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Based on interview and record review, the Governing Body (GB) did not provide adequate oversight to ensure safe and effective patient care. This occurred when:

1. The facility failed to ensure Medical staff have a copy of approved clinical privileges (authorizes medical practitioners for a specific practice of patient care in a specified healthcare facility) for one of 10 sampled physicians' credential files (OBS 1). (Refer to A-0045)

2. The facility failed to appraise the Governing Body of the maternal death from post caesarean hemorrhage for one of 30 sampled patients (Patient 1). This failure had the potential for the Governing Body not to be able to address improvements and safe provision of care for maternal patients. (Refer to A-0049)

The cumulative effects of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment and in accordance with 482.12 Condition of Participation for Governing Body.

Based on interview and record review, the facility failed to ensure Medical staff have a copy of approved clinical privileges (authorizes medical practitioners for a specific practice of patient care in a specified healthcare facility) for one of 10 sampled physicians' credential files (OBS 1).

This deficient practice had the potential to result in patient harm due to a physician practicing without approved clinical privileges.

Findings:

During a concurrent interview and record review on 4/06/2023, at 3:45 p.m., with the Director of Medical Services (DMS), the Medical Staff Credential files for one of 10 physicians (OBS 1), was reviewed. OBS 1's Clinical Privileges request Form was incomplete, it did not specify which clinical privileges were requested. OBS 1's file indicated OBS 1 was not approved to perform the following procedures including: Cesarean Section (Operation to deliver), Hysterectomy (surgical removal of the uterus), and Tubal Sterilization (Surgical procedure to prevent female pregnancy). The record also indicated that the Governing Body approval date for OBS 1's credential file was 10/27/2022. DMS stated it was a clerical error that there was no copy of a complete filled out privilege form for OBS 1.

A review of the Facility's Medical Staff Bylaws (rules and regulations that establish how the members must fulfill their clinical responsibilities), dated 04/26/2018, under the section: Clinical Privileges, indicated "A Practitioner providing clinical services ...shall in connection with such practice, be entitled to exercise only those clinical privileges specifically granted by the Hospital Community Board..." and under the Bylaws Section on Ob-Gyn (Obstetrics-Gynecology-a branch of medicine that specializes in the care of women during pregnancy and childbirth and in the diagnosis and treatment of diseases of the female reproductive organs) Department duties indicated "The Ob -Gyn Department shall: establish criteria for the granting of clinical privileges within the department; recommend members for reappointment; and the delineation of clinical privileges for all practitioners..."

Based on interview and record review the facility failed to appraise the Governing Body of the maternal death from post caesarean hemorrhage for one of 30 sampled patients (Patient 1).

This failure had the potential for the Governing Body not to be able to address improvements and safe provision of care.

Findings:

A review of Patient 1's "Anesthesia Record," dated 3/02/2023, indicated Patient 1 was admitted to the operating room (L&D OR) at 3:48 p.m. for a Cesarean Section (C-section, surgical delivery of a baby through a cut made on the mother's abdomen and uterus) and Bilateral Tubal ligation (a permanent way to prevent pregnancy) and then Patient 1 was transferred from the L&D OR to the PACU (Post Anesthesia Care Unit or recovery room) at 5:46 p.m.

A review of Patient 1's "Hemodynamics (how the blood flows through the blood vessels)/Vitals," dated 3/02/2023, indicated Patient 1's vital signs were as follows in PACU:

Heart rate (HR) reference (desired) range is 51-119, Blood pressure (BP) reference range is from 91/51 to 139/89, Temperature Reference range is 36 - 37.5 degrees Celsius (C).

Patient1 was transferred from OR to PACU at 5:46 pm:
At 5:48 p.m., HR was 118 and BP was 39/26 (low), Anesthesiologist 1 (Anes 1) at the bedside.
At 5:53 p.m., HR was 112 and BP 65/43 (low).
At 5:58 p.m., HR was 71 and BP was 61/48 (low).
At 6:04 p.m., HR was 84 and BP was 47/31 (low).
At 6:08 p.m., HR was 104 and BP 0/0 (low). Anes 1 at bedside, unable to obtain blood pressure, Patient 1 awake, alert ...
At 6:11 p.m., HR was 77 and BP was 0 /0 (low).
At 6:25 p.m., HR 101, and BP was 118/59.
At 6:28 p.m., HR 107 and BP was 109/57. Temperature was 34.3 degrees Celsius (low)
At 6:48 p.m., HR was 105 and BP was 127/53.
At 6:59 p.m., HR was 103 and BP was 119/53.
At 7:29 p.m., HR was 121 (high) and BP was 122/65.
At 8 p.m., HR was 153 (high) and BP was 118/58.
At 8:07 p.m., HR was 151 (high) and BP was 107/49.
At 8:18 p.m., HR was148 (high) and BP was 111/46.
No further HR or BPs were documented.

A review of a nurse's note titled, "Respiratory," dated 3/02/2023 indicated the following:

At 5:48 p.m., Patient 1's oxygen saturation level (or O2 sat, amount of oxygen in the blood, normal is above 93 %) was 94 %, on room air.
At 5:53 p.m., Patient 1's O2 sat was 98 %. Oxygen administration initiated, Patient 1 was receiving 3 Liters (L) of oxygen via nasal cannula (NC, a device used to deliver supplementary oxygen).
At 5:58 p.m., Patient 1's O2 sat dropped to 90 % (normal level is above 93), on three (3) Liters of oxygen via NC.
At 6:04 p.m., Patient 1's O2 sat was 94 %, on three (3) Liters of oxygen via NC.

A review of nurses' notes titled, "PowerChart Maternity," dated 3/02/2023, indicated the following:

At 5:36 p.m., Cytotec (or misoprostol, a medication that promotes uterine contractions) 1000 mg per rectal (PR) placed by Obstetric surgeon 1 (OBS 1).
At 5:47 p.m., Anes 1 at bedside, aware of late blood pressure late entry on 3/3/2023 at 1:31 p.m., for 3/02/2023 at 5:47 p.m., Anes 1 aware of unable to obtain a blood pressure or temperature.
At 5:53 p.m., OBS 1 notified of moderate bleeding observed.
At 6:01 p.m., Hemabate (or carboprost tromethamine, a hormone-like substance used to treat severe bleeding after childbirth) 250 mg given intramuscularly (IM, in the muscle) on right thigh.
At 6:16 p.m., blood loss of 167 ml, OBS 1 at bedside evaluating Patient 1's bleeding. Digital exam of vaginal vault done; no clots expressed.
At 6:22 p.m., Bair (Bair Hugger, warming blanket) applied on high, unable to take temperature.
At 6:40 p.m., OBS 1 at bedside to assess Patient 1.
At 6:48 p.m., ten laps (sponges) given to OBS 1, count correct.
At 6:58 p.m., Bakri balloon (a device used to control bleeding after giving birth) placed by OBS 1...
At 7:48 p.m., first bag of packed red blood cells (PRBC) done.

During an interview, on 4/04/2023, at 12:32 p.m., Obstetric Surgeon 1 (OBS 1) stated she (OBS 1) was not aware Patient 1's blood pressure was low.

During a concurrent interview and record review on 4/06/2023, at 2:11 p.m., with the manager of Labor & Delivery (ML&D), Patient 1's medical record, dated 3/03/2023, was reviewed. The Manager of Labor & Delivery (ML&D) verified that Patient 1's vital signs were out of the desired range and stated there was no documented evidence in the medical record that the physician (OBS 1) was notified of the abnormal vital signs.

A review of Patient 1's progress notes dated 3/02/2023, at 6:24 p.m., documented by OBS 1, indicated "notified of vaginal bleeding post op evaluation. Patient 1 received Cytotec and Hemabate earlier for uterine atony (failure of the uterus to contract [tightening and shortening of the uterine muscles] sufficiently during and after childbirth). Close observation to be done of vaginal bleeding." There was no documentation of evaluation by OBS 1 regarding Patient 1's abnormal vital signs (VS) in the PACU from 5:48 p.m. on 3/2/23 including assessment of Patient 1's temperature of 34 degrees Celsius. Likewise, there was no documentation of communication with Anes 1 regarding treatment plans or documentation of communication with OBS 2.

A review of a physician progress note dated 3/02/2023, at 7:11 p.m., documented by OBS 1, indicated "further bleeding was noted, the lower uterine segment was boggy (soft or enlarged indicating the uterus is not contracting). A Bakri balloon (used for temporary control or reduction of bleeding) was placed ...An additional 150 ml of blood was estimated to have been lost..." There was no documentation of any vital signs of Patient 1 including the abnormal Temperature of 34 degrees Celsius in OBS 1's progress note. There was no documentation of communication with Anes 1 regarding treatment plans or documentation of communication with OBS 2.

A review of nurses' notes titled, "PowerChart Maternity," dated 3/02/2023, indicated the following:

At 8 p.m., Anes 1 at bedside to evaluate Patient 1. Physician aware with difficulty in getting a temperature reading. Bair Hugger still in place.

At 8:08 p.m., OBS 2 at bedside evaluating Patient 1. OBS 2 aware of Patient 1's vital signs, maternal heart rate at 150s.

At 8:09 p.m., attending Obstetric surgeon (OBS 2) orders a DIC panel (a blood test to determine if a serious disorder in which the proteins that control blood clotting become overactive and can cause a cut off in normal blood supply to organs), then start second bag of Packed Red Blood Cells (PRBCs-transfused blood to restore blood volume).

At 8:10 p.m., the registered nurse (RN 3) and charge nurse (CN 4) at bedside attempted to draw (blood). Patient 1 hard stick (difficulty in accessing a patient's veins to draw blood).

At 8:15 p.m., Anesthesiologist (Anes 1) at bedside attempting to draw blood for DIC panel.

At 8:30 p.m., Anes 1 unable to draw blood for DIC panel.

At 8:40 p.m., Anes 1 still at bedside and aware it (referring to Blood pressure machine) is not taking BPs (blood pressures). Patient 1 moving a lot.

At 8:45 p.m., temperature was 94.7 degrees Fahrenheit ([F]), normal body temperature is between 97 to 99 F, temperature taken rectally.

At 8:51 p.m., Anes 1 at bedside giving Albumin (used to treat low blood volume) 12.5 milligrams (mg, a unit of measurement).

At 9:10 p.m., OBS 2 notified unable to draw DIC panel. Patient 1 complained of dizziness and moving a lot.

At 9:14 p.m., OBS 2 at bedside side.

At 9:19 p.m., OBS 2 explaining to Patient 1 has to bring her (Patient 1) back to the operating room (OR).

During an interview, on 4/04/2023, at 9:45 a.m., Obstetric Surgeon 2 (OBS 2) stated she (OBS 2) became aware that Patient 1's heart rate was high because she (OBS 2) checked the monitors (machine that shows patient's heart rate). After 8:18 pm, there was no physician progress note from OBS 1 indicating that OBS 2 or Anes 1 were addressing the abnormal and varied from base line VS and Abnormal Temperature of 34 degrees Celsius that was never corrected.

A review of a Physician Progress Note, dated 3/02/2023, at 8:14 p.m., documented by OBS 2, indicated Patient 1 "noted with pulse rate between 150 - 155 ... Given low starting hemoglobin, will give second unit of PRBCs. Continue to monitor closely." There were no further HR or BPs documented.

A review of the physician progress note, dated 3/02/2023, did not indicate any physician Progress note or Nurses note addressing why there was no HR and BP documentation after 8:18 p.m. on 3/02/2023 or any documentation regarding the inability to improve Patient 1's temperature from 34 degrees Centigrade on 3/02/2023. In addition, there were no tests ordered to further evaluate Patient 1 after 8:18 p.m. Likewise, there was no physician documentation as to why Patient 1 was taken back to the OR at 9:30 p.m. and also why the second surgery (exploratory laparotomy) was not started until around 10 p.m.

A review of nurses' notes titled, "PowerChart Maternity," dated 3/02/2023, indicated the following:

At 9:35 pm, Patient 1 in the OR.
At 9:57 p.m., Anes 2 assisted with transfusing all blood products for Patient 1.
At 10:20 p.m., code blue (medical emergency usually involving a cardiac or respiratory arrest). team called.

A review of Patient 1's "Operative and Procedure Reports," dated 3/03/2023 at 1:46 a.m., documented by OBS 4, indicated Patient 1 "was taken to the operating room for tachycardia (elevated heart rate) and intra-abdominal bleeding. Findings included over 2 Liters of dark un-clotted blood on entry to abdomen ... Total (blood products) infused during case: 14 units of PRBC, 13 units of FFP (fresh frozen plasma), and 2 units of platelets (cell fragments in the blood that form clots and stop or prevent bleeding) ... Patient status: demise (death)."

A review of Patient1's "Autopsy Report," dated 3/15/2023, indicated Patient 1's "Final diagnosis included: Post Caesarean Section uterine atony (clinical); Post Caesarean section hemorrhage and Coagulopathy (lack of ability to clot and stop bleeding) (clinical). Patient 1's Cause of Death is indicated as: Hemorrhagic shock (when severe blood loss leads to inadequate oxygen delivery at the cellular levels leading to death) with coagulopathy."

A review of the physician progress notes reviewed on 4/07/2023, at 10:20 a.m. indicated there was no documentation of hand off or communication of treatment plans between OBS 1 and OBS 2 and with Anes 1. There was no Postoperative Anesthesia evaluation or note documented.

A review of the facility's Policy and Procedure (P&P) titled "medical Staff General Rules & Regulations," dated 12/16/2021, indicated "under Article VII. Patient Care-Surgical, The Surgeon shall be responsible for and personally supervise the post operative care..."

A review of the facility's Policy and Procedure (P&P) titled "Cesarean Section- Standard care," dated 8/2021, indicated under "Standard of Care: post Operative Cae: Reportable conditions: notify physician immediately ... included change in baseline vital signs."

A review of the facility's Policy and Procedure (P&P) titled "Surgery department Rules and Regulations," dated 4/30/2020, indicated under "Anesthesia Services: Promoting policies and practices that maximize the safety of the patient during Anesthetic period and advising those personnel responsible for post-Anesthesia care."

A review of the facility's Governing Body Meeting Minutes, Medical Executive Staff Meeting Minutes, Quality Assurance Patient Safety (QAPI- a written plan that guides the hospital's quality efforts and serves as the main document to support implementation) Meeting Minutes, OB Gyn Department Meeting Minutes, Surgery Meeting Minutes, and Anesthesia Meeting Minutes provided for the past 12 months did not include any documentation of meeting or discussing the incident involving Patient 1's death.

