The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

TULARE REGIONAL MEDICAL CENTER 869 NORTH CHERRY AVENUE TULARE, CA 93274 Nov. 14, 2016
VIOLATION: GOVERNING BODY Tag No: A0043
Based on interviews and document reviews, the hospital failed to effectively govern the activities and conduct of the hospital's operations to provide safe and quality health care in accordance with the Governing Body (GB) bylaws, as evidenced by:

1. The GB failed to provide appropriate resources and support for surgical services to ensure safe and timely care for approximately 45 surgical patients per month, or approximately 500 surgical patients per year. Lengthy (taking between 2 and 8 hours), high-risk (e.g., patients with life threatening conditions, whose surgery posed a risk for life threatening complications), urgent and emergent surgeries were routinely performed during periods when the limited operating room resources (a single on-call surgical team) were needed to care for multiple surgeries at the same time. This failure resulted in delays for assessments and surgical operations and/or alterations in the surgical plan. These delays/alterations contributed to deterioration of patient conditions, medical complications, and/or death for three of six patient records reviewed (A, B, and C).

2. The failure to ensure that the Medical Staff was accountable for the quality of care provided to surgical patients when a shortage of operating room resources caused delays in treating high risk surgical cases. The medical staff failed to implement alternative procedures, or formally request solutions from the Governing Body in a timely manner. The delays put patients at risk for complications and contributed to deterioration and/or alteration in the surgical plan for three of six patient records reviewed (A, B, and C) [Refer to A-49].

3. The failure to ensure that surgical services were organized and provided in accordance with hospital policies and acceptable standards of practice, to ensure safe surgical care to all patients when:

a. Lengthy, high-risk, urgent and emergent surgeries were routinely performed during periods when the limited operating room resources (a single on-call surgical team) were needed to care for multiple surgeries at the same time [Refer to A-941].

b. High risk surgeries were performed without an assistant surgeon [Refer to A-941].

c. The hospital had only one Operating Room on-call surgical team to cover all emergency surgeries and emergent Caesarean sections (also known as a C-section, a surgical procedure used to deliver a baby through incisions in the mother's abdomen) between 5 PM, and 7 AM. The hospital had no plan to enforce their existing policy and procedures regarding surgical services; no criteria to discern different levels of surgical classifications; no plan on how to develop a second Operating Room surgical team; no plan on how to incorporate obstetrics into surgery policies and procedures [Refer to A-941].

These failures resulted in delays for assessments and surgical operations and/or alterations in the surgical plan. These delays/alterations put all surgical patients at risk, and contributed to deterioration of patient conditions, medical complications, and/or death for three of six patient records reviewed (A, B, and C).

Findings:

Review of the 5/22/13 Governing Body bylaws documented under Article I, Section 3-a Mission, "To provide safe, efficient, technologically advanced healthcare with respect for the diversity of our region." Section 3-c Values documented, "Quality: To provide high-quality care, based on the best practices and in collaboration with Medical Staff that exceeds patient expectations."

The GB bylaws Article III, Section 2-c, noted that the GB "shall determine the policies and procedures and shall have control of and be responsible for the overall operations and affairs of the district and its facilities, according to the best interests of the communities served by the District." Article VII, Section 5-a documented that the GB "shall assure that there is an efficient, effective, comprehensive and integrated solution focused Quality of Care/Patient Safety and Performance Improvement Program." Article VII, Section 5-c directed the medical staff and district staff to "implement and report on the activities and mechanisms for monitoring and evaluating the quality of patient care, for identifying and resolving patient care problems, and for identifying opportunities to improve patient care."

The cumulative effect of these systemic problems resulted in the hospital's inability to comply with the statutorily-mandated Condition of Participation for Governing Body.
VIOLATION: MEDICAL STAFF - ACCOUNTABILITY Tag No: A0049
Based on interviews and document reviews, the Governing Body (GB) failed to ensure the Medical Staff was accountable for the quality of care provided to surgical patients when a shortage of operating room resources caused delays in treating high risk (e.g., patients with life threatening conditions, whose surgery posed a risk for life threatening complications) surgical cases; the Medical Staff failed to implement alternative procedures or formally request solutions from the GB in a timely manner, in accordance with Medical Staff bylaws and policies. The delays put patients at risk for complications and contributed to deterioration and/or alteration in the surgical plan for three of six patient records reviewed (A, B, and C).

Findings:

Review of the 5/16/16 Medical Staff Bylaws under Preamble section, documented that the Bylaws provided a framework for organization for the Medical Staff "to discharge its responsibilities in matters involving the quality of medical care, to govern the orderly resolution of issues and the conduct of the Medical Staff functions supportive of those purposes, and to account to the Governing Body for the effective performance of Medical Staff responsibilities. The Medical Staff acknowledges that the Governing Body must act, directly or through its Manager, to protect the quality of medical care provided and the competency of the Medical Staff, and to ensure the responsible governance of the Hospital."

Medical Staff responsibilities listed in Section 1.4.2 included:

"(d) To establish and enforce, subject to the Governing Body approval, professional standards related to the delivery of health care within the Hospital.
(e) To account to the Governing Body for the quality of patient care through regular reports and recommendations concerning the implementation, operation, and results of the quality review and evaluation activities.
(f) To initiate and pursue corrective action with respect to members where warranted."

Section 10 described the organization of clinical services (which would include a surgery service) to be led by a service chief. Section 10.5.5 listed the roles and responsibilities for each service chief including:

"(h) Coordination and integration of interservice and intraservice services;
(i) Development and implementation of policies and procedures that guide and support the provision of care, treatment, and services;
(j) Recommendations for a sufficient number of qualified and competent persons to provide care, treatment, and services;
(l) Continuous assessment and improvement of the quality of care, treatment and services;
(m) Maintenance of quality control programs, as appropriate."

Concurrent review of Medical Staff Peer Review Committee (MSQRC) meeting minutes on 11/8/16 at 9:30 AM, with the Quality Manager (QM) indicated that incidents for three patients (A, B, and C) that occurred in 8/2016 and 9/2016, were referred for an outside peer review on 10/27/16. The QM stated that two of the incidents involved delays in performing surgeries and both patients died (A and B). A third incident involved the retention of a foreign object following surgery, for which additional surgery was performed (Patient C).

Review of patient records indicated that Patient A needed urgent surgery to control suspected bleeding from the lower bowel (intestines), but the surgery on 8/22/16 was delayed by about 12 hours for other urgent/emergent cases. Patient B's urgent/emergent surgery for a bowel obstruction with infection and strangulation (the stoppage of blood flow) of the bowel on 9/16/16 was delayed by more than 9 hours due to other emergent cases. Patient B's surgery was also interrupted and the surgical plan altered when the operating room team was needed for another emergent surgery. Patient C's complex surgery to reconnect portions of bowel on 9/29/16 was lengthy and required additional operating room staff to position the patient.

Per interviews on 10/26/16, beginning at 2 PM, with Medical Doctor (MD) 6, the Operating Room Director (ORD) and Surgical Technician (ST) 1, who was present at Patient C's surgery, toward the end of Patient C's case, operating room staff was called away to help with another emergent surgery case, thereby causing distraction for the instrument count and compromising the positioning which contributed to retention of a surgical device into Patient C's wound.

In an interview on 11/8/16, at 9:30 AM, the QM stated that she created a root cause analysis to evaluate various decision points by all providers who had a hand in Patient B's care. However, no procedures to formally guide the decisions when surgical emergencies were lined up and delayed, to either transfer patients to another hospital or have second on-call teams immediately available, had been implemented. Regarding Patient C's incident, the QM indicated that the short-staffing aspect of the incident was not discussed by medical staff or the quality committees. No referrals to other departments and/or groups to evaluate the impact of surgical staff shortages on patient safety resulted from this opportunity. In a review of the Performance Improvement (PI) Committee materials (tracking of quality indicators and data), the QM acknowledged that formal tracking of the delays for surgical emergencies, shortage of OR (Operating Room) team support, transfers of surgical patients due to insufficient resources, or provider practice patterns were not captured by the PI program.

