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Based on observation, interview and record review the facility failed to ensure 1 (Patient #1) of 16 patients sampled had the correct surgical procedure performed at the correct site. The facility failed to ensure the patient had an adequate update to the history and physical (refer to A952). The facility staff failed to follow policy in identifying the site of the procedure during the time-out before the procedure was started (refer to A951). The wrong site was operated on, and the wrong procedure was performed. As a result, Patient #1 suffered risks of anesthesia, the potential for infection, and continues with the risk of an unrepaired hernia. The failure to maintain their preoperative protocols and failure to correct the disregard of their protocols pose a threat of Immediate Jeopardy for any patient having a similar hernia repair. The potential for harm or death due to the risk of anesthesia and the potential for infection.
The cumulative effect of these systemic failures represents the facility's inability to safely provide surgical services to all patients.
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Based on observation, interview, and record review the facility failed to ensure 1 (Patient #1) of 16 patients sampled had the correct surgical procedure performed at the correct site. Contrary to the facility's policy, the procedure is being exempted from having the surgical site marked. The facility staff failed to follow policy in identifying the site of the procedure during the time-out before the procedure was started. The wrong site was operated on, and the wrong procedure was performed. As a result, Patient #1 suffered risks of anesthesia, the potential for infection, and continues with the risk of an unrepaired hernia. Some 3 months after the incident, the facility has made little effort to correct the disregard of their protocols that resulted in a wrong site surgery. The failure to maintain their preoperative protocol and failure to correct the disregard of their protocols pose a threat of Immediate Jeopardy for any patient having a similar hernia repair with a potential for harm or death due to the risk of anesthesia, the potential for infection, and unnecessary surgery.

Findings include:

1. Patient #1 is a 74-year-old-male patient who was admitted to the facility on 3/20/14 with a Ventral Hernia. A Ventral Hernia is a bulging of the abdominal wall, often at the midline. However, it can occur at any location on the abdominal wall (source: Healthline.com).

Review of the consent for surgery reads, "Repair Ventral Hernia with mesh." The consent was signed 2/26/14. The exact location of the hernia was not specified on the consent.
The surgical report of 3/20/14 for Patient #1 includes:
Preoperative Diagnosis: Ventral Hernia.
Procedure Description: After the patient identified by name for a Ventral Hernia Repair, birth date of (birth date), he was given general anesthesia via endotracheal intubation. His abdomen was prepped and draped in the usual manner. An incision was made over the midline below the umbilicus for about 3 fingerbreadths, carried down to the skin and subcutaneous tissue. The area of firmness and nodularity which is in the right side was then dissected out and appeared to be just some fatty tissue but no evidence of a Ventral Hernia defect. I inspected laterally, and I also inspected down further inferiorly. Still the fascia was intact with no defect whatsoever ..."
Postoperative Diagnosis: Soft-tissue mass, probable lipoma (a common benign tumor composed of body fat).

A telephone interview was conducted on 7/2/14 at 4:08 p.m., by agency surveyor and senior clerk with Patient #1. The patient said in March he had gone to see the doctor about a hernia that was above (the navel) and to the right. The patient said you could see it. The doctor examined him in the office on 3/20/14 and told the patient he would operate to repair the hernia. After the surgery, the doctor told the patient's daughter that he didn't have a hernia; he had a mass. The doctor called it a lipoma. The patient said the doctor opened the wrong place. Right after the surgery the patient was aware he still had a hernia.

Patient #1 said he went to see the doctor 5 days later (after the surgery). He was surprised when the doctor told him he didn't have a hernia. He said he wondered why the doctor didn't find the hernia. He said the hospital was aware the doctor made a mistake. Because of this, he feels that patients are at risk.

In a telephone interview conducted on 7/2/14 at 1:00 p.m., the physician who performed Patient #1's surgery said he thought he had a fool-proof system to prevent such an incident from occurring. He stated he had assessed the patient in his office as having an above the umbilicus (navel) Ventral Hernia. He stated when he completed the H&P (history and physical), he mistakenly documented the hernia to be below the umbilicus. He said he never assessed the patient before the surgery because staff came to him and told him a room was open. He told staff it was okay to move the patient to the OR (operating room).
He stated when he got to the OR the patient was already asleep. He said he went by his H&P and performed the surgery below the umbilicus. He said he found out days later when the patient came to his office for a follow-up. He said the patient told him he still had a hernia. He told the patient he had made a mistake. He reported the issue to the hospital medical director at that time. He said risk management was made aware within days of the surgery.

During a second telephone interview on 7/2/14 at 4:00 p.m., Patient #1's surgeon was asked what he would do in the future to prevent a similar incident from occurring. He stated he would ensure that he assessed the patient and marked the site prior to the patient being moved to the operating room. He said this was his normal process. He explained, "The OR was busy on that day."

During an observation on 7/2/14 at 11:00 a.m., staff were waiting for the surgeon to come to a patient who was to have a right inguinal (groin area) hernia repair with mesh. At 11:10 a.m., the surgeon assessed the patient having the procedure and marked the site where the surgery was to be performed.