Further review of the facility's Governing Body Meeting Minutes and the Medical Executive staff Meeting Minutes did not indicate any communication between the Medical Executive staff and the Governing Body regarding the incident involving Patient 1 about the failure to provide care and recognize signs of bleeding/hemorrhage for a post C-section patient (Patient 1) manifesting internal bleeding in accordance with acceptable standards of practice and the facility's policies and procedures.

During an interview on 4/07/2023, at 1:30 p.m., with the Director of Quality (DOQ), the DOQ stated the facility's QAPI and Patient safety group included a QAPI director, 17 different committee representatives, and Medical Department Directors. The QAPI team is responsible for reviewing and presenting patient case studies to the Governing Board. The DOQ said that the Root Cause Analysis (RCA-a process for identifying causal factors and underlying variations in performance) for Patient 1 had been completed.

A review of the Governing Body meeting minutes did not indicate when the RCA was completed by the QAPI team or if the GB was appraised about the completed RCA.

Based on observation, interview and record review, the facility failed to ensure that the Condition of Participation for Patient's Rights was met as evidenced by:

1. Failure to ensure that the patient's rights information was provided and explained in a language the patient could understand for one of six sampled patients (Patient 11). This deficiency resulted in Patient 11 not being informed of her (Patient 11) rights as a patient. (Refer to A-117)

2. Failure to ensure the portable high efficiency particulate air (HEPA-removes dust, pollen, mold, bacteria, and any airborne particles) filtration machine was inspected inside two of two sampled patient rooms (Room 604 and 926). This deficiency had the potential to negatively affect the HEPA filtration machine's performance in cleaning the patient room's air and prevent the spread of infection. (Refer to A-0144)

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 ensure that the patient's rights information was provided and explained in a language the patient could understand for one of six sampled patients (Patient 11). Patient 11 was not provided the list of patient's rights information in a language and manner that the patient understands.

This deficiency resulted in Patient 11 not being informed of her (Patient 11) rights as a patient.

Findings:

During a concurrent observation and interview on 4/03/2023, at 2 p.m., with the Manager of Labor and Delivery (ML&D), Patient 11 was observed alert and oriented, holding her (Patient 11) baby in bed. Patient 11's husband was sitting at the patient's (Patient 11) bedside. Both Patient 11 and the patient's (Patient 11) husband spoke in Spanish. Patient 11 stated she (Patient 11) delivered her baby today (4/3/2023).

During a concurrent interview and record review on 4/3/2023, at 2 p.m., with the Manager of Labor and Delivery (ML&D), Patient 11's "Conditions of Admission (COA - a form which outlined the patient's obligation with respect to the hospital services received, provisions under which the patient provide informed consent for treatments, and the patient's rights)," was reviewed. The COA was written in English and was signed by the patient (Patient 11) on 4/3/2023. The ML&D stated there was no documentation a COA written in Spanish was signed by Patient 11.

During a concurrent interview and record review on 4/03/2023, at 2:17 p.m., with the ML&D, Patient 11's record was reviewed. The record indicated Patient 11 was admitted to the facility on 4/3/2023. ML&D confirmed that Patient 11's preferred language for healthcare discussion was Spanish.

During an interview on 4/3/2023, at 2:37 p.m., conducted with Patient 11 and the patient's (Patient 11) husband, the patient's husband stated he (Patient 11's husband) signed the COA on behalf of Patient 11 because Patient 11 was in active labor when the facility asked to sign the COA. Both Patient 11 and the patient's (Patient 11) husband stated they (Patient 11 and the husband) preferred to receive healthcare information in Spanish. Both Patient 11 and the patient's (Patient 11) husband stated they did not receive information regarding the COA in Spanish.

During an interview on 4/32023, at 2:47 p.m., conducted with the Business Service Associate 1 (BSA 1), BSA 1 stated one of her (BSA 1) responsibilities was to have the patient (Patient 11) sign the COA upon admission. BSA 1 stated she (BSA 1) was the one who asked Patient 11 to sign the COA and it was the patient's (Patient 11) husband who signed because Patient 11 was in labor.

BSA 1 stated there was no available Spanish version of the COA in the electronic health record (EHR). BSA 1 stated when a patient speaks and understand Spanish language only, she (BSA 1) would give the COA Spanish version copy for the patient to read, and she (BSA 1) will let the patient sign the COA English version in the EHR (Electronic Health Record).

BSA 1 stated she (BSA 1) did not give a copy of the COA Spanish version to Patient 11 or the patient's (Patient 11) husband before asking the patient (Patient 11) to sign her (Patient 11) COA in English version.

During an interview on 4/3/2023, at 4:15 p.m., conducted with the Director of Quality (DOQ), the DOQ stated a Spanish version of COA was available in the EHR. The DOQ stated Patient 11 should have been given and allowed to sign the COA in Spanish version.

A review of the facility's policy and procedure (P&P) titled "Patient Rights and Responsibilities," revised in December 2020, indicated, "... (name of the facility) has defined patient's rights as the following...Receive information about your health status, diagnosis, prognosis, course of treatment, prospect for recovery and outcomes of care...in terms you can understand..."

Based on observation, interview, and record review, the facility failed to ensure the portable high efficiency particulate air (HEPA - removes dust, pollen, mold, bacteria, and any airborne particles) filtration machine was inspected annually inside two of two sampled patient rooms (Room 604 and 926).

This deficiency had the potential to negatively affect the HEPA filtration machine's performance in cleaning the patient room's air which could lead to the spread of infection.

Findings:

During an observation on 4/6/2023, at 9:56 a.m., with Director of Facilities (DOF), in Patient Room 926, a sticker on the portable HEPA filtration machine indicated it was inspected on 9/23/2020. DOF confirmed the inspection sticker indicated 9/23/2020.

During an interview on 4/6/2023, at 10:10 a.m., with (DOF), DOF stated the portable HEPA filtration machines need to be inspected annually, which included replacing the air filter. DOF stated that unchanged air filters will affect the portable HEPA filtration machine's performance in cleaning the air.

During an observation on 4/6/2023, 4:15 p.m., with DOF, in Patient Room 604, a sticker on the portable HEPA filtration machine indicated it was inspected on 8/19/2020. DOF confirmed the inspection sticker indicated 8/19/2020.

A review of the facility's policy and procedure (P&P) titled "Temperature, Humidity, & Air Relationships," dated 1/2020, indicated the facility will maintain a safe environment for the patients by inspecting the portable HEPA filtration machines at least annually.

Based on interview and record review, the facility failed to maintain an effective Quality Assurance Performance Improvement (QAPI) program when:

1. The facility failed to sustain the facility's performance improvement activities to ensure a safe patient outcome for one of one patient (Patient 1), who was at high-risk for hemorrhage (severe bleeding) after having a Cesarean section (C-section, surgical delivery of a baby through a cut made on the mother's abdomen and uterus). This deficient practice resulted in Patient 1's death four hours after a Cesarean section delivery. (Refer to A- 0283)

2. The facility failed to ensure quality resources were available to sustain the facility's performance improvement activities in the prevention of maternal hemorrhage, to ensure a safe patient outcome for one Patient (Patient 1) of one patient, who was at high-risk for hemorrhage (severe bleeding) after having a Cesarean section (C-section, surgical delivery of a baby through a cut made on the mother's abdomen and uterus). This deficient practice resulted in Patient 1's death four hours after a Cesarean section delivery. (Refer to A-0315)

These deficiencies resulted in no opportunities for improvement or changes in activities or increase in resources to improve ineffective hospital operational processes.

Based on interview and record review, the facility failed to sustain the facility's performance improvement activities to ensure a safe patient outcome for one of one patient (Patient 1), who was at high-risk for hemorrhage (severe bleeding) after having a Cesarean section (C-section, surgical delivery of a baby through a cut made on the mother's abdomen and uterus).

This deficient practice resulted in Patient 1's death four hours after a Cesarean section delivery.

Findings:

During a concurrent interview and record review, on 4/06/2023, at 2:11 p.m., with the Manager of Labor & Delivery (ML&D), Patient 1's medical record was reviewed. The ML&D stated the following: "Patient 1 was admitted to the facility on 3/01/2023 for a Cesarean section (CS). Patient 1 was at high-risk for bleeding due to having a history of multiple C-sections. Patient 1 also had a history of chronic hypertension (high blood pressure) and obesity. Patient 1 delivered via C-section on 3/2/2023 at 4:35 p.m. Patient 1 was transferred to the Labor & Delivery (L&D) recovery room at 5:47 p.m. Patient 1 remained in the recovery room from 5:47 p.m. to 9:35 p.m. Upon admission to the recovery room, Patient 1's vital signs were unstable (outside the normal limits). The blood pressure was low. The heart rate was elevated. Patient 1's body temperature was low (34.3 degrees Celsius). Nursing staff was unable to obtain vital signs after 8:18 p.m. Patient 1 returned to the operating room at 9:35 p.m. Surgery started at 10 p.m. Patient 1 coded several times during the procedure and expired at 11:15 p.m. Patient 1 died of hemorrhage."

During an interview on 4/06/2023, at 2:11 p.m., with the Manager of Labor & Delivery (ML&D), the ML&D said that the facility had a process/policy in place for the management of obstetric hemorrhage that applied to obstetric (branch of medicine dealing with childbirth) surgeons (OBS), anesthesiologist, and nursing staff. Abnormal vital signs should have been addressed right away and the facility should have advanced Patient 1's treatment to Stage 3 set of interventions, which included notifying providers, anesthesiologist, charge nurse, and preparing Patient 1 to go back to operating room. According to the ML&D, the facility did not follow the established protocol for the management of maternal hemorrhage.

During an interview, on 4/03/2023, at 1:25 p.m., the Director of Quality & Patient Safety (DOQ) agreed that the facility did not follow their (facility's) process for the management of obstetric hemorrhage and the failure not to follow the policy resulted in Patient 1's death.

A review of Patient 1's History & Physical (H&P) dated 3/01/2023, at 2:49 p.m., with an addendum at 4:21 p.m., indicated Patient 1 presented to the Labor and Delivery (L&D) unit after missing a scheduled Cesarean section. Patient 1 had a history of chronic hypertension (elevated blood pressure), a history of multiple (x4) C-sections, and anemia (low levels of hemoglobin, less than 12 grams per deciliter [gm/dl-a unit of measurement], a protein molecule in the red blood cells that carry oxygen and delivers it to body tissues). Patient 1's hemoglobin (Hgb) level was 9.0 gm/dl (normal values are between 12 to 15 mg/dl) upon admission.

A review of Patient 1's "Operative and Procedure Reports," dated 3/02/2023, at 6 p.m., indicated a repeat C-section and bilateral tubal ligation (surgical procedure to prevent pregnancy) was performed. Patient 1 had an estimated blood loss of 426 cc (or milliliters [ml]).

A review of Patient 1's "Anesthesia Record," dated 3/02/2023, indicated Patient 1 was admitted to the operating room (L&D OR) at 3:48 p.m. and then out of the OR and transferred to the recovery room at 5:46 p.m.

A review of Patient 1's "Hemodynamics (basic measures of how the blood flows through the blood vessels)/Vitals," dated 3/2/2023, indicated Patient 1's vital signs, as follows:

Heart rate (HR) reference (desired) range is 51-119, Blood pressure (BP) reference range is from 91/51 to 139/89). Temperature Reference range is 36 - 37.5 Celsius [C]).

At 5:48 p.m., HR was 118 and BP was 39/26 (low), Anesthesiologist 1(Anes 1) at the bedside.
At 5:53 p.m., HR was 112 and BP 65/43 (low).
At 5:58 p.m., HR was 71 and BP was 61/48 (low).
At 6:04 p.m., HR was 84 and BP was 47/31 (low).
At 6:08 p.m., HR was 104 and BP 0/0 (low). Anes 1 at bedside, unable to obtain blood pressure, Patient 1 awake, alert ...
At 6:11 p.m., HR was 77 and BP was 0/0 (low).
At 6:25 p.m., HR 101, and BP was 118/59.
At 6:28 p.m., HR 107 and BP was 109/57. Temperature was 34.3 (low) degrees Celsius
At 6:48 p.m., HR was 105 and BP was 127/53.
At 6:59 p.m., HR was 103 and BP was 119/53.
At 7:29 p.m., HR was 121 (high) and BP was 122/65.
At 8 p.m., HR was 153 (high) and BP was 118/58.
At 8:07 p.m., HR was 151 (high) and BP was 107/49.
At 8:18 p.m., HR was 148 (high) and BP was 111/46.
No further HR or BPs are documented.

A review of Patient 1's "orders," dated 3/02/2023, at 5:53 p.m., indicated to notify the physician (MD) if:

Pulse is greater than 110 or less than 50.
Systolic blood pressure (indicates how much pressure the blood is exerting on the walls of the arteries each time the heart beats) is greater than 155 or less than 80.
Diastolic blood pressure (pressure in the arteries when the heart rests between beats) greater than 105 or less than 45.
Temperature equal to or greater than 38 degrees Celsius (C) or less than 36 degrees Celsius.

A review of an "Operative and Procedure Report," dated 3/03/2023, at 12:14 a.m., documented by OBS 2, indicated Patient 1 "was taken to the Operating room at 9:35 p.m., on 3/02/2023., with a preoperative diagnosis of intra-abdominal (space between the organs and the inner lining of the abdominal wall) bleeding after C-section. Surgery started at 10 p.m. A code blue (a medical emergency involving a cardiac or respiratory arrest) was called at 10:23 p.m. A hysterectomy (removal of the uterus) was performed. The quantitative blood loss in the operating room (OR) was 5,418 cc. Patient 1 was pronounced (dead) at 11:15 pm."

A review of Patient 1's "Operative and Procedure Reports," dated 3/03/2023, at 1:46 a.m., documented by OBS 4, indicated Patient 1 "was taken to the operating room for tachycardia (elevated heart rate) and intra-abdominal bleeding. Findings included over 2 Liters of dark un-clotted blood on entry to abdomen ... Total (blood products) infused during case: 14 units of PRBC, 13 units of FFP (fresh frozen plasma), and 2 units of platelets (cell fragments in the blood that form clots and stop or prevent bleeding) ... Patient status: demise (death)."

A review of Patient 1's "Autopsy Report," dated 3/15/2023, indicated Patient 1's "Final diagnosis included: Post Cesarean Section uterine atony (soft or weak uterine after childbirth); Post Cesarean section hemorrhage and Coagulopathy (lack of ability to clot and stop bleeding). Patient 1's Cause of Death is indicated as: Hemorrhagic shock (when severe blood loss leads to inadequate oxygen delivery at the cellular levels leading to death) with coagulopathy."

