HospitalInspections.org

Based on staff interview, record review and document review, the hospital's Governing Body (GB) failed to effectively govern the hospital and ensure compliance with federal regulations, as evidenced by the following:

A. Failure to ensure that contracted services had provided services which were safe, effective and permitted the hospital to comply with all applicable conditions of participation. Refer to A 83 and A 84.

B. Failure to ensure that the medical staff enforced its rules and regulations. Refer to A 347.

C. Failure to ensure that the hospital had developed, implemented and maintained an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. Refer to A 83, A 84, A 263, A 273 findings 1-2, A 283 findings 1-3, and A 308.

D. Failure to ensure that surgical policies and procedures were implemented to prevent a reoccurrence of a wrong site procedure. Refer to A 283 findings 1-3, A 940, and A 951 findings 1-4.

E. Failure to ensure surgical care was provided in a well organized manner and in accordance with acceptable standards of practice. Refer to A 395, A 749, findings 1-4, A 940, A 942, A 951 findings 1-2, A 952 findings 1-7, and A 959 findings 1-2.

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of services was in compliance with the statutorily mandated Condition of Participation: Governing Body.

Based on staff interview and document review, for 80 of 80 known contracts, the hospital's Governing Body (GB) failed to ensure that contracted services were monitored to ensure that each contracted service was furnished in a manner which permited the hospital to comply with all applicable conditions of participation and standards for the contracted service(s). The GB failed to develop a mechanism designed to ensure that all services furnished under contracts were provided safely, effectively and in a manner that would always permit the hospital to comply with all applicable standards and conditions of participation. This failure had the potential for substandard services to negatively impact patients' health status.

Findings:

On 8/20/15 at 9 am, the hospital Administrator (Admin) acknowledged that:

1. Specific and measurable Quality Indicators (QI) and/or Performance Indicators (PI) had not yet been identified for each service. Refer to A 84 for details.

2. The hospital had not yet developed a mechanism designed to ensure that all services furnished under contracts were provided safely, effectively and in a manner that would always permit the hospital to comply with all applicable standards and conditions of participation. Refer to A 84 for details.

Based on document review and staff interview, for 80 of 80 known contracts, the hospital's Governing Body (GB) failed to ensure that contracted services were performed in a safe and effective manner when quality indicators were not defined objectively, measured, and evaluated to assess the performance of contracted service vendors on a periodic basis, and the quality plan was not implemented for contracted services. This failure put patients at risk for unsafe, ineffective or poor quality care and services.

Findings:

On 8/18/15 the hospital's list of all contracted services, the Quality Assessment and Performance Improvement (QAPI) Program Plan which governed any aspect of services utilized under contract and/or review of contracted services was requested.

On 8/18/15, the list of contracted services and the current QAPI Plan had been provided and was reviewed. The list of contracted services (contained 80 line entries) did not contain the scope and nature for each service. The QAPI plan contained a statement under collecting data to monitor it's performance... "Quality of care and services provided by contracted services." The QAPI plan did not contain any information concerning a mechanism for review of contracted services.

On 8/20/15 at approximately 10 am, Administrative (Admin) Staff A presented documents that demonstrated contract review was conducted annually. The clinical contract evaluations all contained quality indicators that were not measurable as written such as "Results for STAT (Immediate) radiology readings," and "Chart review prior to day of service" for anesthesiology. These quality indicators (QI) were evaluated with a "met" or "not met" check box. No evidence of actual data collection was present and no action plans were evident for items that were marked "not met." Admin Staff A stated the contract evaluations were kept with the contracts and did not recall them being presented at the Performance Improvement Committee (PIC) that oversees the quality reporting. Admin Staff A further stated the managers completed the contract evaluations based on a subjective evaluation.

The contract evaluation, dated 10/13/14, indicated that, "results for STAT readings " and "Results for after hours readings" were not met. A hand written note on the evaluation stated, "Continue to review and monitor for compliance. Also continue to research other options."

On 8/20/15 at approximately 10:30 am, the Quality and Risk Manager (QRM) reviewed the PIC minutes and the governing body minutes. QRM was unable to find any evidence of specific and measurable QI or quality of service concerns for any of the contracted services.

On 8/20/15 at 9 am, the hospital Administrator (Admin) acknowledged that that specific and measurable QI and/or Performance Indicators (PI) had not been utilized to monitor the contracted services, in a manner which could reasonably determine the services were safe, effective and delivered quality services.

Based on interview and record review, the hospital failed to ensure an active, effective, ongoing, hospital-wide, data-driven Quality Assessment and Performance Improvement (QAPI) program had been developed, implemented, and adjusted in order that the hospital could achieve sustainable regulatory compliance, quality care and safe standards of care, as evidenced by the following:

1. The hospital failed to ensure that processes of care and operations were measured, analyzed, and tracked as quality indicators to demonstrate implementation of corrective actions and sustaining safe care practices. Refer to A 273, findings 1 and 2.

2. The hospital failed to ensure that quality improvement activities were developed and effective actions were taken for previously identified opportunities for improvement. Refer to A 283, findings 1-3.

3. The hospital failed to monitor the quality of contracted services for 80 of 80 contracts. Refer to A 308.

These failures resulted in the hospital's inability to maintain an effective quality assessment and performance improvement program.

The cumulative effect of these systemic failures resulted in the inability of the hospital to comply with the statutorily-mandated Condition of Participation for Quality Assessment and Performance Improvement.

Based on interview and record review, the hospital failed to ensure that the quality assessment and performance improvement program (QAPI) was comprehensive to address all aspects of care, service, and operations in the following areas:

1. The QAPI program did not contain evidence of quality indicators for food service and clinical nutrition services.

2. The QAPI program did not include specific quality indicators that were measurable and/or measured, analyzed, and tracked the quality of contracted services.

The failure to identify and correct deficient practices jeopardizes patient health and safety.

Findings:

On 8/19/15, the hospital policy, titled, "Performance Improvement/Patient Safety Plan," dated 2015, read, "The functions of the PIC (Performance Improvement Committee) included..."1. Assess the quality of care rendered to patients in the hospital and recommend improvements. 2. Set expectations, develop plans, and ensure implementation of procedures to assess the quality of the hospital's clinical and support processes.... 1.5.1 All departments, programs, and services within the hospital participate in the performance improvement /safety program.... (The hospital) collects data to monitor its performance including:... 2.1.25 Quality of Contracted Services; 2.16 Quality of Dietary Services."

