HospitalInspections.org

Based on observation, interview and record review, the hospital failed to have an effective governing body (GB) that is legally responsible for the conduct of the hospital when:

1. The GB did not have a system in place to oversee the priveleging and reappointment of physicians and allied health professionals (AHP) and ensure GB Bylaws were adhered to. The GB did not have a system in place to ensure medical staff conduct was accountable to the GB. (refer to A44, A46, A49, A50, A57)

2. The GB did not have a system in place to ensure medical staff and AHPs complied with state laws. (refer to A47)

3. The GB did not have a system in place to review and approve Medical Staff Bylaws. (refer to A48).

The cumulative effect of these systemic problems resulted in the inability of the hospital to provide care in a safe setting.

Based on interview and record review, the hospital Governing Board (GB) failed to adhere to Bylaws of the Hospital Community Board of [hospital] (GB Bylaws) and ensure that the Medical Executive Committee (MEC) followed GB Bylaws when the MEC recommended providers, physicians (MD) and Allied Health Professionals (AHP), including Physician assistants (PA), for medical staff membership and privileges.

This failure allowed MEC to follow MEC Bylaws, and medical staff rules and regulations that were not consistent with GB Bylaws when providers were granted medical staff membership and privileges; and thus, put the quality of care and safety of patients at risk.

Findings:

A concurrent interview and record review occurred on 3/16/2023 at 2:30 pm via ZOOM with Governing Body (GB) members. In attendance were GB President (PR), CEO family community board member (CEO/CBM), Chief of Medical Staff (CM), and Executive Assistant to the President. (SEA). The GB members acknowledged that the GB was "responsible for the function of the facility, safe patient care and all providers". They acknowledged they had a copy of the GB Bylaws, but the PR was "unsure of the contents". The GB indicated approval of medical staff membership and privileges are made based on MEC's recommendations. The GB indicated they "rely" on Medical Staff Committee (MEC) to "validate" provider credentials and qualifications. The GB indicated for competency and privileges, they "rely" on the title of "physician." The GB indicated privileges are decided at the "level of the MEC". GB indicated the flow of information for privileges flow from the individual department to MEC. [Hospital] Appointment Evaluation form and/or privilege request forms described privileging criterion and required approval signatures from the department chair, Credential Committee Chair, MEC and GB. THE GB indicated they were not aware that GB medical staff requirements were not met. The GB stated, if the provider does not have privileges, he/she must "stop the practice".

The privileges of 18 providers (MD 1 Anesthesiologist, MD 2 Anesthesiologist, MD 3 Family Practice (FP), MD 4 FP MD 5 FP, MD 6 FP, MD 7 Pediatrician (Peds), MD 8 Peds, MD 9 Obstetrician (OB)-gynecology (Gyn), MD 10 OB-Gyn, MD 11 Surgeon, MD 12 FP, MD 13 Internal Medicine (IM), MD 14 IM, MD 15, IM, DRP/FP FP, PA 1, and PA 2) were reviewed.

Eighteen of 18 providers, (MD 1, MD 2, MD 3, MD 4, MD 5, MD 6, MD 7, MD 8, MD 9, MD 10, MD 11, MD 12, MD 13, MD 14, MD 15, DRP/FP, PA 1, PA 2) did not have a MEC authorizing signature for medical membership and/or privileges on the Appointment Evaluation form.

Eighteen of 18 providers, (MD 1, MD 2, MD 3, MD 4, MD 5, MD 6, MD 7, MD 8, MD 9, MD 10, MD 11, MD 12, MD 13, MD 14, MD 15, DRP/FP, PA 1, PA 2) did not have a GB authorizing signature for medical membership and/or privileges on the Appointment Evaluation form.

Eighteen of 18 providers, (MD 1, MD 2, MD 3, MD 4, MD 5, MD 6, MD 7, MD 8, MD 9, MD 10, MD 11, MD 12, MD 13, MD 14, MD 15, DRP/FP, PA 1, PA 2), lacked documented evidence of competency and professional performance at least every two years.

Eighteen of 18 providers (MD 1, MD 2, MD 3, MD 4, MD 5, MD 6, MD 7, MD 8, MD 9, MD 10, MD 11, MD 12, MD 13, MD 14, MD 15, DRP/FP, PA 1, PA 2) lacked regular quality assessment and improvement evaluations for patient care.

Nine of 18 providers (MD 1, MD 2, MD 4, MD 6, MD 7, MD 8, MD 9, PA 1, PA 2) had no meaningful OPPE (Ongoing Professional Practice Evaluations identifies professional practice trends that may impact the quality and safety of care and applies to all practitioners granted privileges) data.

Two of two Advanced health Providers (AHP), (PA 1 and PA 2) lacked a supervising physician of record that providers took direct responsibility for patient care.

One of 18 providers, (MD 13) lacked the appropriate state required licensure/ certificate for x-ray and fluoroscopy.

Five of 16 physicians, (MD 1, MD 2, MD 9, MD 13, MD 14), lacked board certification/eligibility for their privileged specialty.

Twelve of 18 providers (MD 1, MD 2, MD 3, MD 5, MD 6, MD 8, MD 11, MD 12, MD 13, DRP/FP, PA 1, PA 2) lacked documented evidence that demonstrated his/her ability to perform and provide specialized medical and/or surgical service.

Review of hospital bylaws title, 2019 Amended and Restated Bylaws of the Community Board of [Facility] of [City], approved June 24, 2019, indicated that the " Board [GB] is responsible for assuring that health care services provided at the Local Hospital are of high quality, safe, effective, efficient and consistent with community standards. This Hospital Community Board shall be responsible for: (i) ongoing quality assessment, performance improvement, patient safety and utilization management activities ... (ii) assuring that quality and patient safety issues are addressed and resolved appropriately; (iii) assuring quality assessment, performance improvement, patient safety and utilization management activities of the Local Hospital (including outcomes, recommendations and actions undertaken ... be reported ...to the Board"

Review of hospital bylaws title, 2019 Amended and Restated Bylaws of the Community Board of [Facility] of [City], approved June 24, 2019, indicated " Hospital Policies and Procedures ...shall be approved by this Hospital Community Board, where such approval is required to be taken by a governing body ...Such policies and procedures shall be consistent with policies and procedures policies and procedures shall be periodically reviewed by this Hospital Community Board to assure they are accurate, conform to current legal and regulatory requirements, and are consistent with actual practice"

Review of hospital bylaws title, 2019 Amended and Restated Bylaws of the Community Board of [Facility] of [City], approved June 24, 2019, indicated the Hospital Community Board shall assure that the Medical Staff (a) participates in the measurement, assessment and improvement of clinical and non¿clinical processes affecting patient care The activities of the Local Hospital (including outcomes, recommendations and actions) undertaken ...shall be reported to this Hospital Community Board ... The Medical Staff shall identify and implement an appropriate response to findings. Such quality assessment and performance improvement activities shall be regularly reported to this Hospital Community Board

Review of hospital bylaws title, 2019 Amended and Restated Bylaws of the Community Board of [Facility] of [City], approved June 24, 2019, indicated that "MEDICAL STAFF MATTERS ... shall be organized for the adequacy and quality of medical care rendered to patients ...adequacy and quality of medical care and professional work ... There shall be Medical Staff Bylaws and Rules and Regulations for ... Written, defined criteria for Medical Staff appointment and the granting of clinical privileges ... physician responsible for the service be certified or eligible for certification by an appropriate American medical specialty board ... Medical Staff be required to demonstrate their ability to perform surgical and other procedures competently at the time of original appointment and at least every two years ... licensed Practitioner with appropriate clinical privileges shall be directly responsible for patient diagnosis and treatment ... The mechanisms for reviewing credentials, delineating clinical privileges, conducting, evaluating, and revising quality assessment and performance improvement activities ... the Medical Staff Executive Committee shall make recommendations to the Hospital Community Board ... Board shall take final action on such recommendations".

Based on interview and record review, the Governing Body (GB) failed to discontinue, revise and/or revoke the privileges of providers, physicians (MD) and Allied Health Professionals (AHP), including Physician assistants (PA), who did not satisfy requirements as set forth in the GB Bylaws and/or MEC Bylaws.

This failure allowed providers who did not meet the GB standards for privileges provide medical services; and thus, put the quality of care and safety of patients at risk.

Findings:

A concurrent interview and record review occurred on 3/16/2023 at 2:30 pm via ZOOM with Governing Body (GB) members. In attendance were GB President (PR), CEO family community board member (CEO/CBM), Chief of Medical Staff (CM), and Executive Assistant to the President. (SEA). The GB indicated approval of medical staff membership and privileges are made based on MEC's recommendations. The GB indicated they "rely" on Medical Staff Committee (MEC) to "validate" provider credentials and qualifications. The GB indicated for competency and privileges, they "rely" on the title of "physician (MD)." The GB indicated privileges are decided at the "level of the MEC". GB indicated the flow of information for privileges flow from the individual department to MEC. The GB indicated they were not aware that GB medical staff requirements were not met for privileges.

The privileges of 18 providers (MD 1 Anesthesiologist, MD 2 anesthesiologist, MD 3 Family Practice (FP), MD 4 FP MD 5 FP, MD 6 FP, MD 7 Pediatrician (Peds), MD 8 Peds, MD 9 Obstetrician (OB)-gynecology (Gyn), MD 10 OB-Gyn, MD 11 Surgeon, MD 12 FP, MD 13 Internal Medicine (IM), MD 14 IM, MD 15, IM, DRP/FP FP, PA 1, and PA 2) were reviewed.

Five of six Family Practice providers (MD 3, MD 5, MD 6, MD 12, DRP/FP) lacked documented evidence of education, peer review, proctoring, training and/or experience to provide medical services and procedures for obstetric (care of pregnant women) privileges.

Four of six Family Practice providers (MD 3, MD 5, MD 6, DRP/FP) lacked documented evidence of education, peer review, proctoring, training and/or experience for ultrasound (imaging tool that enables views of inside the body) procedures to evaluate and diagnose the status of fetuses (unborn baby) and obstetric patients.

Five of six Family Practice providers (MD 3, MD 5, MD 6, MD 12, DRP/FP) lacked documented evidence of education, peer review, proctoring, training and/or experience to provide medical services for neonatal care (newborn) and/or attendance to delivery of newborn.

Four of six Family Practice providers (MD 5, MD 6, MD 12, DRP/FP) lacked documented evidence of education, peer review, proctoring, training and/or experience to provide medical services for Gynecologic (medical care of female organs) care.

One of 18 providers, (MD 13) lacked the appropriate state required licensure/ certificate to support fluoroscopy (type of xray) and x-ray privileges.

Two of 18 providers (MD 6, MD 13) lacked documented evidence of peer review, proctoring, training, education and/or experience to provide medical services for sedation (providing medication to put patient to sleep for a procedure) privileges.

One of one surgical providers (MD 11) lacked documented evidence of training, education, competency and/or peer review to provide medical services for Robotic surgical services privileges.

One of one surgical providers (MD 11) lacked documented evidence of training, education, competency and peer review to provide medical and surgical services for hernia repair (part of an organ protrude through a body cavity), paraoesophageal hernia (part of esophagus an organ is displaced) repairs, and Nissen (esophagus surgery) surgical procedures.

One of thre Internal Medicine providers (MD 13) lacked documented evidence of training, education, competency, peer review and/or experience to provide medical services for gastroenterology (specialized branch of medicine that deals with the diagnosis and treatment of disorders of the stomach, intestines and other organs) procedures and surgical services privileges.

One of three Internal Medicine providers (MD 13) lacked documented evidence of training, education, competency, peer review and/or experience to provide medical services for provide cardiac (heart) services and procedures.

One of three Internal Medicine providers (MD 13) lacked documented evidence of training, education, competency, peer review and/or experience to provide medical services for physical medicine and rehabilitation privileges.

Two of two surgical providers (MD 13, MD 11) lacked documented evidence of training, education, competency, peer review and/or experience to provide medical and surgical services for laparoscopy (surgical procedure that allows a surgeon to access the inside of the abdomen and pelvis without having to make large incision).

Three of 18 providers (MD 12, PA 1, PA 2) lacked documented evidence of training, education, competency, peer review and/or experience to provide medical services for complex wounds and pressure ulcers care privileges.

Seven of 18 providers (MD 3, MD 5, MD 6, MD 8, MD 12, MD 13, DRP/FP) lacked documented evidence of training, education, competency, peer review and/or experience to provide medical services for intubation (place a breathing tube into a person's lung). and/or laryngoscopy (look deep into a throat using a specialized tool) privileges.

Ten of 18 providers, (MD 1, MD 2, MD 5, MD 6, MD 11, MD 12, MD 13, DRP/FP, PA 1, PA 2) lacked documented evidence of peer review, proctoring, training, education and/or experience to provide medical services for central lines placement (a large tube that is placed in a large, main vein in the neck, upper chest or groin. It requires special training to place).

Review of hospital bylaws title, 2019 Amended and Restated Bylaws of the Community Board of [Facility] of [City], approved June 24, 2019, indicated that the " Board [GB] is responsible for assuring that health care services provided at the Local Hospital are of high quality, safe, effective, efficient and consistent with community standards. This Hospital Community Board shall be responsible for: (i) ongoing quality assessment, performance improvement, patient safety and utilization management activities ... (ii) assuring that quality and patient safety issues are addressed and resolved appropriately; (iii) assuring quality assessment, performance improvement, patient safety and utilization management activities of the Local Hospital (including outcomes, recommendations and actions undertaken ... be reported ...to the Board"

Review of hospital bylaws title, 2019 Amended and Restated Bylaws of the Community Board of [Facility] of [City], approved June 24, 2019, indicated " Hospital Policies and Procedures ...shall be approved by this Hospital Community Board, where such approval is required to be taken by a governing body ...Such policies and procedures shall be consistent with policies and procedures policies and procedures shall be periodically reviewed by this Hospital Community Board to assure they are accurate, conform to current legal and regulatory requirements, and are consistent with actual practice"

Review of hospital bylaws title, 2019 Amended and Restated Bylaws of the Community Board of [Facility] of [City], approved June 24, 2019, indicated that "MEDICAL STAFF MATTERS ... shall be organized for the adequacy and quality of medical care rendered to patients ...adequacy and quality of medical care and professional work ... There shall be Medical Staff Bylaws and Rules and Regulations for ... Written, defined criteria for Medical Staff appointment and the granting of clinical privileges ... physician responsible for the service be certified or eligible for certification by an appropriate American medical specialty board ... Medical Staff be required to demonstrate their ability to perform surgical and other procedures competently at the time of original appointment and at least every two years ... licensed Practitioner with appropriate clinical privileges shall be directly responsible for patient diagnosis and treatment ... The mechanisms for reviewing credentials, delineating clinical privileges, conducting, evaluating, and revising quality assessment and performance improvement activities ... the Medical Staff Executive Committee shall make recommendations to the Hospital Community Board ... Board shall take final action on such recommendations".

Based on interview and record review, the Governing Body failed to assure privileging of providers, physicians (MD) and Allied Health Professionals (AHP), including Physician assistants (PA), adhered to State law.

This failure allowed the MEC to condone the privileges of providers without the required license/certificate, physician supervision and/or reporting of adverse events.

Findings:

A concurrent interview and record review occurred on 3/16/2023, at 2:30 p.m., via ZOOM with Governing Body (GB) members. In attendance were GB President (PR), CEO family community board member (CEO/CBM), Chief of Medical Staff (CM), and Executive Assistant to the President. (SEA). The GB indicated they "rely on Medical Staff Committee (MEC) to "validate" credentials, and qualifications and privileges are done at the level of the MEC. The GB indicated decisions are made based on MEC's recommendations. The GB indicated privileges are decided at the "level of the MEC". GB indicated the MEC Bylaws do not require a GB authorizing signature, and do not review the MEC By laws. THE GB indicated they were not aware that GB medical staff and reporting requirements were unmet.

The privileges of 18 providers (MD 1 Anesthesiologist, MD 2 anesthesiologist, MD 3 Family Practice (FP), MD 4 FP MD 5 FP, MD 6 FP, MD 7 Pediatrician (Peds), MD 8 Peds, MD 9 Obstetrician (OB)-gynecology (Gyn), MD 10 OB-Gyn, MD 11 Surgeon, MD 12 FP, MD 13 Internal Medicine (IM), MD 14 IM, MD 15, IM, DRP/FP FP, PA 1, and PA 2) were reviewed.

One of 16 physicians, (MD 13) provided x-ray and fluoroscopic (type of x-ray) examinations of patients without a state license.

Two of two Advanced health Providers (AHP), (PA 1 and PA 2) lacked a supervising physician of record that took direct responsibility for patient care. (decub, 44, 47 MEC, QA)

The GB did not ensure the MEC and Quality Committee (QMC) reported adverse events, for example pressure ulcers, surgical complications and deaths, to the Medical Board and/or California Department of health (MEC, QA)

Review of hospital bylaws title, 2019 Amended and Restated Bylaws of the Community Board of [Facility] of [City], approved June 24, 2019, indicated that the " Board [GB] is responsible for assuring that health care services provided at the Local Hospital are of high quality, safe, effective, efficient and consistent with community standards. This Hospital Community Board shall be responsible for: (i) ongoing quality assessment, performance improvement, patient safety and utilization management activities ... (ii) assuring that quality and patient safety issues are addressed and resolved appropriately; (iii) assuring quality assessment, performance improvement, patient safety and utilization management activities of the Local Hospital (including outcomes, recommendations and actions undertaken ... be reported ...to the Board"

Review of hospital bylaws title, 2019 Amended and Restated Bylaws of the Community Board of [Facility] of [City], approved June 24, 2019, indicated that "MEDICAL STAFF MATTERS ... shall be organized for the adequacy and quality of medical care rendered to patients ...adequacy and quality of medical care and professional work ... There shall be Medical Staff Bylaws and Rules and Regulations for ... Written, defined criteria for Medical Staff appointment and the granting of clinical privileges ... physician responsible for the service be certified or eligible for certification by an appropriate American medical specialty board ... Medical Staff be required to demonstrate their ability to perform surgical and other procedures competently at the time of original appointment and at least every two years ... licensed Practitioner with appropriate clinical privileges shall be directly responsible for patient diagnosis and treatment ... The mechanisms for reviewing credentials, delineating clinical privileges, conducting, evaluating, and revising quality assessment and performance improvement activities ... the Medical Staff Executive Committee shall make recommendations to the Hospital Community Board ... Board shall take final action on such recommendations".

Based on interview and record review, the Governing Body failed to approve medical staff bylaws and medical departmental rules and regulations which thereby allowed the medical staff and providers, physicians (MD) and Allied Health Professionals (AHP), including Physician assistants (PA), to operate without oversight.

This failure allowed the MEC to condone providers to provide medical services without the required license/certificate, experience, proctoring and/or education; thus, put the quality of care and safety of patients at risk.

Findings:

A concurrent interview and record review occurred on 3/16/2023 at 2:30 pm via ZOOM with Governing Body (GB) members. In attendance were GB President (PR), CEO family community board member (CEO/CBM), Chief of Medical Staff (CM), and Executive Assistant to the President. (SEA).

The GB indicated approval of medical staff membership and privileges are made based on MEC's recommendations. The GB indicated they "rely" on Medical Staff Committee (MEC) to "validate" provider credentials and qualifications. The GB indicated for competency and privileges, they "rely" on the title of "physician." The GB indicated privileges are decided at the "level of the MEC". GB indicated the flow of information for privileges flow from the individual department to MEC. THE GB indicated they were not aware that GB medical staff privileging requirements were not met. The GB stated, if the provider does not have privileges, he/she must "stop the practice".

The privileges of 18 providers (MD 1 Anesthesiologist, MD 2 anesthesiologist, MD 3 Family Practice (FP), MD 4 FP MD 5 FP, MD 6 FP, MD 7 Pediatrician (Peds), MD 8 Peds, MD 9 Obstetrician (OB)-gynecology (Gyn), MD 10 OB-Gyn, MD 11 Surgeon, MD 12 FP, MD 13 Internal Medicine (IM), MD 14 IM, MD 15, IM, DRP/FP FP, PA 1, and PA 2) were reviewed. The following providers did not have documented evidence to meet Medical staff and GB privileging requirements to provide specialized medical services:

Five of six Family Practice providers (MD 3, MD 5, MD 6, MD 12, DRP/FP) provide medical services and procedures for obstetric care (medical care of pregnant women).

Four of six Family Practice providers (MD 3, MD 5, MD 6, DRP/FP) provide ultrasound (imaging tool that enables views of inside the body) procedures to evaluate and diagnose the status of fetuses and obstetric patients.

Five of six Family Practice providers (MD 3, MD 5, MD 6, MD 12, DRP/FP) provide medical services for neonatal care (newborn) and/or attendance to delivery of newborn.

Four of six Family Practice providers (MD 5, MD 6, MD 12, DRP/FP) provide medical services for Gynecologic care (medical care for female organs).

One of 18 providers, (MD 13) provided fluoroscopy (type of x-ray) and x-ray procedures without the state required licensure/ certificate.

Two of 18 providers (MD 6, MD 13) provide medical services for sedation.

One of one surgical providers (MD 11) provide Robotic surgical services.

One of one surgical providers (MD 11) provide medical and surgical services for hernia repair (part of an organ protrude through a body cavity), paraoesophageal hernia (part of esophagus an organ is displaced) repairs, and Nissen (esophagus surgery) surgical procedures.

One of three Internal Medicine providers (MD 13) provide medical services for gastroenterology (specialized branch of medicine that deals with the diagnosis and treatment of disorders of the stomach, intestines and other organs) procedures and surgical services privileges.

One of three Internal Medicine providers (MD 13) provide cardiac (heart) services and procedures.

One of three Internal Medicine providers (MD 13) provide medical services for physical medicine and rehabilitation.

Two of two surgical providers (MD 13, MD 11) provide medical and surgical services for laparoscopy (surgical procedure that allows a surgeon to access the inside of the abdomen and pelvis without having to make large incision).

Three of 18 providers (MD 12, PA 1, PA 2) provide medical services for complex wounds and pressure ulcers care.

Seven of 18 providers (MD 3, MD 5, MD 6, MD 8, MD 12, MD 13, DRP/FP) provide medical services for intubation (place a breathing tube into a person's lung). and/or laryngoscopy (look deep into a throat using a specialized tool) privileges.

Ten of 18 providers, (MD 1, MD 2, MD 5, MD 6, MD 11, MD 12, MD 13, DRP/FP, PA 1, PA 2) provide medical services for central lines placement (a large tube that is placed in a large, main vein in the neck, upper chest or groin. It requires special training to place).

Review of hospital bylaws title, 2019 Amended and Restated Bylaws of the Community Board of [Facility] of [City], approved June 24, 2019, indicated that the " Board [GB] is responsible for assuring that health care services provided at the Local Hospital are of high quality, safe, effective, efficient and consistent with community standards. This Hospital Community Board shall be responsible for: (i) ongoing quality assessment, performance improvement, patient safety and utilization management activities ... (ii) assuring that quality and patient safety issues are addressed and resolved appropriately; (iii) assuring quality assessment, performance improvement, patient safety and utilization management activities of the Local Hospital (including outcomes, recommendations and actions undertaken ... be reported ...to the Board"

Review of hospital bylaws title, 2019 Amended and Restated Bylaws of the Community Board of [Facility] of [City], approved June 24, 2019, indicated " Hospital Policies and Procedures ...shall be approved by this Hospital Community Board, where such approval is required to be taken by a governing body ...Such policies and procedures shall be consistent with policies and procedures policies and procedures shall be periodically reviewed by this Hospital Community Board to assure they are accurate, conform to current legal and regulatory requirements, and are consistent with actual practice"

Review of hospital bylaws title, 2019 Amended and Restated Bylaws of the Community Board of [Facility] of [City], approved June 24, 2019, indicated the Hospital Community Board shall assure that the Medical Staff (a) participates in the measurement, assessment and improvement of clinical and non¿clinical processes affecting patient care The activities of the Local Hospital (including outcomes, recommendations and actions) undertaken ...shall be reported to this Hospital Community Board ... The Medical Staff shall identify and implement an appropriate response to findings. Such quality assessment and performance improvement activities shall be regularly reported to this Hospital Community Board".

Review of hospital bylaws title, 2019 Amended and Restated Bylaws of the Community Board of [Facility] of [City], approved June 24, 2019, indicated that "MEDICAL STAFF MATTERS ... shall be organized for the adequacy and quality of medical care rendered to patients ...adequacy and quality of medical care and professional work ... There shall be Medical Staff Bylaws and Rules and Regulations for ... Written, defined criteria for Medical Staff appointment and the granting of clinical privileges ... physician responsible for the service be certified or eligible for certification by an appropriate American medical specialty board ... Medical Staff be required to demonstrate their ability to perform surgical and other procedures competently at the time of original appointment and at least every two years ... licensed Practitioner with appropriate clinical privileges shall be directly responsible for patient diagnosis and treatment ... The mechanisms for reviewing credentials, delineating clinical privileges, conducting, evaluating, and revising quality assessment and performance improvement activities ... the Medical Staff Executive Committee shall make recommendations to the Hospital Community Board ... Board shall take final action on such recommendations".

Based on interview and record review, the Governing Body failed to have an accountable process that periodically appraised the conduct of providers, physicians (MD) and Allied Health Professionals (AHP), including Physician assistants (PA), and the quality of care given.

This failure jeopardized the health and safety of all patients when provider conduct, patient safety and medical care concerns were not monitored or acted upon.

Findings:

A concurrent interview and record review occurred on 3/16/2023 at 2:30 pm via ZOOM with Governing Body (GB) members. In attendance were GB President (PR), CEO family community board member (CEO/CBM), Chief of Medical Staff (CM), and Executive Assistant to the President. (SEA). The GB indicated they "rely" on Medical Staff Committee (MEC), Quality Committee to monitor and address staff professional performance and competency. THE GB indicated they were not aware that GB medical staff and Quality responsibilities to monitor an act upon provider conduct, patient safety and professional performance were not being met.

The privileges of 18 providers (MD 1 Anesthesiologist, MD 2 anesthesiologist, MD 3 Family Practice (FP), MD 4 FP MD 5 FP, MD 6 FP, MD 7 Pediatrician (Peds), MD 8 Peds, MD 9 Obstetrician (OB)-gynecology (Gyn), MD 10 OB-Gyn, MD 11 Surgeon, MD 12 FP, MD 13 Internal Medicine (IM), MD 14 IM, MD 15, IM, DRP/FP FP, PA 1, and PA 2) were reviewed.

Eighteen of 18 providers, (MD 1, MD 2, MD 3, MD 4, MD 5, MD 6, MD 7, MD 8, MD 9, MD 10, MD 11, MD 12, MD 13, MD 14, MD 15, DRP/FP, PA 1, PA 2), the MEC did not provide the GB with documented evidence of competency and professional performance at least every two years.

For 18 of 18 providers (MD 1, MD 2, MD 3, MD 4, MD 5, MD 6, MD 7, MD 8, MD 9, MD 10, MD 11, MD 12, MD 13, MD 14, MD 15, DRP/FP, PA 1, PA 2), the MEC did not complete regular quality assessment and improvement evalautions for patient care.

For 18 of 18 providers (MD 1, MD 2, MD 3, MD 4, MD 5, MD 6, MD 7, MD 8, MD 9, MD 10, MD 11, MD 12, MD 13, MD 14, MD 15, DRP/FP, PA 1, PA 2) the QMC and MEC did not inform the GB of OPPE (Ongoing Professional Practice Evaluations identifies professional practice trends that may impact the quality and safety of care and applies to all practitioners granted privilege)

Eighteen of 18 providers (MD 1, MD 2, MD 3, MD 4, MD 5, MD 6, MD 7, MD 8, MD 9, MD 10, MD 11, MD 12, MD 13, MD 14, MD 15, DRP/FP, PA 1, PA 2) the MEC and QMC did not inform the GB of all adverse event and occurrences that were "appropriate"," resolved" and/or "closed".

Eighteen of 18 providers(MD 1, MD 2, MD 3, MD 4, MD 5, MD 6, MD 7, MD 8, MD 9, MD 10, MD 11, MD 12, MD 13, MD 14, MD 15, DRP/FP, PA 1, PA 2) the GB was unaware that OPPE data was not followed by MEC or QMC.

A concurrent interview and record review interview occurred on 3/17/2023 at 11:27 am via ZOOM with the Quality Committee (QMC) team. In attendance were Director Medical Staff Administration, (DMSA), Chief Medical Officer (CMO), Quality Director (QD) and Peer Review Nurse, (PRN). QMC team indicated they are unsure who has been responsible for analyzing, monitoring, investigating and acting in upon the data collected for OPPE. The QMC team indicated they do not review the information, and it not part of the hospital QMC program. QMC acknowledged adverse events and Midas information are placed in OPPE, and if they are "closed" are not investigated, even if there was adverse patient outcome The QMC team indicted the CMO and medical staff office deem when grievances, clinical and/or behavioral concerns are "resolved", "appropriate" and/or "closed" and there is Root cause analysis or no further investigation. QMC team acknowledged they do not track hospital acquired infections, surgical complications, length of stay, readmissions, mortality, and pressure ulcers. QMC team indicated there is "no manpower" to "deep dive" and "rigorous analysis" into events that may interfere with patient safety and quality care. The QMC team indicated they "need to do better" for RCA (root cause analysis), verification of competency, oversight, QD indicated the OPPE will be reviewed by the QMC team in the future.

QMC indicated they have OPPE (Ongoing Professional Practice Evaluations identifies professional practice trends that may impact the quality and safety of care and applies to all practitioners granted privileges). QD indicated OPPE is not looked at by QMC and thus there was not any corrective action, monitoring, or tracking. QMC team acknowledged that since QMC doesn't track trends in OPPE they are unaware of events that negatively impact patient outcomes. QMC indicated from the timing and dates of the OPPE's it is difficult to determine what events the data is based on and how they impact pt care and safety.

Review of hospital bylaws title, 2019 Amended and Restated Bylaws of the Community Board of [Facility] of [City], approved June 24, 2019, indicated that the " Board [GB] is responsible for assuring that health care services provided at the Local Hospital are of high quality, safe, effective, efficient and consistent with community standards. This Hospital Community Board shall be responsible for: (i) ongoing quality assessment, performance improvement, patient safety and utilization management activities ... (ii) assuring that quality and patient safety issues are addressed and resolved appropriately; (iii) assuring quality assessment, performance improvement, patient safety and utilization management activities of the Local Hospital (including outcomes, recommendations and actions undertaken ... be reported ...to the Board"

Review of hospital bylaws title, 2019 Amended and Restated Bylaws of the Community Board of [Facility] of [City], approved June 24, 2019, indicated " Hospital Policies and Procedures ...shall be approved by this Hospital Community Board, where such approval is required to be taken by a governing body ...Such policies and procedures shall be consistent with policies and procedures policies and procedures shall be periodically reviewed by this Hospital Community Board to assure they are accurate, conform to current legal and regulatory requirements, and are consistent with actual practice"

Review of hospital bylaws title, 2019 Amended and Restated Bylaws of the Community Board of [Facility] of [City], approved June 24, 2019, indicated the Hospital Community Board shall assure that the Medical Staff (a) participates in the measurement, assessment and improvement of clinical and non¿clinical processes affecting patient care The activities of the Local Hospital (including outcomes, recommendations and actions) undertaken ...shall be reported to this Hospital Community Board ... The Medical Staff shall identify and implement an appropriate response to findings. Such quality assessment and performance improvement activities shall be regularly reported to this Hospital Community Board."

Review of hospital bylaws title, 2019 Amended and Restated Bylaws of the Community Board of [Facility] of [City], approved June 24, 2019, indicated that "MEDICAL STAFF MATTERS ... shall be organized for the adequacy and quality of medical care rendered to patients ...adequacy and quality of medical care and professional work ... There shall be Medical Staff Bylaws and Rules and Regulations for ... Written, defined criteria for Medical Staff appointment and the granting of clinical privileges ... physician responsible for the service be certified or eligible for certification by an appropriate American medical specialty board ... Medical Staff be required to demonstrate their ability to perform surgical and other procedures competently at the time of original appointment and at least every two years ... licensed Practitioner with appropriate clinical privileges shall be directly responsible for patient diagnosis and treatment ... The mechanisms for reviewing credentials, delineating clinical privileges, conducting, evaluating, and revising quality assessment and performance improvement activities ... the Medical Staff Executive Committee shall make recommendations to the Hospital Community Board ... Board shall take final action on such recommendations".

Based on interview and record review, the Governing body failed to verify the quality, competence, training, experience and judgment of providers before granting privileges.

This failure jeopardized the health, safety and quality of care for all patients.

Findings:

A concurrent interview and record review occurred on 3/16/2023 at 2:30 pm via ZOOM with Governing Body (GB) members. In attendance were GB President (PR), CEO family community board member (CEO/CBM), Chief of Medical Staff (CM), and Executive Assistant to the President. (SEA).

The GB indicate they were not aware of any concerns related to patient safety, quality of care or provider performance. The GB indicated they "rely" on the Quality Committee (QMC) to address professional performance of providers, patient safety, patient care outcomes and quality of care. The GB indicated if the committees MEC and QMC "address the concerns" and the committee "resolved" the issue, the GB does not have a "formal discussion". The GB indicated they were not aware of any behavior, clinical and/or grievance reports concerning providers. The GB indicated they had no knowledge of adverse events related to patient care or provider professional performance. The GB indicated they were unaware of events QMC reviewed for infection, surgical errors, surgical complications, readmissions, deaths. The GB indicated they were not aware of events reported to the QMC.

During their most current privileging period, the QMC and MEC gathered behavior, clinical and/or grievance reports from Midas (incident reporting portal) for 12 of 18 providers. Some of QMC and MEC finding's were discussed with the GB :

Eighteen providers were reviewed: (MD 1 Anesthesiologist, MD 2 anesthesiologist, MD 3 Family Practice (FP), MD 4 FP MD 5 FP, MD 6 FP, MD 7 Pediatrician (Peds), MD 8 Peds, MD 9 Obstetrician (OB)-gynecology (Gyn), MD 10 OB-Gyn, MD 11 Surgeon, MD 12 FP, MD 13 Internal Medicine (IM), MD 14 IM, MD 15, IM, DRP/FP FP, PA 1, and PA 2)

Nine of 18 providers had 25 behavioral incident reports The medical staff team indicated, MD 1 had four; MD 7 had one; MD 9 had one; MD 11 had three; MD 12 had five; MD 13 had five; MD 14 had one; MD 15 had one; and PA 1 had four.

Six of 18 providers had 16 "trending" problems. The medical staff team indicated MD 9 had one; MD 11 had five; MD 12 had three; MD 13 had three; MD 15 had two; and PA 1 had two

Eight of 18 providers had a 25 clinical incident reports that were related to patient care and quality care. The medical staff team indicated MD 1 had two; MD 2 (anesthesiologist) had five; MD 9 had one; MD 11 had eight; MD 13 had three; MD 15 had one; PA 1 had one; and DRP/FP (Family Practice) had two.

The MEC lacked documented evidence of communication with the GB that 18 of 18 providers (MD 1, MD 2, MD 3, MD 4, MD 5, MD 6, MD 7, MD 8, MD 9, MD 10, MD 11, MD 12, MD 13, MD 14, MD 15, DRP/FP, PA 1, PA 2) demonstrated his/her ability to perform and provide specialized medical service.

Review of hospital bylaws title, 2019 Amended and Restated Bylaws of the Community Board of [Facility] of [City], approved June 24, 2019, indicated that the " Board [GB] is responsible for assuring that health care services provided at the Local Hospital are of high quality, safe, effective, efficient and consistent with community standards. This Hospital Community Board shall be responsible for: (i) ongoing quality assessment, performance improvement, patient safety and utilization management activities ... (ii) assuring that quality and patient safety issues are addressed and resolved appropriately; (iii) assuring quality assessment, performance improvement, patient safety and utilization management activities of the Local Hospital (including outcomes, recommendations and actions undertaken ... be reported ...to the Board"

Review of hospital bylaws title, 2019 Amended and Restated Bylaws of the Community Board of [Facility] of [City], approved June 24, 2019, indicated " Hospital Policies and Procedures ...shall be approved by this Hospital Community Board, where such approval is required to be taken by a governing body ...Such policies and procedures shall be consistent with policies and procedures policies and procedures shall be periodically reviewed by this Hospital Community Board to assure they are accurate, conform to current legal and regulatory requirements, and are consistent with actual practice"

Review of hospital bylaws title, 2019 Amended and Restated Bylaws of the Community Board of [Facility] of [City], approved June 24, 2019, indicated the Hospital Community Board shall assure that the Medical Staff (a) participates in the measurement, assessment and improvement of clinical and non¿clinical processes affecting patient care The activities of the Local Hospital (including outcomes, recommendations and actions) undertaken ...shall be reported to this Hospital Community Board ... The Medical Staff shall identify and implement an appropriate response to findings. Such quality assessment and performance improvement activities shall be regularly reported to this Hospital Community Board".

Review of hospital bylaws title, 2019 Amended and Restated Bylaws of the Community Board of [Facility] of [City], approved June 24, 2019, indicated that "MEDICAL STAFF MATTERS ... shall be organized for the adequacy and quality of medical care rendered to patients ...adequacy and quality of medical care and professional work ... There shall be Medical Staff Bylaws and Rules and Regulations for ... Written, defined criteria for Medical Staff appointment and the granting of clinical privileges ... physician responsible for the service be certified or eligible for certification by an appropriate American medical specialty board ... Medical Staff be required to demonstrate their ability to perform surgical and other procedures competently at the time of original appointment and at least every two years ... licensed Practitioner with appropriate clinical privileges shall be directly responsible for patient diagnosis and treatment ... The mechanisms for reviewing credentials, delineating clinical privileges, conducting, evaluating, and revising quality assessment and performance improvement activities ... the Medical Staff Executive Committee shall make recommendations to the Hospital Community Board ... Board shall take final action on such recommendations".

Based on interview and record review, the Governing Body (GB) failed to have oversight of the hospital's medical staff, quality program, patient outcomes and safety events/occurrences.