A review of the facility's policy and procedure titled, "Management of Obstetrical Hemorrhage," dated 11/2021 indicated Maternal Hemorrhage Stages are defined as:

Stage 0: Normal blood loss (less than 1000 ml for both vaginal and cesarean delivery)

Stage 1: Abnormal blood loss (more than 1000 ml for both vaginal and cesarean delivery)

Stage 2: Abnormal blood loss and patient does not respond to Stage 1 therapies/uterotonics, OR less than 1,000 ml blood loss but patient requires Stage 2 interventions (See Attachment E). Continue vital signs every 5 minutes. Observe for subtle vital sign changes. Report sustained heart rate over 110. Report blood pressure less than 85/45 and move to Stage 3. Hypotension is a late sign of blood loss in the pregnant patient due to the increased intravascular volume seen in pregnancy. Signs of hypovolemia (urinary output less than 30 ml per hour for two hours). Monitor mental status. Increased anxiety, agitation, combativeness and finally, unresponsiveness likely indicate worsening blood loss and possible cerebral hypoxia (lack of oxygen in the brain).

Stage 3: Continued bleeding with actual or anticipated blood loss over 1500 ml or the presence of abnormal hematologic labs consistent with Disseminated Intravascular Coagulation (DIC) or abnormal vital signs (See Attachment E) consistent with blood loss greater than estimated or measured amount.

Attachment E: Acute Hemorrhage Algorithm / Obstetrical Acute Hemorrhage Algorithm, indicated the following. If QBL loss remains less than 1000 ml but Patient has abnormal clinical findings:

Heart rate above 110
Blood pressure less than or equal to 85/45 or a decrease of over 15 percent (%)
Oxygen saturation of less than or equal to 93 %.
Clinical symptoms: shortness of breath, confusion, agitation.
Consider significant hemorrhage/Stage 3 (QBL over 1500 ml, coagulopathy [body's ability to form clots is impaired], and or abnormal clinical findings). Interventions include the following: Notify circulating nurse, charge nurse, OB physician, anesthesia, and prepare patient for the operating room.

A review of the Facility's Governing Body Meeting Minutes, Medical Executive Staff Meeting Minutes, Quality Assurance Patient Safety (QAPI- a written plan that guides the hospital's quality efforts and serves as the main document to support implementation) Meeting Minutes; OB Gyn (Obstetrics Gynecology-specializes in the care of women during pregnancy and childbirth and in the diagnosis of and treatment of diseases of the female reproductive organs) Department Meeting Minutes; Surgery Meeting Minutes and Anesthesia Meeting Minutes provided for the past 12 months did not include any documentation of a meeting or discussion of the incident involving Patient 1's death.

Based on interview and record review, the facility failed to ensure quality resources were available to sustain the facility's performance improvement projects to ensure a safe patient outcome for one of one patient (Patient 1), who was at high-risk for hemorrhage (severe bleeding) after having a Cesarean section (C-section, surgical delivery of a baby through a cut made on the mother's abdomen and uterus).

This deficient practice resulted in Patient 1's death four hours after a Cesarean section delivery.

Findings:

A review of Patient 1's nurse's notes titled "Gyn (Gynecology-medical specialty involving the female reproductive system) and Maternal Child," dated 3/01/2023, at 12:15 p.m., indicated Patient 1 was a high risk for postpartum hemorrhage (heavy bleeding after childbirth). Risk factors included a previous history of four C-sections.

A review of Patient 1's History & Physical (H&P), dated 3/01/2023, at 2:49 p.m., with an addendum at 4:21 p.m., indicated Patient 1 presented to the Labor and Delivery (L&D) unit after missing a scheduled Cesarean section on 3/01/2023. Patient 1 had a history of chronic hypertension (high blood pressure) and morbid obesity (weight that is more than 80 to 100 pounds above the ideal body weight) and history of multiple (x4) C-sections. Hemoglobin (Hgb, a protein molecule in the red blood cells that carry oxygen and delivers it to body tissues) was 9.0 gm/dl (low, normal levels are between 12 to 16 g/dl [grams/deciliter]).

A review of Patient 1's "Operative and Procedure Reports," dated 3/02/2023, at 6 p.m., indicated a repeat C-section and bilateral tubal ligation (surgical procedure to prevent pregnancy) was performed. Patient 1 had an estimated blood loss of 426 cc (or milliliters [ml]).

A review of Patient 1's "Anesthesia Record," dated 3/02/2023, indicated Patient 1 was admitted to the Labor & Delivery operating room (L&D OR) at 3:48 p.m. and out of the OR and transferred to the recovery room at 5:46 p.m.

A review of Patient 1's "Hemodynamics (basic measures of how the blood flows through the blood vessels)/Vitals," dated 3/2/2023, indicated Patient 1's vital signs were as follows:

Heart rate (HR) reference (desired) range is 51-119, Blood pressure (BP) reference range is from 91/51 to 139/89). Temperature Reference range is 36 - 37.5 Celsius [C]).

At 5:48 p.m., HR was 118 and BP was 39/26 (low), Anesthesiologist 1 (Anes 1) at the bedside.
At 5:53 p.m., HR was 112 and BP 65/43 (low).
At 5:58 p.m., HR was 71 and BP was 61/48 (low).
At 6:04 p.m., HR was 84 and BP was 47/31 (low).
At 6:08 p.m., HR was 104 and BP 0/0 (low). Anes 1 at bedside, unable to obtain blood pressure, Patient 1 awake, alert ...
At 6:11 p.m., HR was 77 and BP was 0/0 (low).
At 6:25 p.m., HR 101, and BP was 118/59.
At 6:28 p.m., HR 107 and BP was 109/57. Temperature was 34.3 (low) degrees Celsius
At 6:48 p.m., HR was 105 and BP was 127/53.
At 6:59 p.m., HR was 103 and BP was 119/53.
At 7:29 p.m., HR was 121 (high) and BP was 122/65.
At 8 p.m., HR was 153 (high) and BP was 118/58.
At 8:07 p.m., HR was 151 (high) and BP was 107/49.
At 8:18 p.m., HR was 148 (high) and BP was 111/46.
No further HR or BPs are documented.

A review of an "Operative and Procedure Report," dated 3/03/2023, at 12:14 a.m., documented by OBS 2, indicated Patient 1 "was taken to the Operating room at 9:35 p.m., on 3/02/2023., with a preoperative diagnosis of intra-abdominal (space between the organs and the inner lining of the abdominal wall) bleeding after C-section. Surgery started at 10 p.m. A code blue (a medical emergency involving a cardiac or respiratory arrest) was called at 10:22 p.m. A hysterectomy (removal of the uterus) was performed. The quantitative blood loss in the operating room (OR) was 5,418 cc. Patient 1 was pronounced (dead) at 11:15 pm."

A review of Patient 1's "Operative and Procedure Reports," dated 3/03/2023, at 1:46 a.m., documented by OBS 4, indicated Patient 1 "was taken to the operating room for tachycardia (elevated heart rate) and intra-abdominal bleeding. Findings included over 2 Liters of dark un-clotted blood on entry to abdomen ... Total (blood products) infused during case: 14 units of PRBC, 13 units of FFP (fresh frozen plasma), and 2 units of platelets (cell fragments in the blood that form clots and stop or prevent bleeding) ... Patient status: demise (death)."

A review of Patient1's "Autopsy Report," dated 3/15/2023, Patient 1's "Final diagnosis included: Post Caesarean Section uterine atony (clinical); Post Caesarean section hemorrhage and Coagulopathy (lack of ability to clot and stop bleeding) (clinical). Patient 1's Cause of Death is indicated as: Hemorrhagic shock (when severe blood loss leads to inadequate oxygen delivery at the cellular levels leading to death) with coagulopathy."

During a concurrent interview and record review, on 4/06/2023 at 2:11 pm with the Manager of Labor & Delivery (ML&D), Patient 1's Medical Record was reviewed. The ML&D stated the following: "Patient 1 was admitted to the facility on 3/1/2023 for a Cesarean section. Patient 1 was at high-risk for bleeding due to having a history of multiple C-sections. Patient 1 also had a history of chronic hypertension (high blood pressure) and obesity. Patient 1 delivered via C-section on 3/2/2023 at 4:35 p.m. Patient 1 was transferred to the Labor & Delivery (L&D) recovery room at 5:47 p.m. Patient 1 remained in the recovery room from 5:47 p.m. to 9:35 p.m. Upon admission to the recovery room, Patient 1's vital signs were unstable. The blood pressure was low. The heart rate was elevated. Patient 1's body temperature was low. Nursing staff was unable to obtain vital signs after 8:18 p.m. Patient 1 returned to the operating room at 9:35 p.m. Surgery started at 10 p.m. Patient 1 coded several times during the procedure and expired at 11:15 p.m. Patient 1 died of hemorrhage."

During an interview on 4/06/2023, at 2:11 p.m., with the facility's Manager of Labor & Delivery (ML&D), the ML&D stated facility had a process/policy in place for the management of obstetric hemorrhage that applied to obstetric (branch of medicine dealing with childbirth) surgeons, anesthesiologist, and nursing staff. ML&D stated abnormal vital signs should have been addressed right away and the facility should have advanced Patient 1's treatment to Stage 3, which included notifying providers, anesthesiologist, charge nurse, and preparing Patient 1 to go back to operating room. According to the ML&D, the facility did not follow the established protocol for the management of maternal hemorrhage.

During an interview, on 4/03/2023, at 1:25 p.m., the Director of Quality & Patient Safety (DOQ) agreed that the facility did not follow their (facility's) process for the management of obstetric hemorrhage.

A review of the facility's Quality Assurance Patient Safety Meeting Minutes and OB Gyn Department Meeting Minutes provided for the past twelve (12) months did not include any documentation of meeting or discussion about Patient 1's case (maternal hemorrhage). In addition, the QAPI records did not indicate what immediate actions were taken by the QAPI committee to prevent similar incidents of maternal death from happening again. The QAPI records did not also indicate how much time and resources were utilized to address maternal death issues as part of the facility's performance improvement activities.

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

1. The venous thromboembolism (VTE - a condition that occurs when a blood clot forms in a vein) prophylaxis interventions were implemented for two of two sampled patients (Patient 6 and 7). This deficiency had the potential to result in serious harm or death to the patient from a deep vein thrombosis (DVT - a blood clot in the leg) or pulmonary embolism (PE). (Refer to A-0392)

2. A comprehensive care plan (provides a framework for evaluating and providing patient care needs related to the nursing process) was developed upon admission for one of six sampled patients (Patient 18). This deficiency had the potential to result in harm to the patient's (Patient 18) safety by not identifying Patient 18's needs and risks. (Refer to A-0396)

3. A blood transfusion was given without delay for one of seven sampled patients (Patient 1) who had a Cesarean section (C-section, surgical delivery of a baby through a cut made in the mother's abdomen and uterus). This deficient practice resulted in an approximate delay of 90 minutes in administering Patient 1 a second unit of PRBCs (packed red blood cells-used in blood transfusion to improve blood volume). (Refer to A-0398)

4. The patient's daily weight before dialysis was documented for three of three sampled patients (Patient 18, 26 and 27) who undergo hemodialysis treatment. This deficiency had the potential to negatively impact the patients' hemodialysis (the process of removing excess water, solutes, and toxins from the blood in people whose kidneys can no longer perform these functions naturally) treatment resulting in extra fluid buildup to not be monitored which may lead to complications affecting the patients' heart and lungs, and deterioration of the patients' condition. (Refer to A-0398)

5. The medications (Ceftriaxone - antibiotics and Nicardipine - used in situations requiring the rapid control of blood pressure) were administered as ordered by the physician for two of six sampled patients (Patients 18 and 19). This deficiency resulted in a delay of treatment and had the potential to cause adverse health outcomes which could negatively affect the patient's health and safety due to unsafe medication administration and may lead to prolonged hospitalization and/or death. (Refer to A-0405)

The cumulative effect of these deficient practices could result 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 ensure venous thromboembolism (VTE - a condition that occurs when a blood clot forms in a vein) prophylaxis interventions (pharmacologic and non-pharmacologic measures to diminish the risk of blood clots and pulmonary emboli [blood clot in the lung]) were implemented for two of two sampled patients (Patient 6 and 7).

This deficiency had the potential to result to Patient 6 and 7 to form a deep vein thrombosis (DVT - a blood clot in the leg) or pulmonary embolism (PE) which could affect the health or even death of the patients.

Findings:

1. During a concurrent observation and interview on 4/06/2023, at 11:20 a.m., with Registered Nurse (RN 8) 8, in Patient 6's Room , Patient 6 was observed lying in bed without the sequential compression devices (SCDs - a method of DVT prevention that improves blood flow in the legs) at the bedside. RN 8 stated Patient 6 did not need SCDs because Patient 6 was capable of walking.

A review of Patient 6's History and Physical (H&P), dated 4/04/2023, indicated Patient 6 was admitted to the facility for a left foot infection.

A review of Patient 6's physician orders, dated 4/04/2023, indicated Patient 6 was to wear SCDs while in bed.

A review of the facility's policy and procedure (P&P) titled, "Prevention of Venous Thromboembolism," dated 10/2019, indicated hospitalized patients at high risk for VTE may develop DVT and die from a PE. The nurse is responsible for applying the SCDs until it is discontinued by the physician.

2. During a concurrent observation and interview on 4/06/2023, at 11:35 a.m., with RN 9, in Patient 7's Room, Patient 7 was observed lying in bed without SCDs at the bedside. RN 9 stated Patient 7 did not need SCDs because Patient 7 was capable of walking.

A review of Patient 7's H&P, dated 4/04/2023, indicated Patient 7 was admitted to the facility for sepsis pneumonia (a life-threatening complication from a lung infection).

A review of Patient 7's physician orders, dated 4/04/2023, indicated Patient 7 was to wear SCDs while in bed.

A review of the facility's policy and procedure (P&P) titled, "Prevention of Venous Thromboembolism," dated 10/2019, indicated hospitalized patients at high risk for VTE may develop DVT and die from a PE. The nurse is responsible for applying the SCDs until it is discontinued by the physician.

