the hospital had failed to listen to the need and requests to follow the AWHONN guidelines for safe nurse-to-patient ratios according to patient type/clinical situation. She had supplied the AWHONN guidelines to the OB Director numerous times; however, hospital administration always responded with concerns about the unit's "productivity (the numbers of nurse to patients, actual amount of work completed)." She stated that they staffed two nurses and one OB technician per shift and the unit averaged about 100 deliveries per month.

During an interview on 10/26/22 at 4:45 PM, Staff NNN, OB Physician, stated that she came on board the hospital in 5/2022. She considered staffing on L&D to be suboptimal. The patients that arrived for care were very sick with very high acuity. The morning of the incident with Patient #29, there were seven patients on L&D, five of them were high-risk. Each of the nurses were assigned three or four patients. She felt that this had contributed to the lack of recognition of the critical BP readings. Staff NNN stated that she had voiced numerous concerns about staffing, competency of the nurses, and lack of on-call staff to the Emergency Room (ER) Manager, CNO, Chief Medical Officer (CMO), CEO, and the OB Unit Manager since 5/2022.

During an interview on 10/26/22 at 5:30 PM, Staff OOO, OB Physician, stated that L&D has had a large number of high acuity patients and there were a lot of newer nurses. She stated that she had previously voiced her staffing concerns to hospital administration.

During an interview on 10/26/22 at 5:50 PM, Staff PPP, OB Physician, stated that there had not been enough staff on L&D the date Patient #29 was laboring. The nurses were overwhelmed, there were two difficult deliveries and another patient exhibited a bad FHT. She had voiced concerns to hospital administration about the staffing issues in the past.

During an interview on 10/28/22 at 10:00 AM, Staff LLL, OB Manager, stated that L&D did not have a nursing on-call schedule. She had provided the CNO and the OB Director with the AWHONN staffing guidelines multiple times. She was not sure if they had ever been passed along the chain of command. She stated that she was approached today, 10/28/22, by hospital administration and asked to provide input and discuss the development of an on-call policy and staffing schedule to put in place that would be based on acuity. She had not been involved in any previous discussions with hospital administration regarding staffing.

During an interview on 10/27/22 at 3:45 PM, Staff M, CNO, stated that the acuity of patients on L&D varied from day-to-day. He stated that the hospital received a high number of patients with limited prenatal care. Conflict amongst the OB providers had made it difficult for the hospital to implement changes. They did not have an OB nursing staff on-call schedule nor any type of surge plan (a plan that allows the activation of additional staff when the acuity or volume of patient exceeds normal operating capacity). The hospital's current staffing did not align with the AWHONN guidelines.



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Based on observation, interview, record review and policy review, the hospital failed to ensure that nursing staff adequately supervised Labor and Delivery (L&D) high-risk patients and recognized the potentially serious complications of hypertension (high blood pressure) during pregnancy for two patients (#1 and #29) of two patients reviewed. The hospital also failed to ensure that nursing staff performed dressing changes according to hospital policy for one patient (#36) of two patients observed. These failed practices placed all patients at risk for their health and safety. The hospital census was 143.

Findings included:

1. Review of the hospital's policy titled, "Patient Assessment and Reassessment," dated 03/2022, showed the following:
- The Registered Nurse (RN) collects and analyzes data about the patient, determines the need for additional data, the patient's healthcare or treatment needs and the care or treatment of the patient per the physician orders.
- The assessment of the care or treatment required to meet the needs of the patient will begin at admission and be ongoing throughout the patient's stay; the assessment and reassessment process shall continue through to the discharge phase.
- Any change in the patient's condition shall require an immediate reassessment with changes in the plan of care reflecting the change in condition.
- Based on the outcome of the screening data, other disciplines will be contacted to perform a more comprehensive assessment of the patient as needed.

Review of the hospital's undated document provided by Staff L, Risk Management Director, titled, "Summary of Current Staffing and Gaps," showed nurse-to-patient ratios should be one-to-one (1:1, continuous visual contact with close physical proximity) for the following patient types and clinical situations:
- Women that presented for initial obstetric (the branch of medical science concerned with childbirth and caring for and treating women in or in connection with childbirth) triage.
- Women with antepartum (the time between conception and the onset of labor) complications who were unstable.
- Women with medical or obstetric complications such as preeclampsia (a disorder of pregnancy characterized by the onset of high blood pressure [BP, a measurement of the force of blood pushing against the walls of the arteries at two different times during a heartbeat, normal is approximately 90/60 to 120/80] and often a significant amount of protein in the urine which increases the risk of the mother and the baby), hypertensive (high blood pressure) crisis and all abnormal fetal heart rate (FHR, measure of the heart rate and rhythm of the fetus) patterns during labor.
- Women who were receiving Oxytocin (a hormone that can cause or strengthen labor contractions during childbirth) during labor.
- Women laboring with minimal to no pain relief or medical intervention.
- Continuous bedside nursing attendance to women receiving intravenous (IV, in the vein) Magnesium Sulfate (a medication used to prevent seizure in women with pre-eclampsia [a disorder of pregnancy characterized by the onset of high blood pressure and often a significant amount of protein in the urine which increases the risk of the mother and the baby]) for the first hour of administration; 1:1 ratio during labor and until at least two hours postpartum.
- Continuous bedside nursing attendance to women during the active pushing phase of second-stage labor.