In an interview on 11/8/16 beginning at 11:15 AM, the interim Operating Room Director (ORD) stated that for two years he had concerns for patient safety from lengthy complex surgical cases backing up emergent cases, mostly when one particular surgeon was on-call (MD 6). The hospital was a non-trauma, community hospital with only one on-call OR team (one anesthesiologist, one registered nurse, and one surgical technician) available afterhours (5 PM to 7 AM weekdays and all weekend hours). The strain on OR resources was frequently discussed at the ORD's internal weekly or monthly steering committee meetings. The ORD also expressed these concerns at Surgery and Anesthesia Department meetings in 2015. Since January of 2016, the medical staff was restructured and the ORD asked the current Surgery Committee Chair to address the concerns and bring the issue forward for solutions. However, formal meetings between the steering committee and the Surgery Committee and/or the Surgery Committee Chair were often canceled and had not yet occurred. The ORD prepared a log to show patterns and causes of delays for surgeries from 1/2016 to 9/2016. The ORD provided the log to the hospital Chief Executive Officer in an appeal for more resources. The ORD indicated that solutions had not been implemented, the same problems continued, and surgeries for urgent and emergent patients were still at times delayed. In some cases, errors were made and patient outcomes suffered. The Surgery Committee Chair was the same surgeon (MD 6) who drove many of the incidents about which the ORD was concerned.

In an interview on 11/1/16 at 2:30 PM, MD 9, an anesthesiologist and past Surgery Committee Chair prior to 1/2016, indicated that concerns about strains on the on-call operating room resources and delays in surgeries were discussed by the Surgery Committee in 2015. MD 9 stated that he requested the hospital administration to address how the surgical resources were utilized, but no solutions were enacted. MD 9 stated that he observed a preference for MD 6 to perform surgeries late in the day and at night, including cases that could be scheduled early in the day when three OR teams were available. To date, no efforts had changed MD 6's practice pattern of arranging for surgeries late in the day when resources were stretched thin.

Review of the OR Delay Log from 1/14/16 to 9/21/16 indicated that more than most other surgeons, surgical patients assigned to MD 6 experienced frequent delays of 2-4 hours, with comments that MD 6 had worked the previous night and was too tired to start cases at several scheduled times prior to 1 PM. MD 6 was also delayed from car problems and health issues. After hours cases done by MD 6 occurred on 1/19/16, 1/20/16, 2/23/16, 3/18/16, 3/29/16, 4/13/16, 4/15/16 (which included a 6 hour delay), 4/18/16, 4/22/16, 4/25/16, 5/2/16, 7/8/16, 8/22/16 (which included Patient A's 12 hour delay), 8/24/16 (which included a 7 hour delay), and 9/16/16 (which included Patient B's 9 hour delay). MD 6 also rescheduled cases to a Saturday (when only one on-call OR team was available) on two occasions, 3/25/16 and 7/8/16.

Review of Medical Executive Committee (MEC, the highest level of Medical Staff leadership) minutes, dated 11/5/15, documented under Obstetric (the branch of medicine and surgery concerned with childbirth and the care of women giving birth) Committee Report, "There needs to be full back-up coverage for emergency cases after hours. Currently after 4:30 p.m. no cases can be scheduled and should a patient come in that needs to have an emergency c-section [also known as a Caesarean section - a surgical procedure used to deliver a baby through incisions into the mother's abdomen] there can be a three or four hour wait to arrange for a back-up surgical team to be available. However, it has been noted that there are non-emergent cases that are being allowed to take place afterhours and on weekends." The MEC recommended that Administration assure full coverage for emergency cases afterhours and on weekends. "Currently there is only a skeleton crew for emergency cases, which puts patients at risk."

Review of the hospital's GB meeting minutes dated 1/26/16 documented a motion to terminate the hospital's relationship with its Medical Staff and adopt an arrangement with a new medical staff association comprised of virtually identical members but with different leadership designees.

Review of the monthly MEC minutes from the new leadership starting 1/2016 showed no documented discussion of delays in surgeries, impact on staff and patients, and over-utilization of the single on-call OR team until the 9/14/16 meeting. "Have been discussing with administration regarding having 2 surgeries simultaneously." "Great safety issue with not being able to provide two surgical crews at the same time (Referring to Emergency Cases)." The MEC minutes noted considerations for hiring additional surgical technicians, anesthesia providers, and a trained surgical assistant; but no discussion for evaluating the procedures for accepting surgical cases late in the day and afterhours, recruiting additional surgeons to share call, when to transfer surgical patients, or how to address the practice patterns of a surgeon who was largely driving the incidents behind these concerns (MD 6). No formal Recommendations or Actions were documented from the discussion. Minutes from the 10/12/16 MEC meeting noted approval of the 8/17/16 Surgery Committee and 9/12/16 Obstetric Committee reports; but no further discussions or solutions related to delays in surgeries or the competing needs of afterhours surgical patients were declared.

Similarly, no discussions or solutions related to delays in surgeries or the competing needs of afterhours surgical patients were documented in the GB minutes in all of 2015 and 2016 (through 10/11/16). Review of Medical Staff policies and procedures (P&Ps), effective since 1/26/16, showed no P&P to revise the organization of surgical services and provision of resources to meet the identified needs of surgical patients.

Review of Medical Staff policies, rules and bylaws showed no formal listing of the surgical procedures that required a surgical assistant. No policies set expectations for surgical practices to conform with nationally recognized organizational standards (e.g., procedures requiring a surgical assistant).

In an interview on 11/8/16 at 11:30 AM, the ORD stated that sometime in the past such a list existed but that he and anesthesia staff were unable to locate it.
VIOLATION: QAPI Tag No: A0263
Based on staff interview and record review, the hospital failed to ensure an effective Quality Assurance and Performance Improvement (QAPI) program in place to protect the safety of its patients when:

1. The hospital's Governing Body (GB) did not specify the detail and frequency of data collection for its QAPI program [Refer to A-273].

2. The hospital failed to correct the long-standing issues on Operating Room (OR) coverage which contributed to serious complications and patient deaths; failed to implement corrective actions and mechanisms after tracking and analyzing adverse patient events, and continued to put its patients' at risk for untoward outcomes [Refer to A-286].

3. The hospital failed to document the reasons why certain quality improvement projects are being conducted, and the measurable progress achieved on the projects [Refer to A-297].

4. The hospital's GB, Medical Staff, and administrative officials failed to ensure that patient safety were not compromised, when issues of OR coverage and faulty physician practice pattern were identified but not corrected; and the hospital did not provide evidence of approval of the GB on its formal QAPI programs, to have clearly written policy and procedures and budgeted resources -- approved by the GB after input from the Chief Executive Officer and medical staff leadership [Refer to A-309].

These failures resulted in the hospital's inability to ensure the provision of quality health care in a safe environment, due to lack of optimal and timely surgical care.

The cumulative effect of these systemic failures resulted in the inability of the hospital to comply with the statutorily-mandated Conditions of Participation for QAPI.
VIOLATION: PROGRAM SCOPE, PROGRAM DATA Tag No: A0273
Based on staff interview and document review, the hospital's Governing Body (GB) failed to specify the detail and frequency of data collection for its Quality Assurance and Performance Improvement (QAPI) programs, in accordance with GB Bylaws. This had the potential to not enable the GB to provide a clear overview and oversight for its QAPI programs.