Based on observation, interview, and record review, the facility failed to ensure that a comprehensive care plan (provides a framework for evaluating and providing patient care needs related to the nursing process) was developed upon admission for one of six sampled patients (Patient 18). Patient 18 did not have a care plan to address Gastrointestinal (GI) bleed, Dialysis (a procedure to remove waste products and excess fluid from the blood when the kidneys stop working properly), and Pneumonia (an infection that inflames the air sacs in one or both lungs.)

This deficiency had the potential to result in the delayed provision of care to the patient (Patient 18) by not identifying Patient 18's needs and risks.

Findings:

During a concurrent observation and interview, on 4/06/2023, at 3:35 p.m., Patient 18 was in bed, alert, oriented, and surveyor observed the following:

- Patient 18 was being administered oxygen via high flow nasal canula (a device used to deliver high concentration of oxygen); and,

- Patient 18 had a dialysis catheter (a catheter used for exchanging blood to and from a hemodialysis machine and a patient) on the right neck.

Patient 18 stated he (Patient 18) had been having dialysis (a procedure to remove waste products and excess fluid from the blood when the kidneys stop working properly) daily.

During a concurrent interview and record review on 4/07/2023, at 10:48 a.m., conducted with Registered Nurse (RN 4) 4, Patient 18's record was reviewed. The "Admission H&P (History and Physical)," dated 4/01/2023, indicated Patient 18 was transferred from another facility with a chief complaint of abdominal pain. Patient 18's assessment included acute gastrointestinal (GI) bleeding and acute kidney injury (AKI-a sudden episode of kidney failure or kidney damage that happens within a few hours). RN 4 stated an individualized care plan addressing Patient 18's condition to meet his (Patient 18) needs and goals should have been developed upon Patient 18's admission.

A review of the physician's order, dated 3/31/2023, indicated Patient 18 was ordered ceftriaxone (antibiotics) 1 gram (a unit of measurement) intravenous (given through the vein) every 24 hours for pneumonia.

There was no documented evidence a care plan for Patient 18's GI bleed, dialysis, and pneumonia were developed. This finding was confirmed by Registered Nurse 4 (RN 4) on 4/07/2023, at 10:48 a.m.

A review of the facility's policy and procedure (P&P) titled, "Interdisciplinary Care Planning," revised in February 2023, indicated, "...Every patient will have a care plan initiated within 24 hours of admission. The plan of care shall be consistent with the medical plan of care...The care plan is individualized and updated when new problems are identified...The interdisciplinary team reviews the care plan to assess and compare actual versus expected progress during care team rounds or when discussing patient with the responsible physician or advance care provider. Document in the electronic health record (EHR)...Changes in status of problem, or condition; new problems..."

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

1. Administer a blood transfusion without delay for one of seven sampled patients (Patient 1) who had a Cesarean section (C-section, surgical delivery of a baby through a cut made in the mother's abdomen and uterus). This deficient practice resulted in an approximate delay of 90 minutes in administering Patient 1 a second unit of PRBCs (packed red blood cells).

2. Report abnormal vital signs (body temperature, pulse or heart rate, respiratory rate and blood pressure) for one of thirty sampled patients (Patient 1), as ordered by the physician. This deficient practice had the potential for the physician to not be informed of abnormal vital signs which may result in delay of emergent patient treatment.

3. Ensure the patient's daily weight was documented for three of three sampled patients (Patient 18, 26 and 27) who undergo hemodialysis treatment. This deficiency had the potential to negatively impact the patient's hemodialysis (the process of removing excess water, solutes, and toxins from the blood in people whose kidneys can no longer perform these functions naturally) treatment resulting in extra fluid build-up to not be monitored which may lead to complications affecting the patients' heart and lungs, and deterioration of the patients' condition.

Findings:

1. A review of Patient 1's History & Physical (H&P) dated 3/01/2023, at 2:49 p.m., with an addendum at 4:21 p.m., indicated Patient 1 presented to the Labor and Delivery (L&D) unit after missing a scheduled Cesarean section. Patient 1 had a history of chronic hypertension (elevated blood pressure), a history of multiple (x4) C-sections, and anemia (low levels of hemoglobin, less than 12 grams per deciliter [gm/dl-a unit of measurement], a protein molecule in the red blood cells that carry oxygen and delivers it to body tissues). Patient 1's hemoglobin (Hgb) level was 9.0 gm/dl (normal values are between 12 to 15 mg/dl) upon admission.

A review of Patient 1's "Operative and Procedure Reports," dated 3/02/2023, at 6 p.m., indicated a repeat C-section and bilateral tubal ligation (surgical procedure to prevent pregnancy) was performed. Patient 1 lost an estimated blood loss of 426 cc (cubic centimeter or milliliters [ml]-a unit of measurement).

A review of Patient 1's "Anesthesia Record," dated 3/02/2023, indicated Patient 1 was admitted to the operating room (L&D OR) at 3:48 p.m. and out of the OR and transferred to the recovery room at 5:46 p.m.

A review of a nurse's note titled "Vascular Access Devices," dated 3/02/2023, indicated that a bag ( first unit of PRBC) of packed red blood cells (PRBCs) was started at 6:30 p.m., and completed at 7:49 p.m.

A review of Patient 1's "Hemodynamics (basic measures of how the blood flows through the blood vessels)/Vitals," dated 3/2/2023, indicated Patient 1's vital signs were as follows:

At 7:29 p.m., heart rate (HR) was 121 (high, reference (desired) range 51 - 119), blood pressure (BP) was 119/93 (Reference range 91/51 to 139/89).
At 8 p.m., HR was 153 and BP was 118/58.
At 8:07 p.m., HR was 151 and BP was 107/49.
At 8:18 p.m., HR was148 (high) and BP was 111/46.
No further HR or BPs were documented.

A review of a physician progress note, dated 3/02/2023, at 8:14 p.m., indicated Patient 1 was "noted with pulse rate between 150 - 155 ... Given low starting hemoglobin, will give second unit of PRBCs ..."

A review of Patient1's nurse's note titled "General Information," dated 3/02/2023, indicated the following:

At 8:09 p.m., attending Obstetric surgeon (OBS 2) orders a DIC panel (a blood test to determine if a serious disorder in which the proteins that control blood clotting become overactive and can cause a cut off in normal blood supply to organs), then start the second bag of PRBCs.

At 8:10 p.m., the registered nurse 3 (RN 3) and charge nurse 4 (CN 4) were at bedside and attempted to draw (blood). Patient 1 was a hard stick (difficulty in accessing a patient's veins to draw blood).

At 8:15 p.m., Anesthesiologist 1 (Anes 1) was at bedside, attempted to draw blood for DIC panel.

At 8:30 p.m., Anesthesiologist 1 was unable to draw blood for DIC panel.

At 8:40 p.m., Anesthesiologist 1 was still at bedside and "aware it (referring to blood pressure machine) is not taking BPs (blood pressures). Patient 1 moving a lot."

At 9:10 p.m., "OBS 2 notified unable to draw DIC panel. Patient 1 complained of dizziness and moving a lot."

A review of a Physician Progress Note dated 3/02/2023, at 10:13 p.m., documented by OBS 1, indicated it (referring to the Physician Progress Note) was a late note of events in the past 90 minutes (from 10:13 p.m.). The Physician Progress Note indicated "Called by the registered nurse (RN 3) around 9 p.m. Notified at that time that PRBC transfusion had not yet started, as RN 3 and Anes 1 (referring to Anesthesiologist 1) had been trying to get labs drawn for DIC panel. On repeat evaluation, patient (referring to Patient 1) complained of dizziness, respiratory rate was elevated ... and Bakri (a balloon inserted into the uterine cavity to temporarily control or reduce postpartum hemorrhage [excessive bleeding after childbirth) had about 350 ml of flood. Pulse remained in the lows 150's ... Decision made to proceed to operating room for exploratory laparotomy (surgery to open up the abdomen), possible hysterectomy (a surgical procedure to remove the uterus or womb), given concern for hemorrhage (a severe amount of bleeding from inside or outside of the body) ... Massive Blood Transfusion (MTP-Massive Transfusion Protocol, a policy to facilitate a rapid response of potentially needed resources in the case a hemorrhagic...) activated."

A review of nurses' notes titled "PowerChart Maternity," dated 3/02/2023, indicated the following:

At 9:19 p.m., "OBS 2 explaining to Patient 1 has to bring her (Patient 1) back to the operating room (OR)."
At 9:25 p.m., second bag of PRBC started.
At 9:35 pm, Patient 1 in the OR.

A review of an "Operative and Procedure Report," dated 3/03/2023, at 12:14 a.m., indicated Patient 1 was taken to the Operating room at 9:35 p.m., on 3/02/2023, with a preoperative diagnosis of intra-abdominal (space between the organs and the inner lining of the abdominal wall) bleeding after C-section. Surgery started at 10 p.m. A code blue (medical emergency usually involving a cardiac or respiratory arrest) was called at 10:23 p.m. A hysterectomy (removal of the uterus or womb) was performed. The quantitative blood loss in the operating room (OR) was 5,418 cc. Patient 1 was pronounced (dead) at 11:15 p.m.

A review of Patient 1's "Operative and Procedure Reports," dated 3/03/2023, at 1:46 a.m., indicated "Patient (Patient 1) was taken to operating room for tachycardia (elevated heart rate) and intra-abdominal bleeding. Findings included over 2 Liters of dark un-clotted blood on entry to abdomen ... Total (blood products) infused during case: 14 units of PRBC, 13 units of FFP (fresh frozen plasma), and 2 units of platelets (cell fragments in the blood that form clots and stop or prevent bleeding) ... Patient status: demise (death)."

During an interview, on 4/04/2023, at 4:27 p.m., the registered nurse 3 (RN 3) stated she (RN 3) assumed care for Patient 1 at 7:25 p.m., on 3/02/2023. RN 3 stated when she (RN 3) started her shift, the first bag of PRBCs was running and almost done. RN 3 stated Patient 1's heart rate was 121, but it was not concerning, then the heart rate increased to the 150's. At that point the Charge Nurse 4 (CN 4) came to assist her (RN 3). RN 3 stated Patient 1 felt cold, and she (RN 3) could not obtain a temperature or any blood pressures or heart rates for Patient 1. RN 3 stated OBS 2 ordered a DIC panel, then a second bag of blood. RN 3 stated neither she (RN 3), CN 4 or Anesthesiologist 1 could draw the DIC panel. RN 3 stated it took a long time and they (referring to RN 3, CN 4, and Anesthesiologist 1) were unable to draw blood.

During an interview on 4/04/2023, at 4:27 p.m., with Registered Nurse 3 (RN 3), RN 3 stated that blood should normally be administered right away but it took a while because they (referring to RN 3, CN 4, and Anes 1) could not draw blood. RN 3 then notified OBS 2 that she (RN 3) was unable to draw blood and that she (RN 3) had not started the second unit of blood yet, and Patient 1 had become restless. RN 3 stated Obstetric Surgeon 2 (OBS 2) arrived at the bedside and explained to Patient 1 that she (Patient 1) was going back to the OR because she (OBS 2) was concerned Patient 1 was bleeding internally. The second bag of blood was started at 9:25 p.m., while Patient 1 was still in the recovery room. Patient 1 was taken to the OR at 9:30 p.m. RN 3 stated the surgery started at 10 p.m. RN 3 said that during the surgery Anesthesiologist 2 (Anes 2) helped administer massive amounts of blood transfusions. RN 3 stated Patient 1 coded (referring to cardiac arrest) 2 or 3 times then expired (died).

During a concurrent interview and record review, on 4/06/2023, at 2:11 pm., with the Manager of Labor & Delivery (ML&D), the ML&D stated Patient 1 was admitted to the facility on 3/01/2023 for a C-section. The ML&D said Patient 1 was a high risk for bleeding due to having a history of multiple C-sections. The ML&D stated OBS 2 ordered a second bag of PRBC for Patient 1 at 8:09 p.m. The ML&D verified that RN 3 had not given the second bag of blood because she (RN 3) was trying to draw blood for an hour, and during that time RN 3 had not been able to obtain vital signs. The ML&D verified the second bag of PRBC was started at 9:25 p.m. ML&D verified that the blood transfusion should not have been delayed in accordance with the facility's policy and procedure.

A review of the facility's policy and procedure (P&P) titled "Management of Obstetrical Hemorrhage," dated 11/2021, indicated blood transfusion should not be delayed if any of the following are present, including vital signs abnormal as outlined in Stage 2 (heart rate above 110, systolic [indicates how much pressure blood is exerting against the artery walls when the heart beats] blood pressure less than 85 or diastolic [force exerted when the heart is at rest]blood pressure less than 45).

2. During an interview, on 4/04/2023, at 9:45 a.m., Obstetric Surgeon 2 (OBS 2) stated she (OBS 2) became aware that Patient 1's heart rate was high because she (OBS 2) checked the monitors (machine that shows patient's heart rate).

During an interview, on 4/04/2023, at 12:32 p.m., Obstetric Surgeon 1 (OBS 1) stated she (OBS 1) was not aware Patient 1's blood pressure was low.

During a concurrent interview and record review on 4/06/2023, at 2:11 p.m., with the Manager of Labor & Delivery (ML&D), Patient 1's medical record, dated 3/03/2023, was reviewed. The (ML&D) verified that Patient 1's vital signs were out of the desired range and stated there was no documented evidence in the medical record that the physician (OBS 1) was notified of the abnormal vital signs either by RN 2 or Anes 1.

A review of Patient 1's "Hemodynamics/Vitals," dated 3/2/2023, indicated Patient 1's vital signs were as follows:

Heart rate (HR) reference (desired) range is 51-119, Blood pressure (BP) reference range is from 91/51 to 139/89). Temperature Reference range is 36 - 37.5 Celsius [C]).

At 5:48 p.m., HR was 118 (high) and BP was 39/26, Anesthesiologist 1 (Anes 1) at the bedside.
At 5:53 p.m., HR was 112 (high) and BP 65/43 (low).
At 5:58 p.m., HR was 71 and BP was 61/48 (low).
At 6:04 p.m., HR was 84 and BP was 47/31 (low).
At 6:08 p.m., HR was 104 and BP 0/0 (low). nes 1 at bedside, unable to obtain blood pressure, Patient 1 awake, alert ...
At 6:11 p.m., HR was 77 and BP was 0 /0 (low).
At 6:28 p.m., Temperature was 34.3 (low) degrees Celsius.
At 6:59 p.m., HR was 103 and BP was 119/53.
At 7:29 p.m., HR was 121(high) and BP was 122/65.
At 8 p.m., HR was 153 (high) and BP was 118/58.
At 8:07 p.m., HR was 151 (high) and BP was 107/49.
At 8:18 p.m., HR was 148 (high) and BP was 111/46.
No further HR or BPs were documented.