This failure resulted in disorganization and a disconnected hospital system that jeopardized the health, safety and quality of care for all patients.

Findings:

A concurrent interview and record review occurred on 3/16/2023, at 2:30 p.m., via ZOOM with Governing Body (GB) members. In attendance were GB President (PR), CEO family community board member (CEO/CBM), Chief of Medical Staff (CM), and Executive Assistant to the President. (SEA). The GB indicated they were not aware that GB requirements were not met. The GB indicated "not involved in day-to-day operations" of the hospital. The GB indicated that there is "limited time" to discuss all the hospital functions and committee duties. The GB indicated they "rely" committees to monitor hospital functions and report the findings to the GB. Community Board, MEC, QMC monitor hospital functions, safety and patient care. Rely on the quality committee members to follow provider competence and performance, patient safety, and quality of care.

The GB indicate they were not aware of any concerns related to patient safety, quality of care or provider performance. The GB indicated they "rely" on the Quality Committee (QMC) to address professional performance of providers, patient safety, patient care outcomes and quality of care. The GB indicated if the committees MEC and QMC "address the concerns" and the committee "resolved" the issue, the GB does not have a "formal discussion". The GB indicated they "rely on Medical Staff Committee (MEC) to "validate" credentials, and qualifications and privileges are done at the level of the MEC. The GB indicated decisions are made based on MEC's recommendations. GB indicated "overkill" to review hospital bylaws, policy and procedures. The GB indicated the "Community Board" and "Spirit Corporation" review and approve policy and procedures and the MEC is "aware" of them. GB indicated that medical staff rules and regulations did not require GB review. The GB indicated, they "rely" on the MEC of medical staff to disseminate hospital requirements, and policy and procedures information to providers and departments. It is their "responsibility". The PR indicated the GB needs "to get Infront of the many layers" of transfer of information. The PR indicated the GB there are "separate opportunities" to consider for improvements related to "leadership development, accountability, oversight"

Review of hospital bylaws title, 2019 Amended and Restated Bylaws of the Community Board of [Facility] of [City], approved June 24, 2019, indicated that the " Board [GB] is responsible for assuring that health care services provided at the Local Hospital are of high quality, safe, effective, efficient and consistent with community standards. This Hospital Community Board shall be responsible for: (i) ongoing quality assessment, performance improvement, patient safety and utilization management activities ... (ii) assuring that quality and patient safety issues are addressed and resolved appropriately; (iii) assuring quality assessment, performance improvement, patient safety and utilization management activities of the Local Hospital (including outcomes, recommendations and actions undertaken ... be reported ...to the Board"

Based on observation interview and record review the facility failed to protect and promote each patient's rights for safety and privacy when:

1. Endoscopes (a flexible instrument used to view internal parts of the body) were not transported, reprocessed (a special process used to prepare the product for reuse) and stored in a manner that assured they were clean, safe, and functional. (Refer to A750 Finding 1 and 3)
2. The facility's humidification system malfunctioned on 1/6/23 and was not promptly repaired. The system was turned off to prevent water leaks which caused humidity (water vapor in the air) levels in the facility to drop below 20% (normal range 20-60%) in the facility's Operating Rooms (OR), Sterile Core (SC), and Sterile processing departments (SPD). (Refer to A701, A750 Finding 2)

3. Protected Health Information (PHI- health information in any form, including physical records, electronic records, or spoken information) was left unattended and not protected in the facility's emergency department (ED) and inpatient setting. This failure had the potential to result in unauthorized access of PHI for patient in the ED and nine of nine patients admitted to the facility. (Refer to A146)

4. Narcotics intravenous (IV- in a vein) drip medications were left unlocked and unattended in the Intensive Care Unit (ICU- a specialized unit a hospital that provides comprehensive care for critically ill patients). (Refer to A405 Finding 4)

The cumulative effect of these systemic problems resulted in failure to ensure patients were cared for in a safe manner, and their rights were protected and promoted at all times.

Based on observation, interview, and record review, the hospital failed to ensure the rights of patients to receive care in a safe environment when:

1. Endoscopes (a flexible instrument used to view internal parts of the body) were not transported, reprocessed (a special process used to prepare the product for reuse) and stored in a manner that assured they were clean, safe, and functional.

2. The facility's humidification system malfunctioned on 1/6/23 and was not promptly repaired. The system was turned off to prevent water leaks which caused humidity (water vapor in the air) levels in the facility to drop below 20% (normal range 20-60%) in the facility's Operating Rooms (OR), Sterile Core (SC), and Sterile processing departments (SPD) and had the potential to cause surgical site infections and/ or fire.

3. The Quality Committee (QMC) failed to develop and implement an effective and ongoing data driven quality program that tracked, monitored, and investigated provider performance, adverse events, patient safety and quality of care.

4. Two of two Licensed Nurses (ICU RN 2 and ICU MGR) did not follow the facility policy "Management of Controlled Substances" and the Smart Pump Manufacturers Instruction for Use (IFU) for one of one patient sampled (Pt 3) which had the potential to result in the removal of medication from the unsecure, unattended controlled substance bag by visitors, patient and staff for unauthorized use.

These failures resulted in an unsafe environment for patients, visitors, and staff.

Findings:

1. During an interview on 3/6/2023 at 10:30 a.m., with the Endoscopy Manager (ENDO MGR) 1, in the Pavilion out-patient Operating Room (OR) Department, the ENDO MGR stated the facility Endoscopy Department followed the ASGE Guidelines when developing processes and policies and procedures and the AORN as a professional reference.

During an observation on 3/7/23, at 11:41 a.m., in Operating Room (OR) 6 of the facility outpatient [Pavilion], at end of the colonoscopy (a procedure in which a doctor uses a colonoscope or scope, to look inside your rectum and colon) and hemorrhoidectomy (surgery to remove internal or external hemorrhoids that are extensive or severe) procedure, the Endoscopy Technician (ET) 1, wiped the outside of the soiled endoscope (a flexible instrument used to view internal parts of the body) with a gauze (a bandage, a cloth, a thin piece of material used to cover wounds) pad. ET 1 placed the endoscope into a biodegradable plant-based material transport container. ET 1 placed a cardboard lid marked "biohazard" on top of the transport container. The transport container was placed on a metal pushcart (the cart is open to air, top shelf is only supported by 2 long metal rods, lower shelf is basket type wire metal cart), and open to air. The ET 1 exited the OR room 6 into an OR corridor leading to the public elevator to the Pavilion Main Lobby (floor 1). The ET 1 pushed the cart through the [Pavilion] out-patient and visitor lobby, and across to the glass enclosed corridor (which connects the outpatient building and the main hospital) to the main hospital. The ET 1 continued transporting the container to the OR staff elevators (1st floor) down to the Sterile Processing Department (SPD) (where the process of repurposing is carried out on a device to allow its subsequent safe use, which can include cleaning, disinfection, and sterilization) at the basement level of the main hospital. This transport process took a total of 14 minutes from time the ET 1 left OR 6 and arrived at the entrance of the SPD decontamination room door.

During an observation on 3/7/2023, at 11:55 a.m., in the SPD, ET 1 entered the "decontamination" (area where manual cleaning of endoscopes is performed) room performed hand hygiene, put on Personal Protective Equipment (PPE) such as mask, face shield, gown and started the endoscope visual inspection and testing process. Once the visual inspection and testing process was completed ET 1 performed manual cleaning of the endoscope and transferred the wet endoscope to a green leak-proof bag. ET 1 placed the green bag on the shelf at the pass-through window from the "dirty" room to the "clean" room. ET 1 removed PPE and performed hand hygiene. ET 1 entered the "clean" side of the SPD. ET 1 collected the green bag and placed it into a new disposable transport container. ET 1 placed a cardboard lid marked "clean" on top of the transport container. ET 1 carried the transport container to the 1st floor Endoscopy Procedure Suite for final High-Level Disinfection (HLD) (includes heat-automated pasteurization (partial sterilization of a product) or liquid immersion chemical sterilant (disinfectant)). The manual cleaning process, including transport back up to the 1st floor for HLD, took the ET 1 36-minutes to complete.

During a concurrent observation and interview on 3/7/23, at 12:26 p.m., in the clean side of the SPD department, Endoscopy Technician (ET) 1 left the dirty decontamination area and entered the clean side of the Sterile Processing Department (SPD) without putting on disposable shoe cover protectors. ET 1 stated, "did you want me to wear it [shoe cover]" ET 1 stated she was wearing her "hospital shoes I don't leave the hospital with these shoes. I leave them in my locker" and that she didn't need to wear shoe protector.

During an interview on 3/7/23, at 12:28 p.m., with Endoscopy Manager (ENDO MGR1), ENDO MGR1 stated, his expectation was for ET 1 to wear shoe covers when going from the dirty to clean decontamination area.

During an observation on 3/7/2023 at 12:31 p.m., in the Endoscopy Procedure Suite (HLD room), ET 1 processed the clean endoscope in one of two [brand name] HLD machine compartments. ET 1 stated the HDL runs for "25 minutes". ET 1 stated there was another HLD-sanitized endoscope that had already completed its sterilization cycle in compartment #2) and would process this endoscope. ET 1 removed the sterilized endoscope from the [brand name] HLD machine, sprayed the endoscope with a chemical, and dried the endoscope with compressed (air pressed into a heavier than atmospheric (air in the atmosphere) air. ET 1 then sprayed the sterilized endoscope with a chemical and dried the endoscope with a towel. ET 1 filled out a tag identifying the endoscopy serial number, date manual wash was completed, date HLD was completed, expiration date, and initials, and placed the tag on the sterilized endoscope. ET 1 stated this sterilized endoscope will be stored in the endoscope storage locker in room next to the HLD room.

During an interview on 3/8/2023 at 9:05 a.m., with the Infection Prevention Manager (IPM), the IPM stated that Dominican Campus now Mercy Outpatient Center (MOC) at the time of pandemic (illness that affects several countries and affects many people) it was decided to move operations to the Pavilion. The IPM stated that the MOC was a self-contained Endoscopy center where the processing of endoscopes was done on site. As the pandemic (Covid 19 (an infection that is caused by the SART-CoV-2 virus)) resolved, decisions were made to combine outpatient and inpatient endoscopy procedures. The IPM stated that the workflow, as she understands it, was that the ET wipes the scope with a red sponge at point of care; places in transport container, container is placed on a cart, transported to decontamination room in SPD. The ET performs a leak, flush, manual clean of scope and then ATP (adenosine triphosphate- measurement of the cleanliness of a surface) testing is done. The IPM stated depending on the readings, the ET either recleans or moves forward. The IPM stated another container is used to place the "clean" scope in the sterile (clean) side through a pass-through window. HLD is done on the 1st floor. ET hooks up, runs through cycle (disinfection, clean, drying) then places endoscope in endoscope cabinet after being tagged, if not used within 5 days ET will reprocess the endoscope.

During a concurrent observation and interview on 3/8/23, at 10:29 a.m., with IPM in the endoscope storage room, the IPM stated that the endoscopes hanging in the cabinet were touching each other and not hung freely. IPM stated the endoscopes should not touch each other to prevent cross contamination.

During an interview on 3/8/2023 at 10:33 a.m., with ET 1, ET 1 stated that endoscopes were reprocessed every five days, per policy, if they were not used before the expiration date on the label. ET 1 stated that the endoscopes are usually used before the five day expiration date. ET 1 stated that the clean endoscope storage locker was ventilated and was cleaned by an "endo tech usually on weekends." Endoscopes were sometimes moved out so that cleaning of the cabinet could take place. ET 1 stated the endoscopes were housed in a clean disposable transport container while they clean the locker out with disinfectant wipes.

During an interview on 3/8/23, at 10:52 a.m., with IPM, IPM stated, the container used during transportation of the dirty endoscope was not sealed (leak proof) but covered and a maximum of two containers could be stacked on each other during transport to SPD.

During concurrent observation and interview on 3/11/23 at 12 p.m., in the endoscopy suite storage room, with Endoscopy Technician (ENDO) 1 and Endoscopy Manager (ENDO MGR) 1, ENDO 1 demonstrated her process for drying and storing the endoscopes. The storage room had one endoscope cabinet that stored sixteen endoscopes. The endoscopes were hung vertically, some hung by the distal (from the point of attachment) tip and others by the control section. The sixteen endoscopes were compacted in the cabinet with the sides contacting each other. ENDO 1 stated, "It's always been like this." ENDO 1 stated had been employed since 2007 and the method of storing the endoscopes had not changed. ENDO MGR 1 stated, he was aware of the inappropriate storage method and the facility was in the process of adding a second storage cabinet to the storage room. ENDO MGR 1 stated, "[Endoscopes] cannot touch ... we knew that."

During an interview on 3/15/23, at 10:40 a.m., with the Infection Preventionist Manager (IPM), the IPM stated she was not consulted when facility decided to move Outpatient Endoscopy (off campus) to the on-campus Outpatient surgical center. The IPM stated she was not consulted on the route the endoscopes would take through the facility in order to get to the decontamination and processing room. The IPM stated she was not consulted on the container the dirty endoscopes would be transported in. The IPM stated the route the endoscopes took from the outpatient to the inpatient was not safe, "If anyone had bumped into them (staff transporting the endoscopes), the lid covers did not seal (to the transport containers used to transport the dirty endoscopes) and could tip over and open and cause cross contamination."

During a review of the [brand name] "Scope Transport Tray" product information, undated, "Scope Transport Tray" indicated, " ...Product description trays are made of a biodegradable plant-based material this is a 100% renewable resource reducing the facilities carbon footprint ..."

During a review of the professional reference retrieved from https://aornguidelines.org/guidelines/content?sectionid=173735349&view=book#229132776, titled, "AORN (Association of periOperative Registered Nurses) (eGuidelines)", dated September 2022, the professional reference indicated, " ...Contaminated endoscopes and accessories must be transported to the decontamination area in a closed container or closed transport cart. The container or cart must be ... leak proof on the sides and bottom ... puncture resistant ... Containing contaminated endoscopes and accessories decreases the potential for injury to personnel or their exposure to blood, body fluids, or other potentially infectious materials and helps prevent damage to the endoscopes during transport. Labeling the transport containment device communicates to others that the contents are potentially infectious ..."

During a review of the professional reference titled, "Association for the Advancement of Medical Instrumentation ANSI/AAMI ST91:" dated 2021, indicated, " ... 3.62: rigid sterilization container system sterilization containment device designed to hold medical devices for sterilization, storage, transportation, and aseptic (free from contamination) presentation of contents Note to entry: The system generally consists of a bottom or base with carrying handles and a lid that Is secured to the base by means of a latching mechanism. A basket or tray to hold instruments or other Items to be sterilized is placed inside. A filter or valve system Is Incorporated into the lid and/or base to provide for air evacuation and sterilant (an agent used to destroy microorganisms) penetration during the sterilization cycle and to act as a barrier to microorganisms during storage, handling, and transport ..."

During a review of the facility policy and procedure titled, "Cleaning of Patient Care Equipment (IC-500-03)", dated 1/24/2029, indicated " ...Procedure; 2. Semi-critical items (a medical device that comes into contact with mucous membranes or non-intact skin) are reprocessed by cleaning, followed by high level disinfection. High level disinfection is documented by Central Sterile Processing Department or the clinical area responsible for high level disinfection ....10. Soiled/contaminated equipment should be transported to Central Supply or moved to the dirty utility room. The dirty utility room should not be utilized for prolonged equipment storage ....14. Healthcare providers are responsible for cleaning/sanitizing patient equipment between patient uses or prior to transport to Central Processing for decontamination ..." 17. Departments must have procedures in place for cleaning, decontamination and disinfection of specialty equipment used in their area (e.g., endoscopes). These policies and procedures will be maintained in the individual departments ..."

During a review of the professional reference retrieved from https://aornguidelines.org/guidelines/content?sectionid=173735349&view=book#229132776, titled, "AORN (Association of periOperative Registered Nurses) (eGuidelines", dated September 2022, the professional reference indicated, " ... Clean and disinfect storage cabinets used for flexible endoscopes with an EPA-registered (Environmental Protection Agency) hospital-grade disinfectant when visibly soiled and on a regular basis (e.g., daily, weekly) ..."

During a review of the Facility Skills titled, "Flexible Endoscope Care and Maintenance" undated, the Skills indicated, " ...Completing the Procedure ...Clean the storage cabinets on a regular basis or when visibly soiled per the organization's practice ..."

During a review of the job description for "Endoscopy technician", dated 10/2019, the job description indicated, " ...Infection Control ...Demonstrates proper hand washing, uses personal protective equipment per policy, follows isolation techniques where indicated, adheres to universal precautions ..."

During a review of the facility policy titled, "surgical instrument cleaning, decontamination, and inspection (SS-417)", dated 2/2018, indicated, " ... employees will be wearing PPE when working with contaminated instrumentation (goggles with mask/face shield, plastic apron, gloves, shoe covers) ..."

2. During a concurrent observation and interview on 3/3/23, at 11:15 a.m. in the Family Birthing Center (FBC) sterile core (designated area adjacent to the OR to store sterile supplies), with Family Birthing Center Manager (FBC MGR), the FBC MGR provided a tour of the FBC department, including the FBC OR and sterile core. The FBC MGR validated water leaked from the ceiling on 1/17/23, resulting in the temporary closure of FBC OR- B and the removal of supplies from the sterile core. The FBC MGR stated the supplies were moved due to potential infection control concerns. The FBC MGR stated staff from the facility's plant operations (FPO) repaired the damaged ceiling but was uncertain if the cause of the leak was repaired.

During an interview on 3/6/23 at 9:05 a.m., with the Plant Operations Director (PO DIR), the PO DIR stated, the facility's humidification system (the part of the heating, ventilation, and air conditioning system that controls humidity) was "turned off" due to ongoing complications related to the system. The PO DIR stated the problem was discovered "sometime" in January 2023 when water leaks emerged in the facility's Intensive Care Unit (ICU- a unit in a hospital providing intensive care for critically ill or injured patients), Neonatal Intensive Care Unit (NICU- an intensive care unit specializing in the care of ill or premature newborn infants in their first 28 days of life), and the FBC sterile core. The PO DIR stated, "we have leaks everywhere" and so the decision was made to turn off the humidification regulation system until it was repaired. No anticipated repair date was provided. The PO DIR stated there were "occasions" when humidity levels in the main operating rooms (ORs), FBC ORs, and FBC sterile core fell below acceptable ranges (20- 60%) and staff had contacted the FPO requesting the system be evaluated. The PO DIR stated he would "turn the [humidification] system back on to correct" the low humidity levels. The PO DIR stated he could not provide work orders (formal request document, paper or digital, for maintenance services) for all work done to the humidification system due to "difficulties" with the facility's "new work-order system" implemented in July 2022. The PO DIR stated his department was short staffed and it was "hard to manage his guys" and the work orders.

During concurrent interviews on 3/6/23 at 9:15 a.m., in the Sterile Processing Department (SPD), with the Sterile Processing Department Supervisor (SPDS) and the PO DIR, the SPDS stated, temperature and humidity in the SPD was checked in the department and logged daily at the start of every shift. The SPDS stated staff notified the FPO when temperature and humidity in the SPD "registered" outside set parameters (between 30-60%). The SPDS stated there was no system that "alarmed" in the SPD department but "If it feels humid, we go to the wall and check" and pointed to the wall mounted thermometer hygrometer (a device that is used to measure both the current air temperature and the relative humidity). The SPDS stated he was told FPO staff remotely monitored (watch or keep track of something from a different location) the SPD. The PO DIR stated the temperature and humidity was tracked by the facility's monitoring system, but the system was dependent on staff reporting abnormal ranges to FPO. The SPDS stated he was not aware the humidification system "turned off."

During an interview on 3/7/23 at 12:10 p.m., with Pharmacy Director (PD), the PD stated, pharmacy followed professional standards outlined in (chapter in the United States Pharmacopeia- National Formulary that describes requirements for the preparation of sterile drugs) for the sterile compounding of medications [the method of preparing custom medications for patients in a sterile environment to prevent contamination and ensure patient safety]. The PD stated this required strict temperature and humidity controls for the compounding and storage of medications in the pharmacy department. The PD stated temperature and humidity levels were not within parameters "about six months ago." The PD stated the FPO was notified and "eventually" the temperature and humidity levels returned to normal (less than 68 degrees Fahrenheit (F); less than 60% humidity). The PD stated he was not aware the humidification system was off and in need of repair.

During an interview on 3/9/23 at 8:15 a.m., with Pediatric Medical Doctor (MD) 7, MD 7 stated, she was the medical director for the facility's Neonatal Intensive Care Unit (NICU). MD 7 stated the NICU was a "separate hospital" within the facility that operated independently and had separate staff, supplies, and equipment. MD 7 stated newborn infants (babies from birth to about 2 months of age) were admitted to NICU with complications and transferred to the "separate hospital" if the newborn required higher level of care. MD 7 stated the NICU, although independent from the facility, depended on facility operations to maintain appropriate temperature and humidification for the NICU. MD 7 stated there was a "[water] leak" in the NICU "over a month ago" due to an issue with the facility's humidification system which "shut down my NICU." MD 7 validated parts of the ceiling collapsed in a newborn patient's room. MD 7 stated NICU staff had to divert newborn patients to the main hospital off campus for safety. MD 7 was not aware the humidification system was off.

During an interview on 3/10/23 at 2:35 p.m., with the PO DIR, the PO DIR stated his department (FPO) was aware of the humidification system leaking on 1/6/23. The PO DIR stated his engineers "repaired" the leak but "a day or so later it happened again." The PO DIR stated the leak kept "moving" to different areas of the facility "a couple more days later." The PO DIR stated the leaks were "taken seriously" when leaks in the OB and NICU occurred on 1/17/23 and "a company was called in." The PO DIR stated he turned on the humidification system after the inspection was performed by the vendor. On 2/12/23, another leak occurred in the OR sterile area and "I made the decision to turn off the [humidification] system" until the necessary parts came in and the vendor could repair the system. The PO DIR stated his plan was to "leave it off for a while and see if it dries up ... we think April weather would be better." The PO DIR stated no one knew but my department (FPO). The PO DIR stated he did not think to notify the departments potentially affected by his decision to turn it off. The PO DIR could not provide the work orders for the repairs done "in house" by his department since July 2022, the start of the facility's "new" work order system. The PO DIR stated no preventative maintenance was performed for the humidification system. The PO DIR stated the system was not accessible.

During an interview on 3/15/23, at 10:40 a.m., with the Infection Preventionist Manager (IPM), the IPM stated, the PO DIR advised her of the leaks caused by the humidification system and his plan to turn off the humidification system. The IPM stated she was not aware that it would affect the whole hospital but was aware it would affect the ORs, SPD, Sterile processing, sterile core and pharmacy. The IPM stated she was not aware that Pharmacy was not informed of the humidification system being turned off. The IPM stated the humidity could affect the efficacy of the medication we administer to our patients, and they should have been notified. The IPM stated if sterile supplies are not stored in the proper temperature and humidity, it could cause condensation or integrity of the wrapping to become null and void, it could lead to a surgical site infection.

During an interview on 3/17/23 at 9:40 a.m., with the Director of Perioperative Services and Cardiac Cath Lab (DPCL), the DPCL stated temperature and humidity controls were vital to maintain safety and sterility in the OR and/ or procedural areas. The DPCL validated humidity above acceptable range (greater than 60%) increased the risk for infection and humidity levels below acceptable range (less than 20%) increased the risk for fires. The DPCL stated she was not aware the facility's humidification system was off.
During a review of the facility's "L&D (labor and delivery) Trend Study" for January 2023, the trend study registered out of range humidity levels on 1/30/23. The humidity levels ranged between 16.96% and 19.92% for five to eight consecutive hours.

During a review of the facility's "L&D Trend Study" for February 2023, humidity levels registered out of range on 2/14, 2/15, 2/16, 2/17, and 2/18. The humidity levels ranged between 17.26% and 19.92% for three to 21 consecutive hours.
During a review of the facility's "Cath [Cardiac Cath lab] Trend Study" for March 2023, the trend study registered out of range temperatures on 3/6/23 and 3/7/23. The temperature levels ranged between 65.89 degrees F and 67.23 degrees F. The trend study had one registered temperature reading for both days.

During a review of the facility's "2nd Floor Sterile Core Trend" for February 2023, temperatures registered out of range on 2/8, 2/9, 2/10, 2/11, 2/12, 2/13, 2/14, 2/15, 2/16, 2/17, 2/18, 2/19, 2/20, 2/21, 2/22, 2/23, 2/24, 2/25, and 2/26. The temperatures ranged between 67.2 degrees F and 67.9 degrees F for one to five consecutive hours. Out of range humidity levels registered on 2/14, 2/15, 2/17, and 2/18. The humidity ranged between 13.82% and 19.96% for one to four consecutive hours.

During a review of the facility's "[Main] OR Temp & Humidity Trend Study" for January and February 2023 the trend study indicated the registered temperatures and humidity ranges once in a 24-hour period for ORs one through five. OR#5 and OR#3 did not have registered readings between 2/9/23 to 2/27/23.

OR#1: Temperatures registered out of range on 2/4, 2/6, 2/9, 2/10, 2/13, 2/15, and 2/16. The temperatures ranged between 67.4 degrees F and 67.7 degrees F. The humidity level registered out of range on 2/15. The humidity on 2/15 was 17.8%.

OR#2: The humidity levels registered out of range on 2/15 and 2/22. The humidity levels ranged between 16.81% and 19.64%.

OR#3: No out of range temperature and humidity readings between 1/31/23 and 2/8/23.

OR#4: Humidity registered out of range on 1/31, 2/15, 2/16, 2/17, 2/18, and 2/22. The humidity levels ranged between 16.27% and 19.87%. The trend study had one registered humidity reading for each day.

OR#5: No out of range temperature and humidity readings between 1/31/23 and 2/8/23.

During a review of the facility policy and procedure (P&P) titled "Perioperative Environmental Controls and HVAC Variances in the Operating Rooms, Cath Lab, Central Sterilization," dated 3/7/23, the P&P indicated, " ... Engineering will contact the Operating Room (OR) manager or charge nurse concerning any "out of range" values, in addition to taking corrective measures ... Design relative humidity ... operating room ... 20-60%... Central Sterilization clean workroom ... 30- 60%... Decontamination room ... 30- 60%... Sterile storage room ... temperature ... 68-73 degrees F ... humidity ... 30- 60%... Gastrointestinal endoscopy procedure room ... 20-60%... post anesthesia care unit ... 20-60%... Procedure room ... Temperature ... 70- 75 degrees F ... humidity ... 20-60%... "

A review of the professional reference at https://www.ashrae.org/file%20library/technical%20resources/bookstore/whitepaper_tc0906-humidcontroleventsinperiopcareareas.pdf titled, "Humidity Control Events in Perioperative Control Areas", dated 2019, indicated, " ...a humidity control event occurs when the RH is above or below the established facility RH [relative humidity] range ... Primary consideration must be for the safety of patients ... Areas of infection risk that are associated with low or high RH ... include ... Development of mold and mildew in high-RH air (water in gas form cannot be utilized by fungi unless the RH is over 85%) ... Loss of healthy immune system functioning (respiratory epithelium, skin, etc.) in vulnerable patients and in on-site hospital staff ... Shelf life and integrity of sterile supplies and equipment calibration ... Transmission of airborne and droplet diseases ... Survival rate of pathogens [germs that cause disease] ... Decreased effectiveness of hand hygiene and surface cleaning because of surface recontamination ... "

A review of the professional reference at https://www.ast.org/uploadedFiles/Main_Site/Content/About_Us/ASTGuidelinesHumidityintheOR.pdf titled "Guidelines for Best Practices for Humidity in the Operating Room", dated 6/17, indicated, " ... RH [relative humidity] level is important to the shelf life of sterile supplies that are stored in the surgery department and the levels established by manufacturers of electromedical devices ... Therefore, shelf life and product integrity can be even more greatly affected if the IFU [information for use] calls for 30-60% RH, but the HDO [healthcare delivery organization] lowers the RH to 20%. Examples of products that are sensitive to humidity include biological and chemical indicators, and EKG [electrocardiogram] electrodes [sticky patches with wires that connect to a monitor used to check electrical activity of the heart]. Manufacturer's test products at a specific RH, of which it can be assumed the testing level has been at 30%... The manufacturers of electro-medical devices (EMD) and healthcare technology management (HTM) have communicated concerns about lower RH levels. Problems with EMDs not working properly at lower RH levels have been reported by HTM technicians, and the lower levels causing problems with calibration ..."

A review of the professional reference at https://www.usp.org/sites/default/files/usp/document/our-work/compounding/proposed-revisions-gc-797.pdf titled "?797? PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS", undated, indicated, " ... Facility Design and Environmental Controls ... continuously maintained at a temperature of 20° or cooler and a relative humidity below 60% to minimize the risk for microbial proliferation ... Temperature and humidity in the cleanroom suite must be controlled through an efficient heating, ventilation, and air conditioning (HVAC) system ..."

During a review of the policy and procedure (P&P) titled, "Preventative Maintenance Policy", dated 9/1/21, the P&P indicated, " ... to establish specific guidelines for the testing and inspection of all equipment supported by clinical engineering... Preventative maintenance shall be performed in accordance with the manufacturer's recommendations and accepted industry standards 1. If the manufacturer does not state any recommended periodic or preventative servicing, the device will be tested for electrical safety and/ or visually inspected for safety as appropriate at least annually. 2. In instances in which manufacturer recommendations are unavailable accepted industry standards will be used to complete a preventative maintenance activity at least annually ... time between PM 's may not exceed the original manufacturers recommendations... and the inventory file will be maintained for each item of medical equipment supported by clinical engineering. Each file will contain a historical data record with the CE number, equipment description, serial number, location, date of installation, and cost ..."

During a review of the manufacturer's manual titled, "H-1-30, [name of manufacturer] steam generating humidifier Installation, Operation, and Maintenance Manual", undated, the manual indicated, "all corrective actions shall be made in accordance with original equipment manufacturer's standards and acceptable industry standards ... Maintenance ... Inspect the strainer screen at least twice during the first year... Steam Trap... At least twice a year verify that the steam trap is functioning properly... Valves... Pneumatic ... Inspect annually to be sure that the valve close this off steam tightly the stem packing is not leaking steam and the diaphragm in the actuator is not leaking air... Electric Modulating... Inspect annually to be sure that the valve operates freely and closes off steam tightly and the stem packing is not leaking... Solenoid Type... Inspect annually to verify proper functioning with steam tight shut off... O-Rings ... Inspect after 2 or 3 years of service replace if necessary... Troubleshooting guide... problem... humidifier discharges water in duct ... Possible cause steam main overloaded with water due to boiler discharging water with steam... steam trap not draining properly... humidifier improperly piped... surges of condensate and steam supply due to condensate collecting at low, undripped point in steam main... inadequate steam trap capacity... Action ... locate cause of priming and correct... replace, repair, or clean trap as required... if condensate return main is overloaded, find an alternative method for draining... correct the piping ... horizontal air flow, steam inlet should be at the top of the assembly and condensate outlet at the bottom of the assembly... installed drips and steam traps as required... replace the larger trap... replace O-rings..."

3. During a concurr

Based on observation, interview, and record review, the facility failed to protect Protected Health Information (PHI- health information in any form, including physical records, electronic records, or spoken information) for nine of nine patients (Patient 33, Patient 42, Patient 43, Patient 44, Patient 45, Patient 46, Patient 47, Patient 48, and Patient 49) when the name, diagnosis, and medical record numbers of Patients 33, 42, 43, 44, 45, 46, 47, 48, and 49 were left unattended and displayed on the Workstation on Wheels (WOW- Electronic Medical Record cart or Mobile Computer cart). Medical records pending storage were left unattended and uncovered in the emergency department (ED).

This failure had the potential to result in unauthorized access of Patient 33, 42, 43, 44, 45, 46, 47, 48, and 49's PHI.

Findings:

During a concurrent observation and interview on 3/3/23, at 11:27 a.m., with the Emergency Department Charge Nurse (ED CN), in the emergency department nurses station, one of three metal baskets containing medical records was left uncovered and unattended. The ED CN validated that the basket contained patient records for collection by the Medical Records department. The ED CN validated the basket was left unattended and in clear view of unauthorized persons (patients, visitors, and staff). The ED CN stated that unauthorized persons do approach the nurse's station and that staff should place the documents underneath a privacy cover (laminated cover, yellow in color with"confidential, PHI-HIPPA, please place charts under this cover sheet").

During a concurrent observation and interview on 3/3/23, at 3:30 p.m., in the Cancer Infusion Center (CAIC), with the CAIC Clinical Manager (CAIC MGR), CAIC MGR provided a guided tour of the infusion room. The infusion room was a large open room with high staff and patient activity. An unattended WOW was positioned facing the center of the room. The workstation had a facility document titled "Daily Master Schedule 3/3/23" left faced up. The document contained Patient 42, 43, 44, 45, 46, 47, 48, and 49's names, diagnoses, medical record numbers and appointment times. The CAIC MGR looked at the facility document and validated the document contained patient PHI and should not have been left unattended, easily accessible to unauthorized persons. The CAIC MGR stated the expectation was that staff maintain patient PHI always protected. The CAIC MGR stated the nurse responsible for the document should have turned the document upside down or take it with her before leaving the workstation.

During an observation on 3/6/23, at 9:44 a.m., in the Intensive Care Unit (ICU), the unattended computer positioned in between patient rooms was open and visible to the public from the hallway. The computer screen displayed Patient (Pt) 33's name, date of birth, weight, sex, room number, admission date, medical record number, vital signs (reflect essential body functions, including your heart rate, breathing rate, and blood pressure), visible to everyone who passed by the computer.

During a concurrent observation and interview on 3/6/23, at 9:46 a.m., with Intensive Care Unit Registered Nurse (ICU RN) 3, ICU RN3 stated, the unattended computer screen displayed Pt 33's information such as name, vital signs, age, and medical record number. ICU RN3 stated she did not log out of the computer prior to going to use the restroom. ICU RN3 stated the computer screen should be logged out when not in use to prevent unauthorized access.

During a review of the facility's policy and procedure (P&P) titled, "Privacy Safeguards for Protected Health Information" dated 6/2021, the P&P indicated, " ...must utilize appropriate Administrative, Technical, and Physical Safeguards to protect the Privacy, security, and integrity of the Protected Health Information (PHI) used, maintained and Disclosed ...Other safeguards may include, but are not limited to, the following ... maintain paper PHI in areas that are not accessible by unauthorized individuals. This includes securing paper PHI in locked cabinets common bins, etc., and ensuring physical access to rooms containing cabinets, bins caps, etc., is restricted from the general public ... Restrict the view of computer monitors/screens with positioning or screensavers ..."

Based on interview and record review, the Quality Committee (QMC), failed to develop and implement an effective and ongoing data driven quality program that track, monitor and investigate provider performance, adverse events, patient safety and quality of care.

These failures failure to complete a root cause analysis on adverse events increased the likelihood of harm to patients. (In addition refer to A 273 and A283)

The cumulative effect of these systemic problems resulted in the inability of the hospital to provide care in a safe setting.

Findings:

A concurrent interview and record review interview occurred on 3/17/2023 at 11:27 am via ZOOM with the Quality Committee (QMC). In attendance were Director Medical Staff Administration, (DMSA), Chief Medical Officer (CMO), Quality Director (QD) and Peer Review Nurse, (PRN). The QMC team acknowledged the Governing Body (GB) "depends" on the medical staff and QMC program to report information to follow patient safety and quality of care. The QMC team indicted that the CMO and Medical Staff team (MEC) deem when grievances, clinical and/or behavioral concerns are "resolved", "appropriate" and/or "closed". The QMC team indicated that a report of the events are tracked by medical staff and QMC and provided to the GB in a report. The QMC indicated they "share" behavioral, grievance and/or clinical concerns with the provider. The CMO and QD stated, if there are concerns, the Chair of the department will discuss them with the provider, and if needed the Chair will bring the concern to the attention of the CMO. The MEC determine what is provided to the GB. There is Root cause analysis or no further investigation.

QMC team indicated that they set up the data collection parameters OPPE(Ongoing Professional Practice Evaluations identifies professional practice trends that may impact the quality and safety of care and applies to all practitioners granted privileges) data collection. QMC indicated OPPE is to be collected at each privileging cycle and the "department chairs" review it medical staff. The CMO will "communicate" with the Chief of Staff who is a member of the GB. The CMO indicated, "don't get into the details of OPPE" but look at "if done of not done". QMC indicated OPPE data is not monitored, tracked, trended or acted upon. QMC indicated the Midas (tracking system for incident reports) events are not tacked or trended in OPPE. Q MC team indicated there is a "gap" in OPPE and RCA review and action.

Review of hospital bylaws title, 2019 Amended and Restated Bylaws of the Community Board of [Facility] of [City], approved June 24, 2019, indicated the "Hospital Community Board shall assure that the Medical Staff (a) participates in the measurement, assessment and improvement of clinical and non¿clinical processes affecting patient care The activities of the Local Hospital (including outcomes, recommendations and actions) undertaken ...shall be reported to this Hospital Community Board ... The Medical Staff shall identify and implement an appropriate response to findings. Such quality assessment and performance improvement activities shall be regularly reported to this Hospital Community Board".

Review of hospital bylaws title, 2019 Amended and Restated Bylaws of the Community Board of [Facility] of [City], approved June 24, 2019, indicated that "Quality Assessment, Performance Improvement, Patient Safety and Utilization Management. This Hospital Community Board is responsible for assuring that health care services provided at the Local Hospital are of high quality, safe, effective, efficient and consistent with community standards. This Hospital Community Board shall be responsible for: (i) ongoing quality assessment, performance improvement, patient safety and utilization management activities of the Local Hospital; (ii) assuring that quality and patient safety issues are addressed and resolved appropriately."

Based on interview and record, the Quality Committee (QMC) , failed to collect data that impacted provider performance, quality of care and treatment outcomes.

The failure to collect data, the QMC could not identify opportunities for improvement and implement change that could lead to safer patient care and quality improvement.

