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Based on review of medical records, Governing Body Bylaws, meeting minutes, Medical Staff Bylaws, quality reports, policy and procedures, and staff interviews, it was determined that the Governing Body failed to ensure that patient's rights were protected and failed to ensure that an effective QAPI program was implemented when one (P#1) of five (P#1, P#2, P#3, P#4, P#5) patients reviewed experienced a serious adverse event, death on 8/19/22 at 4:45 p.m. The facility failed to complete a root cause analysis (RCA) of the serious adverse event. In addition, facility staff failed to complete an incient report when P#1 suffered a syncopal event and hit her head.

Findings included:

Cross refer to A-0263 as it relates to the facility's failure to ensure that an effective, ongoing, quality assessment and performance improvement (QAPI) program was implemented when one (P#1) of five (P#1, P#2, P#3, P#4, P#5) patients reviewed experienced a serious adverse event, death, on 8/19/22 at 4:45 p.m. The facility failed to produce a completed root-cause-analysis (RCA) of the incident.

Cross refer to A-0309 as it relates to the failure of the Governing Body, Medical Staff, and Administration to ensure that an effective, ongoing program for quality assessment and performance improvement (QAPI) was implemented.

Cross-refer to A-1100 as it relates to the facility's failure to ensure that departments render timely emergency services.

A review of the facility's "Amended and restated Bylaws, adopted 1/13/20, revealed in Article IV, Board of Directors, Section 1.
The affairs of the Corporation are governed by the Board of Directors.
Section 2. Obligations and Responsibilities:
a. providing general strategic, managerial, operational, financial, and clinical oversight of the Corporation; and (b) credentialing members of the Corporation's medical staff.

Continued review revealed, Article VII, 4, Duties, Responsibilities, roles, and expectations of officers may be specified in governance protocols.

Continued review revealed, Article IX, Medical Staff are organized according to the bylaws recommended by the facility's medical staff. They shall have the appropriate delegated authority and responsibility for the care of patients, subject to the ultimate authority of the Corporation Board and to such limitations as contained in the bylaws, rules, regulations, and policies of the Corporation, PHC, and in the bylaws, rules, and regulations of the medical staff.

A review of the facility's "Medical Staff Bylaws", last approved 5/1/2023, revealed, Article Five, Medical Staff Committees and Performance Improvement Functions, 5.D.2, Duties:
The Medical Executive Committee (MEC) is delegated with the primary authority over activities related to the functions of the Medical Staff and performance improvement activities regarding the professional services provided by individuals with clinical privileges. The MEC is responsible for the following:
a. Recommending directly to the Board on at least the following:
5. Participation of the Medical Staff in Hospital performance improvement activities and the quality of professional services being provided by the Medical Staff.
d. Reviewing (or delegating the review of) quality indicators to ensure uniformity regarding patient care services.
e. Providing leadership in activities related to patient safety.
Continued review revealed, 5.E., Performance Improvement Functions:
1. The Medical Staff is actively involved in performance improvement functions, including reviewing data and recommending and implementing and implementing processes to address the following:
a. Patient safety, including processes to respond to patient safety alerts, meet patient safety goals, and reduce patient safety risks.
b. The Hospital's and individual practitioners' performance on Centers for Medicare and Medicaid Services (CMS) core measures
c. Medial assessment and treatment of patients
k. Sentinel events, including root cause analyses and responses to unanticipated adverse events
p. Coordination of care, treatment, and services with other practitioners and Hospital personnel

A review of the facility's policy titled, "Reporting Serious Safety Events to External Agencies," last approved 1/7/22, policy #10904519, revealed the purpose was to establish guidance to the staff regarding recognition and reporting of serious safety events to appropriate internal departments and external agencies.
3. Definitions
Adverse Event - An incident in which harm result to a person receiving health care.
Sentinel Event - An unexpected occurrence involving death or serious physical or psychological injury or the risk thereof. The phrase "or the risk thereof" includes any process variation for which a recurrence would carry a significant chance of a serious adverse outcome.
4. Policy- The facility will report those adverse events required by the Georgia Department of Community Health (DCH).
5. Responsibilities-
5.1 Facility Healthcare Employees shall recognize and report serious safety events to the appropriate internal departments according to the internal reporting procedure.
6. Procedures
6.1 Internal Reporting
1. Upon the identification of a potential adverse event or sentinel event, which may be reportable to an external agency, the entity Director of Risk Management, the Nursing supervisor, and the Administrator on Call will be notified immediately
2. The individual reporting the event will complete a report in the Safety Event Reporting System and provide any and all documentation related to the event.
5. The root cause analysis (RCA) is used as a process for identifying the basic or causal factor(s) that underlies variation in performance, including the occurrence or possible occurrence of an adverse event.
6. The RCA team is required to complete the RCA within 45 days of event identification.

During an interview on 10/2/24 at 10:01 a.m. in the conference room, the Director of Quality (DQ) XX said that a root-cause-analysis (RCA) was not conducted on the incident pertaining to P#1. DQ XX said that staff reviewed the incident after staff filed an incident report on the death of P#1 and conducted an interview with all parties involved. DQ XX said that the result of that investigation was that the facility performed care to best of their capabilities.

Based on a review of policy and procedures,Quality Manual, and medical records it was determined that the facility failed to ensure that patient's rights were promoted and protected when 10 (P#6, P#7, P#8, P#10, P#11, P#12, P#13, P#14, P#15, P#16) of 15 (P#1, P#2, P#3, P#4, P#5, P#6, P#7, P#8, P#9, P#10, P#11, P#12, P#13, P#14, P#15) patients records reviewed failed to include a signed Patient Rights and Consent Form.

Findings included:

A review of the facility's policy titled, "Rights and Responsibilities of Patients Policy", policy #16455823, last revised 8/22/24, revealed that the purpose of the policy was to acknowledge patients' rights and responsibilities and the facility's responsibility to respond to each patient with personal dignity and respect.

Continued review revealed that it is the policy of the facility that all patients have the right to considerate, respectful care at all times and under all circumstances, with recognition of their personal dignity and autonomy. The facility will develop, implement and adhere to policies intended to assure practices that will respect the rights of all patients regardless of race, creed, sex, sexual orientation, gender identity, or expression, national origin, religion, age, disability, diagnosis, or sources of payment for care.
Continued review revealed, Four, Policy:
A. Access to Treatment - The facility respects and supports the patient's right to impartial access to treatment and services that are consistent with relevant laws and regulations and medically indicated, regardless of race, creed, sex, sexual orientation, gender identity or expression, national origin, religion, age, disability, diagnosis, or sources of payment for care.
O. Safety/Security - The patient has a right to the provision of care in a safety setting. The Patient Safety Committee, Environment of Care Committee, Infection Control Committee, the Security Department and Risk Management Programs seek to eliminate risks to the patient.

A review of the facility's Quality Manual, last revised on 1/11/2024, revealed that the facility was committed to ongoing improvement in patient satisfaction, clinical outcomes, administrative processes, and community involvement.
Continued reviewed, Eight, Quality Objectives, the facility has established quality metrics for hospitals and priorities are selected which support the system's efforts in continually improving outcomes. Corrective/preventative actions are developed for continual improvement with results monitored, measured, analyzed, and reported to management for review at the Quality/Safety/Service (QSS) meetings.

A continued review revealed that the Director of Quality & Safety Integration (DQSI) is the management representative responsible for ensuring that the quality management system is effectively implemented and maintained and that the quality oversight processes ensure that corrective and preventative actions are carried out and measured for effectiveness. The DQSI reports to the senior leadership on the status of the QMS.
At a minimum, the following processes are presented for management review at the QSS meeting included:
Medical record delinquency

A review of the electronic records revealed the following:
A review of P#6 medical record revealed that P#6 arrived at the facility's ED on 8/5/22 with a chief complaint of vaginal bleeding, pelvic pain, and low back pain. Further review revealed that at 11:31 a.m., P#6's ED disposition was set to surgery. At 1:33 p.m., P#6 was admitted to peri-op. The record failed to reveal a signed consent to treat for P#6.

