HospitalInspections.org

Based on observation, review of facility policy and staff interviews, the governing body failed to meet the Condition of Participation for Governing Body by failing to ensure its medical staff followed the Hospital Medical Staff Bylaws when Physician A did not follow facility policy and standards of care. Physician A continuously failed to participate in the "Time Out Process" even after the issue was brought up to administration, which could lead to adverse events up to and including death by not verifying the correct patient, correct procedure, allergies, lab results, and medications.



Refer to A0049

Based on observation, review of facility policy and staff interviews, the governing body failed to ensure its medical staff were accountable for the quality of care provided to patients. The governing Body by failed to ensure its medical staff followed the Hospital Medical Staff Bylaws even after the issue was brought to the attention of hospital administration. Physician A did not follow facility policy and standards of care. Physician A continuously failed to participate in the "Time Out Process" while performing surgical procedures in the Cardiac Cath Lab, which could lead to adverse events up to and including death by not verifying the correct patient, correct procedure, allergies, lab results, and medications.

This deficient practice had the likelihood to cause harm to all patients (31 in the last month) undergoing procedures in the Cardiac Cath Lab performed by Physician A.


Findings include:

Review of the facility policy "NPSG - 006 - Universal Protocol (UHS)" reflected:
"I. Scope:
The Universal Protocol (UP) policy governs the performance of operative and invasive procedures for patients in both the inpatient and outpatient setting. UP consists of three distinct steps: Pre-procedure Verification, Site Marking and Time Out. Operative and invasive procedures are defined as puncture of the skin, instrument insertion, or inserting foreign material into the body ...
II. Purpose:
To establish a standardized policy for identifying the correct patient, procedure and anatomical site/side prior to all operative and invasive procedures that expose patient to more than minimal risk in order to prevent wrong person, wrong site, wrong procedure, and wrong physician events.
III. Policy:
Universal protocol is the process used to identify the correct patient, the correct procedure, the correct physician, and the correct site. Prior to the initiation of an operative or invasive procedure the UP must be followed and documented. The team members providing care for the patient are accountable for patient safety. Missing information or discrepancies are to be resolved by the team during any point of the procedure verification process ...
... E. Time Out Process
A time out is conducted immediately before the start of an operative or invasive procedure to provide a final verification of the patient, site, procedure, and physician ... The time out should be initiated by the person performing the procedure and should include all members of the surgical or procedural teams. All activities will be suspended for the time out unless a threat to patient safety exists. All members of the team will verbally engage in the time out. The time out will be halted if any of the team members are not actively engaged in the process ..."

Review of "The 2021 Society for Cardiovascular Angiography and Interventions (SCAI) Expert Consensus Statement update on best practices in the cardiac catheterization laboratory updates the 2016 document with the latest scientific evidence and recommendations for the consistent delivery of high-quality care" found at https://scai.org/publications/clinical-documents/scai-expert-consensus-update-best-practices-cardiac-catheterization reflected:
"Intra-Procedure Best Practices
...5.6 Universal protocol and 'time out' procedure
All team members should understand the intended procedure and the sequence of that procedure. This should be confirmed during a dedicated 'time out' protocol, performed before vascular access or moderate sedation is initiated, when all members of the team are present... Universal infection precaution protocols should be followed by the staff."

Observation on the afternoon of 11/14/23 reflected Physician A entered the control room of the cardiac catheterization lab. The physician was introduced to this surveyor prior to entering the Cath lab. Upon entrance to the Cath lab, the physician requested a time out prior to the procedure.

Further observation on the afternoon of 11/14/23 reflected the same physician entering the Cath lab without the knowledge that this surveyor was observing. Physician A entered the Cath lab and began putting on his gown and gloves. During this time, the Cath lab staff conducted the time out without Physician A's participation.