In an interview on 7/2/14 at 11:20 a.m., pre-op nurse Staff E said the policy of the facility is to have the surgeon mark the site before moving the patient to the operating room. Once in the operating room there is a time-out. During this time-out all members of the operating team stop what they are doing and verify the correct patient, procedure, and site before proceeding with the surgery.

Facility Policy #737 'Procedure Verification Process (Pre-Verification, Site Marking, Time-Out)', Chapter M03-05, revised 1/13, contained:

" I. The three components of the procedure verification process include pre-procedure verification, site marking and time-out. When combined, they comprise the process for enhancing safety by correctly identifying the patient, the appropriate procedure and the correct site of the procedure.
Policy Exclusions:
Non-consented procedures ...

A. Pre-procedure Verification Process
1. The Pre-procedure Verification is an ongoing process of information gathering and confirmation to make sure documents and related information are: ...
c. Reviewed and are consistent with the patient ' s expectations and with the teams understanding of the untended patient, procedure and site ...

B. Marking the Site ....
3. Applicable surgical/nonsurgical sites will be marked by a licensed independent practitioner (LIP) who is ultimately accountable for the procedure and will be present when the procedure is performed ...

C. Time Out
1. The final verification of the correct patient, procedure and site is conducted immediately before starting the procedure or making the incision.
2. Active Time Out - An Active Time Out includes verbal communication and visual confirmation among all members of the surgical/procedure team. This includes the verification of the patient, procedure and site with supporting documentation and images.
3. The procedure is not started until any questions or concerns are resolved.

II. PROCEDURE VERIFICATIONS REQUIREMENTS

A. Requirements for Pre-Procedure Verifications
Surgical and nonsurgical procedures that require informed consent, including procedures done in settings other than the operating room, ...

B. Requirements for site marking
1. The method of marking the site is unambiguous (clearly expressed or understood) and is consistently used throughout the organization. The mark:
a. Is made near the site. Includes the initials of the person marking the site ...
2. Sites are marked when there is more than one possible location for the procedure and when performing the procedure in a different location would negatively affect the quality or safety. Examples include:
a. Right or left distinction (laterally);
b. Medial or lateral distinction (i.e. knee arthroplasty site can be medial or lateral) ...
f. Surface sites with multiple wounds or lesions that will require treatment of only ' some ' of the lesions; ...
3. Procedures that are exempt from site marking include:
a. Single organ cases (except craniotomies)
b. Mid-line sternotomies for open-heart surgeries;
c. Cesarean birth procedures;
d. Situations where marking the site would be technically or anatomically impossible; and
e. Sites involving an obvious wound or lesion that is the site of the intended procedure.
f. Procedures completed under direct radiographic visualization.
g. Interventional cases for which the catheter/instrument insertion site is not pre-determined (i.e., cardiac catheterization, central lines)...

C. Requirements for "Time Out"
Consented procedures completed in locations outlined in this policy require an active time-out.

PROCEDURE:

I. SURGICAL PROCEDURAL VERIFICATION PROCESS (OR, Endoscopy, Interventional Radiology, Cardiac Cath Lab and Endovascular Lab)

A. Pre-Procedure Verification Process
1. Verify correct patient per policy S0 305 708 Patient Identification, procedure, and site with patient, parent, or designee, prior to any invasive procedure, including those that do not require surgical site marking ...

B. Marking the Site
1. Site Marking will be done only when all documentation has been reconciled and prior to moving the patient into the room where the procedure will be done. The physician performing the procedure... will review the documentation prior to marking the site. If possible, the site will be marked with the patient's involvement in an effort to promote meaningful patient involvement ...
5. If any discrepancy in the site verification process exists, the procedure must be delayed until a resolution is reached. The following process for reconciling difference is initiated:
a. Safely STOP further progression of procedure.
b. Circulating nurse will review areas of discrepancy with the surgeon ...

C. Time Out
Immediately prior to the start of the procedure, with the patient in the proper position for the procedure and draped, the circulating team member will initiate and complete the
'Time Out' process with the physician and the immediate members of the procedural team who will be participating in the procedure. This process will be done in the location where the procedure is to be performed, using active verbal communication and visual confirmation between all team members to verify at a minimum:
a. Correct patient identity per policy ...;
b. Confirmation of correct site;
c. Agreement on the procedure being done."

In an interview on 7/2/14 at 2:40 p.m., Staff A, the pre-op nurse for Patient #1 stated she had worked for the facility since 2007. She stated she used an interpreter to speak with patient #1 before the procedure and verified with the patient he was having a Ventral Hernia Repair. She stated they do not mark Ventral Hernias because they usually protrude and are visible. She stated ventral hernias are always above the umbilicus.