A review of P#7's medical record revealed arrived in the facility's ED on 10/1/22 at 9:11 a.m. with a chief complaint of abdominal pain and was discharged home on 10/1/22 at 11:55 a.m. The record failed to reveal a signed consent to treat for P#7.

A review of P#8 medical record revealed P#8 arrived at the facility's ED on 10/12/23 at 1:55 a.m. with a chief complaint of vaginal bleeding while 16 weeks pregnant. P#8 was discharged home on 10/12/23 at 6:17 a.m. The record failed to reveal a signed consent to treat for P#8.

A review of P#10's medical record revealed that she arrived at the facility's ED on 11/12/22 at 11:10 p.m. with a chief complaint of vaginal bleeding at 18 weeks gestation. P#10 was discharged home on 11/13/22 at 10:32 a.m. The record failed to reveal a signed consent to treat for P#10.

A review of P#11's medical record revealed that P#11 arrived at the facility's OB-ED on 8/28/23 at 10:11 a.m. with a chief complaint of strong pelvic pain. P#11 was discharged home on 8/28/23 at 1:03 p.m. The record failed to reveal a signed consent to treat for P#11.

A review of P#12's medical record revealed that P#16 arrived at the facility's ED on 2/29/24 at 1:13 p.m. with a chief complaint of abdominal pain and pregnancy. P#12 was discharged home on 2/29/24 at 7:01 p.m. The record failed to reveal a signed consent to treat for P#12.

A review of P#13's medical record revealed that P#13 arrived in the facility's ED on 9/3/24 at 8:40 p.m. with a chief complaint of vaginal bleeding while 14 weeks pregnant. Further review revealed that on 9/4/24 at 12:59 a.m., P#13's status was changed to "admit to inpatient" with diagnosis of sepsis. The record failed to reveal a signed consent to treat for P#13..

A review of P#14's medical record revealed that she arrived at the facility's ED on 12/16/22 at 7:39 p.m. with a chief complaint of abdominal pain while 23 weeks pregnant. On 12/17/22 at 1:14 a.m., P#14 was admitted to the medical-surgical floor with a diagnosis of sepsis. The record failed to reveal a signed consent to treat for P#14.

A review of P#15's medical record revealed that P#15 arrived in the facility's ED on 7/10/23 at 11:40 p.m. with a chief complaint of shortness of breath (SOB), chest pain (CP), and back pain. On 7/11/23 at 8:49 a.m., P#15 was admitted to the cardiac-telemetry unit. The record failed to reveal a signed consent to treat for P#15.

A review of P#16's medical record revealed that she arrived at the facility's OB-ED on 7/2/24 at 1:25 a.m. with a chief complaint of premature labor at 18 weeks. Further review revealed that P#16 had a fetal demise while in the OB-ED and was then taken to surgery for a D&C after the placenta was retained in the uterus. The record failed to reveal a signed consent to treat for P#16.

Based on review of the facility's quality assessment performance improvement (QAPI) plan, Governing Body Bylaws, incident report, QAPI meeting minutes, Medical Staff Bylaws, policy and procedures, and staff interviews, it was determined that the facility failed to maintain an effective QAPI program when one (P#1) of five (P#2, P#3, P#4, P#5) patents reviewed experienced a serious adverse event, death on 8/19/22 at 4:45 p.m.

Findings included:

Cross refer to A-0286 as it relates to the facility's failure to track, analyze, and implement corrective actions in response to adverse events.

Cross refer to A-0309 as it relates to the failure of the governing body, medical staff, and administrative staff to be accountable to ensure that an ongoing quality improvement and patient safety program was implemented and maintained.

Based on review of the facility's quality assessment performance improvement (QAPI) plan, QAPI Committee meeting minutes, policy and procedures, incident report, QAPI meeting minutes, Medical Staff Bylaws, medical records and staff interviews, it was determined that the facility failed to ensure that the quality assessment performance improvement (QAPI) program tracked, analyzed the cause and implemented corrective actions in response to adverse patient events when one (P#1) of five (P#1, P#2, P#3, P#4, P#5) patients reviewed:
1. Experienced a syncopal event that resulted in a fall and the facility failed to initiate an incident report
2. Had a serious adverse event, death on 8/19/22 at 4:45 p.m. and the facility failed to complete a root cause event (RCA).

Findings included:

A review of the facility's Quality Manual, last revised on 1/11/2024, revealed that the facility was committed to ongoing improvement in patient satisfaction, clinical outcomes, administrative processes, and community involvement.

Continued reviewed, Eight, Quality Objectives, the facility has established quality metrics for hospitals and priorities are selected which support the system's efforts in continually improving outcomes. Corrective/preventative actions are developed for continual improvement with results monitored, measured, analyzed, and reported to management for review at the Quality/Safety/Service (QSS) meetings.

At a minimum, the following processes are presented for management review at the QSS meeting included:
" Infection prevention and control program metrics
" Threats to patient safety
" Patient flow issues, including reporting of patients held in the Emergency Department for extended periods of time
" Unanticipated deaths
" Adverse events/Near misses
" Data submitted to or received from Medicare quality reporting and quality performance programs included maternal morbidity and sepsis

A review of the facility's policy titled, "Reporting Serious Safety Events to External Agencies," last approved 1/7/22, policy #10904519, revealed the purpose was to establish guidance to the staff regarding recognition and reporting of serious safety events to appropriate internal departments and external agencies.
3. Definitions
Adverse Event - An incident in which harm result to a person receiving health care.
Sentinel Event - An unexpected occurrence involving death or serious physical or psychological injury or the risk thereof. The phrase "or the risk thereof" includes any process variation for which a recurrence would carry a significant chance of a serious adverse outcome.
4. Policy- The facility will report those adverse events required by the Georgia Department of Community Health (DCH).
5. Responsibilities-
5.1 Facility Healthcare Employees shall recognize and report serious safety events to the appropriate internal departments according to the internal reporting procedure.
6. Procedures
6.1 Internal Reporting
1. Upon the identification of a potential adverse event or sentinel event, which may be reportable to an external agency, the entity Director of Risk Management, the Nursing supervisor, and the Administrator on Call will be notified immediately
2. The individual reporting the event will complete a report in the Safety Event Reporting System and provide any and all documentation related to the event.
5. The root cause analysis (RCA) is used as a process for identifying the basic or causal factor(s) that underlies variation in performance, including the occurrence or possible occurrence of an adverse event.
6. The RCA team is required to complete the RCA within 45 days of event identification.

A review of the facility's QSS committee meeting minutes from 09/2022 through 07/2024 failed to include discussion of an RCA related to P#1.

A review of the facility's Incident Log dated 6/1/22 through 9/24/22 revealed one entry related to P#1, file #429896, event date of 8/19/22, listed as a cardiac/circulatory/respiratory event with a severity level of death. Continued review of the facility's Incident Log failed to reveal an entry related to P#1's syncopal (temporary loss of consciousness) episode on 8/19/22, where she sustained a hematoma (bruise) to the forehead.

Continued review of the facility's Incident Report file #429896 revealed that Anesthesia and Quality were tasked for the review of the incident and a debrief was conducted with all parties involved.

A review of the 'History and Physical' dated 8/18/22 at 11:41 p.m. included that P#1 was sitting on the bedside commode in the ED room and was feeling dizzy and eventually passed out, hitting her forehead.