Following the procedure, Physician A was asked why he did not participate in the time out during the previous procedure and replied, "I did participate, I can do more than one thing at a time, and I was listening. I do not have to stop what I am doing and face the staff during the time out." When asked about the facility policy and standards of care related to the time out, Physician A replied "I have been doing this for over 30 years and have never had a poor outcome, so I don't need to change what I have been doing. If you are telling me that I have to do it differently, then tell me what to do and I will do it."

During an interview with the interim director of the Cath Lab, Staff # 7, on the afternoon of 11/14/23, Staff #7 reported that Physician A does not participate in the time out, but the staff complete a time out prior to each procedure. When asked if this has been addressed, Staff #7 reported that "it has been an issue for a long time and it has never been resolved." Staff #7 continued that "there was a meeting several months ago with the Assistant Administrator, Former Director of the Cath Lab, CFO (Chief Financial Officer), HR (Human Resources) Director, Regional VP (Vice President), and me and there was no resolution at that time."

During a telephone interview with the former Director of the Cath Lab, Staff #8, on the morning of 11/15/2023, he reported that he reported Physician A's refusal to participate in the time out multiple times to hospital administration. At one point he was told by the Regional VP (Staff #9) to just stop reporting.

During an interview on the afternoon of 11/15/23 the Director of Human Resources (Staff#4) reported that he was in the meeting related to the Cath Lab and that the Regional VP (Staff #9) reported "We, meaning administration, would take care of the physicians."

During a telephone interview on the afternoon of 11/14/23, the Regional VP (Staff #9) denied remembering this meeting or conversation.

Review of the facility document titled "Northwest Texas Healthcare System Staff Bylaws" last revised on 01/11/22 stated in part, "Article I,
Purpose:
The Medical Staff of Northwest Texas Healthcare System is established by the Board to assist the Hospital in meeting its mission and to carry out duties assigned to it by the Board in order to enhance the quality and safety of care, treatment, and services provided to patients. The Medical Staff is considered part of the Hospital's Organized Health Care Arrangement.
Article II,
Medical Staff and Membership:
2.3 Responsibilities of Membership
Each Member of the Medical Staff must continuously comply with the provisions of these Bylaws, the Ancillary Manuals and Medical Staff Rules, Regulations and Policies ...
Furthermore, each Member of the Medial Staff by accepting Medical Staff appointment agrees: ...n....and compliance with Hospital efforts to meet standards such as those established by the Joint Commission, insurers, Centers for Medicare and Medicaid Services (CMS) and other governmental agencies (e.g. core measures) ...
u. To abide by all local, state and federal laws and regulations, Joint Commission standards, and state licensure and professional review regulations and standards, as applicable to the Member's professional practice ..."

Based on observation, interview, and record review, the facility failed to ensure that patients received care in a safe setting by not addressing Physicians A failure to follow the facility Policy "NPSG 006 - Universal Protocol (UHS)" last revised 03/19/2021.
Physician A continuously failed to participate in the "Time Out Process" even after the issue was brought to the attention to hospital administration, which could lead to adverse events up to and including death by not verifying the correct patient, correct procedure, allergies, lab results, and medications.

This deficient practice had the likelihood to cause harm to all patients (31 in the last month) undergoing procedures in the Cardiac Cath Lab by Physician A.


Findings include:

Review of the facility policy "NPSG - 006 - Universal Protocol (UHS)" reflected:
"I. Scope:
The Universal Protocol (UP) policy governs the performance of operative and invasive procedures for patients in both the inpatient and outpatient setting. UP consists of three distinct steps: Pre-procedure Verification, Site Marking and Time Out. Operative and invasive procedures are defined as puncture of the skin, instrument insertion, or inserting foreign material into the body ...
II. Purpose:
To establish a standardized policy for identifying the correct patient, procedure and anatomical site/side prior to all operative and invasive procedures that expose patient to more than minimal risk in order to prevent wrong person, wrong site, wrong procedure, and wrong physician events.
III. Policy:
Universal protocol is the process used to identify the correct patient, the correct procedure, the correct physician, and the correct site. Prior to the initiation of an operative or invasive procedure the UP must be followed and documented. The team members providing care for the patient are accountable for patient safety. Missing information or discrepancies are to be resolved by the team during any point of the procedure verification process ...
... E. Time Out Process
A time out is conducted immediately before the start of an operative or invasive procedure to provide a final verification of the patient, site, procedure, and physician ... The time out should be initiated by the person performing the procedure and should include all members of the surgical or procedural teams. All activities will be suspended for the time out unless a threat to patient safety exists. All members of the team will verbally engage in the time out. The time out will be halted if any of the team members are not actively engaged in the process ..."

Review of "The 2021 Society for Cardiovascular Angiography and Interventions (SCAI) Expert Consensus Statement update on best practices in the cardiac catheterization laboratory updates the 2016 document with the latest scientific evidence and recommendations for the consistent delivery of high-quality care" found at https://scai.org/publications/clinical-documents/scai-expert-consensus-update-best-practices-cardiac-catheterization reflected:
"Intra-Procedure Best Practices
...5.6 Universal protocol and 'time out' procedure
All team members should understand the intended procedure and the sequence of that procedure. This should be confirmed during a dedicated 'time out' protocol, performed before vascular access or moderate sedation is initiated, when all members of the team are present... Universal infection precaution protocols should be followed by the staff."

Observation on the afternoon of 11/14/23 reflected Physician A entered the control room of the cardiac catheterization lab. The physician was introduced to this surveyor prior to entering the Cath lab. Upon entrance to the Cath lab, the physician requested a time out prior to the procedure.

Further observation on the afternoon of 11/14/23 reflected the same physician entered the Cath lab without the knowledge that this surveyor was observing. Physician A entered the Cath lab and began putting on his gown and gloves. During this time, the Cath lab staff conducted the time out without Physician A's participation.

Following the procedure, Physician A was asked why he did not participate in the time out during the previous procedure and replied, "I did participate, I can do more than one thing at a time, and I was listening. I do not have to stop what I am doing and face the staff during the time out." When asked about the facility policy and standards of care related to the time out, Physician A replied, "I have been doing this for over 30 years and have never had a poor outcome, so I don't need to change what I have been doing. If you are telling me that I have to do it differently, then tell me what to do and I will do it."

During an interview with the interim director of the Cath Lab, Staff # 7, on the afternoon of 11/14/23, Staff #7 reported that Physician A does not participate in the time out, but the staff complete a time out prior to each procedure. When asked if this has been addressed, Staff #7 reported that "it has been an issue for a long time and it has never been resolved." Staff #7 continued that "there was a meeting several months ago with the Assistant Administrator, Former Director of the Cath Lab, CFO (Chief Financial Officer), HR (Human Resources) Director, Regional VP (Vice President), and me and there was no resolution at that time."

During a telephone interview with the former Director of the Cath Lab, Staff #8, on the morning of 11/15/2023, he reported that he reported Physician A's refusal to participate in the time out multiple times to hospital administration. At one point he was told by the Regional VP (Staff #9) to just stop reporting.

During an interview on the afternoon of 11/15/23 the Director of Human Resources (Staff#4) reported that he was in the meeting related to the Cath Lab and that the Regional VP (Staff #9) reported "We, meaning administration, would take care of the physicians."

During a telephone interview on the afternoon of 11/14/23 the Regional VP (Staff #9) denied remembering this meeting or conversation.

Based on observation, review of facility policy and staff interviews, the governing body failed to ensure its medical staff were accountable for the quality of care provided to patients. The governing Body by failed to ensure its medical staff followed the Hospital Medical Staff Bylaws even after the issue was brought to the attention of hospital administration. Physician A did not follow facility policy and standards of care. Physician A continuously failed to participate in the "Time Out Process" while performing surgical procedures in the Cardiac Cath Lab, which could lead to adverse events up to and including death by not verifying the correct patient, correct procedure, allergies, lab results, and medications.