In an interview on 7/2/14 at 12:10 p.m., the nurse manager of the OR, Staff I said Ventral Hernias are not marked because there are no lateral distinctions. The policy was reviewed with the nurse manager at that time. She was not able to show that the policy exempted Ventral Hernias from marking.

Review of the surgical schedule for 7/2/14 shows Patient #14 was scheduled for "Hernia Repair Ventral with Mesh." Review of the "Universal Protocol" shows the nurse marked the procedure as exempt from being marked. This shows staff continuing to make this procedure exempt from marking.

In an interview on 7/2/14 at 12:05 p.m., risk manager Staff G said after the investigation, it was determined the policy was not clear and that all Ventral Hernias should be marked. She stated she sent the issue to quality improvement. She stated, "As of today (7/2/14) there has been no changes in the policy."

In an interview on 7/2/14 at 2:05 p.m., the director of surgical services for the facility said staff do not ensure Ventral Hernias are marked because they are not seen as right or left. She said policy states they are exempt. She was not able to show that the policy exempted Ventral Hernias from marking. When asked what has been done in the surgical department since this issue occurred, she responded she was aware the issue had been reported to the state. She stated, "I was not aware that we had done anything wrong." She said she had used the incident in a staff meeting with staff as a safety story. She did not document this and did not know what was said during this meeting. She said after this interview she would ensure that all Ventral Hernia procedures were marked before they were moved to the operating room.

In a telephone interview on 7/3/14 at 10:01 a.m., the director of surgical services for the health system said he was made aware of the issue in March when it occurred. He said there has been discussion of changing the policy to mark all Ventral Hernias in the future. He said this will go before the Surgical Service Counsel in July of 2014. When asked what would happen if someone came in the OR today, he responded, "Based on this conversation all surgical directors will be made aware of this today. There is no reason why we cannot move forward with this." He said the policies would be reviewed within the next two weeks.

In an interview on 7/3/14 at 12:16 p.m., registered nurse Staff D said she documented on the "Universal Protocol" that Patient #1 was exempt from being marked. She said she interpreted the policy to be because the Ventral Hernia was not left or right, he was exempt from being marked. She stated, "That is the way all the nurses have interpreted the policy."

During an interview on 7/3/14 at 2:35 p.m., registered nurse Staff B confirmed he was the circulating nurse for Patient #1 ' s surgery. He stated he didn't remember what occurred on the date the procedure was performed. He was asked about the process for "Time-Out" and his role. He stated, "The circulating nurse reads off the consent and from the chart they verify the patient, procedure, and the site." When asked how he verified the site, he stated, "By reading off the procedure from the consent."

During an observation on 7/2/14 at 11:15 a.m., the preoperative area had a large video monitor used as a status board for the patients going to the OR. Pre-op nurse Staff A looked on the status board and was able to tell that the anesthesiologist had not yet seen a patient before surgery.
In an interview at 11:49 a.m., the pre-op nurse said she was not aware when the physician sees the patient. She stated, "There is no way to monitor that." She explained the status board will let you know when the anthologist sees the patient but not the surgeon. She does not know why it does not show when the surgeon sees the patient. She states she was not aware Patient #1 went to the OR without being assessed by the surgeon.

On 7/3/14, the facility issued a memorandum to surgical staff services. The memorandum reviews the current policy in place with the facility. There is no mention of Ventral Hernias in the document.

During an interview on 7/3/14 at 8:44 a.m., the medical staff services director was asked about concerns that nursing will continue to exempt the procedure from marking. She said after the July 27th meeting any nursing issues will be referred back to the proper nursing supervisors.
In an interview on 7/3/14 at 10:30 a.m., when asked about Ventral Hernias not being mentioned in the memorandum, Staff F stated, "We are waiting for the policy to be reviewed."
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Based on interview and record review, the facility failed to ensure an updated physical examination was completed within 24 hours by the physician performing a Ventral Hernia Repair for 1 patient (Patient #1) of 16 patients sampled. Patient #1 was moved to the operating room before physician checked or marked the site of the procedure. As a result, the wrong site operated on and the wrong procedure being performed. As a result, Patient #1 suffered risks of anesthesia, the potential for infection, and continues with the risk of an unrepaired hernia. Marking the site provides a safety check that the physician performed a recent physical examination or update. The facility's policy on history and physical updated was not followed for Patient #1. Likewise, the site marking related to the update was not being followed for other patients with Ventral Hernias. This failure to follow procedures poses a threat of Immediate Jeopardy for any patient having a similar hernia repair with a potential for harm or death due to the risk of anesthesia and the potential for infection.

Findings include:

1. Patient #1 is a 74-year-old-male patient who was admitted to the facility on 3/20/14 with a Ventral Hernia. A Ventral Hernia is a bulging of the abdominal wall, often at the midline. However, it can occur at any location on the abdominal wall (source: Healthline.com).