1. On 8/19/15, the PIC Committee minutes from 9/2014 to 7/2015 were reviewed. These minutes did not contain any evidence that quality indicators had been developed or monitored for the food service or clinical nutrition services.

2. The PIC minutes from 9/2014 to 7/2015, did not include any evidence specifc quality indicators that were measuable and/or measured, analyzed, and tracked the quality of contracted services.

On 8/20/15 at 10:30 am, the Quality/Risk Manager (QRM) B reviewed the PIC minutes from 9/2014 to 7/2015, and acknowledged the quality program did not include quality indicators or monitoring for food service and clinical nutrition services and contracted services.

Based on interview and record review, the hospital failed to ensure that opportunities for improvement were identified following two wrong site procedures (5/22/14 and 6/22/15), and effective actions were taken to ensure a second wrong site procedure did not reoccur. The hospital failed to:

1. Develop an effective data collection mechanism for determining the surgical time out (a pause by the surgical team to ensure the procedure will be on the correct patient, correct site, and the correct procedure types) were performed for each procedure when multiple surgical sites were involved.

2. Provide effective actions, specifically education to nursing staff regarding the surgical time out policy, to address time out process concerns.

3. Provide effective actions, specifically education to medical staff regarding surgical time out procedures for multiple surgical sites, to address time-out process concerns.

These failures resulted in a wrong site procedure to occur again on 6/22/15 and practices remained in place that could result in further wrong site procedures.

Findings:

On 7/7/15 at 1:10 pm, Administrative (Admin) Nurse A reported a wrong site procedure had occurred on 6/22/15 for Patient 1. Process issues were identified including lack of site marking, lack of site marking verification, and time-out procedure lapses. (Refer to A 951, findings 1-3 for further information).

1. On 7/7/15 at 1:10 pm, Admin Nurse A stated the hospital had a previous wrong site procedure approximately a year prior (5/22/14) and had implemented a corrective action plan that included a change in the time out procedures to include a site verification for each of the separate surgical sites/procedures. Admin Nurse A stated she had educated surgical staff to this new process. Admin Nurse A stated she had instituted observations of the surgical time-outs to ensure the process was performed as intended and had 100% results which lead to the discontinuation of this monitoring after the 4/15 Performance Improvement Committee meeting. When asked if new personnel (who had not received the education) were involved in the most recent wrong site surgery, Admin Nurse A responded that all the staff present on the most recent incident (6/22/15) had attended the education.

On 8/19/15, the hospital policy, titled, "Performance Improvement/Patient Safety Plan," dated 2015, was reviewed. The plan did not contain any specific measures or projects for the 2015 calendar year. The plan contained items of focus for 2014 but did not include any measurement of patient safety processes such as time out procedures.

On 8/19/15, the PIC meeting minutes from 8/2014 to 7/2014 were reviewed. The minutes indicated that monitoring related to the 2014 wrong site procedure would include the observation of surgical time outs; two part nerve block (injection of an anesthetic into an area surrounding a nerve to block pain) to re-verify site after position change; time outs for multi-team procedures; and time outs for spinal blocks (injection of an anesthetic into the spinal column to block pain) . Additional monitoring was identified for the preoperative nurse to OR (operating room) nurse hand-off and documentation.

During record review on 8/18 to 8/20/15, Patients 5, 6, 8 and 9 had surgical encounters (7/6; 6/1; 5/25 and 7/10/15 respectively) involving multiple procedures which did not have documentation of time outs that were consistent with the hospital policy, tiled, "Universal Protocol." (Refer to A 951, finding 4a-d for further information).

On 8/20/15 at 10:30 the Quality/Risk Manager acknowledged that the monitorinf that occurred was observational and was not effective to evaluate the adherence to the hospital policy for time outs.

2. On 8/20/15, Staff meeting minutes were reviewed from 1/28/13 to the present (8/20/15). There was no mention of time-out policy changes. On the 6/12/14 staff meeting (after the 5/2014 wrong site surgery incident) there was an item that indicated RCA (root cause analysis - a process for identifying causes of problems) review which contained no detail of what was covered in this meeting. Registered Nurse (RN) A who was involved in the 6/22/15 wrong site surgery was in attendance at that time. None of the other minutes contained any mention of the results of monitoring or further education regarding this incident.

On 7/7/15 at 2:10 pm, RN A was asked about if there had been any changes to the time-out policy over the last year, and she could not recall any policy changes. RN A reported she was unaware of any monitoring that occurred regarding time-out processes.

On 7/7/15 at 1:55 pm, fourteen (14) days following the second wrong site procedure on 6/22/15, Admin Nurse A was asked about what actions the hospital had taken in regards to this incident, and she responded none had been taken other than to report it to the California Department of Public Health as an adverse event. RN A reported that the Quality/ Risk Manager (QRM) A was on vacation and she was responsible for handling the follow-up.

On 8/20/15 at 10:30 the Quality/Risk Manager reviewed the minutes from 1/28/13 to 8/20/15 and acknowledged that there was not enough detail in minutes to determine if education had been provided in order for staff to understand the time out procedures.

3. On 8/20/15, a hospital memo to all the physicians on staff, dated 7/31/15 outlined actions taken following a Medical Staff Executive Committee (MSEC) meeting on 7/28/15 which reviewed the 6/22/15 wrong site procedure. This memo outlined a variety of actions but did not include any direction as to time-outs for multiple procedures which was identified in the hospital analysis of the event as a policy breach.

On 8/20/15 at 1:45 pm, Anesthesiologist A was asked if any follow-up or actions had been taken since the second wrong site procedure and he could not recall any actions.

On 8/20/15 at 12 pm, QRM B reviewed the letter sent to the Medical Staff from the MSEC and acknowledged that the letter did not address time-outs for multiple procedures. QRM B stated Anesthesiologist A should have known about the actions taken because he was sent the MSEC letter.