Findings:

1. A concurrent staff interview and document review was conducted with the Quality Manager (QM) on 11/10/16, between 10:45 AM and 1:35 PM. The Quality improvement project binders, quality committee meeting minutes, board meeting minutes, GB Bylaws, hospital's policy on serious clinical adverse event and internal audit policy were reviewed. The QM showed multiple quality indicators that were tracked by various departments. When the surveyor asked to see the GB's approval for these projects with specifications of instruction on data collection, the QM was not able to provide such evidence. When asked, "Do you have formal approval of your projects by Governing Body?" QM replied, "No."

Subsequent review of the quality management system review meeting minutes, dated in 10/2016, indicated that the hospital plan was to reduce the departmental quality objectives from five to three, and set specific goals for each project. However, there were no specifics about how often each project will collect data and details for the data collection.

2. A concurrent staff interview and document review was conducted with the Chief Nursing Officer (CNO) on 11/10/16, between 1:35 PM and 3 PM. The CNO was able to demonstrate a poster on a QAPI project that was completed in 2015, called the "Provider in Triage" project. The project carried out a baseline study which showed that the rate of patient "Left without being seen (LWBS)" in the Emergency Department (ED) was 12-14%, and it decreased to 4% during the intervention period when a second Physician Assistant was added to the provider in the ED for 5 days a week. When asked, "Have your Governing Body approved this project?" The CNO replied, "Not formally." When asked whether there was any written evidence that this project was discussed at a board meeting, the CNO stated, "No."

Review of the hospital's GB Bylaws, adopted 5/2013, indicated in Article V, Section 4, "Hospital Committees", that Performance Improvement Committee's primary purpose "is to provide oversight of the [hospital]'s performance improvement activities, and to establish a consistent, systematic approach to improving organization wide improvement. A summary of Performance Improvement activities is to be submitted to the Board on periodic basis, but not less than semi-annually."
VIOLATION: PATIENT SAFETY Tag No: A0286
Based on interviews and document reviews, the hospital failed to implement corrective actions and mechanisms after tracking and analyzing patient adverse events; failed to correct the issues on Operating Room (OR) coverage which contributed to several serious complications, including patient deaths, in three of six patient records reviewed (A, B, and C) [refer to A-940, A-941], and continued to put its patients at risk for untoward medical outcomes.

These failures contributed to several serious complications, including patient deaths, and continued to put its patients' at risk for untoward medical outcomes.

Findings:

Concurrent review of medical staff peer review committee (MSQRC) meeting minutes on 11/8/16, at 9:30 AM, with the Quality Manager (QM) indicated that incidents for three patients (A, B, and C) that occurred in August and September of 2016, were referred for an outside peer review on 10/27/16. The QM stated that two of the incidents involved delays in performing surgeries and both patients died (A and B). A third incident involved the retention of a foreign object following surgery, for which additional surgery was performed (Patient C).

Review of patient records indicated that Patient A needed urgent surgery to control suspected bleeding from the lower bowel (intestines), but the surgery on 8/22/16 was delayed by about 12 hours for other urgent/emergent cases. Patient B's urgent/emergent surgery for a bowel obstruction with infection and strangulation (stoppage of blood flow) of the bowel on 9/16/16 was delayed by more than 9 hours due to other emergent cases. Patient B's surgery was also interrupted and the surgical plan altered when the operating room team was needed for another emergent surgery. Patient C's complex surgery to reconnect portions of bowel on 9/29/16 was lengthy and required additional operating room staff to position the patient. Per interviews on 10/26/16 at 2 PM, with Medical Doctor (MD) 6, the Operating Room Director (ORD) and Surgical Technician (ST) 1 who was present at Patient C's surgery, toward the end of Patient C's case, operating room staff was called away to help with another emergent surgery case, thereby causing distraction for the instrument count and compromising the positioning which contributed to retention of a surgical device into Patient C's wound.

In an interview on 11/8/16 at 9:30 AM, the QM stated that she created a root cause analysis to evaluate various decision points by all providers who had a hand in Patient B's care. However, no procedures to formally guide the decisions when surgical emergencies were lined up and delayed, to either transfer patients to another hospital or have second on-call teams immediately available, had been implemented. Regarding Patient C's incident, the QM indicated that the short-staffing aspect of the incident was not discussed by medical staff or quality committees. No referrals to other departments and/or groups to evaluate the impact of surgical staff shortages on patient safety resulted from this opportunity. In a review of the Performance Improvement (PI) Committee materials (tracking of quality indicators and data), the QM acknowledged that formal tracking of the delays for surgical emergencies, shortage of OR team support, transfers of surgical patients due to insufficient resources, or provider practice patterns were not captured by the PI program.

In an interview on 11/8/16 beginning at 11:15 AM, the interim Operating Room Director (ORD) stated that for two years he had concerns for patient safety from lengthy complex surgical cases backing up emergent cases, mostly when one particular surgeon was on-call (MD 6). The hospital was a non-trauma, community hospital with only one on-call OR team (one anesthesiologist, one registered nurse, and one surgical technician) available afterhours (5 PM to 7 AM weekdays and all weekend hours). The strain on OR resources was frequently discussed at the ORD's internal weekly or monthly steering committee meetings. The ORD also expressed these concerns at Surgery and Anesthesia Department meetings in 2015. Since January of 2016, the medical staff was restructured and the ORD asked the current Surgery Committee Chair to address the concerns and bring the issue forward for solutions. However, the ORD stated that the formal meetings between the steering committee and the Surgery Committee and/or the Surgery Committee Chair were often canceled and had not yet occurred. The ORD prepared a log to show patterns and causes of delays for surgeries from 1/2016 to 9/2016. The ORD provided the log to the hospital Chief Executive Officer in an appeal for more resources. The ORD indicated that solutions had not been implemented, the same problems continued, and surgeries for urgent and emergent patients were still at times delayed. In some cases, errors were made and patient outcomes suffered. The Surgery Committee Chair was the same surgeon (MD 6) who drove many of the incidents about which the ORD was concerned.

In an interview on 11/1/16 at 2:30 PM, MD 9, an anesthesiologist and past Surgery Committee Chair prior to 1/2016, indicated that concerns about strains on the on-call operating room resources and delays in surgeries were discussed by the Surgery Committee in 2015. MD 9 stated that he requested the hospital administration to address how the surgical resources were utilized, but no solutions were enacted. MD 9 stated that he observed a preference for MD 6 to perform surgeries late in the day and at night, including cases that could be scheduled early in the day when three OR teams were available. To date, no efforts had changed MD 6's practice pattern of arranging for surgeries late in the day when resources were stretched thin.

Review of the OR Delay Log from 1/14/16 to 9/21/16, indicated that more than most other surgeons, surgical patients assigned to MD 6 experienced frequent delays of 2-4 hours, with comments that MD 6 had worked the previous night and was too tired to start cases at several scheduled times prior to 1 PM. MD 6 was also delayed from car problems and health issues. After hours cases done by MD 6 occurred on 1/19/16, 1/20/16, 2/23/16, 3/18/16, 3/29/16, 4/13/16, 4/15/16 (which included a 6 hour delay), 4/18/16, 4/22/16, 4/25/16, 5/2/16, 7/8/16, 8/22/16 (which included Patient A's 12 hour delay), 8/24/16 (which included a 7 hour delay), and 9/16/16 (which included Patient B's 9 hour delay). MD 6 also rescheduled cases to a Saturday (when only one on-call OR team was available) on two occasions, 3/25/16 and 7/8/16.

