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Based on interview and record review the facility failed to have a documented evidence that one of 30 sampled patients (Patient 5) was fully informed of the type of anesthesia (a state of controlled, temporary loss of sensation or awareness that is induced for medical purposes) to be used during a surgical procedure. The "Anesthesia Consent (a form in which the patient acknowledges agreement to treatment such as the use of anesthesia that is recommended by the physician)," did not indicate the type of anesthesia to be used and the physician failed to certify that informed consent (the process in which the healthcare provider educates a patient about the risks, benefits, and alternatives of a given procedure or intervention) had been obtained and that risks of anesthesia were discussed with Patient 5.

This deficient practice had the potential for Patient 5 to not be fully informed of the type of anesthesia used and the risks of the anesthesia.

Findings:

During a review of Patient 5's Face Sheet (a document that gives a patient ' s information at a quick glance), dated 12/10/2023 at 6:02 a.m., the Face Sheet indicated Patient 5 was admitted to obstetric (a branch of medicine specialized in the care of pregnant women and childbirth) service for a scheduled Cesarean Section (C-section, surgical delivery of a baby).

During a review of Patient 5's "Pre-Operative History & Physical (H&P, a formal and complete assessment of the patient and the problem)," dated 12/10/2023, the H&P indicated Patient 5 was 39 weeks pregnant (40 weeks is full term), admitted to the Labor & Delivery (L&D, a unit that specializes in childbirth) area for a repeat C-section.

During a review of Patient 5's "Consent for Anesthesia," dated 12/10/2023 at 6:53 a.m., the consent did not indicate type of anesthesia (a state of controlled, temporary loss of sensation or awareness that is induced for medical purposes) to be used. In addition, the consent was not signed by the physician indicating his/her physician certification of informed consent: "I, the undersigned physician, hereby certify that I have discussed the procedure named above with this patient, including the risk and benefits of the procedures, any adverse reactions that may reasonably be expected to occur, any alternative efficacious methods of treatment which may be medically viable and any research or economic interest I may have regarding this treatment. I further certify that the patient was encouraged to ask questions and that all questions were answered. "

During a review of Patient 5's "Anesthesia Record," dated 12/10/2023 at 9 a.m., the Anesthesia Record indicated Patient 5 received spinal (injection of a drug into either the fluid of the spinal canal or immediately outside of the canal) anesthesia for a repeat C-section.

During a concurrent interview and record review on 12/12/2023 at 11:16 a.m. with Charge Nurse (CN) 3, CN 3 reviewed Patient 5's "Anesthesia Consent," dated 12/10/2023, and stated the following: Patient 3 delivered by C-section on 12/10/2023 at 9:27 a.m. The consent did not indicate the type of anesthesia that would be used during the C-section. The consent was not signed by the physician certifying that he/she discussed the type of anesthesia or the risk of anesthesia with Patient 3. CN 3 stated the consent should be complete to ensure patients were informed of the type of anesthesia to be used and that the risks were discussed by the physician. CN 3 stated patients had the right to know the type of anesthesia patients would receive and the risks involved.

During a review of the facility's policy and procedure (P&P) titled, "Informed Consent for Procedures and Treatments," dated 5/27/2020, the P&P indicated the following: The hospital recognizes and respects the patient ' s right to be involved in the decision-making of all aspects of their care and to be informed of the risk, benefits and alternatives to proposed procedures and treatments to ensure informed decision-making. The hospital complies with all the state and federal regulations. It is the hospital's policy for its staff to facilitate obtaining voluntary, informed consent (the process in which the healthcare provider educates a patient about the risks, benefits, and alternatives of a given procedure or intervention) from patients (or their legally designated representative [LDR] ..., after the physician has discussed the risk, benefits, and alternatives to the procedure with the patient and prior to rendering medical procedures and treatments that involve material risk. Informed consent must be obtained and documented according to policy ...It is the treating physician's responsibility to obtain the informed consent ...Documentation of Informed Consent: Documentation of the discussion and patient decision is to be noted in the patient ' s medical record ...Signed Consent Form required for ...Anesthesia. Signatures: Consent form must be signed by the physician who had the informed consent discussion and by the patient or LDR.

During a review of the facility's policy and procedure titled, "Patient Rights and Responsibilities," dated 3/22/2023, the P&P indicated "the patient has the right to make decisions regarding medical care, and receive as much information about any proposed treatment or procedure as they may need in order to give informed consent or refuse a course of treatment..."

Based on interview and record review, the facility failed to document and sign a legible History and Physical (H&P, a formal and complete assessment of the patient and the problem) for one of 30 sampled patients (Patient 20).

This deficient practice had the potential to result in lack of clarity in communication between healthcare providers involved in Patient 20's care, leading to a failure to follow through with evaluation and treatment plans and resulting in patient harm.

Findings:

During a review of Patient 20's intraoperative case report (ICR, a summary of a patient's surgical procedure), dated 12/13/2023, the ICR indicated, on 12/13/2023 Patient 20 underwent intrarenal (within the kidney) surgery with left stent placement (A renal artery stent is a tiny, metal mesh tube that opens the artery in the kidney to allow better blood flow to the kidney).

During a review of Patient 20's History and Physical (H&P, a formal and complete assessment of the patient and the problem), dated 12/13/2023, the H&P was handwritten and not readable which was verified by the Vice President of Quality and Risk Management (VPQRM).

During a concurrent interview and record review on 12/14/2023 at 9:35 a.m. with vice president of quality and risk management (VPQRM), Patient 20's History and Physical (H&P), dated 12/13/2023, was reviewed. The H&P was handwritten, incomplete, and not legible. The VPQRM stated, the H&P was not readable and presented the facility's Medical Staff Rules and Regulations (Rules and Regs), dated 10/2020 indicating the H&P must be a durable legible copy that may be used in the patient's medical records.

During a review of the facility's Department of Surgery Rules and Regulations, dated 06/2022, the Rules and Regulations indicated, a complete physical examination must be performed within 30 days prior to admission, and has to be durable, legible copy as per facility's policies and procedures.

During a review of the facility's Medical Staff Rules and Regulations, dated 10/2020, the Rules and Regulations indicated, all physician orders must be written clearly, legibly, and completely.

The Code of Federal Regulations states that the purpose of a medical history and physical examination is to determine whether there is anything in the patient's overall condition that would affect the planned course of the patient's treatment, such as a medication allergy, or a new or existing co-morbid condition (existence of more than one disease in the patient's body at the same time) that requires additional interventions to reduce risk to the patient.

Based on observation, interview, and record review, the facility failed to ensure the Condition of Participation for Nursing Services was met as evidenced by:

1. The facility failed to perform nursing assessments (a process where a nurse gathers, sorts and analyzes a patient's health information), including vital signs (temperature, blood pressure, heart rate, respiratory rate, and pain) upon admission, as ordered by the physician and per the facility's policy regarding assessment and reassessment for one of three sampled patients (Patient 1) who was admitted to the Labor and Delivery unit (L&D, a unit that specializes in childbirth). In addition, the facility failed to report changes in Patient 1's condition immediately when Pitocin (oxytocin, a medication to induce labor [last stage of pregnancy when muscles of the womb start to push the baby out or childbirth]) was discontinued, and when Patient 1 experienced abnormal fetal heart strip reading and continuous decelerations (abrupt decreases in fetal [unborn baby] heart rate which can indicate umbilical cord compression [when the baby's weight puts pressure on the cord during pregnancy or labor and can restrict blood flow and oxygen to the baby] and fetal distress [changes in heart rate, movement, etc.]).

These deficient practices resulted in Patient 1 delivering a baby (Patient 2) who was not breathing, had no heart rate, was limp, and cyanotic (bluish color indicating lack of oxygen). Patient 2 was taken to the Neonatal Intensive Care Unit (NICU, unit that specializes in providing intensive (critical) medical care to newborns) and transferred to an outside hospital for a higher level of care. Patient 2 passed away at the outside hospital. (Refer to A-0392)

2. The facility failed to assess a patient who presented to the Labor and Delivery Unit (L&D, a unit that specializes in childbirth) in a timely manner (within 10 minutes) for one of three sampled patients (Patient 3). Patient 3 arrived at the L&D unit at 8:37 a.m., on 12/12/2023 and was first evaluated by a nurse at 4:15 p.m., 8 hours after arriving at the L&D unit.

This deficient practice had the potential for an emergency medical condition (EMC, example: heart attack, excessive bleeding, etc.) to go unidentified by nursing staff and could delay treatment and result in harm. (Refer to A-0392)

3. The facility failed to ensure Registered Nurse 9 (RN 9) and Registered Nurse 10 (RN 10) were competent in the hemodialysis (the process of removing excess fluid and waste from the body of a person whose kidneys are not working correctly) emergency termination procedure (safe process of disconnecting a patient from the dialysis machine in case of an emergency) for one (1) of 30 sampled patients (Patient 27).

This deficient practice had the potential to result in an inadequate return of blood from the dialysis machine (a machine that removes blood from the body and filters it [referring to the blood] through a dialyzer [an artificial kidney], and then returns the blood to the body) to the patient (Patient 27) causing harm or even death during hemodialysis treatment. (Refer to A-0397)

4. The facility failed to ensure three of three sampled Patients (Patients 8, 11 and 13) received nursing care interventions and assessments per facility policy to promote wound healing, when:

a. Patients 8, 11, and 13 were not repositioned/turned every two hours.

b. Patient 8 had no admission and biweekly ongoing wound photographs, assessments, and measurements.

c. Patient 8 had no daily wound assessment documentation.

These deficient practices had the potential to compromise Patient 11's and Patient 13's wound healing progression, and resulted in Patient 8's sacral and right buttock wounds becoming larger in size, with Patient 8's sacral wound progressing from a Stage III (Full thickness tissue loss where subcutaneous fat may be visible, but bone, tendon, or muscle are not exposed) pressure ulcer (injury to the skin and underlying tissues resulting from prolonged pressure on the skin) to an unstageable (unable to stage, full thickness tissue loss in which the base of the ulcer is covered by slough- yellow, tan, gray, green or brown- and/or eschar- tan, brown or black) pressure ulcer. (Refer to A-0398)

5. The facility failed to ensure two of two Crash Carts (Crash cart 1- adult Crash Cart and Crash Cart 2- neonatal [relating to newborn children] Crash Cart, a cart stocked with emergency equipment, supplies and medications to be used in a medical emergency) in the Labor and Delivery Unit (L&D, a floor of the hospital responsible for the provision of medical care for patients arriving to deliver a baby) were checked every shift per facility's policy to ensure emergency supplies, equipment, and medications were readily available in the event of an emergency.