A request was made on 10/1/24 at 8:42 a.m. to conduct an interview with OB-GYN MD AA and OB-GYN MD DD. The Director of Quality later informed the survey team that OB-GYN MD AA and OB-GYN MD DD have refused and retained legal counsel.

A request was made on 10/1/24 at 8:42 a.m. to conduct an interview with ED MD BB, however the Director of Quality later informed the survey team that ED MD BB was out of the country.

A request was made on 10/1/24 at 8:42 a.m. to conduct an interview with IMS MD GG, however the Director of Quality later informed that survey team that IMS MD GG was no longer on staff with the facility.

During a telephone interview on 10/1/24 at 3:22 p.m., Critical Care Medicine (CCM) Physician Assistant (PA) HH said that she has been a CCM PA for 10 years. CCM PA HH recalled P#1, and that CCM PA HH was called in the early morning to evaluate P#1 due to hypotensive (low blood pressure). CCM PA HH recalled that P#1 was on a medical-surgical unit and that P#1 was hypotensive despite receiving multiple liters of intravenous (IV) fluids overnight. CCM PA HH recalled that nursing staff also reported that P#1 passed out at some point during her time at the facility.

During an interview on 10/2/24 at 10:01 a.m. in the conference room, the Director of Quality (DQ) XX said that a root-cause-analysis (RCA) was not conducted on the incident pertaining to P#1. DQ XX said that staff reviewed the incident after staff filed an incident report on the death of P#1 and conducted an interview with all parties involved. DQ XX said that the result of that investigation was that the facility performed care to best of their capabilities.

Based on review of Medical Staff Bylaws, QAPI Plan, policy and procedures and staff interviews, it was determined that the Governing Body, Medical Staff, and Administration failed to ensure that an ongoing program for quality improvement and patient safety was implemented when it was determined that a root-cause-analysis report was not available in response to an adverse event that occurred on 8/19/22.

Findings included:

A review of the facility's "Medical Staff Bylaws", last approved 5/1/2023, revealed, Article Five, Medical Staff Committees and Performance Improvement Functions, 5.D.2, Duties:
The Medical Executive Committee (MEC) is delegated with the primary authority over activities related to the functions of the Medical Staff and performance improvement activities regarding the professional services provided by individuals with clinical privileges. The MEC is responsible for the following:
Recommending directly to the Board on at least the following:
Participation of the Medical Staff in Hospital performance improvement activities and the quality of professional services being provided by the Medical Staff.
Reviewing (or delegating the review of) quality indicators to ensure uniformity regarding patient care services.
Providing leadership in activities related to patient safety.
Continued review revealed, 5.E., Performance Improvement Functions:
2.1. The Medical Staff is actively involved in performance improvement functions, including reviewing data and recommending and implementing and implementing processes to address the following:
a. Patient safety, including processes to respond to patient safety alerts, meet patient safety goals, and reduce patient safety risks.
b. The Hospital's and individual practitioners' performance on Centers for Medicare and Medicaid Services (CMS) core measures
c. Medial assessment and treatment of patients
Sentinel events, including root cause analyses and responses to unanticipated adverse events. Coordination of care, treatment, and services with other practitioners and Hospital personnel

A review of the facility's "Amended and restated Bylaws, adopted 1/13/20, revealed in Article IV, Board of Directors, Section 1. The affairs of the Corporation are governed by the Board of Directors.
Section 2. Obligations and Responsibilities:
a. providing general strategic, managerial, operational, financial, and clinical oversight of the Corporation; and (b) credentialing members of the Corporation's medical staff.
Continued review revealed, Article VII, 4, Duties, Responsibilities, roles, and expectations of officers may be specified in governance protocols. Continued review revealed, Article IX, Medical Staff are organized according to the bylaws recommended by the facility's medical staff. They shall have the appropriate delegated authority and responsibility for the care of patients, subject to the ultimate authority of the Corporation Board and to such limitations as contained in the bylaws, rules, regulations, and policies of the Corporation, PHC, and in the bylaws, rules, and regulations of the medical staff.

A review of the facility's policy titled, "Reporting Serious Safety Events to External Agencies," last approved 1/7/22, policy #10904519, revealed the purpose was to establish guidance to the staff regarding recognition and reporting of serious safety events to appropriate internal departments and external agencies.

3. Definitions
Adverse Event - An incident in which harm result to a person receiving health care.
Sentinel Event - An unexpected occurrence involving death or serious physical or psychological injury or the risk thereof. The phrase "or the risk thereof" includes any process variation for which a recurrence would carry a significant chance of a serious adverse outcome.
4. Policy- The facility will report those adverse events required by the Georgia Department of Community Health (DCH).
5. Responsibilities-
5.1 Facility Healthcare Employees shall recognize and report serious safety events to the appropriate internal departments according to the internal reporting procedure.
6. Procedures
6.1 Internal Reporting
1. Upon the identification of a potential adverse event or sentinel event, which may be reportable to an external agency, the entity Director of Risk Management, the Nursing supervisor, and the Administrator on Call will be notified immediately
2. The individual reporting the event will complete a report in the Safety Event Reporting System and provide any and all documentation related to the event.
5. The root cause analysis (RCA) is used as a process for identifying the basic or causal factor(s) that underlies variation in performance, including the occurrence or possible occurrence of an adverse event.
6. The RCA team is required to complete the RCA within 45 days of event identification.

A review of the facility's Quality Manual, last revised on 1/11/2024, revealed that the facility was committed to ongoing improvement in patient satisfaction, clinical outcomes, administrative processes, and community involvement.
A continued review revealed that the Director of Quality & Safety Integration (DQSI) is the management representative responsible for ensuring that the quality management system is effectively implemented and maintained and that the quality oversight processes ensure that corrective and preventative actions are carried out and measured for effectiveness. The DQSI reports to the senior leadership on the status of the QMS.
At a minimum, the following processes are presented for management review at the QSS meeting included:
" Infection prevention and control program metrics
" Threats to patient safety
" Patient flow issues, including reporting of patients held in the Emergency Department for extended periods of time
" Unanticipated deaths
" Adverse events/Near misses
" Data submitted to or received from Medicare quality reporting and quality performance programs included maternal morbidity and sepsis

During an interview on 10/2/24 at 10:01 a.m. in the conference room, the Director of Quality (DQ) XX said that a root-cause-analysis (RCA) was not conducted on the incident pertaining to P#1. DQ XX said that staff reviewed the incident after staff filed an incident report on the death of P#1 and conducted an interview with all parties involved. DQ XX said that the result of that investigation was that the facility performed care to best of their capabilities.

Based on review of policy and procedures, medical records, and staff interviews, it was determined that facility policy and procedures were not followed when facility staff failed to notifiy the provider of critical lab results and for one (P#1) of five (P#1, P#2, P#3, P#4, P#5) patients reviewed. These failures contributed to a delay in the treatment of P#1.

Findings included:

A review of the facility's policy titled, "Reporting of Critical Laboratory Values", policy #15163755, last revised 2/2/24, revealed that the purpose of the policy was to provide a standard process to ensure that effective and accurate verbal communication occurs between health care staff regarding all tests that require rapid or immediate communication of the result to the appropriate personnel.
Continued review revealed, 5.4., Provider Responsibility:
3. Receiving Critical Results
1. It is the provider's duty to receive and act upon all critical results provided by laboratory staff and/or nursing staff. It is an expectation that the provider will act within the period of time that meets the clinical needs of the patient to provide safe and high value care.

Continued review revealed, 5.5., Nursing Responsibility:
When a nurse receives a critical result, the ordering provider should be notified of the critical result within 30 minutes. If the ordering provider is not available, notify the attending provider. Document in the electronic health record (EHR) that the result was called to the provider.

A review of P#1's medical record revealed that she presented to the facility's Emergency Department (ED) on 8/18/22 at 6:40 p.m. with a chief complaint of vaginal bleeding.