This deficient practice had the likelihood to cause harm to all patients (31 in the last month) undergoing procedures in the Cardiac Cath Lab performed by Physician A.


Findings include:

Review of the facility policy "NPSG - 006 - Universal Protocol (UHS)" reflected:
"I. Scope:
The Universal Protocol (UP) policy governs the performance of operative and invasive procedures for patients in both the inpatient and outpatient setting. UP consists of three distinct steps: Pre-procedure Verification, Site Marking and Time Out. Operative and invasive procedures are defined as puncture of the skin, instrument insertion, or inserting foreign material into the body ...
II. Purpose:
To establish a standardized policy for identifying the correct patient, procedure and anatomical site/side prior to all operative and invasive procedures that expose patient to more than minimal risk in order to prevent wrong person, wrong site, wrong procedure, and wrong physician events.
III. Policy:
Universal protocol is the process used to identify the correct patient, the correct procedure, the correct physician, and the correct site. Prior to the initiation of an operative or invasive procedure the UP must be followed and documented. The team members providing care for the patient are accountable for patient safety. Missing information or discrepancies are to be resolved by the team during any point of the procedure verification process ...
... E. Time Out Process
A time out is conducted immediately before the start of an operative or invasive procedure to provide a final verification of the patient, site, procedure, and physician ... The time out should be initiated by the person performing the procedure and should include all members of the surgical or procedural teams. All activities will be suspended for the time out unless a threat to patient safety exists. All members of the team will verbally engage in the time out. The time out will be halted if any of the team members are not actively engaged in the process ..."

Review of "The 2021 Society for Cardiovascular Angiography and Interventions (SCAI) Expert Consensus Statement update on best practices in the cardiac catheterization laboratory updates the 2016 document with the latest scientific evidence and recommendations for the consistent delivery of high-quality care" found at https://scai.org/publications/clinical-documents/scai-expert-consensus-update-best-practices-cardiac-catheterization reflected:
"Intra-Procedure Best Practices
...5.6 Universal protocol and 'time out' procedure
All team members should understand the intended procedure and the sequence of that procedure. This should be confirmed during a dedicated 'time out' protocol, performed before vascular access or moderate sedation is initiated, when all members of the team are present... Universal infection precaution protocols should be followed by the staff."

Observation on the afternoon of 11/14/23 reflected Physician A entered the control room of the cardiac catheterization lab. The physician was introduced to this surveyor prior to entering the Cath lab. Upon entrance to the Cath lab, the physician requested a time out prior to the procedure.

Further observation on the afternoon of 11/14/23 reflected the same physician entering the Cath lab without the knowledge that this surveyor was observing. Physician A entered the Cath lab and began putting on his gown and gloves. During this time, the Cath lab staff conducted the time out without Physician A's participation.

Following the procedure, Physician A was asked why he did not participate in the time out during the previous procedure and replied, "I did participate, I can do more than one thing at a time, and I was listening. I do not have to stop what I am doing and face the staff during the time out." When asked about the facility policy and standards of care related to the time out, Physician A replied "I have been doing this for over 30 years and have never had a poor outcome, so I don't need to change what I have been doing. If you are telling me that I have to do it differently, then tell me what to do and I will do it."

During an interview with the interim director of the Cath Lab, Staff # 7, on the afternoon of 11/14/23, Staff #7 reported that Physician A does not participate in the time out, but the staff complete a time out prior to each procedure. When asked if this has been addressed, Staff #7 reported that "it has been an issue for a long time and it has never been resolved." Staff #7 continued that "there was a meeting several months ago with the Assistant Administrator, Former Director of the Cath Lab, CFO (Chief Financial Officer), HR (Human Resources) Director, Regional VP (Vice President), and me and there was no resolution at that time."

