HospitalInspections.org

Based on facility policy reviews, medical record review, and interviews, the facility failed to protect and promote the rights by obtaining informed consent before performing a procedure to permanently sterilize one patient (#4) of 16 patients reviewed.

The findings included:

During the survey it was found one patient (#4) was admitted to the hospital on 3/20/15 for a surgical repair of an Latrogenic Enterotomy (a complication of surgery involving an unintended incision/performation of the bowel) which occurred during an elective laparoscopic (scope used to perform a surgical procedure) tubal ligation (permanent sterilization of the female patient by cutting the fallopian tubes) at an Ambulatory Surgical Center (ASC#1). Further review revealed the Tubal Ligation was not performed at ASC #1. Continued review revealed the facility performed the Tubal Ligation after the Latrogenic Enterotomy was complete, without obtaining consent from Patient #4 or the patient's representative.

During a conference on 2/15/17 at 11:30 AM, in the conference room, with the Chief Executive Officer (on telephone), the Chief Operations Officer, the Chief Nursing Officer, the Chief Financial Officer, the Risk Manager, and the Chief Medical Officer, the facility was informed it had an Immediate Jeopardy (a situation in which the provider's noncompliance with one or more requirements of participation, has caused, or is likely to cause injury, harm, impairment or death) at CFR PART 482.13 Condition of Participation, Patient's Rights.

Review of an Immediate Action Plan, which removed the Immediate Jeopardy on 2/15/17, revealed the following actions were implemented:
1. All surgical staff and physicians were in-serviced on informed consent policy, required informed consent, documentation of all procedures, and time-out procedures.
2. Medical staff was informed of the requirements/expectations regarding rules and regulations, CMS regulation violations and the critical nature of informed consent.
3. Staff was educated on the chain of command policy and empowerment to speak up when there are safety concerns.
4. An emergency Medical Staff Executive Committee meeting was held to implement a corrective action plan per the Medical Staff Bylaws.
5. Mandatory training program for active and courtesy members of the medical staff to include patient rights, culture of safety, informed consent, and procedural documentation.
6. The facility will monitor 30 surgeries involving multiple surgeons/proceduralists for accuracy and completion of informed consent and monitor 30 timeouts per month for discussion of procedures on the consent form for 4 months or until 100% compliance.

See A-0131

Based on facility policy reviews, medical record review, and interviews, the facility failed to protect and promote the rights of one patient (#4) of 16 patients reviewed.

The findings included:

Review of facility policy, Patient Rights and Responsibilities, not dated, revealed "...You or your personal representative has the right to participate in the development and implementation of your plan of care...You have the right to make informed decisions about your care...you have the right to accept or refuse care...You have the right to have medical treatment explained...You have the right to have your treatment preferences honored..."

Review of facility policy, Informed Consent, last revised June 2016, revealed "...The patient has the right to receive information necessary to make intelligent and informed decisions regarding his/her healthcare...It is the responsibility of the practitioner who will be performing the intervention(s) to obtain informed consent for the intervention from the patient or surrogate...The practitioner who obtains the patient's consent will document in the patient's chart that informed consent has been obtained. The documentation may be written in the patient's chart by the practitioner (either in the History and Physical, Consult Notes, or in the Progress Notes), and/or the Authorization for Procedure(s) form...Documentation must be in the record prior to the procedure or intervention...Regardless of where the practitioner documents that the informed consent has occurred, the patient must sign and date the Authorization for Procedure(s) form...The authorization form must be completed and signed prior to the performance of the intervention..."

Review of the medical record for Patient #4 revealed the patient was admitted to the facility (Hospital A) on 3/20/15 for the surgical repair of an Latrogenic Enterotomy (a complication of surgery involving an unintended incision/perforation of the bowel) which occurred during an elective laparoscopic (scope used to perform a surgical procedure) tubal ligation (permanent sterilization of the female patient by cutting the fallopian tubes) at an Ambulatory Surgical Center (ASC #1). Further review revealed the Tubal Ligation was not performed at ASC #1.

Medical record review of an Informed Consent for Surgery/Treatment/Procedures form dated 3/20/15 revealed "...Exploratory Laparotomy Possible Bowel Resection, Possible Ostomy..." Continued review revealed the consent was signed by Patient #4 on 3/20/15 at 4:18 PM. Further review revealed no consent for a tubal ligation.

Medical record review of an Operative/Procedure Note completed by Physician #2 and dated 3/20/15 revealed the patient had an exploratory laparotomy (surgery using a scope to look into the abdominal or pelvic cavity) with surgical repair of a small mesenteric (a membrane like tissue that holds the bowel to the abdominal wall) and serosal (a thin membrane/tissue that covers abdominal organs) defect in the mid jejunum (part of the small intestine). Continued review revealed "...OPERATION PERFORMED...Exploratory Laparotomy...Extensive Lysis of Adhesions...Repair of serosal jejunal injury..." Continued review of the Operative/Procedure Note revealed no documentation a tubal ligation was performed, no documentation the patient was advised of possible sterilization occurring, and no documentation the patient gave consent for a tubal ligation procedure.

Medical record review of a discharge Code Summary dated 4/2/15 revealed "...V25.2 E [list of code numbers used to identify diagnoses and procedures for billing purposes] ENCOUNTER FOR STERILIZATION..."

Telephone interview with Patient #4 on 2/13/17 at 10:09 AM revealed she went to ASC #1 on 3/10/15 for an elective tubal ligation. Continued interview revealed "...[Physician #1]...perforated my bowel and the tubal was not done...they sent me by ambulance across the road to [Hospital #1] for me to have surgery to fix my bowel perforation...I had to wait all day for the surgeon [Physician #2] to come over from the surgery center and fix my bowel...I only consented to having my bowel repaired...I did not want the sterilization surgery now, I decided not to have it because without the ablation [surgical removal of tissue] at the same time it was not going to help me...I was supposed to have an endometrial [inner surface of the uterus] ablation done along with the tubal...I had researched it very well and without the ablation being done it was not going to help me...after I woke up after the surgery, [Physician #1] had told my husband that she [Physician #1] had 'snuck in and tied my tubes...since she [patient] was on the table I finished the job'...[Physician #1] told my husband it was not documented because it was not allowed in this hospital..." Further interview with Patient #4 confirmed the patient did not want a tubal ligation performed at the hospital on 3/20/15, did not sign a consent form for a tubal ligation at the hospital on 3/20/15, and was expecting the surgeon to only repair her bowel injury.

Telephone interview with Patient #4's husband on 2/13/17 at 10:29 AM revealed he remembered speaking with Physician #1 in the hospital waiting room at approximately 9:00 PM on 3/20/15. The patient's husband stated "...the doctor [Physician #1] came in, we were not expecting her and said 'I just saw [Patient #4]...I gloved up and finished what I started...I could not document in the chart as this is a Catholic hospital...it is a don't ask don't tell situation'..." Further interview confirmed Physician #1 told him she had performed a tubal ligation on Patient #4. Continued interview revealed after leaving the surgery center he and Patient #4 discussed the procedure and decided not to have the tubal ligation performed. Further interview revealed he did not give consent for the tubal ligation to be performed at the hospital on 3/20/15, did not want the procedure, and was surprised when he was told the procedure was performed.

