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The facility failed to ensure the following:


1. That there was a written, defined process for Medical Doctor (MD) coverage of Obstetrics and Gynecology (OB/Gyn) patients. This practice increased the risk of a poor health outcome for all OB/Gyn patients. (Refer A-0049 and A-0338).



2. That the Labor and Delivery department (L & D) was following hospital policy and procedure for the prevention of a Retained Surgical Instrument (RSI - surgical instruments unintentionally retained during surgery) during the initial instrument count process. (Refer to A-0263)



The cumulative effect of this systemic problem resulted in the failure of the hospital to deliver care in a safe setting in order to be in compliance with the Condition of Participation for CFR 482.12 Condition of Participation: Governing Body.



34959

Based on interview and record review, the Governing Body did not ensure there was a written, defined process for physician coverage of Obstetrics and Gynecology (Ob/Gyn) patients. This practice increased the risk of a poor health outcome for all facility Obstetrics and Gynecology patients.

Findings:

During an interview with Medical Doctor 1 (MD 1), on January 21, 2016, at 6:00 PM, he stated there was no Obstetrician (MD who delivers babies) present in the hospital 24 hours a day. He stated the physician on-call (ready and available by phone) group has always provided medical care coverage for the unassigned patients (patients without an MD) and stated that a new agreement has been written so they will also cover the assigned patients (patients with an MD) whose assigned physician is not immediately available. He also stated there was "no policy" regarding the specifics of the OB/Gyn MD coverage. He stated, "Everyone knows."

During an interview with MD 2, on January 22, 2016, at 10:20 AM, he stated he was the physician on-call for OB/Gyn. He stated he was responsible for his own group of patients, unassigned pregnant patients, and OB/Gyn Emergency Department patients. When asked if the on-call group had a contract to provide medical services to facility assigned patients, whose assigned physician is not immediately available, he stated, "It's not official, as a courtesy."

During an interview with Governing Board Member 1 (GB 1), on January 22, 2016, at 2:40 PM, he stated, "I expect appropriately trained professionals at the patient bedside." When asked, what the facility back-up plan was, if the assigned physician was not immediately available, he stated, "Not certain."

The contract titled, "Fifth Amendment to Restated Emergency Department Obstetrics/Gynecology Coverage Agreement," dated November 4, 2015, indicated..."2. Coverage Services. Group shall cause one or more Group Physicians in the Specialty to be available on an on-call basis to provide medical care and treatment of Patients, including patients with an assigned physician whose assigned physician is not immediately available (the "Services"), upon the terms and subject to the conditions set forth in this agreement..."

The facility Governing Body Bylaws titled "Amended and Restated Bylaws of Community Hospital of San Bernardino," dated December 15, 2009, indicated "...Article IV. Medical and Professional Staffs, and Quality Assurance... Section 5. Quality of Care. (a) The Board of Directors is responsible for ensuring that quality patient care and services are provided within the Hospital."




34959

The facility failed to ensure the following:


1. That there was a written, defined process for Medical Doctor (MD) coverage of Obstetrics and Gynecology (OB/Gyn) patients. This practice increased the risk of a poor health outcome for all OB/Gyn patients. (Refer A-0347)



2. That the Labor and Delivery department (L & D) was following hospital policy and procedure for the prevention of a Retained Surgical Instrument (RSI - surgical instruments unintentionally retained during surgery) during the initial instrument count process. (Refer to A-0309)

The cumulative effect of this systemic problem resulted in the failure of the hospital to deliver care in a safe setting in order to be in compliance with the Condition of Participation for CFR 482.21 Condition of Participation: Quality Assessment and Performance Improvement Program.



34959

Based on interview and record review, the facility failed to ensure the following:

1. That there was a written, defined process for MD coverage of Obstetrics and Gynecology (OB/Gyn) patients. This practice increased the risk of a poor health outcome for all OB/Gyn patients.

2. That the Labor and Delivery department (L & D) was following hospital policy and procedure for the prevention of a retained foreign body during the initial instrument count process.


3. That the staff member's learning from the education on prevention of Retained Surgical Items (RSI - surgical instruments unintentionally retained during surgery), was consistent with the facility's policy and procedure. This had the potential to result in failure to implement the hospital's policy and procedures safely and accordingly.

Findings:

1. During an interview with Medical Doctor 1 (MD 1), on January 21, 2016, at 6:00 PM, he stated there was no Obstetrician (MD who delivers babies) present in the hospital 24 hours a day. He stated the physician on-call (ready and available by phone) group has always provided medical care coverage for the unassigned patients (patients without an MD) and stated that a new agreement has been written so they will also cover the assigned patients (patients with an MD) whose assigned physician is not immediately available. He also stated there was "no policy" regarding the specifics of the Ob/Gyn MD coverage. He stated, "Everyone knows."