A review of Patient 1's "orders," dated 3/02/2023, at 5:53 p.m., indicated to notify the physician (MD) if:

Pulse is greater than 110 or less than 50.
Systolic blood pressure is greater than 155 or less than 80.
Diastolic blood pressure greater than 105 or less than 45.
Temperature equal to or greater than 38 degrees Celsius (C) or less than 36 C.

3a. A review of Patient 26's History and Physical (H&P), dated 4/05/2023, indicated Patient 26 was admitted to the facility for left upper extremity arteriovenous fistula (AVF-an irregular connection between an artery and a vein) thrombosis (blood clot formation). Patient 26 had a history of end stage renal disease (ESRD - loss of kidney function) and hemodialysis treatment.

A review of Patient 26's daily weight record from 4/04/2023 to 4/06/2023, indicated Patient 26's weight was not documented two of three days (4/05/2023 and 04/06/2023).

During an interview on 4/06/2023, at 3:00 p.m., with Director of Medical Surgical (DMS), DMS stated the patient's daily weights affects how much fluid to remove during hemodialysis.

A review of the facility's policy and procedure (P&P) titled, "Hemodialysis: Care of the Patient, Before, During and After," dated 10/2019, indicated the nurse will check and document the patient's weight prior to the hemodialysis treatment.

3b. A review of Patient 27's History and Physical (H&P), dated 3/24/2023, indicated Patient 27 was admitted to the facility for fluid overload (a condition when you have too much fluid volume in your body). Patient 27 also had a history of ESRD and hemodialysis treatment.

A review of Patient 27's physician orders, dated 4/02/2023, indicated an order to obtain Patient 27's weight once a day.

A review of Patient 27's daily weight record from 3/30/2023 to 4/6/2023, indicated Patient 27's daily weight was not documented seven out of eight days (3/30/2023, 3/31/2023, 4/01/2023, 4/02/2023, 4/03,2023, 4/05,2023, and 4/06/2023).

During an interview on 4/06/2023, at 3:00 p.m., with Director of Medical Surgical (DMS), DMS stated the patient's daily weights affects how much fluid to remove during hemodialysis.

A review of the facility's policy and procedure (P&P) titled, "Hemodialysis: Care of the Patient, Before, During and After," dated 10/2019, indicated the nurse will check and document the patient's weight prior to the hemodialysis treatment.

3c. During a concurrent observation and interview, on 4/06/2023, at 3:35 p.m., Patient 18 was in bed, alert, oriented, and surveyor observed the following:

- Patient 18 was being administered oxygen via high flow nasal canula (a device used to deliver high concentration of oxygen); and,

- Patient 18 had a dialysis catheter (a catheter used for exchanging blood to and from a hemodialysis machine and a patient) on the right neck.

Patient 18 stated he (Patient 18) had been having dialysis (a procedure to remove waste products and excess fluid from the blood when the kidneys stop working properly) daily.

A review of Patient 18's "Admission H&P (History and Physical)," dated 4/01/2023, indicated Patient 18 was transferred from another facility with a chief complaint of abdominal pain. Patient 18's assessment included acute kidney injury (a sudden episode of kidney failure or kidney damage that happens within a few hours).

A review of Patient 18's physician's order from 4/04/2023 to 4/06/2023, indicated an order for Patient 18 to have hemodialysis.

A review of Patient 18's weight record dated4/06/2023, indicated Patient 18's weight was 73.2 kilogram (kg). There was no documented evidence Patient 18's weight was obtained on 4/04/2023 and on 4/05/2023.

During an interview on 4/07/2023, at 10:48 a.m., with Registered Nurse 4 (RN 4), RN 4 stated the patient's (Patient 18) weight should be taken prior to dialysis treatment as indicated in the facility's policy and procedure.

A review of the facility's policy and procedure (P&P) titled, "Hemodialysis: Care of the Patient, Before, During and After," revised in October 2019, indicated, "Pre-procedure care...Nursing staff to check weight prior to treatment and inform the dialysis nurse of weight. Dialysis nurse to document weight on Hemodialysis record..."

Based on interview and record review, the facility failed to ensure that medications were administered as ordered by the physician for two of 30 sampled patients (Patients 18 and 19).

This deficient practice resulted in a delay of treatment and had the potential to cause adverse health outcomes which could negatively affect the patient's health and safety due to unsafe medication administration and may lead to prolonged hospitalization and/or death.

Findings:

1. A review of Patient 18's "Admission H&P (History and Physical)," dated 4/01/2023, indicated Patient 18 was transferred from another facility with a chief complaint of abdominal pain, acute kidney injury and possible pneumonia (an inflammation and fluid in the lungs caused by an infection).

A review of Patient 18's physician's order, dated3/31/2023, indicated an order to administer Ceftriaxone (antibiotics) 1 gram intravenous (given through the vein) every 24 hours for pneumonia.

A review of Patient 18's Medication Administration Record (MAR) indicated that Patient 18 was administered Ceftriaxone on 3/31/2023, at 9:05 p.m. and on 4/01/2023, at 8:18 a.m. (11 hours from the last dose of Ceftriaxone).

During an interview on 4/07/2023, at 10:48 a.m., with Registered Nurse 4 (RN 4), RN 4 stated Patient 18 received ceftriaxone earlier than scheduled instead of every 24 hours as ordered by the physician.

During an interview on 4/07/2023, at 3:15 p.m., conducted with the Director of Telemetry (DOT), the DOT stated if the timing schedule of the next dose of medication needed to be adjusted, the RN should consult the pharmacy to ensure safety of the medication administration. The DOT stated there was no documentation the RN called and consulted the pharmacist when ceftriaxone was given to Patient 18 earlier than scheduled as ordered by the physician.

A review of the facility's policy and procedure (P&P) titled, "Medication Administration," revised on November 2021, the P&P indicated, "...Time-critical scheduled medications...are those for which an early or late administration of greater than thirty minutes might cause harm or have significant, negative impact on the intended therapeutic or pharmacological effect. Accordingly, scheduled medications identified as time-critical must be administered within thirty minutes before or after their scheduled dosing time, for a total window of 1 hour...Examples of time-critical scheduled medications/medication types may include, but are not limited to...Antibiotics..."

2. A review of Patient 19's "Admission H&P (History and Physical)," 3/26/2023, indicated Patient 19's chief complaints were headache, vomiting, and altered mental status. Patient 19 had an acute intracranial hemorrhage (bleeding inside the skull putting pressure on the brain which can lead to rapid brain damage or death) and was taken to surgery.

A review of Patient 19's "Order Sheet," dated 4/26/2023, indicated "...nicardipine (medication used in situations requiring the rapid control of blood pressure [BP]) ...5 mg/hr (milligram/hour)...IV (intravenous - given through the vein)...titrate (change in medication dose to achieve the best clinical response) by 2.5 mg/hr as often as every 5 min to achieve...SBP (systolic BP) < (less than) 140..."

A review of Patient 19's "ICU Flowsheet," indicated the following:

- On 3/26/2023, at 12 p.m. through 1:15 p.m., the patient's BP was taken every 15 mins. The lowest SBP (Systolic Blood Pressure) was 142 and the highest SBP was 163.

- Nicardipine IV solution was started with a dose of 5 mg/hr at 12 p.m. and was titrated to 7.5 mg/hr at 12:15 p.m. (15 minutes after the last dose).

-There was no documented evidence nicardipine was titrated after 12:15 p.m.; and,

- On 3/26/2023, at 7:15 p.m. through 11:45 p.m., Patient 18's BP was taken every 15 mins. The lowest SBP was 141 and the highest SBP was 158.

-Nicardipine IV solution was at 5 mg/hr from 7:15 p.m. through 8:45 p.m. (there was no documented evidence nicardipine was titrated every five minutes to achieve goal of SBP <140).

-Nicardipine IV solution was titrated to 7.5 mg/hr at 9 p.m., and the same dose was administered to Patient 19 until 10:15 p.m. (there was no documented evidence nicardipine was titrated every five minutes to achieve goal of SBP <140).

-Nicardipine was titrated to 10 mg/hr at 10:30 p.m., and the same dose was administered to Patient 19 until 11:45 p.m. (there was no documented evidence nicardipine was titrated every five minutes to achieve goal of SBP <140).

During an interview on 4/07/2023, at 3:26 p.m., with the Director of Critical Care (DOCC), DOCC stated Patient 19's BP should have been checked every five minutes to know if nicardipine dose needed to be adjusted to keep the patient's (Patient 19) SBP <140. The DOCC further stated Patient 19's nicardipine IV was not titrated in accordance with the physician's order. The DOCC said the nicardipine dose should have been titrated every 5 minutes to achieve SBP of <140.

A review of the facility's policy and procedure (P&P) titled "Titrating Medications," revised on October 2022, indicated, "...It is the policy of (name of the facility) to allow orders for medication titration, which are the progressive increase or decrease of the medication dose in response to the patient's clinical status...Nurses will titrate medications in accordance with the medical order..."

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

1. Failure to ensure Medical staff have a completed copy of approved clinical privileges for one of 10 sampled physicians' credential files (OBS 1). This deficient practice had the potential to result in patient harm due to a physician practicing without approved clinical privileges. (Refer to A-0945)

2. Failure to ensure that prior to a scheduled surgery, all pre-operative work-up reports were completed, and the schedule of surgery was coordinated with the Obstetric team and the facility's main OR (Operating Room) team for one of one sampled patient (Patient 1), who was scheduled for a Cesarean section. This deficient practice resulted in a delay in Patient 1's scheduled surgery and had the potential to result in patient harm. (Refer to A-0951)

3. Failure to ensure that one of one sampled patient's (Patient 1) abnormal Vital Signs as well as signs of Hypotension (low blood pressure) and maternal hemorrhage were promptly recognized and addressed. This deficient practice had the potential to result in delay of patient treatment. (Refer to A-0951)

4. Failure to provide care and recognize the signs of bleeding or hemorrhage (severe bleeding) for one of one sampled patient (Patient 1) displaying signs of internal bleeding (increased heart rate, low blood pressure, cold skin, chills, dizziness) after having a Cesarean section (C-section, surgical delivery of a baby through a cut made on the mother's abdomen and uterus), in accordance with acceptable standards of practice and the facility's policy and procedures. This deficient practice resulted in patient 1 returning to the operating room (OR) for suspected internal bleeding four (4) hours after patient 1 started displacing signs of internal hemorrhage. Patient 1 subsequently expired due to maternal hemorrhage.
(Refer to A-0957)

These systemic deficient practices resulted in the failure of the facility to deliver surgical services that safeguard the health of the patients.

Based on interview, and record review, the facility failed to ensure Medical Staff have a complete record of approved privileges (authorizes medical practitioners for a specific practice of patient care in a specified healthcare facility) for one of 10 sampled physicians' credential files (OBS 1).

This deficient practice had the potential to result in patient harm due to a physician practicing without approved clinical privileges.

Findings:

During a concurrent interview and record review on 4/06/2023, at 3:45 p.m., with the Director of Medical Services (DMS), the Medical Staff Credential files for one of 10 physicians (OBS 1), was reviewed. OBS 1's Clinical Privileges request Form was incomplete, it did not specify which clinical privileges were requested. OBS 1's file indicated OBS 1 was not approved to perform the following procedures including: Cesarean Section (Operation to deliver), Hysterectomy (surgical removal of the uterus), and Tubal Sterilization (Surgical procedure to prevent female pregnancy). The record also indicated that the Governing Body approval date for OBS 1's credential file was 10/27/2022. DMS stated it was a clerical error that there was no copy of a complete filled out privilege form for OBS 1.

A review of the Facility's Medical Staff Bylaws (rules and regulations that establish how the members must fulfill their clinical responsibilities), dated 04/26/2018, under the section: Clinical Privileges, indicated "A Practitioner providing clinical services ...shall in connection with such practice, be entitled to exercise only those clinical privileges specifically granted by the Hospital Community Board..." and under the Bylaws Section on Ob-Gyn (Obstetrics-Gynecology-a branch of medicine that specializes in the care of women during pregnancy and childbirth and in the diagnosis and treatment of diseases of the female reproductive organs) Department duties indicated "The Ob -Gyn Department shall: establish criteria for the granting of clinical privileges within the department; recommend members for reappointment; and the delineation of clinical privileges for all practitioners..."

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

1. Ensure that prior to a scheduled surgery, all pre-operative work-up reports were completed, and the schedule of surgery was coordinated with the Obstetric team and the facility's main OR (Operating Room) team for one of one sampled patient (Patient 1), who was scheduled for a Cesarean section. This deficient practice resulted in a delay in Patient 1's scheduled surgery and had the potential to result in patient harm.

2. Ensure that one of one sampled patient's (Patient 1) abnormal Vital Signs as well as signs of Hypotension (low blood pressure) and maternal hemorrhage were promptly recognized and addressed. This deficient practice had the potential to result in delay of patient treatment.

Findings:

1. A review of Patient 1's History & Physical (H&P) dated 3/01/2023, at 2:49 p.m., with an addendum at 4:21 p.m., indicated Patient 1 presented to the Labor and Delivery (L&D) unit after missing a scheduled Cesarean section in the main OR. Patient 1 was then admitted to L&D.

A Review of Patient 1's Progress note dated 3/02/2023, at 2:15 p.m., indicated "C-Section schedule pending for this afternoon. Delay in C-section due to needing medical records to confirm number of c-sections."

A review of the Operating Room Log, dated 3/01/2023, indicated Patient 1 was scheduled to undergo C-section in the Main OR on 3/01/2023, at 7:30 a.m. The C-section was to be performed by Obstetric Surgeon 4 (OBS 4).

During an interview on 4/04/2023, at 12:55 p.m., with the Director of Surgery (DOS) and the OR scheduler (ORS), ORS stated that for Patient 1's scheduled surgery (C-section), the Main OR required pre-operative work-up documents to be completed prior to surgery which included: History and Physical (H&P), pre-Anesthesia evaluation report, pre-operative laboratory results, and consent for surgery. ORS said that all the mentioned documents were not completed prior to Patient 1's arrival at the Main OR. Likewise, the DOS said that there was no documentation of who was the personnel who should have coordinated and communicated with Patient 1 prior to Patient 1's arrival for surgery on 3/01/2023 to ensure completeness of documents. DOS further stated that the Main OR staff should have communicated with the surgeon regarding the completeness of records needed for the surgery.