Telephone interview with Physician #1 on 2/14/17 at 1:15 PM revealed she remembered operating on Patient #4 on 3/20/15. Continued interview revealed the patient was scheduled for a laparoscopic tubal ligation at ASC #1 on the morning of 3/20/15. Further interview revealed at the beginning of the procedure the trocar (hollow tube with a sharp point used to insert a scope during surgery) used for the procedure was inadvertently inserted into the small bowel. Continued interview revealed Physician #1 contacted Physician #2 (General Surgeon at Hospital A) to consult on the case, and he told her to remove the trocar, discontinue the procedure, and transfer the patient to the hospital for observation and a possible surgery to repair the perforated bowel. Further interview revealed Physician #2 decided to do an exploratory laparotomy the afternoon of 3/20/15 and when Physician #1 arrived in the operating room, the patient was under anesthesia, and the procedure was underway. When Physician #2 was finished with repairing the bowel perforation and removing multiple severe adhesions, Physician #1 performed the tubal ligation. Physician #1 stated "...it was the least I could do for her...she wanted it done...I felt the benefits for the patient outweighed any risks...I told her husband and her mother after the surgery...the husband was very grateful I did it...I did not dictate it in the medical record..." Further interview with Physician #1 confirmed she did not obtain a signed informed consent form at the hospital for the tubal ligation procedure.

Interview with the Director of Surgical Services (DSS) on 2/9/17 at 11:00 AM, in his office, confirmed there must be a consent form signed for every procedure performed.

Interview with the facility's Risk Manager on 2/9/17 at 1:30 PM, in the Administration Conference Room, confirmed no informed consent was completed for Patient #4's tubal ligation. Further interview confirmed any surgical procedures must have an informed consent completed prior to the procedure and the facility failed to follow facility policy.

Based on review of medical staff bylaws, facility policy reviews, medical record review, and interviews, the facility failed to follow medical staff bylaws for performing and documenting a surgical treatment for one patient (#4) of 16 patients reviewed.

The findings included:

During the survey it was found one patient (#4) was admitted to the hospital on 3/20/15 for a surgical repair of an Latrogenic Enterotomy (a complication of surgery involving an unintended incision/performation of the bowel) which occurred during an elective laparoscopic (scope used to perform a surgical procedure) tubal ligation (permanent sterilization of the female patient by cutting the fallopian tubes) at an Ambulatory Surgical Center (ASC#1). Further review revealed the Tubal Ligation was not performed at ASC #1. Continued review revealed the facility performed the Tubal Ligation after the Latrogenic Enterotomy was complete, without obtaining consent from Patient #4 or the patient's representative.

During a conference on 2/15/17 at 11:30 AM, in the conference room, with the Chief Executive Officer (on telephone), the Chief Operations Officer, the Chief Nursing Officer, the Chief Financial Officer, the Risk Manager, and the Chief Medical Officer, the facility was informed it had an Immediate Jeopardy (a situation in which the provider's noncompliance with one or more requirements of participation, has caused, or is likely to cause injury, harm, impairment or death) CFR PART 482.22, Condition of Participation Medical Staff.

Review of an Immediate Action Plan, which removed the Immediate Jeopardy on 2/15/17, revealed the following actions were implemented:
1. All surgical staff and physicians were in-serviced on informed consent policy, required informed consent, documentation of all procedures, and time-out procedures.
2. Medical staff was informed of the requirements/expectations regarding rules and regulations, CMS regulation violations and the critical nature of informed consent.
3. Staff was educated on the chain of command policy and empowerment to speak up when there are safety concerns.
4. An emergency Medical Staff Executive Committee meeting was held to implement a corrective action plan per the Medical Staff Bylaws.
5. Mandatory training program for active and courtesy members of the medical staff to include patient rights, culture of safety, informed consent, and procedural documentation.
6. The facility will monitor 30 surgeries involving multiple surgeons/proceduralists for accuracy and completion of informed consent and monitor 30 timeouts per month for discussion of procedures on the consent form for 4 months or until 100% compliance.

Refer to A-0353

Based on review of medical staff bylaws, facility policy reviews, medical record review, and interviews, the facility failed to follow medical staff bylaws for performing and documenting a surgical treatment for one patient (#4) of 16 patients reviewed.

The findings included:

Review of the facility's Medical Staff Bylaws (undated) revealed, "...Each patient's medical record shall include the following...Evidence of appropriate informed consent...operative reports...A post-operative note shall be recorded by the surgeon prior to transfer of the patient from PACU. This note shall include the following...Procedure performed..."

Review of facility policy, Informed Consent, last revised June 2016, revealed "...It is the responsibility of the practitioner who will be performing the intervention(s) to obtain informed consent for the intervention from the patient or surrogate...The practitioner who obtains the patient's consent will document in the patient's chart that informed consent has been obtained. The documentation may be written in the patient's chart by the practitioner (either in the History and Physical, Consult Notes, or in the Progress Notes), and/or the Authorization for Procedure(s) form...Documentation must be in the record prior to the procedure or intervention...Regardless of where the practitioner documents that the informed consent has occurred, the patient must sign and date the Authorization for Procedure(s) form...The authorization form must be completed and signed prior to the performance of the intervention..."

Review of the medical record for Patient #4 revealed the patient was admitted to the facility on 3/20/15 for the surgical repair of an Latrogenic Enterotomy (a complication of surgery involving an unintended incision/perforation of the bowel) which occurred during an elective laparoscopic (scope used to perform a surgical procedure) tubal ligation (permanent sterilization of the female patient by cutting the fallopian tubes) at an Ambulatory Surgical Center (ASC #1). Further review revealed the Tubal Ligation was not performed at ASC #1.

Medical record review of an Informed Consent for Surgery/Treatment/Procedures form dated 3/20/15 revealed "...Exploratory Laparotomy Possible Bowel Resection, Possible Ostomy..." Continued review revealed the consent was signed by Patient #4 on 3/20/15 at 4:18 PM. Further review revealed no consent for a tubal ligation.

Medical record review of an Operative/Procedure Note completed by Physician #2 and dated 3/20/15 revealed the patient had an exploratory laparotomy (surgery using a scope to look into the abdominal or pelvic cavity) with surgical repair of a small mesenteric (a membrane like tissue that holds the bowel to the abdominal wall) and serosal (a thin membrane/tissue that covers abdominal organs) defect in the mid jejunum (part of the small intestine). Continued review revealed the patient had multiple extensive adhesions (scar tissue) and lysis (removal) of these adhesions was performed. Further review revealed "...OPERATION PERFORMED...Exploratory Laparotomy...Extensive Lysis of Adhesions...Repair of serosal jejunal injury..." Continued review of the Operative/Procedure Note revealed no documentation a tubal ligation was performed, no documentation the patient was advised of possible sterilization occurring, and no documentation the patient gave consent for a tubal ligation procedure.

Medical record review of a discharge Code Summary dated 4/2/15 revealed "...V25.2 E [list of code numbers used to identify diagnoses and procedures for billing purposes] ENCOUNTER FOR STERILIZATION..."