Review of the Medical Executive Committee (MEC, the highest level of medical staff leadership) minutes dated 11/5/15, documented under Obstetric (the branch of medicine and surgery concerned with childbirth and the care of women giving birth) Committee Report, "There needs to be full back-up coverage for emergency cases after hours. Currently after 4:30 PM no cases can be scheduled and should a patient come in that needs to have an emergency Cesarean section [also known as a C-section, a surgical procedure used to deliver a baby through incisions in the mother's abdomen] there it can be a three or four hour wait to arrange for back-up surgical team to be available. However, it has been noted that there are non-emergent cases that are being allowed to take place afterhours and on weekends." The MEC recommended that Administration assure full coverage for emergency cases afterhours and on weekends. "Currently there is only a skeleton crew for emergency cases, which puts patients at risk. "

Review of the hospital's Governing Body (GB) meeting minutes dated 1/26/16 documented a motion to terminate the hospital's relationship with its Medical Staff and adopt an arrangement with a new Medical Staff association comprised of virtually identical members but with different leadership designees.

Review of the monthly MEC minutes from the new leadership starting 1/2016, showed no documented discussion of delays in surgeries, impact on staff and patients, and over-utilization of the single on-call OR team until the 9/14/16 meeting. "Have been discussing with administration regarding having 2 surgeries simultaneously." "Great safety issue with not being able to provide two surgical crews at the same time (Referring to Emergency Cases)."

The MEC minutes noted considerations for hiring additional surgical technicians, anesthesia providers, and a trained surgical assistant; but no discussion for evaluating the procedures for accepting surgical cases late in the day and afterhours, recruiting additional surgeons to share call, when to transfer surgical patients, or how to address the practice patterns of a surgeon who was largely driving the incidents behind these concerns (MD 6). No formal Recommendations or Actions were documented from the discussion. Minutes from the 10/12/16 MEC meeting noted approval of the 8/17/16 Surgery Committee and 9/12/16 Obstetric Committee reports; but no further discussions or solutions related to delays in surgeries or the competing needs of afterhours surgical patients were declared.

Similarly, no discussions or solutions related to delays in surgeries or the competing needs of afterhours surgical patients were documented in the GB minutes in all of 2015 and 2016 (through 10/11/16). Review of medical staff policies and procedures (P&Ps) effective since 1/26/16 showed no P&Ps to revise the organization of surgical services and provision of resources to meet the identified needs of surgical patients.
VIOLATION: EXECUTIVE RESPONSIBILITIES Tag No: A0309
Based on staff interview and document review, the hospital's Governing Body (GB), medical staff, and administrative officials failed to ensure, in accordance with GB bylaws, that patient safety were not compromised, after issues of Operating Room (OR) coverage and faulty physician practice pattern were identified; and the hospital did not provide evidence of approval of the GB on its formal Quality Assurance and Performance Improvement (QAPI) programs; to have clearly written policy and procedures, budgeted resources, and clearly identified responsible staff-approved by the GB after input from the Chief Executive Officer (CEO) and medical staff leadership.

These failures contributed to the occurrences of several serious complications, including patient deaths; continued to put patients at risk for untoward health care outcome; and had the potential to not enable the hospital carry out its QAPI program with adequate planning and resources to ensure the success of the programs and the quality of health care provided by the hospital.

Findings:

1. Concurrent review of medical staff peer review committee (MSQRC) meeting minutes on 11/8/16, at 9:30 AM, with the Quality Manager (QM) indicated that incidents for three patients (A, B, and C) that occurred in 8/2016 and 9/2016 were referred for an outside peer review on 10/27/16. The QM stated that two of the incidents involved delays in performing surgeries and both patients died (A and B). A third incident involved the retention of a foreign object following surgery, for which additional surgery was performed (Patient C).

Review of patient records indicated that Patient A needed urgent surgery to control suspected bleeding from the lower bowel (intestine), but the surgery on 8/22/16 was delayed by about 12 hours for other urgent/emergent cases. Patient B's urgent/emergent surgery for a bowel obstruction with infection and strangulation (stoppage of blood flow) of the bowel on 9/16/16 was delayed by more than 9 hours due to other emergent cases. Patient B's surgery was also interrupted and the surgical plan altered when the operating room team was needed for another emergent surgery. Patient C's complex surgery to reconnect portions of bowel on 9/29/16 was lengthy and required additional operating room staff to position the patient.

Per interviews on 10/26/16, at 2 PM, with Medical Doctor (MD) 6, the Operating Room Director (ORD) and Surgical Technician (ST) 1 who was present at Patient C's surgery, toward the end of Patient C's case, operating room staff was called away to help with another emergent surgery case, thereby causing distraction for the instrument count and compromising the positioning which contributed to retention of a surgical device into Patient C's wound.

In an interview on 11/8/16, at 9:30 AM, the QM stated that she created a root cause analysis to evaluate various decision points by all providers who had a hand in Patient B's care. However, no procedures to formally guide the decisions when surgical emergencies were lined up and delayed, to either transfer patients to another hospital or have second on-call teams immediately available, had been implemented. Regarding Patient C's incident, the QM indicated that the short-staffing aspect of the incident was not discussed by medical staff or quality committees. No referrals to other departments and/or groups to evaluate the impact of surgical staff shortages on patient safety resulted from this opportunity. In a review of the Performance Improvement (PI) Committee materials (tracking of quality indicators and data), the QM acknowledged that formal tracking of the delays for surgical emergencies, shortage of OR team support, transfers of surgical patients due to insufficient resources, or provider practice patterns were not captured by the PI program.

During an interview on 11/8/16, beginning at 11:15 AM, the interim Operating Room Director (ORD) stated that for two years he had concerns for patient safety from lengthy complex surgical cases backing up emergent cases, mostly when one particular surgeon was on-call (MD 6). The hospital was a non-trauma, community hospital with only one on-call OR team (one anesthesiologist, one registered nurse, and one surgical technician) available afterhours (5 PM to 7 AM weekdays and all weekend hours). The strain on OR resources was frequently discussed at the ORD's internal weekly or monthly steering committee meetings. The ORD also expressed these concerns at Surgery and Anesthesia Department meetings in 2015. Since January of 2016, the medical staff was restructured and the ORD asked the current Surgery Committee Chair to address the concerns and bring the issue forward for solutions. However, the ORD stated that formal meetings between the steering committee and the Surgery Committee and/or the Surgery Committee Chair were often canceled and had not yet occurred. The ORD prepared a log to show patterns and causes of delays for surgeries from 1/2016 to 9/2016. The ORD provided the log to the hospital CEO in an appeal for more resources. The ORD indicated that solutions had not been implemented, the same problems continued, and surgeries for urgent and emergent patients were still at times delayed. In some cases, errors were made and patient outcomes suffered. The Surgery Committee Chair was the same surgeon (MD 6) who drove many of the incidents about which the ORD was concerned.

In an interview on 11/1/16, at 2:30 PM, MD 9, an anesthesiologist and past Surgery Committee Chair prior to 1/2016, indicated that concerns about strains on the on-call operating room resources and delays in surgeries were discussed by the Surgery Committee in 2015. MD 9 stated that he requested the hospital administration to address how the surgical resources were utilized, but no solutions were enacted. MD 9 stated that he observed a preference for MD 6 to perform surgeries late in the day and at night, including cases that could be scheduled early in the day when three OR teams were available. To date, no efforts had changed MD 6's practice pattern of arranging for surgeries late in the day when resources were stretched thin.

Review of the OR Delay Log from 1/14/16 to 9/21/16, indicated that more than most other surgeons, surgical patients assigned to MD 6 experienced frequent delays of 2-4 hours, with comments that MD 6 had worked the previous night and was too tired to start cases at several scheduled times prior to 1 PM. MD 6 was also delayed from car problems and health issues. After hours cases done by MD 6 occurred on 1/19/16, 1/20/16, 2/23/16, 3/18/16, 3/29/16, 4/13/16, 4/15/16 (which included a 6 hour delay), 4/18/16, 4/22/16, 4/25/16, 5/2/16, 7/8/16, 8/22/16 (which included Patient A's 12 hour delay), 8/24/16 (which included a 7 hour delay), and 9/16/16 (which included Patient B's 9 hour delay). MD 6 also rescheduled cases to a Saturday (when only one on-call OR team was available) on two occasions, 3/25/16 and 7/8/16.