During an interview on 4/04/2023, at 12:15 p.m., with the Manager of Labor & Delivery (ML&D) and the Director of Perinatal Services (DPNS), both the ML&D and the DPNS said that Patient 1 was scheduled for surgery on 3/01/2023 at the Main OR and that the OR scheduler should have coordinated with and called Patient 1.

During a concurrent interview and record review with the ML&D and the Director of Perinatal Services (DPNS) on 4/04/2023, at 12:55 p.m., Patient 1's medical record regarding plan for surgery was reviewed. Both the ML&D and the DPNS stated that OBS 1 and OBS 2 discussed a plan in which both OBS 1 and OBS 2 including 2 Anesthesiologists will be available during Patient 1's surgery (C-section) since Patient 1 was a high risk for hemorrhage. However, there was no documentation of the discussed plan in Patient 1's medical record or any documentation that the said information was communicated among the team who will be attending to Patient 1's surgery. Likewise, the facility did not have a policy regarding how care and admission for contracted patients, coming from an outside clinic and were in need of surgery, were coordinated with the OB and the OR team.

2. A review of Patient 1's History & Physical (H&P) dated 3/01/2023, at 2:49 p.m., with an addendum at 4:21 p.m., indicated Patient 1 presented to the Labor and Delivery (L&D) unit after missing a scheduled Cesarean section in the Main OR. Patient 1 had a history of chronic hypertension (high blood pressure) and morbid obesity (weight that is more than 80 to 100 pounds above the ideal body weight) and history of multiple (x4) C-sections. Hemoglobin (Hgb, a protein molecule in the red blood cells that carry oxygen and delivers it to body tissues) was 9.0 gm/dl (low, normal levels are between 12 to 16 g/dl [grams/deciliter]).

A review of Patient 1's nurse's notes titled "Gyn (Gynecology- a medical specialty involving the female reproductive system) and Maternal Child," dated 3/01/2023, at 12:15 p.m., indicated Patient 1 was a high risk for postpartum hemorrhage (heavy bleeding after childbirth). Risk factors included a previous history of four C-sections (cesarean sections).

A review of Patient 1's "Operative and Procedure Reports," dated 3/02/2023, at 6 p.m., indicated a repeat C-section and bilateral tubal ligation (surgical procedure to prevent pregnancy) was performed. Patient 1 had an estimated blood loss of 426 cc (cubic centimeter or milliliters [ml]).

A review of Patient 1's "Anesthesia Record," dated 3/02/2023, indicated Patient 1 was admitted to the operating room (L&D OR) at 3:48 p.m. and out of the L&D OR and transferred to the recovery room at 5:46 p.m.

A review of Patient 1's "Hemodynamics (basic measures of how the blood flows through the blood vessels)/Vitals," dated 3/2/2023, indicated Patient 1's vital signs were as follows:

Heart rate (HR) reference (desired) range is 51-119, Blood pressure (BP) reference range is from 91/51 to 139/89). Temperature Reference range is 36 - 37.5 Celsius [C]).

At 5:48 p.m., HR was 118 and BP was 39/26 (low), Anesthesiologist 1 (Anes 1) at the bedside.

At 5:53 p.m., HR was 112 and BP 65/43 (low).
At 5:58 p.m., HR was 71 and BP was 61/48 (low).
At 6:04 p.m., HR was 84 and BP was 47/31 (low).
At 6:08 p.m., HR was 104 and BP 0/0 (low). Anes 1 at bedside, unable to obtain blood pressure, Patient 1 awake, alert ...
At 6:11 p.m., HR was 77 and BP was 0 /0 (low).
At 6:25 p.m., HR 101, and BP was 118/59.
At 6:28 p.m., HR 107 and BP was 109/57. Temperature was 34.3 degrees Celsius (low)
At 6:48 p.m., HR was 105 and BP was 127/53.
At 6:59 p.m., HR was 103 and BP was 119/53.
At 7:29 p.m., HR was 121 (high) and BP was 122/65.
At 8 p.m., HR was 153 (high) and BP was 118/58.
At 8:07 p.m., HR was 151 (high) and BP was 107/49.
At 8:18 p.m., HR was148 (high) and BP was 111/46.
No further HR or BPs were documented.
Patient 1's temperature remained at 34 degrees Celsius

During an interview on 4/04/2023, at 9:45 a.m., Obstetric Surgeon 2 (OBS 2) stated the following: Patient 1 was admitted to the facility for a C-section. Patient 1 was at high risk for postpartum hemorrhage due to a history of multiple C-sections, obesity, and anemia. OBS 2 stated she (OBS 2) took over the care of Patient 1 at about 8 p.m., on 3/02/2023, and OBS 2 said that the report she (OBS 2) received from OBS 1, mentioned there were no complications during Patient 1's surgery. OBS 2 checked Patient 1's current vital signs and noted Patient 1's heart rate was elevated. OBS 2 went to Patient 1's bedside and ordered a DIC panel (a blood test to determine if a serious disorder in which the proteins that control blood clotting become overactive and can cause a cut off in normal blood supply to organs) and PRBCs (Packed Red Blood Cells-used in transfusion to restore blood volume). OBS 2 was not aware that RN 3 and Anes 1 were struggling to draw blood or that the second unit PRBCs (ordered at 8:09 p.m.) had not been started until about an hour later (second unit of PRBC administered at 9:25 p.m.). OBS 2 did not check any previous vital signs and was unaware of Patient 1's low blood pressures. OBS 2 was unaware of the medications given by Anes 1 to Patient 1 to help stabilize the blood pressure and had she (OBS 2) known, Patient 1 would have returned to the operating room at 8 p.m. instead of 9:25 p.m., in accordance with the facility's policy.

During an interview on 4/04/2023, at 9:45 a.m., with Obstetric Surgeon 2 (OBS 2), OBS 2 stated that OBS 1 was called back to the facility because Patient 1 was returning to the operating room for an exploratory laparotomy. OBS 1 returned to the facility at approximately 10 p.m. on 3/02/2023, to relieve OBS 2 and start the second surgery (exploratory laparotomy-surgery to open up the abdomen). OBS 1 observed two Liters of un-clotted blood in the abdomen. Patient 1's heart rate stopped (10:22 p.m.). CPR (Cardiopulmonary resuscitation-an emergency life-saving procedure performed when the heart stops beating) was started. Patient 1's heart rate returned so OBS 1 proceeded to remove Patient 1's uterus (otherwise known as womb where an unborn baby develops and grows). Patient 1's heart rate stopped again (10:46 p.m. and 11:05 p.m.). CPR was given for approximately forty minutes. Patient 1 was unresponsive and pronounced dead at 11:15 p.m.

During an interview, on 4/04/2023, at 12:32 p.m., Obstetric Surgeon 1 (OBS 1) stated the following: OBS 1 performed a C-section for Patient 1 on 3/02/2023. The C-section was uneventful. OBS 1 was not informed by the Anesthesiologist (Anes 1) of any issues regarding Patient 1. OBS 1 was informed Patient 1 was having some bleeding. OBS 1 examined Patient 1. Patient 1's fundus was boggy (soft or enlarged indicating the uterus is not contracting), so OBS 1 placed a Bakri balloon (a balloon inserted into the uterine cavity to temporarily control or reduce postpartum hemorrhage [excessive bleeding after childbirth). At that time (referring to the time when the Bakri balloon was placed), Patient 1's vital signs were normal. OBS 1 did not check the trend of vital signs and was not aware of previous low blood pressures or of the medications given by Anes 1 to stabilize Patient 1's blood pressures. OBS 1 said she (OBS 1) would have taken Patient 1 back to the operating room at 6:58 p.m., had OBS 1 known of the low blood pressures. OBS 1 endorsed Patient 1 to OBS 2 around 8 p.m. on 3/02/2023.

Based on interview and record review, the facility failed to provide care and recognize the signs of bleeding or hemorrhage (severe bleeding) for one of one sampled patient (Patient 1) displaying signs of internal bleeding (increased heart rate, low blood pressure, cold skin, chills, dizziness) after having a Cesarean section (C-section, surgical delivery of a baby through a cut made on the mother's abdomen and uterus), in accordance with acceptable standards of practice and the facility's policy and procedures.

This deficient practice resulted in Patient 1 returning to the operating room (OR) for suspected internal bleeding four (4) hours after patient 1 started displaying signs of internal hemorrhage. Patient 1 subsequently expired due to maternal hemorrhage.

On 4/05/2023, at 10:26 a.m., the survey team called an Immediate Jeopardy (IJ, a situation in which the facility's noncompliance with one or more requirement has caused, or is likely to cause, serious injury, harm, impairment, or death to a patient) situation in the presence of the Quality & Patient Safety Director (QPSD), Chief Nurse Executive Officer (CNEO), Chief Executive Officer (CEO), and Chief Medical Officer (CMO). The facility failed to provide care and recognize signs of bleeding and hemorrhage for a patient (Patient 1) who had a Cesarean section (C-section, surgical delivery of a baby through a cut made in the mother's abdomen and uterus) who was displaying signs of internal bleeding, in accordance with acceptable standards of practice and the facility's policies and procedures. This deficient practice resulted in Patient 1 returning to the operating room (OR) for suspected internal bleeding four (4) hours after Patient 1 started displaying signs of internal hemorrhage. Patient 1 subsequently expired due to maternal hemorrhage (heavy bleeding).

On 4/07/2023, at 2:58 p.m., the IJ was removed in the presence of the QPSD, CNEO, CEO, and the CMO after the facility submitted an acceptable IJ Removal Plan (interventions to correct the deficient practices). The elements of the IJ removal Plan were verified and confirmed through interviews and record reviews. The acceptable IJ Removal Plan included re-education of all licensed practitioners, registered nurses, and surgical technicians who provide obstetrical care in the Labor and Delivery Department. Re-education included didactic (method of teaching via lecture/discussion of written material) and simulation training (training created to mirror real life situations) on appropriate care and recognition of signs of bleeding/hemorrhage for post C-section patients displaying signs of internal bleeding, and the use of the facility's algorithm (a list of step-by-step instructions) to identify and treat Obstetrical hemorrhage, and escalation process (clarifies the boundaries and channels of decision-making throughout an organization in order to solve a problem quickly and with clarity) to ensure quality of care. The Plan also included updated policies and procedures addressing the management of obstetrical hemorrhage.


Findings:

During an observation on 4/03/2023, at 1:47 p.m., in the Labor & Delivery (L&D) Unit, an algorithm (step-by-step instructions to solve a problem) titled "Acute Hemorrhage Algorithm / Obstetrical ACUTE Hemorrhage Algorithm," was posted on the wall of the recovery room and on the wall adjacent to the nurses' station.

Concurrently, on 4/03/2023, at 1:47 p.m., charge nurse 1 (CN 1) stated post C-section Patients were monitored in the Recovery room for signs of bleeding. CN 1 stated vital signs were taken at least every fifteen minutes or every five minutes if the vital signs were abnormal. CN 1 stated if a patient's blood pressure or temperature was low, the Anesthesiologist should be notified first. CN 1 stated to notify the obstetric surgeon (OBS), if the blood pressure is unstable or there is a low temperature even after taking additional measures (such as applying a warming blanket). CN 1 said per the facility's policy and algorithm, if within the first two hours after a C-section, a patient's quantitative blood loss (QBL, method for measuring blood loss based on weight of blood) is less than 1000 milliliters (ml) but the Patient has heart rate over 110, a blood pressure under 85/45, an oxygen saturation of equal to or less than 93 percent (%) or if the patient is displaying symptoms of shortness of breath, confusion, or agitation, then Stages 1 and 2 should be skipped (in the algorithm) and the facility should consider significant hemorrhage/Stage 3 interventions. RN 1 stated Stage 3 interventions included: notifying and obtaining assistance from the OB surgeon, the Anesthesiologist, charge nurse, the circulating nurse, and preparing the patient for the operating room (OR) without delay.

A review of Patient 1's nurse's notes titled "Gyn (Gynecology-medical specialty involving the female reproductive system) and Maternal Child," dated 3/01/2023, at 12:15 p.m., indicated Patient 1 was a high risk for postpartum hemorrhage (heavy bleeding after childbirth). Risk factors included a previous history of four C-sections.

A review of Patient 1's History & Physical (H&P) dated 3/01/2023, at 2:49 p.m. with an addendum at 4:21 p.m., indicated Patient 1 presented to the Labor and Delivery (L&D) unit after missing a scheduled Cesarean section on 3/01/2023. Patient 1 had a history of chronic hypertension (high blood pressure) and morbid obesity (weight that is more than 80 to 100 pounds above the ideal body weight) and history of multiple (x4) C-sections. Hemoglobin (Hgb, a protein molecule in the red blood cells that carry oxygen and delivers it to body tissues) was 9.0 gm/dl (low, normal levels are between 12 to 16 g/dl [grams/deciliter]).

A review of Patient 1's "Operative and Procedure Reports," dated 3/02/2023, at 6 p.m., indicated a repeat C-section and bilateral tubal ligation (surgical procedure to prevent pregnancy) was performed. Patient 1 had an estimated blood loss of 426 cc (or milliliters [ml]).

A review of Patient 1's "Anesthesia Record," dated 3/02/2023, indicated Patient 1 was admitted to the operating room (L&D OR) at 3:48 p.m. and out of the OR and transferred to the recovery room at 5:46 p.m.

A review of Patient 1's "Hemodynamics/Vitals," dated 3/02/2023, indicated Patient 1's vital signs were as follows:

Heart rate (HR) reference (desired) range is 51-119, Blood pressure (BP) reference range is from 91/51 to 139/89). Temperature Reference range is 36 - 37.5 degrees Celsius [C]).

At 5:48 p.m., HR was 118 and BP was 39/26 (low), Anesthesiologist 1 (Anes 1) at the bedside.
At 5:53 p.m., HR was 112 and BP 65/43 (low).
At 5:58 p.m., HR was 71 and BP was 61/48 (low).
At 6:04 p.m., HR was 84 and BP was 47/31 (low).
At 6:08 p.m., HR was 104 and BP 0/0 (low). Anes 1 at bedside, unable to obtain blood pressure, Patient 1 awake, alert ...
At 6:11 p.m., HR was 77 and BP was 0 /0 (low).
At 6:25 p.m., HR 101, and BP was 118/59.
At 6:28 p.m., HR 107 and BP was 109/57. Temperature was 34.3 degrees Celsius (low)
At 6:48 p.m., HR was 105 and BP was 127/53.
At 6:59 p.m., HR was 103 and BP was 119/53.
At 7:29 p.m., HR was 121 (high) and BP was 122/65.
At 8 p.m., HR was 153 (high) and BP was 118/58.
At 8:07 p.m., HR was 151 (high) and BP was 107/49.
At 8:18 p.m., HR was148 (high) and BP was 111/46.
No further HR or BPs were documented.