Telephone interview with Patient #4 on 2/13/17 at 10:09 AM revealed she went to ASC #1 on 3/10/15 for an elective tubal ligation. Continued interview revealed "...[Physician #1]...perforated my bowel and the tubal was not done...they sent me by ambulance across the road to [Hospital #1] for me to have surgery to fix my bowel perforation...I had to wait all day for the surgeon [Physician #2] to come over from the surgery center and fix my bowel...I only consented to having my bowel repaired...I did not want the sterilization surgery now, I decided not to have it because without the ablation [surgical removal of tissue] at the same time it was not going to help me...I was supposed to have an endometrial [inner surface of the uterus] ablation done along with the tubal...I had researched it very well and without the ablation being done it was not going to help me...after I woke up after the surgery, [Physician #1] had told my husband that she [Physician #1] had 'snuck in and tied my tubes...since she [patient] was on the table I finished the job'...[Physician #1] told my husband it was not documented because it was not allowed in this hospital..." Further interview with Patient #4 confirmed the patient did not want a tubal ligation performed at the hospital on 3/20/15, did not sign a consent form for a tubal ligation at the hospital on 3/20/15, and was expecting the surgeon to only repair her bowel injury.

Telephone interview with Patient #4's husband on 2/13/17 at 10:29 AM revealed he remembered speaking with Physician #1 in the hospital waiting room at approximately 9:00 PM on 3/20/15. The patient's husband stated "...the doctor [Physician #1] came in, we were not expecting her, and said 'I just saw [Patient #4]...I gloved up and finished what I started...I could not document in the chart as this is a Catholic hospital...it is a don't ask don't tell situation'..." Further interview confirmed Physician #1 told him she had performed a tubal ligation on

Telephone interview with Physician #1 on 2/14/17 at 1:15 PM revealed she remembered operating on Patient #4 on 3/20/15. Continued interview revealed the patient was scheduled for a laparoscopic tubal ligation at ASC #1 on the morning of 3/20/15. Further interview revealed at the beginning of the procedure the trocar (hollow tube with a sharp point used to insert a scope during surgery) used for the procedure was inadvertently inserted into the small bowel. Continued interview revealed Physician #1 contacted Physician #2 (General Surgeon at Hospital A) to consult on the case, and he told her to remove the trocar, discontinue the procedure, and transfer the patient to the hospital for observation and a possible surgery to repair the perforated bowel. Further interview revealed Physician #2 decided to do an exploratory laparotomy the afternoon of 3/20/15 and when Physician #1 arrived in the operating room, the patient was under anesthesia, and the procedure was underway. When Physician #2 was finished with repairing the bowel perforation and removing multiple severe adhesions, Physician #1 performed the tubal ligation. Physician #1 confirmed she did not obtain a signed informed consent for the tubal ligation procedure.

Interview with Physician #2 on 2/9/17 at 10:14 AM, in the Surgery Director's office, revealed he remembered "...it was not performed by me..." Further interview with Physician #2 revealed he did not know if the tubal ligation was documented in the medical record by Physician #1, but he did not document the procedure in his operative note because he did not perform the procedure.

Interview with the Director of Surgical Services (DSS) on 2/9/17 at 11:00 AM, in his office, confirmed the procedures must be documented in the medical record.

Interview with the facility's Risk Manager on 2/9/17 at 1:30 PM, in the Administration Conference Room, confirmed there was no documentation in the medical record Patient #4 had a tubal ligation performed. Further interview confirmed any surgical procedures performed on a patient must be documented in the medical record and the facility failed to follow facility policies and medical staff bylaws.

Based on facility policy reviews, medical record review, and interviews, the facility failed to maintain a complete and accurate medical record for one patient (#4) of 16 patients reviewed.

The findings included:

During the survey it was found one patient (#4) was admitted to the hospital on 3/20/15 for a surgical repair of an Latrogenic Enterotomy (a complication of surgery involving an unintended incision/performation of the bowel) which occurred during an elective laparoscopic (scope used to perform a surgical procedure) tubal ligation (permanent sterilization of the female patient by cutting the fallopian tubes) at an Ambulatory Surgical Center (ASC#1). Further review revealed the Tubal Ligation was not performed at ASC #1. Continued review revealed the facility performed the Tubal Ligation after the Latrogenic Enterotomy was complete, without obtaining consent from Patient #4 or the patient's representative. Further review revealed the facility failed to document the Tubal Ligation in the Medical Record.

During a conference on 2/15/17 at 11:30 AM, in the conference room, with the Chief Executive Officer (on telephone), the Chief Operations Officer, the Chief Nursing Officer, the Chief Financial Officer, the Risk Manager, and the Chief Medical Officer, the facility was informed it had an Immediate Jeopardy (a situation in which the provider's noncompliance with one or more requirements of participation, has caused, or is likely to cause injury, harm, impairment or death) at CFR PART 482.24 Condition of Participation, Medical Records Services.

Review of an Immediate Action Plan, which removed the Immediate Jeopardy on 2/15/17, revealed the following actions were implemented:
1. All surgical staff and physicians were in-serviced on informed consent policy, required informed consent, documentation of all procedures, and time-out procedures.
2. Medical staff was informed of the requirements/expectations regarding rules and regulations, CMS regulation violations and the critical nature of informed consent.
3. Staff was educated on the chain of command policy and empowerment to speak up when there are safety concerns.
4. An emergency Medical Staff Executive Committee meeting was held to implement a corrective action plan per the Medical Staff Bylaws.
5. Mandatory training program for active and courtesy members of the medical staff to include patient rights, culture of safety, informed consent, and procedural documentation.
6. The facility will monitor 30 surgeries involving multiple surgeons/proceduralists for accuracy and completion of informed consent and monitor 30 timeouts per month for discussion of procedures on the consent form for 4 months or until 100% compliance.

Refer to A-0450; A-0466; A-0467; A0468

Based on facility policy reviews, medical record review, and interviews, the facility failed to maintain a complete and accurate medical record for one patient (#4) of 16 patients reviewed.

The findings included:

Review of the facility's Contents of the Medical Record policy, effective date January 2012, revealed "...The inpatient record...Shall include but is not limited to...Consent forms...A Post-operative progress note shall be recorded by the surgeon prior to transfer of the patient from PACU...this note shall include the following...Procedure performed...The discharge summary shall include...Procedures performed and treatment rendered..."

Review of facility policy, Informed Consent, last revised June 2016, revealed "...It is the responsibility of the practitioner who will be performing the intervention(s) to obtain informed consent for the intervention from the patient or surrogate...The practitioner who obtains the patient's consent will document in the patient's chart that informed consent has been obtained. The documentation may be written in the patient's chart by the practitioner (either in the History and Physical, Consult Notes, or in the Progress Notes), and/or the Authorization for Procedure(s) form...Documentation must be in the record prior to the procedure or intervention...Regardless of where the practitioner documents that the informed consent has occurred, the patient must sign and date the Authorization for Procedure(s) form...The authorization form must be completed and signed prior to the performance of the intervention..."

Review of the medical record for Patient #4 revealed the patient was admitted to the facility (Hospital A) on 3/20/15 for the surgical repair of an Latrogenic Enterotomy (a complication of surgery involving an unintended incision/perforation of the bowel) which occurred during an elective laparoscopic (scope used to perform a surgical procedure) tubal ligation (permanent sterilization of the female patient by cutting the fallopian tubes) at an Ambulatory Surgical Center (ASC #1). Further review revealed the Tubal Ligation was not performed at ASC #1.

Medical record review of an Informed Consent for Surgery/Treatment/Procedures form dated 3/20/15 revealed "...Exploratory Laparotomy Possible Bowel Resection, Possible Ostomy..." Continued review revealed the consent was signed by Patient #4 on 3/20/15 at 4:18 PM. Further review revealed no consent for a tubal ligation.