Review of the Medical Executive Committee (MEC, the highest level of medical staff leadership) minutes dated 11/5/15, documented under Obstetric (the branch of medicine and surgery concerned with childbirth and the care of women giving birth) Committee Report, "There needs to be full back-up coverage for emergency cases after hours. Currently after 4:30 p.m. no cases can be scheduled and should a patient come in that needs to have an emergency Cesarean section [also known as C-section, a procedure where a baby is surgically removed by a series of incisions into the mother's abdomen] there it can be a three or four hour wait to arrange for back-up surgical team to be available. However, it has been noted that there are non-emergent cases that are being allowed to take place afterhours and on weekends." The MEC recommended that Administration assure full coverage for emergency cases afterhours and on weekends. "Currently there is only a skeleton crew for emergency cases, which puts patients at risk."

Review of the hospital's GB meeting minutes dated 1/26/16 documented a motion to terminate the hospital's relationship with its Medical Staff and adopt an arrangement with a new Medical Staff association comprised of virtually identical members but with different leadership designees.

Review of the monthly MEC minutes from the new leadership starting 1/2016 showed no documented discussion of delays in surgeries, impact on staff and patients, and over-utilization of the single on-call OR team until the 9/14/16 meeting. "Have been discussing with administration regarding having 2 surgeries simultaneously." "Great safety issue with not being able to provide two surgical crews at the same time (Referring to Emergency Cases)."

The MEC minutes noted considerations for hiring additional surgical technicians, anesthesia providers, and a trained surgical assistant; but no discussion for evaluating the procedures for accepting surgical cases late in the day and afterhours, recruiting additional surgeons to share call, when to transfer surgical patients, or how to address the practice patterns of a surgeon who was largely driving the incidents behind these concerns (MD 6). No formal Recommendations or Actions were documented from the discussion. Minutes from the 10/12/16 MEC meeting noted approval of the 8/17/16 Surgery Committee and 9/12/16 Obstetric Committee reports; but no further discussions or solutions related to delays in surgeries or the competing needs of afterhours surgical patients were declared.

Similarly, no discussions or solutions related to delays in surgeries or the competing needs of afterhours surgical patients were documented in the GB minutes in all of 2015 and 2016 (through 10/11/16). Review of medical staff policies and procedures (P&Ps) effective since 1/26/16 showed no P&P to revise the organization of surgical services and provision of resources to meet the identified needs of surgical patients.

2. A concurrent staff interview and document review was conducted with the QM on 11/10/16 between 10:45 AM and 1:35 PM. Quality improvement project binders, quality committee meeting minutes, board meeting minutes, GB Bylaws, hospital's policy on serious clinical adverse event and internal audit policy were reviewed. The QM showed multiple quality indicators that were tracked by various departments. When the surveyor asked to see the GB's approval for these projects with specifications of instruction on data collection, the QM was not able to provide such evidence. When asked, "Do you have formal approval of your projects by governing body?" QM replied, "No."

The QM stated she was working on setting up Crisis Management Team to evaluate and address serious clinical adverse events (clinical event with untoward impact of harm or death on a patient). When asked whether she reported this plan to the board meeting or MEC meeting, she replied, "Not yet. The meetings are coming up ... ". QM further stated that the hospital's senior leadership team was working on increasing OR after hour coverage. When asked who the senior leadership team included, she replied, "They are the COO (Chief Operating Officer), CFO (Chief Financial Officer), CEO, and [name of the CNO, the Chief Nursing Officer]". When asked whether Medical Staff, such as Chief of Staff, Chief of Surgery, were involved, the QM replied, "No."

3. A concurrent staff interview and document review was conducted with CNO on 11/10/16 between 1:35 PM and 3 PM. The CNO was able to demonstrate a poster on a QAPI project that was completed in 2015, the "Provider in Triage" project. The project carried out a baseline study which showed that the rate of patient "Left without being seen (LWBS)" in Emergency Department (ED) was 12-14%, and it decreased to 4% during the intervention period when a second Physician Assistant was added to the provider in the ED for 5 days a week. When asked, "Have your Governing Body approved this project?" the CNO replied, "Not formally." When asked whether there was any written evidence that this project was discussed at a board meeting to specify the procedures and budgeted resources, the CNO stated, "No."

Review of the hospital's GB Bylaws, adopted 05/2013, Article I, indicated that the hospital's mission is "To provide safe, efficient, technologically advanced healthcare with respect for the diversity of our region." It further indicated in Article VII, Section 5, "Quality of Care/Patient Safety and Performance Improvement Program", that "a. The Board of Directors shall assure that there is an efficient, effective, comprehensive and integrated solution focused Quality of Care/Patient Safety and Performance Improvement Program. b. The Board of Directors delegates the authority and responsibility for carrying out the Quality of Care/Patient Safety and Performance Improvement Program to the Active Medical Staff and CEO, who in turn, shall demonstrate to the Board the effectiveness of such program for quality assurance ... c. The Medical Staff and District [referring the hospital] staff will implement and report on the activities and mechanisms for monitoring and evaluating the quality of patient care, for identifying and resolving patient care problems, and for identifying opportunities to improve patient care within the District."
VIOLATION: ORGANIZATION OF SURGICAL SERVICES Tag No: A0941
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interviews and document reviews, the hospital failed to ensure sufficient resources of qualified staff were available to meet the needs of approximately 45 surgical patients per month, and approximately 500 surgical patients per year, within the hospital's scope as a non-trauma community hospital, as evidenced by one surgeon (Medical Doctor [MD]) 6, performed high risk (e.g., patients with life threatening conditions, whose surgery posed a risk for life threatening complications), and lengthy (lasting between 2 and 8 hours) surgical cases without a surgical assistant after hours; despite existing hospital policy and procedure criteria for surgical services; the hospital had only one Operating Room (OR) on-call surgical team to cover all emergency surgeries and emergent Caesarean sections (also known as C-Sections, a procedure where a baby is surgically removed via a series of incisions into the mother's abdomen), (approximately 20 such cases per month), between 5 PM and 7 AM; hospital had no plan to enforce their existing policy and procedures regarding surgical services; no criteria to discern different levels of surgical classifications; no plan on how to develop a second OR surgical team; no plan on how to incorporate obstetrics (the branch of medicine and surgery concerned with childbirth and the care of women giving birth) into surgery policies and procedures; and no plan on how to ensure a second surgical assistant is available per standards of surgical practice [Refer to A-940].

Because of these issues in surgical services, an Immediate Jeopardy (IJ) was called on 11/9/16, at 2:50 PM, with the Chief Executive Officer, Chief Nursing Officer, Quality Director, and Quality Manager, in attendance. The details of the IJ were given as above, which put approximately 45 surgical patients per month, or approximately 500 surgical cases per year, at risk. Additionally, MD 6 was scheduled to be on-call for surgery from 11/7/16 to 11/13/16.

After accepting the hospital's Plan of Correction, the Immediate Jeopardy was abated on 11/14/16, at 2:30 PM, with the Chief Operating Officer and Chief Nursing Officer in attendance. The immediacy was removed on this date and time, and confirmed by the survey team.

These failures resulted in delays for assessments and surgical operations and/or alterations in the surgical plan. These delays/alterations put the approximate 45 per month, or 500 yearly, surgical patients at risk, and contributed to deterioration of patients' conditions, medical complications, and/or death for three of six patient records reviewed (A, B, and C).