A review of a nurse's note titled, "Respiratory," dated 3/02/2023 indicated the following:

At 5:48 p.m., Patient 1's oxygen saturation level (or O2 sat, amount of oxygen in the blood, normal is above 93 %) was 94 %, on room air.

At 5:53 p.m., Patient 1's O2 sat was 98 %. Oxygen administration initiated, Patient 1 was receiving 3 Liters (L) of oxygen via nasal cannula (NC, a device used to deliver supplementary oxygen).

At 5:58 p.m., Patient 1's O2 sat dropped to 90 % (normal level is above 93), on three (3) Liters of oxygen via NC.

At 6:04 p.m., Patient 1's O2 sat was 94 %, on three (3) Liters of oxygen via NC.

A review of nurses' notes titled, "PowerChart Maternity," dated 3/02/2023, indicated the following:

At 5:36 p.m., Cytotec (or misoprostol, a medication that promotes uterine contractions) 1000 mg per rectal (PR) placed by Obstetric surgeon 1 (OBS 1).

At 5:47 p.m., Anes 1 at bedside, aware of late blood pressure late entry 3/3/2023 at 1:31 p.m., for 3/02/2023 at 5:47 p.m., Anes 1 aware of unable to obtain a blood pressure or temperature.

At 5:53 p.m., OBS 1 notified of moderate bleeding observed.

At 6:01 p.m., Hemabate (or carboprost tromethamine, a hormone-like substance used to treat severe bleeding after childbirth) 250 mg given intramuscularly (IM, in the muscle) on right thigh.

At 6:16 p.m., blood loss of 167 ml, OBS 1 at bedside evaluating Patient 1's bleeding. Digital exam of vaginal vault done; no clots expressed.

At 6:22 p.m., Bair (Bair Hugger, warming blanket) applied on high, unable to take temperature.

At 6:40 p.m., OBS 1 at bedside to assess Patient 1.

At 6:48 p.m., ten laps (sponges) given to OBS 1, count correct.

At 6:58 p.m., Bakri balloon (a device used to control bleeding after giving birth) placed by OBS 1 ...

At 7:48 p.m., first bag of packed red blood cells (PRBC) done.

At 8 p.m., Anes 1 at bedside to evaluate Patient 1. Physician (Anes 1) aware with difficulty in getting a temperature reading. Bair Hugger still in place.

At 8:08 p.m., OBS 2 at bedside evaluating Patient 1. OBS 2 aware of Patient 1's vital signs, maternal heart rate at 150s.

At 8:09 p.m., attending Obstetrician surgeon (OBS 2) orders a DIC panel (a blood test to determine if a serious disorder in which the proteins that control blood clotting become overactive and can cause a cut off in normal blood supply to organs), then start second bag of PRBCs.

At 8:10 p.m., the registered nurse (RN 3) and charge nurse (CN 4) at bedside attempted to draw (blood). Patient 1 hard stick (difficulty in accessing a patient's veins to draw blood).

At 8:15 p.m., Anesthesiologist (Anes 1) at bedside attempting to draw blood for DIC panel.

At 8:30 p.m., Anes 1 unable to draw blood for DIC panel.

At 8:40 p.m., Anes 1 still at bedside and aware it is not taking BPs (blood pressures). Patient 1 moving a lot.

At 8:45 p.m., temperature was 94.7 degrees Fahrenheit ([F]), normal body temperature is between 97 to 99 F), temperature taken rectally.

At 8:51 p.m., Anes 1 at bedside giving Albumin (used to treat low blood volume) 12.5 milligrams (mg, a unit of measurement).

At 9:10 p.m., OBS 2 notified unable to draw DIC panel. Patient 1 complained of dizziness and moving a lot.

At 9:14 p.m., OBS 2 at bedside side.

At 9:19 p.m., OBS 2 explaining to Patient 1 has to bring her (Patient 1) back to the operating room (OR).

At 9:25 p.m., 2nd bag of PRBC started.

At 9:35 pm, Patient 1 in the OR.

At 9:57 p.m., Anes 2 assisted with transfusing all blood products for Patient 1.

At 10:20 p.m., code blue. team called.

At 10:40 p.m., CPR (cardiopulmonary resuscitation, an emergency procedure consisting of chest compressions and artificial ventilation in an effort to restore blood circulation and breathing) restarted.

At 10:46 p.m., CPR restarted.

At 11:05 p.m., CPR restarted.

At 11:15 p.m., called off (chest) compressions.

At 11:19 p.m., called blood bank to stop massive transfusion protocol ...

On 3/03/2023, at 12:25 a.m., transported Patient 1 to morgue ..."

A review of a physician progress note dated 3/02/2023, at 6:24 p.m., documented by OBS 1, indicated "obstetric surgeon 1 (OBS 1) notified of vaginal bleeding post op, on evaluation a small amount of vaginal bleeding was noted. Uterus was firm, no clots present in vagina. Bimanual exam (used to check a woman's internal pelvic organs) with trace blood per vagina. Patient received Cytotec (or misoprostol, a medication that promotes uterine contractions) and Hemabate (or carboprost tromethamine, a hormone-like substance used to treat severe bleeding after childbirth) earlier for uterine atony (uterus fails to contract adequately and could lead to postpartum hemorrhage (PPH, heaving bleeding after childbirth)."

A review of a physician progress note dated 3/02/2023, at 7:11 p.m., documented by OBS 1, indicated "further bleeding was noted, the lower uterine segment was boggy (soft or enlarged indicating the uterus is not contracting). A Bakri balloon was placed ...An additional 150 ml of blood was estimated to have been lost..." There was no documentation of any vital signs of Patient 1 including the abnormal Temperature of 34 degrees Celsius in OBS 1's progress note. There was no documentation of communication with Anes 1 regarding treatment plans or documentation of communication with OBS 2.

After 8:18 p.m., there was a physician progress note from OBS 1 indicating that OBS 2 or Anes 1 were addressing the abnormal and varied from base line VS and Abnormal Temperature of 34 degrees Celsius that was never corrected.

A review of a Physician Progress Note, dated 3/02/2023, at 8:14 p.m., documented by OBS 2, indicated Patient 1 "noted with pulse rate between 150 - 155 ... Given low starting hemoglobin, will give second unit of PRBCs. Continue to monitor closely." There were no further HR or BPs documented.

A review of the physician progress note, dated 3/02/2023, did not indicate any physician Progress note or Nurses note addressing why there was no HR and BP documentation after 8:18 p.m. on 3/02/2023 or any documentation regarding the inability to improve Patient 1's temperature from 34 degrees Centigrade on 3/02/2023. In addition, there were no tests ordered to further evaluate Patient 1 after 8:18 p.m. Likewise, there was no physician documentation as to why Patient 1 was taken back to the OR at 9:30 p.m. and also why the second surgery (exploratory laparotomy) was not started until around 10 p.m.

A review of a nurses note titled "Procedures," dated 3/02/2023, at 9:58 p.m., indicated Patient 1 "arrived at the operating room (L&D OR) at 9:35 p.m., for an emergent exploratory laparotomy (surgery to open the abdomen to identify the cause of bleeding) with possible hysterectomy (removal of the uterus). Surgery started at 10 p.m. Patient 1 out of the OR on 3/03/2023 at 12:25 a.m."

A review of a Physician Progress Note dated 3/02/2023, at 10:13 p.m., documented by OBS 2, indicated it was a late note of events in the past 90 minutes. The Physician Progress Note indicated "Called by the registered nurse (RN 3) around 9 p.m. Notified at that time that PRBC transfusion (referring to the second unit of PRBC ordered) had not yet started, as RN 3 and Anes 1 had been trying to get labs drawn for DIC panel. On repeat evaluation, patient (Patient 1) complained of dizziness, respiratory rate was elevated ... and Bakri (a balloon inserted into the uterine cavity to temporarily control or reduce postpartum hemorrhage [excessive bleeding after childbirth) had about 350 ml of blood. Pulse remained in the lows 150's ... Decision made to proceed to operating room for exploratory laparotomy, possible hysterectomy, given concern for hemorrhage (a severe amount of bleeding from inside or outside of the body) ... Massive Blood Transfusion (MTP-Massive Transfusion Protocol, rapid transfusion of large amounts of blood products) activated."

A review of an "Operative and Procedure Report," dated 3/03/2023, at 12:14 a.m., documented by OBS 2, indicated Patient 1 "was taken to the Operating room at 9:35 p.m., on 3/02/2023., with a preoperative diagnosis of intra-abdominal (space between the organs and the inner lining of the abdominal wall) bleeding after C-section. Surgery started at 10 p.m. A code blue (a medical emergency involving a cardiac or respiratory arrest) was called at 10:23 p.m. A hysterectomy (removal of the uterus) was performed. The quantitative blood loss in the operating room (OR) was 5,418 cc. Patient 1 was pronounced (dead) at 11:15 pm."

A review of Patient 1's "Operative and Procedure Reports," dated 3/03/2023 at 1:46 a.m., documented by OBS 4, indicated Patient 1 "was taken to the operating room for tachycardia (elevated heart rate) and intra-abdominal bleeding. Findings included over 2 Liters of dark un-clotted blood on entry to abdomen ... Total (blood products) infused during case: 14 units of PRBC, 13 units of FFP (fresh frozen plasma), and 2 units of platelets (cell fragments in the blood that form clots and stop or prevent bleeding) ... Patient status: demise (death)."

A review of Patient1's "Autopsy Report," dated 3/15/2023, indicated Patient 1's "Final diagnosis included: Post Caesarean Section uterine atony (clinical); Post Caesarean section hemorrhage and Coagulopathy (lack of ability to clot and stop bleeding) (clinical). Patient 1's Cause of Death is indicated as: Hemorrhagic shock (when severe blood loss leads to inadequate oxygen delivery at the cellular levels leading to death) with coagulopathy."

During an interview, on 4/04/2023, at 9:45 a.m., OBS 2 stated the following: Patient 1 was admitted to the facility for a C-section. Patient 1 was at high risk for postpartum hemorrhage due to a history of multiple C-sections, obesity, and anemia. OBS 2 stated she (OBS 2) took over the care of Patient 1 at about 8 p.m., on 3/02/2023, and per the report that OBS 2 received from OBS 1, there were no complications during the surgery of Patient 1. OBS 2 checked Patient 1's current vital signs and noted Patient 1's heart rate was elevated. OBS 2 went to Patient 1's bedside and ordered a DIC panel and PRBCs. OBS 2 was not aware that RN 3 and Anes 1 were struggling to draw blood or that the PRBCs (referring to the second unit of PRBC) had not been started until about an hour later. According to OBS 2, she (OBS 2) did not check any previous vital signs and was unaware of Patient 1's low blood pressures. OBS 2 was unaware of the medications given by Anes 1 to help stabilize Patient 1's blood pressure in the recovery room, and had she (OBS 2) known, Patient 1 would have returned to the operating room at 8 p.m. instead of 9:25 p.m., in accordance with the facility's policy.

During an interview on 4/04/2023, at 12:32 p.m., OBS 1 stated the following: OBS 1 performed a C-section for Patient 1 on 3/02/2023. The C-section was uneventful. OBS 1 was not informed by the Anesthesiologist (Anes 1) regarding any issues with Patient 1. OBS 1 was informed Patient 1 was having some bleeding. OBS 1 examined Patient 1. Patient 1's fundus was boggy (soft or enlarged indicating the uterus is not contracting), so OBS 1 placed a Bakri balloon. At that time, Patient 1's vital signs were normal (referring to the time when the Bakri balloon was placed). OBS 1 did not check the trend of vital signs and was not aware of previous low blood pressures or of the medications given by Anes 1 to stabilize the blood pressures of Patient 1 in the recovery room. OBS 1 said she (OBS 1) would have taken Patient 1 back to the operating room at 6:58 p.m., had OBS 1 known of the low blood pressures. OBS 1 endorsed Patient 1 to OBS 2 around 8 p.m. OBS 1 was called back to the facility because Patient 1 was returning to the operating room for an exploratory laparotomy. OBS 1 returned to the facility at approximately 10 p.m., to relieve OBS 2 and start the surgery. OBS 1 observed two Liters of un-clotted blood in the abdomen. Patient 1's heart rate stopped. CPR was given. Patient 1's heart rate returned so OBS 1 proceeded to remove the uterus. Patient 1's heart rate stopped again. CPR was given for approximately forty minutes. Patient 1 was unresponsive and pronounced dead at 11:15 p.m.

During an interview on 4/04/2023, at 2:10 p.m., charge nurse 2 (CN 2) stated the following: Patient 1 was admitted to the unit on 3/01/2023. Patient 1 was at high risk for hemorrhage due to a history of multiple C-sections and obesity. On 3/02/2023, Patient 1 had delivered via C-section in the operating room in the Labor & Delivery OR (L&D), then transferred to the L&D recovery room with registered nurse 2 (RN 2) and Anesthesiologist 1 (Anes 1). Patient 1 had no visible signs of bleeding. Patient 1 had a low blood pressure and Patient 1 was shivering (shaking slightly, because of being cold) upon arrival at the recovery room, then CN 2 notified obstetric surgeon 1 (OBS 1). RN 2 started the transfusion of packed red blood cells (PRBC) for Patient 1.

During a concurrent interview and record review on 4/04/2023, at 2:10 p.m., with charge nurse 2 (CN 2), the facility's policy titled "Management of obstetrical hemorrhage," dated 11/2021, was reviewed. CN 2 said that at 6:16 p.m., on 3/02/2023, OBS 1 examined Patient 1. At 6:58 p.m., OBS 1 inserted a Bakri balloon due to trickling (a small or gentle stream) of blood. The quantitative blood loss (QBL, measurement of blood loss after delivery) was less than 1000 ml (426ml, 137 ml, and 38 ml). CN 2 stated that per policy, if a patient's QBL is less than 1000 ml, but is displaying abnormal vital signs, such as a low blood pressure or high heart rate or shortness of breath, confusion, or agitation, then the policy should be followed, a significant hemorrhage should be considered, and interventions should be consistent with Stage 3. Stage 3 interventions included preparing the patient to go to the operating room and notifying the providers, Anesthesiologist, blood bank, and obtaining additional resources. CN 2 confirmed that the stage 3 interventions to address suspected significant hemorrhage was not followed in the case of Patient 1.