Medical record review of an Operative/Procedure Note completed by Physician #2 and dated 3/20/15 revealed the patient had an exploratory laparotomy (surgery using a scope to look into the abdominal or pelvic cavity) with surgical repair of a small mesenteric (a membrane like tissue that holds the bowel to the abdominal wall) and serosal (a thin membrane/tissue that covers abdominal organs) defect in the mid jejunum (part of the small intestine). Continued review revealed the patient had multiple extensive adhesions (scar tissue) and lysis (removal) of these adhesions was performed. Further review revealed "...OPERATION PERFORMED...Exploratory Laparotomy...Extensive Lysis of Adhesions...Repair of serosal jejunal injury..." Continued review of the Operative/Procedure Note revealed no documentation a tubal ligation was performed, no documentation the patient was advised of possible sterilization occurring, and no documentation the patient gave consent for a tubal ligation procedure.

Medical record review of a discharge Code Summary dated 4/2/15 revealed "...V25.2 E [list of code numbers used to identify diagnoses and procedures for billing purposes] ENCOUNTER FOR STERILIZATION..."

Telephone interview with Patient #4 on 2/13/17 at 10:09 AM revealed she went to ASC #1 on 3/10/15 for an elective tubal ligation. Continued interview revealed "...[Physician #1]...perforated my bowel and the tubal was not done...they sent me by ambulance across the road to [Hospital #1] for me to have surgery to fix my bowel perforation...I had to wait all day for the surgeon [Physician #2] to come over from the surgery center and fix my bowel...I only consented to having my bowel repaired...I did not want the sterilization surgery now, I decided not to have it because without the ablation [surgical removal of tissue] at the same time it was not going to help me...I was supposed to have an endometrial [inner surface of the uterus] ablation done along with the tubal...I had researched it very well and without the ablation being done it was not going to help me...after I woke up after the surgery, [Physician #1] had told my husband that she [Physician #1] had 'snuck in and tied my tubes...since she [patient] was on the table I finished the job'...[Physician #1] told my husband it was not documented because it was not allowed in this hospital..." Further interview with Patient #4 confirmed the patient did not want a tubal ligation performed at the hospital on 3/20/15, did not sign a consent form for a tubal ligation at the hospital on 3/20/15, and was expecting the surgeon to only repair her bowel injury.

Telephone interview with Patient #4's husband on 2/13/17 at 10:29 AM revealed he remembered speaking with Physician #1 in the hospital waiting room at approximately 9:00 PM on 3/20/15. The patient's husband stated "...the doctor [Physician #1] came in, we were not expecting her, and said 'I just saw [Patient #4]...I gloved up and finished what I started...I could not document in the chart as this is a Catholic hospital...it is a don't ask don't tell situation'..." Further interview confirmed Physician #1 told him she had performed a tubal ligation on

Telephone interview with Physician #1 on 2/14/17 at 1:15 PM revealed she remembered operating on Patient #4 on 3/20/15. Continued interview revealed the patient was scheduled for a laparoscopic tubal ligation at ASC #1 on the morning of 3/20/15. Further interview revealed at the beginning of the procedure the trocar (hollow tube with a sharp point used to insert a scope during surgery) used for the procedure was inadvertently inserted into the small bowel. Continued interview revealed Physician #1 contacted Physician #2 (General Surgeon at Hospital A) to consult on the case, and he told her to remove the trocar, discontinue the procedure, and transfer the patient to the hospital for observation and a possible surgery to repair the perforated bowel. Further interview revealed Physician #2 decided to do an exploratory laparotomy the afternoon of 3/20/15 and when Physician #1 arrived in the operating room, the patient was under anesthesia, and the procedure was underway. When Physician #2 was finished with repairing the bowel perforation and removing multiple severe adhesions, Physician #1 performed the tubal ligation. Physician #1 confirmed she did not obtain a signed informed consent for the tubal ligation procedure.

Interview with Physician #2 on 2/9/17 at 10:14 AM, in the Surgery Director's office, revealed he remembered "...it was not performed by me..." Further interview with Physician #2 revealed he did not know if the tubal ligation was documented in the medical record by Physician #1, but he did not document the procedure in his operative note because he did not perform the procedure.

Interview with the Director of Surgical Services (DSS) on 2/9/17 at 11:00 AM, in his office, confirmed the procedures must be documented in the medical record.

Interview with the facility's Risk Manager on 2/9/17 at 1:30 PM, in the Administration Conference Room, confirmed there was no documentation in the medical record Patient #4 had a tubal ligation performed. Further interview confirmed any surgical procedures performed on a patient must be documented in the medical record and the facility failed to follow facility policy.

Based on facility policy reviews, medical record review, and interviews, the facility failed to obtain an executed informed consent for one patient (#4) of 16 patients reviewed.

The findings included:

Review of the facility's Contents of the Medical Record policy, effective date January 2012, reveale "...The inpatient record...Shall Include but is not limited to...Consent Forms..."

Review of facility policy, Informed Consent, last revised June 2016, revealed "...It is the responsibility of the practitioner who will be performing the intervention(s) to obtain informed consent for the intervention from the patient or surrogate...The practitioner who obtains the patient's consent will document in the patient's chart that informed consent has been obtained. The documentation may be written in the patient's chart by the practitioner (either in the History and Physical, Consult Notes, or in the Progress Notes), and/or the Authorization for Procedure(s) form...Documentation must be in the record prior to the procedure or intervention...Regardless of where the practitioner documents that the informed consent has occurred, the patient must sign and date the Authorization for Procedure(s) form...The authorization form must be completed and signed prior to the performance of the intervention..."

Review of the medical record for Patient #4 revealed the patient was admitted to the facility (Hospital A) on 3/20/15 for the surgical repair of an Latrogenic Enterotomy (a complication of surgery involving an unintended incision/perforation of the bowel) which occurred during an elective laparoscopic (scope used to perform a surgical procedure) tubal ligation (permanent sterilization of the female patient by cutting the fallopian tubes) at an Ambulatory Surgical Center (ASC #1). Further review revealed the Tubal Ligation was not performed at ASC #1.

Medical record review of an Informed Consent for Surgery/Treatment/Procedures form dated 3/20/15 revealed "...Exploratory Laparotomy Possible Bowel Resection, Possible Ostomy..." Continued review revealed the consent was signed by Patient #4 on 3/20/15 at 4:18 PM. Further review revealed no consent for a tubal ligation.

Medical record review of an Operative/Procedure Note completed by Physician #2 and dated 3/20/15 revealed the patient had an exploratory laparotomy (surgery using a scope to look into the abdominal or pelvic cavity) with surgical repair of a small mesenteric (a membrane like tissue that holds the bowel to the abdominal wall) and serosal (a thin membrane/tissue that covers abdominal organs) defect in the mid jejunum (part of the small intestine). Continued review revealed the patient had multiple extensive adhesions (scar tissue) and lysis (removal) of these adhesions was performed. Further review revealed "...was undergoing an elective laparoscopic tubal ligation by [Physician #1] today at [ASC #1]...a 5 mm [millimeter] trocar [a surgical instrument with a sharp point] was placed into a loop of small bowel...the patient was transferred to the hospital...After extensive discussion with the patient, she decided on an exploratory laparotomy...The risks, benefits, and alternatives were discussed with the patient including the possibility of bleeding, infection, sepsis, and even death...She understood these risks and agreed to proceed..." Further review of the Operative/Procedure Note revealed "...OPERATION PERFORMED...Exploratory Laparotomy...Extensive Lysis of Adhesions...Repair of serosal jejunal injury..." Continued review of the Operative/Procedure Note revealed no documentation a tubal ligation was performed, no documentation the patient was advised of possible sterilization occurring, and no documentation the patient gave consent for a tubal ligation procedure.