Review of the hospital's policy titled, "Cause Analysis Policy and Procedure," revised 06/30/13, provided the following direction for staff:
- The purpose of the policy is to provide structure and guidance for detection and correction of systemic and/or individual failures or weaknesses and to prevent the future occurrence of events of harm.
- A Root Cause Analysis (RCA) is defined as a structured problem-solving technique that results in one or more corrective actions to prevent recurrence of an event.
- A Sentinel Event is defined as an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof. Such events are called "sentinel" because it signals the need for immediate investigation and response.
- An RCA will be conducted in response to serious safety events or sentinel events.
- Immediately following knowledge of a potential serious safety event, staff will address immediate patient, family and staff needs and address any immediate additional threats impacting other patients, family and staff.
- Conduct the first RCA meeting (facts meeting) within 24-48 hours post event.

Review of Patient #29's OB Triage Note, dated 10/14/22 at 2:08 AM, showed that the patient was a 29-year-old female that came in through the Emergency Department (ED) with contractions and elevated blood pressure [BP, the measurement of the force of blood pushing against the walls of the arteries at two different times during a heartbeat]. The patient's initial blood pressure was 154/107 (normal in pregnancy 140/90) and pulse was 130 (normal is 60-100). Staff OOO, OB Physician, was called and new orders were received.

Review of Patient #29's Physician Orders, dated 10/14/22 at 6:08 AM, showed that nurses in L&D were to monitor the patient under the Obstetrics (OB, the branch of medical science concerned with childbirth and caring for and treating women in or in connection with childbirth) Hypertensive (high blood pressure) Urgency - Severe Pre-Eclampsia (a disorder of pregnancy characterized by the onset of high blood pressure) Order Set. The orders showed the patient was admitted with the diagnosis of pre-eclampsia and she was to be monitored to keep her BP below 160/110. This order set was for patients with a BP of 160/110 or greater with two measurements within 15 to 60 minutes. The values did not have to be consecutive. If the BP was not controlled, the nurse was to initiate Anti-Hypertensive Medication Orders. The goal was to begin treatment as soon as possible if severe elevation of BP persisted for 15 minutes or more.

Review of Patient #29's Physician Orders, dated 10/14/22 at 6:09 AM, showed that nurses in L&D were to monitor vital signs prior to the epidural (anesthesia [a state of controlled, temporary loss of sensation] injected into the space around the spinal cord to reduce pain) placement and then every five minutes for 30 minutes, then every 30 minutes thereafter.

Review of Patient #29's Fetal Heart Monitoring (FHM, electronic tracing of a fetal heart rate during pregnancy, where nurses document timed details, such as the mother's blood pressure and medication administration) strip, dated 10/14/22 from 5:31 AM to 6:09 AM, showed the patient's BP was 166/109 and 170/107. On 10/14/22 at 6:30 AM, Patient #29 received Labetalol (medication used to treat high blood pressure) 20 mg intravenous (IV, in the vein) as ordered, but nursing staff failed to concurrently initiate the magnesium sulfate (a medication used to treat seizures in pregnancy) IV infusion, as ordered by the physician.

Review of Patient #29's FHM strip, dated 10/14/22 from 9:48 AM to 10:48 AM, showed the patient's BP was 189/102, 181/111, 182/110 and 217/142. The nurse failed to recognize the elevation in the patient's BP and follow the physician's orders to implement treatment and repeat the Labetalol order.

Review of Patient #29's FHM strip, dated 10/14/22 at 11:16 AM, showed an epidural was started and a BP was not taken prior to the procedure and every five minutes for 30 minutes, as ordered by the physician. A BP was not taken from 10:48 AM to 11:49 AM, at which time the BP was then elevated above the threshold at 176/104 and she had an oxygen saturation (measure of how much oxygen is in the blood, normal 95-100% in pregnancy) of 82%.

Review of Patient #29's Anesthesia Progress Report on 10/14/22 at 11:40 AM, showed that the patient's BP was normal, she was tachycardic (abnormally rapid heart rate, greater than 100 beats per min) with a heart rate of 133, anxious, removing her oxygen mask. The patient had decreased oxygen saturation that ranged from 88%-92% and was cyanotic (skin turns blue to purplish in color of skin due to low oxygen presence in the blood). Respiratory Therapy was called and the patient required 100% oxygen per Ambu bag (a hand held device used to provide positive pressure ventilation to patients who are not breathing or not breathing adequately). The patient continued to struggle to breathe and was then sedated and intubated (a process where a healthcare provider inserts a tube through a person's mouth or nose down into their windpipe when a person is not breathing on their own) and placed on a ventilator (a machine that supports breathing). The patient was taken for an emergency C-section (removal of a fetus surgically) after the OB physician assessed Patient #29 and found the fetus was in distress. After the fetus was delivered, the patient suffered cardiac arrest (when the heart suddenly and unexpectedly stops pumping) and Cardiopulmonary Resuscitation (CPR, emergency life-saving procedure performed when a person's breathing or heartbeat has stopped) was started. The patient was then transferred to the intensive care unit (ICU, a unit where critically ill patients are cared for) for respiratory failure after cardiac arrest.

Review of Patient #29's Operative Note, dated 10/14/22, showed that Staff NNN, OB Physician, performed an emergency C-section after the fetus was found in distress with a low pulse rate, and the patient's condition was deteriorating quickly. The physician's review of the patient's admission records noted multiple severe range blood pressures, although laboratory values were within normal range for pre-eclampsia. The patient had reportedly received Labetalol, but did not receive Magnesium Sulfate, as ordered, despite having severe pregnancy-induced high BP.