Findings:

A concurrent interview and record review interview occurred on 3/17/2023 at 11:27 am via ZOOM with the Quality Committee (QMC) team. In attendance were Director Medical Staff Administration, (DMSA), Chief Medical Officer (CMO), Quality Director (QD) and Peer Review Nurse, (PRN). QMC team indicated they are unsure who has been responsible for analyzing, monitoring, investigating and acting in upon the data collected for OPPE. The QMC team indicated they do not review the information, and it not part of the hospital QMC program. QMC acknowledged adverse events and Midas information are placed in OPPE, and if they are "closed" are not investigated, even if there was adverse patient outcome The QMC team indicted the CMO and medical staff office deem when grievances, clinical and/or behavioral concerns are "resolved", "appropriate" and/or "closed" and there is Root cause analysis or no further investigation. QMC team acknowledged they do not track hospital acquired infections, surgical complications, length of stay, readmissions, mortality, and pressure ulcers. QMC team indicated there is "no manpower" to "deep dive" and "rigorous analysis" into events that may interfere with patient safety and quality care. The QMC team indicated they "need to do better" for RCA (root cause analysis), verification of competency, oversight, QD indicated the OPPE will be reviewed by the QMC team in the future.

Review of hospital bylaws title, 2019 Amended and Restated Bylaws of the Community Board of [Facility] of [City], approved June 24, 2019, indicated the "Hospital Community Board shall assure that the Medical Staff (a) participates in the measurement, assessment and improvement of clinical and non¿clinical processes affecting patient care The activities of the Local Hospital (including outcomes, recommendations and actions) undertaken ...shall be reported to this Hospital Community Board ... The Medical Staff shall identify and implement an appropriate response to findings. Such quality assessment and performance improvement activities shall be regularly reported to this Hospital Community Board".

Review of hospital bylaws title, 2019 Amended and Restated Bylaws of the Community Board of [Facility] of [City], approved June 24, 2019, indicated that "Quality Assessment, Performance Improvement, Patient Safety and Utilization Management. This Hospital Community Board is responsible for assuring that health care services provided at the Local Hospital are of high quality, safe, effective, efficient and consistent with community standards. This Hospital Community Board shall be responsible for: (i) ongoing quality assessment, performance improvement, patient safety and utilization management activities of the Local Hospital; (ii) assuring that quality and patient safety issues are addressed and resolved appropriately."

Based on observation, interview and record, the Quality Committee (QMC) , failed to focus activities and data collection of high risk, high problem areas and provider performance and competence.

The failure to focus QA activities on readmission, infection rates, pressure sores, surgical errors, length of stay, and patient satisfaction, and missed opportunities for improvement and put patient safety and quality of care at risk.

Findings:

A concurrent interview and record review interview occurred on 3/17/2023 at 11:27 am via ZOOM with the Quality Committee (QMC) team. In attendance were Director Medical Staff Administration, (DMSA), Chief Medical Officer (CMO), Quality Director (QD) and Peer Review Nurse, (PRN). 18 provider records were reviewed and discussed: (MD 1 Anesthesiologist, MD 2 anesthesiologist, MD 3 Family Practice (FP), MD 4 FP MD 5 FP, MD 6 FP, MD 7 Pediatrician (Peds), MD 8 Peds, MD 9 Obstetrician (OB)-gynecology (Gyn), MD 10 OB-Gyn, MD 11 Surgeon, MD 12 FP, MD 13 Internal Medicine (IM), MD 14 IM, MD 15, IM, DRP/FP FP, PA 1, and PA 2).

QMC indicated they have OPPE (Ongoing Professional Practice Evaluations identifies professional practice trends that may impact the quality and safety of care and applies to all practitioners granted privileges). QD indicated OPPE is not looked at by QMC and thus there was not any corrective action, monitoring, or tracking. QMC team acknowledged that since QMC doesn't track trends in OPPE they are unaware of events that negatively impact patient outcomes. QMC indicated from the timing and dates of the OPPE's it is difficult to determine what events the data is based on and how they impact pt care and safety.

OPPE reports were information provided by [Hospital] was discussed. QMC team stated "there is a lot of red" which indicated trends provider performance and patient care concerns. Except for the number of patients seen, 9 of 18 providers (MD 1, MD 2, MD 4, MD 6, MD 7, MD 8, MD 9, PA 1, PA 2) had no data. The data metrics for 9 of 18 providers (MD 3, MD 5, MD 7, MD 10, MD 11, MD 12, MD 13, MD 14, MD 15, DRP/FP) reflected: percentage for readmissions within 7 days (target 2.25% ), a range 2.24% to 5.69% ; high percentage of readmits within 30 days (target 8.935%) a range 16.7 % to 57.1%;
high percentage for length of stay (target 1% ) a range of 1.94% to 5.82%; high percentage mortality due to sepsis (target 16.43% ) a range 18.37% to 28%; low percentage patient satisfaction (target 85%) a range 30.77% to 100%. There was no data metrics for pressure ulcers, no data. There was no to little data for peer review.

Review of hospital bylaws title, 2019 Amended and Restated Bylaws of the Community Board of [Facility] of [City], approved June 24, 2019, indicated the "Hospital Community Board shall assure that the Medical Staff (a) participates in the measurement, assessment and improvement of clinical and non¿clinical processes affecting patient care The activities of the Local Hospital (including outcomes, recommendations and actions) undertaken ...shall be reported to this Hospital Community Board ... The Medical Staff shall identify and implement an appropriate response to findings. Such quality assessment and performance improvement activities shall be regularly reported to this Hospital Community Board".

Review of hospital bylaws title, 2019 Amended and Restated Bylaws of the Community Board of [Facility] of [City], approved June 24, 2019, indicated that "Quality Assessment, Performance Improvement, Patient Safety and Utilization Management. This Hospital Community Board is responsible for assuring that health care services provided at the Local Hospital are of high quality, safe, effective, efficient and consistent with community standards. This Hospital Community Board shall be responsible for: (i) ongoing quality assessment, performance improvement, patient safety and utilization management activities of the Local Hospital; (ii) assuring that quality and patient safety issues are addressed and resolved appropriately."

Based on observation, interview and record, the Quality Committee (QMC) , failed to compile, measure, analyze, monitor/track medical errors and adverse events regarding provider competence and performance.

The failure to monitor, track and evaluate provider professional performance and competency endangered patient safety and the deliverance of quality care.

Findings:

A concurrent interview and record review interview occurred on 3/17/2023 at 11:27 am via ZOOM with the Quality Committee (QMC) team. In attendance were Director Medical Staff Administration, (DMSA), Chief Medical Officer (CMO), Quality Director (QD) and Peer Review Nurse, (PRN).

The Discussion continued with QMC regarding the MEC created a summary of reports related to clinical, behavioral and grievances for 18 providers (MD 1 Anesthesiologist, MD 2 anesthesiologist, MD 3 Family Practice (FP), MD 4 FP MD 5 FP, MD 6 FP, MD 7 Pediatrician (Peds), MD 8 Peds, MD 9 Obstetrician (OB)-gynecology (Gyn), MD 10 OB-Gyn, MD 11 Surgeon, MD 12 FP, MD 13 Internal Medicine (IM), MD 14 IM, MD 15, IM, DRP/FP FP, PA 1, and PA 2).

The QMC team indicated they "look at all" of Midas and incident reports. For the most recent privileging period, QMC shared that 8 of 18 providers had 25 Clinical incident reports that were related to patient care and quality, 9 of 18 providers had 25 behavioral incident reports, 6 of 18 providers had 11 grievance incident reports, and 6 of 18 providers had 16 "trending" problems. The QMC indicated they "shared" behavioral, grievance and/or clinical concerns with the provider. The QMC indicated events that are related to "communication" problems and professional behavior are discussed between the provider and staff and other providers. There is Root Cause Analysis or no further investigation.

QMC team indicated they address and "look at all" of Midas and incident reports. The QMC team acknowledged there are concerning mortality and morbidity trends for some of provider files. The QMC team indicted the CMO and medical staff office deem when grievances, clinical and/or behavioral concerns are "resolved", "appropriate" and/or "closed" and there is no Root Cause Analysis or further investigation. QMC acknowledged the cases were not reported to OPPE, and no restrictions were placed on provider privileges. The QMC team indicated that a report of the events tracked by medical staff and QMC and provided to the GB in a report.

The QD and CMO shared the clinical care of six patients they reviewed during the MEC and QMC interviews. MEC acknowledged there were concerning events regarding surgical complications, death, surgical errors, infections, competency, provider performance. MEC indicated the event had been "resolved", "appropriate" or "closed". There is no RCA or further investigations done. MEC acknowledged no reports were made to the Medical Board or California Department of Public Health. No data was submitted to OPPE. The complete records were requested but only incomplete records were provided. The records did not contain, consents, operating room notes, anesthesia records, consents, medications, nursing notes, physician notes, code sheets, vital signs and/or consult notes.

Patient 35 (Pt 35). QMC indicated that a complaint was received regarding MD 13 practicing beyond his privileges and scope of practice. MEC indicated MD 13 performed a treadmill myocardial perfusion stress test (special test to heart function and strength performed by cardiologist) for chest pain on Patient 35. MEC acknowledged MD 13 did not privileges, certification, education, or competency to provide cardiac services. QD and CMO indicated the care of Pt 35 "reviewed" and "closed".

Patient 36. QMC indicated a complaint was received regarding MD 13 from another provider that MD 13 took an inappropriate patient who was actively bleeding to the operating room and died shortly after. The chart indicated the following:

On 12/14/2021 at 1:20 pm, "actively bleeding in ED [emergency department]"
On 12/14/2021 at 2:34 pm, MD 13 charted "to unstable to undergo" procedure
On 12/14/2021 at 4:59 MD 13 charted to undergo a procedure in the operating room
On 12/14/2021 at 7:15 pm procedure and post-operative diagnosis was "bleeding" and "full of blood "
On 12/14/2021 at 7:32 pm "actively bleeding". For available records, last entry by MD 13
On 12/14/2021 from 8:45 pm to 12:12 am the telemedicine physician, MD 21, indicated "camera assessment", "major shock", "high risk for life threatening clinical deterioration". The chart indicated there was no bedside physician. There were no physician notes.
On 12/15/2021 at 2:00 am records reflected respiratory rate 29, oxygen saturation 100%, heart rate 93, blood pressure 61/44. There are no notes for medical care or additional vitals until 3:00 am.
12/15/2021 at 3:00 am respiratory rate 28, oxygen saturation 95%, heart rate 0, blood pressure not recorded, ventilator discontinued.
12/15/2021 at 3:27 am, a physician indicated the "expired 3:01 hours, 12/15/2021".
12/15/2021 at 6:48 am "resuscitated" by "telemedicine" the "during the night" by MD 21.

MEC acknowledged MD 13 lacked documented evidence of training, education, competency, peer review and/or experience to provide medical services for gastroenterology (specialized branch of medicine that deals with the diagnosis and treatment of disorders of the stomach, intestines and other organs) procedures and surgical services privileges. QD and CMO indicated the care of Patient 36 was "appropriate" and "closed".

MEC acknowledged MD 12, PA 1, PA 2 lacked documented evidence of training, education, competency, peer review and/or experience to provide medical services for Decubitus ulcers (Pressure ulcers). The MEC acknowledged the facility failed to report Pt 4's pressure ulcer to the Medical Board or California Department of Public Health. No data was submitted to OPPE. There is no RCA or further investigations done to evaluate the care provided to Pt 4 who declined and died.

Patient 37 . QMC indicated a complaint was received from another provider that MD 11 "lacked judgment". The MEC referenced a case for a woman who had no active medications or medical issues except diabetes and heartburn. MD 11 performed a "laparoscopic take down of Nissen (surgery on the esophagus)". Patient 37 suffered unusual surgical complications during surgery-- stomach injury requiring partial gastrectomy (removal of the stomach), esophageal perforation (hole) into the lung cavity causing lung empyema (large collection of pus ) to both lungs, lung injury due to esophageal pleural fistula (abnormal connection between the esophagus and lungs), pneumonia, and pneumothorax (air escaping from lung into the surrounding body cavity). Patient 37 was transfered to another facility for cardiothoracic surgery. MD 11 lacked documented evidence of privileges, training, education, competency and peer review to provide medical and surgical services for hernia repair (part of an organ protrude through a body cavity), paraoesophageal hernia (part of esophsgus an organ is displaced) repairs, and Nissen (esophagus surgery) surgical procedures. . QD and CMO indicated the care of Patient 3 QMC was "appropriate" and "resolved" because the patient was transferred to another facility for cardiothoracic surgery

Patient 38. QMC indicated MD 11 was referred to the QA department for surgical complications. MD 11 placed a central line in Patietn 38 and sustained injured the patient's lung. The injury caused a "hemopneumothorax (air and blood in cavity that contains the lungs) and the need for ventilatory (breathing tube and machine) support". QD and CMO indicated the care of Patient 38 was "appropriate" and "closed".

Patient 39. QMC indicated MD 11 was referred to the QA department for surgical complications. MD 11 performed a tracheostomy on Patient 39, and there were complications and "concern of tracheocutaneous fistula" and a revision of tracheostomy was required. MD 20 revised the tracheostomy, but the case "was complicated pneumothorax requiring placing a right sided chest tube, cardiac arrest and being pulseless for 7 minutes". QD and CMO indicated the care of Patient 4 QMC was "appropriate" and "closed".

Patient 40. QMC indicated MD 11 was referred to the QA department for surgical complications. MD 11 preformed a "laparoscopic hiatal hernia repair (part of an organ protrude through a body cavity), with TIF fundoplasty (surgery on the esophagus)" and returned to the operating room for "esophageal foreign body and esophageal stricture". . MD 11 lacked documented evidence of privileges, training, education, competency and peer review to provide medical and surgical services for hernia repair, paraoesophageal hernia (part of esophagus an organ is displaced) repairs, and Nissen (esophagus surgery) surgical procedures. There was no investigation or RCA. QD and CMO indicated the care of Patient 40 was "appropriate" and "closed"

Patient 41. QMC indicated MD 11 was referred to the QA department for surgical complications. MD 11 preformed a "diagnostic laparoscopy, lysis of adhesion (cutting of scar tissue), excision of colon fistula with right colectomy and small bowel resection" and "infection". QD and CMO indicated the care of Patient 41 was "appropriate" and "closed".

Review of hospital bylaws title, 2019 Amended and Restated Bylaws of the Community Board of [Facility] of [City], approved June 24, 2019, indicated that the "Quality Assessment, Performance Improvement, Patient Safety and Utilization Management. This Hospital Community Board is responsible for assuring that health care services provided at the Local Hospital are of high quality, safe, effective, efficient and consistent with community standards. This Hospital Community Board shall be responsible for: (i) ongoing quality assessment, performance improvement, patient safety and utilization management activities of the Local Hospital; (ii) assuring that quality and patient safety issues are addressed and resolved appropriately; (iii) assuring quality assessment, performance improvement, patient safety and utilization management activities of the Local Hospital are consistent with the standards, policies and procedures established by the Dignity Health and/or System Corporation Boards and their respective Quality Committees; and (iv) communicating quality and patient safety issues of concern and potential performance improvement measures to the Dignity Health Quality Committee. The Hospital Community Board shall assure that the Medical Staff (a) participates in the measurement, assessment and improvement of clinical and non¿clinical processes affecting patient care and (b) takes a leadership role where the clinical processes are the primary responsibility of physicians. The activities of the Local Hospital (including outcomes, recommendations and actions) undertaken pursuant to this Section 8.2 shall be reported to this Hospital Community Board, and also to the Dignity Health Quality Committee in accordance with policies and procedures adopted from time to time by the Dignity Health Quality Committee".

Review of hospital bylaws title, 2019 Amended and Restated Bylaws of the Community Board of [Facility] of [City], approved June 24, 2019, indicated the "Hospital Community Board shall assure that the Medical Staff (a) participates in the measurement, assessment and improvement of clinical and non¿clinical processes affecting patient care The activities of the Local Hospital (including outcomes, recommendations and actions) undertaken ...shall be reported to this Hospital Community Board ... The Medical Staff shall identify and implement an appropriate response to findings. Such quality assessment and performance improvement activities shall be regularly reported to this Hospital Community Board".

Based on interview and record review, the Medical Staff team (MEC) failed to have a Quality Assurance and Performance Improvement (QAPI) program that collected data, managed, and tracked the performance and competency of physicians (MD) and Allied Health Professionals (AHP), including Physician assistants (PA), and take action when it effected patient safety and quality medical care.

This failure resulted in jeopardizing the health and safety of all patients.

Findings:

A concurrent interview and record review occurred on 3/13/2023 at 10:00 and continued on 3/16/2023 at 10:30 am via ZOOM with the Medical Staff team who are oversee the medical staff credentialing and privileging and Peer review of providers. In attendance were Director Medical Staff Administration, (DMSA), Chief Medical Officer (CMO), Quality Director (QD), Medical Staff Coordinator, (MSC), Credentialing Coordinator, (CC), and Peer Review Nurse, (PRN) (not present on 3/13/2023). The privileges of 18 providers (MD 1 Anesthesiologist, MD 2 Anesthesiologist, MD 3 Family Practice (FP), MD 4 FP MD 5 FP, MD 6 FP, MD 7 Pediatrician (Peds), MD 8 Peds, MD 9 Obstetrician (OB)-gynecology (Gyn), MD 10 OB-Gyn, MD 11 Surgeon, MD 12 FP, MD 13 Internal Medicine (IM), MD 14 IM, MD 15, IM, DRP/FP FP, PA 1, and PA 2) were reviewed. The MEC acknowledged there was not complete documentation for competency, training, education, certificates, proctoring, peer review and/or provider performance for providers. The MEC team indicated OPPE data (Ongoing Professional Practice Evaluations identifies professional practice trends that may impact the quality and safety of care and applies to all practitioners granted privileges), is not monitored, tracked, trended or acted upon. QMC indicated OPPE is to be collected at each privileging cycle and the "department chairs" review it medical staff. The CMO will "communicate" with the Chief of Staff who is a member of the GB. The CMO and QD stated, if there are concerns the Chair of the department will discuss concerns with the provider, and if needed the Chair will bring the concern to the attention of the CMO. The CMO indicated, "don't get into the details of OPPE" but look at "if done of not done". MEC indicated OPPE data was not monitored, tracked, trended or acted upon. MEC team indicated the data to track adverse events, like infections, pressure ulcers, surgical errors, death, are not placed in the OPPE. MEC indicated if the MEC and/or QMC deemed the grievances, clinical and/or behavioral concerns "resolved", "appropriate" or "closed", the inciting event and data were not tacked or trended in OPPE.

QD indicated that data and information reported in MIDAS and adverse events are tracked and monitored by the QMC team. They collected data, reviewed medical charts and make the determination to close, resolve or track the adverse events. MEC indicated the Midas (tracking system for incident reports) events are not tacked or trended in OPPE.

18 of 18 providers, (MD 1, MD 2, MD 3, MD 4, MD 5, MD 6, MD 7, MD 8, MD 9, MD 10, MD 11, MD 12, MD 13, MD 14, MD 15, DRP/FP, PA 1, PA 2) did not have documentation for competency, training, education, certificates, proctoring, peer review and/or provider performance for providers.

Nine of 18 dates of the data collection did not align with provider privileging cycles. The data metrics for 9 of 18 providers (MD 3, MD 5, MD 7, MD 10, MD 11, MD 12, MD 13, MD 14, MD 15, DRP/FP).

A concurrent interview and record review interview occurred on 3/17/2023 at 11:27 am via ZOOM with the Quality Committee (QMC) team. In attendance were Director Medical Staff Administration, (DMSA), Chief Medical Officer (CMO), Quality Director (QD) and Peer Review Nurse, (PRN). The privileges of 18 providers (MD 1 Anesthesiologist, MD 2 Anesthesiologist, MD 3 Family Practice (FP), MD 4 FP MD 5 FP, MD 6 FP, MD 7 Pediatrician (Peds), MD 8 Peds, MD 9 Obstetrician (OB)-gynecology (Gyn), MD 10 OB-Gyn, MD 11 Surgeon, MD 12 FP, MD 13 Internal Medicine (IM), MD 14 IM, MD 15, IM, DRP/FP FP, PA 1, and PA 2) were reviewed. OPPE reports were information provided by [Hospital] was discussed.

QMC team stated "there is a lot of red" which indicated trends provider performance and patient care concerns. Except for the number of patients seen, 9 of 18 providers (MD 1, MD 2, MD 4, MD 6, MD 7, MD 8, MD 9, PA 1, PA 2) had no data. The data metrics for 9 of 18 providers (MD 3, MD 5, MD 7, MD 10, MD 11, MD 12, MD 13, MD 14, MD 15, DRP/FP) reflected: percentage for readmissions within 7 days (target 2.25% ), a range 2.24% to 5.69%; high percentage of readmits within 30 days (target 8.935%) a range 16.7 % to 57.1%; high percentage for length of stay (target 1% ) a range of 1.94% to 5.82%; high percentage mortality due to sepsis (target 16.43% ) a range 18.37% to 28%; low percentage patient satisfaction (target 85%) a range 30.77% to 100%. There was no data. The QMC acknowledged there was no to little data for peer review, scant data for infections, and no data metrics for pressure ulcers.

QMC indicated they have OPPE (Ongoing Professional Practice Evaluations identifies professional practice trends that may impact the quality and safety of care and applies to all practitioners granted privileges). QD indicated OPPE is not looked at by QMC and thus there was not any corrective action, monitoring, or tracking. QMC team acknowledged that since QMC doesn't track trends in OPPE they are unaware of events that negatively impact patient outcomes. QMC team indicated they are unsure who has been responsible for analyzing, monitoring, investigating and acting upon the data collected in OPPE. QMC team indicated Midas report, the portal to report adverse events and incidents, data is not placed in the OPPE. QMC team indicated the data to track adverse events, like infections, pressure ulcers, surgical errors, death, are not placed in the OPPE. The QMC team indicted that the CMO and Medical Staff team (MEC) deem when grievances, clinical and/or behavioral concerns are "resolved", "appropriate" and/or "closed". . The QMC indicated they "share" behavioral, grievance and/or clinical concerns with the provider. The CMO and QD stated, if there are concerns, the Chair of the department will discuss them with the provider, and if needed the Chair will bring the concern to the attention of the CMO. The QMC team indicated that a report of some events are tracked by medical staff and QMC and provided to the GB in a report. The MEC determine what is provided to the GB. There is Root cause analysis or no further investigation.

Review of hospital bylaws title, 2019 Amended and Restated Bylaws of the Community Board of [Facility] of [City], approved June 24, 2019, indicated that "MEDICAL STAFF MATTERS ... shall be organized for the adequacy and quality of medical care rendered to patients ... Medical Staff shall be responsible to this Hospital Community ...adequacy and quality of medical care and professional work ... There shall be Medical Staff Bylaws and Rules and Regulations for the Local Hospital, setting forth the Medical Staff's organization ... Written, defined criteria for Medical Staff appointment and the granting of clinical privileges ... physician responsible for the service be certified or eligible for certification by an appropriate American medical specialty board ...establishment of controls to facilitate the achievement and maintenance of high standards of ethical practices, including a requirement that all members of the Medical Staff be required to demonstrate their ability to perform surgical and other procedures competently at the time of original appointment and at least every two years ... licensed Practitioner with appropriate clinical privileges shall be directly responsible for patient diagnosis and treatment within the scope of such Practitioner's license and privileges ... The mechanisms for reviewing credentials, delineating clinical privileges, conducting, evaluating, and revising quality assessment and performance improvement activities, appointment, reappointment, corrective action, and fair hearing procedures, and restriction, reduction, suspension, termination, and revocation of Medical Staff membership or clinical privileges .... Medical Staff Executive Committee shall make recommendations to the Hospital Community Board".

Review of hospital bylaws title, 2019 Amended and Restated Bylaws of the Community Board of [Facility] of [City], approved June 24, 2019, indicated "Quality Assessment and performance Improvement (QAPI). The Medical Staff shall be responsible to the Hospital Community Board and the Dignity Health Board for the quality of medical care provided by Medical Staff members and other Practitioners to patients of the Local Hospital ... Medical Staff is responsible for ensuring that the professional care furnished to patients ... is of high quality, safe, efficient and effective and meets professional standards ... The Medical Staff shall discharge this responsibility by meeting regularly to review, analyze, and appraise its clinical experience and the quality of care rendered by members of the Medical Staff, in conformance with its Medical Staff Bylaws and Local Hospital policies and procedures. The review and analysis shall be based on patient medical records and such other documents and patient ... The Medical Staff shall identify and implement an appropriate response to findings. Such quality assessment and performance improvement activities shall be regularly reported to this Hospital Community Board".

Review of the hospital document titled, [Hospital] Medical Staff Bylaws, dated 12/6/2018, not signed by a responsible GB or MEC member, indicated "Appointment Qualifications ... Detailed information concerning the practitioner's qualifications ... Medical Staff quality assessment process relevant to the involved practitioner, including the Medical Staff's ongoing professional practice evaluation ...evaluation of the practitioner's competence ... The proctor shall monitor the practitioner's performance of the requested privilege(s) in at least three major cases and shall complete the Proctor Reporting Form and any other pertinent information for each case .... Reappointment ... shall be based upon review of such practitioner's professional ability and clinical judgment in the treatment of patients, the practitioner's professional ethics, the practitioner's discharge of Medical Staff obligations ... Medical Executive Committee recommends appointment and the granting of all requested privileges, the recommendation shall be promptly forwarded, together with any necessary supporting documentation ...to the Board".

Review of the American Board of Internal Medicine (ABIM) subspecialty training requirements for Gastroenterology, indicated "at the time of application, be previously certified in internal medicine by ABIM ... Satisfactorily complete the requisite graduate medical education fellowship training ...Demonstrate clinical competence, procedural skills, and moral and ethical behavior in the clinical setting ...Pass the Gastroenterology Certification Examination ....Gastroenterology fellowship training must be accredited by the Accreditation Council for Graduate Medical Education".
abim.org/certification/policies/internal-medicine-subspecialty-policies/gastroenterology/. Accessed 3/18/2023.

Based on observation, interview and record review, the hospital failed to have an effective medical staff that operates under by laws approved by the governing body, and which is responsible for the quality of medical care provided to patients by the hospital when:

1. The Medical Staff team (MEC) did not have documented evidence of education, licensure, experience, training and/or peer references for providers, physicians (MD) and Allied Health Professionals (AHP), including Physician assistants (PA), a before recommending candidates to the Governing Body for medical staff membership and privileges. (Refer to A341)

2. The Medical Staff team (MEC) failed to follow the Governing Body (GB) Bylaws, MEC Bylaws, and medical staff rules and regulations for competency, privileging, monitoring, peer review, and/or education requirements. (Refer to A353)

3. The Medical Staff team (MEC) failed to ensure the list the specific privileges and scope of practice approved for individual providers reflected the provider's /experience, competency, and education. (Refer to A355)

4. The Medical Staff team (MEC) failed to have a well-organized system that relayed professional performance and competency of providers to the GB which was needed to grant or not grant medical staff membership and privileges. (Refer to A347)

5. Before recommending the provider for medical staff membership and privileges, the MEC failed to vet the qualifications of the providers to provide medical services. (Refer to A357)

6. The Medical Staff team (MEC) failed to have a Quality Assurance and Performance Improvement (QAPI) program that collected data, managed, and tracked the performance and competency of physicians (MD) and Allied Health Professionals (AHP), including Physician assistants (PA), and take action when it effected patient safety and quality medical care. (Refer to A309)

7. The Medical Staff team (MEC) failed to ensure Medical staff Bylaws and medical staff rules and regulations were approved by the GB. (Refer to A354)

8. The Medical Staff team (MEC) failed to appraise the professional performance of medical providers at regular intervals to prove the competency and appropriateness of the medical services provided to patients. (Refer A340)

The cumulative effect of these deficient practices resulted in the hospital not organizing the medical staff to operate under the medical staff by laws in order to provide quality patient medical care.

Based on interview and record review, the Medical Staff team (MEC) failed to appraise the professional performance of medical providers at regular intervals to prove the competency and appropriateness of the medical services provided to patients.

The failure to appraise physicians (MD) and Allied Health Professionals (AHP), including Physician assistants (PA), during privileging periods allowed providers who did not have documented safe and quality patient care outcomes to hold privileges and provide medical services.

Findings:

A concurrent interview and record review occurred on 3/13/2023 at 10:00 and continued on 3/16/2023 at 10:30 am via ZOOM with the Medical Staff team who are oversee the medical staff credentialing and privileging and Peer review of providers. In attendance were Director Medical Staff Administration, (DMSA), Chief Medical Officer (CMO), Quality Director (QD), Medical Staff Coordinator, (MSC), Credentialing Coordinator, (CC), and Peer Review Nurse, (PRN) (not present on 3/13/2023). The privileges of 18 providers (MD 1 Anesthesiologist, MD 2 Anesthesiologist, MD 3 Family Practice (FP), MD 4 FP MD 5 FP, MD 6 FP, MD 7 Pediatrician (Peds), MD 8 Peds, MD 9 Obstetrician (OB)-gynecology (Gyn), MD 10 OB-Gyn, MD 11 Surgeon, MD 12 FP, MD 13 Internal Medicine (IM), MD 14 IM, MD 15, IM, DRP/FP FP, PA 1, and PA 2) were reviewed. The MEC acknowledged there was not complete documentation for competency, training, education, certificates, proctoring, peer review and/or provider performance for providers. The CMO indicated OPPE data is not monitored, tracked, trended or acted upon. The CMO (Chief Medical Officer) and QD stated, if there are concerns the Chair of the department will discuss concerns with the provider, and if needed the Chair will bring the concern to the attention of the CMO. The CMO will "communicate" with the Chief of Staff who is a member of the GB. The CMO indicated, "don't get into the details of OPPE" but look at "if done of not done".

For the most current privileging cycle for 18 of 18 providers, (MD 1, MD 2, MD 3, MD 4, MD 5, MD 6, MD 7, MD 8, MD 9, MD 10, MD 11, MD 12, MD 13, MD 14, MD 15, DRP/FP, PA 1, PA 2), there was no documented evidence of peer review.

18 of 18 providers, (MD 1, MD 2, MD 3, MD 4, MD 5, MD 6, MD 7, MD 8, MD 9, MD 10, MD 11, MD 12, MD 13, MD 14, MD 15, DRP/FP, PA 1, PA 2), lacked documented evidence of competency and professional performance at least every two years.

18 of 18 providers (MD 1, MD 2, MD 3, MD 4, MD 5, MD 6, MD 7, MD 8, MD 9, MD 10, MD 11, MD 12, MD 13, MD 14, MD 15, DRP/FP, PA 1, PA 2), lacked regular quality assessment and improvement evalautions for patient care.

Nine of 18 dates of the data collection did not align with provider privileging cycles. The data metrics for 9 of 18 providers (MD 3, MD 5, MD 7, MD 10, MD 11, MD 12, MD 13, MD 14, MD 15, DRP/FP). 9 of 18 providers had "no data" for analysis, for example, pressure ulcers, infection rates, mortality, peer review.

A concurrent interview and record review interview occurred on 3/17/2023 at 11:27 am via ZOOM with the Quality Committee (QMC) team. In attendance were Director Medical Staff Administration, (DMSA), Chief Medical Officer (CMO), Quality Director (QD) and Peer Review Nurse, (PRN). The QMC team indicated that OPPE is to be completed at every "privileging cycle" and reflects "proof of competence", and contains peer review. QMC indicated OPPE is to be collected at each privileging cycle and the "department chairs" review it medical staff. The QMC team acknowledged the GB "depends" on the medical staff and QMC program to report information.

Review of hospital bylaws title, 2019 Amended and Restated Bylaws of the Community Board of [Facility] of [City], approved June 24, 2019, indicated that "MEDICAL STAFF MATTERS ... shall be organized for the adequacy and quality of medical care rendered to patients ... Medical Staff shall be responsible to this Hospital Community ...adequacy and quality of medical care and professional work ... There shall be Medical Staff Bylaws and Rules and Regulations for the Local Hospital, setting forth the Medical Staff's organization ... Written, defined criteria for Medical Staff appointment and the granting of clinical privileges ... physician responsible for the service be certified or eligible for certification by an appropriate American medical specialty board ...establishment of controls to facilitate the achievement and maintenance of high standards of ethical practices, including a requirement that all members of the Medical Staff be required to demonstrate their ability to perform surgical and other procedures competently at the time of original appointment and at least every two years ... licensed Practitioner with appropriate clinical privileges shall be directly responsible for patient diagnosis and treatment within the scope of such Practitioner's license and privileges ... The mechanisms for reviewing credentials, delineating clinical privileges, conducting, evaluating, and revising quality assessment and performance improvement activities, appointment, reappointment, corrective action, and fair hearing procedures, and restriction, reduction, suspension, termination, and revocation of Medical Staff membership or clinical privileges .... Medical Staff Executive Committee shall make recommendations to the Hospital Community Board".

Review of the hospital document titled, [Hospital] Medical Staff Bylaws, dated 12/6/2018, not signed by a responsible GB or MEC member, indicated "Appointment Qualifications ... Detailed information concerning the practitioner's qualifications ... Medical Staff quality assessment process relevant to the involved practitioner, including the Medical Staff's ongoing professional practice evaluation ...evaluation of the practitioner's competence ... The proctor shall monitor the practitioner's performance of the requested privilege(s) in at least three major cases and shall complete the Proctor Reporting Form and any other pertinent information for each case .... Reappointment ... shall be based upon review of such practitioner's professional ability and clinical judgment in the treatment of patients, the practitioner's professional ethics, the practitioner's discharge of Medical Staff obligations ... Medical Executive Committee recommends appointment and the granting of all requested privileges, the recommendation shall be promptly forwarded, together with any necessary supporting documentation ...to the Board".


Review of hospital bylaws title, 2019 Amended and Restated Bylaws of the Community Board of [Facility] of [City], approved June 24, 2019, indicated "Quality Assessment and performance Improvement (QAPI). The Medical Staff shall be responsible to the Hospital Community Board and the Dignity Health Board for the quality of medical care provided by Medical Staff members and other Practitioners to patients of the Local Hospital ... Medical Staff is responsible for ensuring that the professional care furnished to patients ... is of high quality, safe, efficient and effective and meets professional standards ... The Medical Staff shall discharge this responsibility by meeting regularly to review, analyze, and appraise its clinical experience and the quality of care rendered by members of the Medical Staff, in conformance with its Medical Staff Bylaws and Local Hospital policies and procedures. The review and analysis shall be based on patient medical records and such other documents and patient ... The Medical Staff shall identify and implement an appropriate response to findings. Such quality assessment and performance improvement activities shall be regularly reported to this Hospital Community Board".

Review of the hospital document titled, [Hospital] Medical Staff Bylaws, dated 12/6/2018, not signed by a responsible GB or MEC member, section 4.12 indicated "all deaths in which the cause of death is not known with certainty on clinical grounds or where autopsy may help to explain unknown and unanticipated medical complications to the attending physician ... Unexpected or unexplained deaths occurring during or within 48 hours following any surgical or invasive procedure or therapy ... Deaths that are suspected to be due to an infectious disease when the confirmation of the diagnosis may be of epidemiological significance ... Any death where there is a possibility that a medical device may be implicated pursuant to the Safe Medical Devices Act of 1990.

Review of the hospital document titled, [Hospital] Medical Staff Bylaws, dated 12/6/2018, not signed by a responsible GB or MEC member, section 7.10, indicated "to protect the patient, improve systems and prevent further harm, physicians who experience operative or postoperative complications shall promptly complete an iVOS report (type of incident event report), and contact the Surgical Department Chair. For those still in Practical Training for Robotics, your mentor should also be contacted".

Review of the hospital document titled, Department of Anesthesiology Privilege List, did not indicate appointment requirements for competence, performance evalautions, peer review evaluations, proctoring, demonstrate procedural skills, case requirements or demonstrate up-to-date competence

Review of the hospital document titled, Department of Medicine Privilege Checklist, General Internal Medicine, did not indicate appointment requirements for competence, performance evalautions, proctoring, demonstrate procedural skills, peer review evaluations, or demonstrate up-to-date competence.

Review of the hospital document titled, [Hospital] Privilege Application, Gastroenterology, indicated "this category is applicable to physicians who are board certified, eligible; or fully trained in a recognized [Gastroenterology ] sub-specialty medicine board as defined by the AMA (American Medical Association". The checklist did not indicate appointment requirements for competence, performance evalautions, proctoring, peer review evaluations, demonstrate procedural skills, case requirements or demonstrate up-to-date competence.

Based on interviews and record review, the Medical Staff team (MEC) did not have documented evidence of education, licensure, experience, training and/or peer references for providers, physicians (MD) and Allied Health Professionals (AHP), including Physician assistants (PA), a before recommending candidates to the Governing Body for medical staff membership and privileges.

The failure of the MEC to appraise providers' professional qualifications and competence allowed providers to bypass GB scrutiny and staffing requirements; in turn, compromised the health and safety of all patients.

Findings:

A concurrent interview and record review occurred on 3/13/2023 at 10:00 and continued on 3/16/2023 at 10:30 am via ZOOM with the Medical Staff team who are oversee the medical staff credentialing and privileging and Peer review of providers. In attendance were Director Medical Staff Administration, (DMSA), Chief Medical Officer (CMO), Quality Director (QD), Medical Staff Coordinator, (MSC), Credentialing Coordinator, (CC), and Peer Review Nurse, (PRN) (not present on 3/13/2023). The MEC indicated all providers had the proper education, training, certificates, proctoring and monitoring to provide medical services. The MEC indicated this was true because the provider "completed residency" at the [Hospital] and had a verified license.

The privileges of 18 providers (MD 1 Anesthesiologist, MD 2 Anesthesiologist, MD 3 Family Practice (FP), MD 4 FP MD 5 FP, MD 6 FP, MD 7 Pediatrician (Peds), MD 8 Peds, MD 9 Obstetrician (OB)-gynecology (Gyn), MD 10 OB-Gyn, MD 11 Surgeon, MD 12 FP, MD 13 Internal Medicine (IM), MD 14 IM, MD 15, IM, DRP/FP FP, PA 1, and PA 2) were reviewed.