Continued review of P#1's medical record revealed that a white blood cell (WBC) count of 56.50 (normal was 3.40-10.8 10*3/uL) resulted from a specimen collected on 8/18/22 at 7:31 p.m. The record failed to reveal that a provider was notified of the abnormal value.

Continued review of P#1's medical record revealed that on 8/19/22 at 3:22 a.m., P#1 had a white blood cell (WBC) count of 80.10. Continued review of the record failed to reveal that the provider had been notified of the abnormal results.

Continued review of P#1's medical record revealed that IMS MD GG ordered a STAT lactic acidon 8/19/22 at 5:06 a.m. and it was collected on 8/19/22 at 9:18 a.m. The results revealed that the lactate level was 4.85 mmol/L (normal is 0.50 to 2.20). Continued review of the record failed to reveal that the provider was notified of the abnormal results.

Continued review of P#1's medical record revealed that on 8/19/22 at 9:18 a.m., P#1 had a WBC count of 100.70. Documentation failed to reveal that the provider was notified of the abnormal results.
Continued review of P#1's medical record revealed that lactic acid was collected on 8/19/22 at 1:04 p.m. resulting in a level of 9.95 mmol/L. Continued review failed to reveal documentation of provider notification of abnormal results.

During a telephone interview on 10/1/24 at 9:50 a.m., Emergency Department (ED) Physician Assistant (PA) PP said that she has been a PA for 17 years and worked in emergency medicine for 15 years. ED PA PP said that she does not recall P#1. ED PA PP said that her role and responsibilities at work depend on which area of the emergency department (ED) she is scheduled to work.

ED PA PP said that she does not recall P#1. ED PA PP said that for a patient presenting with the VS that P#1 presented with, she would have to gauge if it was due to an infection versus fluid loss.
ED PA PP said that once a patient leaves triage, sometimes lab may call the RNs in triage to report severe abnormal values. ED PA PP said that many severe abnormal lab values are reported to the Flow Coordinator and reassessment RN who see the patients after triage.

An interview was conducted on 10/1/24 at 10:41 a.m. in the facility's conference room with ED Nursing Director (ND) TT. ED ND TT explained that the triage nurse is an individual who generally has one year of experience or more as a Registered Nurse (RN). ED ND TT explained that all nurses in this role receive training in the triage process, Emergency Severity Index (ESI) levels, and the Sepsis Screening tool. ED ND TT explained that during the triage process, there is generally a mid-level provider, i.e., Physician's Assistant (PA) or Nurse Practitioner (NP), also at the screening station. ED ND TT explained that once the triage process is completed, a patient will be taken to the protocol room, where lab work and any additional tests are completed. The ED has its own technicians who take the blood samples. ED ND TT said that most ED lab work is considered STAT and completed within 30 minutes, and the turnaround time for results is generally around 45 minutes. ED ND TT explained that if there is an abnormal result, the lab typically will call the Primary RN or the Charge RN with abnormal values, and they are responsible for communicating this to the ED Provider.

During an interview on 10/1/24 at 11:26 a.m. in the conference room, the Director of Critical Care (DCC) SS said that she has been employed at the facility for five years and serves as the Director representative for the Sepsis Operations Team (SPOT). DCC SS said that the facility now has a dedicated phlebotomist to respond to Code Red Sepsis calls and this was recent as of six weeks ago. DCC SS said that if there was a delay in laboratory collection, nursing staff should continue to make calls and follow up to ensure a collection will be done, but also not delay care in administering any medications to the patient. DCC SS said leadership has tried many different interventions to reduce in lab collection time for the STAT labs such as performing an overhead page or having the RRT collect the lab, but leadership also did not want to increase contamination levels. DCC SS said that there is now an increased amount of phlebotomist dedicated to the emergency department (ED).

During an interview on 10/2/24 at 9:11 a.m. in the conference room, rapid response team (RRT) Registered Nurse (RN) KK said that she has been an RN for 10 years and three years with the RRT. RRT RN KK said that the RRT responds when nursing or medical staff call them for anything regarding patient concerns or care to facilitate movement to a higher level of care. RRT RN KK said that when nurses receive any critical lab values, they should inform the provider so that they are aware and provide any changes to the current medical treatment. RRT RN KK said that that nurses have a spot in EPIC to chart all provider notifications.

Based on a review of medical records, policies and procedures, and staff interviews, it was determined that the facility failed to adhere to the facility's laboratory policies when one (P#1) of five (P#1, P#2, P#3, P#4, P#5) patients was ordered a STAT (now) lactic acid blood draw on 8/19/22 at 5:06 a.m., and it was not collected until 8/19/22 at 9:18 a.m. This failure resulted in a delay of care and treatment for P#1.

Findings include:
A review of the facility's policy titled "Collection Priority", policy #12543509, last revised 4/6/20, revealed that the purpose was to provide uniform guidelines to specify which conditions under which laboratory tests are ordered STAT, timed, and routine, and the priority in which they are collected.
Further review revealed that it applied to all laboratory personnel who were responsible for collecting blood samples to be processed, analyzed, and/or tested.
V. Procedure at the discretion of the ordering physician; labs are routinely ordered as STAT, timed, or routine.
A. STAT Orders
a. Take priority over all other collection priorities, except stroke alerts, code blue, sepsis alert, and code STEMI.
b. Collected within 30 minutes of the order.
c. Specimen is delivered to the lab immediately after collection.
B. Timed Orders
a. Take priority over all routine orders.
b. Collected within 30 minutes before or after the specified time.
C. Routine Orders
d. Every effort should be made to collect routine orders within two hours of order.
D. Code Alerts
a. The phlebotomist responds to all Stroke, STEMI, Sepsis, and code Blue within minutes of them being called over PBX intercom.
c. Code Sepsis blood cultures must be collected within two hours.

A review of an Internal Medicine (IMS) Consultation Note dated 8/19/22 at 5:14 a.m. by IMS MD GG revealed that he had been consulted to see P#1 about acute-severe sepsis with refractory hypotension consistent with shock.

IMS MD GG ordered a lactic acid, STAT, on 8/19/22 at 5:06 a.m. and it was collected on 8/19/22 at 9:18 a.m. The results revealed that the lactate level was 4.85 (normal is 0.50 to 2.20).Continued review of P#1's medical record revealed that lactic acid was collected on 8/19/22 at 1:04 p.m. resulting in a level of 9.95.

During an interview on 10/1/24 at 11:26 a.m. in the conference room, the Director of Critical Care (DCC) SS said that she has been employed at the facility for five years and serves as the Director representative for the Sepsis Operations Team (SPOT).

DCC SS said that if there was a delay in laboratory collection, nursing staff should continue to make calls and follow up to ensure a collection will be done, but also not delay care in administering any medications to the patient. DCC SS said leadership has tried many different interventions to reduce in lab collection time for the STAT labs such as performing an overhead page or having the RRT collect the lab, but leadership also did not want to increase contamination levels. DCC SS said that there is now an increased amount of phlebotomist dedicated to the emergency department (ED).

During a telephone interview on 10/1/24 at 3:22 p.m., Critical Care Medicine (CCM) Physician Assistant (PA) HH said that she has been a CCM PA for 10 years. CCM PA HH said that she has had lab collection times take longer than the allotted time for STAT orders to be completed and usually has to reach out to the nurse to have them follow up with lab.

During an interview on 10/2/24 at 9:11 a.m. in the conference room, rapid response team (RRT) Registered Nurse (RN) KK said that she has been an RN for 10 years and three years with the RRT. RRT RN KK said that the RRT responds when nursing or medical staff call them for anything regarding patient concerns or care to facilitate movement to a higher level of care. RRT RN KK said that when patients are placed on a sepsis protocol, the labs are STAT and often collected by lab. RRT RN KK said that lab has been late in the past to collect these on time and sometimes it has taken the lab over an hour to collect it.