Review of Hospital B's medical record showed that on 10/14/22, Patient #29 was airlifted from Poplar Bluff Regional Medical Center and taken to the ICU of Hospital B. The patient was intubated, on a ventilator and unresponsive to stimuli (something which causes a response). From 10/14/22 to 10/24/22, radiology imaging showed that Patient #29 suffered a collapsed lung with pulmonary edema (an abnormal buildup of fluid in the lungs), a possible stroke (a medical emergency that occurs when the blood supply to part of the brain is interrupted or reduced, preventing brain tissue from getting oxygen and nutrients), and a brief seizure (sudden, uncontrolled electrical disturbances in the brain which causes changes in behavior, movements, and/or in levels of consciousness). The electroencephalography (EEG, a recording of brain activity often used to evaluate presence of seizure activity) showed that there was generalized periodic discharges and moderate to severe slowing which commonly occurs with severe encephalopathy (inflammation of the brain) which is caused by hypoxia (not enough oxygen reaching the cells and tissues in the body) or anoxia (low oxygen). The plan was to place a percutaneous endoscopic gastrostomy (PEG, a tube inserted through a person's abdomen directly into the stomach to provide means of feeding when oral intake is not possible) and a tracheostomy (an opening created in the neck in order to place a tube into a person's windpipe that allows air to enter into the lungs). The prognosis was indeterminate at the time of review.

During an interview on 10/26/22 at 5:10 PM, Staff JJJ, RN, stated that vital signs were normally checked every 15-30 minutes depending on what was going on with the patient. She stated that Patient #29 came in with high blood pressure and no prenatal care. Staff OOO, OB Physician, wrote for Hypertension Protocol Orders. She stated that she "thought" the doctor had said, "We may have to mag her," but that she should have clarified the doctor's order. The day shift nurse, Staff KKK, OB RN, was given report at 7:00 AM, and it was reported that labetalol was given for high BP.

During an interview on 10/27/22 at 4:20 PM, Staff KKK, RN, stated that she was told in report that the patient was given labetalol, but not that magnesium sulfate was ordered. Staff JJJ, OB RN, knew that magnesium sulfate was routinely given with labetalol. She had not given any medications for the patient's BP.

During an interview on 10/26/22 at 5:30 PM, Staff OOO, OB Physician, stated that when she arrived on the unit, Staff JJJ, OB RN, was too busy at that time to give an update. In review of the documentation, it was found that the patient had three elevated BPs that were not reported or treated. She told Staff JJJ that the patient needed medications immediately. Staff OOO expected that labetalol was given and then the magnesium Sulfate to have been started, per the physician's orders.

During an interview on 10/26/22 at 5:50 PM, Staff PPP, OB Physician, stated that she received report from Staff OOO, OB Physician, that the patient had Magnesium Sulfate started as well as the Hypertension Protocol. She was never told the patient had spikes in BP that morning. She expected that the Magnesium Sulfate was started.

During an interview on 10/26/22 at 4:50 PM, Staff NNN, OB Physician, stated that when the documentation was reviewed after delivery, it was noted that both the day shift nurse and the night shift nurse failed to start the Magnesium Sulfate and the day shift nurse failed to report or treat the continued high BPs. Staff NNN received an update from Patient #29's physician at hospital B that indicated the patient had suffered a stroke from high BP and lack of oxygen. The patient had just received a PEG tube and a tracheostomy The patient's outcome was grave.

During an interview on 10/26/22 at 1:45 PM, Staff LLL, OB Unit Manager, stated that the Hypertensive order set were urgent orders. The nurse was to start stat orders immediately and routine orders within an hour. As Staff LLL reviewed the physician's orders for Patient #29 and the medication administration record (MAR), she stated that the magnesium sulfate should have been started immediately, as ordered, and it was not. Nurse-to-nurse report was given at the bedside and the oncoming nurse was to finish any orders that were incomplete.

During an interview on 10/27/22 at 3:45 PM, Staff M, Chief Nursing Officer (CNO), stated that he was concerned that the patient had elevated BP without treatment and the elevated BP was not communicated to the physician. It was expected that the nurse had treated and reported the elevated BP to the physician. Staff had to have been in the room to have seen the results of the vital signs.

During an interview on 10/26/22 at 12:50 PM, Staff L, Risk Management Director, stated that the hospital had not completed a RCA for the incident related to Patient #29. The hospital had their first meeting to obtain background information on 10/24/22.

During an interview on 10/27/22 at 11:00 AM, Staff AAA, Chief Executive Officer (CEO), stated that administrative staff had not had time to complete a RCA related to the sentinel event of Patient #29 that occurred on 10/14/22. He stated that administrative staff had just held their first meeting on 10/24/22, and initiated the timeline of events, 10 days post event.

2. Review of Patient #1's L&D Flowsheet, dated 10/24/22, showed the following:
- She was a 21-year-old pregnant female that arrived to L&D at 12:00 Noon, for electronic fetal monitoring (EFM, a continuous test that records contractions and the baby's heart rate that can indicate fetal distress during labor and delivery), and was subsequently admitted for induction of labor.
- At 12:04 PM, the patient's BP was 175/91.
- At 2:01 PM, the patient's BP was 193/96.