Based on staff interview and document review, the hospital's Governing Body (GB) failed to ensure that the Quality Assessment and Performance Improvement (QAPI) Program reflected the complexity of the hospital's organization and services. The QAPI Program did not include all hospital departments and each of the services, including contracted services, for 80 of 80 contracts. The GB failed to identify and measure specific Quality Indicators (QI) and/or Performance Indicators (PI) to ensure each contracted service was safe, effective and provided services which facilitated the hospital's compliance with all applicable conditions of participation and standards for the contracted services. This resulted in the potential for services to not meet quality standards of practice for care given.

Findings:



On 8/20/15 at approximately 10:30 am, during a review of the hospital Quality Plan, the Quality and Risk Manager (QRM) B acknowledged the Quality Plan did not contain the scope and nature of the services provided by contract for the hospital (Refer to A 83 and A 84).

QRM B also acknowledged that Quality Indicators (QI) and/or Performance Indicators (PI) for contract services had not been developed in a measurable format and that no data collection for contact services was present in the Quality Improvement Committee or Governing Body minutes.

Based on interview and record review, the hospital failed to ensure that the medical staff enforced its medical staff rules and regulations when an automatic suspension for delinquent operative reports was not enforced at the direction of the Chief Executive Officer, who was not a member of the medical staff. This failure had the potential for the medical staff to defer its accountability for quality of care and services.

Findings:

On 8/19/15, the hospital's Medical Staff Rules and Regulations, dated 4/25/13, page 14, read, "Members... must complete medical records in a timely manner not to exceed fourteen (14) days after discharge.... An automatic suspension shall be imposed for the failure of a Member .. to complete the records in the required time period and shall remain in effect until incomplete records are complete. The Member... shall be given periodic updates on the status of their delinquent record and at least a seven day (7) day written notice and a warning of the automatic suspension that would be imposed if the records remain incomplete on the date specified in the notice. Automatic suspension shall result in the withholding of the Member's... privilege."

a. Patient 11's record was reviewed on 8/19/15. Patient 11 had surgery on her left elbow on 5/1/15 and discharged the same day. Patient 11's operative report indicated it was dictated on 5/1/15 and transcribed on 5/2/15. The operative report was signed by Physician B on 6/22/15 (52 days later).

b. Patient 12's record was reviewed on 8/19/15. Patient 12 had surgery on her right shoulder on 5/8/15 and discharged the same day. Patient 12's operative report indicated it was dictated on 5/8/15 and transcribed on 5/9/15. The operative report was signed by Physician B on 6/22/15 (45 days later).

On 8/18/15 at 2:30 pm, Administrative (Admin) Staff B stated she had called Physician B's office to inform him of the delinquent records and the impending suspension, and was told Physician B was on vacation (defined as good cause in the Medical Staff bylaws.) Admin Staff B reported that she reported this to the Chief Executive Officer (CEO) who told her not to send out the letter.

The Medical Staff Bylaws, dated 4/25/13, page 30, read, "For failure to complete medial records within the time limits established by the rules and regulations, and after receiving notice of the delinquency, a Member's clinical Privileges and the rights to admit patients and to provide other professional services,... shall be automatically suspended until all delinquent records are completed. The Member may be asked to appear before the MSEC Notwithstanding the foregoing, the MSEC (Medical Staff Executive Committee) to explain the delinquency... Notwithstanding the foregoing, the MSEC may waive the administrative suspension for Good Cause.

On 8/19/15 at 1:15 pm, the Chief Administrative Officer reviewed the Medical Staff Bylaws and Rules and Regulations and acknowledged that the Medical Staff Bylaws were not carried out as intended when CEO decided to bypass an automatic suspension without the consult of the MSEC.

On 8/19/15, the hospital's surgery schedule indicated that Physician B performed four surgeries on three days following his return from vacation, 6/15, 6/17 and 6/19/15.

The hospital website indicated that Physician B was on the governing body of the hospital.

Based on observation, interview, and record review, the hospital failed to complete one of 17 sampled patient's assessments for past surgeries and alcohol usage. This failure had the potential for the patient to experience surgical complications, due to risks and factors the anesthesiologist (the physician who gives the medication to put the patient temporarily to sleep) and surgeon were not aware of or prepared for.

Findings:

Patient 2's record was reviewed. Patient 2 was pre-admitted to the hospital on 8/17/15, for abdominal surgery scheduled for 8/19/15.

The hospital's Pre surgical Patient Screening policy, dated 9/14, showed that the patient's comprehensive health history was to be reviewed and was to include their gastrointestinal (GI, stomach/digestive) issues, Psychological and Social information (alcohol consumption) and recent hospitalizations. The policy showed the pre-surgical screening assessment prior to surgery was to ensure patient safety.

On 8/18/15 at 9:40 am, Patient 2's Pre Surgical Screening included a section for alcohol use that was checked "yes" but the quantity section was left blank. Patient 2's Pre Surgical Assessment, dated 8/17/15, was concurrently reviewed with Registered Nurse (RN) B, who confirmed she had done his Pre-Op (operative) Surgical Assessment. The section for History of Alcohol Use was marked "No." RN B stated she did not know why she put "No" in that section and confirmed Patient 2's Pre Surgical Assessment was incorrect and his Pre Surgical Screening should have included a quantity of alcohol consumed.

A review of Patient 2's History and Physical (H&P), dated 1/29/15, revealed his alcohol usage as "More than 5 glasses consumed daily."

On 8/19/15 at 11:35 am, Patient 2 was observed in the Pre Operative unit awaiting surgery. RN D was observed interviewing Patient 2 about his alcohol usage. RN D stated that Patient 2 said he consumed 3-4 drinks daily. Patient 2's Pre Surgical Assessment that indicated no alcohol usage, was concurrently reviewed with RN D. When RN D was asked about the conflicting alcohol usage history, she stated that she did not know if Patient 2 understood her when he answered that he drank 3-4 drinks daily.

According to the British Journal of Anesthesia (2009), alcohol consumption of 3 or more glasses daily impacts surgical complications of post operative infections, bleeding and heart function. Complication rates are 200 to 400% higher when drinking five or more drinks per day.

On 8/19/15, Patient 2's Pre Surgical Assessment dated 8/17/15, included the sections titled GI Medical History and Other Medical History that showed he had no history of surgeries or anesthesia.