During an interview on 10/2/24 at 9:45 a.m. in the conference room, Lab Manager (LM) VV said that she has been employed at the facility for three years, and in her current position for three months. LM VV said that phlebotomy collects the labs for all patients with the exception of the emergency department (ED), intensive care unit (ICU), and mother-baby units. LM VV said that when lab orders are received, lab technicians have a certain amount of time to collect them. LM VV said that for timed orders staff have 30 minutes before and after the time to collect them, and STAT orders are immediate and done under 30 minutes.

LM VV said that if there are many STAT orders placed, then lab assistants can go up to the units to help the phlebotomists in the collection process. LM VV said that phlebotomists have specific assignments and areas they are assigned to each day that they are responsible for. LM VV said that if some units are busier than others, then it is the expectation that other phlebotomists assist others. LM VV said that leadership has been working on staffing to ensure that there is enough coverage now to reduce late collection times. LM VV said that if late collection time is a daily occurrence, then she would verify the numbers and identify if there is a need to staff up in one department/unit. LM VV said that the process for clinical staff is to contact the phlebotomist first to inquire on the collection time of a lab, then down to the main lab if there are still issues in collection time, and if it is not resolved at this point, then to contact the supervisor or LM VV at which it is usually resolved.

Based on review of medical records, policy and procedures and interviews with staff, it was determined that the facility failed to ensure that the emergency services rendered by facility departments were provided in a timely manner when one (P#1) presented to the facility for treatment. Despite clinical presentation and abnormal diagnostic and laboratory test results P#1 was not assessed by a consultative physician until after five hours and surgical intervention was not attempted until 17 hours after arrival.

Findings included:

Cross-refer to A-1103 related to the failure of the faciilty to ensure that departments were integrated to provide emergency care.

Based on review of medical records, policy and procedures and interviews with staff it was determined that the facility failed to ensure that all departments were integrated to provide safe and timely care. P#1 presented to the ED 8/18/2022 at 6:40 P.M. with complaints after a medically induced abortion days prior. Despite P#1 having critical lab values, abnormal blood pressure readings and abnormal ultrasound findings she was not assessed by an obstetrician until 11:41 P.M., five hours after arrival to the ED. P#1 taken to the operating room on 8/19/2022 at 2:00 P.M. or approximately 17 hours after initial presentation to the ED.

Findings included:

A review of patient #1's medical record revealed that she arrived at the facility on 8/19/2022 at 6:40 P.M. via car, escorted by a family member. The patient was admitted to the hospital's ED on 8/18/2022 at 6:53 P.M. The patient 's arrival complaint was listed as "Vaginal bleeding /Abdominal pain." The patient's updated complaint was listed as "Chief Complaints Updated: Vaginal Bleeding (Pt. Reports beginning abortion process on Sunday and states she has had extreme vaginal bleeding. Filling a pad in under an hour, states she is dizzy and passes out once)." The patient's vital signs were listed at 6:52 P.M. was Temperature 98. Degrees Fahrenheit, Heart rate 105 (Tachycardia- fast heart rate), Blood Pressure 86/60 (hypotension- Low blood pressure); Respirations-18; Oxygen-96% and Pain Assessment was left Blank. The patient was triaged (the process of sorting patients by the urgency of their needs for care and treatment) by the Registered Nurse CC. The patient was triaged as an ESI (Emergency Severity Index- a scale used in the emergency department where patients are classified and prioritized based on severity of their injuries and or disease)- 3 urgent (a patient is urgent and requires multiple resources to investigate or treat).


Further review of the medical record revealed in part the following orders were entered by ED PA (Physician Assistant) PP on 8/18/2022 at 6:54 P.M. Nursing "Obtain LMP/GYN (Last Menstrual Period/Gynecology) surgery history, pregnancy history; Assess and document bleeding , amount , color and duration; NPO (Nothing by mouth ); Nursing- save any tissue or products of conception, place in pathology specimen container, Vital Signs ED Routine; ...if symptomatic or hypotensive place in treatment area and notify MD; CBC auto differential (Complete blood count-measures red blood cells, white blood cells, and platelets -stop bleeding by helping blood to clot); ABO/Rh (test identifies blood group, Rh factor (positive or negative); hCG, quantitative, pregnancy (test that provides a positive or negative test for pregnancy ); Urinalysis complete with reflex cultures ( Lab test to check for bacteria or other germs in a urine sample); Type and screen (pre-transfusion test determines a patient's blood type and RH type); Ultrasound combo pelvis complete ( a noninvasive diagnostic exam that produces images that are used to assess organs and structures within the female pelvis)." Documentation by ED PA PP revealed "First Provider Evaluation." The orders placed by the ED PA PP were acknowledged by ED RN EE 8/28/22 at 8:33 P.M. There was no documentation in the medical record to indicate that EDMD BB was notified the patient was hypotensive upon arrival to the hospital's ED. Additionally, there was no documentation by nursing as per orders to assess and document bleeding amount, color and duration; obtain LMP/GYN surgery history, pregnancy history. According to review of the ED patient Care Timeline revealed that on 8/18/2022 at 8:14 P.M., Physician ED MD BB was the assigned attending physician for P#1.


On 8/18/2022 at 9:38 P.M., ED MD BB documented in part, "History Chief Complaint Patient Presents with Vaginal Bleeding Pt. Reports beginning abortion process on Sunday and states she has had extreme vaginal bleeding. Filling a pad in under an hour. States she is dizzy and passed out once. The history is provided by the patient: Vaginal Beeding: This is a new problem. The condition started 3 days ago. The problem is constant. The pain is moderate. The quality of the pain is described as cramping. The pain is at a severity of 6/10. The pain is the same all the time. ..The condition improved by nothing. Associated symptoms include abdominal pain. ...Patient ...presenting to the emergency room with complaints of vaginal bleeding and abdominal pain for the past few days. Patient states that she did an elective abortion (the interruption of pregnancy at the request of the woman) started taking abortion pills 5 days ago. Patient states over the past 2 (two) to 3 (three) days she started having heavy vaginal bleeding and abdominal cramping. States she also feel lightheaded and fainted once. The Review of Systems, revealed in part " ... Gastrointestinal: Positive for abdominal pain ...Genitourinary: Positive for vaginal bleeding ...Neurological: Positive for light-headedness. Physical Exam (Examination): ...Mouth: Mucous membranes dry ...Cardiovascular: Tachycardia present ...Abdominal: There is abdominal tenderness in the periumbilical area and suprapubic area ...Genitourinary: ...No active vaginal bleeding on pelvic exam. Skin: ... is pale ...MDM (Medical Decision Making) ... Hypocalcemia (Low Calcium level); Leukocytosis (a condition where the white blood cells count blood is higher than normal); ...vasovagal syncope) a sudden drop in heart rate and blood pressure leading to fainting) Patient reports ...took Cytotec for 2 days. On exam patient appears to be dehydrated and pale. Pelvic ultrasound shows possible retained products of conception (any placental or fetal tissue left in the uterus after miscarriage, planned pregnancy termination or preterm/delivery) Continued review of the "ED Provider Note" revealed that ED MD BB noted to start P#1 on intravenous (IV) fluids, that the pelvic ultrasound showed possible retained products of conception (RPOC), P#1's Hematocrit and Hemoglobin (H&H) was within normal limits, significantly elevated white blood cell (WBC) count at 56.50 (normal is 4.5 to 11) with no known source at this time. ED MD BB discussed the case with Obstetrical-Gynecology (OB-GYN) MD AA who agreed to start P#1 on IV antibiotics and admit for further evaluation. Continued review revealed that P#1 got up to urinate and had a syncopal episode and sustained a hematoma (bruise) to the forehead, a computed tomography (CT) of the head was ordered for further evaluation.