During an interview on 4/04/2023, at 3:46 p.m., registered nurse 2 (RN 2) stated the following: RN 2 cared for Patient 1 before, during, and after Patient 1's C-section. During the C-section Patient 1's oxygen saturation level and blood pressure dropped, and Patient 1 vomited multiple times. Patient 1 was stabilized by the Anesthesiologist (Anes 1). Patient 1 had a QBL of 426 ml in the operating room. A dime-size amount of blood was noted on the abdominal dressing at the end of the procedure. RN 2 and Anes 1 accompanied Patient 1 to the recovery room. Initially, RN 2 was unable to obtain a blood pressure reading on the right or left arm. RN 2 had to take the blood pressure on Patient 1's calf. Anes 1 was notified of low blood pressures. About 5 to 10 minutes later, OBS 1 arrived at the bedside and examined Patient 1. RN 2 was calling out the blood pressure readings out loud while both Anes 1 and OBS 1 were at the bedside. Patient 1's intravenous fluid (fluids given via the vein) was wide open, and the blood pressures continued to be low. Anes 1 gave Patient 1 medications to stabilize the blood pressure.

During a concurrent interview and record review on 4/04/2023, at 3:36 p.m., with registered nurse 2 (RN 2), the facility's policy titled "Management of Obstetrical Hemorrhage," dated 11/2021, was reviewed. RN 2 stated Patient 1's vital signs were abnormal (referring to the high heart rate and low blood pressures). However, Patient 1 was awake and alert. RN 2 gave report to oncoming registered nurse 3 (RN 3), informing her (RN 3) that at 6:28 p.m., Patient 1's temperature was 34 degrees Celsius (C, 37 C is normal, 34 C is equal to 93.2 degrees Fahrenheit, normal body temperature range was 97 to 99 degrees Fahrenheit). Patient 1 was covered with a warming blanket. RN 2 said that she (RN 2) informed RN 3 that blood transfusion started at 6:58 p.m. RN 2 informed RN 3 of the struggles with obtaining blood pressure, and Anes 1 gave medications to stabilize the blood pressure. RN 2 further stated if a patient's QBL is less than 1000 ml, but is displaying abnormal vital signs, such as a low blood pressure or high heart rate or shortness of breath, confusion, or agitation, then the policy should be followed, a significant hemorrhage should be considered, and interventions should be consistent with Stage 3. Stage 3 interventions included preparing the patient to go to the operating room and notifying the providers. RN 2 said that the policy was not followed in the case of Patient 1.

During an interview, on 4/04/2023, at 4:27 p.m., the registered nurse 3 (RN 3) stated she (RN 3) assumed care for Patient 1 at 7:25 p.m. on 3/02/2023, in the recovery room. RN 3 stated the first bag of PRBC was running and almost done. RN 3 stated the heart rate was 121, but it was not concerning, then the heart rate increased to the 150's. RN 3 stated OBS 2 ordered a DIC panel, then a 2nd bag of blood to be transfused. RN 3 stated she (RN 3), charge nurse (CN) 4, and Anes 1 were unable to draw the blood for the DIC panel. RN 3 stated Patient 1's skin felt cold, and RN 3 was no longer able to obtain a temperature, a blood pressure or heart rate. RN 3 notified OBS 2 that she (RN 3) was unable to draw blood, had not started the second unit of blood yet, and Patient 1 had become restless. RN 3 stated OBS 2 came to the bedside and explained to Patient 1 that she (Patient 1) was going back to the OR because bleeding was suspected. The second bag of blood was given at 9:25 p.m., Patient 1 was taken to the OR at 9:30 p.m. RN 3 stated the surgery started at 10 p.m. RN 3 stated the Anesthesiologist 2 (Anes 2) helped give massive amounts of blood transfusions in the OR during the second surgery. RN 3 stated Patient 1 coded two or three times and then expired (died).

During an interview on 4/04/2023, at 5:06 p.m., Anesthesiologist 1 (Anes 1) stated the following: Anes 1 administered spinal Anesthesia for Patient 1 on 3/02/2023. Spinal Anesthesia usually causes a person's blood pressure to drop for thirty minutes to one hour. Spinal Anesthesia started at 4:10 p.m. During the procedure, Patient 1's blood pressure dropped, Patient 1 vomited multiple times, and complained of shortness of breath. Anes 1 gave multiple medications during the procedure. Anes 1 gave Ephedrine (a medication used to prevent low blood pressure during Anesthesia) 20 mg at 4:35 p.m., 10 mg at 4:50 p.m., and 10 mg at 5:35 p.m. Anes 1 gave Albumin 12.5 mg at 5:20 p.m. Anes 1 also administered Neo-synephrine (helps maintain adequate blood pressure levels during Anesthesia). Anes 1 informed OBS 1 that Patient 1 was stable (during the C-section surgery).

During an interview on 4/04/2023, at 5:06 p.m., with Anesthesiologist 1 (Anes 1), Anes 1 said that she (Anes 1) and RN 2 transferred Patient 1 to the recovery room at 5:46 p.m. after completion of C-section for Patient 1. Anes 1 remained at the bedside because, initially, RN 2 was unable to obtain a blood pressure for Patient 1 upon arrival in the recovery room. Anes 1 administered more Ephedrine (three times) and Neo-synephrine. Anes 1 remained with Patient 1 and then left for another procedure at 6:25 p.m., when OBS 1 came to evaluate Patient 1. Anes 1 did not inform OBS 1 of the medications she (Anes 1) had given in the recovery room to help stabilize the blood pressure of Patient 1. According to Anes 1, she (Anes 1) "relied on RN 2 to inform OBS 1 of the medications previously administered to Patient 1 when OBS 1 arrived to assess Patient 1. Anes 1 also said that Patient 1 returned to the operating room at 9:35 p.m. Patient 1 lost 2000 ml of blood. Patient 1's QBL was 5,418 ml. Patient 1 expired."

A review of the physician progress notes conducted on 4/07/2023, at 10:20 a.m. indicated there was no documentation of hand off or communication of treatment plans between OBS 1 and OBS 2 and with Anes 1.

A review of the facility's Policy and Procedure (P&P) titled "Medical Staff General Rules & Regulations," dated 12/16/2021, indicated "under Article VII. Patient Care-Surgical, The Surgeon shall be responsible for and personally supervise the post operative care..."

A review of the facility's Policy and Procedure (P&P) titled "Cesarean Section- Standard care," dated 8/2021, indicated under "Standard of Care: post Operative Cae: Reportable conditions: notify physician immediately ... included change in baseline vital signs."

A review of the facility's Policy and Procedure (P&P) titled "Surgery department Rules and Regulations," dated 4/30/2020, indicated under "Anesthesia Services: Promoting policies and practices that maximize the safety of the patient during Anesthetic period and advising those personnel responsible for post-Anesthesia care."

A review of the facility's policy and procedure (P&P) titled "Management of Obstetrical Hemorrhage," dated 11/2021, indicated Maternal Hemorrhage Stages are defined as:

Stage 0: Normal blood loss (less than 1000 ml for both vaginal and cesarean delivery)

Stage 1: Abnormal blood loss (more than 1000 ml for both vaginal and cesarean delivery)

Stage 2: Abnormal blood loss and patient does not respond to Stage 1 therapies/uterotonics (a type of medication used to induce contraction [when the muscles of the uterus tighten up and then relax]), OR less than 1000 ml blood loss but patient requires Stage 2 interventions (See Attachment E). Continue vital signs every 5 minutes. Observe for subtle vital sign changes. Report sustained heart rate over 110. Report blood pressure less than 85/45 and move to Stage 3. Hypotension is a late sign of blood loss in the pregnant patient due to the increased intravascular volume seen in pregnancy. Signs of hypovolemia (urinary output less than 30 ml per hour for two hours). Monitor mental status. Increased anxiety, agitation, combativeness and finally, unresponsiveness likely indicate worsening blood loss and possible cerebral hypoxia (lack of oxygen in the brain).

Stage 3: Continued bleeding with actual or anticipated blood loss over 1500 ml or the presence of abnormal hematologic labs consistent with Disseminated Intravascular Coagulation (DIC) or abnormal vital signs (See Attachment E) consistent with blood loss greater than estimated or measured amount.

Attachment E: Acute Hemorrhage Algorithm / Obstetrical Acute Hemorrhage Algorithm, indicated the following. If QBL loss remains less than 1000 ml but Patient has abnormal clinical findings:

Heart rate above 110.
Blood pressure less than or equal to 85/45 or a decrease of over 15 percent (%)
Oxygen saturation of less than or equal to 93 %.
Clinical symptoms: shortness of breath, confusion, agitation.
Consider significant hemorrhage / Stage 3 (QBL over 1500 ml, coagulopathy (body's ability to form clots is impaired), and or abnormal clinical findings. Interventions include the following: Notify circulating nurse, charge nurse, OB physician, Anesthesia, and prepare patient for the operating room.

Based on interview and record review, the facility failed complete a post operative evaluation and documentation for one of 30 sampled patients (Patient 1) displaying signs of abnormal vital signs.

This deficient practice resulted in delayed patient treatment for Patient 1.

Findings:

A review of Patient 1's History & Physical (H&P) dated 3/01/2023, at 2:49 p.m. with an addendum at 4:21 p.m., indicated Patient 1 presented to the Labor and Delivery (L&D) unit after missing a scheduled Cesarean section on 3/01/2023. Patient 1 had a history of chronic hypertension (high blood pressure) and morbid obesity (weight that is more than 80 to 100 pounds above the ideal body weight) and history of multiple (x4) C-sections. Hemoglobin (Hgb, a protein molecule in the red blood cells that carry oxygen and delivers it to body tissues) was 9.0 gm/dl (low, normal levels are between 12 to 16 g/dl [grams/deciliter]).

A review of Patient 1's "Anesthesia Record," dated 3/2/2023, indicated Anesthesiologist 1 (Anes 1) and registered nurse 2 (RN 2) transferred Patient 1 to the recovery room at 5:46 p.m.

A review of Patient 1's "Hemodynamics / Vitals," dated 3/2/2023, indicated Patient 1's vital signs were as follows:

At 5:47 p.m., Anes 1 at bedside, aware of late blood pressure late entry 3/03/2023 at 1:31 p.m., for 3/02/2023 at 5:47 p.m., Anes 1 aware of unable to obtain a blood pressure or temperature

At 5:48 p.m., HR was 118 and BP was 39/26 (low), Anesthesiologist 1 (Anes 1) at the bedside.
At 5:53 p.m., HR was 112 and BP 65/43 (low).
At 5:58 p.m., HR was 71 and BP was 61/48 (low).
At 6:04 p.m., HR was 84 and BP was 47/31 (low).
At 6:08 p.m., HR was 104 and BP 0/0 (low). Anes 1 at bedside, unable to obtain blood pressure, Patient 1 awake, alert ...
At 6:11 p.m., HR was 77 and BP was 0 /0 (low).
At 6:22 p.m., Bair (Bair Hugger, warming blanket) applied on high, unable to take temperature.
At 6:25 p.m., HR 101, and BP was 118/59.
At 6:28 p.m., HR 107 and BP was 109/57. Temperature was 34.3 degrees Celsius (low)
At 6:22 p.m., Bair (Bair Hugger, warming blanket) applied on high, unable to take temperature.
At, 8:15 p.m., Anesthesiologist (Anes 1) at bedside attempting to draw blood for DIC panel.
At, 8:30 p.m., Anes 1 unable to draw blood for DIC panel.
At, 8:40 p.m., Anes 1 still at bedside and aware it is not taking BPs (blood pressures). Patient 1 moving a lot.
At 8:45 p.m., temperature was 94.7 degrees Fahrenheit ([F]), normal body temperature is between 97 to 99 F), temperature taken rectally.
At 8:51 p.m., Anes 1 at bedside giving Albumin (used to treat low blood volume) 12.5 milligrams (mg, a unit of measurement).

During an interview on 4/04/2023, at 3:46 p.m., registered nurse 2 (RN 2) stated she (RN 2) was unable to obtain a blood pressure for Patient 1.

During an interview on 4/04/2023, at 5:35 p.m. with Anesthesiologist 1 (Anes 1), Anes 1 stated additional Ephedrine and Neo-synephrine were administered to stabilize Patient 1's BP on 3/02/2023 upon arrival to the recovery room. Anes 1 said the Ephedrine and Neo-synephrine that were administered to Patient 1 to stabilize Patient 1's BP were not documented. In addition, there was no Postoperative evaluation and Post Anesthesia assessment note completed when Patient 1 was transferred to the recovery room on 3/02/2023, at 5:46 p.m.

During an interview on 4/07/2023, at 10:30 a.m., with the Director of Quality (DOQ), DOQ confirmed a Postoperative Anesthesia evaluation and assessment was not completed and documented for Patient 1 after Patient 1 was transferred from the Operating Room (L&D OR) to the recovery room on 3/02/23, at 5:46 p.m. after completion of C-section surgery.

During an interview on 4/04/2023, at 6:10 p.m., with Anesthesiologist 1 (Anes 1), Anes 1 stated registered nurse 2 (RN 2) called OBS 1 to go to the recovery room as requested by Anes 1. Anes 1 also stated OBS 1 "can see on tracking shell Patient 1's vital signs by computer." Anes 1 also said that OBS 1 evaluates and determines if Patient 1 needed to go to OR. There was no documentation of communication of concerns or Plans for Patient 1 or hand off between Anes 1 and OBS 1 and OBS 2 while Patient 1 was in the recovery room on 3/02/2023.

A review of the facility's Policy and Procedure (P&P) titled "Surgery department Rules and Regulations," dated 4/30/2020, indicated under Anesthesia Services: "Promoting policies and practices that maximize the safety of the patient during Anesthetic period and advising those personnel responsible for post-Anesthesia care..." and "Provide appropriate pre-Anesthesia and post-Anesthesia management of the patient..." The P&P also indicated "Post Anesthesia Care Unit Report shall be recorded upon arrival at the PACU (Post Anesthesia Care Unit-otherwise known as recovery room where patients go immediately after surgery), Verbal report will include: procedures performed; Fluids, blood products, administered; PACU admission vital signs, including blood pressure, temperature, pulse, respiratory rate and oxygen saturation." The P&P further indicated "Post Anesthesia evaluation must include: Respiratory function; Cardiovascular function; mental status; Temperature; Pain; Nausea /Vomiting and Postoperative hydration..."