Patient 2's record showed he had been admitted to the hospital on 1/7/15, for diverticulitis (pouches in the intestine that become inflamed/infected) and included operative reports for abdominal surgery done on 2/25/15 and on 3/4/15.

On 8/19/15 at 1:30 pm, Administrative (Admin) Nurse B confirmed that Patient 2's Pre Surgical Assessment was incomplete and that his previous surgical history was inaccurate. Admin Nurse B stated that all of Patient 2's previous surgical history and admission history was available to the nurse during his Pre Op visit. Admin Nurse B confirmed that the missing information was pertinent to his current surgery.

On 8/19/15 at 3:49 pm, Patient 2's family member confirmed that his previous surgeries were done at this hospital and that Patient 2 and Patient 2's family member had reviewed these surgeries with the Pre Op Nurse (RN B) during his Pre Op visit on 8/17/15.

Based on interview and record review, the hospital failed to ensure three of 17 sampled patient's medical records were complete. (Patients 5, 6, and 9) This had the potential for patients to experience a lack of continuity of care between providers, due to missing health care information.

Findings:

The hospital's Medical Staff Rules and Regulations, dated 2/21/12, included a section on Medical Records that read, "...2. All entries in the medical records shall be legible, complete, permanently recorded, dated, timed and authenticated by the person making the entry..."

1. Patient 5's record was reviewed. Patient 5 was admitted to the hospital on 5/6/15 for hernia repair and hemorrhoid surgery.

On 8/19/15, Patient 5's record included physicians orders (undated) for pre-operative labs, a chest X-ray, an electrocardiogram (measures heart rhythms), hernia repair and hemorrhoid removal and an informed consent clause. There was an area for the patient's signature and date signed, and the physician's signature and date signed. There were no signatures or dates signed documented on the form prior to surgery on 5/6/15. There was only an electronic physician's signature, dated 6/5/15 (30 days after surgery).

On 8/19/15 at 10:05 am, Administrative Nurse B confirmed the physician's orders for Patient 5's surgeries were not signed.

2. Patient 6's record was reviewed. Patient 6 was admitted to the hospital on 7/6/15 for nasal and tonsil surgery.

On 8/19/15, Patient 6's H&P (History and Physical) update for his 7/6/15 surgery was not dated or signed, except for an electronic physician's signature on 8/3/15, 28 days later.

On 8/19/15 at 2:15 pm, Admin Nurse C confirmed there was no date or signature on Patient 6's H&P to confirm it was updated prior to surgery.

3. Patient 9's record was reviewed. Patient 9 was admitted to the hospital for abdominal surgery and hemorrhoid surgery on 7/10/15.

On 8/20/15, Patient 9's Pathology (exam of body part for diagnostic purposes) Tissue Report, dated 7/10/15, showed that a lymph node (small gland) was submitted to pathology by the surgeon, in addition to the gall bladder that was removed.

Patient 9's Pathology Tissue Exam Request form, dated 7/10/15, included the gall bladder specimen but no reference to the lymph node submitted.

Patient 9's Surgical Case Record, dated 7/10/15, included documentation that the gall bladder specimen was removed and sent to pathology, yet there was no reference to the lymph node that was submitted.

Patient 9's Operative Report, dated 7/13/15, did not include documentation that a lymph node was removed.

On 8/20/15 at 11:48 am, Admin Staff B stated that the lymph node removal should have been included in Patient 9's Pathology Tissue Exam Request, Operative Report and Surgical Case Record and confirmed there was no reference to it.

The hospital's Medical Staff Rules and Regulations, dated 2/21/12, included a section on Operative Reports that read, "The operative report shall include... A description of techniques, findings, and tissues removed or altered."

Based on interview and record review, the hospital failed to ensure one of 17 sampled patient's physicians orders were signed, prior to surgery. This had the potential to result in miscommunications that could negatively impact patients' health status. (Patient 5)

Findings:

Patient 5's record was reviewed. Patient 5 was admitted to the hospital on 5/6/15 for hernia repair and hemorrhoid surgery.

On 8/19/15, Patient 5's record included the surgeon's Pre-Op (operative) Orders (undated) for pre operative labs, a chest X-ray, an electrocardiogram (measures heart rhythms), hernia repair and hemorrhoid removal and an informed consent clause. There was an area for the patient's signature and date signed and the physician's signature and date signed. There were no signatures or dates signed documented on the Pre-Op Orders prior to surgery on 5/6/15. There was only an electronic physician's signature, dated 6/5/15 (30 days after surgery).

On 8/19/15 at 10:05 am, Administrative Nurse B confirmed the Pre-Op Orders for Patient 5's surgeries were not signed.

The hospital's Pre-Operative Standing Orders policy, dated 9/14, included a procedure that read, "...9. The Standing Pre-Operative orders shall be signed, including date, and time, by the ordering physician..."

The hospital's Rules and Regulations included a section on Medical Records that read, "...2. All entries in the medical records shall be legible, complete, permanently recorded, dated, timed and authenticated by the person making the entry..."

Based on observation and interview, the hospital failed to ensure the integrity (level of safety and quality) of their supplies, when expired supplies were found on the inpatient unit. This failure had the potential for ineffective and/or defective products to be used that could create infection control problems to patients.

Findings:

During an initial tour of the hospital's inpatient unit on 8/18/15 at 9:45 am with Administrative (Admin) Nurse C, a Huber needle (an access port implanted under the skin for vein access) marked expired as of 5/15 and several HemoCue Cleaner packets (swabs used to clean the optical lens of machine that measures blood component) marked expired as of 4/17/15 were observed.

Admin Nurse C confirmed the items were expired.

Based on observation, interview, and record review, the hospital failed to ensure that systems to control infections were followed consistently in the following instances:

1. Immediate use steam sterilization was relied on due to lack of sufficient surgical instrument inventory.

2. During the cleaning of the operating room, the sanitizer wipe touched the floor and was then used to clean the anesthesia cart.

3. Scissors were sterilized in a closed position.

4. Hair was not covered for three surgical personnel while in the restricted area of the OR (operating room).

These failures had the potential to expose patients to infectious diseases.