Documentation by EDMD BB revealed, " ...11:33 P.M. EDMD BB discussed with OB-GYN MD AA all pertinent aspects of the case including HPI (History of Present illness) details, physical exam findings, testing completed, medications given, the pt's current condition, my clinical impression, and need for admission for further evaluation and treatment. The doctor agrees to accept the patient at this time for admission."

Documentation by OB-GYN MD AA, on 8/18/2022 at 11:41 P.M. revealed in part, " ...28 y. o. (year old) female on whom I have been asked to consult for evaluation and treatment of Pelvic pain and syncopal episode at home and in the ER (Emergency Room) today. She reports she had an elective termination on 8/13 with medication management. She reports she started having heavy bleeding at home today and was changing her pad every hour before coming to the ER. ER MD reported minimal vaginal bleeding on exam (examination), but foul odor noted. The patient reports cramping also. She was sitting on the bedside commode in the ER room and was feeling dizzy and eventually passed out hitting her forehead ... She is able to give the history to me ...Obstetrical History OB History ... Gravida (number often to indicate the number pregnancies a woman has had) 1; Para (number of births a female has had after 20 weeks gestation) 1; Term (full term); Living 1" The abnormal laboratory resulted on 8/18/22 were : WBC 56.60 (Hospital reference range 3.4 -10.80); Platelet Count -109 (Hospital reference range:130-400); Creatinine: 1.29 (Hospital reference range-.30-1.00); Glucose: 117 (Hospital reference range: 74-100), and pregnancy test 11,628 -positive. Continued documentation by OB-GYN MD AA revealed in part, Physical Exam: "The patient appears well, alert, oriented x3, in no distress ... ABD (abdomen): soft, non-tender; bowel sounds normal ...Pelvic: examination done by (ERMD). Further documentation revealed under the section titled "Assessment/Plan: revealed, in part, " ...Repeat CBC, BMP, PT.PTT in am ...Make NPO for possible D&C tomorrow. Principal Problem: Retained products of conception following abortion."

A review of the ED Patient Care Timeline revealed that on 8/19/2022 at 4:16 A.M. Patient #1 was admitted to an observation Unit and new orders were acknowledged. The orders revealed in part, New -Head CT (Computed Tomography -Imaging diagnostic test to obtain detailed images of the body) without contrast, Place in observation "Full Code (individual who wants everything done to save their life in the event of an emergency)" Laboratory work, medication for pain and nausea, Zosyn and Flagyl antibiotics.

Continued review of the medical record revealed that on 8/19/2022 at 5:14 A.M. OBGYNMD AA ordered a consult for IMS MD Hospitalist GG to evaluate patient #1. The patient was listed to be room 3210/3210-01 (Observational Unit). IMS MD Hospitalist GG documented in part, "Pt. (patient) Reports beginning abortion process on Sunday and states she has had extreme vaginal bleeding. Filling a pad in under an hour. States she is dizzy and passed out once." Further documentation by IMS MD Hospitalist GG revealed in part, History of Present illness, " ...OB GYN MD AA consulted me due to concern of persistent hypotension despite appropriate IV fluids. Patient reports lightheadedness upon sitting up and generalized abdominal pain. He also documented the following abnormal Blood pressures, pulse and respirations:2:05 A.M.- Blood pressure (B/P) 89/58; Pulse: 105; 3:13 A.M. - Pulse 105,
Respiration: 30; 4:27 A.M. BP 79/42; and 4:33 A.M. BP 72/38, Pulse: 18; and Respirations: 25. IMS MD Hospitalist GG documented, in part, Physical Examination: General Appearance: "Appears Ill ... Throat: Dry oral mucosa ...Abdomen: Soft, right lower quadrant abdominal tenderness, rebound noted, involuntary guarding noted, hypoactive bowel sounds active in all quadrants." The patient's most recent laboratory work on 8/19/2022 at 3:22 A.M., WBC increased to 80.10 and Platelet count further decreased to 71. The patient's Creatinine Level was 1.29 (indicating possible kidney failure); Glucose 117; and calcium level was 6.5. He also documented an Assessment -Hospital Problem list: 1. (Principal) Retained products of conception following; 2. Leukocytosis; 3. Tachycardia; 4. Sepsis; 5. Shock; 6. ARF (acute renal failure). Further documentation revealed the "PLAN": Sepsis (the body's response to extreme to an infection. It is a Life- threatening medical emergency), Acute-Severe. Complicated by refractory hypotension consistent with shock; initiate Levophed. Discussed case with ICU (Intensive care unit) pending evaluation; escalate antibiotics-Zosyn, vancomycin doxycycline, blood cultures, obtain serum lactic acid (occurs when lactic acid builds up in the blood, body produces more lactic acid and body tissues are deprived of oxygen), CT abdomen pelvis with IV contrast-concern for possible abscess versus acute abdomen-peritoneal signs on exam; Place on telemetry; Shock Acute. Likely secondary to sepsis (Continue IV fluids, Exam bed placed in Trendelenburg (used as first line intervention in the treatment of acute hypotension and/or shock); Leukocytosis Acute worsening; Acute renal failure Acute. Likely to sepsis. IMS MD hospitalist GG documented the findings were discussed with OB GYNMD AA, "Pending ICU evaluation."

Documentation by the RN dated 8/19/2022 at 6:29 AM revealed, "Awaiting assignment for patient to be transferred.

Review of the Rapid Response Note dated 8/19/2022 at 6:45 A.M. the RRT (Rapid Response Team) was called by the Intensivist for hypotension: Started patient on levo (Levophed) gtt (drip) and transferred to ICU Room 2210. Review of the record revealed that at 7:05 A.M. the patient's BP was 65/50.

Review of the Critical care note dated 8/19/2022 at 7:14 A.M. CCM (Critical Care Management) PA HH documented that a critical care consult was placed because IMS was asked to look at P#1 for septic shock. She documented in part, "She was admitted for volume resuscitation and IV antibiotics with plans of D&C. Overnight 8/18-19 she was hypotensive despite 5.5 L (liters) of IV fluids. Patient transferred to the ICU for pressors (type of medication used in the ICU to treat conditions such as shock).

Review of the medical record revealed that on 8/19/2022 at 12:05 P.M., OB GYN Surgeon DD, notified CCM MD II, the patient's condition was deteriorating, and the patient was now on 2 pressors, the blood pressure was 80/40's. She also documented the patient's WBC had increased from 80.1 to 100.70.

A review of an "Operative Note" dictated on 8/19/22 at 3:25 p.m., revealed that General Surgeon (GEN) MD JJ performed an exploratory laparotomy on P#1 and listed the pre- and post- operative diagnosis as ischemic (less-than-normal amount of blood flow) gut. Continued review of the "Operative Note" revealed that P#1 was already in the operative room (OR) by gynecologic service and GEN MD JJ was consulted for evaluation of what appeared to be ischemic small bowl. GEN MD JJ noted that there was no frank necrosis, but some injury as expected. GEN MD JJ noted that there was nothing that could be done at that point, as a complete small bowel resection was not consistent with life and there was still a possibility that the ischemic injury can reverse itself. GEN MD JJ noted that P#1 was severely acidotic and hypotensive requiring medication with low platelets and that a Disseminated Intravascular Coagulation (DIC) panel was still running. GEN MD JJ noted that gynecologic service will continue with an operation and perform a hysterectomy, which GEN MD JJ agreed was in P#1's best interest.