This deficient practice had the potential for emergency supplies to not be readily available in case of an emergency and had the potential to result in a delayed provision of emergency care needed by patients, which may lead to patient harm and/or death. (Refer to A-0398)

The cumulative effect of these deficient practices resulted in the facility's inability to provide quality health care in a safe environment.

Based on observation, interview, and record review, the facility failed to:

1. Perform nursing assessments (a process where a nurse gathers, sorts and analyzes a patient's health information), including vital signs (temperature, blood pressure, heart rate, respiratory rate, and pain) upon admission, as ordered by the physician and per the facility's policy regarding assessment and reassessment, for one of three sampled patients (Patient 1) who was admitted to the Labor and Delivery unit (L&D, a unit that specializes in childbirth). In addition, the facility failed to report changes in Patient 1 ' s condition immediately when Pitocin (oxytocin, a medication to induce labor) was discontinued, and when Patient 1 experienced abnormal fetal heart strip (heart rhythm) reading and continuous decelerations (abrupt decreases in fetal [unborn baby] heart rate which can indicate umbilical cord compression [when the baby's weight puts pressure on the cord during pregnancy or labor and can restrict blood flow and oxygen to the baby] and fetal distress [changes in heart rate, movement, etc.]).

These deficient practices resulted in Patient 1 delivering a baby (Patient 2) who was not breathing, had no heart rate, was limp, and cyanotic (bluish color indicating lack of oxygen). Patient 2 was taken to the Neonatal Intensive Care Unit (NICU, unit that specializes in providing intensive [critical] medical care to newborns) and transferred to an outside hospital for a higher level of care (a hospital capable of providing diagnostic or interventional care beyond the capacity of the hospital from which a patient originates). Patient 2 passed away at the outside hospital.

2. Assess a patient who presented to the Labor and Delivery (L&D, a unit that specializes in childbirth) in a timely manner (within 10 minutes) for one of three sampled patients (Patient 3). Patient 3 arrived at the L&D unit at 8:37 a.m., on 12/12/2023, and was first evaluated by a nurse at 4:15 p.m., 8 hours after arriving at the L&D unit.

This deficient practice had the potential for an emergency medical condition (EMC, example: heart attack, excessive bleeding, etc.) to go unidentified by nursing staff and could delay treatment and result in patient harm.

On 12/14/2023 at 5:50 p.m., the survey team called an Immediate Jeopardy (IJ, a situation in which the facility's noncompliance with one or more requirements has caused, or is likely to cause, a serious injury, harm, impairment, or death to a patient) in the presence of the Chief Nursing Officer (CNO), the Vice President of Quality & Risk Management (CPQRM), the Medical Director/Chief Medical Officer (CMO), the Chief Operating Officer (COO), the Chief Executive Officer (CEO), the Chief Information Officer (CIO), and the Manager for Accreditation, Licensing, and Regulatory (MALR).

1. The facility failed to perform nursing assessments (a process where a nurse gathers, sorts and analyzes a patient's health information), including vital signs (temperature, blood pressure, heart rate, respiratory rate, and pain) upon admission, as ordered by the physician and per the facility's policy regarding assessment and reassessment, for one of three sampled patients (Patient 1) who was admitted to the Labor and Delivery unit (L&D, a unit that specializes in childbirth). In addition, the facility failed to report changes in Patient 1's condition immediately when Pitocin (oxytocin, a medication to induce labor [a series of continuous and progressive contractions, the tightening of uterine muscles [middle and thickest layer of the uterus, which is a part of the female reproductive system where the baby grows], that allows the fetus [unborn baby] to move through the birth canal]) was discontinued, and when there were signs of fetal [unborn baby] distress (when there are changes in heart rate, fetal movement, or signs of oxygen deprivation before or during labor). Patient 1 delivered a baby (Patient 2) who was not breathing, had no heart rate, was limp, and cyanotic (bluish color indicating lack of oxygen). Patient 2 was taken to the Neonatal Intensive Care Unit (NICU, unit that specializes in providing intensive [critical] medical care to newborns) and transferred to an outside hospital for a higher level of care (a hospital capable of providing diagnostic or interventional care beyond the capacity of the hospital from which a patient originates). Patient 2 passed away at the outside hospital.

2. The facility failed to assess one of three sampled patients (Patient 3), who presented to the Labor and Delivery (L&D) unit, in a timely manner (within 10 minutes). Patient 3 complained of contractions (tightening of uterine muscles [middle and thickest layer of the uterus, which is a part of the female reproductive system where the baby grows] during labor) upon arrival to the L&D unit on 12/12/2023 at 8:37 a.m., Patient 3 waited on the unit without a nursing or medical assessment for eight (8) hours. At 4:30 p.m., Patient 3's Flow Sheet (contains important data regarding a patient's condition) indicated variable decelerations (an abrupt decrease in fetal [unborn baby] heart rate which could indicate umbilical cord compression [when the baby's weight puts pressure on the cord during pregnancy or labor and can restrict blood flow and oxygen to the baby]) were present on the fetal heart monitor (measures the heart rate and rhythm of the fetus [unborn baby]).

These deficient practices had the potential for abnormal vital signs and an emergency medical condition (EMC, example: heart attack, excessive bleeding, etc.) to go unidentified and can result in the delay of rendering potential life-saving treatment and had the potential to result in harm.

On 12/15/2023 at 7:35 p.m., the survey team informed the facility in the presence of the CEO, CMO, CIO, CNO, VPQRM, and MALR, that the survey team was unable to verify, though observations and interviews, that the IJ Removal Plan (interventions to correct the deficient practices) had been implemented, and therefore, the IJ had not been removed. The facility was informed that the Department would recommend a 23-day termination (preliminary notice issued to the facility indicating that the provider agreement [Medicare and Medical payment agreement] will be terminated in 23 days if the facility does not correct the identified deficiencies) to the Centers for Medicare & Medicaid Services (CMS, a Federal agency that runs Federal healthcare programs) pending the removal of the IJ. The facility needed to submit evidence that the IJ Removal Plan had been implemented by the facility and verified by the survey team.

On 12/22/2023, at 10 a.m., the IJ was removed in the presence of the VP for Quality and Risk Management, Manager for Accreditation, Licensing and Regulatory, Chief Nursing Officer, Chief Executive Officer, Chief Information Officer, and in attendance by phone were the Chief Operating Officer and the Chief Medical Officer, after the facility submitted an acceptable IJ removal plan. The elements of the IJ removal plan were verified and confirmed through observation, interviews and record reviews. The acceptable IJ removal plan included the following:

1. Creation and implementation of a new policy titled "Triage (preliminary assessment to determine the urgency of the patient ' s need and the nature of treatment needed), Assessment and Reassessment Standards Labor & Delivery Department" which went into effect on 12/15/2023

2. Education of all applicable clinical and contracted services staff regarding the new policy on "Triage, Assessment and Reassessment Standards Labor & Delivery Department"

3. Creation and implementation of a new policy "Labor & Delivery Intake Process Workflow (a structured approach to gathering/collecting information from patients)," which went into effect on 12/14/2023.

4. Education of all applicable clinical and contracted services staff regarding the new policy on "Labor & Delivery Intake Process Workflow"

5. Revision of the facility ' s daily safety briefing to review any safety incidents or operations that have a high potential to negatively impact patient care and safety within the organization

6. Inservice of the Nursing staff regarding "Fetal and Uterine Monitoring (a method of tracking the Fetal Heart Rate along with the occurrence of uterine contractions): Assessment, Interpretation, and Documentation"

7. Monitoring compliance to ensure patients are registered and triaged within 10 minutes of arrival

8. Monitoring compliance to ensure notification to physicians is communicated immediately when there is no improvement after interventions have been implemented

Findings:

1. During a review of Patient 1's Face sheet (a document that gives a patient's information at a quick glance), dated 6/25/2023, the Face sheet indicated, Patient 1 was admitted to the facility on 6/25/2023 at 2:29 a.m. to the obstetric (a branch of medicine specialized in the care of pregnant women and childbirth) service.

During a review of Patient 1's un-timed "Obstetric Admission History & Physical (H&P, a formal and complete assessment of the patient and the problem)," dated 6/25/2023, the Obstetric Admission History & Physical indicated, Patient 1 was thirty-nine (39) weeks pregnant (full-term is 40 weeks) and complained of uterine contractions (tightening of uterine muscles [middle and thickest layer of the uterus, which is a part of the female reproductive system where the baby grows] during labor). "AROM (artificial rupture of membrane, when a healthcare provider intentionally breaks a person's amniotic sac [a bag of waters that surrounds the fetus [unborn baby]) clear, IUPC (intrauterine pressure catheter placement is device that measures contractions during labor)." Assessment indicated Patient 1 was in labor (last stage of pregnancy when muscles of the womb start to push the baby out or childbirth). The plan was to admit to the Labor and Delivery Unit (L&D, a unit that specializes in childbirth) for delivery.

During a review of Patient 1's "LD (Labor & Delivery) Flowsheet (contains important data regarding a patient ' s condition)," dated 6/25/2023, the LD Flowsheet indicated the following: At 3:09 a.m., blood pressure (BP) was 131/81 (normal 120/80) and pulse (Heart rate [HR]) was 78 (normal 60 to 100).

At 4:01 a.m., Respiratory Rate (RR) was 18 (normal), Temperature was 98.6 (normal) and 5/10 pain to the abdomen, uterine contractions. Membranes intact (amniotic sac not yet ruptured).

At 7:40 a.m., Physician (MD 1) examined Patient 1. Membranes ruptured by MD 1. IUPC (intrauterine pressure catheter is a device that measures contractions during labor) inserted. Dilation (when cervix [the lower part of the uterus] opens to allow the baby to move through the birth canal) 2.5 cm (10 is completely dilated)...

At 7:43 a.m., BP was 139/90 and HR was 91.

At 9:14 a.m., Patient 1 was in labor (a series of continuous and progressive contractions that allows the fetus [unborn baby] to move through the birth canal). Uterine activity monitored by IUPC (intrauterine pressure catheter placement is a device that measures contractions during labor). Fetal assessment by external ultrasound, fetal heart rate (FHR) 130 (normal 120-160), no decelerations (decrease in fetal heart rate), FHR category 1 (fetus is reactive and HR is reassuring [when FHR is within normal range between 12-160 beats per minute]). Pitocin (oxytocin, a hormone to strengthen labor contractions during childbirth) was started at 9:14 a.m.

At 10 a.m., "Pitocin D/C (discontinue) Post Teaching."

At 10:02 a.m., FHR with prolonged deceleration (an abnormal fetal heart rate under 120 usually lasting at least 2 minutes). Patient 1 positioned to left-lateral (side) and semi-fowlers position (sitting).