Findings:

Review of patient records indicated the following:

1. Patient A, [AGE], was admitted on [DATE], for acute (of abrupt onset, often also connotes an illness that is of short duration, rapidly progressive, and in need of urgent care) bleeding from the rectum. Patient A's coexisting conditions included diabetes (unregulated sugar in the blood), high blood pressure, [DIAGNOSES REDACTED], and a heart rhythm disorder. Medical support treatments were provided to Patient A in the Intensive Care Unit (ICU). Intermittent drops in Patient A's blood count suggested continued bleeding between 8/9/16 and 8/21/16. Patient A's providers suspected the bleeding source was from rectal hemorrhoids (a swollen vein or group of veins in the area of the anus) and advised blood transfusions and surgery to remove the hemorrhoids. Patient A refused the advised treatments until 8/21/16, when blood transfusions were first given. On the morning of 8/22/16, Patient A consented to the surgery, to be performed by MD 6.

In a concurrent review of Medical Staff Quality Review Committee (MSQRC) meeting minutes with the Quality Manager (QM) on 11/18/15 at 9:30 AM, the QM indicated that concerns about delays in surgeries were brought to her attention since 6/2016. The QM stated that adverse outcomes for some patients of MD 6 were reviewed by the MSQRC and sent out for peer review by a neutral third party on 10/27/16. The 10/12/16 MSQRC meeting minutes documented a review of Patient A's care, "surgery was decided at 0845 (8:45 AM). Surgery was not performed until 2000 (8 PM). The case had to be stopped and the patient was moved out of OR due to an emergent c-section."

Further review of Patient A's medical record noted in a surgeon progress note written by MD 6, dated 8/22/16 at 2000 (8 PM), that Patient A "refused urgent hemorrhoidectomy [surgical removal of hemorrhoids] last night, said she would do it today... but I was already tied up with another emergency case." "I was called by RN [Registered Nurse] while I was still operating and told pt [patient] was bleeding heavily, had dropped BP [blood pressure], was tachy [high heart rate] to 170's [normal heart rate is 60-100 beats per minute]." [Intravenous] Fluids [Normal Saline, a salt water solution] and blood products were ordered. "Pt had poor IV [intravenous, or into the vein] access and ERMD [physician from the emergency room ] came up and placed right subclavian central line [a tube placed into the vein beneath the shoulder, for a rapid infusion of blood]." Heart rate was now 134 and patient was confused, cool and clammy. Large copious amounts of blood were exiting from her rectum. MD 6's impression was a life-threatening exsanguination (bleeding out) that required blood transfusion and surgery "ASAP" (as soon as possible).

Patient A's Anesthesia (insensitivity to pain, especially as artificially induced by the administration of gases or the injection of drugs before surgical operations) Record, dated 8/22/16, noted the arrival time to the operating room was 8:37 PM. Anesthesia was immediately begun and surgery started at 9:02 PM. No Surgical Assistant was in attendance. Per MD 6's Operative Report, dated 9/13/16, for a "Stapled internal hemorrhoidectomy", the hemorrhoids were not the source of the bleeding, but were surgically stapled shut. Another 500 milliliters (1/2 liter) of blood from higher in the colon (large intestine) was seen during surgery. The surgical plan was to call in a gastroenterologist (MD 3, a Medical Doctor that specializes in diseases of the stomach and intestines) to inspect the colon by way of a viewing device that was inserted into the rectum (colonoscopy), search for a bleeding source, repair it if possible, and be ready to open the abdomen to emergently excise (remove) the entire colon (abdominal colectomy) to control bleeding if needed.

However, as MD 6 was completing the initial hemorrhoidectomy and brief visualization of the rectum with a sigmoidoscope device (long hose with camera) at 9:37 PM, the OR and staff were immediately needed to perform an emergency Cesarean section (STAT C-section) to rescue a fetus (unborn baby) in distress from an obstetric patient in labor. MD 6 altered the surgical plan for Patient A by moving Patient A (still unconscious and under the effects of anesthesia with a breathing tube inserted into her lungs) out of the Operating Room and back to the ICU for MD 3 to perform the colonoscopy there at the bedside.

The Procedural Moderate Sedation Record for Colonoscopy documented that on 8/22/16, between 10:10 AM and 10:21 PM, MD 3 attempted the colonoscopy portion of the surgical plan, unsuccessfully due to "excessive blood clots" extending "35-40 cm (centimeters) from the anal verge." Patient A's sedation scale scores were above the optimal level (more sedated) despite no sedation administered throughout the procedure. MD 3 was unable to see a bleeding source, active bleeding continued, and Patient A's blood pressure dropped to a level below normal. At 10:53 PM, Patient A was brought back to the operating room (c-section was over) for an emergency total abdominal colectomy. Surgery time was recorded as 10:56 PM to 12:14 AM.

Findings from the Operative Report, dated 9/13/16, for a "Emergency total abdominal colectomy", documented that a tumor (a swelling of a part of the body caused by an abnormal growth of tissue) had invaded the colon and large pelvic blood vessels, as the likely source of the bleeding. Intraoperative blood loss was estimated at 2 liters. Despite transfusions of 8 units of blood and other fluids, Patient A's bleeding continued after return to the ICU, where she failed to respond to rescue efforts. Patient A died at 2:30 AM.

During an interview on 11/8/16, at 9:30 AM, the QM acknowledged that the delay to perform surgery on Patient A on 8/22/16, was in part due to MD 6 being tied up all day with other surgical cases, and that the alterations in the surgical plan at 9:37 PM occurred because of insufficient surgical resources and staff, and competing needs of other surgical emergency cases. The QM acknowledged that the disruption of Patient A's surgical plan added 30-60 minutes of delays to locate the bleeding source, during which time bleeding continued and further compromised Patient A's ability to respond to supportive and rescue measures.

2. Patient B, [AGE], presented to the hospital Emergency Department (ED) triage on 9/16/16 at 10:50 AM, with complaints of abdominal pain for 5 days, vomiting all food and fluids, no urine production, and a history of ventral hernia (weakness in the stomach muscles that cause contents of the abdominal cavity to protrude and get pinched off) repair four years ago. ED care included orders for laboratory tests and imaging studies. A CT (computerized tomography, type of imaging x-ray) of the abdomen showed possible strangulated bowel (intestine that had had blood flow stopped) in the ventral hernia protrusion (a surgical emergency). The first ED nursing assessment was documented at 1 PM, a dictated note by an ED physician was documented at 1:17 PM, "discussed with surgeon" and "Admit to Surgery."

However, Patient B was not moved to a surgical inpatient bed or intensive care unit, but stayed in the ED. Between 1:30 PM and 8:29 PM, brief entries by ED staff recorded vital signs, pain scores, administration of antibiotic and narcotic (a strong and addictive type of) pain medications, insertion of a plastic tube (catheter) into the urinary bladder, and fluids administered into the vein via catheter. At 2:45 PM, MD 6 (the admitting surgeon) documented an impression of "SBO [small bowel obstruction] with incarcerated [where the intestine is pinched off, thereby stopping blood flow, and a medical emergency] ventral incision hernia [a hernia near the site of a previous hernia], possible strangulated [stoppage of blood flow, and a medical emergency] hernia, severe dehydration [loss of fluid and vital chemicals], septic [infection in the bloodstream, a medical emergency] and hypovolemic shock [an emergency condition in which severe blood or fluid loss makes the heart unable to pump enough blood to the body, and can cause many organs to stop working], being resuscitated in prep for OR." ED staff noted a call to the admitting surgeon (MD 6) at 7:10 PM to report that Patient B's blood pressure was too low. No insertion of a tube (often a standard of practice) to decompress Patient B's intestine (which was obstructed by the strangulated hernia) was documented.