For five of 6 Family Practice providers (MD 3, MD 5, MD 6, MD 12, DRP/FP), lacked documented evidence of education, peer review, proctoring, training and/or experience to provide medical services and procedures for obstetric (care of pregnant women and fetuses) privileges.

For four of 6 Family Practice providers (MD 3, MD 5, MD 6, DRP/FP), lacked documented evidence of education, peer review, proctoring, training and/or experience for ultrasound procedures to evaluate and diagnose the status of fetuses and obstetric patients.

Five of 6 Family Practice providers (MD 3, MD 5, MD 6, MD 12, DRP/FP), lacked documented evidence of education, peer review, proctoring, training and/or experience to provide medical services for neonatal care (newborn) and/or attendance to delivery of newborn.

Five of 6 Family Practice providers, (MD 3, MD 5, MD 6, MD 12, DRP/FP), lacked documented evidence of education, peer review, proctoring, training and/or experience to provide medical services for neonatal care (newborn) and/or attendance to delivery of newborn

Five of 6 Family Practice and 2 of 2 OB providers, (MD 3, MD 5, MD 6, MD 9, MD 10, MD 12, DRP/FP), lacked documented evidence of education, peer review, proctoring, training and/or experience to provide medical services for neonatal care (newborn) and/or pediatric resuscitation (life support for infants and children).

Four of 6 Family Practice providers, (MD 5, MD 6, MD 12, DRP/FP), lacked documented evidence of education, peer review, proctoring, training and/or experience to provide medical services for Gynecologic care.

For one of 1 surgical providers, (MD 11), lacked documented evidence of training, education, competency and/or peer review to provide medical services for Robotic surgical services privileges.

For one of 1 surgical providers, (MD 11), lacked documented evidence of training, education, competency and peer review to provide medical and surgical services for hernia repair (part of an organ protrude through a body cavity), paraoesophageal hernia (part of esophagus an organ is displaced) repairs, and Nissen (esophagus surgery) surgical procedures.

For one of 3 Internal Medicine providers, (MD 13), lacked documented evidence of training, education, competency, peer review and/or experience to provide medical services for gastroenterology (specialized branch of medicine that deals with the diagnosis and treatment of disorders of the stomach, intestines, and other organs) procedures and surgical services privileges.

For one of 3 Internal Medicine providers, (MD 13), lacked documented evidence of training, education, competency, peer review and/or experience to provide medical services for provide cardiac (heart) services and procedures.

For one of 3 Internal Medicine providers, (MD 13), lacked documented evidence of training, education, competency, peer review and/or experience to provide medical services for physical medicine and rehabilitation privileges.

Two of 2 surgical providers, (MD 13, MD 11), lacked documented evidence of training, education, competency, peer review and/or experience to provide medical and surgical services for laparoscopy (a type of surgical procedure that allows a surgeon to access the inside of the abdomen and pelvis without having to make large incision).

Three of 18 providers, (MD 12, PA 1, PA 2), lacked documented evidence of training, education, competency, peer review and/or experience to provide medical services for complex wounds and pressure ulcers care privileges.

One of 18 providers, (MD 13), lacked the appropriate state required licensure/certificate to support fluoroscopy (type of x-ray) and x-ray privileges.

Two of 18 providers,(MD 6, MD 13), lacked documented evidence of peer review, proctoring, training, education and/or experience to provide medical services for sedation privileges.

Seven of 18 providers, (MD 3, MD 5, MD 6, MD 8, MD 12, MD 13, DRP/FP), lacked documented evidence of training, education, competency, peer review and/or experience to provide medical services for intubation (place a breathing tube into a person's lung). and/or laryngoscopy (look deep into a throat using a specialized tool) privileges.

For 10 of 18 providers, (MD 1, MD 2, MD 5, MD 6, MD 11, MD 12, MD 13, DRP/FP, PA 1, PA 2), lacked documented evidence of peer review, proctoring, training, education and/or experience to provide medical services for central lines placement (a large tube that is placed in a large, main vein in the neck, upper chest or groin. It requires special training to place)

For one of 18 providers, (PA 2), did not have documented evidence of a National Practitioner Databank (created by Congress to improve health care quality, protect the public, and reduce health care fraud and tack medical malpractice payment and adverse action reports on health care professional).

Review of hospital bylaws title, 2019 Amended and Restated Bylaws of the Community Board of [Facility] of [City], approved June 24, 2019, indicated that "MEDICAL STAFF MATTERS ... shall be organized for the adequacy and quality of medical care rendered to patients ... Medical Staff shall be responsible to this Hospital Community ...adequacy and quality of medical care and professional work ... There shall be Medical Staff Bylaws and Rules and Regulations for the Local Hospital, setting forth the Medical Staff's organization ... Written, defined criteria for Medical Staff appointment and the granting of clinical privileges ... physician responsible for the service be certified or eligible for certification by an appropriate American medical specialty board ...establishment of controls to facilitate the achievement and maintenance of high standards of ethical practices, including a requirement that all members of the Medical Staff be required to demonstrate their ability to perform surgical and other procedures competently at the time of original appointment and at least every two years ... licensed Practitioner with appropriate clinical privileges shall be directly responsible for patient diagnosis and treatment within the scope of such Practitioner's license and privileges ... The mechanisms for reviewing credentials, delineating clinical privileges, conducting, evaluating, and revising quality assessment and performance improvement activities, appointment, reappointment, corrective action, and fair hearing procedures, and restriction, reduction, suspension, termination, and revocation of Medical Staff membership or clinical privileges .... Medical Staff Executive Committee shall make recommendations to the Hospital Community Board".

Review of the hospital document titled, [Hospital] Medical Staff Bylaws, not signed by a responsible GB or MEC member, indicated "Appointment Qualifications ... Detailed information concerning the practitioner's qualifications ... Medical Staff quality assessment process relevant to the involved practitioner, including the Medical Staff's ongoing professional practice evaluation ...evaluation of the practitioner's competence ... The proctor shall monitor the practitioner's performance of the requested privilege(s) in at least three major cases and shall complete the Proctor Reporting Form and any other pertinent information for each case .... Reappointment ... shall be based upon review of such practitioner's professional ability and clinical judgment in the treatment of patients, the practitioner's professional ethics, the practitioner's discharge of Medical Staff obligations ... Medical Executive Committee recommends appointment and the granting of all requested privileges, the recommendation shall be promptly forwarded, together with any necessary supporting documentation ...to the Board".

Review of the hospital document titled, [Hospital] Health Administrative Policy Manual Clinical Policy And Procedure Procedural Sedation, Management of, effective 6/27/2018, indicated "Competency Requirements For Moderate And Deep Sedation: 1. Physicians: The Physician supervising the administration of or administering the medication will be competent to perform sedation as evidenced by privileging criteria ... To administer deep sedation, an individual must be a physician with appropriate privileges to administer deep sedation and have demonstrated competency in rescuing a patient from general anesthesia including management of an unstable cardiovascular system, a compromised airway and inadequate oxygenation and ventilation ... ASA requirements Anesthesia."

Review of the hospital document titled, [Hosptal] Credentialing for Moderate and/or Deep Sedation Outside the Operating Room Policy and Procedure, effective 1/24/2019, indicated, "required sedation education for those providers not board certified or board eligible in Emergency Medicine or Critical Care Medicine include: successful completion of "Safe Sedation Training - Moderate" (SST moderate) module offered by the American Society of Anesthesiologists (ASA) and current certification in ACLS, and PALS (for pediatric privileges)... must demonstrate that they are competent to rescue patients from sedation including management of a compromised airway, providing adequate oxygenation and ventilation, and management of an unstable cardiovascular system ... The Director of the Department of Anesthesiology or designee will document demonstration of competency in rescue of patients from deep and moderate sedation".

Review of the hospital document titled, [Hospital] Medical Staff Bylaws, dated 12/6/2018, not signed by a responsible GB or MEC member, indicated "a member of the Medical Staff with appropriate clinical privileges shall be responsible for the medical care and treatment of each patient in the hospital".

Review of the hospital document titled, [Hospital] Medical Staff Bylaws, dated 12/6/2018, not signed by a responsible GB or MEC member Section 8.4, indicated "all High Risk deliveries... will have either 1) a separate physician or 2) a designated resuscitation team consisting of a NRP certified Registered Nurse and a Respiratory Care Practitioner who is certified in advanced practice by Children's Hospital Central California whose sole responsibility will be the resuscitation and care of the newborn infant. The physician responsible for the care of the newborn must have current privileges in newborn resuscitation and, in consultation with the Obstetrician and the team, determine the need for his/her physical presence at the time of the high-risk delivery and in compliance with any current patient care guidelines of Children's Hospital Central California. Medical emergencies in the perinatal area including, but not limited to: o Meconium staining ...Fetal Distress ... Multiple Births.

Review of the hospital document titled, [Hospital] Medical Staff Bylaws, dated 12/6/2018, not signed by a responsible GB or MEC member, indicated "a query of the National Practitioner Databank will be performed on all practitioners" (Created by Congress to improve health care quality, protect the public, and reduce health care fraud and tack medical malpractice payment and adverse action reports on health care professional).

Review of the hospital document titled, [Hospital] Policy and Procedure, Resuscitation of the Newborn (PC-63), effective 1/1976, indicated "newborn resuscitation will be provided in accordance with the Neonatal Resuscitation Program Standards as set by the American Heart Association. Current NRP [Neonatal Resuscitation Program team-based care for healthcare professionals who care for newborns at the time of delivery] (newborn handbook and updates from the American Heart Association will be followed".

Review of the hospital document titled, Family Medicine Department Rules and Regulations indicated categories that "require special skill and knowledge and, therefore, require documentation of such training and experience .... proctors with special privileges ... Family Medicine Chair will assign the proctor in consultation with the respective Department Chair ...the applicant must demonstrate current competence and an adequate volume of experience with acceptable results, reflective of the scope of privileges requested, for the last two (2) years based on the results of Ongoing Professional Practice Evaluation (OPPE). Evidence of current physical and mental ability to perform privileges requested ... Consultation should be considered in unusually complicated situations where specific skill of other practitioners may be needed".

Review of the hospital document titled, [Hospital] Pediatric Privilege form indicated, "Successful completion of an ACGME or AOA accredited post-graduate training program In Pediatrics ... Hold PALS or NRP certification ... provide documentation of the number and types of hospital cases during the past 24 months ... evaluation of current competence, and other qualifications ... recent experience ... procedures at previous hospital affiliations ...number of procedures performed in a specified period of time that are believed to be necessary to maintain clinical competence".

Review of the hospital document titled, [Hosptal] General Surgery Privilege Applications indicated "demonstrated and minimum number of cases as indicated with acceptable results in the privileges requested for the past 14 months as a result of quality assessment/improvement activities outcomes ... Diagnostic, basic and advance laparoscopic privileges required minimum cases for past 2 years (14 cases) ... Robotics training 5 supervised proctored cases, 10 cases in past 2 years ... and laparoscopic privileges".

Review of the hospital document titled, Department of Anesthesiology Privilege List, did not indicate appointment requirements for competence, performance evalautions, peer review evaluations, proctoring, demonstrate procedural skills, case requirements or demonstrate up-to-date competence

Review of the hospital document titled, Department of Medicine Privilege Checklist, General Internal Medicine, did not indicate appointment requirements for competence, performance evalautions, proctoring, demonstrate procedural skills, peer review evaluations, or demonstrate up-to-date competence.

Review of the hospital document titled, [Hospital] Privilege Application, Gastroenterology, indicated "this category is applicable to physicians who are board certified, eligible; or fully trained in a recognized [Gastroenterology ] sub-specialty medicine board as defined by the AMA (American Medical Association". The checklist did not indicate appointment requirements for competence, performance evalautions, proctoring, peer review evaluations, demonstrate procedural skills, case requirements or demonstrate up-to-date competence.

Review of the hospital document titled, [Hospital] Nurse Practitioner & Physician Assistant Hosptal Checklist for Scope of Practice, indicated the" Scope Practice as an physician assistant or Nurse Practitioner ... requires a designed supervising physician with clinical privileges at this hospital in the same area of specialty practice. All practice is performed under the supervision of this physician ... demonstrated competence and an adequate volume of experience 12 patient within 24 months with acceptable results ... ongoing professional practice evaluation and outcomes. Evidence of current ability to perform practice requested ...advanced privileges requiring special expertise and/or documentation of special training and/or certification ... All orders are to be countersigned by the supervising physician".

California Health and Safety Code 107110 indicated "It shall be unlawful for any licentiate of the healing arts to administer or use diagnostic, mammographic, or therapeutic x-ray on human beings in this state, unless that person is certified pursuant to subdivision (e) of Section 114870, Section 114872, or Section 114885".

Review of the American Board of Internal Medicine (ABIM) subspecialty training requirements for Gastroenterology, indicated "at the time of application, be previously certified in internal medicine by ABIM ... Satisfactorily complete the requisite graduate medical education fellowship training ...Demonstrate clinical competence, procedural skills, and moral and ethical behavior in the clinical setting ...Pass the Gastroenterology Certification Examination ....Gastroenterology fellowship training must be accredited by the Accreditation Council for Graduate Medical Education".abim.org/certification/policies/internal-medicine-subspecialty-policies/gastroenterology/. Accessed 3/18/2023.

Based on interview and record review, the Medical Staff team (MEC) failed to have a well-organized system that relayed professional performance and competency of providers to the GB which was needed to grant or not grant medical staff membership and privileges.

This failure allowed physicians (MD) and Allied Health Professionals (AHP), including Physician assistants (PA), to bypass hospital quality and safety standard and allowed providers who were not qualitied and/or competent to provide patient care services.

Findings:

A concurrent interview and record review occurred on 3/13/2023 at 10:00 and continued on 3/16/2023 at 10:30 am via ZOOM with the Medical Staff team who are oversee the medical staff credentialing and privileging and Peer review of providers. In attendance were Director Medical Staff Administration, (DMSA), Chief Medical Officer (CMO), Quality Director (QD), Medical Staff Coordinator, (MSC), Credentialing Coordinator, (CC), and Peer Review Nurse, (PRN) (not present on 3/13/2023). The privileges of 18 providers (MD 1 Anesthesiologist, MD 2 Anesthesiologist, MD 3 Family Practice (FP), MD 4 FP MD 5 FP, MD 6 FP, MD 7 Pediatrician (Peds), MD 8 Peds, MD 9 Obstetrician (OB)-gynecology (Gyn), MD 10 OB-Gyn, MD 11 Surgeon, MD 12 FP, MD 13 Internal Medicine (IM), MD 14 IM, MD 15, IM, DRP/FP FP, PA 1, and PA 2) were reviewed.

MEC indicated they follow Midas (incident reporting portal) reports for performance data, clinical competency and/or adverse events. MEC created a summary of reports related to clinical, behavioral and grievances for 18 providers (MD 1 Anesthesiologist, MD 2 anesthesiologist, MD 3 Family Practice (FP), MD 4 FP MD 5 FP, MD 6 FP, MD 7 Pediatrician (Peds), MD 8 Peds, MD 9 Obstetrician (OB)-gynecology (Gyn), MD 10 OB-Gyn, MD 11 Surgeon, MD 12 FP, MD 13 Internal Medicine (IM), MD 14 IM, MD 15, IM, DRP/FP FP, PA 1, and PA 2). MEC indicated they "shared" behavioral, grievance and/or clinical concerns with the provider. The Medical Staff team indicated if the MEC have deemed the MIDAS grievance, clinical and/or behavioral concern had been "resolved", "appropriate" or "closed", there is no RCA or further investigations done. The MEC indicated the CMO, MEC and QMC determine what information will be provided to GB.

The medical staff team indicated 9 of 18 providers had 25 behavioral incident reports during their most current privileging period. The medical staff team indicated, MD 1 had four; MD 7 had one; MD 9 had one; MD 11 had three; MD 12 had five; MD 13 had five; MD 14 had one; MD 15 had one; and PA 1 had four. The Med staff team indicated the physician "interaction" was "disruptive" to patient care , and such behavior did not reflect the [Hosptal] "code of behavior". The team indicted they are not a "clinical" concern. The indicated the events were related to "communication" problems and professional behavior are "resolved" discussed between the provider and department chair. There is Root Cause Analysis or no further investigation.

The medical staff team indicated 6 of 18 providers had a 11 grievance incident reports were related to patient complaints during their most current privileging period. The medical staff team indicated MD 1 had one; MD 4 had one; MD 12 had one; MD 13 had four; MD 14 had three; and PA 1 had two. The medical Staff team indicated the "grievance events" were related to "family concerns" or "patient advocate". The Medical staff team indicated the grievance form can be completed by the patient, family member, physician or nurse. The Team indicated they respond to the concerned party within 30 days.
For example, the Medical Staff team indicated MD 13 had a reported episode where he a patient complained that he "laughed" at his/her cancer diagnosis.

The medical staff team indicated 6 of 18 providers had a 16 that were on watch for "trending" problems during their most current privileging period . The medical staff team indicated MD 9 had one; MD 11 had five; MD 12 had three; MD 13 had three; MD 15 had two; and PA 1 had two

The medical staff team indicated 8 of 18 providers had a 25 Clinical incident reports that were related to patient care and quality during their most current privileging period. The medical staff team indicated MD 1 had two; MD 2 had five; MD 9 had one; MD 11 had eight; MD 13 had three; MD 15 had one; PA 1 had one; and DRP/FP had two.

The MEC shared the clinical care of six patients they reviewed. MEC acknowledged there were concerning events regarding surgical complications, death, surgical errors, infections, competency, provider performance. MEC indicated the event had been "resolved", "appropriate" or "closed". There is no RCA or further investigations done. MEC acknowledged no reports were made to the Medical Board or California Department of Public Health. No data was submitted to OPPE. The complete records were requested but only incomplete records were provided. The records did not contain, consents, operating room notes, anesthesia records, consents, medications, nursing notes, physician notes, code sheets, vital signs and/or consult notes.

Patient 35 (Pt 35). MEC indicated that a complaint was received regarding MD 13 practicing beyond his privileges and scope of practice. MEC indicated MD 13 performed a treadmill myocardial perfusion stress test (special test to heart function and strength performed by cardiologist) for chest pain on Patient 35. MEC acknowledged MD 13 did not privileges, certification, education, or competency to provide cardiac services. QD and CMO indicated the care of Pt 35 "reviewed" and "closed". There was no investigation or RCA. MEC acknowledged the case was not reported to MBC, GB or OPPE, and no restrictions were placed on his privileges.

Patient 36. MEC indicated a complaint was received regarding MD 13 from another provider that MD 13 took an inappropriate patient who was actively bleeding to the operating room and died shortly after. The chart indicated the following:

On 12/14/2021 at 1:20 pm, "actively bleeding in ED [emergency department]"
On 12/14/2021 at 2:34 pm, MD 13 charted "to unstable to undergo" procedure
On 12/14/2021 at 4:59 MD 13 charted to undergo a procedure in the operating room
On 12/14/2021 at 7:15 pm procedure and post-operative diagnosis was "bleeding" and "full of blood "
On 12/14/2021 at 7:32 pm "actively bleeding". For available records, last entry by MD 13
On 12/14/2021 from 8:45 pm to 12:12 am the telemedicine physician, MD 21, indicated "camera assessment", "major shock", "high risk for life threatening clinical deterioration". The chart indicated there was no bedside physician. There were no physician notes.
On 12/15/2021 at 2:00 am records reflected respiratory rate 29, oxygen saturation 100%, heart rate 93, blood pressure 61/44. There are no notes for medical care or additional vitals until 3:00 am.
12/15/2021 at 3:00 am respiratory rate 28, oxygen saturation 95%, heart rate 0, blood pressure not recorded, ventilator discontinued.
12/15/2021 at 3:27 am, a physician indicated the "expired 3:01 hours, 12/15/2021".
12/15/2021 at 6:48 am "resuscitated" by "telemedicine" the "during the night" by MD 21.

MEC acknowledged MD 13 lacked documented evidence of training, education, competency, peer review and/or experience to provide medical services for gastroenterology (specialized branch of medicine that deals with the diagnosis and treatment of disorders of the stomach, intestines and other organs) procedures and surgical services privileges. QD and CMO indicated the care of Patient 36 was "appropriate" and "closed". There was no investigation or RCA. The QMC acknowledged the case was not reported to MBC, CDPH, GB or OPPE, and no restrictions were placed on his privileges.

Patient 37. MEC indicated a complaint was received from another provider that MD 11 "lacked judgment". The MEC referenced a case for a woman who had no active medications or medical issues except diabetes and heartburn. MD 11 performed a "laparoscopic take down of Nissen (surgery on the esophagus)". Patient 37 suffered unusual surgical complications during surgery-- stomach injury requiring partial gastrectomy (removal of the stomach), esophageal perforation (hole) into the lung cavity causing lung empyema (large collection of pus ) to both lungs, lung injury due to esophageal pleural fistula (abnormal connection between the esophagus and lungs), pneumonia, and pneumothorax (air escaping from lung into the surrounding body cavity). Patient 37 was transfered to another facility for cardiothoracic surgery. QD and CMO indicated the care of Patient 3 QMC was "appropriate" and "resolved" because the patient was transferred to another facility for cardiothoracic surgery. MD 11 lacked documented evidence of privileges, training, education, competency and peer review to provide medical and surgical services for hernia repair (part of an organ protrude through a body cavity), paraoesophageal hernia (part of esophsgus an organ is displaced) repairs, and Nissen (esophagus surgery) surgical procedures. There was no investigation or RCA. QMC indicated the case was not reported to MBC, GB or CDPH, and no restrictions were placed on his privileges.

Patient 38. MEC indicated MD 11 was referred to the QA department for surgical complications. MD 11 placed a central line in Patietn 38 and sustained injured the patient's lung. The injury caused a "hemopneumothorax (air and blood in cavity that contains the lungs) and the need for ventilatory (breathing tube and machine) support". QD and CMO indicated the care of Patient 38 was "appropriate" and "closed". There was no investigation or RCA. The QMC acknowledged the case was not reported to GB or OPPE.

Patient 39. MEC indicated MD 11 was referred to the QA department for surgical complications. MD 11 performed a tracheostomy on Patient 39, and there were complications and "concern of tracheocutaneous fistula" and a revision of tracheostomy was required. MD 20 revised the tracheostomy, but the case "was complicated pneumothorax requiring placing a right sided chest tube, cardiac arrest and being pulseless for 7 minutes". QD and CMO indicated the care of Patient 4 QMC was "appropriate" and "closed".

Patient 40. MEC indicated MD 11 was referred to the QA department for surgical complications. MD 11 preformed a "laparoscopic hiatal hernia repair (part of an organ protrude through a body cavity), with TIF fundoplasty (surgery on the esophagus)" and returned to the operating room for "esophageal foreign body and esophageal stricture". QD and CMO indicated the care of Patient 40 was "appropriate" and "closed". MD 11 lacked documented evidence of privileges, training, education, competency and peer review to provide medical and surgical services for hernia repair, paraoesophageal hernia (part of esophagus an organ is displaced) repairs, and Nissen (esophagus surgery) surgical procedures. There was no investigation or RCA. The QMC acknowledged the case was not reported to MBC, CDPH, GB or OPPE, and no restrictions were placed on his privileges MBC, CDPH, GB or OPPE.

Patient 41. MEC indicated MD 11 was referred to the QA department for surgical complications. MD 11 preformed a "diagnostic laparoscopy, lysis of adhesion (cutting of scar tissue), excision of colon fistula with right colectomy and small bowel resection" and "infection". QD and CMO indicated the care of Patient 41 was "appropriate" and "closed". There was no investigation or RCA. The QMC acknowledged the case was not reported to GB or OPPE, and no restrictions were placed on his privileges.

A concurrent interview and record review interview occurred on 3/17/2023 at 11:27 am via ZOOM with the Quality Committee (QMC) team. In attendance were Director Medical Staff Administration, (DMSA), Chief Medical Officer (CMO), Quality Director (QD) and Peer Review Nurse, (PRN). The CMO indicated OPPE data is not monitored, tracked, trended or acted upon. The CMO (Chief Medical Officer) and QD stated, if there are concerns the Chair of the department will discuss concerns with the provider, and if needed the Chair will bring the concern to the attention of the CMO. The CMO will "communicate" with the Chief of Staff who is a member of the GB. The CMO indicated, "don't get into the details of OPPE" but look at "if done of not done". The QMC team acknowledged the GB "depends" on the medical staff and QMC program to report information. The QMC team indicated that OPPE is to be completed at every "privileging cycle" and reflects "proof of competence", and contains peer review.

Review of hospital bylaws title, 2019 Amended and Restated Bylaws of the Community Board of [Facility] of [City], approved June 24, 2019, indicated that "MEDICAL STAFF MATTERS ... shall be organized for the adequacy and quality of medical care rendered to patients ... Medical Staff shall be responsible to this Hospital Community ...adequacy and quality of medical care and professional work ... There shall be Medical Staff Bylaws and Rules and Regulations for the Local Hospital, setting forth the Medical Staff's organization ... Written, defined criteria for Medical Staff appointment and the granting of clinical privileges ... physician responsible for the service be certified or eligible for certification by an appropriate American medical specialty board ...establishment of controls to facilitate the achievement and maintenance of high standards of ethical practices, including a requirement that all members of the Medical Staff be required to demonstrate their ability to perform surgical and other procedures competently at the time of original appointment and at least every two years ... licensed Practitioner with appropriate clinical privileges shall be directly responsible for patient diagnosis and treatment within the scope of such Practitioner's license and privileges ... The mechanisms for reviewing credentials, delineating clinical privileges, conducting, evaluating, and revising quality assessment and performance improvement activities, appointment, reappointment, corrective action, and fair hearing procedures, and restriction, reduction, suspension, termination, and revocation of Medical Staff membership or clinical privileges .... Medical Staff Executive Committee shall make recommendations to the Hospital Community Board".

Review of the hospital document titled, [Hospital] Medical Staff Bylaws, dated 12/6/2018, not signed by a responsible GB or MEC member, indicated "Appointment Qualifications ... Detailed information concerning the practitioner's qualifications ... Medical Staff quality assessment process relevant to the involved practitioner, including the Medical Staff's ongoing professional practice evaluation ...evaluation of the practitioner's competence ... The proctor shall monitor the practitioner's performance of the requested privilege(s) in at least three major cases and shall complete the Proctor Reporting Form and any other pertinent information for each case .... Reappointment ... shall be based upon review of such practitioner's professional ability and clinical judgment in the treatment of patients, the practitioner's professional ethics, the practitioner's discharge of Medical Staff obligations ... Medical Executive Committee recommends appointment and the granting of all requested privileges, the recommendation shall be promptly forwarded, together with any necessary supporting documentation ...to the Board".

Review of hospital bylaws title, 2019 Amended and Restated Bylaws of the Community Board of [Facility] of [City], approved June 24, 2019, indicated "Quality Assessment and performance Improvement (QAPI). The Medical Staff shall be responsible to the Hospital Community Board and the Dignity Health Board for the quality of medical care provided by Medical Staff members and other Practitioners to patients of the Local Hospital ... Medical Staff is responsible for ensuring that the professional care furnished to patients ... is of high quality, safe, efficient and effective and meets professional standards ... The Medical Staff shall discharge this responsibility by meeting regularly to review, analyze, and appraise its clinical experience and the quality of care rendered by members of the Medical Staff, in conformance with its Medical Staff Bylaws and Local Hospital policies and procedures. The review and analysis shall be based on patient medical records and such other documents and patient ... The Medical Staff shall identify and implement an appropriate response to findings. Such quality assessment and performance improvement activities shall be regularly reported to this Hospital Community Board".

Review of the hospital document titled, [Hospital] Medical Staff Bylaws, dated 12/6/2018, not signed by a responsible GB or MEC member, section 4.12 indicated "all deaths in which the cause of death is not known with certainty on clinical grounds or where autopsy may help to explain unknown and unanticipated medical complications to the attending physician ... Unexpected or unexplained deaths occurring during or within 48 hours following any surgical or invasive procedure or therapy ... Deaths that are suspected to be due to an infectious disease when the confirmation of the diagnosis may be of epidemiological significance ... Any death where there is a possibility that a medical device may be implicated pursuant to the Safe Medical Devices Act of 1990.

Review of the hospital document titled, [Hospital] Medical Staff Bylaws, dated 12/6/2018, not signed by a responsible GB or MEC member, section 7.10, indicated "to protect the patient, improve systems and prevent further harm, physicians who experience operative or postoperative complications shall promptly complete an iVOS report (type of incident event report), and contact the Surgical Department Chair. For those still in Practical Training for Robotics, your mentor should also be contacted".

Review of the hospital document titled, [Hospital] Medical Staff Bylaws, dated 12/6/2018, not signed by a responsible GB or MEC member Section 8.4, indicated "all High Risk deliveries... will have either 1) a separate physician or 2) a designated resuscitation team consisting of a NRP certified Registered Nurse and a Respiratory Care Practitioner who is certified in advanced practice by Children's Hospital Central California whose sole responsibility will be the resuscitation and care of the newborn infant. The physician responsible for the care of the newborn must have current privileges in newborn resuscitation and, in consultation with the Obstetrician and the team, determine the need for his/her physical presence at the time of the high-risk delivery and in compliance with any current patient care guidelines of Children's Hospital Central California. Medical emergencies in the perinatal area including, but not limited to: o Meconium staining ...Fetal Distress ... Multiple Births.

Review of the hospital document titled, Pediatric Department Rules and Regulations, revised 03/28/13, indicated "A Neonatal Resuscitation Team may attend high risk deliveries".

Review of the hospital document titled, [Hosptal] General Surgery Privilege Applications indicated "demonstrated and minimum number of cases as indicated with acceptable results in the privileges requested for the past 14 months as a result of quality assessment/improvement activities outcomes ... Diagnostic, basic and advance laparoscopic privileges required minimum cases for past 2 years (14 cases) ... Robotics training 5 supervised proctored cases, 10 cases in past 2 years ... and laparoscopic privileges".

Review of the hospital document titled, Department of Medicine Privilege Checklist, General Internal Medicine, did not indicate appointment requirements for competence, performance evalautions, proctoring, demonstrate procedural skills, peer review evaluations, or demonstrate up-to-date competence.

Review of the hospital document titled, [Hospital] Privilege Application, Gastroenterology, indicated "this category is applicable to physicians who are board certified, eligible; or fully trained in a recognized [Gastroenterology ] sub-specialty medicine board as defined by the AMA (American Medical Association". The checklist did not indicate appointment requirements for competence, performance evalautions, proctoring, peer review evaluations, demonstrate procedural skills, case requirements or demonstrate up-to-date competence.

Review of the hospital document titled, [Hospital] Nurse Practitioner & Physician Assistant Hosptal Checklist for Scope of Practice, indicated the" Scope Practice as an physician assistant or Nurse Practitioner ... requires a designed supervising physician with clinical privileges at this hospital in the same area of specialty practice. All practice is performed under the supervision of this physician ... demonstrated competence and an adequate volume of experience 12 patient within 24 months with acceptable results ... ongoing professional practice evaluation and outcomes. Evidence of current ability to perform practice requested ...advanced privileges requiring special expertise and/or documentation of special training and/or certification ... All orders are to be countersigned by the supervising physician".

Review of the American Board of Internal Medicine (ABIM) subspecialty training requirements for Gastroenterology, indicated "at the time of application, be previously certified in internal medicine by ABIM ... Satisfactorily complete the requisite graduate medical education fellowship training ...Demonstrate clinical competence, procedural skills, and moral and ethical behavior in the clinical setting ...Pass the Gastroenterology Certification Examination ....Gastroenterology fellowship training must be accredited by the Accreditation Council for Graduate Medical Education".
abim.org/certification/policies/internal-medicine-subspecialty-policies/gastroenterology/. Accessed 3/18/2023.

Based on interview and record review, the Medical Staff team (MEC) failed to follow the Governing Body (GB) Bylaws, MEC Bylaws, and medical staff rules and regulations for competency, privileging, monitoring, peer review, and/or education requirements

This failure allowed medical staff, physicians (MD) and Allied Health Professionals (AHP), including Physician assistants (PA), to divert requirements and provide medical services for which they were not vetted to provide.

Findings:

A concurrent interview and record review occurred on 3/13/2023 at 10:00 and continued on 3/16/2023 at 10:30 am via ZOOM with the Medical Staff team who are oversee the medical staff credentialing and privileging and Peer review of providers. In attendance were Director Medical Staff Administration, (DMSA), Chief Medical Officer (CMO), Quality Director (QD), Medical Staff Coordinator, (MSC), Credentialing Coordinator, (CC), and Peer Review Nurse, (PRN) (not present on 3/13/2023). MEC indicated all providers had satisfied the requirements required by Medical staff. Recommendations for staff membership and privileges were "based on judgment" of the MEC. The MEC acknowledged there were no documentation for competency, training, education, certificates, proctoring, peer review and/or provider performance. The MEC indicated if the physician was not board certified or eligible, it was a "problem". MEC indicated, only requirement for tuberculosis clearance was" symptom affidavit". If there were "no symptoms", there were "no requirements" for CXR or Tb testing. MEC indicated they "follow CDC guidelines" instead of Bylaws and medical rules and regulations.

The privileges of 18 providers (MD 1 Anesthesiologist, MD 2 anesthesiologist, MD 3 Family Practice (FP), MD 4 FP MD 5 FP, MD 6 FP, MD 7 Pediatrician (Peds), MD 8 Peds, MD 9 Obstetrician (OB)-gynecology (Gyn), MD 10 OB-Gyn, MD 11 Surgeon, MD 12 FP, MD 13 Internal Medicine (IM), MD 14 IM, MD 15, IM, DRP/FP FP, PA 1, and PA 2) were reviewed. The following providers did not have documented evidence to meet Medical staff and GB privileging requirements for:

18 of 18 providers, (MD 1, MD 2, MD 3, MD 4, MD 5, MD 6, MD 7, MD 8, MD 9, MD 10, MD 11, MD 12, MD 13, MD 14, MD 15, DRP/FP, PA 1, PA 2) did not have a MEC authorizing signature for medical membership and/or privileges on the Appointment Evaluation form.

18 of 18 providers, (MD 1, MD 2, MD 3, MD 4, MD 5, MD 6, MD 7, MD 8, MD 9, MD 10, MD 11, MD 12, MD 13, MD 14, MD 15, DRP/FP, PA 1, PA 2) did not have a GB authorizing signature for medical membership and/or privileges on the Appointment Evaluation form.

Five of 16 physicians, (MD 1, MD 2, MD 9, MD 13, MD 14), lacked board certification/eligibility for their privileged specialty.

One of 16 physicians, (MD 13) provided x-ray and fluoroscopic (type of x-ray) examinations of patients without a State license/certificate.

Two of 2 Advanced health Providers (AHP), (PA 1 and PA 2) lacked a supervising physician of record that took direct responsibility for patient care.

One of 18 providers (PA 2) did not have documented evidence of a National Practitioner Databank (created by Congress to improve health care quality, protect the public, and reduce health care fraud and tack medical malpractice payment and adverse action reports on health care professional) .

17 of 18, providers, (MD 1, MD 2, MD 3, MD 4, MD 5, MD 6, MD 7, MD 8, MD 9, MD 10, MD 11, MD 12, MD 13, MD 14, MD 15, DRP/FP, PA 1), lacked documented evidence of annual PDD (skin test for tuberculosis) screening.

Five of 6 Family Practice and 2 of 2 OB providers, (MD 3, MD 5, MD 6, MD 9, MD 10, MD 12, DRP/FP), lacked documented evidence of cardiac life support, Pediatric Life Support (PALS) and/or Neonatal Resuscitation (NRP), certificates to provide medical services for neonatal care (newborn) and/or pediatric resuscitation (life support for infants and children),

Review of hospital bylaws title, 2019 Amended and Restated Bylaws of the Community Board of [Facility] of [City], approved June 24, 2019, indicated that "MEDICAL STAFF MATTERS ... shall be organized for the adequacy and quality of medical care rendered to patients ... Medical Staff shall be responsible to this Hospital Community ...adequacy and quality of medical care and professional work ... There shall be Medical Staff Bylaws and Rules and Regulations for the Local Hospital, setting forth the Medical Staff's organization ... Written, defined criteria for Medical Staff appointment and the granting of clinical privileges ... physician responsible for the service be certified or eligible for certification by an appropriate American medical specialty board ...establishment of controls to facilitate the achievement and maintenance of high standards of ethical practices, including a requirement that all members of the Medical Staff be required to demonstrate their ability to perform surgical and other procedures competently at the time of original appointment and at least every two years ... licensed Practitioner with appropriate clinical privileges shall be directly responsible for patient diagnosis and treatment within the scope of such Practitioner's license and privileges ... The mechanisms for reviewing credentials, delineating clinical privileges, conducting, evaluating, and revising quality assessment and performance improvement activities, appointment, reappointment, corrective action, and fair hearing procedures, and restriction, reduction, suspension, termination, and revocation of Medical Staff membership or clinical privileges .... Medical Staff Executive Committee shall make recommendations to the Hospital Community Board".

Review of the hospital document titled, [Hospital] Medical Staff Bylaws, dated 12/6/2018, not signed by a responsible GB or MEC member, indicated "a member of the Medical Staff with appropriate clinical privileges shall be responsible for the medical care and treatment of each patient in the hospital".

Review of the hospital document titled, [Hospital] Medical Staff Bylaws, dated 12/6/2018, not signed by a responsible GB or MEC member, indicated "Appointment Qualifications ... Detailed information concerning the practitioner's qualifications ... Medical Staff quality assessment process relevant to the involved practitioner, including the Medical Staff's ongoing professional practice evaluation ...evaluation of the practitioner's competence ... The proctor shall monitor the practitioner's performance of the requested privilege(s) in at least three major cases and shall complete the Proctor Reporting Form and any other pertinent information for each case .... Reappointment ... shall be based upon review of such practitioner's professional ability and clinical judgment in the treatment of patients, the practitioner's professional ethics, the practitioner's discharge of Medical Staff obligations ... Medical Executive Committee recommends appointment and the granting of all requested privileges, the recommendation shall be promptly forwarded, together with any necessary supporting documentation ...to the Board".