Medical record review of a discharge Code Summary dated 4/2/15 revealed "...V25.2 E [list of code numbers used to identify diagnoses and procedures for billing purposes] ENCOUNTER FOR STERILIZATION..."

Telephone interview with Patient #4 on 2/13/17 at 10:09 AM revealed she went to ASC #1 on 3/10/15 for an elective tubal ligation. Continued interview revealed "...[Physician #1]...perforated my bowel and the tubal was not done...they sent me by ambulance across the road to [Hospital #1] for me to have surgery to fix my bowel perforation...I had to wait all day for the surgeon [Physician #2] to come over from the surgery center and fix my bowel...I only consented to having my bowel repaired...I did not want the sterilization surgery now, I decided not to have it because without the ablation [surgical removal of tissue] at the same time it was not going to help me...I was supposed to have an endometrial [inner surface of the uterus] ablation done along with the tubal...I had researched it very well and without the ablation being done it was not going to help me...after I woke up after the surgery, [Physician #1] had told my husband that she [Physician #1] had 'snuck in and tied my tubes...since she [patient] was on the table I finished the job'...[Physician #1] told my husband it was not documented because it was not allowed in this hospital..." Further interview with Patient #4 confirmed the patient did not want a tubal ligation performed at the hospital on 3/20/15, did not sign a consent form for a tubal ligation at the hospital on 3/20/15, and was expecting the surgeon to only repair her bowel injury.

Telephone interview with Patient #4's husband on 2/13/17 at 10:29 AM revealed he remembered speaking with Physician #1 in the hospital waiting room at approximately 9:00 PM on 3/20/15. The patient's husband stated "...the doctor [Physician #1] came in, we were not expecting her, and said 'I just saw [Patient #4]...I gloved up and finished what I started...I could not document in the chart as this is a Catholic hospital...it is a don't ask don't tell situation'..." Further interview confirmed Physician #1 told him on 3/20/15 she had performed a tubal ligation on Patient #4 and had not documented this procedure in the medical record. Continued interview revealed after leaving the surgery center he and Patient #4 discussed the procedure and decided not to have the tubal ligation performed. Further interview with the patient's husband revealed he did not give consent for the tubal ligation to be performed at the hospital on 3/20/15, did not want the procedure, and was surprised when he was told the procedure was performed.

Telephone interview with Physician #1 on 2/14/17 at 1:15 PM revealed she remembered operating on Patient #4 on 3/20/15. Continued interview revealed the patient was scheduled for a laparoscopic tubal ligation at ASC #1 on the morning of 3/20/15. Further interview revealed at the beginning of the procedure the trocar (hollow tube witha sharp point used to insert a scopy during surgery) used for the procedure was inadvertently inserted into the small bowel. Continued interview revealed Physician #1 contacted Physician #2 (General Surgeon at Hospital A) to consult on the case, and he told her to remove the trocar, discontinue the procedure, and transfer the patient to the hospital for observation and a possible surgery to repair the perforated bowel. Further interview revealed Physician #2 decided to do an exploratory laparotomy the afternoon of 3/20/15 and when Physician #1 arrived in the operating room, the patient was under anesthesia, and the procedure was underway. When Physician #2 was finished with repairing the bowel perforation and removing multiple severe adhesions, Physician #1 performed the tubal ligation. Further interview revealed "...I did not dictate it in the medical record..." Continued interview revealed she did not obtain a signed informed consent form at the hospital for the tubal ligation procedure.

Interview with the Director of Surgical Services (DSS) on 2/9/17 at 11:00 AM, in his office, confirmed there must be a signed consent form documented in the medical record.

Interview with the facility's Risk Manager on 2/9/17 at 1:30 PM, in the Administration Conference Room, confirmed there was no documentation in the medical record of an informed consent for Patient #4's tubal ligation. Further interview confirmed any surgical procedures must have an informed consent completed prior to the procedure and the facility failed to follow facility policy.

Based on policy review, record review, and interviews, the facility failed to document a complete and accurate operative report for one (#4) patient of 16 reveiwed.

The findings included:

Review of the facility's Contents of the Medical Record policy, effective date January 2012, revealed "...A Post-operative progress note shall be recorded by the surgeon prior to transfer of the patient from PACU...this note shall include the following...Procedure performed..." Further review of the policy revealed, "...The discharge summary shall include...Procedures performed and treatment rendered..."

Review of the medical record for Patient #4 revealed the patient was admitted to the facility (Hospital A) on 3/20/15 for the surgical repair of an Latrogenic Enterotomy (a complication of surgery involving an unintended incision/perforation of the bowel) which occurred during an elective laparoscopic (scope used to perform a surgical procedure) tubal ligation (permanent sterilization of the female patient by cutting the fallopian tubes) at an Ambulatory Surgical Center (ASC #1). Further review revealed the Tubal Ligation was not performed at ASC #1.

Medical record review of an Informed Consent for Surgery/Treatment/Procedures form dated 3/20/15 revealed "...Exploratory Laparotomy Possible Bowel Resection, Possible Ostomy..." Continued review revealed the consent was signed by Patient #4 on 3/20/15 at 4:18 PM. Further review revealed no consent for a tubal ligation.

Medical record review of an Operative/Procedure Note completed by Physician #2 and dated 3/20/15 revealed the patient had an exploratory laparotomy (surgery using a scope to look into the abdominal or pelvic cavity) with surgical repair of a small mesenteric (a membrane like tissue that holds the bowel to the abdominal wall) and serosal (a thin membrane/tissue that covers abdominal organs) defect in the mid jejunum (part of the small intestine). Continued review revealed "...OPERATION PERFORMED...Exploratory Laparotomy...Extensive Lysis of Adhesions...Repair of serosal jejunal injury..." Continued review of the Operative/Procedure Note revealed no documentation a tubal ligation was performed, no documentation the patient was advised of possible sterilization occurring, and no documentation the patient gave consent for a tubal ligation procedure.

Medical record review of a discharge Code Summary dated 4/2/15 revealed "...V25.2 E [list of code numbers used to identify diagnoses and procedures for billing purposes] ENCOUNTER FOR STERILIZATION..."

Telephone interview with Patient #4 on 2/13/17 at 10:09 AM revealed she went to ASC #1 on 3/10/15 for an elective tubal ligation. Continued interview revealed "...[Physician #1]...perforated my bowel and the tubal was not done...they sent me by ambulance across the road to [Hospital #1] for me to have surgery to fix my bowel perforation...I had to wait all day for the surgeon [Physician #2] to come over from the surgery center and fix my bowel...I only consented to having my bowel repaired...I did not want the sterilization surgery now, I decided not to have it because without the ablation [surgical removal of tissue] at the same time it was not going to help me...I was supposed to have an endometrial [inner surface of the uterus] ablation done along with the tubal...I had researched it very well and without the ablation being done it was not going to help me...after I woke up after the surgery, [Physician #1] had told my husband that she [Physician #1] had 'snuck in and tied my tubes...since she [patient] was on the table I finished the job'...[Physician #1] told my husband it was not documented because it was not allowed in this hospital..." Further interview with Patient #4 confirmed the patient did not want a tubal ligation performed at the hospital on 3/20/15, did not sign a consent form for a tubal ligation at the hospital on 3/20/15, and was expecting the surgeon to only repair her bowel injury.