During a telephone interview with the former Director of the Cath Lab, Staff #8, on the morning of 11/15/2023, he reported that he reported Physician A's refusal to participate in the time out multiple times to hospital administration. At one point he was told by the Regional VP (Staff #9) to just stop reporting.

During an interview on the afternoon of 11/15/23 the Director of Human Resources (Staff#4) reported that he was in the meeting related to the Cath Lab and that the Regional VP (Staff #9) reported "We, meaning administration, would take care of the physicians."

During a telephone interview on the afternoon of 11/14/23, the Regional VP (Staff #9) denied remembering this meeting or conversation.

Review of the facility document titled "Northwest Texas Healthcare System Staff Bylaws" last revised on 01/11/22 stated in part, "Article I,
Purpose:
The Medical Staff of Northwest Texas Healthcare System is established by the Board to assist the Hospital in meeting its mission and to carry out duties assigned to it by the Board in order to enhance the quality and safety of care, treatment, and services provided to patients. The Medical Staff is considered part of the Hospital's Organized Health Care Arrangement.
Article II,
Medical Staff and Membership:
2.3 Responsibilities of Membership
Each Member of the Medical Staff must continuously comply with the provisions of these Bylaws, the Ancillary Manuals and Medical Staff Rules, Regulations and Policies ...
Furthermore, each Member of the Medial Staff by accepting Medical Staff appointment agrees: ...n....and compliance with Hospital efforts to meet standards such as those established by the Joint Commission, insurers, Centers for Medicare and Medicaid Services (CMS) and other governmental agencies (e.g. core measures) ...
u. To abide by all local, state and federal laws and regulations, Joint Commission standards, and state licensure and professional review regulations and standards, as applicable to the Member's professional practice ..."

Based on observation, review of facility policy and staff interviews, the governing body failed to ensure its medical staff were accountable for the quality of care provided to patients. The governing Body by failed to ensure its medical staff followed the Hospital Medical Staff Bylaws even after the issue was brought to the attention of hospital administration. Physician A did not follow facility policy and standards of care. Physician A continuously failed to participate in the "Time Out Process" while performing surgical procedures in the Cardiac Cath Lab, which could lead to adverse events up to and including death by not verifying the correct patient, correct procedure, allergies, lab results, and medications.

This deficient practice had the likelihood to cause harm to all patients (31 in the last month) undergoing procedures in the Cardiac Cath Lab performed by Physician A.


Findings include:

Review of the facility policy "NPSG - 006 - Universal Protocol (UHS)" reflected:
"I. Scope:
The Universal Protocol (UP) policy governs the performance of operative and invasive procedures for patients in both the inpatient and outpatient setting. UP consists of three distinct steps: Pre-procedure Verification, Site Marking and Time Out. Operative and invasive procedures are defined as puncture of the skin, instrument insertion, or inserting foreign material into the body ...
II. Purpose:
To establish a standardized policy for identifying the correct patient, procedure and anatomical site/side prior to all operative and invasive procedures that expose patient to more than minimal risk in order to prevent wrong person, wrong site, wrong procedure, and wrong physician events.
III. Policy:
Universal protocol is the process used to identify the correct patient, the correct procedure, the correct physician, and the correct site. Prior to the initiation of an operative or invasive procedure the UP must be followed and documented. The team members providing care for the patient are accountable for patient safety. Missing information or discrepancies are to be resolved by the team during any point of the procedure verification process ...
... E. Time Out Process
A time out is conducted immediately before the start of an operative or invasive procedure to provide a final verification of the patient, site, procedure, and physician ... The time out should be initiated by the person performing the procedure and should include all members of the surgical or procedural teams. All activities will be suspended for the time out unless a threat to patient safety exists. All members of the team will verbally engage in the time out. The time out will be halted if any of the team members are not actively engaged in the process ..."