The section of the medical record titled "Admission Orders" was reviewed. The review revealed that on 8/18/2022 at 11:33 OB GYN MD AA, wrote orders which stated, "Place in Observation (patient is being closely monitored in the ED while medical professionals further evaluate their condition to determine if they need to be admitted as an inpatient)". Further review of the section titled "Updates' revealed the admitting provider was OBGYN MD AA, and the diagnosis was "Retained products of conception following abortion" The patient's class was listed as "observation". Further review of the ED Patient Care Timeline revealed at 11:39 OB GYN MD AA an ED admit order was placed and completed to place the patient in observation for gynecology. At 11:57 an inpatient bed was assigned PHH -3NE (Observation unit). On 8/19/22 at 1:3 9 a.m., OB GYN MD AA, listed the patient as an ED Boarder Patient (The practice holding patients in the ED or another temporary location after the decision to admit or transfer has been made). Review of the admission orders revealed on 8/19/2022 at 1:27 P.M., revealed a verbal order per OB GYN MD AA, on 8/19/2022 at 1:27 P.M. was communicated to a Registered Nurse to admit Patient #1 as an inpatient.

A review of a "Discharge Summary - Expired" dated 8/19/22 at 6:37 p.m., by a PA FF revealed that P#1's immediate cause of death was listed as septic shock due to retained products of conception. Continued review revealed that the manner of death was listed as natural.

The County Coroner's Office Report for Patient #1 dated 8/19/2022 was reviewed. Patient #1 cause of death was listed as "Sepsis due to retained products of conception."

A review of the facility's document, "Order Set for Sepsis", revealed an order set and treatment course checklist. Continued review revealed that the categories of sepsis are separated by suspected/presumed sepsis, severe sepsis normotensive/lactate, severe sepsis/septic shock MAP greater than 65 and/or Lactate greater than four.
A review of the facility's Sepsis 1-hour bundle- Initial Resuscitation for Sepsis and Septic Shock revealed that:
Medical Emergency- Initiate bundle upon recognition of sepsis/septic shock
1. measure lactate level- remeasure if initial lactate is elevated (greater than two)
2. Obtain blood cultures before administering antibiotics
3. Administer broad spectrum of antibiotics
4. Begin rapid administration of 30 mL/kg crystalloid for hypotension or lactate greater than or equal to four.
5. Apply vasopressors if hypotensive during or after fluid resuscitation to maintain a mean arterial pressure greater than or equal 65 mm Hg
A review of the facility's Sepsis three-hour Bundle revealed that within three hours, a patient should receive antibiotics and normal saline bolus, lactic acid STAT, and blood cultures.

A review of the facility's policy titled, "Piedmont Henry Hospital Emergency Department Patient Assessment and Reassessment Policy", policy #10603466, last revised 10/22/21, revealed that the purpose of the policy was to establish guidelines for assessing and reassessing patients who present to the emergency department (ED).
Continued review revealed, Definitions:
Assessment - the collection/interpretation of data for the purpose of matching an individual's need with the appropriate setting, care level, or intervention. Assessments are completed upon admission to the hospital at a variety of entry points and continued throughout the hospital stay. In the ED, an assessment is performed based on the patient's acuity upon arrival and their chief complaint.
Continued review revealed, Procedure, Triage:
The purpose of the triage is to prioritize incoming patients and identify those patients who cannot wait to be seen. The Emergency Severity Index (ESI) is used to determine which patient prioritization and determine what resources are necessary in order to determine an ED disposition. Triage level can be changed to a higher acuity but not downgraded. A final assessment/reassessment will occur within 60 minutes of discharge, admission to a unit, or transfer to another hospital. Frequency of reassessments are based on ESI level.
ESI level two: high-risk situation, confused/lethargic, disoriented, severe pain/distress, abnormal vital signs. Frequency of reassessment is every two hours and components to include full vital signs (heart rate, blood pressure, O2 saturation, respiratory rate, pain score), note patients general appearance, and mental status.
ESI level three: considered stable, but requires therapeutic observation or treatment and require two or more resources. Frequency of reassessment is every four hours and components to include full vital signs (heart rate, blood pressure, O2 saturation, respiratory rate, pain score), note patients general appearance, and mental status.
Continued review revealed, Responsibilities:
Triage Nurse
" Provide the initial assessment of the patient in relation to the patient's acuity and chief complaint.
" Perform all reassessments for the patients that are in the waiting room waiting.
" Primary personnel responsible for monitoring the waiting room dashboard to ensure that patients are receiving timely reassessments in coordination with the department's Flow Coordinator.
Charge Nurse/Flow Coordinator
" Assist in the flow and coordination of patients and providers.
" Tertiary personnel monitoring the waiting room dashboard to ensure that patients are getting the care they require.
Triage Provider
" Assist with reassessments as needed by the triage nurse.


A review of the facility's policy titled "Scope of Care/Service: Facility -Ultrasound", policy #15651448, last revised 2/12/22, revealed that the hours of operation for the ER and Inpatients- 24 hours per day/7 days per week.
A further review revealed, Descriptions of Assessment and Reassessment Practices, including timeframes: Patient assessment is made to provide the best care possible and the most relevant information to the Radiologist and to allow for the best possible exam and results. The order is reviewed by the technologist prior to the exam, and the patient is questioned about his or her reason for the exam, which is documented in PACS for the radiologist to review. The Radiologist will communicate with the referring physician if needed regarding the proper exam and/or if any immediate follow-up is required of the patient or the referring physician.

A review of the facility's policy titled, "Assessment/Reassessment/Prioritization of Obstetrical Emergency Department Patients Policy", policy #5953504, last revised 6/4/19, revealed that the purpose of the policy was to provide guidance for triaging and assigning patients an acuity level.
Continued review revealed, Assessment, Examples of High-Risk Situations:
" Active vaginal bleeding (not spotting or show)
" Unstable high risk medical conditions

A review of the facility's policy titled, "Obstetrical ED Patient Assessment and Reassessment", policy #14881883, last revised 11/28/23, revealed that the purpose of the policy was to establish guidelines for assessing and reassessing patients who present to the Obstetrical Emergency Department (OBED).
Continued review revealed, Procedure, Triage, the purpose of triage is to prioritize incoming patients and identify those patients who cannot wait to be seen.
Continued review revealed, Responsibilities:
OBED Nurse:
" Provide the initial assessment of the patient in relation to the patient's acuity and chief complaint. Perform assessments of the patients in the OBED and report findings to the appropriate provider.
OBED Provider
" Perform initial assessments and examinations on patients in OBED as per EMTALA guidelines.


A review of the facility's policy titled, "Obstetrical Patients in the Emergency Department Policy", policy #7351718, last revised 12/16/19, revealed that the purpose of the policy was to define the guidelines for all obstetrical (OB) patients presenting to the emergency department (ED).
Continued review revealed, Six, Procedures, OB patients who present ot the ED with:
Gestation less than 20 weeks
" A qualified medical provider will perform an evaluation and medical screening exam in the ED.
" The ED physician will notify the patient's attending OB, on-call, or in-house.
A review of the facility's policy titled, "Obstetrical Patients in the Emergency Department Policy", policy #12824579, last revised 12/29/22, revealed that the purpose of the policy was to define the guidelines for all obstetrical (OB) patients presenting to the Emergency Department (ED).
Continued review revealed, Six, Procedures, OB patients who present to the ED with:
Gestation less than 20 weeks
" A qualified medical provider will perform an evaluation and MSE in the ED.
" The ED physician will notify the patient's attending obstetrician, on-call, or in-house.
" Hospitals with an OB ED may see patients with gestation less than 20 weeks.
Other complaints or who are not exhibiting obvious signs and symptoms of labor
" A qualified medical professional will perform and evaluation and MSE in the ED in accordance with ED protocol.