Review of the consent for surgery reads, "Repair Ventral Hernia with Mesh." The consent was signed 2/26/14. The exact location of the hernia was not specified on the consent.
The surgical report of 3/20/14 for Patient #1 includes:
Preoperative Diagnosis: Ventral Hernia.
Procedure Description: After the patient identified by name for a Ventral Hernia Repair, birth date of (birth date), he was given general anesthesia via endotracheal intubation. His abdomen was prepped and draped in the usual manner. An incision was made over the midline below the umbilicus for about 3 fingerbreadths, carried down to the skin and subcutaneous tissue. The area of firmness and nodularity which is in the right side was then dissected out and appeared to be just some fatty tissue but no evidence of a ventral hernia defect. I inspected laterally, and I also inspected down further inferiorly. Still the fascia was intact with no defect whatsoever ..."
Postoperative Diagnosis: Soft-tissue mass, probable lipoma.

A telephone interview was conducted on 7/2/14 at 4:08 p.m. by agency surveyor and senior clerk with Patient #1. The patient said in March he had gone to see the doctor about a hernia that was above (the navel) and to the right. The patient said you could see it. The doctor examined him in the office on 3/20/14 and told the patient he would operate to repair the hernia. After the surgery, the doctor told the patient's daughter that he didn't have a hernia; he had a mass. The doctor called it a lipoma (a common benign tumor composed of body fat). The patient said the doctor opened the wrong place. Right after the surgery the patient was aware he still had a hernia.
Patient #1 said he went to see the doctor 5 days later (after the surgery). He was surprised when the doctor told him he didn't have a hernia. He said he wondered why the doctor didn't find the hernia. He said the hospital was aware the doctor made a mistake. Because of this, he feels that patients are at risk.

In a telephone interview conducted on 7/2/14 at 1:00 p.m., the physician who performed Patient #1's surgery said he thought he had a fool-proof system to prevent such an incident from occurring. He stated he had assessed the patient in his office as having an above the umbilicus (navel) ventral hernia. He stated when he completed the H&P (history and physical); he mistakenly documented the hernia to be below the umbilicus. He said he never assessed the patient before the surgery because staff came to him and told him a room was open. He told staff it was ok to move the patient to the OR (operating room). He stated when he got to the OR the patient was already asleep. He said he went by his H&P and performed the surgery below the umbilicus. He said he found out days later when the patient came to his office for a follow-up. He said the patient told him he still had a hernia. He told the patient he had made a mistake. He reported the issue to the hospital medical director at that time. He said Risk Management was made aware within days of the surgery.

Facility policy #428 " Interdisciplinary Patient Assessment/Reassessment " , Chapter M02-01, revised 4/14, contained:
" POLICY:
A. The assessment process will be a continuous, collaborative effort with all departments functioning as a team ...
D. A physician shall perform a written medical history and physical within 30 days and the history and physical must be updated within 24 hours of admission and prior to surgery ...
PROCEDURE:
D. Scope and Responsibilities of Involved Disciplines / Departments
1. Medical Staff Responsibilities: A member of the medical staff will be responsible for the medical care and treatment for each patient, including completion of a history and physical, according to Medical Staff Rules and Regulations.
a. A physician shall perform a written medical history and physical within 30 days and the history and physical must be updated within 24 hours of admission and prior to surgery. The scope of the history and physical includes:
Chief complaint.
Details of present illness.
Relevant past psychological and family histories.
Review of body system.
Physical Examination ..."

During a second telephone interview on 7/2/14 at 4:00 p.m., Patient #1's surgeon was asked what he would do in the future to prevent a similar incident from occurring. He stated he would ensure that he assessed the patient and marked the site prior to the patient being moved to the operating room. He said this was his normal process. He explained, "The OR was busy on that day."

During an observation on 7/2/14 at 11:00 a.m., staff were waiting for the surgeon to come to a patient who was to have a right inguinal (groin area) hernia repair with mesh. At 11:10 a.m., the surgeon assessed the patient having the procedure and marked the site where the surgery was to be performed.