At 10:07 a.m., "Uterine activity normal ...Fetal Assessment: Late and Variable decelerations present. Actions for decelerations; side to side, oxygen applied, Pitocin off; IV (intravenous- through the vein) bolus (administering a medication over a short period of time), Category II (FHR tracing is considered indeterminate [not exactly known] and cannot be considered either reassuring (within normal variation) or non-reassuring (with heart rate pattern abnormalities).

At 10:16 a.m., "Fetal decelerations heard, staff called at bedside to help out."

At 10:18 a.m., Patient 1's HR was 88 and SpO2 (oxygen saturation- measures the amount of oxygen in the blood) was 100 %.

At 10:19 a.m., Patient 1's position, right lateral and semi-fowlers.

At 10:20 a.m., Charge Nurse (CN) 2 is at bedside repositioning Patient 1 and helping out.

At 10:23 a.m., Patient 1's HR was 83 and SpO2 was 100 %.

At 10:28 a.m., Patient 1's HR was 70 and SpO2 at 100 %.

At 10:33 a.m., Patient 1's HR was 79 and SpO2 was 100%.

At 10:38 a.m., Patient 1's HR was 99 and SpO2 was 100%.

At 10:39 a.m., MD 1 examined Patient 1 ...Dilation 3 cm ...Membranes leak, clear fluid noted. Registered Nurse (RN) 6 at bedside, reviewed strip (recording of the heart rhythm). Patient 1 kept on her right side.

At 10:43 a.m., Patient 1's HR was 72 and SpO2 was 100 %.

At 10:48 a.m., Patient 1's HR was 78 and SpO2 was 100 %.

At 10:51 a.m., Patient 1's BP was 139/80 and HR was 97.

At 10:53 a.m., Patient 1's HR was 78 and SpO2 was 100 %.

At 10:58 a.m., Patient 1's HR was 71 and SpO2 was 100 %.

At 11 a.m., Uterine assessment pattern was normal ...Fetal assessment: Late decelerations, actions taken for decelerations; side to side; oxygen applied; Pitocin off; IV bolus. Call/Page placed to provider. MD 1 notified. MD 1 was busy delivering another patient.

At 11:03 a.m., Patient 1's HR was 83 and SpO2 was 100 %.

At 11:04 a.m., Provider (MD 1) reviewed strip (FHR), RN 6 at bedside. MD 1 at bedside. Status update; Fetal status, labor status and membrane status. "Informed MD 1 of fetal decelerations, Pitocin discontinued at 10 a.m., FSE (fetal scalp electrode, a wire placed on the scalp of the fetus to monitor their heart rate) ordered.

At 11:08 a.m., Patient 1's HR was 72 and SpO2 was 100 %.

At 11:13 a.m., Patient 1's HR was 76 and SpO2 was 100 %.

At 11:18 a.m., Patient 1's HR was 86 and SpO2 was 100%, Dilation 3 cm ...MD 1 reviewed strip (FHR). RN 6 at bedside. RN 6 reviewed strip. MD 1 at bedside. Vaginal exam done by MD 1. Informed MD 1 of difficulty to monitor FHR, tracing reviewed by RN 6 with MD 1.

At 11:19 a.m., FSE (fetal scalp electrode, a wire placed on the scalp of the fetus to monitor their heart rate) applied by MD 1.

At 11:20 a.m., RN 6 at bedside; RN 6 reviewed strip; MD 1 at bedside. MD 1 informed Patient 1 "that if there were more fetal decelerations, he will do a Cesarean section (surgical delivery of a baby). Patient 1 and FOB (father of baby) verbalized understanding to teaching (referring to the need to perform CS if there were more fetal decelerations).

At 11:21a.m., Patient 1's BP was 132/87 and HR was 88.

At 11:23 a.m., Patient 1's HR was 96 and SpO2 was 100 %.

At 11:28 a.m., Patient 1's HR was 85 and SpO2 was 100 %.

At 11:31 a.m., Patient 1's HR was 107 and SpO2 was 94 %.

At 11:33 a.m., Patient 1's HR was 98 and SpO2 was 99 %...Epidural (an injection in the back to stop feeling pain) in progress ...

At 11:38 a.m., Patient 1's HR was 87, 95 and SpO2 was 87 and 98 %.

At 11:43 a.m., Patient 1's HR was 95 and SpO2 was 99 %...Epidural catheter placed.

At 11:44 a.m., Patient 1's HR was 114 (elevated, normal is 60 - 100) ...

At 11:46 a.m., Patient 1's BP was 148/94 (elevated, normal is 120/80).

At 11:47 a.m., Patient 1's BP was 140/71 and HR was 102 (elevated).

At 11:48 a.m., Patient 1's HR was 91 and SpO2 was 98 %.

At 11:51 a.m., Patient 1's BP was 129/77 and HR was 103. Dilation was 4 cm ...Foley catheter inserted.

At 11:56 a.m., Position; right lateral and semi-fowlers.

At 11:57 a.m., Fetal assessments comments indicated Patient 1 repositioned post epidural.

At 12:22 p.m., Uterine activity; IUPC, normal ...Fetal Assessment, mode; internal scalp electrode, FHR baseline 130, actions for decelerations (decrease in fetal heart rate); side to side, oxygen applied, IV bolus, sterile vaginal exam. Category II (indeterminate [not exactly known]). Comments: CN 2 and staff at bedside, decelerations in fetal HR noted.

At 12:24 p.m., oxygen 10 Liters via face mask ... RN 6 at bedside. CN 2 at bedside helping out, repositioning Patient 1. Staff called at bedside to help out.

At 12:25 p.m., "FSE (fetal scalp electrode) seemed to be not working. External applied while FSE was in place. CN 2 helping, repositioning and applying external doppler.

At 12:27 p.m., Patient 1's BP was 125/80, HR was 103 (elevated). Fetal Assessment: mode; internal scalp electrode. FHR baseline: 50. FHR baseline changes: bradycardia (a heart rate less than 110 beats per minute). Prolonged decelerations (decrease in fetal heart rate) present. Category III (non-reassuring fetal heart rate associated with neurological (affects the brain and the nerves found throughout the body) abnormalities). CN 2 and RN 6 at bedside along with the team, such as L&D staff RN and student doctors; resuscitation efforts done to help with fetus out, MD 1 is at bedside. MD 1 walked at bedside, Patient 1 to take to the OR (operating room) stat (immediately) for C/S (Cesarean Section).

At 12:29 p.m., MD 1 at bedside, applied FSE.

At 12:29 p.m., IUPC removed. RN 6 and MD 1 at bedside. CN 2 and L&D staff and student doctors at bedside helping in moving the bed.

During a review of Patient 1's "Operative Report," dated 6/26/2023 at 11:57 p.m., the Operative Report indicated the following: Date of surgery: 6/25/2023. Preoperative (before the surgery) Diagnosis: Intrauterine pregnancy (when a fertilized egg implants and starts to develop within the uterus) at term, fetal bradycardia (a heart rate less than 110 beats per minute). Operative procedure: Emergency C-Section. Findings: Description of procedure: ...infant was delivered gently with vacuum ...The infant was handed off to the awaiting NICU team.

During a review of Patient 1's "Neonatal Delivery and Resuscitation (methods used to restart the heart and lungs if they stop working) Record," dated 6/25/2023, the Neonatal Delivery and Resuscitation Record indicated the following: Patient 1's baby (Patient 2) was born at 12:47 p.m. Apgar scores (a scoring system from 0 - 10, used to assess newborns at one minute and five minutes of life to determine whether or not the baby needs medical intervention or assistant) at one minute and five minutes the APGAR scores were 0 (indicating no heart rate, no respirations, no tone (contributes to the control and amount of movement), no reflex (involuntary action that the body does in response to something), bluish skin color). At 10 minutes, the score was 1. At 15 minutes Patient 2 had a heart rate. Comments indicated a "crash" C-section (an emergency C-section due to immediate concern for the health of the mother and/or the baby) for a non-reassuring (with heart rate pattern abnormalities) fetal heart rate (FHR), no FHR detected for 25 minutes prior to delivery. Patient 2 was ventilated and intubated (a tube is inserted through the mouth or airway to keep the airway open so air can get through). Patient 2 was taken to NICU.

During a concurrent interview and record review on 12/13/2023 at 1:31 p.m., with the Clinical Educator (CED) of the Labor & Delivery Unit and the Quality Coordinator (QC), the CED stated the following: Patient 1 arrived at the L&D unit at 2:29 a.m. Patient 1 was admitted at 4:01 a.m. A full set of vital signs (VS) was not taken upon admission. Patient 1 had a rupture of membranes (ROM, membranes surrounding fetus [unborn baby] are ruptured and result in leakage of amniotic fluid [fluid that surrounds the fetus]) at 7:40 a.m. Pitocin (medication to induce labor) was started at 9:14 a.m., and discontinued it at 10 a.m. The fetal monitoring strip (record of the heart rate and rhythm) indicated there was a prolonged deceleration (slowing down of the fetus' heart rate below 120 per minute, indicating fetal distress [changes in heart rate, movement, etc.]). The physician was not notified that Pitocin was discontinued or of the fetal decelerations, until an hour later, at 11 a.m.

The Quality Coordinator (QC) said, the physician should have been notified right away to evaluate Patient 1 at 10 a.m. The QC also verified that Patient 1's Temperature was not checked every 2 hours after the ROM, as ordered by the physician. QC said it was important to take the temperature to check for possible infection. The QC also verified that complete VS (BP, HR, RR, pain) were not taken upon admission or every hour, as ordered, only blood pressure and heart rate were checked. The QC stated VS should be taken to help determine Patient 1's baseline and to check for abnormal vital signs.

The QC said that assessments for uterine contractions and fetal heart rate should be performed every 30 minutes, and the QC verified an assessment was not performed at 10:30 a.m., and between 11 a.m., and 12:22 a.m., Per the L&D Flowsheet, the fetal heart rate assessments indicated there were continuous decelerations from 10 a.m. to 12:22 p.m. The QC stated decelerations were a sign of fetal distress. The QC verified that Patient 1 delivered via emergency Cesarean Section (C-section, surgical delivery of a baby) at 12:47 p.m. Patient 1's baby (Patient 2) was not breathing, had no heart rate, was limp and cyanotic (bluish color indicating lack of oxygen). Patient 2 was intubated, and a heart rate was obtained at 14 minutes of life. Patient 2 was taken to the Neonatal Intensive Care Unit and transferred to an outside hospital for a higher level of care.

During a concurrent interview and record review of Patient 2's medical record with the Manager of the Neonatal Intensive Care Unit (MNICU) on 12/14/2023 at 3:41 p.m., the MNICU stated Patient 2 was admitted to the NICU then transferred to an outside hospital and passed away.