Review of the hospital document titled, Medical staff Rules and Regulations, indicated "Annual Tuberculin Skin Testing ("PPD") ... All Medical Staff members shall be responsible for completing an annual symptom review questionnaire regarding their Tuberculin skin test ("PPD"). Medical Staff members with negative symptoms and no documentation of prior positive TB screening shall provide evidence of a completed PPD on an annual basis to the Medical Center's Department of Medical Staff Services .... Failure to comply may result in the suspension and/or termination of Medical Staff membership as determined by the Executive Committee".

Review of the hospital document titled, [Hospital] Medical Staff Bylaws, approved by GB 12/6/2018, but not signed by a responsible GB member, indicated "a query of the National Practitioner Databank will be performed on all practitioners" (Created by Congress to improve health care quality, protect the public, and reduce health care fraud and tack medical malpractice payment and adverse action reports on health care professional".

California Health and Safety Code 107110 indicated "It shall be unlawful for any licentiate of the healing arts to administer or use diagnostic, mammographic, or therapeutic x-ray on human beings in this state, unless that person is certified pursuant to subdivision (e) of Section 114870, Section 114872, or Section 114885".

Review of the hospital document titled, [Hosptal] Credentialing for Moderate and/or Deep Sedation Outside the Operating Room Policy and Procedure, effective 1/24/2019 indicated ... 1. Moderate sedation privileges are granted to those providers board certified or board eligible in Emergency Medicine and Critical Care Medicine ... 3. Required sedation education for those providers not board certified or board eligible in Emergency Medicine or Critical Care Medicine include: successful completion of "Safe Sedation Training - Moderate" (SST moderate) module offered by the American Society of Anesthesiologists (ASA) and current certification in ACLS, and PALS (for pediatric privileges) .... Physicians, who are not board certified or board eligible in critical care medicine and physicians who are not privileged in the Department of Emergency Medicine must demonstrate that they are competent to rescue patients from sedation including management of a compromised airway, providing adequate oxygenation and ventilation, and management of an unstable cardiovascular system ... The Director of the Department of Anesthesiology or designee will document demonstration of competency in rescue of patients from deep and moderate sedation".
Review of the hospital document titled, [Hospital] Privilege Application, Gastroenterology, indicated "this category is applicable to physicians who are board certified, eligible; or fully trained in a recognized [Gastroenterology ] sub-specialty medicine board as defined by the AMA (American Medical Association". The checklist did not indicate appointment requirements for competence, performance evalautions, proctoring, peer review evaluations, demonstrate procedural skills, case requirements or demonstrate up-to-date competence.

Review of the hospital document titled, [Hospital] Medical Staff Bylaws, dated 12/6/2018, not signed by a responsible GB or MEC member, indicated "a member of the Medical Staff with appropriate clinical privileges shall be responsible for the medical care and treatment of each patient in the hospital ... Supervision Required. Review and approve all standardized procedures and clinical protocols utilized by nurses practicing in expanded roles and/or practitioners providing clinical services utilizing protocols under the supervision of a Medical Staff member ... Evaluating and reporting whether in-hospital services proposed to be performed or actually performed by AHPs are inconsistent with the rendering of quality medical care and with the responsibilities of members of the Medical Staff."

Review of the hospital document titled, [Hospital] Nurse Practitioner & Physician Assistant Hosptal Checklist for Scope of Practice, indicated the" Scope Practice as an physician assistant or Nurse Practitioner ... requires a designed supervising physician with clinical privileges at this hospital in the same area of specialty practice. All practice is performed under the supervision of this physician ... demonstrated competence and an adequate volume of experience 12 patient within 24 months with acceptable results ... ongoing professional practice evaluation and outcomes. Evidence of current ability to perform practice requested ...advanced privileges requiring special expertise and/or documentation of special training and/or certification ... All orders are to be countersigned by the supervising physician".

Review of the American Medical Association (AMA) guidelines indicated, "a supervising physician shall delegate to a PA only those tasks and procedures consistent with the supervising physician's specialty or usual and customary practice. A supervising physician shall observe or review evidence of the PAs performance until assured of competency. (CCR 1399.545) ... Sample of at least 10 charts per month, for at least 10 months during the year. (Minimum of 5% of the PAs medical records). (CCR 3502) ... § 3502. Services (a) Notwithstanding any other law, a PA may perform medical services as authorized by this chapter if the following requirements are met: (1) The PA renders the services under the supervision of a licensed physician and surgeon who is not subject to a disciplinary condition". https://www.ama-assn.org/sites/ama-assn.org/files/corp/media-browser/public/arc-public/state-law-physician-assistant-scope-practice.pdf. Accessed 3/25/2023.

Review of the American Board of Internal Medicine (ABIM) subspecialty training requirements for Gastroenterology, indicated "at the time of application, be previously certified in internal medicine by ABIM ... Satisfactorily complete the requisite graduate medical education fellowship training ...Demonstrate clinical competence, procedural skills, and moral and ethical behavior in the clinical setting ...Pass the Gastroenterology Certification Examination ....Gastroenterology fellowship training must be accredited by the Accreditation Council for Graduate Medical Education".
abim.org/certification/policies/internal-medicine-subspecialty-policies/gastroenterology/. Accessed 3/18/2023.

Based on interview and record review, the Medical Staff team (MEC) failed to ensure Medical staff Bylaws and medical staff rules and regulations were approved by the GB.

This failure allowed MEC to function outside GB oversight and created unsafe medical care and support a harmful environment.

Findings:

A concurrent interview and record review occurred on 3/13/2023 at 10:00 and continued on 3/16/2023 at 10:30 am via ZOOM with the Medical Staff team who are oversee the medical staff credentialing and privileging and Peer review of providers. In attendance were Director Medical Staff Administration, (DMSA), Chief Medical Officer (CMO), Quality Director (QD), Medical Staff Coordinator, (MSC), Credentialing Coordinator, (CC), and Peer Review Nurse, (PRN) (not present on 3/13/2023). The CMO acknowledged the medical staff Medical staff bylaws, rules and regulations did not have signature of approval by the GB. The CMO indicated that they do not require a signature of approval by the GB.

A concurrent interview and record review occurred on 3/16/2023 at 2:30 pm via ZOOM with Governing Body (GB) members. In attendance were GB President (PR), CEO family community board member (CEO/CBM), Chief of Medical Staff (CM), and Executive Assistant to the President. (SEA). The GB indicated the MEC Bylaws do not require a GB authorizing signature. GB indicated that medical staff rules and regulations did not require GB review. The GB indicated, they "rely" on the MEC of medical staff to disseminate requirements in the Medical staff bylaws, rules and regulations information to providers. It is their "responsibility".

Review of hospital bylaws title, 2019 Amended and Restated Bylaws of the Community Board of [Facility] of [City], approved June 24, 2019, indicated that "MEDICAL STAFF MATTERS ... shall be organized for the adequacy and quality of medical care rendered to patients ... Medical Staff shall be responsible to this Hospital Community ...adequacy and quality of medical care and professional work ... There shall be Medical Staff Bylaws and Rules and Regulations for the Local Hospital, setting forth the Medical Staff's organization ... Written, defined criteria for Medical Staff appointment and the granting of clinical privileges ... physician responsible for the service be certified or eligible for certification by an appropriate American medical specialty board ...establishment of controls to facilitate the achievement and maintenance of high standards of ethical practices, including a requirement that all members of the Medical Staff be required to demonstrate their ability to perform surgical and other procedures competently at the time of original appointment and at least every two years ... licensed Practitioner with appropriate clinical privileges shall be directly responsible for patient diagnosis and treatment within the scope of such Practitioner's license and privileges ... The mechanisms for reviewing credentials, delineating clinical privileges, conducting, evaluating, and revising quality assessment and performance improvement activities, appointment, reappointment, corrective action, and fair hearing procedures, and restriction, reduction, suspension, termination, and revocation of Medical Staff membership or clinical privileges .... Medical Staff Executive Committee shall make recommendations to the Hospital Community Board".

Review of the hospital document titled, [Hospital] Medical Staff Bylaws, dated 12/6/2018, not signed by a responsible GB or MEC member, indicated "Appointment Qualifications ... Detailed information concerning the practitioner's qualifications ... Medical Staff quality assessment process relevant to the involved practitioner, including the Medical Staff's ongoing professional practice evaluation ...evaluation of the practitioner's competence ... The proctor shall monitor the practitioner's performance of the requested privilege(s) in at least three major cases and shall complete the Proctor Reporting Form and any other pertinent information for each case .... Reappointment ... shall be based upon review of such practitioner's professional ability and clinical judgment in the treatment of patients, the practitioner's professional ethics, the practitioner's discharge of Medical Staff obligations ... Medical Executive Committee recommends appointment and the granting of all requested privileges, the recommendation shall be promptly forwarded, together with any necessary supporting documentation ...to the Board".

Based on interview and record review, the Medical Staff team (MEC) failed to ensure the list the specific privileges and scope of practice approved for individual providers reflected the provider's /experience, competency, and education.

This failure to limit a provider's scope of practice based on his/her qualifications, risked patient safety and the quality of care.

Findings:

A concurrent interview and record review occurred on 3/13/2023 at 10:00 and continued on 3/16/2023 at 10:30 am via ZOOM with the Medical Staff team who are oversee the medical staff credentialing and privileging and Peer review of providers. In attendance were Director Medical Staff Administration, (DMSA), Chief Medical Officer (CMO), Quality Director (QD), Medical Staff Coordinator, (MSC), Credentialing Coordinator, (CC), and Peer Review Nurse, (PRN) (not present on 3/13/2023).

Recommendations for staff membership and privileges were "based on judgment" of the MEC. MEC indicated all providers had satisfied the requirements to provide medical services that they had approval for. MEC indicated, providers qualified for privileges because the " completed residency training here [at Hospital]". The MEC acknowledged there were no complete documentation for competency, training, education, certificates, proctoring, peer review and/or provider performance for providers.

The privileges of 18 providers (MD 1 Anesthesiologist, MD 2 anesthesiologist, MD 3 Family Practice (FP), MD 4 FP MD 5 FP, MD 6 FP, MD 7 Pediatrician (Peds), MD 8 Peds, MD 9 Obstetrician (OB)-gynecology (Gyn), MD 10 OB-Gyn, MD 11 Surgeon, MD 12 FP, MD 13 Internal Medicine (IM), MD 14 IM, MD 15, IM, DRP/FP FP, PA 1, and PA 2) were reviewed. The following providers did not have documented evidence to meet Medical staff and GB privileging requirements to provide specialized medical services:

Five of 6 Family Practice providers (MD 3, MD 5, MD 6, MD 12, DRP/FP) provide medical services and procedures for obstetric care (medical care of pregnant women).

Four of 6 Family Practice providers (MD 3, MD 5, MD 6, DRP/FP) provide ultrasound (imaging tool that enables views of inside the body) procedures to evaluate and diagnose the status of fetuses and obstetric patients.

Five of 6 Family Practice providers (MD 3, MD 5, MD 6, MD 12, DRP/FP) provide medical services for neonatal care (newborn) and/or attendance to delivery of newborn.

Five of 6 Family Practice and 2of 2 OB providers, (MD 3, MD 5, MD 6, MD 9, MD 10,MD 12, DRP/FP), provide neonatal care (newborn) and/or pediatric resuscitation (life support for infants and children).

Four of 6 Family Practice providers (MD 5, MD 6, MD 12, DRP/FP) provide medical services for Gynecologic care (medical care for female organs).

One of 18 providers, (MD 13) provided fluoroscopy (type of x-ray) and x-ray procedures without the state required licensure/ certificate.

Two of 18 providers (MD 6, MD 13) provide medical services for sedation.

One of 1 surgical providers (MD 11) provide Robotic surgical services.

One of 1 surgical providers (MD 11) provide medical and surgical services for hernia repair (part of an organ protrude through a body cavity), paraoesophageal hernia (part of esophagus an organ is displaced) repairs, and Nissen (esophagus surgery) surgical procedures.

One of 3 Internal Medicine providers (MD 13) provide medical services for gastroenterology (specialized branch of medicine that deals with the diagnosis and treatment of disorders of the stomach, intestines and other organs) procedures and surgical services privileges.

One of 3 Internal Medicine providers (MD 13) provide cardiac (heart) services and procedures.

For 1 of 3 Internal Medicine providers (MD 13) provide medical services for physical medicine and rehabilitation.

For 2 of 2 surgical providers (MD 13, MD 11) provide medical and surgical services for laparoscopy (surgical procedure that allows a surgeon to access the inside of the abdomen and pelvis without having to make large incision).

For 3 of 18 providers (MD 12, PA 1, PA 2) provide medical services for complex wounds and pressure ulcers care.

For 7 of 18 providers (MD 3, MD 5, MD 6, MD 8, MD 12, MD 13, DRP/FP) provide medical services for intubation (place a breathing tube into a person's lung). and/or laryngoscopy (look deep into a throat using a specialized tool) privileges.

For 10 of 18 providers, (MD 1, MD 2, MD 5, MD 6, MD 11, MD 12, MD 13, DRP/FP, PA 1, PA 2) provide medical services for central lines placement (a large tube that is placed in a large, main vein in the neck, upper chest or groin. It requires special training to place).

Review of hospital bylaws title, 2019 Amended and Restated Bylaws of the Community Board of [Facility] of [City], approved June 24, 2019, indicated that "MEDICAL STAFF MATTERS ... shall be organized for the adequacy and quality of medical care rendered to patients ... Medical Staff shall be responsible to this Hospital Community ...adequacy and quality of medical care and professional work ... There shall be Medical Staff Bylaws and Rules and Regulations for the Local Hospital, setting forth the Medical Staff's organization ... Written, defined criteria for Medical Staff appointment and the granting of clinical privileges ... physician responsible for the service be certified or eligible for certification by an appropriate American medical specialty board ...establishment of controls to facilitate the achievement and maintenance of high standards of ethical practices, including a requirement that all members of the Medical Staff be required to demonstrate their ability to perform surgical and other procedures competently at the time of original appointment and at least every two years ... licensed Practitioner with appropriate clinical privileges shall be directly responsible for patient diagnosis and treatment within the scope of such Practitioner's license and privileges ... The mechanisms for reviewing credentials, delineating clinical privileges, conducting, evaluating, and revising quality assessment and performance improvement activities, appointment, reappointment, corrective action, and fair hearing procedures, and restriction, reduction, suspension, termination, and revocation of Medical Staff membership or clinical privileges .... Medical Staff Executive Committee shall make recommendations to the Hospital Community Board".

Review of the hospital document titled, [Hospital] Medical Staff Bylaws, dated 12/6/2018, not signed by a responsible GB or MEC member, indicated "Appointment Qualifications ... Detailed information concerning the practitioner's qualifications ... Medical Staff quality assessment process relevant to the involved practitioner, including the Medical Staff's ongoing professional practice evaluation ...evaluation of the practitioner's competence ... The proctor shall monitor the practitioner's performance of the requested privilege(s) in at least three major cases and shall complete the Proctor Reporting Form and any other pertinent information for each case .... Reappointment ... shall be based upon review of such practitioner's professional ability and clinical judgment in the treatment of patients, the practitioner's professional ethics, the practitioner's discharge of Medical Staff obligations ... Medical Executive Committee recommends appointment and the granting of all requested privileges, the recommendation shall be promptly forwarded, together with any necessary supporting documentation ...to the Board".

Review of the hospital document titled, [Hospital] Health Administrative Policy Manual Clinical Policy And Procedure Procedural Sedation, Management of, effective 6/27/2018, indicated "Competency Requirements For Moderate And Deep Sedation: 1. Physicians: The Physician supervising the administration of or administering the medication will be competent to perform sedation as evidenced by privileging criteria ... To administer deep sedation, an individual must be a physician with appropriate privileges to administer deep sedation and have demonstrated competency in rescuing a patient from general anesthesia including management of an unstable cardiovascular system, a compromised airway and inadequate oxygenation and ventilation ... ASA requirements Anesthesia."

Review of the hospital document titled, [Hosptal] Credentialing for Moderate and/or Deep Sedation Outside the Operating Room Policy and Procedure, effective 1/24/2019 indicated, "required sedation education for those providers not board certified or board eligible in Emergency Medicine or Critical Care Medicine include: successful completion of "Safe Sedation Training - Moderate" (SST moderate) module offered by the American Society of Anesthesiologists (ASA) and current certification in ACLS, and PALS (for pediatric privileges)... must demonstrate that they are competent to rescue patients from sedation including management of a compromised airway, providing adequate oxygenation and ventilation, and management of an unstable cardiovascular system ... The Director of the Department of Anesthesiology or designee will document demonstration of competency in rescue of patients from deep and moderate sedation".

Review of the hospital document titled, [Hosptal] Policy and Procedure, Resuscitation of the Newborn (PC-63), effective 1/1976, indicated "newborn resuscitation will be provided in accordance with the Neonatal Resuscitation Program Standards as set by the American Heart Association. Current NRP [Neonatal Resuscitation Program team-based care for healthcare professionals who care for newborns at the time of delivery] (newborn handbook and updates from the American Heart Association will be followed".

Review of the hospital document titled, [Hospital] Pediatric Privilege form indicated, "Successful completion of an ACGME or AOA accredited post-graduate training program In Pediatrics ... Hold PALS or NRP certification ... provide documentation of the number and types of hospital cases during the past 24 months ... evaluation of current competence, and other qualifications ... recent experience ... procedures at previous hospital affiliations ...number of procedures performed in a specified period of time that are believed to be necessary to maintain clinical competence".

Review of the hospital document titled, [Hosptal] General Surgery Privilege Applications indicated "demonstrated and minimum number of cases as indicated with acceptable results in the privileges requested for the past 14 months as a result of quality assessment/improvement activities outcomes ... Diagnostic, basic and advance laparoscopic privileges required minimum cases for past 2 years (14 cases) ... Robotics training 5 supervised proctored cases, 10 cases in past 2 years ... and laparoscopic privileges".

Review of the hospital document titled, Department of Anesthesiology Privilege List, did not indicate appointment requirements for competence, performance evalautions, peer review evaluations, proctoring, demonstrate procedural skills, case requirements or demonstrate up-to-date competence

Review of the hospital document titled, Department of Medicine Privilege Checklist, General Internal Medicine, did not indicate appointment requirements for competence, performance evalautions, proctoring, demonstrate procedural skills, peer review evaluations, or demonstrate up-to-date competence.

Review of the hospital document titled, [Hospital] Privilege Application, Gastroenterology, indicated "this category is applicable to physicians who are board certified, eligible; or fully trained in a recognized [Gastroenterology ] sub-specialty medicine board as defined by the AMA (American Medical Association". The checklist did not indicate appointment requirements for competence, performance evalautions, proctoring, peer review evaluations, demonstrate procedural skills, case requirements or demonstrate up-to-date competence.

Review of the hospital document titled, [Hospital] Medical Staff Bylaws, dated 12/6/2018, not signed by a responsible GB or MEC member Section 8.4, indicated "all High Risk deliveries... will have either 1) a separate physician or 2) a designated resuscitation team consisting of a NRP certified Registered Nurse and a Respiratory Care Practitioner who is certified in advanced practice by Children's Hospital Central California whose sole responsibility will be the resuscitation and care of the newborn infant. The physician responsible for the care of the newborn must have current privileges in newborn resuscitation and, in consultation with the Obstetrician and the team, determine the need for his/her physical presence at the time of the high risk delivery and in compliance with any current patient care guidelines of Children's Hospital Central California. Medical emergencies in the perinatal area including, but not limited to: o Meconium staining ...Fetal Distress ... Multiple Births.

Review of the hospital document titled, [Hospital] Nurse Practitioner & Physician Assistant Hosptal Checklist for Scope of Practice, indicated the" Scope Practice as an physician assistant or Nurse Practitioner ... requires a designed supervising physician with clinical privileges at this hospital in the same area of specialty practice. All practice is performed under the supervision of this physician ... demonstrated competence and an adequate volume of experience 12 patient within 24 months with acceptable results ... ongoing professional practice evaluation and outcomes. Evidence of current ability to perform practice requested ...advanced privileges requiring special expertise and/or documentation of special training and/or certification ... All orders are to be countersigned by the supervising physician".

Review of the American Board of Internal Medicine (ABIM) subspecialty training requirements for Gastroenterology, indicated "at the time of application, be previously certified in internal medicine by ABIM ... Satisfactorily complete the requisite graduate medical education fellowship training ...Demonstrate clinical competence, procedural skills, and moral and ethical behavior in the clinical setting ...Pass the Gastroenterology Certification Examination ....Gastroenterology fellowship training must be accredited by the Accreditation Council for Graduate Medical Education".
abim.org/certification/policies/internal-medicine-subspecialty-policies/gastroenterology/. Accessed 3/18/2023.

Based on interview and record review, before recommending the provider for medical staff membership and privileges, the MEC failed to vet the qualifications of the providers to provide medical services.

This failure to allowed providers, physicians (MD) and Allied Health Professionals (AHP), including Physician assistants (PA), who did not meet to meet the educational, training, experience, certification and/or licensing requirements to render medical services to patients and risked the safety and quality of patient care.

Findings:

A concurrent interview and record review occurred on 3/13/2023 at 10:00 and continued on 3/16/2023 at 10:30 am via ZOOM with the Medical Staff team who are oversee the medical staff credentialing and privileging and Peer review of providers. In attendance were Director Medical Staff Administration, (DMSA), Chief Medical Officer (CMO), Quality Director (QD), Medical Staff Coordinator, (MSC), Credentialing Coordinator, (CC), and Peer Review Nurse, (PRN) (not present on 3/13/2023). The MEC indicated all privileges were approved by the MEC. The privileges of 18 providers (MD 1 Anesthesiologist, MD 2 Anesthesiologist, MD 3 Family Practice (FP), MD 4 FP MD 5 FP, MD 6 FP, MD 7 Pediatrician (Peds), MD 8 Peds, MD 9 Obstetrician (OB)-gynecology (Gyn), MD 10 OB-Gyn, MD 11 Surgeon, MD 12 FP, MD 13 Internal Medicine (IM), MD 14 IM, MD 15, IM, DRP/FP FP, PA 1, and PA 2) were reviewed. MEC indicated recommendations for staff membership and privileges were "based on judgment" of the MEC. MEC indicated all providers had satisfied the requirements to provide medical services that they had approval for. MEC indicated, providers qualified for privileges because the " completed residency training here [at Hospital]". The MEC acknowledged there was not complete documentation for competency, training, education, certificates, proctoring, peer review and/or provider performance for the 18 providers.

18 of 18 providers, (MD 1, MD 2, MD 3, MD 4, MD 5, MD 6, MD 7, MD 8, MD 9, MD 10, MD 11, MD 12, MD 13, MD 14, MD 15, DRP/FP, PA 1, PA 2) did not have a MEC authorizing signature recommending medical staff privileges. [Hospital] Reappointment Evaluation form and/or privilege request forms required signatures from the department chair, Credential Committee Chair, MEC and Governing Body (GB). The forms did not have the approval signature of the MEC chair that recommended the provider after meeting requirements for privileges.

18 of 18 providers, (MD 1, MD 2, MD 3, MD 4, MD 5, MD 6, MD 7, MD 8, MD 9, MD 10, MD 11, MD 12, MD 13, MD 14, MD 15, DRP/FP, PA 1, PA 2) did not have documentation for competency, training, education, certificates, proctoring, peer review and/or provider performance for providers.

Review of hospital bylaws title, 2019 Amended and Restated Bylaws of the Community Board of [Facility] of [City], approved June 24, 2019, indicated that "MEDICAL STAFF MATTERS ... shall be organized for the adequacy and quality of medical care rendered to patients ... Medical Staff shall be responsible to this Hospital Community ...adequacy and quality of medical care and professional work ... There shall be Medical Staff Bylaws and Rules and Regulations for the Local Hospital, setting forth the Medical Staff's organization ... Written, defined criteria for Medical Staff appointment and the granting of clinical privileges ... physician responsible for the service be certified or eligible for certification by an appropriate American medical specialty board ...establishment of controls to facilitate the achievement and maintenance of high standards of ethical practices, including a requirement that all members of the Medical Staff be required to demonstrate their ability to perform surgical and other procedures competently at the time of original appointment and at least every two years ... licensed Practitioner with appropriate clinical privileges shall be directly responsible for patient diagnosis and treatment within the scope of such Practitioner's license and privileges ... The mechanisms for reviewing credentials, delineating clinical privileges, conducting, evaluating, and revising quality assessment and performance improvement activities, appointment, reappointment, corrective action, and fair hearing procedures, and restriction, reduction, suspension, termination, and revocation of Medical Staff membership or clinical privileges .... Medical Staff Executive Committee shall make recommendations to the Hospital Community Board".

Review of the hospital document titled, [Hospital] Medical Staff Bylaws, dated 12/6/2018, not signed by a responsible GB or MEC member, indicated "Appointment Qualifications ... Detailed information concerning the practitioner's qualifications ... Medical Staff quality assessment process relevant to the involved practitioner, including the Medical Staff's ongoing professional practice evaluation ...evaluation of the practitioner's competence ... The proctor shall monitor the practitioner's performance of the requested privilege(s) in at least three major cases and shall complete the Proctor Reporting Form and any other pertinent information for each case .... Reappointment ... shall be based upon review of such practitioner's professional ability and clinical judgment in the treatment of patients, the practitioner's professional ethics, the practitioner's discharge of Medical Staff obligations ... Medical Executive Committee recommends appointment and the granting of all requested privileges, the recommendation shall be promptly forwarded, together with any necessary supporting documentation ...to the Board".

Review of the hospital document titled, Department of Anesthesiology Privilege List, did not indicate appointment requirements for competence, performance evalautions, peer review evaluations, case requirements or demonstrated up-to-date competence

Review of the hospital document titled, Department of Medicine Privilege Checklist, General Internal Medicine, did not indicate appointment requirements for competence, performance evalautions, peer review evaluations, or demonstrated up-to-date competence.

Review of the hospital document titled, [Hosptal] Credentialing for Moderate and/or Deep Sedation Outside the Operating Room Policy and Procedure, effective 1/24/2019 indicated, "required sedation education for those providers not board certified or board eligible in Emergency Medicine or Critical Care Medicine include: successful completion of "Safe Sedation Training - Moderate" (SST moderate) module offered by the American Society of Anesthesiologists (ASA) and current certification in ACLS, and PALS (for pediatric privileges)... must demonstrate that they are competent to rescue patients from sedation including management of a compromised airway, providing adequate oxygenation and ventilation, and management of an unstable cardiovascular system ... The Director of the Department of Anesthesiology or designee will document demonstration of competency in rescue of patients from deep and moderate sedation".

Review of the hospital document titled, [Hosptal] Policy and Procedure, Resuscitation of the Newborn (PC-63), effective 1/1976, indicated "newborn resuscitation will be provided in accordance with the Neonatal Resuscitation Program Standards as set by the American Heart Association. Current NRP [Neonatal Resuscitation Program team-based care for healthcare professionals who care for newborns at the time of delivery] (newborn handbook and updates from the American Heart Association will be followed".

Review of the hospital document titled, [Hospital] Nurse Practitioner & Physician Assistant Hosptal Checklist for Scope of Practice, indicated the" Scope Practice as an physician assistant or Nurse Practitioner ... requires a designed supervising physician with clinical privileges at this hospital in the same area of specialty practice. All practice is performed under the supervision of this physician ... demonstrated competence and an adequate volume of experience 12 patient within 24 months with acceptable results ... ongoing professional practice evaluation and outcomes. Evidence of current ability to perform practice requested ...advanced privileges requiring special expertise and/or documentation of special training and/or certification ... All orders are to be countersigned by the supervising physician".

Review of the hospital document titled, [Hosptal] General Surgry Privilege Applications indicated "demonstrated and minimum number of cases as indicated with acceptable results in the privileges requested for the past 14 months as a result of quality assessment/improvement activities outcomes ... Diagnostic, basic and advance laparoscopic privileges required minimum cases for past 2 years (14 cases) ... Robotics training 5 supervised proctored cases, 10 cases in past 2 years ... and laparoscopic privileges".

Review of the hospital document titled, [Hospital] Pediatric Privilege form indicated, "Successful completion of an ACGME or AOA accredited post-graduate training program In Pediatrics ... Hold PALS or NRP certification ... provide documentation of the number and types of hospital cases during the past 24 months ... evaluation of current competence, and other qualifications ... recent experience ... procedures at previous hospital affiliations ...number of procedures performed in a specified period of time that are believed to be necessary to maintain clinical competence".

Review of the hospital document titled, [Hospital] Medical Staff Bylaws, dated 12/6/2018, not signed by a responsible GB or MEC member Section 8.4, indicated "all High Risk deliveries... will have either 1) a separate physician or 2) a designated resuscitation team consisting of a NRP certified Registered Nurse and a Respiratory Care Practitioner who is certified in advanced practice by Children's Hospital Central California whose sole responsibility will be the resuscitation and care of the newborn infant. The physician responsible for the care of the newborn must have current privileges in newborn resuscitation and, in consultation with the Obstetrician and the team, determine the need for his/her physical presence at the time of the high risk delivery and in compliance with any current patient care guidelines of Children's Hospital Central California. Medical emergencies in the perinatal area including, but not limited to ...Meconium staining ...Fetal Distress ... Multiple Births.

Review of the hospital document titled, Department of Anesthesiology Privilege List, did not indicate appointment requirements for competence, performance evalautions, peer review evaluations, proctoring, demonstrate procedural skills, case requirements or demonstrate up-to-date competence

Review of the hospital document titled, Department of Medicine Privilege Checklist, General Internal Medicine, did not indicate appointment requirements for competence, performance evalautions, proctoring, demonstrate procedural skills, peer review evaluations, or demonstrate up-to-date competence.

Review of the hospital document titled, [Hospital] Privilege Application, Gastroenterology, indicated "this category is applicable to physicians who are board certified, eligible; or fully trained in a recognized [Gastroenterology ] sub-specialty medicine board as defined by the AMA (American Medical Association". The checklist did not indicate appointment requirements for competence, performance evalautions, proctoring, peer review evaluations, demonstrate procedural skills, case requirements or demonstrate up-to-date competence.

Review of the American Board of Internal Medicine (ABIM) subspecialty training requirements for Gastroenterology, indicated "at the time of application, be previously certified in internal medicine by ABIM ... Satisfactorily complete the requisite graduate medical education fellowship training ...Demonstrate clinical competence, procedural skills, and moral and ethical behavior in the clinical setting ...Pass the Gastroenterology Certification Examination ....Gastroenterology fellowship training must be accredited by the Accreditation Council for Graduate Medical Education".
abim.org/certification/policies/internal-medicine-subspecialty-policies/gastroenterology/. Accessed 3/18/2023.

Based on observation, interview and record review, the hospital failed to have a well-organized and effective nursing service when:

1. Licensed Nurses failed to meet the needs of ten of 30 sampled patients (Patient (Pt) 1, 5, 8, 10, 13, 14, 21, 15, 19 and 16) when the nursing care plans (goals of treatment for safe nursing care) did not include nursing interventions (actions that were performed to help patients reach their goals of care) corresponding to the primary diagnoses and treatments of each patient. (Refer to A396)

2. Licensed Nurses did not follow the following hospital's policies and procedures for Tracheostomy care, Skin Assessment and Maintenance, and Wound Care Guidelines for four of ten sampled patients (Pts 16 and 18). (Refer to A398, findings 1 and 2)

3. Licensed Nurses did not follow the hospital's protocols for high-risk high-alert (drugs that bear a heightened risk of causing significant patient harm when they are used in error) medications and narcotics (drug that relieves pain) for seven of seven sampled patients (Pts 21, 23, 8, 5, 13, 3 and 1). (Refer to A405, findings 1, 2, 3, 4 and 5)

4. Licensed Nurses did not supervise and evaluate the nursing care of patients when pain reassessments were not performed for two of seven sampled patients (Pt 18 and 19). (Refer to A395)

The cumulative effects of these systemic problems resulted in the hospital's inability to provide nursing services in a safe and effective manner in accordance with the statutory-mandated Conditions of Participation for Nursing Services.

Based on interview and record review the Licensed Nursing staff failed to follow the facility policy titled, "Pain, Assessment and Management of (PC-56B) for two of seven sampled patients (Pt 18 and 19), when Licensed Nursing staff did not reassess for pain after pain medication was given nor complete a reassessment for pain.
These failures placed Pt 18 and 19at risk of not having their pain controlled and put patients at risk of being over sedated because no reassessment was done this could not be determined.

Findings:

During a concurrent interview and record review on 3/6/23, at 3:30 p.m., with the New Grad Coordinator (NGC), Pt 18's "Face sheet" (provides demographics of the patient, name, date of birth, admission date, chief complaint), "electronic Medication Administration Record" (eMAR), and "electronic health records" (EHR), were reviewed for Pt 18's admission dated 2/24/23. The NGC stated Pt 18 has an order for Morphine (intravenous (IV) narcotic pain medication) 2 mg (unit of measurement- milligrams) every four hours as need for severe pain 7 out of 10. The eMAR indicated on 3/4/23 at 5:01 a.m. Pt 18 received 2 mg of Morphine for a 9 out of 10 pain score, no reassessment was documented. At 2:23 p.m. Pt 18 received 2 mg of Morphine for a 10 out of 10 pain, no reassessment was documented. On 3/5/23 at 3:41 a.m. Pt 18 received 2 mg of Morphine for a 10 out of 10 pain, no reassessment was documented. The NGC validated the missing pain reassessments for Pt 18 and stated IV pain medication should be reassessed within 30 minutes to make sure Pt 18's pain was controlled, if not provide other interventions and to make sure Pt 18 was not having any adverse reactions to the pain medication.

During an observation on 3/3/23, at 12:05 p.m., Pt 19 was seen in her hospital bed with head slightly elevated and eyes closed, three bed rails were seen up and a fall matt was on the side of her bed.

During a review of Pt 19's,"PATIENT INSURANCE & DEMOGRAPHICS," dated 3/10/23, the "PATIENT INSURANCE & DEMOGRAPHICS," indicated, Pt 19 was admitted on 2/24/23, "Reason for Visit: ACUTE BLOOD LOSS ANEMIA (not enough blood- causing weakness, fatigue, irregular heartbeat, shortness of breath, dizziness, chest pain, cold extremities) ..."

During a concurrent interview and record review on 3/10/23, at 10:50 a.m., with the Clinical Nurse Educator (RN EDU 1), Pt 19's eMAR and EHR were review for her admission dated 2/24/23. The RN EDU 1 stated Pt 19 had an order for Norco 5/325 (narcotic pain medication) one PO (by mouth) Q 8 hrs. (every 8 hours) as needed for a pain level between 4 and 10 (10 being the highest pain score). Review of Pt 19's eMAR dated 2/25/23 at 10:07 a.m. Pt 19 received one Norco for a pain level of 6 out of 10, a reassessment of pain was done at 2:09 p.m. The RN EDU 1 stated oral pain medication should be reassessed within one hour after given and this was not done. Review of Pt 19's eMAR dated 3/6/23 at 10:20 p.m. Pt 19 was given Morphine 2 mg (unit of measurement- milligrams) IV (through the vein) for a pain level of six out of ten. The RN EDU 1 stated no pain reassessment was done for the Morphine given at 10:20 p.m. The RNEDU stated the expectation is a pain reassessment should be completed within 30 minutes after administration.

During an interview on 3/17/23, at 10:26 a.m., with the Interim Chief Nursing Officer (CNO), the CNO stated, it is important to reassess pain after pain medication is given to ensure the patient is out of pain and to ensure if further interventions are needed. The CNO stated if pain reassessment is not done it could be a patient safety issue if the patient has been over medicated or if there is a reaction to the medication. The CNO stated the expectation is reassessment is done within an hour of PO pain medication is given and within 30 minutes if an IV pain medication is given.

During a review of the facility's policy and procedure titled, "Pain, Assessment and Management (PC-56B), dated 12/20, the policy indicated, "POLICY: [name of hospital] staff support the belief that patients have the right to attentive pain medication and that the single most reliable indicator of the existence and intensity of pain is the patient's self-report. [name of hospital] staff is to provide careful assessment of pain levels, timely and appropriate interventions, accurate evaluation of those interventions, and communication of effectiveness of interventions to other healthcare workers and demonstrate an empathetic and positive regard to patients in pain. Pain management goals are to be mutually set by the care providers and patient. Interdisciplinary collaboration and problem solving will occur as it applies to pain management. Guidelines... D. The patient self-report of pain is obtained and recorded on the vital signs flow sheet. 1. Using the appropriate tool 2. Each and every time vital signs are taken a period or at least once per shift B. At a reasonable interval after every pain intervention to determine effectiveness no more than 30 minutes after IV analgesics. No more than 60 minutes after po analgesics... G. All assessments, reassessments and interventions for pain management are to be documented appropriately in electronic health record ..."

Based on interview and record review, the hospital failed to ensure nursing care was provided to meet the needs of ten of 30 sampled patients (Patient (Pt) 1, Pt 5, Pt 8, Pt 10, Pt 13, Pt 14, Pt 21, Pt 15, Pt 19 and Pt 16) when the nursing care plans (goals of treatment for safe nursing care) did not include nursing interventions (actions that were performed to help patients reach their goals of care) corresponding to the primary diagnoses and treatments of each patient.

These failures had the potential to result in necessary nursing care not being provided and the potential for patient harm for Pt 1, Pt 5, Pt 8, Pt 10, Pt 13, Pt 14, Pt 21, Pt 15, Pt 19, and Pt 16.