2. Facility policy #737 'Procedure Verification Process (Pre-Verification, Site Marking, Time-Out)', Chapter M03-05, revised 1/13, contained:
" I. The three components of the procedure verification process include pre-procedure verification, site marking and time-out. When combined, they comprise the process for enhancing safety by correctly identifying the patient, the appropriate procedure and the correct site of the procedure.
Policy Exclusions:
Non-consented procedures ...
A. Pre-procedure Verification Process
1. The pre-procedure verification is an ongoing process of information gathering and confirmation to make sure documents and related information are: ...
c. Reviewed and are consistent with the patient ' s expectations and with the teams understanding of the untended patient, procedure and site ...
B. Marking the Site ....
3. Applicable surgical/nonsurgical sites will be marked by a licensed independent practitioner (LIP) who is ultimately accountable for the procedure and will be present when the procedure is performed ...
C. Time Out
1. The final verification of the correct patient, procedure and site is conducted immediately before starting the procedure or making the incision.
2. Active Time Out - An Active Time Out includes verbal communication and visual confirmation among all members of the surgical/procedure team. This includes the verification of the patient, procedure and site with supporting documentation and images.
3. The procedure is not started until any questions or concerns are resolved.
II. PROCEDURE VERIFICATIONS REQUIREMENTS
A. Requirements for Pre-Procedure Verifications
Surgical and nonsurgical procedures that require informed consent, including procedures done in settings other than the operating room, ...
B. Requirements for site marking
1. The method of marking the site is unambiguous (clearly expressed or understood) and is consistently used throughout the organization. The mark:
a. Is made near the site. Includes the initials of the person marking the site ...
2. Sites are marked when there is more than one possible location for the procedure ...
C. Requirements for " Time Out "
Consented procedures completed in locations outlined in this policy require an active time-out.
PROCEDURE:
I. SURGICAL PROCEDURAL VERIFICATION PROCESS (OR, Endoscopy, Interventional Radiology, Cardiac Cath Lab and Endovascular Lab)
A. Pre-procedure Verification Process
1. Verify correct patient per policy S0 305 708 Patient Identification, procedure, and site with patient, parent, or designee, prior to any invasive procedure, including those that do not require surgical site marking ...
B. Marking the Site
1. Site Marking will be done only when all documentation has been reconciled and prior to moving the patient into the room where the procedure will be done. The physician performing the procedure... will review the documentation prior to marking the site. If possible, the site will be marked with the patient's involvement in an effort to promote meaningful patient involvement ...
5. If any discrepancy in the site verification process exists, the procedure must be delayed until a resolution is reached. The following process for reconciling difference is initiated:
a. Safely STOP further progression of procedure.
b. Circulating nurse will review areas of discrepancy with the surgeon ...
C. Time out
Immediately prior to the start of the procedure, with the patient in the proper position for the procedure and draped, the circulating team member will initiate and complete the 'Time Out' process with the physician and the immediate members of the procedural team who will be participating in the procedure. This process will be done in the location where the procedure is to be performed, using active verbal communication and visual confirmation between all team members to verify at a minimum:
a. Correct patient identity per policy ...;
b. Confirmation of correct site;
c. Agreement on the procedure being done."

During an observation on 7/2/14 at 11:15 a.m., the preoperative area had a large video monitor used as a status board for the patients going to the OR. Pre-Op Nurse Staff A looked on the status board and was able to tell that the anesthesiologist had not yet seen a patient before surgery.
In an interview at 11:49 a.m., the Pre Op Nurse said she was not aware when the physician sees the patient. She stated, "There is no way to monitor that." She explained the status board will let you know when the anthologist sees the patient but not the surgeon. She does not know why it does not show when the surgeon sees the patient. She states she was not aware Patient #1 went to the OR without being assessed by the surgeon.

Review of the surgical schedule for 7/2/14 shows Patient #14 was scheduled for "hernia repair ventral with mesh". Review of the "Universal Protocol" shows the nurse marked the procedure as exempt from being marked. This shows staff continuing to make this procedure exempt from marking.

In an interview on 7/2/14 at 12:05 p.m., Risk Manager Staff G said after the investigation, it was determined the policy was not clear and that all ventral hernias should be marked. She stated she sent the issue to Quality Improvement. She stated, "As of today (7/2/14) there has been no changes in the policy."

In an interview on 7/2/14 at 2:05 p.m., the Director of Surgical Services for the facility said staff do not ensure ventral hernias are marked because they are not seen as right or left. She said policy states they are exempt. She was not able to show that the policy exempted ventral hernias from marking. When asked what has been done in the surgical department since this issue occurred, she responded she was aware the issue had been reported to the state. She stated, "I was not aware that we had done anything wrong." She said she had used the incident in a staff meeting with staff as a safety story. She did not document this and did not know what was said during this meeting. She said after this interview she would ensure that all ventral hernia procedures were marked before they were moved to the operating room.

In a telephone interview on 7/3/14 at 10:01 a.m., the Director of Surgical Services for the health system said he was made aware of the issue in March when it occurred. He said there has been discussion of changing the policy to mark all ventral hernias in the future. He said this will go before the Surgical Service Counsel in July of 2014. When asked what would happen if someone came in the OR today, he responded, "Based on this conversation all surgical directors will be made aware of this today. There is no reason why we cannot move forward with this." He said the policies would be reviewed within the next two weeks.

In an interview on 7/3/14 at 12:16 p.m., Registered Nurse Staff D said she documented on the "Universal Protocol" that Patient #1 was exempt from being marked. She said she interpreted the policy to be because the ventral hernia was not left or right, he was exempt from being marked. She stated, "That is the way all the nurses have interpreted the policy."

During an interview on 7/3/14 at 2:35 p.m., Registered Nurse Staff B confirmed he was the circulating nurse for Patient #1's surgery. He stated he didn't remember what occurred on the date the procedure was performed. He was asked about the process for "Time-Out" and his role. He stated, "The circulating nurse reads off the consent and from the chart they verify the patient, procedure, and the site." When asked how he verified the site, he stated, "By reading off the procedure from the consent."