During a review of Patient 1's physician's order, dated 6/25/2023 at 8:54 a.m., the physician's order indicated, "BP (blood pressure), P (pulse), R (respiratory rate) every 60 minutes."

During a review of Patient 1's physician's order, dated 6/25/2023 at 8:56 a.m., the physician's order indicated, "Temperature every 2 hours, if ROM (Rupture of Membrane)."

During a review of the Facility's policy and procedure (P&P) titled, "Admission Assessment and Reassessment Labor and Delivery," dated 10/27/2021, the P&P indicated, "an initial assessment is to be performed by a Registered Nurse (RN) on all patients within two (2) hours of admission. This initial assessment includes maternal vital signs and pain level ...The initial assessment includes ...vital signs."

During a review of the Facility's policy and procedure (P&P) titled, "Induction or Augmentation of Labor (prompting the uterus to contract [tightening and shortening] during pregnancy before labor begins on its own): Oxytocin (Pitocin)," dated 6/23/2021, the P&P indicated during oxytocin should be discontinued immediately and the OB (Obstetric) provider notified when ...symptoms/conditions where continuation of oxytocin is assessed as detrimental to maternal and or fetal well-being according to the registered nurse's (RN) judgment/assessment.

2. During an interview on 12/11/2023 at 4:47 p.m., with the Chief Nursing Officer (CNO), the CNO stated there was no current OB (Obstetric, care of pregnant women and their babies) triage (preliminary assessment to determine the urgency of the patient ' s need and the nature of treatment needed) policy in place. The policy had not been approved yet.

During a concurrent observation and interview, on 12/12/2023 at 10:08 a.m., Patient 3 was observed sitting on a chair in the hallway of the Labor and Delivery Unit (L&D, a unit that specializes in childbirth). Patient 3 stated she (Patient 3) arrived at 8:37 a.m., checked in by filling out a form, and has been waiting for approximately an hour and a half. Patient 3 stated she had not been evaluated by a nurse or a doctor, and vital signs (temperature, blood pressure, heart rate, respiratory rate, pain) had not been taken. Patient 3 stated she (Patient 3) was having contractions (tightening of uterine muscles [middle and thickest layer of the uterus, which is a part of the female reproductive system where the baby grows] during labor, a series of continuous and progressive contractions that allows the fetus [unborn baby] to move through the birth canal).

During an interview on 12/12/2023 at 10:54 a.m., with the Chief Nursing Officer (CNO), the CNO stated the following: Patients arrive to the unit (L&D unit), fill out a "Maternity Check-In Form" then sit down until the charge nurse puts the patient in a room. CNO was currently covering for the Charge Nurse (CN 1) who was assisting in the Operating Room (OR). CNO stated there was a total of 6 triage (preliminary assessment to determine the urgency of the patient's need and the nature of treatment needed) beds on the unit and 4 of the beds were occupied.

During an interview on 12/12/2023 at 11:13 a.m., with Charge Nurse (CN) 1, CN 1 stated the following: CN 1 called the CNO to assist in the L&D unit because CN 1 had to help with a procedure in the OR from 8 a.m., to 11 a.m. CN 1 stated Patients including Patient 3, had not been triaged because she (CN1) was out of the unit for 3 hours. CN 1 confirmed patients were not evaluated until the patients were placed in a room.

During an interview and review of Patient 3's "Maternity Check-In Form, on 12/14/2023 at 10:02 a.m., with the Manager of the Neonatal Intensive Care Unit (MNICU), the NMICU verified Patient 3 checked into the L&D unit on 12/12/2023 at 8:37 a.m. for "having contractions/baby hasn't been active as much."

During a review of Patient 3's "OB History and Physical (H&P, a formal and complete assessment of the patient and the problem) Note," dated 12/12/2023 at 5:47 p.m., the OB History and Physical Note indicated the following: Patient 3 was a 21-year-old who was pregnant for the first time. Patient 3 was 39 - 5/7 weeks (40 weeks is full term) pregnant and presented to the L&D unit complaining of uterine contractions. Patient was 5 cm dilated (when cervix [the lower part of the uterus] opens to allow the baby to move through the birth canal), (10 is fully dilated).

During the review of Patient 3's "OB Triage (preliminary assessment to determine the urgency of the patient's need and the nature of treatment needed)," Flowsheet, dated 12/12/2023 at 4:15 p.m., the OB triage Flowsheet indicated the following: At 4:29 p.m., the vaginal exam indicated Patient 3 was 5.5 cm dilated (range 0 to 10, 10 means fully dilated). At 4:30 p.m., Patient 3 was placed on an external monitor to detect uterine contractions (tightening of uterine muscles [middle and thickest layer of the uterus, which is a part of the female reproductive system where the baby grows] during labor). Patient 3 was having moderate contractions. An external ultrasound monitor was also placed to assess the fetus (unborn baby). Patient 3 had variable decelerations (abrupt decrease in the fetus heart rate, under 110) and at a Category II (indeterminate assessment of FHR tracing). Patient complained of abdominal pain rated at a 7 (ranges 0 to 10, 10 being the worse possible pain), cramping and contractions.

During a concurrent interview and review of Patient 3's Flowsheets, on 12/14/2023 at 10:03 a.m., with the Quality Coordinator (QC), the QC stated the following: Patient 3 was placed on a monitor to check maternal contractions and the fetus's heart rate at 3:50 p.m. Patient 3 had a limited Maternal assessment on 12/12/2023 at 4:15 p.m. At 4:30 p.m., the Flow sheet indicated variable decelerations (an abrupt decrease in fetal [unborn baby] heart rate which could indicate umbilical cord compression [when the baby's weight puts pressure on the cord during pregnancy or labor and can restrict blood flow and oxygen to the baby]) were present, which could indicate that umbilical cord was compressed, which could result to decreased oxygenation to the fetus. In addition, QC verified that vital signs (VS, Temperature, blood pressure, pulse, and respiratory rate) were not taken upon admission at 4:30 p.m. First set of vital signs (VS) were taken at 7 p.m.

The QC stated VS should be assessed to determine if patient was having a fever, which was a sign of infection and also check for increased blood pressure in pregnant women which could lead to seizures (sudden, uncontrolled burst of electrical activity in the brain that causes changes in behavior, movements, feelings, and level of consciousness [state of awareness of what's happening around]). The QC verified there was no nursing documentation for Patient 3 from 8:37 a.m., to 4:14 p.m. The QC stated eight (8) hours was a long time for Patient 3 to be evaluated because Patient 3 could have been having an unidentified medical emergency.

During a review of the Facility's policy and procedure (P&P) titled, "Admission Assessment and Reassessment Labor and Delivery," dated 10/27/2021, the P&P indicated, "an initial assessment is to be performed by a Registered Nurse (RN) on all patients within two (2) hours of admission. This initial assessment includes maternal vital signs and pain level ...The initial assessment includes ...vital signs."

Based on observation, interview, and record review, the facility failed to ensure Registered Nurse 9 (RN 9) and Registered Nurse 10 (RN 10) were competent in the hemodialysis (the process of removing excess fluid and waste from the body of a person whose kidneys are not working correctly) emergency termination procedure (safe process of disconnecting a patient from the dialysis machine in case of an emergency) for one (1) of 30 sampled patients (Patient 27).

This deficient practice had the potential to result in an inadequate return of blood from the dialysis machine (a machine that removes blood from the body, filters it [refers to the blood] through a dialyzer [an artificial kidney], and returns the cleaned blood to the body) to the patient (Patient 27) causing harm or even death during hemodialysis treatment.

Findings:

During a review of Patient 27's History and Physical (H&P, a formal and complete assessment of the patient and the problem), dated 12/12/23, the H&P indicated Patient 27 was admitted to the facility to restart Hemodialysis (the process of removing excess fluid and waste from the body of a person whose kidneys are not working correctly).

During an observation on 12/12/2023 at 3:15 p.m., on the 8th floor of the facility, with the Chief Nursing Officer (CNO), three dialysis machines were observed to have a sign titled "Emergency procedure for incapacitated Acute dialysis teammate" with instructions.

During an interview on 12/15/2023 at 4:22 p.m. with the Medical Director of Hemodialysis program (MD 5), MD 5 stated signs were posted in the dialysis machines regarding instructions on how to shut off the Hemodialysis machine safely in case of an emergency.

During a concurrent interview and record review on 12/15/2023 at 5:28 p.m. with the Vice President of Quality and Risk Management (VPQRM), Registered Nurse 9 (RN 9), and Registered Nurse 10 (RN 10), both RN 9 and RN 10 stated that they were not provided in-service or training on how to shut off the hemodialysis machine in case of an emergency such as during a power outage or an incapacitated dialysis nurse during dialysis. Likewise, the VPQRM was not able to provide evidence of in-service or training provided to the facility's staff for emergencies during hemodialysis including safely shutting-off dialysis in case of an emergency.

Based on observation, interview, and record review, the facility failed to ensure:

1. Three of three sampled Patients (Patients 8, 11 and 13) received nursing care interventions and assessments per facility policy to promote wound healing, when:

a. Patients 8, 11, and 13 were not repositioned/turned every two hours.

b. Patient 8 had no admission and biweekly ongoing wound photographs, assessments, and measurements.

c. Patient 8 had no daily wound assessment documentation.

These deficient practices had the potential to compromise Patient 11's and Patient 13's wound healing progression, and resulted in Patient 8's sacral and right buttock wounds becoming larger in size, with Patient 8's sacral wound progressing from a Stage III (Full thickness tissue loss where subcutaneous fat may be visible, but bone, tendon, or muscle are not exposed) pressure ulcer (injury to the skin and underlying tissues resulting from prolonged pressure on the skin) to an unstageable (unable to stage, full thickness tissue loss in which the base of the ulcer is covered by slough- yellow, tan, gray, green or brown- and/or eschar- tan, brown or black) pressure ulcer.

2. Two of two Crash Carts (Crash cart 1- adult Crash Cart and Crash Cart 2- neonatal [relating to newborn children] Crash Cart, a cart stocked with emergency equipment, supplies and medications to be used in a medical emergency) in the Labor and Delivery Unit (L&D, a floor of the hospital responsible for the provision of medical care for patients arriving to deliver a baby) were checked every shift per facility's policy to ensure emergency supplies, equipment, and medications were readily available in the event of an emergency.

This deficient practice had the potential for emergency supplies to not be readily available in case of an emergency and had the potential to result in a delayed provision of emergency care needed by patients, which may lead to patient harm and/or death.

Findings:

1a. During a review of Patient 8's Face Sheet (a document that gives a patient ' s information at a quick glance), dated 10/23/2023, the Face Sheet indicated, Patient 8 was admitted to the facility on 10/23/2023 at 10:13 a.m. with diagnoses of paraparesis (partial paralysis of the lower limbs), paraplegia (paralysis of the legs and lower body, typically caused by spinal injury or disease), and intractable pain (severe, constant, relentless, and debilitating pain that is not curable by any known means).