A review of the facility's policy titled, "Guidelines for Management of Obstetric and Gynecologic Patients that Present to the Main ED", policy #11533615, last revised 3/25/19, revealed, A., Management of Pregnant Patients Less than 20 Weeks, One, Threatened Miscarriage.
Patients who present to the Emergency Department (ED) with vaginal bleeding and are found to have an intrauterine pregnancy on ultrasound are considered to have threatened miscarriage. These patients should be assessed by the ED physician. The assessment should include a CBC, quantitative pregnancy test, Rh screen and Pelvic ultrasound. Pelvic exam should be performed for any patient with bleeding, discharge, and/or pain. These patients should be advised on the possibility of miscarriage and referred for follow-up based on the following stratification:
a. Less than 12 weeks gestation: if unassigned then give the patient list of OB/GYN practices in the community.
c. Inevitable abortion: Patients who present with rupture of membranes, presentation of fetal body part or precipitous delivery. Contact the OB/GYN Hospitalist for unassigned patients or the OB/GYN on call for those assigned to a particular group on staff.
Continued review revealed, Three, How to Manage Ultrasound Findings
b. If there is a pregnancy visualized but not fetal heart tones (FHTs) (missed ab, incomplete ab), then proceed to pelvic exam to determine rate of bleeding/cervical status, check Rh status and refer appropriately.
Continued review revealed, Four, Admissions, the admitting service should be based on the primary indication for admission, if it is an OB issue, then the OB/GYN should be called for admission. If the indication for admission is not OB, the patient should be admitted to the appropriate service based on that indication.

A review of the facility's policy titled, "Guidelines for Management of Obstetric and Gynecologic Patients that Present to the Main ED", policy #14256833, last revised 8/30/23 revealed, A., Management of Pregnancy Patients Less than 16 Weeks, One, Threatened Miscarriage.
Patients who present to the Emergency Department (ED) with vaginal bleeding and are found to have an intrauterine pregnancy on ultrasound are considered to have threatened miscarriage. These patients should be assessed by the ED physician. The assessment should include a CBC, quantitative pregnancy test, Rh screen and Pelvic ultrasound. Pelvic exam should be performed for any patient with bleeding, discharge, and/or pain. These patients should be advised on the possibility of miscarriage and referred for follow-up based on the following stratification:
c. Less than 12 weeks gestation: if unassigned then give the patient list of OB/GYN practices in the community.
d. Inevitable abortion: Patients who present with rupture of membranes, presentation of fetal body part or precipitous delivery. Contact the OB/GYN Hospitalist for unassigned patients or the OB/GYN on call for those assigned to a particular group on staff.
Continued review revealed, Three, How to Manage Ultrasound Findings
d. If there is a pregnancy visualized but not fetal heart tones (FHTs) (missed ab, incomplete ab), then proceed to pelvic exam to determine rate of bleeding/cervical status, check Rh status and refer appropriately.
Continued review revealed, Four, Admissions, the admitting service should be based on the primary indication for admission, if it is an OB issue, then the OB/GYN should be called for admission. If the indication for admission is not OB, the patient should be admitted to the appropriate service based on that indication.

A request was made on 10/1/24 at 8:42 a.m. to conduct an interview with OB-GYN MD AA and OB-GYN MD DD. The Director of Quality later informed the survey team that OB-GYN MD AA and OB-GYN MD DD have refused and retained legal counsel.

A request was made on 10/1/24 at 8:42 a.m. to conduct an interview with ED MD BB, however the Director of Quality later informed the survey team that ED MD BB was out of the country.

A request was made on 10/1/24 at 8:42 a.m. to conduct an interview with IMS MD GG, however the Director of Quality later informed that survey team that IMS MD GG was no longer on staff with the facility.

An interview was conducted on 10/1/24 at 10:41 a.m. in the facility's conference room with ED Nursing Director (ND) TT. ED ND TT explained that the triage nurse is an individual who generally has one year of experience or more as a Registered Nurse (RN). ED ND TT explained that all nurses in this role receive training in the triage process, Emergency Severity Index (ESI) levels, and the Sepsis Screening tool. ED ND TT explained that during the triage process, there is generally a mid-level provider, i.e., Physician's Assistant (PA) or Nurse Practitioner (NP), also at the screening station. ED ND TT explained that once the triage process is completed, a patient will be taken to the protocol room, where lab work and any additional tests are completed. The ED has its own technicians who take the blood samples. ED ND TT said that most ED lab work is considered STAT and completed within 30 minutes, and the turnaround time for results is generally around 45 minutes. ED ND TT explained that if there is an abnormal result, the lab typically will call the Primary RN or the Charge RN with abnormal values, and they are responsible for communicating this to the ED Provider.
ED ND TT explained that the Sepsis Screening is a drop-down tool in the electronic medical record EPIC, and if the nurse marks "no" suspected infection, the drop-down questions do not populate to proceed further. ED ND TT explained that if any abnormal lab results indicate "sepsis," an alert will trigger a BPA alert, requiring the RN to note that the provider was notified of the abnormal results.

ED ND TT explained that once the ED Provider examines the patient and determines that a patient may need to be admitted, they will contact that Provider to discuss the patient. When a Provider agrees to accept the patient, that Provider writes the admitting orders and is the Provider contacted if additional orders are needed while the patient is waiting to be transferred to an inpatient bed. ED ND TT explained that once a decision is made to admit the patient and a Provider agrees to admit, the ED Provider initiates the bed request. ED ND TT said that the location of a medical-surgical floor or critical care unit is a decision made between the ED Provider and the Admitting Provider, then bed control will assign a bed. ED ND TT said that once a bed is assigned, an ED nurse will call the nursing unit to give a report. ED ND TT said that a delay in transfer may occur if any outstanding tests need to be completed, i.e., x-ray or CT. ED ND TT further explained that vasopressors can be administered in the ED and Intensive care areas but not generally on the medical-surgical floor.

ED ND TT explained that patients waiting to be transferred to an inpatient bed are considered boarding, and a patient in observation is a level of admission where it is anticipated that the length of stay will be under 24 hours.

During a telephone interview on 10/1/24 at 1:13 p.m., General Surgeon (GS) JJ said that he vaguely recalls P#1 and the time he encountered her. GS JJ recalled that P#1 was already in the operating room (OR) when GS JJ was consulted. GS JJ recalled that he was consulted for concerns of an ischemic gut possibly related to disseminated intravascular coagulation (DIC).
GS JJ said that an ischemic gut is usually caused by a decrease of blood flow and oxygenation that could be caused by a clot, obstruction, low blood pressure, medication, or poisons. GS JJ said that in the case of DIC, it is the concept of many smaller clots that cause a decrease in blood flow. GS JJ said that when another provider identifies an issue while operating on a patient they cannot manage or treat, they will consult another provider to see if the problem is fixable or not.
GS JJ said that he does not recall P#1's case after the consultation, but that based on a review of his notes at the time of consult, there was nothing that could be done for P#1 regarding the ischemic gut.

During an interview on 10/1/24 at 2:59 p.m., Critical Care Medicine (CCM) Medical Doctor (MD) II said that he has been a provider working in CCM for eight years.CCM MD II said that when the emergency department (ED) consults CCM, the advanced practice provider (APP) and or MD will go and evaluate the patient for critical care (CC) needs. CCM MD II said that he would decide if the patient required CC needs and then input an admission order for either the intensive care unit (ICU) or intermediate care unit (IMCU), as appropriate. CCM MD II said that once the admission order is placed, then the bed control will take over in placing the patient in a bed. CCM MD II said that if the ICU was at capacity, then the patient would have to remain in the ED or could overflow into the IMCU, but only if it were appropriate for the level of care staff could provide.

CCM MD II recalled that he was the CCM attending and that he evaluated P#1 due septic shock following an abortion. CCM MD II recalled that P#1 presented to the CCM team requiring blood pressure medication to keep it elevated as P#1 had low blood p