During an observation on 7/2/14 at 11:15 a.m., the preoperative area had a large video monitor used as a status board for the patients going to the OR. Pre-Op Nurse Staff A looked on the status board and was able to tell that the anesthesiologist had not yet seen a patient before surgery.
In an interview at 11:49 a.m., the Pre Op Nurse said she was not aware when the physician sees the patient. She stated, "There is no way to monitor that." She explained the status board will let you know when the anthologist sees the patient but not the surgeon. She does not know why it does not show when the surgeon sees the patient. She states she was not aware Patient #1 went to the OR without being assessed by the surgeon.

On 7/3/14 the Facility issued a memorandum to surgical staff services. The memorandum reviews the current policy in place with the facility. There is no mention of ventral hernias in the document.
In an interview on 7/3/14 at 10:30 a.m., when asked about ventral hernias not being mentioned in the memorandum, Staff F stated, "We are waiting for the policy to be reviewed."
During an interview on 7/3/14 at 8:44 a.m., the Medical Staff Services Director verified that on 5/13/14 she received a peer review referral from Risk Management regarding a wrong procedure. She stated, "It went before Physician Quality Committee on 5/27/14. We at that time requested a response letter from the physician. She said the Committee will be reviewing the incident on 7/27/14. She was told that the physician had stated the patient had been moved before the site was marked for surgery. She was asked about concerns nursing will continue to exempt the procedure from marking. She said after the July 27th meeting any nursing issues will be referred back to the proper nursing supervisors.

Based on observation, interview, and record review the facility failed to ensure 1 (Patient #1) of 16 patients sampled had the correct surgical procedure performed at the correct site. Contrary to the facility's policy, the procedure is being exempted from having the surgical site marked. The facility staff failed to follow policy in identifying the site of the procedure during the time-out before the procedure was started. The wrong site was operated on, and the wrong procedure was performed. As a result, Patient #1 suffered risks of anesthesia, the potential for infection, and continues with the risk of an unrepaired hernia. Some 3 months after the incident, the facility has made little effort to correct the disregard of their protocols that resulted in a wrong site surgery. The failure to maintain their preoperative protocol and failure to correct the disregard of their protocols pose a threat of Immediate Jeopardy for any patient having a similar hernia repair with a potential for harm or death due to the risk of anesthesia, the potential for infection, and unnecessary surgery.

Findings include:

1. Patient #1 is a 74-year-old-male patient who was admitted to the facility on 3/20/14 with a Ventral Hernia. A Ventral Hernia is a bulging of the abdominal wall, often at the midline. However, it can occur at any location on the abdominal wall (source: Healthline.com).

Review of the consent for surgery reads, "Repair Ventral Hernia with mesh." The consent was signed 2/26/14. The exact location of the hernia was not specified on the consent.
The surgical report of 3/20/14 for Patient #1 includes:
Preoperative Diagnosis: Ventral Hernia.
Procedure Description: After the patient identified by name for a Ventral Hernia Repair, birth date of (birth date), he was given general anesthesia via endotracheal intubation. His abdomen was prepped and draped in the usual manner. An incision was made over the midline below the umbilicus for about 3 fingerbreadths, carried down to the skin and subcutaneous tissue. The area of firmness and nodularity which is in the right side was then dissected out and appeared to be just some fatty tissue but no evidence of a Ventral Hernia defect. I inspected laterally, and I also inspected down further inferiorly. Still the fascia was intact with no defect whatsoever ..."
Postoperative Diagnosis: Soft-tissue mass, probable lipoma (a common benign tumor composed of body fat).

A telephone interview was conducted on 7/2/14 at 4:08 p.m., by agency surveyor and senior clerk with Patient #1. The patient said in March he had gone to see the doctor about a hernia that was above (the navel) and to the right. The patient said you could see it. The doctor examined him in the office on 3/20/14 and told the patient he would operate to repair the hernia. After the surgery, the doctor told the patient's daughter that he didn't have a hernia; he had a mass. The doctor called it a lipoma. The patient said the doctor opened the wrong place. Right after the surgery the patient was aware he still had a hernia.

Patient #1 said he went to see the doctor 5 days later (after the surgery). He was surprised when the doctor told him he didn't have a hernia. He said he wondered why the doctor didn't find the hernia. He said the hospital was aware the doctor made a mistake. Because of this, he feels that patients are at risk.

In a telephone interview conducted on 7/2/14 at 1:00 p.m., the physician who performed Patient #1's surgery said he thought he had a fool-proof system to prevent such an incident from occurring. He stated he had assessed the patient in his office as having an above the umbilicus (navel) Ventral Hernia. He stated when he completed the H&P (history and physical), he mistakenly documented the hernia to be below the umbilicus. He said he never assessed the patient before the surgery because staff came to him and told him a room was open. He told staff it was okay to move the patient to the OR (operating room).
He stated when he got to the OR the patient was already asleep. He said he went by his H&P and performed the surgery below the umbilicus. He said he found out days later when the patient came to his office for a follow-up. He said the patient told him he still had a hernia. He told the patient he had made a mistake. He reported the issue to the hospital medical director at that time. He said risk management was made aware within days of the surgery.