During a review of Patient 8's integumentary (skin) admission assessment note, dated 12/23/2023 at 8 p.m., the integumentary admission assessment note indicated, Patient 8's skin integrity was not intact (break in the skin) with a Stage II (partial-thickness skin loss into but no deeper than the middle layer of the skin) pressure injury to the sacrum/coccyx (tailbone).

During a review of Patient 8's integumentary (skin) admission assessment note, dated 10/23/2023 at 8:00 p.m., the integumentary admission assessment note indicated, Patient 8's Braden Scale (a tool used to measure the risk of getting a pressure ulcer) was 13 out of 23. A score of less than 18 or less, indicated actions were pressure injury prevention and management plan (PIPP), turn clock signs, repositioned/turned every two hours, floated heels off mattress with foam boots and other off-loading devices (ie. wedges, pillow, heel protectors, etc.), managed moisture with incontinence (lack of voluntary control over urination or defecation) care products and encouraged adequate nutrition/fluid intake.

During a concurrent interview and record review on 12/12/2023 at 1:28 p.m. with the Manager of the Intensive Care Unit (MICU), Patient 8's Daily Living Daily Assessment record was reviewed. The Daily Living Daily Assessment record indicated Patient 8 was not turned and refusal of Patient 8 to be turned was not documented for the following dates: 10/24/2023 at 7:34 a.m. through 10/25/2023 at 8 a.m., 10/27/2023 at 7:30 a.m. through 10/27/2023 at 7:25 p.m., 11/1/2023 at 7 a.m. through 11/2/2023 at 8 a.m., 11/13/2023 at 8 a.m. through 11/13/2023 at 6 p.m., 11/26/2023 at 10 a.m. through 11/26/2023 6 p.m., and 11/28/2023 8 a.m. through 11/29/2023 at 8:00 a.m.

The MICU stated Patient 8 should have been turned every 2 hours or the refusal for turning documented. However, the documentation was not done. The MICU further said that not turning patients can add more pressure to the site, making the wound worse or adding new wounds.

During a review of Patient 8's wound, ostomy (bowel or bladder diversion), and continence (issues of bowel and bladder control) nurse assessment record, dated 10/24/2023 at 9:57 a.m., the wound, ostomy, and continence nurse assessment record indicated, Patient 8 had a Stage III (Full thickness tissue loss where subcutaneous fat may be visible, but bone, tendon, or muscle are not exposed) pressure injury (injury to the skin and underlying tissues resulting from prolonged pressure on the skin) measuring 3.0 centimeter (cm, a unit of measurement- length) x 2.0 cm (width) x 0.2 cm (depth). Wound appearance was moist, erythemic (superficial reddening of the skin, usually in patches, because of injury or irritation causing dilation of the blood capillaries), yellow and red.

During a review of Patient 8's wound photograph and assessment record dated 11/15/2023 at 2:30 a.m., the wound photograph and assessment record indicated, Patient 8 had a right buttock wound, measuring 2.0 cm (centimeter [a unit of measurement], length) x 2.0 cm (width) x 0.1 cm (depth). Patient 8's right buttock wound appearance was documented as red and pink excoriation (a scratch in the skin) without drainage.

During a review of Patient 8's wound, ostomy, and continence nurse assessment note, dated 11/16/2023, the wound, ostomy, and continence nurse assessment note indicated, Patient 8 had a right buttock excoriation becoming larger. Wound measurements were not documented. Wound appearance was documented as excoriation, wound edges macerated (skin appears wrinkly, soft and wet when exposed for too long with moisture such as from urine), scant drainage, and moist.

During a review of Patient 8's wound, ostomy, and continence nurse assessment, dated 11/30/2023, the wound, ostomy, and continence nurse assessment note indicated, Patient 8 had a sacrum (triangular bone at the bottom of the spinal column) unstageable pressure injury (a full thickness tissue loss in which the actual depth of the ulcer/injury is completely obscured in the wound bed), measuring 7.0 cm (length) x 12.0 cm (width) x UTD (unable to determine; depth). Wound appearance was documented as irregular wound edges, small purulent (pus formation) drainage, mild odor, and wound appearance as moist.

During a concurrent interview and record review on 12/12/2023 at 1:28 p.m. with Wound Care Ostomy Nurse (WCON), Patient 8's admission wound record was reviewed. Patient 8's admission wound record, documented as "sacrum," did not include a photograph, assessment, or measurements of the right buttocks wound. WCON stated that Patient 8's admission wound documentation did not capture the entire right buttock wound, and the buttock wound was cut off in the picture. WCON stated that wound photos were supposed to be taken at admission, transfer, bi-weekly Wednesday and Sunday, and at discharge. WCON confirmed there was no photograph of Patient 8's right buttock wound on admission.

WCON further stated the admission nursing assessment on 10/23/2023, at 8 p.m., indicated a sacral stage II (partial-thickness skin loss into but no deeper than the middle layer of the skin) pressure injury, but this was incorrect and was documented as a stage III at admission by WCON. A concurrent review of the nursing admission skin assessment documentation indicated the primary nurse did not complete an assessment of the right buttock wound. This incomplete assessment was verified by the WCON.

Additional review of the wound care ostomy nurse assessment record, dated 10/23/2023 at 11:44 a.m., indicated Patient 8's right buttock condition was documented as excoriation (a scratch in the skin), moist and erythemic (redness of the skin caused by injury or inflammation). No measurements were documented on the WCON's right buttock wound documentation for Patient 8. WCON stated there was no initial wound assessment done by the primary nurse, and the WCON documentation was done after 24 hours of Patient 8's admission. WCON stated she was unable to find any wound photograph documentation of Patient 8's right buttock until 11/15/2023.

During a concurrent interview and record review on 12/12/2023 at 1:28 p.m. with the Manager of Intensive Care Unit (MICU) and the WCON, Patient 8's wound care documentation record was reviewed. WCON stated they (both the MICU and the WCON) did not see any documentation in Patient 8's chart for Patient 8's refusal of wound photographs. WCON also said interventions should have been implemented for Patient 8's right buttock wound, such as: offloading, turning, and photographs.

During an interview on 12/12/2023 at 1:28 p.m., with WCON, the WCON stated that only the wound care nurse and physician can stage a wound. WCON said the assessment policy is to assess and photograph a wound within 24 hours of admission. WCON stated a pressure ulcer/injury can become worse if it is not documented on admission and a photo is not taken. WCON said there should be ongoing wound documentation per facility policy.

During an interview on 12/12/2023 at 3:04 p.m. with Registered Nurse 2 (RN 2), RN 2 stated if a patient comes in the facility with a wound, the wound policy is to take wound pictures at admission, complete a wound care consult, and request initial treatment for the wound. RN 2 further said wounds are supposed to be assessed every day and every shift.

During a concurrent interview and record review on 12/14/2023 at 3:44 p.m. with the Manager of Medical Surgical (MMS) Unit, Patient 8's wound care record was reviewed. MMS stated there were no nursing assessments documented in Patient 8 ' s chart for the right buttocks wound from 10/25/2023 through 11/26/2023. MMS stated that the admission photograph of Patient 8's right buttocks was not properly labeled and did not include an assessment. MMS stated that multiple wound photographs for Patient 8's sacrum and right buttocks were missing the assessment which was supposed to include wound's size, wound color, periwound (tissue surrounding a wound) appearance, and drainage. MMS also said that biweekly wound photos were not taken for Patient 8.

During an interview on 12/14/2023 at 3:44 p.m. with the Manager of Medical Surgical (MMS) Unit, MMS stated wound photos are taken biweekly and wounds should be measured at this time. MMS said if a wound was not assessed or documented, nursing staff would not know if wounds were progressing or if it was healing. MMS also said it was part of the admission assessment to identify and describe a wound, and the wound care nurse will appropriately stage the wound. MMS stated that the wound care nurse and doctors can stage wounds. MMS said if wounds were not documented and a picture was not taken, the staff would not be able to identify the appropriate treatment for the wound. MMS stated that lack of treatment can cause infection of the wound and can result in patient harm.

During a review of the facility's policy and procedure (P&P) titled "Wound Care: Assessment and Documentation," dated 4/22/2022, the P&P indicated:

"A. Skin Integrity (skin health):

The patient's skin integrity from head to toe will be assessed upon admission and each shift.

Procedure:

Wound Assessment:

Document description of each wound in the electronic medical record in the "Daily Assessment" under the integumentary (skin) and pressure injury tab to include the following:

Location (Specific injury location on body).

Size (length x width x depth in cm)

Length: Longest head ¿¿- to - toe measurement

Width: Longest hip - to - hip measurement

Depth: Deepest part of the wound (perpendicular to the skin surface)

Undermining (separation of the wound edges from the surrounding health tissue, often creating a pocket under the wound surface)/Tunneling (when a wound extends deeper into the tissue than its surface, creating a channel or tunnel)

Document if present

Wound/Periwound (tissue surrounding a wound) Appearance...

Photographing:

Photographs should be included in the medical record to support documentation to determine progress of wound healing and effectiveness of therapy.

Photographed open wounds and pressure injuries are to be posted on the Wound Photograph

Wound will be photographed:

Within 24 hours of admission.

ii. Change of condition

iii. Upon discovery of a new wound

iv. Within 24 hours of discharge

Bi-weekly on Wednesday and Sunday. The photo label should include:

i. Patient's date of birth or medical record number

ii. Location of wound/lesion

iii. Date and time of photograph

iv. Measurement device

v. Optional body alignment sticker

If unable to obtain a photograph, document the reason in the medical record.

C. Risk Prevention

2. Positioning and care and documentation:

a. The nursing team will position the patient to ensure the skin integrity is maintained in accordance with the patient care plan and document the following interventions in the "Daily Assessment" under ADL's (Activities of Daily Living) tab:

i. Reposition patient as frequently as the patient can tolerate, minimum every 2 hours.

ii. Clarify and document any limitations per physician or any patient refusal."

1b. During a review of Patient 11's Face Sheet (a document that gives a patient's information at a quick glance), dated 12/2/2023, the Face Sheet indicated, Patient 11 was admitted to the facility on 12/2/2023 at 6:44 a.m., with a diagnosis of altered mental status (AMS, a change in mental function that stems from illnesses, disorders and injuries affecting your brain).

During a review of Patient 11's integumentary (skin) admission assessment note, dated 12/2/ 2023 at 10:46 a.m., the integumentary admission assessment note indicated, Patient 11 had a stage I (mildest stage of pressure injury that does not have open wounds) pressure ulcer/injury (injury to the skin and underlying tissues resulting from prolonged pressure on the skin) to the sacrum/coccyx (tailbone), present on admission.