Observation and concurrent interview, on 10/24/22 at 3:19 PM, in the L&D Unit, showed Patient #1 ambulated in the hallway following two elevated BPs without BP recheck, notification to the physician or intervention. Staff C, RN, Charge Nurse, stated that Patient #1 was sent over to L&D from her physician's office for induction of labor due to a history of high BP. Staff C stated that BPs were usually monitored every two hours or more frequently, if needed, for patients that were induced due to high BP. Staff C reviewed Patient #1's vital signs and stated that the patient's BP was not rechecked following each of the two elevated BP readings.

3. Although requested, the hospital failed to provide a policy specific to the step-by-step directions for staff to follow when completing dressing changes.

Review of the hospital's policy titled, "Pressure Ulcer Prevention," dated 10/15/20, showed that staff were to date, time, and initial wound treatments/dressings.

Observation and concurrent interview, on 10/26/22 at 9:50 AM, in Medical/Surgical Unit 6, Staff ZZ, Wound Care Nurse (WCN), removed an undated soiled coccyx dressing from Patient #36. Staff ZZ stated that the dressing should have had the date, time, and initials written on the outside.

During an interview on 10/27/28 at 3:40 PM, Staff M, CNO, stated that all wound dressings should be dated and timed at the time of application.


39147




39841

Based on observation, interview, record review, policy review, and review of hospital provided reference material, the hospital failed to ensure that staff administered medications as ordered by the physician for one discharged patient (#29) of one discharged patient reviewed, and failed to ensure staff followed medication administration guidance when staff administered medications to two current patients (#11 and #16) of 10 current patient medication administrations observed. These failed practices placed all patients at risk for their health and safety. The hospital census was 143.

Findings included:

1. Review of the hospital's policy titled, "Patient Assessment and Reassessment," dated 03/2022, showed the directive for the Registered Nurse (RN) to care and provide treatment to the patient per the physician orders.

Review of Staff OOO, Obstetrician (OB), physician orders dated 10/14/22 at 6:08 AM, showed the directive for the nurse to:
- Administer a magnesium sulfate (a medication used to treat/prevent seizures in pregnancy) infusion 20 grams (gm, a metric unit of mass) per 500 milliliters (mls, a measurement of liquid) with a loading dose of six gms and then a rate of two gms per hour;

- Administer labetalol (a medication used to decrease high BP) 20 milligrams (mg, a measure of dosage strength) IV (in the vein) over two minutes for systolic (pressure against the artery during the heartbeat, when the heart is pushing blood out) BP of 160 or above, or a diastolic (pressure against the wall of the artery when the heart rests, between the beats) BP of 110 or above; and
- Repeat the BP in 10 minutes. If BP is below the threshold, continue to monitor BP closely and if it is above the threshold, administer additional labetalol 40 mg IV over two minutes to bring the BP down.

Review of Patient #29's Fetal Heart Monitoring (FHM, electronic tracing of a fetal heart rate during pregnancy, where nurses document timed details, such as the mother's blood pressure and medication administration) strip dated 10/14/22 from 5:31 AM to 6:09 AM, showed the patient's blood pressure (BP) was 166/109 and 170/107 (normal high range of BP in pregnancy is 140/90). On 10/14/22 at 6:30 AM, Staff JJJ, RN, administered labetalol (a medication to treat high blood pressure) 20 mg intravenous (IV, in the vein) to Patient #29, but failed to initiate the magnesium sulfate (a medication used to treat/prevent seizures in pregnancy) IV infusion, as ordered by Staff OOO.

Review of Patient #29's FHM strip dated 10/14/22 from 9:48 AM to 10:48 AM, showed the patient's BP was 189/102, 181/111, 182/110 and 217/142.

Review of Patient #29's Medication Administration Record (MAR) dated 10/14/22, showed no additional administration of labetalol after 6:30 AM or administration of the magnesium sulfate as ordered by Staff OOO, OB Physician.

The nursing staff failed to recognize the elevation in the patient's BP and follow the physician orders to repeat the administration of labetalol and initiate magnesium sulfate IV per physician's orders. This failed practice resulted in the patient requiring a higher level of care with a profound change in condition.

During an interview on 10/26/22 at 5:10 PM, Staff JJJ, OB RN, stated that she thought the doctor said, "We may have to mag her," but she should have clarified the doctor's order. She stated that she did not start magnesium sulfate.

During an interview on 10/27/22 at 4:20 PM, Staff KKK, OB RN, stated that she had not given any medications for the patient's elevated BP.

During an interview on 10/26/22 at 1:45 PM, Staff LLL, OB Unit Manager, stated that the hypertensive (high blood pressure) order set were urgent orders. The nurse was to start stat (immediate) orders immediately and routine orders within an hour. As Staff LLL reviewed the physician's orders for Patient #29 and the MAR, she stated that the magnesium sulfate should have been started immediately as ordered, and it was not.

During an interview on 10/26/22 at 4:50 PM, Staff NNN, OB Physician, stated that documentation showed that the day shift and the night shift nurses failed to start the magnesium sulfate, and the day shift nurse failed to treat the continued high blood pressures with labetalol.

During an interview on 10/26/22 at 5:30 PM, Staff OOO, OB Physician, stated that in review of the documentation, it was found that the patient had three elevated BPs that were not reported, and she had informed Staff JJJ, OB RN, that Patient #29 needed medications immediately. Staff OOO expected the nurse to have administered the labetalol and then started the magnesium sulfate, per the physician orders.