During a second telephone interview on 7/2/14 at 4:00 p.m., Patient #1's surgeon was asked what he would do in the future to prevent a similar incident from occurring. He stated he would ensure that he assessed the patient and marked the site prior to the patient being moved to the operating room. He said this was his normal process. He explained, "The OR was busy on that day."

During an observation on 7/2/14 at 11:00 a.m., staff were waiting for the surgeon to come to a patient who was to have a right inguinal (groin area) hernia repair with mesh. At 11:10 a.m., the surgeon assessed the patient having the procedure and marked the site where the surgery was to be performed.

In an interview on 7/2/14 at 11:20 a.m., pre-op nurse Staff E said the policy of the facility is to have the surgeon mark the site before moving the patient to the operating room. Once in the operating room there is a time-out. During this time-out all members of the operating team stop what they are doing and verify the correct patient, procedure, and site before proceeding with the surgery.

Facility Policy #737 'Procedure Verification Process (Pre-Verification, Site Marking, Time-Out)', Chapter M03-05, revised 1/13, contained:

" I. The three components of the procedure verification process include pre-procedure verification, site marking and time-out. When combined, they comprise the process for enhancing safety by correctly identifying the patient, the appropriate procedure and the correct site of the procedure.
Policy Exclusions:
Non-consented procedures ...

A. Pre-procedure Verification Process
1. The Pre-procedure Verification is an ongoing process of information gathering and confirmation to make sure documents and related information are: ...
c. Reviewed and are consistent with the patient ' s expectations and with the teams understanding of the untended patient, procedure and site ...

B. Marking the Site ....
3. Applicable surgical/nonsurgical sites will be marked by a licensed independent practitioner (LIP) who is ultimately accountable for the procedure and will be present when the procedure is performed ...

C. Time Out
1. The final verification of the correct patient, procedure and site is conducted immediately before starting the procedure or making the incision.
2. Active Time Out - An Active Time Out includes verbal communication and visual confirmation among all members of the surgical/procedure team. This includes the verification of the patient, procedure and site with supporting documentation and images.
3. The procedure is not started until any questions or concerns are resolved.

II. PROCEDURE VERIFICATIONS REQUIREMENTS

A. Requirements for Pre-Procedure Verifications
Surgical and nonsurgical procedures that require informed consent, including procedures done in settings other than the operating room, ...

B. Requirements for site marking
1. The method of marking the site is unambiguous (clearly expressed or understood) and is consistently used throughout the organization. The mark:
a. Is made near the site. Includes the initials of the person marking the site ...
2. Sites are marked when there is more than one possible location for the procedure and when performing the procedure in a different location would negatively affect the quality or safety. Examples include:
a. Right or left distinction (laterally);
b. Medial or lateral distinction (i.e. knee arthroplasty site can be medial or lateral) ...
f. Surface sites with multiple wounds or lesions that will require treatment of only ' some ' of the lesions; ...
3. Procedures that are exempt from site marking include:
a. Single organ cases (ex

Based on interview and record review, the facility failed to ensure an updated physical examination was completed within 24 hours by the physician performing a Ventral Hernia Repair for 1 patient (Patient #1) of 16 patients sampled. Patient #1 was moved to the operating room before physician checked or marked the site of the procedure. As a result, the wrong site operated on and the wrong procedure being performed. As a result, Patient #1 suffered risks of anesthesia, the potential for infection, and continues with the risk of an unrepaired hernia. Marking the site provides a safety check that the physician performed a recent physical examination or update. The facility's policy on history and physical updated was not followed for Patient #1. Likewise, the site marking related to the update was not being followed for other patients with Ventral Hernias. This failure to follow procedures poses a threat of Immediate Jeopardy for any patient having a similar hernia repair with a potential for harm or death due to the risk of anesthesia and the potential for infection.

Findings include:

1. Patient #1 is a 74-year-old-male patient who was admitted to the facility on 3/20/14 with a Ventral Hernia. A Ventral Hernia is a bulging of the abdominal wall, often at the midline. However, it can occur at any location on the abdominal wall (source: Healthline.com).

Review of the consent for surgery reads, "Repair Ventral Hernia with Mesh." The consent was signed 2/26/14. The exact location of the hernia was not specified on the consent.
The surgical report of 3/20/14 for Patient #1 includes:
Preoperative Diagnosis: Ventral Hernia.
Procedure Description: After the patient identified by name for a Ventral Hernia Repair, birth date of (birth date), he was given general anesthesia via endotracheal intubation. His abdomen was prepped and draped in the usual manner. An incision was made over the midline below the umbilicus for about 3 fingerbreadths, carried down to the skin and subcutaneous tissue. The area of firmness and nodularity which is in the right side was then dissected out and appeared to be just some fatty tissue but no evidence of a ventral hernia defect. I inspected laterally, and I also inspected down further inferiorly. Still the fascia was intact with no defect whatsoever ..."
Postoperative Diagnosis: Soft-tissue mass, probable lipoma.