During a review of Patient 11's integumentary admission assessment note, dated 12/2/2023 at 10:46 a.m., the integumentary admission assessment note indicated, Patient 11's Braden Scale (a tool used to measure the risk of getting a pressure ulcer) was 14 out of 23. A score of less than 18 or less, indicated actions were: pressure injury prevention and management plan (PIPP), turn clock signs, repositioned/turned every two hours, floated heels off mattress with foam boots and other off-loading devices (ie. wedges, pillow, heel protectors, etc.), managed moisture with incontinence (lack of voluntary control over urination or defecation) care products and encouraged adequate nutrition/fluid intake.

During a concurrent interview and record review on 12/15/2023 at 10:55 a.m. with the Manager of the Medical Surgical (MMS) Unit, Patient 11's Daily Living Daily Assessment record was reviewed. The Daily Living Daily Assessment record indicated Patient 11 was not repositioned/turned every two hours per facility policy on turning/repositioning and Patient 11's refusal for turning was also not documented for the following dates: 12/6/2023 at 7:45 a.m. through 12/6/2023 at 7 p.m., 12/7/2023 at 8 a.m. through 12/7/2023 at 7 p.m., 12/9/2023 at 7:00 p.m. through 12/10/2023 at 8 am., and 12/12/2023 at 7:00 a.m. through 12/13/2023 at 7:08 a.m. This lack of documentation regarding Patient 11's turning/repositioning was verified by the facility's MMS.

During a review of the facility's policy and procedure (P&P) titled, "Wound Care: Assessment and Documentation," dated 4/22/2022, the P&P indicated:

"A. Skin Integrity (skin health):

The patient's skin integrity from head to toe will be assessed upon admission and each shift.

Procedure:

Wound Assessment:

Document description of each wound in the electronic medical record in the "Daily Assessment" under the integumentary (skin) and pressure injury tab to include the following:

Location (Specific injury location on body).

Size (length x width x depth in cm)

Length: Longest head ¿¿- to - toe measurement

Width: Longest hip - to - hip measurement

Depth: Deepest part of the wound (perpendicular to the skin surface)

Undermining (separation of the wound edges from the surrounding health tissue, often creating a pocket under the wound surface)/Tunneling (when a wound extends deeper into the tissue than its surface, creating a channel or tunnel)

Document if present

Wound/Periwound (tissue surrounding a wound) Appearance...

Photographing:

Photographs should be included in the medical record to support documentation to determine progress of wound healing and effectiveness of therapy.

Photographed open wounds and pressure injuries are to be posted on the Wound Photograph

Wound will be photographed:

Within 24 hours of admission.

ii. Change of condition

iii. Upon discovery of a new wound

iv. Within 24 hours of discharge

Bi-weekly on Wednesday and Sunday. The photo label should include:

i. Patient's date of birth or medical record number

ii. Location of wound/lesion

iii. Date and time of photograph

iv. Measurement device

v. Optional body alignment sticker

If unable to obtain a photograph, document the reason in the medical record.

C. Risk Prevention

2. Positioning and care and documentation:

a. The nursing team will position the patient to ensure the skin integrity is maintained in accordance with the patient care plan and document the following interventions in the "Daily Assessment" under ADL's (Activities of Daily Living) tab:

i. Reposition patient as frequently as the patient can tolerate, minimum every 2 hours.

ii. Clarify and document any limitations per physician or any patient refusal."

1c. During a review of Patient 13's Face Sheet (a document that gives a patient's information at a quick glance), dated 12/11/2023, the Face Sheet indicated, Patient 13 was admitted to the facility on 12/11/2023 at 9:33 p.m. with a diagnosis of gastrostomy tube (g-tube, a tube surgically placed through the abdomen into the stomach for feeding) placement.

During a review of Patient 13's integumentary (skin) admission assessment note, dated 12/11/2023 at 11:00 p.m., the integumentary admission assessment note indicated, Patient 13 had a stage IV (most severe type of pressure injury. The skin was severely damaged, and the surrounding tissue begins to die) pressure ulcer/injury (injury to the skin and underlying tissues resulting from prolonged pressure on the skin) to the sacrum/coccyx (tailbone).

During a review of Patient 13's integumentary admission assessment note, dated 12/11/2023 at 11 p.m., the integumentary admission assessment note indicated, Patient 13's Braden Scale (a tool used to measure the risk of getting a pressure ulcer) was 12 out of 23. A Braden score of less than 18 or less, indicated actions were: pressure injury prevention and management plan (PIPP), turn clock signs, repositioned/turned every two hours, floated heels off mattress with foam boots and other off-loading devices (ie. wedges, pillow, heel protectors, etc.), managed moisture with incontinence (lack of voluntary control over urination or defecation) care products and encouraged adequate nutrition/fluid intake, and wound care nurse referral.

During a concurrent interview and record review on 12/15/2023 at 9:20 a.m. with the Manager of the Medical Surgical (MMS) unit, Patient 13's Daily Living Daily Assessment record was reviewed. The Daily Living Daily Assessment record indicated Patient 13 was not repositioned/turned every two hours per facility's policy regarding turning/repositioning and Patient 13's refusal for turning/repositioning was also not documented for dates 12/12/2023 at 12 a.m. through 12/15/2023 at 7:05 a.m. This lack of documentation was verified by the MMS.

During a review of the facility's policy and procedure (P&P) titled, "Wound Care: Assessment and Documentation," dated 4/22/2022, the P&P indicated:

"A. Skin Integrity (skin health):

The patient ' s skin integrity from head to toe will be assessed upon admission and each shift.

Procedure:

Wound Assessment:

Document description of each wound in the electronic medical record in the "Daily Assessment" under the integumentary (skin) and pressure injury tab to include the following:

Location (Specific injury location on body).

Size (length x width x depth in cm)

Length: Longest head ¿¿- to - toe measurement

Width: Longest hip - to - hip measurement

Depth: Deepest part of the wound (perpendicular to the skin surface)

Undermining (separation of the wound edges from the surrounding health tissue, often creating a pocket under the wound surface)/Tunneling (when a wound extends deeper into the tissue than its surface, creating a channel or tunnel)

Document if present

Wound/Periwound (tissue surrounding a wound) Appearance...

Photographing:

Photographs should be included in the medical record to support documentation to determine progress of wound healing and effectiveness of therapy.

Photographed open wounds and pressure injuries are to be posted on the Wound Photograph

Wound will be photographed:

Within 24 hours of admission.

ii. Change of condition

iii. Upon discovery of a new wound

iv. Within 24 hours of discharge

Bi-weekly on Wednesday and Sunday. The photo label should include:

i. Patient's date of birth or medical record number

ii. Location of wound/lesion

iii. Date and time of photograph

iv. Measurement device

v. Optional body alignment sticker

If unable to obtain a photograph, document the reason in the medical record.

C. Risk Prevention

2. Positioning and care and documentation:

a. The nursing team will position the patient to ensure the skin integrity is maintained in accordance with the patient care plan and document the following interventions in the "Daily Assessment" under ADL's (Activities of Daily Living) tab:

i. Reposition patient as frequently as the patient can tolerate, minimum every 2 hours.

ii. Clarify and document any limitations per physician or any patient refusal."

2. During a concurrent observation and record review on 12/11/2023 at 3:13 p.m., in the Labor and Delivery Unit (L&D, a unit that specializes in childbirth), Crash Cart (a cart stocked with emergency equipment, supplies and medications to be used in a medical emergency) 1's (adult crash cart) log titled "Crash Cart and Defibrillator Checklist," was reviewed. There was no documentation to indicate that Crash Cart 1 was checked for emergency medications, supplies, and equipment on 9/8/2023, 9/14/2023, 9/16/2023, 9/24/2023, 10/11/2023, 10/14/2023, 11/17/2023, 12/7/2023, and 12/8/2023.

During a concurrent interview and record review on 12/11/2023 at 3:35 p.m. with Charge Nurse 1 (CN 1), the Crash Cart 1 ' s (adult crash cart) log was reviewed. CN 1 stated the Charge Nurse is responsible for checking the crash cart each shift for day shift and night shift. Verified with CN 1 that the Crash Cart 1 was missing Crash Cart checks from the "Crash Cart Checklist" for September 2023, October 2023 and December 2023. Items on the "Crash Cart Checklist" that should have been checked included: cart locked, defibrillator (a device that apply an electric charge or current to the heart to restore a normal heartbeat) checked, code blue (requiring resuscitation or otherwise in need of immediate medical attention, most often as the result of a respiratory or cardiac arrest) record/form present, RRT (Rapid Response Team, a team of medical providers that respond when a patient demonstrates signs of imminent clinical deterioration) form present, O2 (oxygen tank, a container with oxygen inside it, used for helping people to breathe) Above 2000 PSI (pounds per square inch, a unit of measurement), and transport defibrillator checked with pads. CN 1 stated she (CN 1) was unaware why the dates and Crash Cart checks were not completed, and also stated she (CN 1) was not working on the missing dates. CN 1 said if the Crash Carts were not checked, items can be missing, and patients can be harmed.

During an observation on 12/11/2023 at 3:45 p.m., in the L&D unit, Crash Cart 2's (neonatal [relating to newborn children] crash cart) log titled "Crash Cart and Defibrillator Checklist" was reviewed. There was no documentation to indicate that Crash Cart 2 was checked for emergency medications, supplies, and equipment on 11/1/2023, 11/2/2023, 11/4/2023, 11/5/2023, 11/8/2023, 11/9/2023, 11/14/2023, 11/15/2023, 11/17/2023, 11/18/2023, 11/22/2023, 11/24/2023, 11/25/2023, 11/26/2023, and 11/30/2023.

During a concurrent interview and record review on 12/11/2023 at 3:35 p.m. with the Manager of Neonatal Intensive Care Unit (MNICU), the MNICU verified missing entries for Crash Cart 2 on the "Crash Cart and Defibrillator Checklist," for the month of November 2023. MNICU stated this (Crash Cart 2) was the only neonatal crash cart in the L&D unit and once it was identified that the crash cart checks were not being completed by L&D, the NICU Charge Nurses took over checking this Crash Cart on 12/5/2023, once in the morning and once at night. MNICU stated that not checking the Crash Cart can lead to the patient getting expired equipment or medications and the patient can have an injury.

During a review of the facility's policy and procedure (P&P) titled, "Crash Cart and Defibrillator Check Procedures," dated 12/30/2016, the P&P indicated, " ...The Defibrillator and external area of each Crash Cart will be checked once per shift to ensure that the necessary items are present and in working order. Confirmation of the Crash Cart/Defibrillator (a device that apply an electric charge or current to the heart to restore a normal heartbeat) check will be documented on the Code Blue (indicate a patient requiring resuscitation [to revive] as the result of respiratory or cardiac arrest [when the heart stops beating]) Cart Checklist stored with each cart.