During an interview on 10/26/22 at 5:50 PM, Staff PPP, OB Physician, stated that she received report from Staff OOO, OB Physician, that the magnesium sulfate administration had been started. Staff PPP expected the nurse to have administered the magnesium sulfate.

During an interview on 10/27/28 at 3:40 PM, Staff M, Chief Nursing Officer (CNO), stated that he was concerned that Patient #29 had an elevated BP without treatment. It was expected that the nurse would treat the elevated BP as ordered by the physician.

2. Although requested, the hospital failed to provide a policy that detailed the nursing process for the administration of medications.

Review of the hospital's reference information related to transdermal patch medications, "Essentials for Nursing Practice," Potter and Perry, Seventh Edition, copyright 2008, pages 541 through 543, directed staff to perform hand hygiene, apply clean gloves, remove any old patches, then date and initial the outer side of the new patch prior to application.

Observation on 10/25/22 at 9:45 AM, on Medical/Surgical (Med/Surg) Unit 5, showed Staff AA, Licensed Practical Nurse (LPN), applied an analgesic (medications designed to relieve pain) patch to Patient #11 without dating or timing the patch.

During an interview on 10/27/28 at 3:40 PM, Staff M, Chief Nursing Officer (CNO), stated that the hospital did not have detailed policies with step-by-step instructions for nursing staff to follow for medication administration. Anytime a transdermal patch was applied, it should be dated and timed.

Review of the hospital's reference information related to the administration of medications through gastrostomy tubes (G-tube, soft, flexible tube inserted through the skin of the abdomen and into the stomach) titled, "Essentials for Nursing Practice," Potter and Perry, Ninth Edition, copyright 2019, pages 414 through 415, directed staff to crush each medication separately, dissolve each crushed tablet in 30 ml of warm water in separate cups, and when administering more than one medication, give each one separately and flush between medications with 15 to 30 mls of water.

Observation, interview and concurrent record review, on 10/25/22 at 10:25 AM, on Med/Surg Unit 5, showed Staff AA, LPN, administered seven medications to Patient #16. She crushed all seven medications together, diluted them with 30 mls of warm water, and then administered them through Patient #16's G-tube. Staff AA stated that the medications could be crushed together at one time.





40189

Based on observation, interview, record review, policy review and review of the standard practice guidelines from the Association of periOperative Registered Nurses (AORN), Association for the Advancement of Medical Instrumentation (AAMI), and Association of Professionals in Infection Control and Epidemiology, Inc. (APIC); the hospital failed to ensure that staff followed infection control policies and infection prevention standards when they failed to:
- Document the date, time and staff initials on intravenous (IV, small flexible tube inserted into a vein to deliver medications and fluids into the blood stream) catheter dressings, when IVs were inserted and/or dressings applied for 11 patients (#2, #3, #4, #18, #19, #20, #22, #33, #34, #35 and #36) of 20 patients observed.
- Label IV tubing with date to be changed for three patients (#3, #18 and #35) IV tubing of 20 patients observed.
CM- Perform hand hygiene (wash hands with soap and water or use hand sanitizer) and change gloves after touching a patient and their environment and prior to preparation and/or administration of blood and medications for 11 patients (#3, #7, #8, #11, #13, #16, #19, #20, #35, #36 and #37) of 19 patients observed.
- Clean a stethoscope and/or scissors before performing patient care or having direct contact with three patients (#13, #16, and #35) of 15 patients observed.
- Clean or place a barrier prior to laying supplies or medications on surfaces for five patients (#7, #13, #16, #35, and #36) of 12 patients observed.
- Separate one unclean endoscope (lighted tube with a camera, used to visualize the inside of organs) transport container from a cleaned/disinfected endoscope transport container during decontamination and disinfection processing.
- Maintain acceptable temperature, humidity and appropriate pressure parameters in seven operating rooms (OR) out of 11 ORs reviewed.

These deficient practices had the potential to increase the risks of preventable hospital acquired infections (HAI, infection that was transmitted to the patient while in the hospital) and surgical site infections (SSIs) and cause harm by infection to all patients, visitors and staff. The hospital census was 143.

The cumulative effects of these systemic failures resulted in the hospital's non-compliance with 42 CFR 482.42 Condition of Participation: Infection Prevention and Control and Antibiotic Stewardship Programs. Refer to A-0749 for additional information.

Based on observation, interview, record review, policy review and review of the standard practice guidelines from the Association of periOperative Registered Nurses (AORN), Association for the Advancement of Medical Instrumentation (AAMI), and Association of Professsionals in Infection Control and Epidemiology, Inc. (APIC), the hospital failed to ensure that staff followed infection control policies and infection prevention standards when they failed to:
- Document the date, time and staff initials on intravenous catheter (IV, small flexible tube inserted into a vein to deliver medications and fluids into the blood stream) dressing covers when IVs were inserted and/or dressings were applied for 11 patients (#2, #3,#4, #18, #19, #20, #22, #33, #34, #35, and #36) of 20 patients observed.
- Label IV tubing with date to be changed for three patients (#3, #18 and #35) IV tubing of 20 patients observed.
- Perform hand hygiene (wash hands with soap and water or use hand sanitizer) and change gloves after touching a patient and the patient's environment and prior to preparation and/or administration of blood and medications for 11 patients (#3, #7, #8, #11, #13, #16, #19, #20, #35, #36, and #37) of 19 patients observed.
- Clean a stethoscope and scissors before performing patient care tasks or direct contact with three patients (#13, #16, and #35) of 15 patients observed.
- Clean or place a barrier prior to laying medications or supplies on room surfaces for five patients (#7, #13, #16, #35, and #36) of 12 patients observed.
- Separate one unclean endoscope (lighted tube with a camera, used to visualize the inside of organs) transport container from a cleaned/disinfected endoscope transport container during decontamination and disinfection processing.
- Maintain acceptable temperature, humidity and appropriate pressure parameters in seven operating rooms (OR) out of 11 ORs reviewed.