Findings:

1. During a concurrent interview and record review, on 3/6/23, at 10 a.m., with Family Birthing Center Manager (FBC MGR), Patient (Pt) 1's Electric Health Record (EHR), "Physician orders" and "Care plan" were reviewed. FBC MGR stated, Pt 1 was admitted to the hospital on 1/17/23, with a primary diagnosis (the main condition treated or investigated during the hospital episode) induction of labor (process or treatment that stimulates childbirth and delivery). Physician orders indicated Pt 1 was prescribed an epidural (a procedure that injects medicine into the space into the lower back) with continuous infusion (method of putting fluid or drugs into the blood stream) of opioid medication (to treat persistent or severe pain) to help control pain. FBC MGR reviewed Pt 1's nursing care plan and stated, it did not address Pt 1's pain status or potential opioid related side effects. FBC MGR stated an appropriate nursing care plan for Pt 1 would include at minimum interventions (i.e., assess for swelling, monitor intake and output, labs, weight, etc.) to measure and monitor the effectiveness and/or side effects of the intravenous (in a vein) pain medications.

During a concurrent interview and record on 3/6/23, at 11:05 a.m., with FBC MGR, Pt 8's EHR was reviewed. The FBC MGR, stated Pt 8 was admitted to the hospital on 3/2/23, for induction of labor. Physician orders indicated Pt 8 was prescribed an epidural with continuous infusion of opioid medications for pain. FBC MGR reviewed Pt 8's nursing care plan and validated it did not contain interventions to appropriately monitor and manage Pt 8's pain. The FBC MGR stated a nursing care plan for pain should have been implemented for this patient. The FBC MGR stated the nursing care plan was used as a communication tool between health care providers to ensure the patient's pain goals were met.

During a concurrent interview and record review of, on 3/6/23, at 2 p.m., with FBC MGR, Pt 10's EHR was reviewed. FBC MGR stated Pt 10 was admitted to the hospital on 3/1/23, with primary diagnoses of intrauterine growth restriction (IUGR- when the baby does not grow as expected inside the womb) and preeclampsia (high blood pressure disorder during pregnancy). Physician orders indicated Pt 10 was prescribed intravenous magnesium sulfate (used to prevent uncontrolled electrical activity in the brain [seizures] in women with preeclampsia), labetalol (medicine used to control high blood pressure), and an epidural for pain. FBC MGR reviewed Pt 10's nursing care plan and validated it did not contain interventions to appropriately monitor and manage Pt 10's blood pressure, neurological status (brain function), and pain. FBC MGR stated the care plan also lacked indication when to safely discontinue the magnesium sulfate infusions.

During a concurrent interview and record review, on 3/7/23, at 11 a.m., with FBC MGR, Pt 13's EHR was reviewed. FBC MGR stated Pt 13 was admitted to the hospital on 1/26/23, with primary diagnoses of induction of labor and elevated blood pressure. The EHR indicated, the induction failed and a cesarean section (a surgery to deliver a baby through an incision to the abdomen and uterus) was performed. Physician orders indicated Pt 13 was prescribed an epidural for pain and labetalol for elevated blood pressures. FBC MGR reviewed Pt 13's nursing care plan and validated it did not contain interventions to appropriately monitor and manage Pt 13's pain and elevated blood pressure.

During a concurrent interview and record review, on 3/7/23, at 11:35 a.m., with FBC MGR, Pt 14's EHR was reviewed. FBC MGR stated Pt 14 was admitted to the hospital on 1/26/23, with a primary diagnosis of placenta insufficiency (disc of tissue responsible for delivering oxygen and nutrients to the fetus is not properly working), preeclampsia, and labor induction. Physician orders indicated Pt 14 was prescribed an epidural for pain and magnesium sulfate. FBC MGR reviewed Pt 14's nursing care plan and validated it did not contain interventions to appropriately monitor and manage Pt 14's pain and blood pressure. FBC MGR stated magnesium sulfate was ordered but not administered. The FBC MGR stated although Pt 14 did not meet criteria to administer magnesium, a nursing care plan should have been initiated to prompt nurses to monitor symptoms (i.e., elevated blood pressures, seizure activity).

During a concurrent interview and record review, on 3/8/23, at 9:30 a.m., with FBC MGR, Pt 5's EHR was reviewed. FBC MGR stated Pt 5 was admitted to the hospital on 1/16/23, with primary diagnosis of prolonged labor (slow progression) and spontaneous rupture of membrane (a hole or tear forms in the fluid-filled bag that surrounds and protects your baby). Physician orders indicated Pt 5 was prescribed an epidural for pain. FBC MGR validated no nursing care plan for pain was initiated.

During a concurrent observation and interview on 3/3/23, at 2:40 p.m., Pt 21 was in her hospital bed with an intravenous (IV) line in her right forearm and attached to a device to administer medication. The medication bag indicated heparin was being administered in a drip (used to decrease the clotting ability of the blood and help prevent harmful clots from forming in blood vessels). Pt 21 stated she was on the heparin for a something they found in her in her neck.
During of a review of Patient 21's Face sheet titled, "PATIENT INSURANCE & DEMOGRAPHICS," dated 3/10/23, indicated Patient 21 was admitted on 3/3/23 "Reason of Visit: CVA (cerebrovascular accident- stroke- interruption in the flow of blood to the brain) TIA (transient ischemic attack-stroke that lasts only a few minutes) ESRD (End-Stage Renal Disease- kidneys stop functioning permanently) ON HD (Hemodialysis- a treatment to filter wastes and water from the blood) R (right) INT (internal) JUGULAR VEIN (major blood vessels that stretch from head to upper chest) DVT (Deep vein thrombosis- blood clot) ..."
During a review of Patient 21's "Heparin order," dated start date 3/2/23 at 11:40 p.m., Stop date 3/7/23 at 6:10 p.m., the "Heparin order," indicated, "Heparin Infusion for DVT/PE ... Heparin Infusion (DVT/PE) Reference Text ... heparin additive 25,000 Unit [13.89 Units/kg/hr (unit of measure- kilogram/hour)] + Dextrose (sugar water) 5% (percent) Heparin New 500 mL (unit of measurement- milliter) Details: 500 mL, IV (intravenous- in a vein), 30 mL/hr, Diagnosis: Deep Vein Thrombosis, See nomogram (ref text) for titration instructions, Routine Start: 03/03/23 0:10:00 PST (pacific standard time) ... Dose Based On 108 kg ... Order Comment: Order PTT (prothrombin time- time it takes for blood to clot) 6 hrs (hours) after initiating Heparin Infusion and 6 hrs after every rate change until 2 consecutive Therapeutic PTT's obtained (or per facility protocol). Once patient is therapeutic, order PTT qAM (every morning) ..."

During a concurrent interview and record review on 3/16/23, at 11:36 a.m., with Manager of Medical/Surgical (MMS), Pt 21's heparin order and care plans were reviewed. The MMS stated no care plan was created for Pt 21's Heparin drip and for Pt 21's risk for bleeding. The MMS stated, Registered Nurse (RN) 1 received Pt 21 around 2 a.m. on 3/3/23 and should have initiated a care plan for the Heparin drip and it is the responsibility of the nurse. The MMS stated care plans are important for nurses to create as a guide for the care of the patient.

During a concurrent interview and record review, on 3/17/23, at 7:41 a.m., with RN 1, Pt 21's Heparin order and care plans were reviewed. RN 1 stated she did not recall if she started a care plan for the Heparin drip for Pt 21. RN 1 stated care plans should be started on admission, change in condition, they are important to help direct the care for the nurses to follow for that patient.

During a concurrent observation and interview on 3/3/23, at 11:30 a.m., with Pt 15, his family member (FM), and Intensive Care Unit and Telemetry Clinical Manager (ICU MGR), while in Pt 15's room, Pt 15 was awake sitting up in bed, with all four bed rails up, head of bed elevated 30-40 degrees, a lab technician was finishing up drawing blood from Pt 15 and as she was leaving Pt 15's left side of bed she almost tripped on a soft wrist restraint tied to the side of the patients bed. On the right side of Pt 15's bed the second soft wrist restraint was seen tied to the frame of the patient's bed hanging down almost touching the floor. The FM stated Pt 15 was placed on restraints because he was pulling on his IV's, it was for his safety, and they just removed the restraints this morning.

During a review of Pt 15's "Face Sheet"(document that has patient demographics, admit date, contact persons and diagnoses), undated, the "Face Sheet" indicated Pt 15 was admitted on 2/25/23 at 11:13 p.m. with a chief complaint of Sepsis (a serious medical condition resulting in an infection that can lead to multisystem failure of organs, shock, and death).

During a concurrent interview and record review, on 3/9/23, at 11 a.m., with the Nurse Educator for Staff Development (NE), Pt 15's physician order for restraints and care plans were reviewed. The physician order for "Restraints-Non Violent /Non Destructive" (used on patients that attempt to pull on medical devices and cannot be reoriented not to, these patients are not violent), was placed on 3/1/23 at 1:35 p.m., the order indicated, "Monitor q2hr (interval every two hours) for 24 hr [hour], Soft Limb, Bilateral Wrists, Climbing out of bed/chair risking safety." The NE was not able to locate a care plan for the bilateral wrist restraints. The NE stated a care plan should have been created for the restraints.

During an interview on 3/16/23, at 5:35 p.m., with ICU MGR, the ICU MGR stated, care plans should be done on admission, with a change in condition, and interventions should be continually reassessed. The ICU MGR stated she "absolutely expects" a care plan to be created if a patient is placed on restraints. The ICU MGR stated the care plan gives staff a plan of what the facility is going to do for the patient and is clear communication of what we are doing with this patient.

During a review of the facility's P&P titled, "Restraint Seclusion (PC- 37)," dated 4/22, the policy indicated "... Policy: The decision to use restraints at [name of facility] were driven by a comprehensive individual assessment which concludes the use of less restrictive interventions possess a greater risk than the risk of using restraints ... a. The patients plan of care must be updated to indicate the ongoing need for restraint b. Plans of care will be initiated and discontinued as appropriate to the individual patient..."

During an observation on 3/3/23, at 12:05 p.m., Pt 19 was seen in her hospital bed with head slightly elevated and eyes closed, three bed rails were seen up and a fall matt was on the floor by the side of her bed.
During a review of Pt 19's Face Sheet titled, "PATIENT INSURANCE & DEMOGRAPHICS," dated 3/10/23, the Face Sheet indicated Pt 19 was admitted on 2/24/23, "Reason for Visit: ACUTE BLOOD LOSS ANEMIA (not enough blood- causing weakness, fatigue, irregular heartbeat, shortness of breath, dizziness, chest pain, cold extremities) ..."

During a concurrent interview and record review on 3/10/23, at 10:50 a.m., with the Clinical Nurse Educator (RN EDU 1), Pt 19's care plans were review for her admission dated 2/24/23. The RN EDU 1 stated, she was not able to locate a care plan for Pt 19's acute blood loss anemia. The RN EDU 1 validated a care plan was not created for Pt 19's admitting diagnosis and the expectation is one should have been created. The RN EDU 1 stated the care plan is how nurses prepare and direct the care of the patient. The RN EDU 1 stated the staff evaluate the interventions on the care plan to determine if they are working.

During a concurrent interview and record review, on 3/16/23, at 5:23 p.m., with Nurse Manager for 5th floor (NM), Pt 19's care plans were reviewed. The NM validated Pt 19 did not have a care plan started for her acute blood loss anemia. The NM stated care plans are to be started on admission and every shift staff should be updated. The NM stated the care plans guide nursing care for each patient. The NM stated the expectation is the nurse always wants to have the right care plan and interventions for their patient.

During a review of Pt 16's Face Sheet, (no date), the Face Sheet indicated Pt 16 was admitted on 2/21/23, at 2:26 a.m. with a Chief Complaint of Hypoxia (deficiency in the amount of oxygen reaching the tissues).
During a concurrent interview and record review on 3/10/23, at 9:27 a.m., with the RN EDU 1, Pt 16's electronic health records (EHR) for his admission on 2/21/23 were reviewed. Review of Pt 16's Physician progress note on 2/22/23 indicated, Pt 16 would benefit from a Trach (a surgically created hole in your windpipe (trachea) that provides an alternative airway for breathing). On 2/23/23 at 5:57 p.m. Pt 16 had a Trach surgically placed. The RN EDU 1 stated there was no care plan created for the Trach and the expectation is one would be made to guide staff on what is needed to care for the Trach.

During a concurrent interview and record review on 3/16/23, at 5:35 p.m., with ICU MGR, Pt 16's care plans were reviewed. The ICU MGR stated, care plans should be done on admission and created whenever the need arises, and interventions should be continually reassessed. The ICU MGR stated no care plan was created for Pt 16's Trach and the expectation is one should have been made. The ICU MGR stated the care plan gives staff a plan of what the facility is going to do for the patient and is clear communication of what we are doing with this patient.

During an interview on 3/17/23 at time, with the Interim Chief Nursing Officer (CNO), the CNO stated nurses were expected to develop a nursing care plan for every patient admitted to the hospital, when there was a change of condition and/ or a newly identified problem for the patient. The CNO stated nursing care plans were individualized plans of care established by nurses to direct the nursing care of each patient. The CNO stated the purpose of the care plan was to establish measurable goals based on the diagnoses and conditions of each patient. The CNO stated every nursing care plan should be routinely evaluated and updated to accurately reflect the condition of the patient and appropriately measure the effectiveness of treatments. The CNO stated nursing care plans were important communication tools used by nurses to help meet the needs of patients.

During a review of the facility policy and procedure (P&P) titled "Standards of Care for Mother Baby Unit Family Birthing Center", dated 1/13/21, the P&P indicated, " ... Plan of Care: The Registered Nurse develops a plan of Care as the basis for the individualized care of the patient and for the use by other health care team members. The goals of the plan of care are related to physically safe and emotionally satisfying outcome of the mother and infant ... The Plan of Care is continuously evaluated and revised as necessary ..."

During a review of the facility P&P titled "Plan of care Development", dated 5/20/22, the P&P indicated, " ... [name of facility] uses a collaborative, interdisciplinary approach to patient care in order to achieve optimal patient outcomes ... Through the use of the Nursing Process, these findings become the basis for developing and individualized and interdisciplinary Plan of Care. Goals, or expected outcomes, are identified for the patient based on their unique needs, age, primary illness, other disease conditions, physical impairments and available resources identified through on going assessments and other evaluations. As nursing interventions are delivered the patient's progress is periodically evaluated and the Plan of Care revised based on their response to implemented interventions and treatments ... Problems will be prioritized as a. Level 1 (High) Requiring Immediate Attention ... Cardiac/ Circulatory/ Dysrhythmia Problems ... Changes in Vital Signs/ Hypoglycemia/ Seizures ... Critical Lab Values ... Level 2 (Moderate) Assessed after treatment of Level 1 problems ... Acute Pain ... Other medical problems ... Infection Control issues ..."

Based on observation, interview, and record review the facility failed to follow its policy and procedure for two of two sampled patients (Patient (Pt) 16 and 18) when:

1. Pt 16 was not provided trach care and assessment per the facility policy titled, "Tracheostomy Tube Care and Management (PC-501)". This failure resulted in the tracheostomy coming out on 3/4/23 and had the potential to cause the patient breathing difficulties and infection.

2. Registered Nurses (RNs) did not follow the policy and procedures titled, "Standardized Procedure for Skin Assessment and Maintenance of Integrity" and "Wound Care Guidelines", for Patient 18. ICU RN 7 did not order a wound consult when skin damage/issue was discovered and failed to have a second RN verification. This failure had the potential to result in substantial skin breakdown and poor patient outcome.

Findings:

1. During an observation on 3/3/23, at 11:15 a.m., Pt 16 was seen in bed awake with tracheostomy in place, head of bed elevated approximately 45 degrees, three side rails up, fall matt on the floor and a sitter watching him.
During a review of Pt 16's "Face Sheet", undated, the "Face Sheet" indicated, Pt 16 was admitted on 2/21/23, at 2:26 a.m. with a chief complaint (define) of Hypoxia (deficiency in the amount of oxygen reaching the tissues).

During a concurrent interview and record review on 3/10/23, at 9:27 a.m., with the RN EDU 1, Pt 16's electronic health records (EHR) for his admission on 2/21/23 was reviewed. RN EDU 1 stated the EHR indicated on 2/22/23 Pt 16 would benefit from a Tracheostomy (Trach - a surgically created hole in your windpipe (trachea) that provides an alternative airway for breathing) and on Pt 2/23/23 at 5:57 p.m. Pt 16 had a Trach surgically placed. The RN EDU 1 stated there was no care plan created for the Trach and the expectation is one would be made to guide staff on what is needed to care for the Trach.

During a review of Pt 16's, "NURSING COMMUNICATION," dated 2/23/23 at 5:45 p.m., indicated, "Call [doctors name] for problems with the tracheostomy at [phone number]. Suction the trachea frequently. Lavage the trachea with saline as needed. Do not change the trach ties for four days. Change and clean the inner cannula as needed."

During a review of Pt 16's "NURSING COMMUNICATION," dated 3/4/23 at 8:54 a.m., indicated, "Check the tracheostomy ties every six hours, to make sure they are tight, and the tube is in good position in the trachea. Listen for any stridor. Call me if tracheostomy tube problems at [phone number]. The tube came out this morning due to lose ties."

During a concurrent interview and record review, on 3/10/23, at 9:40 a.m., with the RN EDU 1, Pt 16's Nursing and Respiratory Care Practioners (RPC) Tracheostomy Tube care "flow sheets" for 2/23/23 to 3/10/23 was reviewed. The Nursing and RPC Tracheostomy Tube care "flow sheets" indicated, on 2/24/23 at 8:49 a.m. trach care/assessment was done then the next trach care was at 5:26 p.m. approximately 8 hrs later. On 2/25/23 at 4 a.m. trach care and assessment was done the next trach care was at 8 p.m. 12 hrs. later. On 2/26/23 at 4 a.m. trach care and assessment done, next done at 8 p.m. 12 hrs. later. On 3/9/23 at 8 p.m. trach care/assessment next done on 3/10/23 at 11 a.m. approximately 15 hrs. later. RN EDU 1 validated that trach care and assessment was not being completed every 12 hours per the facility policy and trach ties were not being checked every 6 hours per the "NURSING COMMUNICATION" order dated 3/4/23 at 8:54 a.m. The RN EDU 1 stated trach care is important and if not done can put the patient at risk for infection, dislodgement define of the trach, and possibly breathing issues.

During a concurrent interview and record review, on 3/16/23, at 5:35 p.m., with Intensive Care Unit/Telemetry Manager (ICU MGR), Pt 16's Nursing Communication orders, Nursing and Respiratory Care Practioners (RCP) trach care, assessments and care plans for admission dated 2/21/23 were reviewed. The ICU MGR stated the RN is expected to work with the RCP to manage trach care. The ICU MGR stated trach care should be done once a shift or more if needed. The ICU MGR stated the trach ties should have been checked every six hours and the expectation is that the nurse would document that they were checked, and this was not done for Pt 16. The ICU MGR stated, "I would not be surprised that it wasn't documented as done every 6 hours [checking the trach ties]. We have identified that there are gaps in our staffs understanding of trach care. Educators are working with staff to get them better trach care."

During a review of the facility's policy and procedure titled, "Tracheostomy Tube Care and Management (PC-501)," dated 4/21, the care plan indicated, " ... POLICY/GUIDELINES: A. Tracheostomy care is performed using sterile technique to prevent initiation of infection 1. Tracheostomy care, maintenance of tracheostomy tubes, and the care of the tracheostomy site is primarily the responsibility of the bedside Registered Nurse (RN) in collaboration with the Respiratory Care Practitioner (RCP). 2. Routine tracheostomy care will consist of changing the disposable inner cannula or cleaning of inner cannula, cleaning the stoma site, changing drain sponge and a tracheostomy holder, and performing a general assessment of the tracheal stoma site and area covered by tracheostomy holder. 3. All patients with a tracheostomy tube or open stoma site will receive tracheostomy care. 4. During the first 7 days, tracheostomy ties will be changed at least every 3 days and PRN by two (2) care practitioners (RCP and RN), to avoid accidental dislodgment of the tracheostomy tube (The stoma takes approximately one week to heal post tracheostomy). After the tracheostomy ties will be changed every 24 hours the straps should be tight but not uncomfortable: caregiver should be able to pass one finger under ties... 5. Tracheostomy care will be performed every 12 hours and as needed..."

2. During a review of Patient 18's "skin assessment", dated 2/25/23, the "skin assessment" indicated, Intensive Care Unit Nurse (ICU RN) 7 completed the skin assessment (process used to learn about a patient's skin condition) of Patient 18. The "skin assessment" indicated, " ... Bony Prominences Assessed- skin tear right thigh, brown spot on coccyx (tailbone)". The "skin assessment" indicated, ICU RN 7 did not enter a wound consult (notification to the wound nurse for a focused exam). The "skin assessment" indicated, ICU RN 7 did not have a second Registered Nurse (RN) verify the skin issue upon assessment.

During a review of Patient 18's "Wound Care Note", dated 3/2/23, the "Wound Care Note" indicated, it was written by Wound Care Supervisor (WCS). The "Wound Care Note" indicated, there was an " ...ulcer to the coccyx, that was maroon in color, open to the superior (toward the head of the body) margin with 5 maroon pustules (blister-like sores on the skin surface) off the right and right superior margin ...". "Wound Care Note" indicated no pictures were taken of Patient 18's wound.

During a review of Patient 18's "Wound Care Order", dated 3/2/23, the "Wound Care Order" indicated, " ...Apply dressing, irrigate with normal saline, clean dressing type, special instructions: [brand name wound cream], sacral foam, please take photos with each dressing change, frequency: [every Monday, Wednesday, Friday] ...".

During a review of Patient 18's "Wound Care Note", dated 3/8/23, "Wound Care Note" indicated " ...the maroonish areas have continued to expand the previously open area size is now 3 x 2.2 x 0.1 [cm] open to full thickness the pustules (a small blister or pimple on the skin containing pus) are resolving with no increase in size or number in the overall 6 x 6cm area. Continue current treatment ....".

During a review of Patient 18's "flow sheet" for turns in the Electronic Medical Record (EMR), dated 2/25/23 to 3/8/23, the "flow sheet" indicated, Patient 18 did not have a position change every two hours on 3/1/23 6 a.m. to 3/2/23 8 a.m., on 3/3/23 4 p.m. to 10:30 p.m., on 3/4/23 12 p.m. to 8:43 p.m., on 3/7/23 6 a.m. to 8 p.m., and 3/8/23 12 p.m. to 8 p.m.

During a concurrent interview and record review on 3/8/23, at 11:00 a.m., with Interim Chief Nursing Officer (CNO), Patient 18's "flow sheet", dated 2/25/23 to 3/8/23 was reviewed. The "flow sheet" indicated, Patient 18 did not have a position change every two hours. CNO stated, "Expectation is for nurses to be turning patients when a wound is present [every 2 hours] per the policy and that is clearly not happening here. Multiple nurses missed this." CNO stated negative patient outcomes can happen due to the lack of position changes. CNO stated it was possible for Patient 18's wound to get worse.

During a concurrent interview and record review on 3/8/23, at 11:05 a.m., with Registered Nurse Educator (RN EDU) 1, Patient 18's "flow sheet", dated 2/25/23 to 3/8/23 was reviewed. The "flow sheet" indicated, Patient 18 had not been repositioned regularly. RN EDU 1 stated, "nurses should have been turning [Patient 18] every two hours and multiple shifts and it was not being done, if it was very sparingly which is not correct and not per the wound policy. Because turns not being done the wound could have gotten worse." RN EDU 1 stated, "This is bad," [position changes] were being missed almost every shift for Patient 18. EDU RN 1 stated, when a patient is not repositioned, it can cause "bad patient outcome especially for [Patient 18]".

During an interview on 3/8/23, at 11:10 a.m., with CNO, CNO stated the expectation for staff is that nurses follow facility policy and procedure (P&P) on wound and skin assessment. CNO stated P&P was not followed for Patient 18. CNO stated if P&P is not followed, negative patient outcome is likely. CNO stated Registered Nurses (RN) should be completing a two RN skin assessment at change of shift per P&P, or when skin damage/issues are discovered. CNO stated based on review of Patient 18's EMR that was not done. CNO stated the first missed skin assessment started on 2/25/23 when ICU RN 7 did not complete a two RN skin assessment when skin damage/issue was discovered. CNO stated when ICU RN 7 discovered Patient 18's wound the P&P was not followed. CNO stated Patient 18's wound assessment continued to be missed.

During a concurrent interview and record review, on 3/8/23 at 11:15 a.m., with CNO, a review of Patient 18 "wound care note" dated 3/2/23, "Wound Care Note" indicated, it was written by Wound Care Supervisor (WCS). The "Wound Care Note" indicated, there was an " ...ulcer to the coccyx, that was maroon in color, open to the superior (toward the head of the body) margin with 5 maroon pustules (blister-like sores on the skin surface) off the right and right superior margin ...". "Wound Care Note" indicated; no pictures were taken of Patient 18's wound. CNO stated the Wound Care Supervisor (WCS) failed to take pictures of the wound when Patient 18's wound was identified. CNO stated the expectation is for WCS to take pictures. CNO stated that because a picture and measurements are missing on his 3/2/23 assessment, the hospital is unable to know if wound is progressing (increasing in severity).

During a concurrent interview and record review on 3/8/23, at 11:20 a.m., with RN EDU 1, Patient 18's electronic medical record (EMR), dated 2/25/23 to 3/8/23 was reviewed. The EMR indicated, "Skin Assessments Bony Prominences Assessed with ... [no name] ...". RN EDU 1 stated ICU RN 7 should have completed a wound consult after Patient 18's skin damage/issue was discovered. RN EDU 1 stated ICU RN 7 should have had another registered nurse sign off on the skin assessment at the time of discovery. RN EDU 1 stated because ICU RN 7 did not request a wound consult or have the second RN skin verification, Patient 18's wound may have worsened.

During a concurrent interview and record review on 3/13/23, at 3:25 p.m., with Wound Care Supervisor (WCS),
Patient 18's EMR, dated 2/25/23 to 3/8/23 was reviewed. WCS stated the expectation is for a wound consult to be placed by a patients' nurse. WCS stated the expectation was for him to had seen Patient 18 within 24 hours of the wound being discovered by ICU RN 7. WCS stated, that he should had received the wound consult on 2/25/23 and assessed the patient the following "day or two after". WCS stated nursing should document a two-person verification when skin damage/issue is discovered. The EMR indicated there was no pictures taken of Patient 18's wound on 3/2/23 when he assessed the patient. WCS stated, "I took pic on 3/2 but if not in chart than it's not in the chart". WCS stated, the orders he entered, and were co-signed by the Physician Assistant (PA) were not followed. WCS stated, the expectation was to turn Patient 18 every two hours, it was not done. WCS stated not turning could have contributed to Patient 18's decubital ulcer (damage to skin caused by constant pressure).

During a concurrent interview and record review, on 3/14/23, at 9:00 a.m., with ICU RN 7, Patient 18's Electronic Medical Record (EMR), dated 2/25/23 was reviewed. The EMR indicated, Patient 18 did not receive a wound consult after Patient 18's skin damage/issue was discovered. ICU RN 7 stated, she did not complete a wound consult or get a second RN verification after she discovered Patient 18's skin damage/issue. ICU RN 7 stated, she knew Patient 18 had a "skin issue and a wound consult is to be done within 24 hours of finding that issue". ICU RN 7 stated, Patient 18 did not receive a wound consult and the wound could have gotten worse. ICU RN 7 stated, she did not consult a doctor or wound nurse for Patient 18.

During an interview on 3/14/23, at 9:50 a.m., with Intensive Care Unit Manager (ICU MGR), ICU MGR stated, hospital staff did not meet expectations per the hospital policy, when Patient 18's skin assessment and wound were discovered. ICU MGR stated that when Patient 18 was in the Intensive Care Unit (ICU) staff should had completed a wound consult after each skin assessment when damaged skin was discovered. ICU MGR stated when facility policy and procedure are not followed wounds get worse. ICU MGR stated that a two RN skin assessment verification should have been completed when initial skin issue/damage was found.

During a review of the facility's policy and procedure (P&P) titled, "Standardized Procedure for Skin Assessment and Maintenance of Integrity,", dated 1/23, the P&P indicated, " ... effort is made to maintain skin integrity and prevent skin breakdown. This is the responsibility of the entire health care team. Every patient's skin will be assessed upon admission, on each and every shift thereafter, and on transfer between units. Assessments and interventions will facilitate prevention of skin breakdown, provide prompt recognition, promote healing and minimize complications ...Physical Assessment of Skin: All patients will receive a head-to-toe skin assessment by two (2) Registered Nurses within two (2) hours of admission and upon transfer. Skin assessments at change of shift are to be completed with both primary nurses on all patients. The beside assessment with two (2) RNs is intended to provide continuity of care and identify support for patients requiring additional assistance. Any significant skin damage/issue is to be photographed and verified by a second RN upon discovery. Wound Care Consult to be entered into the electronic health record (EHR) by nursing ... Consult other members of healthcare team as needed ...".

During a review of the facility's policy and procedure (P&P) titled, "Wound Care Guidelines", dated 3/22, the P&P indicated, "Maintaining skin integrity and prevention of skin breakdown (pressure injury formation) is the responsibility of the entire health care team at [name of facility]. Every patient's skin will be assessed upon admission, on each and every shift thereafter, and on transfer between units. Assessments and preventative care will be provided to avoid the formation of pressure injuries in those patients with the potential for alteration in skin integrity ... however upon discovery pressure injuries are to be described in detail by nursing staff with staging done by Wound Care Nurses or physicians ... Wound Measurement: Appropriate and consistent wound measuring and documentation of such is necessary to accurately assess wound healing. RN staff will use a consistent wound measurement procedure as outlined in this Policy ... A measurable wound is defined as one that measures greater than 0.5cm x 0.5cm x 0.1cm at the time of the initial assessment ... Photograph: Photos of the wounds are taken. Photos must contain: Patient name, medical record number, Date, time and location of the wound, RN signature ... Assessment: a complete assessment is to be completed ... Notify Wound Care Nurse and the primary physician on discovery of any wound ... Consult the primary provider or Wound Care Nurse for evaluation on wounds that demonstrate signs of infection ... Interventions: For all at risk patients ... Reposition patient every two hours ... Documentation: Document/Record all measurements in the designated areas in the Wound Assessment of the electronic health record (EHR), ... Definitions: Pressure Injury- A localized injury to the skin and/or underlying tissue usually over a bony prominence or related to a medical or other device. The injury can present as intact skin or an open ulcer and may be painful. The injury occurs as a result of intense and/or prolonged pressure or pressure in combination with shear ...".

Based on observation, interview and record review, the hospital failed to administer high-risk, high-alert medications for seven of seven sampled patients (Patient (Pt) 21, Pt 23, Pt 8, Pt 5, Pt 13, Pt 14, Pt 3 and Pt 1) in accordance with policies and procedures and professional standards of practice when:

1. Licensed Nurses did not strictly follow the protocol for administering continuous drip of physician ordered heparin for Patient (Pt) 21. Licensed Nurses did not adjust the drip in accordance with interval aPTT levels in order to maintain effective anti-coagulation levels. This failure could have resulted in Pt 21 experiencing blood clots or increased bleeding and worsening clinical status.

2. Licensed Nurse did not strictly follow the protocol for administering continuous drip of physician ordered insulin for Pt 23. Licensed Nurse did not have a second License Nurse sign off on the insulin drip titrations (changes to medication doses to achieve the best clinical response). This failure could have resulted in hypoglycemia (low blood sugar), brain damage, and even death for Pt 23.

3. Staff did not follow facility policy and procedures titled "Epidural Analgesia Management" and "Medication Administration" for four of four Patients (Patient 8, Patient 5, Patient 13, and Patient 14) in the Family Birthing Center (FBC). According to the hospital policy, two RNs were required to verify medication administrations and two RNS were not available to verify doses. These failures could have resulted in wrong doses being given to patients and possible under or over dosing of patients.

4. Two of two Licensed Nurses (ICU RN 2 and ICU MGR) did not follow the facility policy "Management of Controlled Substances" and the Smart Pump Manufacturers Instruction for Use (IFU) for one of one patient sampled (Pt 3). This failure had the potential to result in the removal of medication from the unsecure, unattended controlled substance bag by visitors, patient and staff for unauthorized use.

5. One of one FBC Nurse (FBC RN 3) discontinued an epidural (a procedure that injects medicine into the space into the lower back) prescribed by a physician for Pt 1, without orders to do so. This failure had the potential for Pt 1's pain not to be managed and for the clinical status of Pt 1 to deteriorate.

Findings:

1.During a concurrent observation and interview on 3/3/23, at 2:40 p.m., Pt 21 was in her hospital bed with an intravenous (IV) line in her right forearm and attached to a device to administer medication. The medication bag indicated heparin was being administered in a drip (used to decrease the clotting ability of the blood and help prevent harmful clots from forming in blood vessels). Pt 21 stated she was on the heparin for a something they found in her in her neck.

During of a review of Patient 21's Face sheet titled, "PATIENT INSURANCE & DEMOGRAPHICS," dated 3/10/23, indicated Patient 21 was admitted on 3/3/23 "Reason of Visit: CVA (cerebrovascular accident- stroke- interruption in the flow of blood to the brain) TIA (transient ischemic attack-stroke that lasts only a few minutes) ESRD (End-Stage Renal Disease- kidneys stop functioning permanently) ON HD (Hemodialysis- a treatment to filter wastes and water from the blood) R (right) INT (internal) JUGULAR VEIN (major blood vessels that stretch from head to upper chest) DVT (Deep vein thrombosis- blood clot) ..."

During a review of Patient 21's order titled, "Heparin order," start date 3/2/23 at 11:40 p.m., Stop date 3/7/23 at 6:10 p.m., indicated, "Heparin Infusion for DVT/PE (Pulmonary Embolism- blood clot in the lung) ... Heparin Infusion (DVT/PE) Reference Text ... heparin additive 25,000 Unit [13.89 Units/kg/hr (unit of measure- kilogram/hour)] + Dextrose (sugar water) 5% (percent) Heparin New 500 mL (unit of measurement- milliter) Details: 500 mL, IV (intravenous- in a vein), 30 mL/hr, Diagnosis: Deep Vein Thrombosis, See nomogram (ref text) for titration instructions, Routine Start: 03/03/23 0:10:00 PST (pacific standard time) ... Dose Based On 108 kg ... Order Comment: Order PTT (prothrombin time- time it takes for blood to clot) 6 hrs (hours) after initiating Heparin Infusion and 6 hrs after every rate change until 2 consecutive Therapeutic PTT's obtained (or per facility protocol). Once patient is therapeutic, order PTT qAM (every morning) ..."

During a review the facility's Reference Text titled, "HEPARIN ORDERS/ PE AND DVT," indicated, "1) Laboratory: ... Have the aPTT drawn 6 hours after the heparin infusion is initiated ... 5) RN (registered nurse) to adjust rate according to heparin dosing adjustment nomogram (below) to maintain aPTT between 61 to 95 seconds. 6) Notify physician if bleeding event occurs or aPTT>150 seconds ... 7) Patients on long term heparin to be assessed every 48 hours to identify thromboembolic disorders ... [for] aPTT (seconds) 41-60 (give) Bolus Dose (units/kg) 40 ... Rate Change (units/kg/hr.) Increase by 2 units/kg/hr. Repeat aPTT in 6 hrs. ... [for] aPTT 61-95 Therapeutic Range No Change ... Repeat aPTT in 6 hrs ... [for] aPTT 96-110 ... Rate Change ... Decrease by 2 units/kg/hr. Repeat aPTT in 6 hrs ... [for] aPTT 111-150 ... Stop Infusion (minutes) 60 Decrease by 3 units/kg/hr. Repeat aPTT in 6 hrs ... [for] aPTT >150 ... Stop Infusion (minutes) 120 Decrease by 3 units/kg/hr. Repeat aPTT in 6 hrs. NOTE: Enter all rate changes and time of change on Medication Administration Record (MAR)."

During a concurrent interview and record review on 3/16/23, at 9:45 a.m., with the Nursing Educator for Staff Development (NE), Pt 21's Heparin order, Reference Text, labs, and Medication Administration Records (MAR) were reviewed. The NE stated the first PTT was drawn on 3/2/23 at 11:53 p.m. and was 29, then the heparin drip was started; the next was drawn on 3/3/23 at 5 a.m. and was 46. Based on the Reference text above a PTT of 46 requires a Bolus Dose of 40 units/kg (current weight of Pt 21 is 108 kg) which is approximately 4,300 units. The NE stated she was not able to locate that this was given to Pt 21 after reviewing Pt 21's electronic health records (EHR) for admission date 3/3/23. The NE stated the next dose adjustment to the heparin was done at 9:10 a.m. on 3/3/23 and a rate change was done per the reference text, but it was based on the PTT results drawn at 5 a.m. The NE stated it should not take four hours to adjust the drip, this places the patient at risk for bleeding and staff not knowing if the patient is therapeutic. The NE stated she used to do the audits for all heparin drips on the floor but was told to stop and that the floor Manager's would be taking over but does not know if this occurred. The NE stated then next PTT for Pt 21 was drawn on 3/3/23 at 7:18 p.m. approximately 14 hours after the last draw at 5 a.m. The NE stated this placed the patient at risk for bleeding, the next PTT should have been drawn at 3:10 p.m. based on the last adjustment made at 9:10 a.m. The NE stated she provides education on heparin drips to new hires during orientation and it is also a yearly assignment on the nurse's annual competencies.