Telephone interview with Patient #4's husband on 2/13/17 at 10:29 AM revealed he remembered speaking with Physician #1 in the hospital waiting room at approximately 9:00 PM on 3/20/15. The patient's husband stated "...the doctor [Physician #1] came in, we were not expecting her, and said 'I just saw [Patient #4]...I gloved up and finished what I started...I could not document in the chart as this is a Catholic hospital...it is a don't ask don't tell situation'..." Further interview confirmed Physician #1 told him on 3/20/15 she had performed a tubal ligation on Patient #4 and had not documented the procedure in the medical record.

Telephone interview with Physician #1 on 2/14/17 at 1:15 PM revealed she remembered operating on Patient #4 on 3/20/15. Continued interview revealed the patient was scheduled for a laparoscopic tubal ligation at ASC #1 on the morning of 3/20/15. Further interview revealed at the beginning of the procedure the trocar (hollow tube with a sharp point used to insert a scope during surgery) used for the procedure was inadvertently inserted into the small bowel. Continued interview revealed Physician #1 contacted Physician #2 (General Surgeon at Hospital A) to consult on the case, and he told her to remove the trocar, discontinue the procedure, and transfer the patient to the hospital for observation and a possible surgery to repair the perforated bowel. Further interview revealed Physician #2 decided to do an exploratory laparotomy the afternoon of 3/20/15, and when Physician #1 arrived in the operating room, the patient was under anesthesia, the procedure was underway. When Physician #2 was finished with repairing the bowel perforation and removing multiple severe adhesions, Physician #1 performed the tubal ligation. Continued interview revealed "...I did not dictate it in the medical record..." Further interview confirmed she did not obtain a signed informed consent form at the hospital for the tubal ligation procedure.

Interview with the Director of Surgical Services (DSS) on 2/9/17 at 11:00 AM, in his office, confirmed all procedures performed must be documented in the medical record.

Interview with the facility's Risk Manager on 2/9/17 at 1:30 PM, in the Administration Conference Room, confirmed there was no documentation in the medical record Patient #4 had a tubal ligation and the facility failed to follow facility policy.

Based on policy review, medical record review, and interviews, the facility failed to document a complete and accurate discharge summary for one (#4) patient of 16 patients reviewed.

The findings included:

Review of the facility's Contents of the Medical Record policy, effective date January 2012, revealed, "...Procedures performed and treatment rendered..."

Review of the medical record for Patient #4 revealed the patient was admitted to the facility (Hospital A) on 3/20/15 for the surgical repair of an Latrogenic Enterotomy (a complication of surgery involving an unintended incision/perforation of the bowel) which occurred during an elective laparoscopic (scope used to perform a surgical procedure) tubal ligation (permanent sterilization of the female patient by cutting the fallopian tubes) at an Ambulatory Surgical Center (ASC #1). Further review revealed the Tubal Ligation was not performed at ASC #1.

Medical record review of an Informed Consent for Surgery/Treatment/Procedures form dated 3/20/15 revealed "...Exploratory Laparotomy Possible Bowel Resection, Possible Ostomy..." Continued review revealed the consent was signed by Patient #4 on 3/20/15 at 4:18 PM. Further review revealed no consent for a tubal ligation.

Medical record review of an Operative/Procedure Note completed by Physician #2 and dated 3/20/15 revealed the patient had an exploratory laparotomy (surgery using a scope to look into the abdominal or pelvic cavity) with surgical repair of a small mesenteric (a membrane like tissue that holds the bowel to the abdominal wall) and serosal (a thin membrane/tissue that covers abdominal organs) defect in the mid jejunum (part of the small intestine). Continued review revealed "...OPERATION PERFORMED...Exploratory Laparotomy...Extensive Lysis of Adhesions...Repair of serosal jejunal injury..." Continued review of the Operative/Procedure Note revealed no documentation a tubal ligation was performed, no documentation the patient was advised of possible sterilization occurring, and no documentation the patient gave consent for a tubal ligation procedure.

Medical record review of a discharge Code Summary dated 4/2/15 revealed "...V25.2 E [list of code numbers used to identify diagnoses and procedures for billing purposes] ENCOUNTER FOR STERILIZATION..."

Telephone interview with Patient #4 on 2/13/17 at 10:09 AM revealed she went to ASC #1 on 3/10/15 for an elective tubal ligation. Continued interview revealed "...[Physician #1]...perforated my bowel and the tubal was not done...they sent me by ambulance across the road to [Hospital #1] for me to have surgery to fix my bowel perforation...I had to wait all day for the surgeon [Physician #2] to come over from the surgery center and fix my bowel...I only consented to having my bowel repaired...I did not want the sterilization surgery now, I decided not to have it because without the ablation [surgical removal of tissue] at the same time it was not going to help me...I was supposed to have an endometrial [inner surface of the uterus] ablation done along with the tubal...I had researched it very well and without the ablation being done it was not going to help me...after I woke up after the surgery, [Physician #1] had told my husband that she [Physician #1] had 'snuck in and tied my tubes...since she [patient] was on the table I finished the job'...[Physician #1] told my husband it was not documented because it was not allowed in this hospital..." Further interview with Patient #4 confirmed the patient did not want a tubal ligation performed at the hospital on 3/20/15, did not sign a consent form for a tubal ligation at the hospital on 3/20/15, and was expecting the surgeon to only repair her bowel injury.

Telephone interview with Patient #4's husband on 2/13/17 at 10:29 AM revealed he remembered speaking with Physician #1 in the hospital waiting room at approximately 9:00 PM on 3/20/15. The patient's husband stated "...the doctor [Physician #1] came in, we were not expecting her, and said 'I just saw [Patient #4]...I gloved up and finished what I started...I could not document in the chart as this is a Catholic hospital...it is a don't ask don't tell situation'..." Further interview confirmed Physician #1 told him on 3/20/15 she had performed a tubal ligation on Patient #4 and had not documented this procedure in the medical record.

Telephone interview with Physician #1 on 2/14/17 at 1:15 PM revealed she remembered operating on Patient #4 on 3/20/15. Continued interview revealed the patient was scheduled for a laparoscopic tubal ligation at ASC #1 on the morning of 3/20/15. Further interview revealed at the beginning of the procedure the trocar (hollow tube with a sharp point used to insert a scope during surgery) used for the procedure was inadvertently inserted into the small bowel. Continued interview revealed Physician #1 contacted Physician #2 (General Surgeon at Hospital A) to consult on the case, and he told her to remove the trocar, discontinue the procedure, and transfer the patient to the hospital for observation and a possible surgery to repair the perforated bowel. Further interview revealed Physician #2 decided to do an exploratory laparotomy the afternoon of 3/20/15, and when Physician #1 arrived in the operating room, the patient was under anesthesia, the procedure was underway. When Physician #2 was finished with repairing the bowel perforation and removing multiple severe adhesions, Physician #1 performed the tubal ligation. Continued interview revealed "...I did not dictate it in the medical record..."

Interview with the facility's Risk Manager on 2/9/17 at 1:30 PM, in the Administration Conference Room, confirmed there was no documentation on the discharge summary of the tubal ligation performed on Patient #4 and the facility failed to follow facility policy.

Based review of medical staff bylaws, facility policy reviews, medical record review, and interviews, the facility's staff failed to provide surgical services in accordance with facility policies for one patient (#4) of 16 patients reviewed.