At 7:45 PM, MD 6 recorded a preoperative history and physical assessment (H&P). The H&P, dated 9/17/16, noted that Patient B was possibly infected and dehydrated, and in shock but being supported in preparation for surgery. Patient B's temperature was mildly elevated, her abdomen was tender with redness over the incarcerated hernia site, her skin was pale, cold and clammy.

At 10:30 PM, a Pre-anesthesia Assessment, dated 9/16/16, by an anesthesiologist noted Patient B to be at high risk for surgery. The Anesthesia start time was 11 PM. Immediately upon administration of anesthesia medications, and placement of a breathing tube into the lungs, Patient B vomited bowel contents into the mouth and lungs. Heart and lung function declined such that a Code Blue was called at 11:15 PM to perform advanced live-saving rescue maneuvers. Copious bleeding from the breathing tube occurred. The rescue attempts were unsuccessful and Patient B died at 12:25 AM.

The Operative Report and Death Note, dated 9/17/16, documented by MD 6 noted, "we concurrently had two separate emergencies, which required the operating room. One of these was an acutely bleeding patient who required immediate surgery. This was followed by a stat c-section. This patient was brought to the OR after the stat c-section."

In a concurrent review of the MSQRC meeting minutes, on 11/8/16 at 9:30 AM, the QM acknowledged that Patient B's surgery to relieve a life-threatening bowel obstruction was delayed and the delay may have further compromised Patient B's ability to respond to rescue efforts. The MSQRC minutes addressed a complaint by Patient B's family about why Patient B was not transferred knowing that the surgical department had placed other emergency cases before hers. "Time admitted was 1345 (1:45 PM) and time to OR (Operating Room) was 2300 [11:00 PM], this was a total of 9 hours and 15 minutes before surgery." The QM stated she created a root cause analysis to evaluate various decision points by all providers who had a hand in Patient B's care. However, no procedures to formally guide the decisions when surgical emergencies were lined up and delayed, to either transfer patients to another hospital or have second on-call teams immediately available, had been implemented.

3. In interviews on 10/26/16, between 2 PM and 5 PM, MD 6, the ORD, and Surgical Technician (ST 1, who was present during Patient C's 9/29/16 surgery), were interviewed about Patient C's surgery. The ORD and ST 1 both stated it was determined that several operating room staff were needed to position Patient C on the surgical table at the beginning of the case. But at the end of the case, staff had been called to help with another emergency obstetric case and fewer persons were available to position Patient C back to a gurney. During Patient C's surgery, MD 6 did not have a surgical assistant to hold retractors and help keep track of instrument utilization.

MD 6 stated the retractor device that she usually used was out of stock, and a yellow plastic retractor device called a SurgiFish was used instead. Patient C's abdomen was very large. The SurgiFish device was set to one side of the portion of a wound that was left open at the end of the case. As Patient C was turned, no staff noticed that the device slid into the open wound and was not identified as missing during the instrument counts. MD 6 stated the other emergent case distracted members of Patient C's surgical team during the counting of instruments. MD 6 stated that on 10/9/16, as Patient C was developing more abdominal pain, an x-ray identified a suspicious image consistent with the SurgiFish retractor inside the open wound (which was not visible from the outside). On 10/10/16, an additional surgery was required to remove the Fish retractor device.

In an interview on 10/26/16, at 1:10 PM, the QM acknowledged that the competing emergency surgeries on 9/28/16 left Patient C's case short-handed, and may have contributed to distraction in counting instruments and more difficulty in positioning, thereby allowing the SurgiFish retractor to slide into the wound and not be noticed.

During a record review for Patient C, the document titled "Final Report", dated 10/29/16, indicated she was [AGE] years old, and morbidly obese with many prior abdominal surgeries that chronically compromised her digestive function. Patient C was admitted on [DATE] for treatment of a chemical burn to the skin and tissue of an ostomy port (small intestine was temporarily diverted to open directly to the outside through the abdominal wall while portions of the remaining intestine were healing) that resulted from seepage of intestinal contents onto the surrounding abdominal skin. A reversal of the ostomy to reconnect the bowel passage, and to release adhesions between intestine and wall, was planned for 9/29/16 and expected to be a surgery lasting several hours. Per the Anesthesia Record, dated 9/29/16, Patient C weighed 278 pounds. Surgery started at 2:49 PM, and ended at 8:03 PM.

In a concurrent interview and record review of the MSQRC meeting minutes on 11/8/16 at 9:30 AM, the QM acknowledged that the retained foreign object incident for Patient C was noted in 10/12/16 minutes and referred for outside peer review. However, the QM stated the incident was not discussed with the short-staffing aspect as contributing to the incident. No referrals to other departments and/or groups to evaluate the impact of surgical staff shortages on patient safety resulted from this opportunity. In a review of the Performance Improvement (PI) Committee materials (tracking of quality indicators and data), the QM acknowledged that formal tracking of the delays for surgical emergencies, shortage of the OR team support, transfers of surgical patients due to insufficient resources, or provider practice patterns were not captured by the PI program.

In an interview on 11/8/16, beginning at 11:15 AM, the interim Operating Room Director (ORD) explained that elective and urgent surgeries were typically scheduled during the day between 8 AM and 5 PM. The hospital was not a trauma center and had only one on-call OR team (one anesthesiologist, one registered nurse, one surgical technician) available between 5 PM and 7 AM for emergent surgeries. The ORD said that the on-call team could support Level I surgeries (a life/limb/organ-threatened case that must start now or bump the next available room), and some Level II cases (case must start within two hours). The Level classifications were defined in Surgery and Medical Policy 12-3038.

The ORD further indicated that over the past 2 years as interim ORD, he had expressed concerns about the stresses and impacts on his on-call OR staff when multiple urgent and emergent surgeries were requested simultaneously by general surgeons and obstetricians. Complex abdominal surgeries for bowel obstruction or ruptured organs could take 6-8 hours. Emergency Cesarean section cases to rescue a distressed fetus during labor routinely occurred without warning, as the hospital had an active obstetric service. The OR team would get very tired and sometimes the same staff were needed to work the next day. Of the three general surgeons on staff, two surgeons split their availability such that each covered call for 1-3 week blocks averaging 50% for each month. The incidents ORD was most concerned about, however, tended to occur mostly when one particular surgeon (MD 6) covered for emergencies after hours and on weekends. That particular surgeon also performed most of the complex surgeries "solo," without a qualified surgical assistant. Decisions to accept complex cases, and when to do them, were "physician driven." The OR managers and teams had no authority to participate in the decisions or to recommend transfer for urgent cases to other hospitals, even though a well-equipped trauma center was located 15 miles away.

Review of on-call schedules for surgical services between 6/2016 and 11/2016, confirmed that MD 6 was assigned to an average of 50% of the days, in 1-3 week blocks. It was noted that in 7/2016, MD 6 covered 20 out of 31 days; in 8/2016, MD 6 covered 22 out of 31 days. MD 6 was scheduled to cover call from 11/7/16 to 11/13/16.

In the 11/8/16, at 11:15 AM interview, the ORD stated that the strain on OR resources was frequently discussed at the ORD's internal weekly or monthly steering committee meetings. The ORD also expressed these concerns at Surgery and Anesthesia Department meetings in 2015. Since 1/2016, the medical staff was restructured and the ORD asked the current Surgery Committee Chair to address the concerns and bring the issue forward for solutions. However, the ORD stated that the formal meetings between the steering committee, the Surgery Committee, and/or the Surgery Committee Chair were often canceled and had not yet occurred. The ORD prepared a log to show patterns and causes of delays for surgeries from 1/2016 to 9/2016. The ORD provided the log to the hospital Chief Executive Officer in an appeal for more resources. The ORD indicated that solutions had not been implemented, the same problems continued, and surgeries for Level I and Level II patients were still at times delayed. In some cases, errors were made and patient outcomes suffered. The Surgery Committee Chair was the same surgeon (MD 6) who drove many of the incidents about which the ORD was concerned.