During a concurrent interview and record review on 3/16/23, at 11:36 a.m., with the Manager of Medical/Surgical (MMS), Pt 21's Heparin Reference text above, labs and Medication Administration Record (MAR) were reviewed. The MMS stated after reviewing Pt 21's EHR for admission 3/3/23 the PTT drawn on 3/3/23 at 5 a.m. and was 46, based on the Reference Text a PTT of 46 requires Pt 21 to get a Bolus Dose of 40 units/kg, current weight of patient is 108 kg, makes the bolus dose approximately 4,300 units. The MMS stated no bolus was found in Pt 21's EHR to address the PTT results of 46. Further review of Pt 21's PTT results indicated the next PTT drawn was at 7:18 p.m. on 3/3/23, 14 hours after the last one at 5 a.m. The MMS stated a PTT should have been ordered and drawn six hours after the adjustment of the heparin drip based on the 5 a.m. PTT results. The MMS stated the adjustment to the heparin drip should be made as soon as possible after receiving the results of the last PTT. The next PTT resulted at 1:47 a.m. on 3/4/23 and was 113, based on the Reference Text the heparin drip was to be stopped for one hour. The MMS stated she was not able to locate that the heparin drip had been stopped for this one hour. The next PTT resulted at 11:25 a.m. approximately 9 hours later. The MMS stated these medication errors could have put the patient at risk for bleeding and kept the patient longer on this drip to get the patient to a therapeutic level. The MMS stated the pharmacy is involved in the setup of the rate for the start of the heparin drip and the nursing staff is responsible for the PTT orders, rate changes, and boluses that need to be given. The MMS stated she had not been doing audits on heparin drips but believes this is needed to help staff prevent future errors.

During a concurrent interview and record review on 3/17/23, at 7:41 a.m., with Registered Nurse (RN) 1, Pt 21's Heparin order, heparin Reference text, labs and Medication Administration Record (MAR) were reviewed. RN 1 stated she took care of Pt 21 on 3/2/23 and 3/3/23 from 7 p.m. to 7:30 a.m. night shift. RN 1 stated Pt 21 came to her with the heparin drip started. RN 1 stated she did not make any changes to the Pt 21's heparin drip for the 3/3/23 5 a.m. PTT results of 46. RN 1 stated she cannot recall if the pharmacy had called her with the results and if she had relayed this information to the day shift nurse. RN 1 stated she took care of Pt 21 the next night. RN 1 stated on 3/4/23 at 1:47 a.m. PTT results 113 she stopped Pt 21's heparin drip for 60 minutes based on the reference text and decreased the rate by 3 units/kg/hr. RN 1 was not able to provide documentation in the electronic health record (EHR) that the heparin drip was stopped for the 60 minutes nor was she able to provide documentation that she checked with another nurse when she stopped it and then restarted it. RN 1 stated Heparin is an anticoagulant and can cause bleeding and it may take longer for patients to become therapeutic if it is not monitored appropriately.

During a review of the facility's policy and procedure (P&P) titled, "Heparin Infusion Order Protocol (MM-36),"
dated 4/21, the policy indicated, " ... POLICY Upon an order from a Licensed Independent Practitioner (LIP), Weight-based Heparin Therapy will be initiated and administered according to the Standard Heparin Order Sheet (See Associated Documents). In an effort to reach and maintain therapeutic anticoagulation levels, activated partial thromboplastin time (aPTT) test will be drawn every six (6) hours for monitoring and adjusting of the heparin infusion. GUIDELINES... B. Rate Changes 1. Will be made based on the Standard Heparin Order nomogram. 2. Documentation a. Heparin Protocol will appear on the electronic Medication Administration Record (e-MAR) when ordered b. The dosing nomogram will appear as a reference screen c. Nursing will document the administration of the Heparin Protocol in the electronic medical record under the interventions ... C. Nursing Key Points 1. Weight for calculating infusion bolus dosing and infusion rates must be an actual mechanically measured weight, not a stated weight 2. Two registered nurses (RN 's) are to perform an independent calculations and double check the dosage, concentration, and rate infusion. a. Upon initiation of Heparin b. With every rate change c. Each time the IV bag is changed 3. The witnessing RN will sign as a co-signer in the Medical Record a. Under interventions: IV Heparin Titrate 4. Once two (2) consecutive aPTTs are in therapeutic range aPTT draws will be reduced to daily. 5. If the daily aPTT is out of therapeutic range dosages to be adjusted according to the nomogram and the every six (6) hours aPTT is to be reinstituted."

During a review of the facility's P&P titled, "Medication "High Alert," Administration of (MM-384)," dated 1/22, indicated, " ... At [name of facility] "Hight-Alert" medications ae those medications involved in a high percentage of errors and/or sentinel events as well as medications that carry a higher risk for abuse or other adverse outcomes. To promote safe management of High-Alert medications [initials of facility] has developed a list of "High-Alert" medications that require specific safeguards prior to administration to reduce the risk of harm to our patients. GUIDELINES: A. Medications considered to be "High Alert" are: ... 5. H Heparin ... F. Administration: 1. All "High Alert" medications will have an independent double check performed and documented prior to initial administration, during dosage adjustment, and "hand off" communication/shift change (for continuous drip medications). This will be carried out by two (2) licensed nurses ... c. Each nurse independently verifies that the correct dose has been prepared ... e. Each nurse independently documents in the e-MAR ... 4. The following medications have special administration required elements. A. Therapeutic Heparin-verify the most current aPTT prior to administration ..."

During a review of a professional reference retrieved from: https://www.ncbi.nlm.nih.gov/books/NBK538247/ National Library of Medicine, titled, "Heparin," last updated 7/12/22, indicated, "Unfractionated heparin is an anticoagulant indicated for both the prevention and treatment of thrombotic events such as deep vein thrombosis (DVT) and pulmonary embolism (PE) ... Administration Heparin administration can be by intravenous (IV) route or subcutaneous SQ) route. Intravenous heparin is continuously administered for therapeutic anticoagulation, while intermittent subcutaneous administration is used to prevent thromboembolism ... When administered SQ, the onset of action is usually within 1 to 2 hours compared to an immediate anticoagulant effect with IV administration of heparin ... Adverse Effects Heparin use's typical adverse effects include bleeding, thrombocytopenia, injection site reactions, and other adverse effects only seen with chronic heparin administration. Bleeding is a major complication associated with heparin use. Patients should undergo monitoring for new bleeding that may present in the urine or stool. Bleeding may also present as bruising, petechial rash, and nosebleeds. Thrombocytopenia typically occurs in up to 30% of patients who receive heparin. Serious events seen with thrombosis include pulmonary embolism, deep vein thrombosis, stroke, myocardial infarction, and thrombosis in main arteries to organs that could lead to severe complications, including limb amputation or death ... According to ISMP (Institute for Safe Medication Practices), heparin is in the high-risk medication classification that correlates with a multitude of patient safety errors and has the potential to cause significant harm. Many factors can contribute to potential errors, including dosing, monitoring, adverse effects, and dispensing logistics. To mitigate these potential errors, major safety monitoring organizations and several clinical studies have been conducted to delineate the most effective management standards for hospitals ... Weight-based dosing offers another area for potential errors with calculations ... Monitoring aPTT levels throughout heparin therapy can also offer an area for errors. Protocols are in place to instruct nursing staff on titration instructions based solely on the aPTT level ... The heparin prescribing information states that dosing and titration often require an interprofessional double check to ensure the correct dose and indication. One study evaluated the use of pharmacist management of heparin that showed significantly fewer errors in the hospitals where pharmacists were managing anticoagulation ..."

2. During a concurrent interview and record review, on 3/15/23, at 11:00 a.m., with Registered Nurse Educator (RN EDU) 1, Pt 23's Insulin Drip Titration Sign-off Verification Flowsheet (IVF) in the Electronic Medical Record (EMR) dated 3/2/23 was reviewed. Pt 23's IVF in the EMR indicated, " ... Action ... Perform ... Performed by ... [ICU RN 6] ... Performed date ... 03/02/2023 2:14 PST ... Action Status ... Completed ... Action ... VERIFY ... Performed by ... [ICU RN 6] .... Performed date ... 03/02/2023 2:14 PST ... Action Status ... Completed". The IVF in the EMR indicated " ... Action ... Perform ... Performed by ... [ICU RN 6] ... Performed Date ... 03/02/2023 5:58 PST ... Action Status ... Completed ... Action ... VERIFY ... Performed by ... [ICU RN 6] .... Performed date ... 03/02/2023 5:58 PST ... Action Status ... Completed". RN EDU 1 stated based on the Pt 23's EMR documentation ICU RN 6 verified her own insulin (medication to control blood sugar) drip (continuous medication administration intravenously) medication titration (when medication is changed to a higher or lower dose). RN EDU 1 stated insulin intravenously (administered through tube into a patient's blood) is considered a high alert medication (medication that could cause great harm to patient if not administered correctly) and Pt 23 could have received a dangerously high dose without another nurse to verify the correct dosage. RN EDU 1 stated, when a nurse does not get a second RN to verify the titration it "could have been very bad for the patient".

During a concurrent interview and record review, on 3/16/23, at 10:00 a.m., with Intensive Care unit Manager (ICU MGR), Pt 23's Insulin Drip Titration Sign-off Verification Flowsheet (IVF) in the Electronic Medical Record (EMR) dated 3/2/23 was reviewed. Patient 23's IVF in the EMR indicated, " ... Action ... Perform ... Performed by ... [ICU RN 6] ... Performed date ... 03/02/2023 2:14 PST ... Action Status ... Completed ... Action ... VERIFY ... Performed by ... [ICU RN 6] ... Performed date ... 03/02/2023 2:14 PST ... Action Status ... Completed". The IVF in the EMR indicated " ... Action ... Perform ... Performed by ... [ICU RN 6] ... Performed Date ... 03/02/2023 5:58 PST ... Action Status ... Completed ... Action ... VERIFY ... Performed by ... [ICU RN 6] ... Performed date ... 03/02/2023 5:58 PST ... Action Status ... Completed". ICU MGR stated ICU RN 6 signed and verified Pt 23's dosage titration herself. ICU MGR stated insulin would not be considered a high alert medication (drug that can cause significant patient harm when used in error) that would need a second Registered Nurse (RN) sign off. ICU MGR stated she had not reviewed the high alert medication policy but would review it.

During a concurrent interview and record review, on 3/16/23, at 10:05 a.m., with ICU MGR, of the facility's policy and procedure (P&P) titled, "Medication "High Alert, Administration of ...'", dated 1/22 was reviewed. The P&P indicated, " ... High-Alert medications are those medications involved in a high percentage of errors and/or sentinel (event that results in death or permanent harm) events as well as medications that carry a higher risk for abuse or other adverse outcomes ... High-Alert mediations require specific safeguards prior to administration to reduce the risk of harm to patients ... Medications to be considered "High Alert" are ... Insulin (drips only)- IV only ... All "High Alert" medications will have an independent double check performed and documented prior to initial administration, during dosage adjustment, and "hand off" communication/shift change (for continuous drip medications). This will be carried out by two (2) licensed nurses ... Each nurse independently verifies that the correct dose ... Each nurse independently documents in the e-MAR (electronic Medication Administration Record)." ICU MGR stated ICU RN 6 did not have verification of another licensed staff member when the Insulin drip was titrated for Pt 23. ICU MGR stated ICU RN 6 did not follow the facility's P&P. ICU MGR stated there should be two licensed nurses documenting when an insulin drip is tritiated. ICU MGR stated this could have caused "real harm" and Pt 23 could have died if a mistake was made. ICU MGR stated two RN verification is there for another "set of eyes to catch any fatal mistakes".

3. During a concurrent interview and record review on 3/9/23, at 9:30 a.m., with Family Birthing Center Manager (FBC MGR), Patient (Pt) 8's "Physician Orders" and "e-MAR" (documents medication administration into the electronic health record) were reviewed. FBC MGR stated Pt 8 was admitted to the hospital on 3/2/23, for induction of labor (process or treatment that stimulates childbirth and delivery). Physician orders indicated Pt 8 was prescribed "200 mL [milliliters- unit of volume] Epidural solution FentaNYL [opioid] 2 mcg [micrograms- unit of measure]/ ml Ropivacaine [analgesic] 0.2% 8 mL/hr [hour]" for pain. The e-MAR indicated the medication was administered at 4:37 a.m. on 1/26/23. FBC MGR stated there was no "TWO RN verification" performed at nurse shift change and documented in the e-MAR.

During an interview on 3/9/23 at 9:36 a.m., with the FBC MGR and Registered Nurse Educator (RN EDU) 2, FBC MGR stated she was uncertain when "TWO RN" verification occurred when managing epidurals in FBC. RN EDU 2 stated the "TWO RN" verification process was required facility- wide and nurses were expected to follow the policy and procedure to ensure safe delivery of medication to patients. RN EDU 2 stated "TWO RN" verification as it related to epidurals was required upon initiation, with every dose change, at every shift change, and when medication was wasted.

During a concurrent interview and record review, on 3/6/23, at 9:40 a.m., with FBC MGR, Pt 13's "Physician Orders" and "e-MAR" were reviewed. FBC MGR stated Pt 13 was admitted to the hospital on 1/26/23, for induction of labor and elevated blood pressure. Physician orders indicated Pt 13 was prescribed "200 mL Epidural solution FentaNYL 2 mcg/ ml Ropivacaine 0.2% 8 mL/hr" for pain. The e-MAR indicated the medication was administered at 3:01 a.m. on 3/3/23. FBC MGR stated there was no "TWO RN verification" performed at nurse shift change and documented in the e-MAR.

During a concurrent interview and record review, on 3/6/23, at 9:50 a.m., with FBC MGR, Pt 14's "Physician Orders" and "e-MAR" were reviewed. FBC MGR stated Pt 14 was admitted to the hospital on 1/26/23, for placenta insufficiency (disc of tissue responsible for delivering oxygen and nutrients to the fetus is not properly working), preeclampsia (high blood pressure disorder during pregnancy), and labor induction. Physician orders indicated Pt 14 was prescribed "100 mL Epidural solution FentaNYL 2 mcg/ ml Ropivacaine 0.2% 8 mL/hr" for pain. The e-MAR indicated the medication was administered at 3:19 a.m. on 3/3/23 and a second bag was administered at 11:03 p.m. on 1/26/23. FBC MGR stated there was no "TWO RN verification" performed at nurse shift changes and documented in the e-MAR at 7 a.m. and 7 p.m. on 1/27/23.

During a concurrent interview and record review, on 3/6/23, at 10:10 a.m., with FBC MGR, Pt 5's "Physician Orders" and "e-MAR" were reviewed. FBC MGR stated Pt 5 was admitted to the hospital on 1/16/23, for prolonged labor (slow progression) and spontaneous rupture of membrane (a hole or tear forms in the fluid-filled bag that surrounds and protects your baby). Physician orders indicated Pt 14 was prescribed on 1/17/23, at 4:31 a.m., "200 mL Epidural solution FentaNYL 2 mcg/ ml Ropivacaine 0.2% 8 mL/hr" for pain. FBC MGR stated the medication was not scanned into Pt 5's medical record. FBC MGR stated facility policy and procedure was not followed during the administration this medication. FBC MGR stated the expectation was for staff to scan all medications prior to administration to ensure patients received the right medication and right dose. FBC MGR stated this was a patient safety issue.

During a review of the P&P titled, "Epidural Analgesia Management", dated 7/22, the P&P indicated, " ... Patients with continuous epidural analgesia will receive nursing care in accordance with established standards of safe patient care ... Role of the RN [registered nurse]... TWO RN verification required at every staff handoff, bad change, tubing change, dose change, and with any machine delivered bolus dose... bags are changed every 24 hours or when empty by a RN using Two RN verification process. Epidural tubing changes every 72 hours. This requires a TWO RN verification..."

During a review of the P&P titled, "Medication Administration", dated 12/21, the P&P indicated, " ... at [name of facility] medications are safely and accurately administered following the six rights (patient, drug, dose, route, time, reason) ... Medication administration is performed by the following licensed staff in accordance with their scope of practice ... Medications administered on the nursing units will be documented in the electronic medication administration record (e-MAR)... Nurse is to electronically scan patient's wristband comparing the e-MAR and confirming that the barcode has appeared adjacent to the patients name on the e-MAR... Documentation of medication administration on the e-MAR occurs while the medication is being administered ... scan medication(s) to 1) Verify product label matches the order. 2) Verify proper dose is being administered..."

4. During a concurrent observation and interview on 3/6/2023 at 09:55 a.m., in the Intensive Care Unit with ICU RN 2 and ICU MGR, ICU RN 2 stated Patient 3 is on comfort care (end of life care) now, Patient 3 was extubated at 1:01 p.m. and family is at bedside. A [Brand Name] narcotic (substance used to treat moderate to severe pain) pain medication was infusing Intravenously (IV- trough a vein) through the Smart Pump. The ICU MGR validated the smart IV pump was not locked. The ICU MGR stated she did not know if the Smart IV pumps are capable of being locked. ICU RN 2 stated the change of shift report is done at the bedside in the patient room and is a verbal process. ICU RN 2 stated the amount of fluid remaining in the narcotic drip is not documented in the EMR at change of shift nurse report, nor is the pump "cleared" (the IV Smart Pump tracks the total amount of fluid infused and can be used to identify how much fluid has infused during a shift, professional practice recommends clearing pumps at the end of each shift). ICU RN 2 stated the (Smart IV) Pump system "does not have a lock, it is not a Patient Controlled Analgesia (A method of pain relief in which the patient controls the amount of pain medicine that is used) [IV pump]. ICU RN 2 could not verbalize the process for monitoring and recording the amount of narcotic infused during a 12-hour shift.

During a review of Pt 3's Face Sheet, (no date), the Face Sheet indicated Pt 3 was admitted on 2/4/23, no time listed, with a chief complaint of Colon Cancer (Colorectal cancer is a disease in which cells in the colon or rectum grow out of control), Cholangiopathy (Any disease of the bile ducts (a tube that carries bile from the liver and gallbladder, through the pancreas, and into the small intestine)), and Sepsis (a serious medical condition resulting in an infection that can lead to multisystem failure of organs, shock, and death).

During a review of the facility's P&P titled, "Medication "High Alert," Administration of (MM-384)," dated 1/22, indicated, " ... At [name of facility] "Hight-Alert" medications are those medications involved in a high percentage of errors and/or sentinel events as well as medications that carry a higher risk for abuse or other adverse outcomes. To promote safe management of High-Alert medications [initials of facility] has developed a list of "High-Alert" medications that require specific safeguards prior to administration to reduce the risk of harm to our patients. GUIDELINES: A. Medications considered to be "High Alert" are: ... 3. N Narcotic drips (including PCA's) ... F. Administration: 1. All "High Alert" medications will have an independent double check performed and documented prior to initial administration, during dosage adjustment, and "hand off" communication/shift change (for continuous drip medications). This will be carried out by two (2) licensed nurses ... c. Each nurse independently verifies that the correct dose has been prepared ... d. Each nurse independently verifies that the "IV Smart" pump settings are correct (if applicable) ... e. Each nurse independently documents in the e-MAR ... 3. All "High Alert" medications requiring infusion must be administered via an "IV Smart" pump using the programmed drug library ... b. When administering medication, as part of the independent drug verification, the lines should be traced from pump to port by 2 RN's ... D. Dispensing of Controlled Substances ...1) Controlled substances will be dispensed from the pharmacy to the nursing units through the Automated Dispensing Machine (ADM). In the event that a controlled substance cannot be stocked in an ADM, such items will be supplied to the nursing station as individual patient doses and must be secured ..."

During a review of the facility's P&P titled, "Management of Controlled Substances (MM-193)" dated 6/20, indicated " ... J. Monitoring of Controlled Substances ... 1.1 Diversion monitoring reports will also be sent to the Nurse Manager (or designee) for investigation and follow up ..."

During a review of the [Smart IV Pump] manufacturer Instruction For Use (IFU), dated December 2015, the IFU indicated, " ... General Setup and Operation 1-10 PC Unit Section ... Lock/Unlock Tamper Resist 1. Initiate operation of applicable module. 2. Press and hold Tamper Resist Switch, on back of PC unit, for 3 to 4 seconds (see "General Information," "Features and Displays," "Operating features, Controls, Indicators"). -An advisory tone (if Key Click Audio is enabled) and a three-second PANEL LOCKED prompt on Main Display confirm activation ..."

5.During a concurrent interview and record review on 3/6/23, at 10 a.m., with FBC MGR, Pt 1's "Physician Orders" and "Nursing notes" were reviewed. FBC MGR stated Pt 1 was admitted to the hospital on 1/17/23, with a primary diagnosis (the main condition treated or investigated during the hospital episode) induction of labor. Physician orders indicated Pt 1 was prescribed an epidural on 1/17/23 at 8:44 a.m. for pain. FBC MGR stated the nursing notes indicated FBC RN 3 discontinued the epidural on 1/17/23 at 7:14 p.m. FBC MGR stated there was no discontinue order entered in the EHR until 1/18/23 at 12:21 p.m. when Pt 1 was discharged from the facility. FBC MGR stated FBC RN 3 should have obtained a physician order prior to discontinuing the epidural. FBC MGR stated FBC RN 3 did not follow facility policy and procedure when she discontinued the medication without an order.

During a review of the P&P titled, "Epidural Analgesia Management", dated 7/22, the P&P indicated, " ... Patients with continuous epidural analgesia will receive nursing care in accordance with established standards of safe patient care ... Removal of the catheter... Removal of the epidural catheter is completed by order of the responsible Anesthesia Provider... "

During a review of the facility document titled "Waste Audit Report", dated 3/9/23, the document indicated, " ... Epidural 2 mcg/ ml Fent [Fentanyl]/ Rop [Ropivacaine] 0.2% 200 ml Bag ... 1/17/23 ... waste amt [amount] 170 ml ... Patient Condition Changed ..."

During a record review of the FBC RN 3 employee record on 3/8/23, at 2 p.m., with the Human Resources Partner (HRP), HRP stated FBC RN 3 voluntarily terminated her employment with facility and was not available for interview.

Based on observation, interview, and document review, the facility failed to provide facilities that ensured a safe environment for patients and staff when:

1. The facility's humidification define system (an electrical appliance, that increases moisture in a single room or an entire building) malfunctioned on 1/6/23 and was not promptly repaired. The system was turned off to prevent water leaks which caused humidity (water vapor in the air) levels in the facility to drop below 20% (normal range 20-60%) in the facility's Operating Rooms (ORs), Sterile Core (SC - sterile supply storage), and Sterile processing departments (SPD, a department where the process of cleaning, preparing, sterilizing, and storing reusable medical and surgical instruments occurs) and had the potential to create an unsafe environment for the patients. (Refer to A 701)

2. There was no working eyewash station (a unit for washing off chemicals or substances that might have splashed into an individual's eyes) in the Sterile Processing Department (Refer to A 724)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality healthcare in a safe and sanitary environment.

Based on interview and record review, the facility failed to maintain facility mechanical equipment in a safe operating condition when the facility's humidification system failed to properly work on 1/6/23 and was not repaired.

This failure to repair the facility's humidification system resulted in the deactivation of the system due to water leaks in the facility. Humidity (water vapor in the air) levels dropped below 20% in the Operating Rooms (OR), Sterile Core (SC), and Sterile processing department (SPD) and had the potential to create an unsafe environment for the patients.

Findings:

During a concurrent observation and interview on 3/3/23, at 11:15 a.m. with Family Birthing Center Manager (FBC MGR), in the Family Birthing Center (FBC) sterile core (designated area adjacent to the OR to store sterile supplies), the FBC MGR provided a tour of the FBC department, including the FBC OR and sterile core. The FBC MGR validated water leaked from the ceiling on 1/17/23, resulting in the temporary closure of FBC OR- B and the removal of supplies from the sterile core. The FBC MGR stated staff from the facility's plant operations (FPO) repaired the damaged ceiling but was uncertain if the cause of the leak was repaired.

During an interview on 3/6/23 at 9:05 a.m., with the Plant Operations Director (PO DIR), the PO DIR stated, the facility's humidification system (the part of the heating, ventilation, and air conditioning system that controls humidity) was "turned off" due to ongoing complications related to the system. The PO DIR stated the problem was discovered "sometime" in January 2023 when water leaks emerged in the facility's Intensive Care Unit (ICU- a unit in a hospital providing intensive care for critically ill or injured patients), Neonatal Intensive Care Unit (NICU- an intensive care unit specializing in the care of ill or premature newborn infants in their first 28 days of life), and the FBC sterile core. The PO DIR stated, "we have leaks everywhere" and so the decision was made to turn off the humidification regulation system until it was repaired. No anticipated repair date was provided. The PO DIR stated there were "occasions" when humidity levels in the main operating rooms (ORs), FBC ORs, and FBC sterile core fell below acceptable ranges (20- 60%) and staff had contacted the FPO requesting the system be evaluated. The PO DIR stated he would "turn the [humidification] system back on to correct" the low humidity levels. The PO DIR stated he could not provide work orders (formal request document, paper or digital, for maintenance services) for all work done to the humidification system due to "difficulties" with the facility's "new work-order system" implemented in July 2022. The PO DIR stated his department was short staffed and it was "hard to manage his guys" and the work orders.

During an interview on 3/10/23, at 2:35 a.m., with the PO DIR, the PO DIR stated, his department (FPO) was aware of the humidification system leaking on 1/6/23. The PO DIR stated his engineers "repaired" the leak but "a day or so later it happened again." The PO DIR stated the leak kept "moving" to different areas of the facility "a couple more days later." The PO DIR stated the leaks were "taken seriously" when leaks in the OB and NICU occurred on 1/17/23 and "a company was called in." The PO DIR stated he turned on the humidification system after the inspection was performed by the vendor. On 2/12/23, another leak occurred in the OR sterile area and "I made the decision to turn off the [humidification] system" until the necessary parts came in and the vendor could repair the system. The PO DIR stated his plan was to "leave it off for a while and see if it dries up ... we think April weather would be better." The PO DIR stated no one knew but my department (FPO). The PO DIR stated he did not think to notify the departments potentially affected by his decision to turn it off. The PO DIR could not provide the work orders for the repairs done "in house" by his department since July 2022, the start of the facility's "new" work order system. The PO DIR stated no preventative maintenance was performed for the humidification system. The PO DIR stated the system was not accessible.

During an interview on 3/15/23, at 10:40 a.m., with the Infection Preventionist Manager (IPM), the IPM stated, the PO DIR advised her of the leaks caused by the humidification system and his plan to turn off the humidification system. The IPM stated she was not aware that it would affect the whole hospital but was aware it would affect the ORs, SPD, SC, and Pharmacy. The IPM stated she was not aware that Pharmacy was not informed of the humidification system being turned off. The IPM stated the humidity could affect the efficacy of the medication administered to patients, and Pharmacy should have been notified. The IPM stated when sterile supplies were not stored in proper temperature and humidity, the potential for condensation (water which collects as droplets on a cold surface when humid air is in contact with it) and/ or compromises the integrity of the wrapping which could lead to a surgical site infections.

During an interview on 3/17/23 at 9:40 a.m., with the Director of Perioperative Services and Cardiac Cath Lab (DPCL), the DPCL stated, temperature and humidity controls were vital to maintain safety and sterility in the OR and/ or procedural areas. The DPCL validated humidity above acceptable range (greater than 60%) increased the risk for infection and humidity levels below acceptable range (less than 20%) increased the risk for fires.

During a review of the facility's "L&D (labor and delivery) Trend Study" datedJanuary 2023, the "L&D Trend Study" indicated, humidity registered out of range on 1/30/23. The humidity levels ranged between 16.96% and 19.92% for five to eight consecutive hours.

During a review of the facility's "L&D Trend Study" dated February 2023, the "L&D Trend Study" indicated, humidity levels registered out of range on 2/14, 2/15, 2/16, 2/17, and 2/18. The humidity levels ranged between 17.26% and 19.92% for three to 21 consecutive hours.

During a review of the facility's "2nd Floor Sterile Core Trend" dated February 2023, the "2nd Floor Sterile Core Trend" indicated, humidity levels registered out of range on 2/14, 2/15, 2/17, and 2/18. The humidity ranged between 13.82% and 19.96% for one to four consecutive hours.

During a review of the facility's "[Main] OR Temp & Humidity Trend Study" dated January 2023 and February 2023, "[Main] OR Temp & Humidity Trend Study" indicated, the registered temperatures and humidity ranges once in a 24-hour period for ORs one through five. OR#5 and OR#3 did not have registered readings between 2/9/23 to 2/27/23.
OR#1: The humidity level registered out of range on 2/15. The humidity on 2/15 was 17.8%.
OR#2: The humidity levels registered out of range on 2/15 and 2/22. The humidity levels ranged between 16.81% and 19.64%.
OR#3: No out of range temperature and humidity readings between 1/31/23 and 2/8/23.
OR#4: Humidity registered out of range on 1/31, 2/15, 2/16, 2/17, 2/18, and 2/22. The humidity levels ranged between 16.27% and 19.87%. The trend study had one registered humidity reading for each day.
OR#5: No out of range temperature and humidity readings between 1/31/23 and 2/8/23.

During a review of the facility P&P titled "Perioperative Environmental Controls and HVAC Variances in the Operating Rooms, Cath Lab, Central Sterilization," dated 3/7/23, the P&P indicated, " ... Engineering will contact the Operating Room (OR) manager or charge nurse concerning any "out of range" values, in addition to taking corrective measures ... Design relative humidity ... operating room ... 20-60%... Central Sterilization clean workroom ... 30- 60%... Decontamination room ... 30- 60%... Sterile storage room ... humidity ... 30- 60%... Gastrointestinal endoscopy procedure room ... 20-60%... post anesthesia care unit ... 20-60%... Procedure room ... humidity ... 20-60%... "

During a review of the policy and procedure (P&P) titled, "Preventative Maintenance Policy", dated 9/1/21, the P&P indicated, " ... to establish specific guidelines for the testing and inspection of all equipment supported by clinical engineering... Preventative maintenance shall be performed in accordance with the manufacturer's recommendations and accepted industry standards 1. If the manufacturer does not state any recommended periodic or preventative servicing, the device will be tested for electrical safety and/ or visually inspected for safety as appropriate at least annually. 2. In instances in which manufacturer recommendations are unavailable accepted industry standards will be used to complete a preventative maintenance activity at least annually ... time between PM 's may not exceed the original manufacturers recommendations... and the inventory file will be maintained for each item of medical equipment supported by clinical engineering. Each file will contain a historical data record with the CE number, equipment description, serial number, location, date of installation, and cost ..."

During a review of the manufacturer's manual titled, "H-1-30, [name of manufacturer] steam generating humidifier Installation, Operation, and Maintenance Manual", undated, the manual indicated, "all corrective actions shall be made in accordance with original equipment manufacturer's standards and acceptable industry standards ... Maintenance ... Inspect the strainer screen at least twice during the first year... Steam Trap... At least twice a year verify that the steam trap is functioning properly... Valves... Pneumatic ... Inspect annually to be sure that the valve close this off steam tightly the stem packing is not leaking steam and the diaphragm in the actuator is not leaking air... Electric Modulating... Inspect annually to be sure that the valve operates freely and closes off steam tightly and the stem packing is not leaking... Solenoid Type... Inspect annually to verify proper functioning with steam tight shut off... O-Rings ... Inspect after 2 or 3 years of service replace if necessary... Troubleshooting guide... problem... humidifier discharges water in duct ... Possible cause steam main overloaded with water due to boiler discharging water with steam... steam trap not draining properly... humidifier improperly piped... surges of condensate and steam supply due to condensate collecting at low, undripped point in steam main... inadequate steam trap capacity... Action ... locate cause of priming and correct... replace, repair, or clean trap as required... if condensate return main is overloaded, find an alternative method for draining... correct the piping ... horizontal air flow, steam inlet should be at the top of the assembly and condensate outlet at the bottom of the assembly... installed drips and steam traps as required... replace the larger trap... replace O-rings..."

Based on observation, interview, and record review, the facility failed to maintain safety supplies and equipment readily accessible to ensure safe care when there was no working eyewash station in the Sterile Processing Department where high-level disinfectants were stored.

This failure had the potential to delay emergent treatment and create an unsafe environment.

Findings:

During a concurrent observation and interview on 3/8/2023, at 10:27 a.m., with the Endoscopy Technician (ET) 1, Endoscopy Manager (ENDO MGR) 1, and the Infection Prevention Manager (IPM), in the Endoscopy Suite-High Level Disinfection (HLD) room, the IPM stated that because there were chemicals stored in this room, an eyewash station was required for staff safety. The IPM validated that there was no eyewash station present. ET 1 stated she noticed that the eyewash device, which normally was affixed to the sink faucet, was not connected on 3/6/2023. ET 1 stated she found the device on the counter to the right of the handwashing sink earlier in the week, so she thought it was not working. ET 1 stated she had not reported the broken eyewash device to a supervisor, nor had she completed a work order request for Plant Operations to come evaluate the problem. ET 1 validated that it was staff's responsibility to report broken equipment to a supervisor or request a work order. ENDO MGR 1 stated that he was not aware that the eyewash station was not working. IPM stated she did not realize an eyewash device was not present in this room. the eye wash station should be available for use because there were chemicals in use in the sterile processing room.
The IPM validated that an eyewash device was required because this room because there were chemicals in use in the sterile processing room (HLD room). The IP MGR stated that she noted gallon bottles should be secured (in a reinforced holder) to prevent accidental spills or splash of the chemical. The IPM stated an eyewash station was required for staff safety.

During an interview on 3/8/2023, at 9:05 a.m., with the IPM, the IPM stated rooms that stored HLD chemicals should have an eyewash station. The IPM stated engineering performed routine preventative maintenance (PMs) of eyewash stations "I think monthly." A "yellow tag" placed on the eyewash station indicated PMs were completed.

During a review of the facility policy and procedure (P&P) EVS Chemicals (PC-105), undated, the P&P indicated, " ...Manufacturer recommendations are always followed unless not specified, chemicals are always stored in locked secured compartment ... Chemicals are not to be left unattended outside of locked and secured area. Doing so will lead to disciplinary action up to and including termination ..."

During a professional reference reviewed retrieved from https://www.sgna.org/Portals/0/SGNA%20Standards%20of%20infection%20prevention%20in%20reprocessing_FINAL.pdf?ver=2018-11-16-084835-387, titled, " Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes", dated 2018, the professional reference indicated, " ...Reprocessing Environment ...Eye was stations, either plumbed or self-contained, should be installed in the sink where reprocessing occurs ..."

Based on observation, interview, and record review, the hospital failed to have an active Infection Prevention and Control program which adhered to nationally recognized infection prevention and control guidelines for the surveillance, prevention, and control of HAIs (hospital acquired infections) and other infectious diseases, when:

1.One of one staff member sampled in the Endoscopy (Endo-a procedure in which an instrument is introduced into the body to give a view of internal parts) department did not follow professional standards of practice and the hospital's policies and procedures in the transport and storage of endoscopes (a flexible instrument used to view internal parts of the body). Staff indicated the hospital adhered to the professional standards as published by Association of periOperative (the period of time around the surgical operation) Registered Nurses (AORN a professional organization and primary source of national standards for perioperative practices to help deliver safe patient care and achieve workplace safety) and the Association for the Advancement of Medical Instrumentation (AAMI primary source of national and international standards for the medical device industry and guidance for healthcare technology and sterilization professionals). The facility transported endoscopes in a non secure manner from the procedure room on the first floor of the hospital through public areas and corridors to an elevator used by the public and down to the ground level to be cleaned, traveling hundreds of feet throughout the hospital. Sixteen of sixteen endoscopes were stored touching each other which is not in accordance with the standards published by AORN. The facility was not able to provide any documentation that they were providing routine cleaning of the cabinets, and the storage bins used to store endoscope supplies (Refer to A0750, Finding 1).