Findings:

1. On 8/18/15 at approximately 10 am, Administrative (Admin) Nurse A stated the hospital uses the AORN (Association of periOperative Registered Nurses) standards as a national accepted standard of surgical practice.

AORN Guideline for Sterilization Recommendation VII read, "Immediate use steam sterilization (IUSS) should be kept to a minimum and should be used only in selected clinical situations and in a controlled manner....VII.a. Immediate use steam sterilization should be used only when there is insufficient time to process by the preferred wrapped or container method intended for terminal sterilization. Immediate use steam sterilization should not be used as a substitute for sufficient instrument inventory."

On 8/18/15, the IUSS log was reviewed and the following was noted:

a. On 7/20/15, a "Brown deltoid (shoulder muscle) ret (retractor) was processed for Patient 15 and the reason was listed as "Only one sterile item available."

b. On 8/6/15, a "Vascular(vein) Tray also Nuvasive (vendor tray) Customs" was processed for Patient 16 and the reason listed was "Only one sterile item available."

c. On 8/6/15, a "Bipolar Forcep Spine" (tong) was processed for Patient 16 and the reason listed was "Only one sterile item available."

d. On 8/12/15, a "Starker Suture Passer" (assists with stitches) for Patient 17 was processed and the reason listed was "Only one sterile item available."

On 8/18/15 at approximately 10:30 am, Administrative (Admin) Nurse A and Admin Staff C acknowledged that they had scheduled surgeries back to back or concurrently that needed the same equipment and had to rely on IUSS. Both acknowledged that this was not an appropriate use of IUSS.

2. The AORN Online Guideline for Environmental Cleaning Recommendation II read, "The patient should be provided with a clean, safe environment....II.e.1. Items that contact the floor for any amount of time should be considered contaminated."

On 8/18/15 at approximately 10 am, an operating room (OR) turnover (between surgeries) was observed. Anesthesia Tech A was observed wiping an intravenous pole from top to bottom and the sanitizing wipe brushed the floor leaving a wet mark. Anesthesia Tech A proceeded to use the wipe to clean the anesthesia cart.

In a concurrent interview, Admin Nurse A acknowledged that the wipe should have been discarded after the wipe touched the floor. Registered Nurse A, who was present cleaning the OR, was asked about how the OR staff knew everything was cleaned in the OR suite, and she responded that they had all worked together for so long that each person knew what the other was doing.

On 8/18/15, the hospital policy, titled, "Cleaning of Operating Rooms, dated 10/2014, included guidance for cleaning prior to the first procedure of the day and the terminal cleaning each day but did not include clear guidance for the turnover cleaning of operating rooms. The hospital policy, titled, "Infection Control and Environmental Controls in the OR," dated 10/14, read, "Barriers for isolating the operative wound from infectious contaminants are as follows:... Disinfection of OR surfaces following every surgical procedure."

The AORN Online Guideline for Environmental Cleaning Recommendation III read, "A clean environment should be reestablished after the patient is transferred from the area...III.c. Operating and procedure rooms must be cleaned after each patient."

3. On 8/18/15 at approximately 10:30 am, during the initial tour of the Sterile Processing Department (SPD), numerous types of surgical scissors, a count of 12 total scissors, were noted to be sterilized in the closed position.

In a concurrent interview with the SPD Manager, she stated that scissors closed sometimes during processing. When asked if she had tips or other items available to prevent this from happening (such as stringers or racks), she responded that they "don't like us to use them because it slows them down in the OR." SPD Manager further stated that the scissors should be sterilized in an open position.

The AORN Online Guideline for Selection and Use of Packaging Systems for Sterilization Recommendation 4 read, "Items to be sterilized should be packaged in a manner that facilitates sterilization and provides for an aseptic presentation of the package contents.... IV.h. Items to be sterilized should be placed in the package or tray in an open or unlocked position. The open or unlocked position facilitates sterilant contact of all surfaces of the item. IV.h.1. Racks or stringers designed and intended for sterilization can be used to maintain instruments in their open position.

The hospital policy, titled, "Infection Control and Environmental Controls in the OR," dated 10/14, read, "Barriers for isolating the operative wound from infectious contaminants are as follows:... Proper packaging of supplies and sterilization procedures."

4. On 8/18/15 at approximately 10 am, during the initial tour of the surgical department in OR 1 (a restricted area), RN A had hair hanging down outside her surgical bonnet, Anesthesiologist B had uncovered facial hair and wore a skull cap that did not cover hair at the nape of his neck, and Anesthesia Tech A had uncovered facial hair and wore a skull cap that did not cover hair at the nape of his neck.

In a concurrent interview, Admin Nurse A acknowledged that these personnel should have their hair covered when in the restricted area (OR).

Guideline for Surgical Attire Recommendation III read, "Personnel entering the semi-restricted and restricted areas should cover the head, hair, ears, and facial hair... III.a. A clean surgical head cover or hood that confines all hair and completely covers the ears, scalp skin, sideburns, and nape of the neck should be worn."

A hospital policy for surgical attire was requested but never received. The hospital policy, titled, "Infection Control and Environmental Controls in the OR," dated 10/14, read, "Barriers for isolating the operative wound from infectious contaminants are as follows:... Special OR attire...Wearing of masks and hair cover."

Based on observation, staff interviews, medical record and document reviews, the hospital failed to provide surgical services that were well organized and in accordance with nationally recognized standards of practice, in order to ensure safe and high quality surgical care to all patients evidenced by:

A. Failure to implement patient safety policies to prevent a wrong site procedure. Refer to A 951, findings 1-4.

B. Failure to have an experienced registered nurse supervising the operating room. Refer to A 942.

C. Failure to ensure that surgical services consistently met the unique needs of each patient by developing and/or implementing surgical care policies and procedures designed to assure the achievement and maintenance of high standards of medical practice and patient care. Refer to A 951, findings 5-7.

D. Failure to ensure that a complete and accurate examination and assessment of the patient, performed by a qualified individual and updated by the operating surgeon, to reflect the current condition of the patient was documented prior to surgery, in accordance with hospital policies and acceptable standards of practice. Refer to A 952, findings 1-2.

E. Failure to complete operative reports with the required elements within the required time frame. Refer to A 959, findings 1-2.