Review of "The 2021 Society for Cardiovascular Angiography and Interventions (SCAI) Expert Consensus Statement update on best practices in the cardiac catheterization laboratory updates the 2016 document with the latest scientific evidence and recommendations for the consistent delivery of high-quality care" found at https://scai.org/publications/clinical-documents/scai-expert-consensus-update-best-practices-cardiac-catheterization reflected:
"Intra-Procedure Best Practices
...5.6 Universal protocol and 'time out' procedure
All team members should understand the intended procedure and the sequence of that procedure. This should be confirmed during a dedicated 'time out' protocol, performed before vascular access or moderate sedation is initiated, when all members of the team are present... Universal infection precaution protocols should be followed by the staff."

Observation on the afternoon of 11/14/23 reflected Physician A entered the control room of the cardiac catheterization lab. The physician was introduced to this surveyor prior to entering the Cath lab. Upon entrance to the Cath lab, the physician requested a time out prior to the procedure.

Further observation on the afternoon of 11/14/23 reflected the same physician entering the Cath lab without the knowledge that this surveyor was observing. Physician A entered the Cath lab and began putting on his gown and gloves. During this time, the Cath lab staff conducted the time out without Physician A's participation.

Following the procedure, Physician A was asked why he did not participate in the time out during the previous procedure and replied, "I did participate, I can do more than one thing at a time, and I was listening. I do not have to stop what I am doing and face the staff during the time out." When asked about the facility policy and standards of care related to the time out, Physician A replied "I have been doing this for over 30 years and have never had a poor outcome, so I don't need to change what I have been doing. If you are telling me that I have to do it differently, then tell me what to do and I will do it."

During an interview with the interim director of the Cath Lab, Staff # 7, on the afternoon of 11/14/23, Staff #7 reported that Physician A does not participate in the time out, but the staff complete a time out prior to each procedure. When asked if this has been addressed, Staff #7 reported that "it has been an issue for a long time and it has never been resolved." Staff #7 continued that "there was a meeting several months ago with the Assistant Administrator, Former Director of the Cath Lab, CFO (Chief Financial Officer), HR (Human Resources) Director, Regional VP (Vice President), and me and there was no resolution at that time."

During a telephone interview with the former Director of the Cath Lab, Staff #8, on the morning of 11/15/2023, he reported that he reported Physician A's refusal to participate in the time out multiple times to hospital administration. At one point he was told by the Regional VP (Staff #9) to just stop reporting.

During an interview on the afternoon of 11/15/23 the Director of Human Resources (Staff#4) reported that he was in the meeting related to the Cath Lab and that the Regional VP (Staff #9) reported "We, meaning administration, would take care of the physicians."

During a telephone interview on the afternoon of 11/14/23, the Regional VP (Staff #9) denied remembering this meeting or conversation.

Review of the facility document titled "Northwest Texas Healthcare System Staff Bylaws" last revised on 01/11/22 stated in part, "Article I,
Purpose:
The Medical Staff of Northwest Texas Healthcare System is established by the Board to assist the Hospital in meeting its mission and to carry out duties assigned to it by the Board in order to enhance the quality and safety of care, treatment, and services provided to patients. The Medical Staff is considered part of the Hospital's Organized Health Care Arrangement.
Article II,
Medical Staff and Membership:
2.3 Responsibilities of Membership
Each Member of the Medical Staff must continuously comply with the provisions of these Bylaws, the Ancillary Manuals and Medical Staff Rules, Regulations and Policies ...
Furthermore, each Member of the Medial Staff by accepting Medical Staff appointment agrees: ...n....and compliance with Hospital efforts to meet standards such as those established by the Joint Commission, insurers, Centers for Medicare and Medicaid Services (CMS) and other governmental agencies (e.g. core measures) ...
u. To abide by all local, state and federal laws and regulations, Joint Commission standards, and state licensure and professional review regulations and standards, as applicable to the Member's professional practice ..."