During an interview with MD 2, on January 22, 2016, at 10:20 AM, he stated he was the physician on-call for Ob/Gyn. He stated he was responsible for his own group of patients, unassigned pregnant patients, and Ob/Gyn Emergency Department patients. When asked if the on-call group had a contract to provide medical services to facility assigned patients, whose assigned physician is not immediately available, he stated, "It's not official, as a courtesy."

During a group interview with Quality Assurance staff, on January 22, 2016, at 3:05 PM, when asked about the written policy and procedures for the on-call coverage of the Ob/Gyn patients, the Senior Director Quality/Infection Control (SDQ/IC) stated "hospital policies don't always come through quality (a quality committee that meets to improve the quality of medical services)."

The Medical Staff Bylaws, dated January 28, 2015, indicated "...G. Department Chair Responsibility...5. be a member of the medical executive committee, and give guidance on the overall medical policies of the medical staff and hospital and make specific recommendations and suggestions regarding the department;"






33549

2. During an observation on January 19, 2016, at 10:25 AM, in the labor and delivery operating room (L&D OR), the Circulating (a nurse who coordinates the flow of the surgery) Nurse (RN 2), conducted the initial (first) instrument count with the Surgical Scrub Technician (SST - passes desired surgical instruments to the surgeon) without completing the required preprinted instrument count sheet.

During an interview with RN 2, on January 19, 2016, at 4:30 PM, RN 2 stated she did not know she was supposed to use the preprinted count sheet (an itemized list of instruments needed for the surgical case) when conducting the initial count of instruments with the SST. She stated she was not aware she was supposed to sign the count sheet after completing the initial count, and return it to the central processing (an area in the hospital that stores hospital equipment that require sterilization, or cleaning with specific chemicals, for reuse such as, surgical instruments) department with the instruments used in the operation.

Concurrently, she stated for as long as she has worked in the department, she has never used the instrument count sheet, and was unaware of the hospital's policy and procedure for completing the count sheet.

There was no observation of the preprinted instrument count sheet being used during the initial instrument count between RN 2 and the SST. RN 2 stated the instrument count sheet was in her pocket.

During an interview with the SST, on January 19, 2016, at 4:30 PM, the SST stated he is a Travel Surgical Scrub (works for an agency contracted by the hospital for services) and does his own count when setting up the instrument table, and again when the circulating nurse is ready to do the initial count. He stated he gives the check list to the circulating nurse but was not aware of the hospital's policy and procedure for completing the instrument check list.

During an interview with the Registered Nurse Manager for Labor and Delivery (RNM for L&D), on January 21, 2016, at 10:42 AM, she stated she was not aware the instrument check list was to be completed during the initial count, signed, and returned to the central processing department.

During a concurrent interview with the hospital's Director of Surgical Services (DSS), on January 21, 2016, at 10:42 AM, he stated the purpose of the checklist was to have an accurate account of all functional instruments and of any damaged packaging that would cause the contents to be contaminated. The DSS stated the check list is to be used during the count of instruments, signed by the nurse who completed the count, and returned with the instrument tray after surgery.

A review of the hospital's document titled "Surgical Count (includes all Surgical Items) - A Learning Module" dated September 2015, indicated "Surgical Count...The surgical count is performed to identify any packaging errors and to monitor the number of items used during the operation or procedure...The Registered Nurse (RN) is responsible for documenting all counts appropriately."

The hospital's policy and procedure titled "Prevention of Retained Surgical Items...Hospital Wide" dated June, 2011, indicated the "Purpose...1.0 To provide safety rules for preoperative registered nurses and surgical technologists in the performance of sponge, sharps, instrument, and miscellaneous item counts...5.1.13 Instrument counts will be recorded on the preprinted instrument count sheets...5.4.1.4 The initial count will be documented on the preprinted count sheet to verify that what was on the count sheet during the assembly agrees with what was present in the sets at the start of the case."