F. Failure to maintain a sanitary environment, and ensure an infection control system that effectively conformed with nationally recognized infection control standards to identify, report, investigate and control infections and communicable diseases of patients and personnel. Refer to A 749, findings 1-4.

G. Failure to ensure that pre-operative nursing assessments were complete. Refer to A 395.

These failures put patients at risk for adverse surgical outcomes or infections. The cumulative effect of these systemic problems resulted in the inability of the hospital to comply with the statutorily-mandated Condition of Participation for Surgical Services.

Based on interview and record review, the hospital failed to ensure that an experienced operating room (OR) nurse was supervising the OR. This failure had the potential for substandard practices to persist and negatively impact patient's health status.

Findings:

On 8/18/15 at 9:45 am, Administrative (Admin) Nurse A stated she was in charge of the pre- and post- operative programs and was also over the operating rooms. Admin Nurse A further stated that she did not have an OR background and that the hospital's management had not approved any OR training for her.

On 8/18/15, the hospital job description, dated 3/2015, for Nurse Manager for the OR/Pre-op/Post-op/Radiology (X-ray department)/ and Sterile Processing (cleaning and disinfecting surgical equipment) Department listed under the heading experience, "Significant experience working in a multispecialty OR, GI (gastrointestinal), and/or PACU (post anesthesia care unit), preferably in a surgical hospital and/or ASC (ambulatory surgical center.) This level of experience is typically achieved in approximately three years. Must have successful experience as an OR and/or PACU nurse.

On 8/20/15, Admin Nurse A's personnel file was reviewed. The file did not contain any evidence of education, background or specialized training in the OR.

On 8/18/15 at 11:30 am, Chief Nursing Officer B stated she was aware of Admin Nurse A's lack of experience and had planned to send her to educational opportunities.

Based on interview and record review, the hospital failed to develop and implement policies governing surgical care for seven of 17 sampled patients. (Patients 1, 2, 5, 6, 8, 9, and 10)

1. Physician A failed to mark an injection site prior to entering the operating room (OR) on Patient 1's elbow.

2. OR registered nurse (RN) A failed to confirm injection site marking prior to transporting Patient 1 to the OR.

3. The surgical team failed to conduct a time out (a time out is when the surgical team stops everything they are doing to verify that they have the correct patient, correct procedure and correct site before starting surgery) for Patient 1's injection procedure.

4. Patient's 5, 6, 8, and 9 did not have time out procedures documented according to hospital policy.

5. Patient 2's pre-surgical nursing assessment did not include prior surgical history and alcohol use.

6. Patient 10's record did not include documentation of a steroid (reduces inflammation) injection performed in the OR.

7. Patient 9's Pre operative surgical orders were not signed, dated, or timed.

These failures resulted in a wrong site surgery for Patient 1's elbow and placed other patients at risk for surgical mishaps such as wrong site surgery.

Findings:

On 7/7/15, the hospital policy, titled, "Universal Protocol," dated 6/2014, read, "All patients undergoing a procedure that exposes patients to more than minimal risk... will have a pre-procedure verification process performed, the procedure site marked and a time-out performed immediately prior to starting the procedure. Any procedure that involves the puncture or incision of the skin, insertion of an instrument, or insertion of foreign material into the body or invasive procedures that may be performed for diagnostic or treatment-related purposes will meet these requirements... Verification of the correct person, correct site, and correct procedure will occur at the following times:...3.3 At the time of admission or entry into the facility for a procedure, whether elective or emergency; 3.4 Before the patient leaves the pre-procedure (Pre-op) area or enters the procedure room; Anytime the responsibility for care of the patient is transferred to another member of the procedure team, (including anesthesia providers, the medical professional who give medications to cause sedation/sleepiness) at the time of, and during the procedure....Site marking will be performed by the ...provider ...to perform the intended surgical or non-surgical invasive procedure.... Site marking is done before the patient is moved to the location where the procedure will be performed and takes place with the patient involved, awake and aware , if possible. A time-out will be conducted prior to starting the procedure and, ideally, prior to the introduction of the anesthesia process: It involves all members of the procedure team including the anesthesia provider, the circulating nurse (the nurse who monitors the patient during surgery) the operating room technician (assists nurses and surgeons), and other active participants appropriate for the procedure, who will be participating in the procedure from its inception... It involves interactive verbal communication between all team members, and any team member can express concerns regarding procedure verification... Any invasive procedure involving multiple sites requires verification for each additional site.... The time-out must be performed prior to the initial invasive procedure. Re-verification for the correct site will occur after repositioning the patient... The time-out will be documented in the OR electronic record... The site must be identified (in the documentation)."

1. On 6/22/15, the California Department of Public Health received a report from the hospital of a potential adverse event for Patient 1, described as "Wrong site Kenalog (steroid) injection."

On 7/7/15, Patient 1's record was reviewed. Patient 1's was admitted on 6/22/15. Patient 1's record contained a consent for surgery that read, "Right wrist arthroscopy (viewing of a joint using a scope through a small incision), examination under anesthesia for instability, removal of orthopedic (bones) plate from healed distal ulna (forearm), tenolysis of flexor carpi ulnaris tendon (release of adhesion (sticking together) on forearm tendon) and Kenolog injection right lateral epicondyle with ultrasound guidance (injection to the elbow using an x-ray form to visualize location)."

Patient 1's operative report, dated 6/22/15, read under description of procedure read, "The.. left upper extremity was injected at the lateral epicondyle, 1 cc (cubic centimeter) Kenalog and Xylocaine (for numbing)."

On 7/7/15 at 1:10 pm, Administrative (Admin) Nurse A reported that on 6/23/15, during the post-operative follow-up phone call, Patient 1 questioned why she had a bandage on her left elbow and it was realized that the elbow steroid injection procedure had been performed on the wrong site/side.

Admin Nurse A stated Patient 1's surgeon, Physician A, came to the pre-op area to discuss the surgery, answer Patient 1's questions, and perform the marking of the procedural sites. Admin Nurse A stated Physician A was a friend of Patient 1 and may have been distracted from his routine. Physician A marked Patient 1's wrist for surgery but did not mark the elbow for the injection. Admin Nurse A stated that this was not consistent with the hospital policy. Admin Nurse A verified that the injection had been given into the wrong elbow.