2. Five of five hospital departments (Main operating room (OR), Family Birthing Center (FBC) OR, Sterile core (designated area adjacent to the OR to store sterile supplies), Sterile processing and Pharmacy) were not able to provide evidence to demonstrate Temperature and Humidity was being monitored effectively in a manner to maintain accepted ranges in accordance with the hospital policy and nationally recognized professional standards for the following areas: Main Operating Rooms (OR), Family Birthing Center OR, Sterile processing, and Pharmacy. The hospital Plant Operations Director (PO DIR) was aware of continued issues with the humidity that had caused multiple leaks in the facility and did not implement effective actions to correct. This failure placed patients and staff at risk for fires in the OR and patients at risk of infections associated with low or high humidity. (Refer to A0750, Finding 2)

3. The hospital failed to follow policy and procedures related to infection control in multiple areas. 1) Not wearing proper Personal Protective Equipment (PPE- goggles with mask/face shield, plastic apron, gloves, shoe covers) in the decontamination area of Sterile Processing Department (SPD- cleaning and disinfecting of instruments and medical equipment); 2) Multiple staff failed to perform hand hygiene after removal of dirty gloves; 3) Not wearing proper PPE in the surgical suites or wearing it inappropriately; 4) Surgical Technician 1 did not keep his sterile hands above the sterile field; 5) Intensive Care Unit (ICU) staff did not dispose of reusable equipment per Occupational Safety and Health Administration (OSHA) standards of practice; 6) Family Birthing Center Registered Nurse (FBC RN) 1 discarded bodily waste products inappropriately, placing staff at risk of cross contamination; 7) ICU medication room was not kept sanitary; 8) Ice/water machines in ICU and Emergency Department (ED) were found with black colored substance inside the chute and orange colored substance in the other chute; 9) ED staff did not maintain the Charge Nurses station in a sanitary manner when dried blood was observed stuck to it; 10) Port protectors (alcohol-containing caps that twist onto intravenous (IV) access points for disinfection and protection) were not being used in the ICU; 11) Isolation signs were not being used for isolation rooms in the OR's; 12) Infection Preventionist Manager (IPM) and Manager of Endoscopy did not provide evidence of oversight of Endoscopy, no audits were being done; 13) One Surgical Technician (Obstetrics (OB-branch of medicine dealing with childbirth)Tech) did not effectively cover all surgical instruments to prevent them from drying with enzymatic solution (spray used to decontaminate medical devices and instruments) at point of use; 14) One Environmental Staff (EVS) 1 did not follow hospital policy for the terminal clean of Family Birthing Center OR. Multiple standards published by the Association of Perioperative Registered Nurses (AORN a professional organization and primary source of national standards for perioperative practices to help deliver safe patient care and achieve workplace safety) were not followed. (Refer to A0750, Finding 3-18)

4. The hospital failed to ensure the Infection Preventionist (IP-Professionals who make sure healthcare workers and patients are doing all the things they should do to prevent infections) effectively oversaw the facility's Infection Control Program and facility practices for the
adherence of infection prevention and control policies and procedures and best practices. The hospital was found to not follow professional standards of practice and hospital policies and procedures for the safe transport and storage of endoscopes. The IP was aware of the situation and did not have a program to oversee and monitor the day to day practices. (Refer to A0772)

As a result of these failures all patients, visitors and staff were at risk for transmission of infections (an infectious agent is transferred from a reservoir to a susceptible host) and cross contamination (the process by which bacteria or other microorganisms are unintentionally
transferred from one substance or object to another, with harmful effect) and increased the potential for hospital acquired infections and illnesses. Because of the serious potential harm of not practicing the professional standards for Endoscope transport and storage and not having a comprehensive systemic approach to ensure effective infection control practices, surveillance, prevention monitoring and a system to maintain professional standards of practice an Immediate Jeopardy (IJ a situation in which the provider's noncompliance with one or more conditions of participation has caused or is likely to cause serious injury, harm, impairment, or death to a patient) situation was called on 3/8/23 at 5:45 p.m., under Code of Federal A 0750 §482.42(a)(3) with the Interim Chief Nursing Officer (CNO), Chief Operation Officer (COO), and the Manager of Accreditation Regulatory and Compliance (MARC). The Immediate Jeopardy (IJ- a situation in which the provider's noncompliance with one or more conditions of participation has caused or is likely to cause serious injury, harm, impairment, or death to a patient) template was provided to the facility. The hospital submitted an acceptable IJ Plan of Removal (Version 3) on 3/10/23 at 5:07 p.m., which addressed the actions needed to remove the IJ situation. The IJ Plan of Removal included but was not limited to the following: 1) No longer performing outpatient endoscopes, all have been moved to inpatient; no longer moving dirty endoscopes through common areas 2) Endoscope storage cabinets were cleaned; proper PPE is being worn during processing of endoscopes 3) Temperature and humidity are to be monitored in procedure rooms prior to each case, if out of range case will be moved to a separate procedure room that is within range and report outliers; facility has scheduled an appointment to have the humidification system looked at and repaired 4) Attestations received from staff seen not performing hand hygiene and don and doffing
PPE appropriately and education has gone out for all other staff members 5) OR tech reeducated on sterile field and dropping of hands below the sterile field, OR staff to do monitoring 6) Education to front line staff in OB about not returning single use supplies from a contaminated surface back to clean storage 7) New process established for dirty stylets (hard, sharp, reusable instrument to guide the insertion of a breathing tube in a patient) and staff educated, ordered new disposable stylets 8) Education provided to staff on how to transport medical waste and use of urinal instead of plastic bag 9) ICU med room cleaned, and patients provided with one person use pill crushers for each room 10) Ice machines cleaned and to be maintained per manufacturers guidelines 11) ED charge nurse station was cleaned, and staff educated on cleaning process 12) Education put out to all nursing areas for use of port protectors 13) Signage placed and staff educated to place isolation signs on surgical suites when needed 14) Housekeeper with long acrylic nails was educated and all staff in direct contact with patients were reeducated as well 15) Audits to be completed and continued by IP and Endo Manager for compliance of infection prevention. Process for monitoring compliance was established. Training and competencies of staff were validated. The components of the IJ Plan of Removal were validated onsite through observations, interviews, and record review. The IJ was removed on 3/15/23 at 10:45 a.m. with the facility Interim Chief Nursing Officer (CNO).

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality patient care in a safe environment.

Based on observation, interview and record review, the hospital failed to maintain a clean and sanitary environment for all patients, visitors, and staff when:

1.One of one Endoscopy (a procedure in which an instrument is introduced into the body to give a view of internal parts) Technicians (ET's) transported soiled endoscopes (a flexible instrument used to view internal parts of the body) from the Endoscopy Procedure Room, on the first floor, through public areas and corridors, through elevator down to the ground level to be cleaned and then the paths of travel back to the first floor for sterilization. Transport of the endoscopes to the processing area was not by the shortest distance. The soiled endoscopes were transported in unsecured containers that could easily be tipped over, they were not puncture proof and did not seal. These processes are not supported by the Association of periOperative (the period of time around the surgical operation) Registered Nurses (AORN), the Association for the Advancement of Medical Instrumentation (AAMI- primary source of national and international standards for the medical device industry and guidance for healthcare technology and sterilization professionals), Centers for Disease Control and Prevention (CDC) and the American Society for Gastrointestinal (relating to stomach and intestines) Endoscopy (ASGE) professional standards. The Endoscopy staff did not provide evidence to demonstrate the storage cabinets for endoscopes were cleaned per manufacturer's guidelines, and according to facility policy and procedures. Clean (unpackaged) supplies were stored in dirty storage bins in the Sterile Processing Department (SPD) decontamination (the removal of dangerous germs from medical instruments or devices) room which was not in accordance with hospital policy. Sixteen (16) clean endoscopes were not stored in accordance with manufacturer's guidelines (upright, not touching other endoscopes/cabinet walls or bottom of the cabinet), hospital policy and procedures, and professional standards. These hospital practices resulted in the transport of endoscopes in a non-secure manner and the potential harm of spreading infections to patients, visitors and staff.

2.Hospital staff did not provide evidence to demonstrate temperature (T) and humidity (H) was effectively monitored in a manner to maintain accepted ranges in accordance with hospital policy and nationally recognized professional standards of practice for the following five of five areas: Main operating room (OR), Family Birthing Center (FBC) OR, Sterile core (designated area adjacent to the OR to store sterile supplies), Sterile processing and Pharmacy. Plant Operations staff were aware the hospital mechanical system meant to maintain T and H did not always function normally and the hospital did not implement effective interventions and actions to correct the situation. These failures increased the risk of infectious disease and had the potential to cause fire.

3.One of one Endo Technician (ET) 1 was seen in the decontamination area of Sterile Processing not wearing appropriate Personal Protective Equipment (PPE- goggles with mask/face shield, plastic apron, gloves, shoe covers) and did not follow infection control procedures to prevent cross contamination (the process by which bacteria or other microorganisms (organism that can only been seen by a microscope) are unintentionally transferred from one substance or object to another, with harmful effect) from the dirty area to the designated clean area. ET 1 did not put on shoe covers prior to entering the decontamination area, nor did she remove the shoe covers to head into the designated clean area. ET 1 walked back and forth from the decontamination area in the same shoes into the clean area not following the facility's policy titled, "surgical instrument cleaning, decontamination, and inspection (SS (surgical services)-417)."

4. Four of 10 staff members (Medical Doctor (MD) 18, MD 19, FBC Registered Nurse (RN) 1, Environmental Services Personnel (EVS) 2) failed to perform hand hygiene after removal of dirty gloves and failed to follow the facility policy and procedure titled, "Hand Hygiene."

5. Five of 10 staff members (MD 18, MD 19, Surgical Technician (ST) 3, OR RN 3, and FBC RN 1) did not don and doff (put on and take off) surgical attire (gown, gloves, shoe covers, hair cover, eye wear) or wear surgical attire appropriately while in the OR per facility policy and procedure titled, "Surgical Attire Procedure".

6. One of one Surgical Technicians (ST) 1 did not follow hospital policy and procedure and AORN standards to keep hands above the surgical field as a technique to keep the surgical field sterile. ST 1 was observed to lower hands below the surgical field multiple times during the surgical procedure. The Surgical Team consisting of MD 18, MD 19, OR RN 1, OR RN 2 and Surgical Safety Specialist (SSS) were aware of this conduct and did not redirect the behavior and have the ST 1 remove dirty gloves and replace with sterile gloves. This failure had the potential to contaminate the surgical field and possibly negatively affect the outcome of the surgery for Patient 7.

7. One of one Family Birthing Center (FBC- designated area in a facility designed to provide a homelike setting for birth) surgical technician (OB TECH) did not follow hospital policy and procedure and AORN standards for storage of sterile supplies. FBC OB Tech returned supplies that were exposed to the operating room environment back to the FBC sterile core. This practice resulted in the potential harm of contaminating sterile supplies stored in the sterile core and the possibility of using non-sterile supplies for surgical procedures.

8. One of one staff members (Intensive Care Unit (ICU) Manager (MGR)) in the ICU did not follow the Occupational Safety and Health Administration (OSHA) standards of practice for the appropriate manner to dispose of used equipment within each ICU room. The ICU MGR stated ICU staff transport dirty equipment and devices, such as stylets (hard, sharp, reusable instrument to guide the insertion of a breathing tube in a patient), to the nurses' station. The standard per OSHA indicates, "Immediately or as soon as possible after use, contaminated reusable sharps shall be placed in appropriate containers until properly reprocessed." This practice resulted in the potential harm of contaminating surfaces at the nurse's station and possibly spreading the contamination to patients, staff and visitors.

9. One of one staff members (FBC RN 1) in the FBC did not discard bodily waste products in accordance with the standards referenced in the facility's policy and procedures on Isolation Precautions. FBC RN 1 discarded urine directly into the room's common waste hamper rather than a sealed biohazard (potentially dangerous waste i.e., urine, blood, other bodily secretions) container. This practice resulted in the potential harm of contaminating patients, staff and visitors.

10. Staff in the ICU did not maintain one of one medication room in a sanitary manner in accordance with the standards referenced by the CDC. Powder was observed on the surface areas around multiple pill crushers. This failure resulted in the potential harm of contaminating other areas of the ICU.

11. Two of two Ice/water machines in the ICU and Emergency Department (ED) were not cleaned and maintained per manufacturer guidelines. The ice/water machine in the ED, the interior of the chute (the passage through which ice falls into the dispenser) that dispensed water was wiped with a white colored paper towel, the paper contained black colored substance. The ICU ice/water machine interior of the chute was wiped with a white paper towel and had an orange-colored substance on it. This failure had the potential to harm any staff, patients, or visitors who received water or ice from these machines.

12. One of one Charge Nurse stations in the Emergency Department (ED) was not maintain in a sanitary manner. Dried blood was observed on the surface of the desk. Staff did not provide evidence of cleaning schedule for the Charge Nurse desk. Staff did not follow the facility policy and procedure titled, "Cleaning of Patient Care Equipment (IC [infection control]-500-03)." This failure resulted in the potential harm of cross contamination to patients, staff and visitors.

13. One of three patients (Pt 34) In the ICU had no port protectors (alcohol-containing caps that twist onto intravenous (IV) access points for disinfection and protection) being used for IV (meaning through the vein) tubing and IV medication tubing left open against facility Policy titled, "Central Venous Catheter (CVS- catheter placed into a large vein) Insertion and Maintenance (Adult)." This failure put Pt 34 at risk for infection.

14. Two of six OR rooms had no signage for isolation type on the door per facility policy and CDC guidelines.

16. Infection Preventionist Manager (IPM) and Manager of Endoscopy did not provide evidence demonstrating oversight of Endoscopy. No schedule of audits or monitoring of techniques was provided. The IPM stated she did not do any infection control audits for Endoscopy. The Endoscopy manager did not provide a schedule of monitoring staff to ensure the facility's policies and procedures and professional standards such as the Society of Gastroenterology Nurses Associates (SGNA) were followed. These failures put staff, visitors and patients at risk of cross contamination when policies and standards were not followed.

17. One of one Surgical Technician (OB TECH- member of the surgical team assisting with surgical procedures) did not effectively (did not cover each instrument and was not sufficient to maintain a moist environment to prevent drying) spray surgical instruments with enzymatic solution (spray used to decontaminate medical devices and instruments) at point of use in accordance Association of periOperative Registered Nurses (AORN- a professional organization and primary source of national standards for perioperative practices to help deliver safe patient care and achieve workplace safety). Staff in the FBC OR did not follow the standards per AORN and hospital policy to spray surgical instruments with enzymatic solution at the point of use prior to transporting the surgical instruments to the Sterile Processing Department.

18. One of one EVS staff (EVS 1) did not follow the policy and procedure titled, "Environmental Cleaning in Procedural Areas," for the terminal cleaning (a cleaning method used in healthcare environments to control the spread of infections) of the FBC OR- A.
As a result of these failures all patients, visitors and staff were at risk for transmission of infections (an infectious agent is transferred from a reservoir to a susceptible host) and cross contamination and increased the potential for hospital acquired infections and illnesses.

Because of the serious potential harm of not practicing the professional standards for Endoscope transport and storage and hospital-wide failure of not following the principles of Infection Control and Prevention and not having a comprehensive systemic approach to ensure effective infection control practices, surveillance, prevention monitoring and a system to maintain professional standards of practice an Immediate Jeopardy (IJ- a situation in which the provider's noncompliance with one or more conditions of participation has caused or is likely to cause serious injury, harm, impairment, or death to a patient) situation was called on 3/8/23 at 5:45 p.m., under Code of Federal A-0750 §482.42(a)(3) with the Interim Chief Nursing Officer (CNO), Chief Operation Officer (COO), and the Manager of Accreditation Regulatory and Compliance (MARC). The Immediate Jeopardy (IJ- a situation in which hospital noncompliance has placed the health and safety of patients, staff and or visitors at risk of serious injury, serious harm, serious impairment or death) template was provided to the facility. The hospital submitted an acceptable IJ Plan of Removal (Version 3) on 3/10/23 at 5:07 p.m., which addressed the actions needed to remove the IJ situation. The IJ Plan of Removal included but was not limited to the following: 1) No longer performing outpatient endoscopes, all have been moved to inpatient; no longer moving dirty endoscopes through common areas 2) Endoscope storage cabinets were cleaned; proper PPE is being worn during processing of endoscopes 3) Temperature and humidity are to monitored in procedure rooms prior to each case, if out of range case will be moved to a separate procedure room that is within range and report outliers; facility has scheduled an appointment to have the humidification system looked at and repaired 4) Attestations (a declaration that something exits or is the case) received from staff seen not performing hand hygiene and don and doffing PPE appropriately and education has gone out for all other staff members 5) OR tech reeducated on sterile field and dropping of hands below the sterile field, OR staff to do monitoring 6) Education to front line staff in OB about not returning single use supplies from a contaminated surface back to clean storage 7) New process established for dirty stylets and staff educated, ordered new disposable stylets 8) Education provided to staff on how to transport medical waste and use of urinal instead of plastic bag 9) ICU med room cleaned and patients provided with one person use pill crushers for each room 10) Ice machines cleaned and to be maintained per manufacturers guidelines 11) ED charge nurse station was cleaned and staff educated on cleaning process 12) Education put out to all nursing areas for use of port protectors 13) Signage placed and staff educated to place isolation signs on surgical suites when needed 14) Housekeeper with long acrylic nails was educated and all staff in direct contact with patients were reeducated as well 15) Audits to be completed and continued by IP and Endo Manager for compliance of infection prevention. Process for monitoring compliance was established. Training and competencies of staff were validated. The components of the IJ Plan of Removal were validated onsite through observations, interviews, and record review. The IJ was removed on 3/15/23 at 10:45 a.m. with the facility Interim Chief Nursing Officer (CNO).

Findings:

1. During an interview on 3/6/2023 at 10:30 a.m., with the Endoscopy Manager (ENDO MGR) 1, in the Pavilion out-patient Operating Room (OR) Department, the ENDO MGR stated the facility Endoscopy Department followed the ASGE Guidelines when developing processes and policies and procedures and the AORN as a professional reference.
During an observation on 3/7/23, at 11:41 a.m., in Operating Room (OR) 6 of the facility outpatient [Pavilion], at end of the colonoscopy (a procedure in which a doctor uses a colonoscope or scope, to look inside your rectum and colon) and hemorrhoidectomy (surgery to remove internal or external hemorrhoids that are extensive or severe) procedure, the Endoscopy Technician (ET) 1, wiped the outside of the soiled endoscope (a flexible instrument used to view internal parts of the body) with a gauze (a bandage, a cloth, a thin piece of material used to cover wounds) pad. ET 1 placed the endoscope into a biodegradable plant-based material transport container. ET 1 placed a cardboard lid marked "biohazard" on top of the transport container. The transport container was placed on a metal pushcart (the cart is open to air, top shelf is only supported by 2 long metal rods, lower shelf is basket type wire metal cart), and open to air. The ET 1 exited the OR room 6 into an OR corridor leading to the public elevator to the Pavilion Main Lobby (floor 1). The ET 1 pushed the cart through the [Pavilion] out-patient and visitor lobby, and across to the glass enclosed corridor (which connects the outpatient building and the main hospital) to the main hospital. The ET 1 continued transporting the container to the OR staff elevators (1st floor) down to the Sterile Processing Department (SPD) (where the process of repurposing is carried out on a device to allow its subsequent safe use, which can include cleaning, disinfection, and sterilization) at the basement level of the main hospital. This transport process took a total of 14 minutes from time the ET 1 left OR 6 and arrived at the entrance of the SPD decontamination room door.

During an observation on 3/7/2023, at 11:55 a.m., in the SPD, ET 1 entered the "decontamination" (area where manual cleaning of endoscopes is performed) room performed hand hygiene, put on Personal Protective Equipment (PPE) such as mask, face shield, gown and started the endoscope visual inspection and testing process. Once the visual inspection and testing process was completed ET 1 performed manual cleaning of the endoscope and transferred the wet endoscope to a green leak-proof bag. ET 1 placed the green bag on the shelf at the pass-through window from the "dirty" room to the "clean" room. ET 1 removed PPE and performed hand hygiene. ET 1 entered the "clean" side of the SPD. ET 1 collected the green bag and placed it into a new disposable transport container. ET 1 placed a cardboard lid marked "clean" on top of the transport container. ET 1 carried the transport container to the 1st floor Endoscopy Procedure Suite for final High-Level Disinfection (HLD) (includes heat-automated pasteurization (partial sterilization of a product) or liquid immersion chemical sterilant (disinfectant)). The manual cleaning process, including transport back up to the 1st floor for HLD, took the ET 1 36-minutes to complete.

During an observation on 3/7/2023 at 12:31 p.m., in the Endoscopy Procedure Suite (HLD room), ET 1 processed the clean endoscope in one of two [brand name] HLD machine compartments. ET 1 stated the HDL runs for "25 minutes". ET 1 stated there was another HLD-sanitized endoscope that had already completed its sterilization cycle in compartment #2) and would process this endoscope. ET 1 removed the sterilized endoscope from the [brand name] HLD machine, sprayed the endoscope with a chemical, and dried the endoscope with compressed (air pressed into a heavier than atmospheric (air in the atmosphere) air. ET 1 then sprayed the sterilized endoscope with a chemical and dried the endoscope with a towel. ET 1 filled out a tag identifying the endoscopy serial number, date manual wash was completed, date HLD was completed, expiration date, and initials, and placed the tag on the sterilized endoscope. ET 1 stated this sterilized endoscope will be stored in the endoscope storage locker in room next to the HLD room.

During an interview on 3/8/2023 at 9:05 a.m., with the Infection Prevention Manager (IPM), the IPM stated that Dominican Campus now Mercy Outpatient Center (MOC) at the time of pandemic (illness that affects several countries and affects many people) it was decided to move operations to the Pavilion. The IPM stated that the MOC was a self-contained Endoscopy center where the processing of endoscopes was done on site. As the pandemic (Covid 19 (an infection that is caused by the SART-CoV-2 virus)) resolved, decisions were made to combine outpatient and inpatient endoscopy procedures. The IPM stated that the workflow, as she understands it, was that the ET wipes the scope with a red sponge at point of care; places in transport container, container is placed on a cart, transported to decontamination room in SPD. The ET performs a leak, flush, manual clean of scope and then ATP (adenosine triphosphate- measurement of the cleanliness of a surface) testing is done. The IPM stated depending on the readings, the ET either recleans or moves forward. The IPM stated another container is used to place the "clean" scope in the sterile (clean) side through a pass-through window. HLD is done on the 1st floor. ET hooks up, runs through cycle (disinfection, clean, drying) then places endoscope in endoscope cabinet after being tagged, if not used within 5 days ET will reprocess the endoscope.

During a concurrent observation and interview on 3/8/23, at 10:29 a.m., with IPM in the endoscope storage room, the IPM stated that the endoscopes hanging in the cabinet were touching each other and not hung freely. IPM stated the endoscopes should not touch each other to prevent cross contamination.

During an interview on 3/8/2023 at 10:33 a.m., with ET 1, ET 1 stated that endoscopes were reprocessed every five days, per policy, if they were not used before the expiration date on the label. ET 1 stated that the endoscopes are usually used before the five day expiration date. ET 1 stated that the clean endoscope storage locker was ventilated and was cleaned by an "endo tech usually on weekends." Endoscopes were sometimes moved out so that cleaning of the cabinet could take place. ET 1 stated the endoscopes were housed in a clean disposable transport container while they clean the locker out with disinfectant wipes.

During an interview on 3/8/23, at 10:52 a.m., with IPM, IPM stated, the container used during transportation of the dirty endoscope was not sealed (leak proof) but covered and a maximum of two containers could be stacked on each other during transport to SPD.

During concurrent observation and interview on 3/11/23 at 12 p.m., in the endoscopy suite storage room, with Endoscopy Technician (ENDO) 1 and Endoscopy Manager (ENDO MGR) 1, ENDO 1 demonstrated her process for drying and storing the endoscopes. The storage room had one endoscope cabinet that stored sixteen endoscopes. The endoscopes were hung vertically, some hung by the distal (from the point of attachment) tip and others by the control section. The sixteen endoscopes were compacted in the cabinet with the sides contacting each other. ENDO 1 stated, "It's always been like this." ENDO 1 stated had been employed since 2007 and the method of storing the endoscopes had not changed. ENDO MGR 1 stated, he was aware of the inappropriate storage method and the facility was in the process of adding a second storage cabinet to the storage room. ENDO MGR 1 stated, "[Endoscopes] cannot touch ... we knew that."

During an interview on 3/15/23, at 10:40 a.m., with the Infection Preventionist Manager (IPM), the IPM stated she was not consulted when facility decided to move Outpatient Endoscopy (off campus) to the on-campus Outpatient surgical center. The IPM stated she was not consulted on the route the endoscopes would take through the facility in order to get to the decontamination and processing room. The IPM stated she was not consulted on the container the dirty endoscopes would be transported in. The IPM stated the route the endoscopes took from the outpatient to the inpatient was not safe, "If anyone had bumped into them (staff transporting the endoscopes), the lid covers did not seal (to the transport containers used to transport the dirty endoscopes) and could tip over and open and cause cross contamination."

During a review of the [brand name] "Scope Transport Tray" product information, undated, "Scope Transport Tray" indicated, " ...Product description trays are made of a biodegradable plant-based material this is a 100% renewable resource reducing the facilities carbon footprint ..."

During a review of the professional reference retrieved from https://aornguidelines.org/guidelines/content?sectionid=173735349&view=book#229132776, titled, "AORN (Association of periOperative Registered Nurses) (eGuidelines)", dated September 2022, the professional reference indicated, " ...Contaminated endoscopes and accessories must be transported to the decontamination area in a closed container or closed transport cart. The container or cart must be ... leak proof on the sides and bottom ... puncture resistant ... Containing contaminated endoscopes and accessories decreases the potential for injury to personnel or their exposure to blood, body fluids, or other potentially infectious materials and helps prevent damage to the endoscopes during transport. Labeling the transport containment device communicates to others that the contents are potentially infectious ..."

During a review of the professional reference titled, "Association for the Advancement of Medical Instrumentation ANSI/AAMI ST91:" dated 2021, indicated, " ... 3.62: rigid sterilization container system sterilization containment device designed to hold medical devices for sterilization, storage, transportation, and aseptic (free from contamination) presentation of contents Note to entry: The system generally consists of a bottom or base with carrying handles and a lid that Is secured to the base by means of a latching mechanism. A basket or tray to hold instruments or other Items to be sterilized is placed inside. A filter or valve system Is Incorporated into the lid and/or base to provide for air evacuation and sterilant (an agent used to destroy microorganisms) penetration during the sterilization cycle and to act as a barrier to microorganisms during storage, handling, and transport ..."

During a review of the facility policy and procedure titled, "Cleaning of Patient Care Equipment (IC-500-03)", dated 1/24/2029, indicated " ...Procedure; 2. Semi-critical items (a medical device that comes into contact with mucous membranes or non-intact skin) are reprocessed by cleaning, followed by high level disinfection. High level disinfection is documented by Central Sterile Processing Department or the clinical area responsible for high level disinfection ....10. Soiled/contaminated equipment should be transported to Central Supply or moved to the dirty utility room. The dirty utility room should not be utilized for prolonged equipment storage ....14. Healthcare providers are responsible for cleaning/sanitizing patient equipment between patient uses or prior to transport to Central Processing for decontamination ..." 17. Departments must have procedures in place for cleaning, decontamination and disinfection of specialty equipment used in their area (e.g., endoscopes). These policies and procedures will be maintained in the individual departments ..."

During a review of the professional reference retrieved from https://aornguidelines.org/guidelines/content?sectionid=173735349&view=book#229132776, titled, "AORN (Association of periOperative Registered Nurses) (eGuidelines", dated September 2022, the professional reference indicated, " ... Clean and disinfect storage cabinets used for flexible endoscopes with an EPA-registered (Environmental Protection Agency) hospital-grade disinfectant when visibly soiled and on a regular basis (e.g., daily, weekly) ..."

During a review of the Facility Skills titled, "Flexible Endoscope Care and Maintenance" undated, the Skills indicated, " ...Completing the Procedure ...Clean the storage cabinets on a regular basis or when visibly soiled per the organization's practice ..."
2. During a concurrent observation and interview on 3/3/23, at 11:15 a.m. in the Family Birthing Center (FBC) sterile core (designated area adjacent to the OR to store sterile supplies), with Family Birthing Center Manager (FBC MGR), the FBC MGR provided a tour of the FBC department, including the FBC OR and sterile core. The FBC MGR verbally validated water leaked from the ceiling on 1/17/23, resulting in the temporary closure of FBC OR- B and the removal of supplies from the sterile core. The FBC MGR stated the supplies were moved due to potential infection control concerns. The FBC MGR stated staff from the facility's plant operations (FPO) repaired the damaged ceiling but was uncertain if the cause of the leak was repaired.

During an interview on 3/6/23 at 9:05 a.m., with the Plant Operations Director (PO DIR), the PO DIR stated, the facility's humidification system (the part of the heating, ventilation, and air conditioning system that controls humidity) was "turned off" due to ongoing complications related to the system. The PO DIR stated the problem was discovered "sometime" in January 2023 when water leaks emerged in the facility's Intensive Care Unit (ICU- a unit in a hospital providing intensive care for critically ill or injured patients), Neonatal Intensive Care Unit (NICU- an intensive care unit specializing in the care of ill or premature newborn infants in their first 28 days of life), and the FBC sterile core. The PO DIR stated, "we have leaks everywhere" and so the decision was made to turn off the humidification regulation system until it was repaired. No anticipated repair date was provided. The PO DIR stated there were "occasions" when humidity levels in the main operating rooms (ORs), FBC ORs, and FBC sterile core fell below acceptable ranges (20- 60%) and staff had contacted the FPO requesting the system be evaluated. The PO DIR stated he would "turn the [humidification] system back on to correct" the low humidity levels. The PO DIR stated he could not provide work orders (formal request document, paper or digital, for maintenance services) for all work done to the humidification system due to "difficulties" with the facility's "new work-order system" implemented in July 2022. The PO DIR stated his department was short staffed and it was "hard to manage his guys" and the work orders.

During concurrent interviews on 3/6/23 at 9:15 a.m., in the Sterile Processing Department (SPD), with the Sterile Processing Department Supervisor (SPDS) and the PO DIR, the SPDS stated, temperature and humidity in the SPD was checked in the department and logged daily at the start of every shift. The SPDS stated staff notified the FPO when temperature and humidity in the SPD "registered" outside set parameters (T- 68-73 degrees and H between 30-60%). The SPDS stated there was no system that "alarmed" in the SPD department but "If it feels humid, we go to the wall and check" and pointed to the wall mounted thermometer hygrometer (a device that is used to measure both the current air temperature and the relative humidity). The SPDS stated he was told FPO staff remotely monitored (watch or keep track of something from a different location) the SPD. The PO DIR stated the temperature and humidity was tracked by the facility's monitoring system, but the system was dependent on staff reporting abnormal ranges to FPO. The SPDS stated he was not aware the humidification system "turned off."

During an interview on 3/7/23 at 12:10 p.m., with Pharmacy Director (PD), the PD stated, pharmacy followed professional standards outlined in (chapter in the United States Pharmacopeia- National Formulary (formulas to preparation of medications) that describes requirements for the preparation of sterile drugs) for the sterile compounding of medications [the method of preparing custom medications for patients in a sterile environment to prevent contamination and ensure patient safety]. The PD stated this required strict temperature and humidity controls for the compounding and storage of medications in the pharmacy department. The PD stated temperature and humidity levels were not within parameters "about six months ago." The PD stated the FPO was notified and "eventually" the temperature and humidity levels returned to normal (less than 68 degrees Fahrenheit (F); less than 60% humidity). The PD stated he was not aware the humidification system was off and in need of repair.

During an interview on 3/9/23 at 8:15 a.m., with Pediatric Medical Doctor (MD) 7, MD 7 stated, she was the medical director for the facility's Neonatal Intensive Care Unit (NICU). MD 7 stated the NICU was a "separate hospital" within the facility that operated independently and had separate staff, supplies, and equipment. MD 7 stated newborn infants (babies from birth to about 2 months of age) were admitted to NICU with complications and transferred to the "separate hospital" if the newborn required higher level of care. MD 7 stated the NICU, although independent from the facility, depended on facility operations to maintain appropriate temperature and humidification for the NICU. MD 7 stated there was a "[water] leak" in the NICU "over a month ago" due to an issue with the facility's humidification system which "shut down my NICU." MD 7 verbally validated parts of the ceiling collapsed in a newborn patient's room. MD 7 stated NICU staff had to divert newborn patients to the main hospital off campus for safety. MD 7 was not aware the humidification system was off.

During an interview on 3/10/23 at 2:35 a.m., with the PO DIR, the PO DIR stated his department (FPO) was aware of the humidification system leaking on 1/6/23. The PO D

Based on observation, interview and record review, the facility failed to ensure the Infection Preventionist (Professionals who make sure healthcare workers and patients are doing all the things they should do to prevent infections) effectively oversaw the facility's Infection Control Program and facility practices for the adherence of infection prevention and control policies and procedures and best practices. The hospital was found to not follow professional standards of practice and hospital policies and procedures for the safe transport and storage of endoscopes (a flexible instrument used to view internal parts of the body). The IP was aware of the situation and did not have a program to oversee and monitor the day to day practices. (cross reference A750).

This failure resulted in the potential harm of cross contamination and the spread of infectious diseases throughout the facility due to ineffective oversight, monitoring, and maintenance of a sanitary environment. This deficient practice potentially affected all patients, visitors, and staff who entered the hospital.

Findings:

During an observation on 3/7/23, at 11:41 a.m., in Operating Room (OR) 6 of the facility outpatient [Pavilion], at end of the colonoscopy (a procedure in which a doctor uses a colonoscope or scope, to look inside your rectum and colon) and hemorrhoidectomy (surgery to remove internal or external hemorrhoids that are extensive or severe) procedure, the Endoscopy Technician (ET) 1, wiped the outside of the soiled endoscope (a flexible instrument used to view internal parts of the body) with a gauze (a bandage, a cloth, a thin piece of material used to cover wounds) pad. ET 1 placed the endoscope into a biodegradable (capable of being decomposed by bacteria or other living organism's plant based material transport container. ET 1 placed a cardboard lid marked "biohazard" on top of the transport container. The transport container was placed on a metal pushcart (the cart is open to air, top shelf is only supported by 2 long metal rods, lower shelf is basket type wire metal cart), and
open to air. The ET 1 exited the OR room 6 into an OR corridor leading to the public elevator to the Pavilion Main Lobby (floor 1). The ET 1 pushed the cart through the [Pavilion] out patient and visitor lobby, and across to the glass enclosed corridor (which connects the outpatient building and the main hospital) to the main hospital. The ET 1 continued transporting the container to the OR staff elevators (1st floor) down to the Sterile Processing Department (SPD) (where the process of repurposing is carried out on a device to allow its subsequent safe use, which can include cleaning, disinfection, and sterilization) at the basement level of the main hospital. This transport process took a total of 14 minutes from time the ET 1 left OR 6 and arrived at the entrance of the SPD decontamination (the removal of dangerous germs from medical instruments or devices) room door.

During an observation on 3/7/2023, at 11:55 a.m., in the SPD, ET 1 entered the "decontamination" (area where manual cleaning of endoscopes is performed) room performed hand hygiene, put on Personal Protective Equipment (PPE) such as mask, face shield, gown and started the endoscope visual inspection and testing process. Once the visual inspection and testing process was completed ET 1 performed manual cleaning of the endoscope and transferred the wet endoscope to a green leak proof bag. ET 1 placed the green bag on the shelf at the pass through window from the "dirty" room to the "clean" room. ET 1 removed PPE and performed hand hygiene. ET 1 entered the "clean" side of the SPD. ET 1 collected the green bag and placed it into a new disposable transport container. ET 1 placed a cardboard lid marked "clean" on top of the transport container. ET 1 carried the transport container to the 1st floor Endoscopy Procedure Suite for final High Level
Disinfection (HLD) (includes heat automated (pasteurization-the partial sterilization of a product) or liquid immersion (chemical sterilant-to chemically treat surgical instruments and medical supplies to ensure infectious pathogens are not transmitted to patients). The manual cleaning process, including transport back up to the 1st floor for HLD, took the ET 1 36 minutes to complete.

During an observation on 3/7/2023 at 12:31 p.m., in the Endoscopy Procedure Suite (HLD room), ET 1 processed the clean endoscope in one of two [brand name] HLD machine compartments. ET 1 stated the HDL runs for "25 minutes". ET 1 stated there was another
HLD sanitized endoscope that had already completed its sterilization cycle in compartment #2) and would process this endoscope. ET 1 removed the sterilized endoscope from the [brand name] HLD machine, sprayed the endoscope with a chemical, and dried the endoscope
with compressed (air pressed into a heavier than atmospheric (air in the atmosphere) air. ET 1 then sprayed the sterilized endoscope with a chemical and dried the endoscope with a towel. ET 1 filled out a tag identifying the endoscopy serial number, date manual wash was
completed, date HLD was completed, expiration date, and initials, and placed the tag on the sterilized endoscope. ET 1 stated this sterilized endoscope will be stored in the endoscope storage locker in room next to the HLD room.

During an interview on 3/8/23, at 9:05 a.m., with the Infection Preventionist Manager (IPM), the IPM described the transport and reprocessing (cleaning and high level disinfection) of endoscopes (a flexible tube designed to look at tissues inside the body) in the facility.
The IPM stated the process was changed and approved by the facility's infection control committee during the COVID 19 pandemic (a highly infectious respiratory disease outbreak caused by SARS CoV2 coronavirus that started December 2019). The IPM stated she had not observed the process since the implementation one and a half years ago.

During an interview on 3/15/23, at 10:40 a.m., with the IPM, the IPM stated there were multiple infection control concerns identified throughout the facility. The IPM stated she was not aware glide scope intubation stylets (a metal wire used to insert a tube through mouth into the lungs) were not transported in biohazard containers (used for the disposal of waste that may be contaminated with pathogens (germs that cause disease) that present a danger to people and the environment) from the patient's rooms. The IPM stated she was not aware pill crushers
were used for multiple patients and not cleaned in between uses. The IPM stated she had not observed the transport of endoscopes throughout the facility therefore, did not identify the risk for potential cross contamination and transmission of disease within the facility. The IPM stated although she was aware the facility humidification system (the part of the heating, ventilation, and air conditioning system that controls humidity) was turned off, she did not perform a risk assessment of each department potentially affected (sterile processing, operating rooms and procedural areas, sterile core (designated area adjacent to the OR to store sterile supplies), and pharmacy) and did not notify the departments of any potential risk. The IPM stated each department had temperature and humidity controls that had to be followed to maintain the integrity and sterility of supplies and medications for the safety of the patients.

During a record review of the IPM employee record on 3/8/23, at 2 p.m., with the Human Resources Partner (HRP), the record indicated the IPM was a registered nurse with CIC (Certification Board of Infection Control and Epidemiology (the branch of medicine which deals with the incidence, distribution, and possible control of diseases and other factors relating to health) certification (the CIC credential identifies health care professionals who have shown mastery and knowledge of infection prevention and control). The certification expired on 4/30/24.


During a review of a document by the Association for Professionals in Infection Control and Epidemiology (APIC the leading professional association for infection preventionists) guidelines for infection prevention and control, undated, the document indicated, " ... certification indicates competence in the actual practice of infection prevention and control and healthcare epidemiology... the certification is intended for individuals who are directly responsible for the infection prevention and control program within their current position ... Infection Preventionists are professionals who make sure healthcare workers and patients are doing all the things they should do to prevent infections."

During a review of the facility's Job Description (JD) "MGR [manager] OF INFECTION PREVENTION", (undated), the JD indicated, " ... Coordinates all infection prevention related activities associated with surveillance, performance improvement, and education which are
intended to ensure that the facilities patients, personnel, and visitors will be protected from transmission of diseases and infection within the facilities environment... Responsible for oversight of daily operations of the infection prevention department and employee health in regard to the facility compliance with hospital accreditation standards, state and CMS regulations... Ongoing assessment and development of programs policies and procedures and forms to address the infection prevention needs of employees, volunteers, contract workers,
independent contractors, physicians, registry workers and students in accordance with the guidelines established by the regulatory agencies..."

During a review of the facility document titled "Infection Prevention and Control Program Plan FY [Fiscal Year] 23", dated 10/22, the document indicated, "The purpose of [name of facility] Infection Prevention (IP) Program is to establish, maintain and insure the implementation of an
IP plan that encompasses all facility departments and involves all employees and care providers in meeting the hospital 's mission of providing quality of care ... the infection preventionist has the responsibility to carry out the daily functions of the IP program and is
appointed by [name of facility] 's governing body... surveillance is an essential component of the infection prevention program at [name of facility] ... surveillance of high risk, high volume, problem prone procedures or health care associated infections [HAI] with potentially
preventable outcomes ...