The findings included:

During the survey it was found one patient (#4) was admitted to the hospital on 3/20/15 for a surgical repair of an Latrogenic Enterotomy (a complication of surgery involving an unintended incision/performation of the bowel) which occurred during an elective laparoscopic (scope used to perform a surgical procedure) tubal ligation (permanent sterilization of the female patient by cutting the fallopian tubes) at an Ambulatory Surgical Center (ASC#1). Further review revealed the Tubal Ligation was not performed at ASC #1. Continued review revealed the facility performed the Tubal Ligation after the Latrogenic Enterotomy was complete, without obtaining consent from Patient #4 or the patient's representative.

During a conference on 2/15/17 at 11:30 AM, in the conference room, with the Chief Executive Officer (on telephone), the Chief Operations Officer, the Chief Nursing Officer, the Chief Financial Officer, the Risk Manager, and the Chief Medical Officer, the facility was informed it had an Immediate Jeopardy (a situation in which the provider's noncompliance with one or more requirements of participation, has caused, or is likely to cause injury, harm, impairment or death) at CFR PART 482.51 Condition of Participation, Surgical Services.

Review of an Immediate Action Plan, which removed the Immediate Jeopardy on 2/15/17, revealed the following actions were implemented:
1. All surgical staff and physicians were in-serviced on informed consent policy, required informed consent, documentation of all procedures, and time-out procedures.
2. Medical staff was informed of the requirements/expectations regarding rules and regulations, CMS regulation violations and the critical nature of informed consent.
3. Staff was educated on the chain of command policy and empowerment to speak up when there are safety concerns.
4. An emergency Medical Staff Executive Committee meeting was held to implement a corrective action plan per the Medical Staff Bylaws.
5. Mandatory training program for active and courtesy members of the medical staff to include patient rights, culture of safety, informed consent, and procedural documentation.
6. The facility will monitor 30 surgeries involving multiple surgeons/proceduralists for accuracy and completion of informed consent and monitor 30 timeouts per month for discussion of procedures on the consent form for 4 months or until 100% compliance.

Refer to A-0955; A-0959

Based on facility policy reviews, medical record review, and interviews, the facility failed to obtain a properly executed informed consent for one patient (#4) of 16 patients reviewed.

The findings included:

Review of the facility's Contents of the Medical Record policy effective date January 2012, revealed, "...The inpatient record...Shall Include but is not limited to...Consent Forms..."

Review of facility policy, Informed Consent, last revised June 2016, revealed "...It is the responsibility of the practitioner who will be performing the intervention(s) to obtain informed consent for the intervention from the patient or surrogate...The practitioner who obtains the patient's consent will document in the patient's chart that informed consent has been obtained. The documentation may be written in the patient's chart by the practitioner (either in the History and Physical, Consult Notes, or in the Progress Notes), and/or the Authorization for Procedure(s) form...Documentation must be in the record prior to the procedure or intervention...Regardless of where the practitioner documents that the informed consent has occurred, the patient must sign and date the Authorization for Procedure(s) form...The authorization form must be completed and signed prior to the performance of the intervention..."

Review of the medical record for Patient #4 revealed the patient was admitted to the facility on 3/20/15 for the surgical repair of an Latrogenic Enterotomy (a complication of surgery involving an unintended incision/perforation of the bowel) which occurred during an elective laparoscopic (scope used to perform a surgical procedure) tubal ligation (permanent sterilization of the female patient by cutting the fallopian tubes) at an Ambulatory Surgical Center (ASC #1). Continued review revealed the Tubal Ligation was not performed at ASC #1.

Medical record review of an Informed Consent for Surgery/Treatment/Procedures form dated 3/20/15 revealed "...Exploratory Laparotomy Possible Bowel Resection, Possible Ostomy..." Continued review revealed the consent was signed by Patient #4 on 3/20/15 at 4:18 PM. Further review revealed no consent for a tubal ligation.

Medical record review of an Operative/Procedure Note completed by Physician #2 and dated 3/20/15 revealed the patient had an exploratory laparotomy (surgery using a scope to look into the abdominal or pelvic cavity) with surgical repair of a small mesenteric (a membrane like tissue that holds the bowel to the abdominal wall) and serosal (a thin membrane/tissue that covers abdominal organs) defect in the mid jejunum (part of the small intestine). Continued review revealed "...OPERATION PERFORMED...Exploratory Laparotomy...Extensive Lysis of Adhesions...Repair of serosal jejunal injury..." Continued review of the Operative/Procedure Note revealed no documentation a tubal ligation was performed, no documentation the patient was advised of possible sterilization occurring, and no documentation the patient gave consent for a tubal ligation procedure.

Medical record review of a discharge Code Summary dated 4/2/15 revealed "...V25.2 E [list of code numbers used to identify diagnoses and procedures for billing purposes] ENCOUNTER FOR STERILIZATION..."

Telephone interview with Patient #4 on 2/13/17 at 10:09 AM revealed she went to ASC #1 on 3/10/15 for an elective tubal ligation. Continued interview revealed "...[Physician #1]...perforated my bowel and the tubal was not done...they sent me by ambulance across the road to [Hospital #1] for me to have surgery to fix my bowel perforation...I had to wait all day for the surgeon [Physician #2] to come over from the surgery center and fix my bowel...I only consented to having my bowel repaired...I did not want the sterilization surgery now, I decided not to have it because without the ablation [surgical removal of tissue] at the same time it was not going to help me...I was supposed to have an endometrial [inner surface of the uterus] ablation done along with the tubal...I had researched it very well and without the ablation being done it was not going to help me...after I woke up after the surgery, [Physician #1] had told my husband that she [Physician #1] had 'snuck in and tied my tubes...since she [patient] was on the table I finished the job'...[Physician #1] told my husband it was not documented because it was not allowed in this hospital..." Further interview with Patient #4 confirmed the patient did not want a tubal ligation performed at the hospital on 3/20/15, did not sign a consent form for a tubal ligation at the hospital on 3/20/15, and was expecting the surgeon to only repair her bowel injury.

Telephone interview with Patient #4's husband on 2/13/17 at 10:29 AM revealed he remembered speaking with Physician #1 in the hospital waiting room at approximately 9:00 PM on 3/20/15. The patient's husband stated "...the doctor [Physician #1] came in, we were not expecting her, and said 'I just saw [Patient #4]...I gloved up and finished what I started...I could not document in the chart as this is a Catholic hospital...it is a don't ask don't tell situation'..." Further interview confirmed Physician #1 told him on 3/20/15 she had performed a tubal ligation on Patient #4 and had not documented this procedure in the medical record. Continued interview revealed after leaving the surgery center he and Patient #4 discussed the procedure and decided not to have the tubal ligation performed. Further interview with the patient's husband revealed he did not give consent for the tubal ligation to be performed at the hospital on 3/20/15, did not want the procedure, and was surprised when he was told the procedure was performed.

Telephone interview with Physician #1 on 2/14/17 at 1:15 PM revealed she remembered operating on Patient #4 on 3/20/15. Continued interview revealed the patient was scheduled for a laparoscopic tubal ligation at ASC #1 on the morning of 3/20/15. Further interview revealed at the beginning of the procedure the trocar (hollow tube with a sharp point used to insert a scope during surgery) used for the procedure was inadvertently inserted into the small bowel. Continued interview revealed Physician #1 contacted Physician #2 (General Surgeon at Hospital A) to consult on the case, and he told her to remove the trocar, discontinue the procedure, and transfer the patient to the hospital for observation and a possible surgery to repair the perforated bowel. Further interview revealed Physician #2 decided to do an exploratory laparotomy the afternoon of 3/20/15, and when Physician #1 arrived in the operating room, the patient was under anesthesia, the procedure was underway. When Physician #2 was finished with repairing the bowel perforation and removing multiple severe adhesions, Physician #1 performed the tubal ligation. Continued interview revealed "...I did not dictate it in the medical record..." Further interview with Physician #1 confirmed she did not obtain a signed informed consent form at the hospital for the tubal ligation procedure.