Physician A and OR Technician E were unavailable for interview during the complaint investigation and the subsequent complaint validation survey. Hospital and patient records were consistent with Admin Nurse A's description of events.

2. On 7/715 at 2:10 pm, OR RN A stated that during her pre-procedure verification in the pre-op area, she did not specifically clarify verbally which wrist was to be done but touched Patient 1's right wrist to indicate the site for surgery. RN A further stated she did not think of the injection to the elbow as a second procedure and did not pick up on the lack of marking for that site.

On 7/7/15 at 1:10 pm, Admin Nurse A stated that RN A's actions were not consistent with the hospital policy.

3. Patient 1's record contained OR documentation of a time-out at 3:19 pm, prior to the anesthesia nerve block (to numb ) in the right axilla (armpit) and again at 3:36 pm just prior to the right wrist surgery. Patient 1's record did not contain a time-out documentation prior to the elbow injection.

On 7/715 at 2:10 pm, OR RN A confirmed that a time-out had not been done for Patient 1's elbow injection and that Patient 1 had been positioned for a left elbow injection.

On 8/20/15 at 1:45 pm, Anesthesiologist A stated he became aware of Patient 1's wrong site surgery several days later. Anesthesiologist A explained that he had been involved in a wrong site procedure at the hospital approximately a year prior (5/22/14) and the hospital instituted a process to do time-outs prior to each separate procedure. Anesthesiologist A recalled there had been no time-out prior to the elbow injection. Anesthesiologist reported that team members did not routinely interact verbally during the time-out procedures.

On 7/7/15 at 1:10 pm, Admin Nurse A stated that the hospital policy for time-out procedures was not followed.


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4. a. Patient 5's record was reviewed. Patient 5 was admitted to the hospital on 5/6/15 for an abdominal hernia repair and hemorrhoid surgery.

On 8/19/15 at 10:05 am, Patient 5's Surgical Case Record, dated 5/6/15, was concurrently reviewed with Admin Nurse B and Patient 5 had an abdominal hernia repair and hemorrhoid surgery. Admin Nurse B confirmed there was no second time out prior to the second procedure (hemorrhoid surgery) documented and that a second time out should have been done.

b. Patient 6's record was reviewed. Patient 6 was admitted to the hospital on 7/6/15 for tonsil and nasal surgery.

On 8/19/15 at 2:15 pm, Patient 6's Surgical Case Record, dated 7/6/15, was concurrently reviewed with Admin Nurse C, who confirmed Patient 6 had both the tonsil and nasal surgeries. Admin Nurse C confirmed these were two different surgical sites and procedures and that a second time out and Site Verification should have been done. She confirmed the second time out with Site Verification was not done on Patient 6's nasal surgery.

c. Patient 8's record was reviewed. Patient 8 was admitted on 5/28/15 for surgical repair for a bunion (bony bump) and hammer toes (crooked second and third toes) to her right foot.

On 8/20/15 at 10:36 am, Patient 8's Operative Report, dated 5/29/15, was concurrently reviewed with Admin Nurse B and showed three procedures were done to Patient 8's right foot: bunion repair, hammer toe repair on the second toe and hammer toe repair on the third toe. Patient 8's Surgical Case Record, dated 5/28/15, was also reviewed with Admin Nurse B, who confirmed three separate incisions were made and that there were not separate time outs done for the second and third toe surgeries. Admin Nurse B stated that a second time out was done but it was for Patient 8's right foot injection

d. Patient 9's record was reviewed. Patient 9 was admitted to the hospital for gall bladder removal and hemorrhoid surgery on 7/10/15.

On 8/20/15 at 11:20 am, Patient 9's Surgical Case Record, dated 7/10/15, was concurrently reviewed with Admin Nurse B, who confirmed the gall bladder and hemorrhoid surgeries were done. She confirmed they were two separate procedures and surgical sites and that no second time out was done for Patient 9's hemorrhoid surgery.

5. The hospital's Pre surgical Patient Screening policy, dated 9/14, showed that the patient's comprehensive health history was to be reviewed and was to include gastrointestinal (GI, stomach/digestive) issues, Psychological and Social information (alcohol consumption) and recent hospitalizations. The policy showed the pre-surgical screening assessment prior to surgery was to ensure patient safety and, "all data will be collected."

Patient 2's record was reviewed. Patient 2 was pre-admitted to the hospital on 8/17/15 for abdominal surgery scheduled for 8/19/15.

On 8/18/15 at 9:40 am, Patient 2's Pre-Surgical Screening included a section for alcohol use that was checked, "yes" but the quantity section was not completed. Patient 2's Pre Surgical Assessment, dated 8/17/15, was concurrently reviewed with Registered Nurse (RN) B, who confirmed she incorrectly marked, "No" in the section for History of Alcohol Use and did not complete the quantity consumed.

A review of Patient 2's History and Physical (H&P), dated 1/29/15, revealed his alcohol usage was, "More than 5 glasses consumed daily."

According to the British Journal of Anesthesia (2009), alcohol consumption of 3 or more glasses daily impacts surgical complications of post operative infections, bleeding and heart function. Complication rates are 200 to 400% higher when drinking 5 or more drinks per day.

On 8/19/15, Patient 2's Pre Surgical Assessment included sections titled GI Medical History and Other Medical History for surgical history that were marked, "No."

Patient 2's record showed he had been hospitalized on 1/7/15 for diverticulitis (intestinal pouches that become inflamed/infected) and had abdominal surgeries done on 2/25/15 and 3/4/15.

On 8/19/15 at 1:30 pm, Admin Nurse B confirmed that Patient 2's Pre Surgical Assessment was incomplete and that his previous surgical history was inaccurate. Admin Nurse B stated that all of Patient 2's previous surgical history and admission history was available to the nurse during his Pre Op visit. Admin Nurse B confirmed that the missing information was pertinent to his current surgery.

On 8/19/15 at 3:49 pm, Patient 2's family member confirmed she reviewed his previous surgeries (both done at this hospital) with the Pre Op Nurse (RN B) during his Pre Op visit on 8/17/15.