A telephone interview was conducted on 7/2/14 at 4:08 p.m. by agency surveyor and senior clerk with Patient #1. The patient said in March he had gone to see the doctor about a hernia that was above (the navel) and to the right. The patient said you could see it. The doctor examined him in the office on 3/20/14 and told the patient he would operate to repair the hernia. After the surgery, the doctor told the patient's daughter that he didn't have a hernia; he had a mass. The doctor called it a lipoma (a common benign tumor composed of body fat). The patient said the doctor opened the wrong place. Right after the surgery the patient was aware he still had a hernia.
Patient #1 said he went to see the doctor 5 days later (after the surgery). He was surprised when the doctor told him he didn't have a hernia. He said he wondered why the doctor didn't find the hernia. He said the hospital was aware the doctor made a mistake. Because of this, he feels that patients are at risk.

In a telephone interview conducted on 7/2/14 at 1:00 p.m., the physician who performed Patient #1's surgery said he thought he had a fool-proof system to prevent such an incident from occurring. He stated he had assessed the patient in his office as having an above the umbilicus (navel) ventral hernia. He stated when he completed the H&P (history and physical); he mistakenly documented the hernia to be below the umbilicus. He said he never assessed the patient before the surgery because staff came to him and told him a room was open. He told staff it was ok to move the patient to the OR (operating room). He stated when he got to the OR the patient was already asleep. He said he went by his H&P and performed the surgery below the umbilicus. He said he found out days later when the patient came to his office for a follow-up. He said the patient told him he still had a hernia. He told the patient he had made a mistake. He reported the issue to the hospital medical director at that time. He said Risk Management was made aware within days of the surgery.

Facility policy #428 " Interdisciplinary Patient Assessment/Reassessment " , Chapter M02-01, revised 4/14, contained:
" POLICY:
A. The assessment process will be a continuous, collaborative effort with all departments functioning as a team ...
D. A physician shall perform a written medical history and physical within 30 days and the history and physical must be updated within 24 hours of admission and prior to surgery ...
PROCEDURE:
D. Scope and Responsibilities of Involved Disciplines / Departments
1. Medical Staff Responsibilities: A member of the medical staff will be responsible for the medical care and treatment for each patient, including completion of a history and physical, according to Medical Staff Rules and Regulations.
a. A physician shall perform a written medical history and physical within 30 days and the history and physical must be updated within 24 hours of admission and prior to surgery. The scope of the history and physical includes:
Chief complaint.
Details of present illness.
Relevant past psychological and family histories.
Review of body system.
Physical Examination ..."

During a second telephone interview on 7/2/14 at 4:00 p.m., Patient #1's surgeon was asked what he would do in the future to prevent a similar incident from occurring. He stated he would ensure that he assessed the patient and marked the site prior to the patient being moved to the operating room. He said this was his normal process. He explained, "The OR was busy on that day."

During an observation on 7/2/14 at 11:00 a.m., staff were waiting for the surgeon to come to a patient who was to have a right inguinal (groin area) hernia repair with mesh. At 11:10 a.m., the surgeon assessed the patient having the procedure and marked the site where the surgery was to be performed.


2. Facility policy #737 'Procedure Verification Process (Pre-Verification, Site Marking, Time-Out)', Chapter M03-05, revised 1/13, contained:
" I. The three components of the procedure verification process include pre-procedure verification, site marking and time-out. When combined, they comprise the process for enhancing safety by correctly identifying the patient, the appropriate procedure and the correct site of the procedure.
Policy Exclusions:
Non-consented procedures ...
A. Pre-procedure Verification Process
1. The pre-procedure verification is an ongoing process of information gathering and confirmation to make sure documents and related information are: ...
c. Reviewed and are consistent with the patient ' s expectations and with the teams understanding of the untended patient, procedure and site ...
B. Marking the Site ....
3. Applicable surgical/nonsurgical sites will be marked by a licensed independent practitioner (LIP) who is ultimately accountable for the procedure and will be present when the procedure is performed ...
C. Time Out
1. The final verification of the correct patient, procedure and site is conducted immediately before starting the procedure or making the incision.
2. Active Time Out - An Active Time Out includes verbal communication and visual confirmation among all members of the surgical/procedure team. This includes the verification of the patient, procedure and site with supporting documentation and images.
3. The procedure is not started until any questions or concerns are resolved.
II. PROCEDURE VERIFICATIONS REQUIREMENTS
A. Requirements for Pre-Procedure Verifications
Surgical and nonsurgical procedures that require informed consent, including procedures done in settings other than the operating room, ...
B. Requirements for site marking
1. The method of marking the site is unambiguous (clearly expressed or understood) and is