These deficient practices had the potential to increase the risks of preventable hospital acquired infection (HAI, infection that was transmitted to the patient while in the hospital) and surgical site infections (SSIs) and cause harm by infection to all patients, visitors and staff. The hospital census was 143.

Findings included:

1. Review of the hospital's policy titled, "Vascular (relating to or containing blood vessels) Lines Policy and Procedure," dated 07/2016, directed staff to:
- Perform hand hygiene;
- Don gloves;
- Cleanse the insertion site;
- Insert the vascular access device;
- Apply a transparent dressing over the insertion site;
- Label the dressing with insertion date, catheter gauge and inserter's initials, and
- Label administration sets and change every 96 hours.

Observation on 10/24/22 at 3:30 PM, on the Progressive Care Unit (PCU) showed that Patient #2's IV dressing was not dated or timed.

Observation on 10/24/22 at 3:55 PM, on the PCU, showed that Patient #3's IV dressing was not dated or timed and the IV tubing was not labeled.

Observation on 10/24/22 at 3:35 PM, on the PCU, showed that Patient #4's IV dressing was not dated or timed.

Observation on 10/25/22 at 9:35 AM, on the Intensive Care Unit (ICU, a unit where critically ill patients are cared for), showed that Patient #18's IV dressing was not dated or timed and the two IV tubings were not labeled.

Observation on 10/25/22 at 10:10 AM, on the PCU, showed that Patient #19's IV dressing was not dated or timed.

Observation on 10/25/22 at 10:20 AM, on the PCU, showed that Patient #20's IV dressing was not dated or timed.

Observation on 10/25/22 at 10:55 AM, on the PCU, showed that Patient #22's IV dressing was not dated or timed.

Observation on 10/26/22 at 10:45 AM, on Medical/Surgical (Med/Surg) Unit 5, showed Patient #33's IV dressing was not dated or timed.

Observation on 10/26/22 at 11:05 AM, on Med/Surg Unit 4, showed Patient #34's two IV dressings were not dated or timed.

Observation and concurrent interview on 10/26/22 at 9:30 AM, on the Obstetrical (OB, the branch of medical science concerned with childbirth and caring for and treating women in or in connection with childbirth) Unit, showed Patient #35's IV dressing was not dated or timed and her IV tubing was not labeled. Patient #35 stated that her IV had been started the previous night by a nurse on the OB unit.

Observation on 10/26/22 at 9:45 AM, on Med/Surg Unit 6, showed that Patient #36's IV dressing was not dated or timed.

During an interview on 10/25/22 at 10:55 AM, Staff MM, Licensed Practical Nurse (LPN), stated that IV dressings were labeled with the date, time and initials when started.

During an interview on 10/26/22/ at 11:07 AM, Staff YY, Registered Nurse (RN), stated that nursing staff documented the date, time and their initials on the IV dressing when they inserted a patient's IV.

During an interview on 10/25/22 at 9:45 AM, Staff J, ICU Nurse Manager, stated that IV tubing was expected to be labeled with the date it was to be changed.

During an interview on 10/27/22 at 10:20 AM, Staff N, Quality Control Officer and Infection Control Practitioner, stated that IV dressings were labeled with the date, time and the initials of the person who started the IV. He stated that staff were instructed of the requirement during initial orientation and during preceptorship. Staff N stated that the expectation would be when nurses identified an IV dressing that was not dated or timed, the IV would be restarted and the undated IV removed.

2. Review of the hospital's policy titled, "Hand Hygiene," revised 06/14/16, directed staff to:
- Perform hand hygiene before any patient contact;
- Perform hand hygiene after touching wounds, body part or surface likely to contain body fluids or microorganisms;
- Perform hand hygiene after contact with inanimate environmental sources likely to be contaminated (such as IV pumps, bedrails, tray tables, etc.);
- Perform hand hygiene after contact with all patients and equipment;
- Perform hand hygiene after removing gloves;
- Perform hand hygiene prior to departing patient rooms, and
- Perform hand hygiene and change gloves after using gloves for contaminated activities.

Review of the hospital's policy titled, "Standard Transmission Based Precautions," dated 01/03/22, showed that standard precautions should be used on all patients. Staff should perform hand hygiene, change gloves, and wear gowns to protect clothing when performing patient care activities. Staff should ensure that reusable equipment is cleansed prior to use on another patient. All guidelines are to prevent the transfer of microorganisms from one patient and/or their environment to another patient.

Review of the hospital's reference information related to intravenous medications, "Essentials for Nursing Practice," Potter and Perry, Ninth Edition, copyright 2019, pages 463 through 467, directed staff to perform hand hygiene, apply clean gloves, cleanse injection port, assess the patency of the saline lock (a thin flexible tube placed into a vein used for fluid or medication or nutrition administration) by flushing it with three milliliters (mls, a measurement of liquid) of sterile (without bacteria) sodium chloride, cleanse the port with antiseptic swab, attach syringe, administer medication, cleanse the port with antiseptic swab, flush port with three mls of sterile sodium chloride.