Crash Cart Checks:

1. Every department in possession of a crash cart must check the external area of the cart once per shift.

3. The Crash Cart check will include verification that: a. all items are present; b. all items are in working order; c. There are no outdated or expired products; and d. Any missing or outdated items are replaced.

8. The Emergency Crash Cart Check list will be used each shift to document the timely completion of the Crash Cart Check. a. For each item listed on the Emergency Crash Cart checklist. A check-mark will be placed in each column to confirm inspection and is in the row consistent with the date. b. The tag number of the Crash Cart lock will be recorded to confirm that the lock is in place and intact. c. The nurse completing the Crash Cart check will print and sign their name in the appropriate column consistent with the row for date.

D. Defibrillator Checks:

1. Defibrillator checks will include: a. An employee will be designated by the charge nurse/lead to check the Defibrillator each and every shift. b. Departments/units with 24-hour care: A visual inspection. Ensure that the defibrillator is plugged into the A/C outlet to include completion of the Crash Cart Checklist for each shift. -0700-1900 shift between 0700-0730, 1900-0700 shift between 1900-1930. -The designated employee will check the assigned defibrillator during the time frames indicated above. d. Manual testing with verification of Code Readiness Log will be performed during the completion of the Crash Cart Checklist ..."

Based on observation, interview, and record review, the facility failed to ensure the Condition of Participation for Surgical Services was met as evidenced by:

1. The facility failed to ensure to correctly count and document surgical count of sponges (an absorbent pad used during operations and surgical procedures) for one of 30 sampled patients (Patient 16) in accordance with accepted standards of practice and with the facility's policies and procedures regarding surgical counts (count of items during surgery which is an essential practice to ensure patient safety).

This deficient practice resulted in Patient 16 undergoing another procedure to reopen the incision (a surgical cut into the skin) to remove the remaining sponge inside Patient 16's abdominal cavity and had the potential to compromise Patient 16's health and wellbeing. (Refer to A-0951)

2. The facility failed to ensure a Physician provided ongoing monitoring and treatment for one of 30 sampled Patients (Patient 1) and ensure Patient 1 received medical care in a safe and effective manner. Patient 1 required emergency Cesarean Section (C-section, surgical delivery of a baby) due to Fetus (unborn baby) bradycardia (slow heart rate; Normal fetal heart rate is between 110-160 beats per minute).

This deficient practice had the potential to place all newborn patients at risk for serious injury, harm, or death. (Refer to A-0951)

3. The facility failed to ensure a properly executed informed surgical consent was in the medical record for one of 30 sampled patients (Patient 5), prior to Patient 5's Cesarean Section (C-section, surgical delivery of a baby), in accordance with the facility's policy and procedure regarding obtaining an informed consent (the process in which the healthcare provider educates a patient about the risks, benefits, and alternatives of a given procedure or intervention).

This deficient practice had the potential for the surgical team to perform the wrong procedure on Patient 5 and had the potential for Patient 5 to not be fully informed of the type of surgical procedure/s she (Patient 5) was having. (Refer to A-0955)

The cumulative of these deficient practices resulted in the facility's inability to provide quality health care in a safe environment

Based on interview and record review, the facility failed to:

1. Ensure to correctly count and document surgical count of sponges (an absorbent pad used during operations and surgical procedures) for one of 30 sampled patients (Patient 16) in accordance with accepted standards of practice and with the facility's policies and procedures regarding surgical counts (count of items during surgery which is an essential practice to ensure patient safety).

This deficient practice resulted in Patient 16 undergoing another procedure to reopen the incision (a surgical cut into the skin) to remove the remaining sponge inside Patient 16's abdominal cavity and had the potential to compromise Patient 16's health and wellbeing.

2. Ensure a Physician provided ongoing monitoring and treatment for one of 30 sampled Patients (Patient 1) and ensure Patient 1 received medical care in a safe and effective manner. Patient 1 required emergency Cesarean Section (C-section, surgical delivery of a baby) due to Fetus (unborn baby) bradycardia (slow heart rate; Normal fetal heart rate is between 110-160 beats per minute).

This deficient practice had the potential to place all newborn patients at risk for serious injury, harm, or death.

Findings:

1. During a review of Patient 16's History and Physical (H&P, a formal and complete assessment of the patient and the problem), dated 11/20/2023, the H&P indicated, on 11/20/2023 Patient 16 presented to the facility with contractions (tightening of uterine muscles [middle and thickest layer of the uterus, which is a part of the female reproductive system where the baby grows] during labor [a series of continuous and progressive contractions that allows the fetus [unborn baby] to move through the birth canal]) after Patient 16's membranes raptured (a sac that holds the fluid that surround a baby in the womb), but the fetus was in transverse lie (a fetus that's lying sideways in the uterus [part of the female reproductive system where the baby grows] during labor), and Patient 16 needed a cesarian section (CS, surgical delivery of a baby through a cut [incision] made in the mother's abdomen and uterus).

During a review of Patient 16's post operative (after surgery) note (PON), dated 11/20/2023, the PON indicated, by the time the surgeon (S2) scrubbed in (elaborate hygiene procedure that surgeons go through right before surgery), the baby was already delivered, and the uterine incision (cutting through a womb) was already closed in one layer by the surgeon (S1) who started the procedure. The PON further indicated, the S2 proceeded to close the second layer of uterine incision, the uterus was returned into the abdomen, and the skin was closed with staples.

The PON further indicated, the X-ray (an X-ray is an imaging study that takes pictures of bones and soft tissues) of the abdomen was performed because the instruments and the laparotomy sponges (an absorbent pad used during operations and surgical procedures) were not counted before the procedure due to the emergency nature of the procedure. The PON also indicated, X-ray revealed that there was a laparotomy sponge left inside the abdomen. The PON indicated, the S2 then returned to the operating room and re-opened Patient 16 ' s incision and removed the sponge.

During a review of Patient 16's intraoperative report (IOR, during surgery report), dated 11/20/2023, the IOR indicated instrument count was performed four times during the procedure, and all four times the count was documented as "Correct."

During an interview on 12/13/2023 at 9:00 a.m. with relief charge nurse (RCN 1), the RCN 1 stated, count of instruments and sponges was done by two people during the procedure and communicated out loud to the rest of the team during the procedure. If the count was not done or was incorrect, due to an urgency of a situation and inability to perform count, this should be documented as "not performed," as per facility's policies and procedures and an X-ray should be done before the surgeon proceeds to close the layers of the skin.

The RCN 1 further stated, on 11/20/2023, the RCN 1 was present during Patient 16's crash (rapid) CS (necessary to save the fetus from death or disability) and the RCN 1 stated the team was aware the count of instruments and sponges was not accurate because it (the surgical count) was not done before starting the procedure, and further stated participating surgeons were aware of it (not performing the surgical count).

During an interview on 12/13/2023 at 3:34 p.m. with the vice president of quality and risk management (VPQRM), the VPQRM said the facility conducted the internal investigation and the S2 stated, the S2 was not aware of the policy about the need for an X-ray before closing Patient 16's skin layers during the procedure.

During an interview on 12/14/2023 at 2:04 p.m. with surgeon 2 (S2), the S2 stated during the procedure on 11/20/2023, after scrubbing in, the S2 was aware of no count done during the procedure and did not know why the count was not done. The S2 the stated the X-ray was done after closing the skin layers of Patient 16.

During an interview on 12/14/2023 at 2:23 p.m. with Chief Nursing Officer (CNO), the CNO stated, the circulator nurse (RN 6) who documented on 11/20/2023, in Patient 16 ' s intraoperative report, that the count was correct, had to document that count was incorrect and/or not done due to the emergency circumstances of the procedure, but the nurse (RN 6) did not. The CNO stated, the nurse (RN 6) was interviewed, and the nurse recognized that documentation in Patient 16's chart was wrong, because the count of all instruments and sponges was not done prior to starting the crash CS on Patient 16, but the RN 6 forgot to correct the documentation.

During an interview on 12/14/2023 at 2:38 p.m. with surgeon assistant (MD3), the MD 3 stated, the count was always performed before the procedure, and multiple times during the procedure. The MD 3 then stated, in rare instances when the count was not performed, before closing the layers of the skin, the surgeon must ask if the count was correct, and if the count was not performed or incorrect, the Xray needs to be done immediately before closing the skin and the surgery must be stopped until all missing items were located.

During a review of the facility's policy and procedure (P&P) titled, "Surgical Counts," dated 04/2022, the P&P indicated sponges, sharps (any objects that can prick or cut causing injury to the user), instruments and miscellaneous items shall be accounted for during surgical procedures. The RN and the scrub tech (technician) are responsible for accurately accounting of items used during surgical procedures. The scrub person shall maintain an organized sterile (free from germs) field; maintain awareness of location of soft goods (example: sponges, towels, etc. Used in surgery). The registered nurse shall document and sign the surgery record, the occurrence, accuracy and personnel involved in all counts. Counts not done due to a patient's emergency shall be documented on the operative record and incident report filled. An Xray shall be taken whenever the physician declines count to be performed. If the count is incorrect, the surgeon is notified, a recount is taken, a search is made for the missing item, and if not found, an Xray should be taken.

During a review of the facility's policy and procedure (P&P) titled, "Surgical Counts," dated 04/2022, the P&P indicated, "The surgeon and surgical assistant shall maintain awareness of sponges, sharps, and instruments used and shall communicate to the surgical team any item placed into the wound for documentation and tracking purpose. Each sponge must be completely separated, visualized by the circulator RN (responsible for the delivery and documentation of patient care during the intra-operative period [the time period from when the patient is on the operating table to when the operation has finished and the wound is closed]) and scrub tech (technician) and counted audibly. Sponges shall be counted on all procedures."

2. During a review of Patient 1's medical record titled, "Obstetric Admission History and physical (H&P, a formal and complete assessment of the patient and the problem)," dated 6/25/2023, documented by MD 1, the Obstetric Admission History and Physical indicated, Patient 1 was admitted to the Labor and Delivery (L&D, a unit that specializes in childbirth) for uterine contractions (tightening of uterine muscles [middle and thickest layer of the uterus, which is a part of the female reproductive system where the baby grows] during labor) and pain. Patient 1's Pelvic exam (used to check the health of the reproductive organs) indicated, Cervical Dilation (when cervix [the lower part of the uterus] opens to allow the baby to move through the birth canal) of 2 to 3 centimeter (cm, range 0 to 10, 10 means fully dilated), and Station -2 (how far into the birth canal the baby's head is located; scale ranges from a -5 to a +5), Artificial Rupture of Membrane (AROM, when a healthcare provider intentionally breaks a person's amniotic sac [a bag of waters that surrounds the fetus [unborn baby]) and placement of Intrauterine Pressure Catheter (IUPC) device used to measure uterine contractions. Patient 1's Fetal Assessment indicated a Fetal Heart Rate (FHR) of 120 (Normal FHR 110 to 160 bpm) and a FHR pattern Category I (Normal baseline FHR of 100 to 160 beats per minute). Patient 1 did not have risk factors documented. Physician Orders included continuous Fetal Heart monitoring.