Interview with Physician #2 on 2/9/17 at 10:14 AM, in the Surgery Director's office, revealed he remembered Patient #4's surgical procedure at the hospital on 3/20/15. Further interview revealed a tubal ligation was performed on Patient #4 on 3/20/15, at the hospital by Physician #1. Further interview revealed "...it was not performed by me..." Further interview with Physician #2 revealed he did not know if the tubal ligation was documented in the medical record by Physician #1, but he did not document the procedure in his operative note because he did not perform the procedure.

Interview with the Director of Surgical Services (DSS) on 2/9/17 at 11:00 AM, in his office, confirmed there must be a consent form signed for every procedure documented in the medical record. Further interview confirmed the informed consent was not obtained and the facility failed to follow facility policy.

Interview with the facility's Risk Manager on 2/9/17 at 1:30 PM, in the Administration Conference Room, confirmed there was no informed consent executed for Patient #4's tubal ligation and the facility failed to follow facility policy.

Based on policy review, record review, and interviews the facility failed to document a complete and accurate operative report for one (#4) patient of 16 reveiwed.

The findings included:

Review of the facility's Contents of the Medical Record policy, effective date January 2012, revealed "...A Post-operative progress note shall be recorded by the surgeon prior to transfer of the patient from PACU...this note shall include the following...Procedure performed..."

Review of the medical record for Patient #4 revealed the patient was admitted to the facility on 3/20/15 for the surgical repair of an Latrogenic Enterotomy (a complication of surgery involving an unintended incision/perforation of the bowel) which occurred during an elective laparoscopic (scope used to perform a surgical procedure) tubal ligation (permanent sterilization of the female patient by cutting the fallopian tubes) at an Ambulatory Surgical Center (ASC #1). Further review revealed the Tubal Ligation was not performed at ASC #1.

Medical record review of an Informed Consent for Surgery/Treatment/Procedures form dated 3/20/15 revealed "...Exploratory Laparotomy Possible Bowel Resection, Possible Ostomy..."

Medical record review of an Operative/Procedure Note completed by Physician #2 and dated 3/20/15 revealed the patient had an exploratory laparotomy (surgery using a scope to look into the abdominal or pelvic cavity) with surgical repair of a small mesenteric (a membrane like tissue that holds the bowel to the abdominal wall) and serosal (a thin membrane/tissue that covers abdominal organs) defect in the mid jejunum (part of the small intestine). Continued review revealed the patient had multiple extensive adhesions (scar tissue) and lysis (removal) of these adhesions was performed. Further review revealed no documentation in the operative notes, progress notes, discharge summary, or elsewhere in the medical record of a tubal ligation performed on Patient #4. Continued review revealed "...was undergoing an elective laparoscopic tubal ligation by [Physician #1] today at [ASC #1]...a 5 mm [millimeter] trocar [a surgical instrument with a sharp point] was placed into a loop of small bowel...the patient was transferred to the hospital...After extensive discussion with the patient, she decided on an exploratory laparotomy...The risks, benefits, and alternatives were discussed with the patient including the possibility of bleeding, infection, sepsis, and even death...She understood these risks and agreed to proceed..." Further review of the Operative/Procedure Note revealed "...OPERATION PERFORMED...Exploratory Laparotomy...Extensive Lysis of Adhesions...Repair of serosal jejunal injury..." Continued review of the Operative/Procedure Note revealed no documentation a tubal ligation was performed, no documentation the patient was advised of possible sterilization occurring, and no documentation the patient gave consent for a tubal ligation procedure.

Medical record review of a discharge Code Summary dated 4/2/15 revealed "...V25.2 E [list of code numbers used to identify diagnoses and procedures for billing purposes] ENCOUNTER FOR STERILIZATION..."

Telephone interview with Patient #4 on 2/13/17 at 10:09 AM revealed she went to ASC #1 on 3/10/15 for an elective tubal ligation. Continued interview revealed "...[Physician #1]...perforated my bowel and the tubal was not done...they sent me by ambulance across the road to [Hospital #1] for me to have surgery to fix my bowel perforation...I had to wait all day for the surgeon [Physician #2] to come over from the surgery center and fix my bowel...I only consented to having my bowel repaired...I did not want the sterilization surgery now, I decided not to have it because without the ablation [surgical removal of tissue] at the same time it was not going to help me...I was supposed to have an endometrial [inner surface of the uterus] ablation done along with the tubal...I had researched it very well and without the ablation being done it was not going to help me...after I woke up after the surgery, [Physician #1] had told my husband that she [Physician #1] had 'snuck in and tied my tubes...since she [patient] was on the table I finished the job'...[Physician #1] told my husband it was not documented because it was not allowed in this hospital..." Further interview with Patient #4 confirmed the patient did not want a tubal ligation performed at the hospital on 3/20/15, did not sign a consent form for a tubal ligation at the hospital on 3/20/15, and was expecting the surgeon to only repair her bowel injury.

Telephone interview with Patient #4's husband on 2/13/17 at 10:29 AM revealed he remembered speaking with Physician #1 in the hospital waiting room at approximately 9:00 PM on 3/20/15. The patient's husband stated "...the doctor [Physician #1] came in, we were not expecting her, and said 'I just saw [Patient #4]...I gloved up and finished what I started...I could not document in the chart as this is a Catholic hospital...it is a don't ask don't tell situation'..." Further interview confirmed Physician #1 told him on 3/20/15 she had performed a tubal ligation on #4 and had not documented this procedure in the medical record.

Telephone interview with Physician #1 on 2/14/17 at 1:15 PM revealed she remembered operating on Patient #4 on 3/20/15. Continued interview revealed the patient was scheduled for a laparoscopic tubal ligation at ASC #1 on the morning of 3/20/15. Further interview revealed at the beginning of the procedure the trocar (hollow tube with a sharp point used to insert a scope during surgery) used for the procedure was inadvertently inserted into the small bowel. Continued interview revealed Physician #1 contacted Physician #2 (General Surgeon at Hospital A) to consult on the case, and he told her to remove the trocar, discontinue the procedure, and transfer the patient to the hospital for observation and a possible surgery to repair the perforated bowel. Further interview revealed Physician #2 decided to do an exploratory laparotomy the afternoon of 3/20/15, and when Physician #1 arrived in the operating room, the patient was under anesthesia, the procedure was underway. When Physician #2 was finished with repairing the bowel perforation and removing multiple severe adhesions, Physician #1 performed the tubal ligation. Continued interview revealed "...I did not dictate it in the medical record..."

Interview with the Director of Surgical Services (DSS) on 2/9/17 at 11:00 AM, in his office, confirmed all procedures performed must be documented in the medical record.

Interview with the facility's Risk Manager on 2/9/17 at 1:30 PM, in the Administration Conference Room, confirmed there was no documentation in the operative report Patient #4 had a tubal ligation performed and the facility failed to follow facility policy.