Observation on 10/25/22 at 10:05 AM, on the PCU, showed Staff LL, RN, failed to perform hand hygiene and glove changes before and after environmental surfaces were touched, medications were opened and administered, and water was handed to the patient during Patient #3's medication administration.

During an interview on 10/25/22 at 10:25, Staff LL, RN, stated that:
- No gloves were needed as long as the medications were not touched.
- She was not told to change gloves and perform hand hygiene between touching inanimate objects and administration of IV medications.
- IV dressings were labeled with the date, time and the initials.

Observation on 10/24/22 at 3:38 PM, on Med/Surg Unit 6, showed Staff Q, RN, failed to:
- Perform hand hygiene and glove changes after multiple surfaces in the patient environment were touched and before blood IV tubing was inserted to an IV bag of normal saline for Patient #7.
- Perform hand hygiene and glove changes after surfaces in the patient environment were touched and before blood was prepared with blood tubing for Patient #7.
- Place a barrier before uncapped, exposed blood tubing was placed on Patient #7's bed.
- Perform hand hygiene and glove changes after equipment was touched and before the blood tubing was connected to Patient #7's saline lock for infusion.

Observation on 10/25/22 at 9:30 AM, showed Staff T, RN, failed to perform hand hygiene prior to donning gloves when she performed IV insertion for Patient #8.

During an interview on 10/25/22 at 9:45 AM, Staff T, RN, stated that she did not perform hand hygiene prior to donning gloves for the initiation of IV access for Patient #8.

Observation on 10/25/22 at 9:45 AM, on Med/Surg Unit 5, showed Staff AA, LPN, failed to perform hand hygiene and change gloves prior to performing a subcutaneous (under the skin) injection during Patient #11's medication administration.

Observation on 10/25/22 at 9:10 AM, on Med/Surg Unit 5, showed Staff AA, LPN, failed to:
- Place a barrier or clean the surface of the bedside table before medications were laid on the surface.
- Perform hand hygiene and glove changes before and after surfaces in the patient environment were touched, medications were opened and administered, and water was handed to the patient during Patient #13's medication administration.
- Cleanse her personal stethoscope when she removed it from around her neck, listened to Patient #13's abdomen, then replaced it around her neck.

Observation on 10/25/22 at 10:25 AM, on Med/Surg Unit 5, showed Staff AA, LPN, failed to clean or place a barrier on Patient #16's sink before medications were laid on the surface. She then failed to perform hand hygiene and glove changes after she touched the faucet, drew up the crushed medications, and administered the medications through the gastrostomy (G-tube, soft, flexible tube inserted through the skin of the abdomen and into the stomach) tube. She also failed to cleanse her personal scissors upon removal and return to her pocket. She then sat upon Patient #16's bed while she administered a bolus (large volume) feeding through the patient's G-tube.

Observation on 10/25/22 at 10:35 AM, on Med/Surg Unit 5, showed Staff EE, Student Nurse, failed to perform hand hygiene and change gloves before she performed the blood glucose check for Patient #16.

Observation on 10/25/22 at 10:10 AM, on the PCU, showed Staff MM, LPN, failed to perform hand hygiene and don gloves prior to administration of an IV medication for Patient #19.

During an interview on 10/25/22 at 10:15 AM, Staff MM, LPN, stated that she failed to wear gloves for the IV medication administration.

Observation on 10/26/22 at 9:25 AM, on the OB Unit, showed Staff ZZ, Wound Care Nurse (WCN), failed to clean or place a barrier on the sink before she laid dressing supplies on the surface. She failed to clean a pair of scissors that she removed from her pocket and utilized to score a silver dressing for Patient #25's dressing change for his knee. Staff ZZ failed to clean the scissors before she placed them back into her pocket.

During an interview on 10/25/22 at 9:30 AM, Staff ZZ, WCN, stated that scissors should always be cleaned using an antiseptic wipe before and after use on each individual patient.

Observation and concurrent interview, on 10/26/22 at 9:35 AM, on the OB Unit, showed Staff C, RN, failed to clean or place a barrier upon the sink before she laid IV fluids and medications on the surface. She failed to apply clean gloves before she flushed Patient #35's saline lock, administered IV medications and attached IV tubing. Staff C, RN, stated that she did not need to wear gloves when administering medications since she had washed her hands with soap and water.

Observation on 10/26/22 at 9:45 AM, Med/Surg Unit 6, showed Staff ZZ, WCN, failed to clean or place a barrier before she laid dressing supplies upon Patient #36's bedside table. She failed to perform hand hygiene after she removed her gloves to exit the room to obtain wound cleanser.

Observation and concurrent interview, on 10/26/22 at 9:50 AM, Med/Surg Unit 6, showed Staff BBB, RN, failed to perform hand hygiene before she applied gloves and assisted with the change of Patient #36's linens. Staff BBB, RN, stated that she did not complete hand hygiene before she applied her gloves.

Observation on 10/26/22 at 10:55 AM, in the Emergency Department (ED), showed Staff HHH, RN, failed to perform hand hygiene and glove changes before she administered medications to Patient #37, after she touched multiple surfaces within the room.