Review of the OR Delay Log from 1/14/16 to 9/21/16, indicated that more than most other surgeons, surgical patients assigned to MD 6 experienced frequent delays of 2-4 hours, with comments that MD 6 had worked the previous night and was too tired to start cases at several scheduled times prior to 1 PM. MD 6 was also delayed from car problems and needing physical therapy and knee injections. After hours cases occurred on 1/19/16, 1/20/16, 2/23/16, 3/18/16, 3/29/16, 4/13/16, 4/15/16 (which included a 6 hour delay), 4/18/16, 4/22/16, 4/25/16, 5/2/16, 7/8/16, 8/22/16 (which included Patient A's 12 hour delay), 8/24/16 (which included a 7 hour delay), and 9/16/16 (which included Patient B's 9 hour delay). MD 6 rescheduled cases to a Saturday when only one on-call OR team was available on 3/25/16 and on 7/8/16.

Review of Policy 12-3038 titled "Surgery and Medical Procedures," approved 10/28/15, under item IV-B-2 and 3, described the procedures for scheduling emergency surgeries. The Level classification was defined as the ORD stated. All Level I and II cases were to be reviewed by the Surgical Steering Committee. The treating surgeon was responsible to assign the Level of urgency. Any dispute over the Level would be settled by the service chief (which would be the Surgery or Obstetric Committee Chair for these incidents). The treating surgeon was responsible to notify the anesthesia provider and the nursing supervisor.

However, during the interview on 11/8/16, at 11:15 AM, the ORD acknowledged that there were no procedures for anesthesia or nursing managers to set limits on whether the case could be accepted, or to call in additional staff, if operating room resources were inadequate to manage concurrent surgeries.

In an interview on 11/1/16, at 2:30 PM, MD 9, an anesthesiologist and past Surgery Committee Chair prior to 1/2016, indicated that concerns about strains on the on-call operating room resources and delays in surgeries were discussed by the Surgery Committee in 2015. MD 9 stated that he requested the hospital administration to address how the surgical resources were utilized, but no solutions were enacted. MD 9 stated that he observed a preference for MD 6 to perform surgeries late in the day and at night, including cases that could be scheduled early in the day when three OR teams were available. MD 9 described situations that put patients in jeopardy. For example, minimally invasive surgeries (e.g., laparoscopic where a device to visualize the contents within the abdomen through a small cut of the skin) were done late in the day when they may have safely been performed early the following day. Then during the case an emergency Cesarean section was needed and staff had to "go down the list" of operating room personnel to get a second OR team to come in. Delays would occur if people could not be reached or were unavailable. The past response from the hospital Chief Executive Officer (CEO) was "No" for a second on-call OR team, and no efforts had changed MD 6's practice pattern of arranging for surgeries late in the day when resources were stretched thin.

In an interview on 11/3/16, beginning at 11:45 AM, the hospital CEO and Chief Operations Officer (COO) identified more operating room staff coverage, including anesthesia providers, surgeons and assistant surgeons, and OR team personnel for afterhours and weekends as a major need for the hospital's surgical services.

Review of the current medical staff policies, rules and bylaws showed no formal listing of the surgical procedures that required a surgical assistant. In an interview on 11/8/16, at 11:30 AM, the ORD stated that sometime in the past such a list existed but that he and anesthesia staff were unable to locate it.

In an interview on 11/8/16 at 11:15 AM, the ORD indicated that the hospital had limited surgical capabilities for adults and not all surgical specialties were available. The ORD indicated that Level I and II emergencies for children, trauma patients, and patients needing some surgical specialties, were routinely transferred to appropriate hospitals that did have capability to care for the patients. For example, women in labor with high-risk obstetric needs were transferred to a center with the ability to care for newborns with special needs if delivery was not imminent. The ORD stated that when adult patients with general surgery conditions were "lining up" and competing for the operating room resources, one of the two on-call surgeons would transfer such patients to a hospital that had capability. However, the ORD stated that MD 6 would commonly NOT transfer patients, and would over-commit to take on more than the hospital was prepared to manage.

Review of the current transfer agreements indicated that the hospital did have active arrangements with an ambulance transport company, with two trauma centers located 15 and 45 miles away respectively, with a children's hospital, and with another community hospital of capability similar to this hospital located 20 miles away. The hospital formally participated in an area-wide network intended to expedite the timely transfer of patients and records when emergency patients and inpatients needed specialized care for which the hospital did "not have the capacity or capability, including resources that are temporarily unavailable."
VIOLATION: QAPI PERFORMANCE IMPROVEMENT PROJECTS Tag No: A0297
Based on staff interview and document review, the hospital failed to document the reasons why certain quality improvement projects are being conducted and the measurable progress achieved on the projects. This failure had the potential to not enable the hospital to clearly recognize the impact of the Quality Assurance and Performance Improvement (QAPI) project on health care quality and effectively monitor its progress.

Findings:

A concurrent staff interview and document review was conducted with the Chief Nursing Officer (CNO) on 11/10/16, between 1:35 PM and 3 PM. The CNO was able to demonstrate a poster about a QAPI project that was completed in 2015, the "Provider in Triage" project. The project carried out a baseline study which showed that the rate of patient "Left without being seen (LWBS)" in Emergency Department (ED) was 12-14%, and it decreased to 4% during the intervention period when a second Physician Assistant was added to the provider in the ED for 5 days in a week. The CNO stated that in her presentation to the leadership team for the hospital, the leadership was aware that decreasing the rate of LWBS was beneficial for the quality of health care. When asked whether she can provide formal documentation of the reasons why this project was chosen, and what the goal and expectations were, the CNO stated "There were no written explanation of the project". The CNO further stated that these questions were not formally addressed.
VIOLATION: SURGICAL SERVICES Tag No: A0940
Based on interviews and document reviews, the hospital failed to ensure that surgical services were organized and provided in accordance with hospital policies and acceptable standards of practice to ensure safe care to approximately 45 surgical patients per month, and approximately 500 surgical patients per year, when:

1. High-risk (e.g., patients with life threatening conditions, whose surgery posed a risk for life threatening complications), lengthy (taking between 2 and 8 hours), urgent and emergent surgeries, were routinely performed during periods when the limited operating room resources (a single on-call surgical team) were needed to care for multiple surgeries at the same time [Refer to A-941].

2. Hospital had no plan to ensure high risk surgeries were performed with an assistant surgeon per standards of surgical practice [Refer to A-941].

3. Hospital only had one Operating Room (OR) on-call surgical team to cover all emergency surgeries and emergent Caesarean sections (also known as C-Sections, a procedure where a baby is surgically delivered via a series of incisions into the mother's abdomen), affecting an average of approximately 20 C-Sections per month, between 5 PM and 7 AM [Refer to A-941].

4. Hospital had no plan to enforce their existing policy and procedure regarding surgical services [Refer to A-941].

5. Hospital had no criteria to discern between different levels of surgical classifications [Refer to A-941].

6. Hospital had no plan on how to develop a second OR [Refer to A-941].

7. Hospital had no plan on how to incorporate obstetrics (the branch of medicine and surgery concerned with childbirth and the care of women giving birth) into surgery policies and procedures [Refer to A-941].

Because of these issues, an Immediate Jeopardy (IJ) was called on 11/9/16, at 2:50 PM, with the Chief Executive Officer and Chief Nursing Officer, Quality Director, and Quality Manager, in attendance.

After accepting the hospital's Plan of Correction, the IJ was abated on 11/14/16, at 2:30 PM, with the Chief Operating Officer and Chief Nursing Officer in attendance.

The cumulative effect of these systemic problems resulted in the hospital's inability to comply with the statutorily-mandated Condition of Participation for Surgical Services.