6. Patient 10's record was reveiwed. Patient 10 was admitted to the hospital on 8/18/15 for right shoulder manipulation (adjustment by force) and an injection to the right shoulder.

The hospital's Medication Administration policy, dated 10/14, read, "9. Each dose of medication administered was to be recorded in the patient's medical record."

On 8/18/15 Patient 10's Surgical Case Record showed her right shoulder was injected by the surgeon. There was no documentation under the "Operative Medications" section to show what drug was injected into Patient 10's right shoulder.

Patient 10's medication administration record was reviewed and did not include the medication used to inject her right shoulder.

On 8/18/15 at 1:15 pm, Admin Nurse A stated the Patient 10's Surgical Case Record and Operative Report should have shown what medication was injected into her right shoulder and that the nurse was to have documented the steroid medication that was admininstered.

7. Patient 5's record was reviewed. Patient 5 was admitted to the hospital on 5/6/15 for hernia repair and hemorrhoid surgery.

The hospital's Pre-Operative Standing Orders policy, dated 9/14, included a procedure that read, "...9. The Standing Pre-Operative orders shall be signed, including date, and time, by the ordering physician..."

On 8/19/15, Patient 5's record included the surgeon's Pre-Op (operative) Orders (undated) for pre operative labs, a chest X-ray, an electrocardiogram (measures heart rhythms), hernia repair and hemorrhoid removal and an informed consent clause. There was an area for the patient's signature and date signed and the physician's signature and date signed. There were no signatures or dates signed documented on the Pre-Op Orders prior to surgery on 5/6/15. There was only an electronic physician's signature, dated 6/5/15 (30 days after surgery).

On 8/19/15 at 10:05 am, Administrative Nurse B confirmed the Pre-Op Orders for Patient 5's surgeries were not signed and should have been prior to surgery.

Based on interview and record review, the hospital failed to ensure that history and physical (H&P) examinations were complete, updated, and documented no more than 30 days before admission for two of 17 sampled patients. (Patients 1 and 6)

1. Patient 1's H&P did not include family history, social history, current medications, and allergies as defined in the Medical Staff Rules and Regulations.

2. Patients 6's H&P update did not include a time and/or date when it was performed.

These failures placed patients at risk for surgical complications.

Findings:

1. On 8/19/15, the Medical Staff Rules and Regulations, dated 2/21/12, page 8, read, "A H&P must contain a chief complaint, history of present illness, past history, social history, current medications, allergies to medications, physical examination, and provisional diagnosis..."

On 8/18/15, Patient 1's record was reviewed. Patient 1 had surgery on 6/22/15 on her right wrist to remove hardware and a Kenalog (steroid, to reduce inflammation) injection to her right elbow.

Patient 1's history and physical was recorded by hand on a form provided by the hospital. The form was not filled in for family history and allergies. The form did not contain a section for recording patient's social history. The section for medications had initials "WNL" (within normal limits) recorded but did not list any medications.

On 8/18/15 at 12:30 pm pm, Administrative (Admin) Nurse A reviewed Patient 1's H&P and acknowledged that it did not contain all the required elements of an H&P as defined in the Medical Staff Rules and Regulations.



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2. Patient 6's record was reviewed. Patient 6 was admitted to the hospital on 7/6/15 for nasal and tonsil surgery.

On 8/19/15, Patient 6's H&P update was reviewed and it was not dated or signed, except for an electronic signature on 8/3/15, 28 days following surgery.

On 8/19/15 at 2:15 pm, Admin Nurse C confirmed there was no date or signature on Patient 6's H&P update, to confirm that it was completed prior to his surgery.

The hospital's Rules and Regulations dated 2/21/12, included a section on Medical Records that read, "...2. All entries in the medical records shall be legible, complete, permanently recorded, dated, timed and authenticated by the person making the entry..."

Based on interview and record review, the hospital failed to ensure that operative reports were completed and signed by the surgeon for three of 17 sampled patients (Patients 9, 11, and 12)

1. Patients 11 and 12 did not have signed operative reports in accordance with the medical staff rules and regulations.

2. Patient 9's operative report did not include tissues removed.

These failure have the potential for miscommunication that could negatively impact a patient's health status.

Findings:

1. On 8/219/15, the hospital's Medical Staff Rules and Regulations, page 14, read, "Members... must complete medical records in a timely manner not to exceed fourteen (14) days after discharge."

a. Patient 11's record was reviewed on 8/19/15. Patient 11 had surgery on her left elbow on 5/1/15 and discharged the same day. Patient 11's operative report indicated it was dictated on 5/1/15 and transcribed on 5/2/15. The operative report was signed by Physician B on 6/22/15 (52 days later).

b. Patient 12's record was reviewed on 8/19/15. Patient 12 had surgery on her right shoulder on 5/8/15 and discharged the same day. Patient 12's operative report indicated it was dictated on 5/8/15 and transcribed on 5/9/15. The operative report was signed by Physician B on 6/22/15 (45 days later).

On 8/19/15 at 2:30 pm, Administrative (Admin) Staff B reviewed Patient 11 and 12's operative reports and acknowledged that they were not completed timely.



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2. Patient 9's record was reviewed. Patient 9 was admitted to the hospital for abdominal surgery and hemorrhoid surgery on 7/10/15.

The hospital's Medical Staff Rules and Regulations, dated 2/21/12, included a section on Operative Reports that read, "The operative report shall include... A description of techniques, findings, and tissues removed or altered."

On 8/20/15, Patient 9's Pathology (exam of body part for diagnostic purposes) Tissue Report, dated 7/10/15, showed that a lymph node (small gland) was submitted to pathology by the surgeon, in addition to the gall bladder that was removed.

Patient 9's Pathology Tissue Exam Request form, dated 7/10/15, included the gall bladder specimen but no reference to the lymph node submitted.

Patient 9's Surgical Case Record, dated 7/10/15, included documentation the gall bladder specimen was removed and sent to pathology, yet there was no reference to the lymph node that was submitted.

Patient 9's Operative Report, dated 7/13/15, did not include documentation that a lymph node was removed.

On 8/20/15 at 11:48 am, Admin Staff B stated that the lymph node should have been included in Patient 9's Pathology Tissue Exam Request, Operative Report and Surgical Case Record and confirmed there was no reference to it.