During an interview on 10/27/22 at 3:40 PM, Staff M, Chief Nursing Officer (CNO), stated that he would expect staff to perform hand hygiene and wear gloves when they performed IV care and administered medications. Supplies should be placed on a clean surface. Any items used on multiple patients should be cleaned before and after use. Staff should date, time, and initial all IV dressings. IV tubing should have a sticker applied that would indicate the day that the tubing should be discarded.

3. Review of the Association of PeriOperative Registered Nurses (AORN), "Perioperative Standards and Recommended Practices, Guideline for Processing Flexible Endoscopes," dated 2021, showed that flexible endoscopes should be stored in a manner that minimizes contamination.

Review of the Association for the Advancement of Medical Instrumentation (AAMI) standards "ST79:2017 Comprehensive guide to steam sterilization and sterility assurance in health care facilities," dated 2107, showed that clean/sterile items should be contained and segregated from contaminated items.

Observation on 10/25/22 at 9:48 AM, showed Staff V, Endoscope Processing Technician, placed a contaminated, "dirty" endoscope transport container on a storage rack above a container containing a disinfected, "clean" endoscope.

During an interview on 10/25/22 at 9:50 AM, Staff U, Surgery Director, stated that contaminated endoscope containers should be stored separately from disinfected "clean" endoscope containers.

4. Review of the AORN, "Perioperative Standards and Recommended Practices, Guidelines for Design and Maintenance of the Surgical Suite," dated 2021, showed the recommended temperature range for ORs was 68° to 75° Fahrenheit (F, unit of temperature) and acceptable relative humidity range was 20% to 60% for ORs.

Review of the Association of Professsionals in Infection Control and Epidemiology, Inc. (APIC) "Implementation Guide: Infection Preventionist's Guide to the OR," dated 2018, showed that positive pressure was maintained in an OR as standard practice and facilitated reduced SSI risk.

Review of the hospital policy titled, "Temperature and Humidity Indicators - Heating, ventilation and air condition (HVAC) System," revised 11/01/18, showed that the charge nurse was responsible for documentation of temperature and humidity levels Monday through Friday, and the on-call circulating nurse documented temperature and humidity levels for surgical cases performed outside of the department's normal operating hours. The policy showed that when readings were outside of acceptable parameters, any surgeries in progress were completed and no further non-emergent surgeries were begun until the environmental readings were within an acceptable range.

Although requested, the hospital's Facilities Management department could not provide central monitoring logs for the OR temperature, humidity and positive pressure after 09/29/22.

Review of the hospital documents titled, "Daily Temperature, Humidity and Pressure Log," dated 10/2022, showed hand-written documentation of temperature, humidity and positive or negative pressure readings for 11 ORs dated 10/01/22 through 10/26/22. The documents showed that the targeted temperature ranges within the OR were between 68° to 75° at 20%-60% relative humidity and that positive pressure was required. Comparison between the hospital's operative register of surgical cases performed and the hospital's temperature, humidity, pressure logs showed the following:
- On 10/03/22, ORs #1, #2, #3 and #4 were documented as out of range for temperature. The log did not show temperatures were reassessed. Four surgical cases were completed in ORs #1, #2, #3 and #4.
- On 10/04/22, OR #2 was documented as out of range for temperature. The log did not show that temperature was reassessed. Three surgical cases were completed in OR #2.
- On 10/05/22, OR #2 was documented as out of range for temperature. The log did not show that temperature was reassessed. Five surgical cases were completed in OR #2.
- On 10/15/22, all ORs were documented as "Closed" or no environmental readings documented. Five surgical cases were completed in ORs #1, #4, and #7.
- On 10/16/22, all ORs were documented as "Closed" or no environmental readings were documented. Three surgical cases were completed in ORs #4, #7, and #8.
- On 10/20/22, OR #9 was documented as out of range for humidity. The log did not show that relative humidity was reassessed. Five surgical cases were completed in OR #9.
- On 10/25/22, ORs #4 and #9 were documented as out of range for presence of negative pressure with no documentation that positive pressure was reassessed in either room. Seven surgical cases were completed in ORs #4 and #9.

During an interview on 10/25/22 at 3:00 PM, Staff QQ, Facilities Management Manager, stated that the hospital performed a generator test the previous week that affected the batteries on the system controllers to the air handlers and HVAC which monitored and automatically maintained temperatures, humidity and air handling in certain ORs. He stated that since the generator test the affected ORs required manual adjustment to maintain temperature, humidity and positive pressure within acceptable parameters. Staff QQ stated that the Facilities Management department could not provide central monitoring logs for the operating room temperature, humidity and positive pressure monitoring after 09/29/22, due to upgrades to the HVAC system which no longer interfaced with the previous central monitoring program and due to the central handler problems related to a hospital generator test.

During an interview on 10/26/22 at 9:18 AM, Staff U, Surgery Director, stated that the hospital followed recommended guidelines and national practice standards from AORN, APIC, and AAMI.

During an interview on 10/27/22 at 9:00 AM, Staff U, Surgery Director, stated that temperature, humidity and positive pressure parameters of each operative suite were monitored by the OR staff and logged daily. ORs that did not meet the environmental parameters set by policy were not used for surgical procedures until adjustments to the HVAC and/or thermostat were made, parameters were reassessed and documented within accepted ranges.

The ORs were used for surgical cases while documented to be outside of the environmental parameters stated in the hospital's policy and nationally recognized standard practice guidelines, thus potentially exposing patients to SSI.




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