During a Concurrent interview and record review on 12/13/2023 at 1:40 p.m. with the Clinical Educator (CED) of the L&D unit, Patient 1's LD Flowsheet (contains important data regarding a patient's condition) and FHR monitor strips (a record of the FHR and contractions) were reviewed. The records indicated, Patient 1 was started on pitocin (medication to increase uterine contractions) at 9:14 a.m. on 6/25/2023, and Pitocin was discontinued at 10 a.m. At 10:02 a.m., Patient 1 had prolonged decelerations (fetal heart rate below baseline for more than two minutes but less than 10 minutes). At 10:07 a.m., fetal assessment in the LD Flowsheet indicated late decelerations (a decrease in fetal heart rate associated with contractions) and variable deceleration (an abrupt decrease in fetal [unborn baby] heart rate which could indicate umbilical cord compression [when the baby's weight puts pressure on the cord during pregnancy or labor and can restrict blood flow and oxygen to the baby]) and Fetal Heart Pattern was changed from category one (Normal- late or variable decelerations are absent in category one) to category Two (indeterminate [not exactly known]).

During a review of a facility document titled, "Fetal and uterine monitoring assessment interpretation and documentation," dated 4/28/2021, the document indicated "Category one included: baseline FHR 110 to 160 beats per minute, early decelerations are present or absent, late or variable decelerations absent, and predicts normal acid base status (measure of oxygenation of the fetus). Category 2 is indeterminate and includes when not enough evidence is available to classify as category one or category three. Category two requires evaluation surveillance and reevaluation. Category 3 predicts abnormal acid base status and includes absent baseline fetal heart rate and any of the following: recurrent late decelerations, recurrent variable decelerations, Bradycardia."

During a Concurrent interview and record review on 12/13/2023 at 2:15 p.m. with the Clinical Educator (CED) of the L&D Unit, Patient 1's LD Flowsheet and FHR monitor strips, dated 6/25/2023, were reviewed. The CED stated Patient 1 needed to be on continuous fetal monitoring. CED also said Patient 1 had a rupture of membrane and, therefore, fetal assessment should have been completed every 30 minutes. The CED stated late, variable, and prolonged decelerations indicated fetal distress (changes in heart rate, movement, etc.). Further review of Patient 1's LD Flowsheet indicated, Patient 1 had Late Decelerations at 11 a.m. Fetal Assessment was conducted. MD 1 was notified, but MD 1 was "delivering another Patient" and ordered Fetal Scalp electrode (FSE, a device attached to fetus' scalp to monitor FHR). At 11:18 a.m., MD 1 reviewed the FHR tracing, and Placed FSE. At 11:20 a.m., MD 1 informed Patient 1 that if Patient 1 had more fetal decelerations, he (MD 1) will take Patient 1 for Caesarean Section." The record also indicated Patient 1 had an epidural (an injection in the back to stop feeling pain) placed at 11:33 a.m. The CED reviewed and confirmed there were no Fetal Assessments and documentations of FHR from 11 a.m. to 12:22 p.m. on 6/25/2023.

During a review of Patient 1's LD flowsheet, dated 6/25/2023, the LD Flowsheet indicated that at 12:22 p.m., decelerations in heart rate was noted by staff at bedside, intervention included repositioning. At 12:27 p.m., the LD Flowsheet indicated Patient 1 was Category 3 with "FHR baseline rate of 50, minimum undetectable variability, and prolonged decelerations."

During a review of Patient 1's "OB (Obstetric, a branch of medicine specialized in the care of pregnant women and childbirth) Cesarean Section Note," dated 6/25/2023 at 2:34 p.m., the OB Cesarean Section note indicated, a preoperative (before surgery/procedure) diagnosis of intrauterine pregnancy (when a fertilized egg implants and starts to develop within the uterus) at term, fetal bradycardia. Patient 2 (Patient 1's baby) was delivered at 12:47p.m.

During a review of Patient 1's "Neonatal (relating to newborn children) Delivery and Resuscitation (methods used to restart the heart and lungs if they stop working) Record," dated 6/25/2023, the Neonatal Delivery and Resuscitation Record indicated, the NICU team attended the delivery of Patient 2 (Patient 1's baby). Patient 2 was delivered at 12:47 p.m. Patient 2's APGAR scores (a scoring system from 0 - 10, used to assess newborns at one minute and five minutes of life to determine whether or not the baby needs medical intervention or assistance) were: at one minute was 0, at 5 minutes was zero, at 10 minutes was one, and at 15 minutes was 4. Further review of the Neonatal Delivery and Resuscitation Record indicated Crash C-section (rapid C-section necessary to save the fetus from death or disability) was for "NR FHR (Non reassuring FHR [abnormal fetal heart rate]) and indicated "no fetal heart rate detected for 25 minutes prior to delivery." The record also indicated that upon delivery, Patient 2 (Patient 1's baby) "was limp, cyanotic (blue in skin color) and no heart rate. NRP (Neonatal Resuscitation Protocol) was started. Patient 2 was intubated (a tube is inserted through the mouth or airway to keep the airway open so air can get through) and was transported to the Neonatal Intensive Care Unit (NICU, unit that specializes in providing intensive [critical] medical care to newborns)."

During a review of Patient 1's "Delivery Summary," dated 6/25/2023, the Delivery Summary indicated, the indication for C-section was "non reassuring tracing strip" and Assessment also indicated "extended fetal bradycardia, multiple variable Decels (deceleration)."

During an interview on 12/15/2023 at 2:36 p.m. with the Vice President of Quality and Risk Management (VPQRM), the VPQRM said that Patient 1's and Patient 2's cases were not reviewed.

During a review of the facility's document titled, Rules and Regulations of OB GYN (obstetrics gynecology, a branch of medicine specialized in the care of pregnant women and childbirth)," dated 7/16/2022 indicated, "the admitting physician shall be primarily responsible for patient care, and the ongoing professional evaluation of the quality of obstetric and gynecology care will be conducted on an ongoing basis by routine collection of information concerning important aspects of care."

Based on interview and record review, the facility failed to ensure a properly executed informed surgical consent was in the medical record for one of 30 sampled patients (Patient 5), prior to Patient 5's Cesarean Section (C-section, surgical delivery of a baby), in accordance with the facility's policy and procedure regarding obtaining an informed consent (the process in which the healthcare provider educates a patient about the risks, benefits, and alternatives of a given procedure or intervention).

This deficient practice had the potential for the surgical team to perform the wrong procedure on Patient 5 and had the potential for Patient 5 to not be fully informed of the type of surgical procedure/s she (Patient 5) was having.

Findings:

During a review of Patient 5's Face Sheet (a document that gives a patient ' s information at a quick glance), dated 12/10/2023 at 6:02 a.m., the Face Sheet indicated Patient 5 was admitted to the obstetric (a branch of medicine specialized in the care of pregnant women and childbirth) service for a scheduled Cesarean Section (C-section, surgical delivery of a baby).

During a review of Patient 5's "Pre-Operative (before surgery) History & Physical (H&P, a formal and complete assessment of the patient and the problem)," dated 12/10/2023, the H&P indicated Patient 5 was 39 weeks pregnant (40 weeks is full term), admitted to the Labor & Delivery (L&D, a unit that specializes in childbirth) area for a repeat C-section.

During a review of Patient 5's "Labor and Delivery Consent Form: Authorization for Consent to Surgery or Special Diagnostic or Therapeutic Procedures," dated 12/20/2023, the consent indicated the following: Patient 5 signed the consent at 6:53 a.m., and the physician signed the consent at 7:30 a.m. Section 3 of the consent was blank and did not indicate whether Patient 5 would have a vaginal delivery with possible episiotomy (a surgical cut made at the opening of the vagina during childbirth), primary (without a previous C-section) C-section, repeat C-section, or other procedure.

During a review of Patient 5's "Anesthesia (a state of controlled, temporary loss of sensation or awareness that is induced for medical purposes) Record," dated 12/10/2023 at 9 a.m., the Anesthesia Record indicated Patient 5 received spinal (injection of a drug into either the fluid of the spinal canal or immediately outside of the canal) anesthesia for a repeat C-section. The procedure (C-section) started at 9:23 a.m., and ended at 10 a.m.

During a review of Patient 5's "Operative Note," dated 12/20/2023 at 3:15 p.m., the Operative Note indicated the following: Operations Performed: Repeat low transverse (lower part of the uterus) cesarean section plus lysis (cutting bands of scar issue that form after surgery) of pelvic and abdominal adhesions (bands of scar-like tissue that form between two surfaces inside the body and cause them to stick together).

During a concurrent interview and record review on 12/12/2023 at 11:16 a.m. with Charge Nurse (CN) 3, CN 3 reviewed Patient 5's "Labor and Delivery Consent Form," dated 12/10/2023, and stated the following: Patient 5 delivered by C-section on 12/10/2023 at 9:27 a.m. CN 3 verified that the consent was incomplete. The consent did not indicate whether Patient 5 was having a vaginal delivery or C-section. CN 3 stated the consent should indicate the type of procedure to be performed on Patient 5, so that the patient and staff involved in the procedure would know the type of surgery Patient 5 was having.

During a review of the facility's policy and procedure (P&P) titled, "Informed Consent for Procedures and Treatments," dated 5/27/2020, the P&P indicated the following: "The hospital recognizes and respects the patient ' s right to be involved in the decision-making of all aspects of their care and to be informed of the risk, benefits and alternatives to proposed procedures and treatments to ensure informed decision-making. The hospital complies with all the state and federal regulations. It is the hospital's policy for its staff to facilitate obtaining voluntary, informed consent from patients (or their legally designated representative [LDR] ..., after the physician has discussed the risk, benefits, and alternatives to the procedure with the patient and prior to rendering medical procedures and treatments that involve material risk. Informed consent must be obtained and documented according to policy ...Informed consent involves a detailed discussion between the patient (or LDR) and the treating physician that includes: Nature of the proposed care, treatment, and services ...It is the treating physician's responsibility to obtain the informed consent ...Documentation of Informed Consent: Documentation of the discussion and patient decision is to be noted in the patient's medical record ..."