32496

3. During an interview on January 19, 2016 at 3:20 PM, the Computed Tomography/Magnetic Resonance Imaging Lead Technician (CT/MR Lead Tech - operates the CT and MRI scanners for diagnostic purposes) was asked about the education she had received on the process of ensuring prevention of RSI (surgical instruments unintentionally retained during surgery) by the radiology department. CT/MR Lead Tech stated, whenever there was a suspected RSI on a patient who was in the Operating Room (OR) undergoing or had underwent a surgical procedure, a Medical Doctor (MD) order and a requisition for a "STAT (immediately)" radiologic image (diagnostic imaging procedure) would be sent to the Radiology Department. After obtaining and processing the radiologic image, the CT/MR Lead Tech would bring up the radiologic image on the image "monitor" located in the OR. This would allow the OR surgeon to have immediate access to the radiologic image. CT/MR Lead Tech stated, she would have the onsite radiologist (who was present in the facility during regular hours of 8 AM- 5 PM, Monday through Friday), read and interpret the radiologic results.

When asked about the process of reading and interpreting the radiologic results after the regular hours 8 AM- 5 PM, CT/MR Lead Tech stated, she would call the "online" radiologist (radiologist who reads and interprets the radiologic results offsite of the facility after the routine 8 AM-5 PM schedule of the onsite radiologists). CT/MR Lead Tech stated, the online radiologist would read and generate the radiologic report and immediately send this report to the OR nurse, through the fax (facsimile) machine and that would be it; unless the online radiologist "chooses" to call the OR surgeon. CT/MR Lead Tech stated, the OR surgeon would have been able to immediately view the radiologic image in the OR and would be able "to make the determination" even before the radiologic image was sent to the online radiologist for reading and interpretation.

A concurrent interview with the Director of Medical Imaging (DMI) and the Manager of Imaging (MI) was conducted on January 19, 2016, at 3:45 PM. DMI and the MI stated the facility's process was to ensure the radiologic results that were read and interpreted by the online radiologist, were communicated to the OR surgeon directly. The OR surgeon may have immediate view to the radiologic image, but the online radiologist should conduct the reading and the interpretation of the radiologic results. Whether the results came back positive for RSI or not, the online radiologist was supposed to call the OR surgeon directly.

A review of the facility's policy and procedure titled, "PREVENTION OF RETAINED SURGICAL ITEMS," Effective Date 6/11, revealed, "...7.0 RADIOGRAPHIC PROCEDURES AND SAFETY RULES ...7.4 Radiology department and on-call technologist: ...7.4.2 The notified Radiologist or designee will review the STAT images and call the provided number (OR room) to discuss findings directly with the OR physician..."



34959

Based on interview and record review, the facility did not ensure there was a written, defined process for physician coverage of Obstetrics and Gynecology patients. This practice increased the risk of a poor health outcome for all Obstetrics and Gynecology patients.

Findings:

During an interview with Medical Doctor 1 (MD 1), on January 21, 2016, at 6:00 PM, he stated there was no Obstetrician (MD who delivers babies) present in the hospital 24 hours a day. He stated the physician on-call (ready and available by phone) group has always provided medical care coverage for the unassigned patients (patients without an MD) and stated that a new agreement has been written so they will also cover the assigned patients (patients with an MD) whose assigned physician is not immediately available. He also stated there was "no policy" regarding the specifics of the Ob/Gyn MD coverage. He stated, "Everyone knows."

During an interview with MD 2, on January 22, 2016, at 10:20 AM, he stated he was the physician on-call for Ob/Gyn. He stated he was responsible for his own group of patients, unassigned pregnant patients, and Ob/Gyn Emergency Department patients. When asked if the on-call group had a contract to provide medical services to facility assigned patients, whose assigned physician is not immediately available, he stated, "It's not official, as a courtesy."

During an interview with Governing Board Member 1 (GB 1), on January 22, 2016, at 2:40 PM, he stated, "I expect appropriately trained professionals at the patient bedside." When asked, what the facility back-up plan was, if the assigned physician was not immediately available, he stated "Not certain."

The contract titled, "Fifth Amendment to Restated Emergency Department Obstetrics/Gynecology Coverage Agreement," dated November 4, 2015, indicated..."2. Coverage Services. Group shall cause one or more Group Physicians in the Specialty to be available on an on-call basis to provide medical care and treatment of Patients, including patients with an assigned physician whose assigned physician is not immediately available (the "Services"), upon the terms and subject to the conditions set forth in this agreement..."


The facility document titled "Community Hospital of San Bernardino Medical Staff OB/GYN Department Rules and Regulations", dated September 21, 2015, indicated "...IV. Conduct...B. The standard of the professional care given to patients shall be in keeping with the highest generally accepted levels of care."


The Medical Staff Bylaws, dated January 28, 2015, indicated "...G. Department Chair Responsibility...5. be a member of the medical executive committee, and give guidance on the overall medical policies of the medical staff and hospital and make specific recommendations and suggestions regarding the department;"