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Based on interview and record review, the facility's Governing Body failed to ensure facility operations were conducted in an effective, safe, and organized manner by failing to:


1. Implement and maintain an effective, ongoing, hospital driven Quality Assessment and Performance Improvement (QAPI) program (Refer to A0263, A0273, A0283, A0286, and A308).


2. Ensure Surgical Services were provided in accordance with acceptable standards of practice (Refer to A0940, and A0951).


The cumulative effect of these systemic problems resulted in the failure of the Governing Body to ensure patients were receiving quality care in a safe and effective manner.

Based on interview and record review, the facility failed to implement and maintain an effective, ongoing, hospital driven Quality Assessment and Performance Improvement (QAPI) program by failing to:

1. Ensure data collected for three quality indicators were analyzed (A0273);

2. Ensure for two quality indicators, data was analyzed, interventions implemented, and evaluated (A0283);

3. Ensure an analysis was conducted, preventative actions, and interventions were implemented for two identified potential adverse events (A0286);

4. Ensure the facility's Quality Assessment and Performance Improvement (QAPI) program, reflected all departments within the facility (A0308), and;

The cumulative effect of these systemic problems resulted in the facility's failure to analyze the data collected, provide interventions, and to provide improvements in the quality of services in the perioperative department, the emergency department (ED) and the pharmacy.

Based on interview and document review, the facility failed to ensure the data collected for three quality indicators was analyzed. The failure to analyze data collected had the potential to result in a delay in the facility providing interventions for quality improvement in the perioperative area, the emergency department (ED) and the pharmacy.

Findings:

The facility's "Quality and Performance Improvement Plan (Board approval: 6/17/2014)," was reviewed. The plan indicated, "The Quality and Safety Department serves as the designated department to oversee the organization wide Quality and Safety program based on the following: aggregate and analyze finding for presentation to the Performance Improvement committee, MEC (medical executive committee), Medical Staff committees, Quality Review committees and the Board of Managers...assist with planning, design and analysis of quality activities, statistical analysis, facilitation of teams and coaching in the deployment of quality strategies..."

A. The surgery department's perioperative quality indicators dated January, 2014, through April, 2015, were reviewed. One indicator reviewed comprised of all patients requiring re-intubation in the post anesthesia care unit following a surgical procedure.

A total of 20 patients required re-intubation during the reviewed period.

Further document review failed to show analysis of the data and review of the overall safety and quality of care related to the chosen indicator.

An interview was conducted with the interim Quality Director (QD) on May 28, 2015, at 3 p.m. The QD stated there was no analysis of the statistics received regarding the patients who required re-intubation in the post anesthesia care unit following a surgical procedure.

B. A review of the ED's quality indicators dated May, 2014, through March, 2015, was conducted. The specific indicator reviewed was the number of patients who received a follow up phone call after having left the ED without being seen.

A total of 780 patients were phoned in 2014, and 397 patient were phoned in 2015.

Further document review failed to show an analysis regarding why 1,177 patients left the ED without being seen during the chosen time frame.

An interview was conducted with the interim Chief Nursing Officer (CNO) on May 28, 2015, at 3:15 p.m. The CNO stated an analysis of the results of the phone calls made to the ED patients who left the ED without being seen was not done.

C. A review of the pharmacy department's quality indicators for January, February and March, 2015, which addressed the number of times injectable promethazine was administered correctly was conducted (promethazine-medication to treat nausea and vomiting).

Further document review failed to show an analysis of why the percentage of times the administration of promethazine was implemented correctly remained under the facility's goal of 100%.

An interview was conducted with the CNO on May 28, 2015, at 3:20 p.m. The CNO stated she went to the ED directly and addressed the problem verbally, but no documented analysis or interventions were conducted.

Based on interview and document review, the facility failed to ensure the data collected for two quality indicators was analyzed, with interventions implemented and evaluated. This failure had the potential for the facility to miss opportunities for improvement in the quality of services provided in the perioperative area, emergency department (ED) and pharmacy.

Findings:

A review of the facility's "Quality and Performance Improvement Plan (Board approval: 6/17/2014)," was conducted. The policy indicated the "Quality and Performance Improvement Plan supports the systematic organization wide approach to plan, design, measure, assess and improve organizational performance."

A. The surgery department's perioperative quality indicators dated January, 2014, through April, 2015, were reviewed. One indicator reviewed comprised of all patients requiring re-intubation in the post anesthesia care unit following a surgical procedure.

A total of 20 patients required re-intubation during the reviewed period.

Further document review failed to show analysis of the data and review of the overall safety and quality of care related to the chosen indicator.

An interview was conducted with the interim Quality Director (QD) on May 28, 2015, at 3 p.m. The QD stated there was no analysis or interventions of the statistics received regarding the patients who required re-intubation in the post anesthesia care unit following a surgical procedure.

B. A review of the ED's quality indicators dated May, 2014, through March, 2015, was conducted. The specific indicator reviewed was the number of patients who received a follow up phone call after having left the ED without being seen.

A total of 780 patients were phoned in 2014, and 397 patient were phoned in 2015.

Further document review failed to show the results of these phone calls followed with an analysis of why these 1,177 patients left the ED without being seen, and a plan for improvement to decrease the number of ED patients who left without being seen.

An interview was conducted with the interim Chief Nursing Officer (CNO) on May 28, 2015, at 3:15 p.m. The CNO stated there has not been an analysis of the results of the phone calls made to the ED patients who left the ED without being seen.

C. A review of the pharmacy department's quality indicators for January, February and March, 2015, which addressed the number of times injectable promethazine was administered correctly was conducted (promethazine-medication for nausea and vomiting).

Further document review failed to show an analysis of why the percentage of correct administration of promethazine remained under 100%, or interventions to alleviate this problem.

An interview was conducted with the CNO on May 28, 2015, at 3:20 p.m. The CNO stated that she went to the ED directly and addressed the problem verbally, but no documented analysis or interventions were conducted.

Based on interview and document review, the facility failed to ensure an analysis of potential adverse events was conducted with preventive actions and interventions implemented, when two needles were unable to be located during surgery. This failure may potentially impact the safety of all surgical patients.

Findings:

A review of the minutes from the Patient Safety And Reliability Council (PSRC) meetings were conducted. On February 19, 2014, the facility received a sentinel event notification which addressed the prevention of unintended retained foreign bodies (during surgery). This notification was referred to the Director of Perioperative Services to conduct a analysis.

During the PSRC on May 21, 2014, the discussion indicated a transition in leadership precluded the completion of the analysis for perioperative and perinatal areas regarding the prevention of unintended retained foreign bodies. The action at this time was referred to the Directors of Perioperative Services and the Perinatal Department to conduct an analysis.

During the PSRC on July 16, 2014, the discussion indicated a recent transition in leadership precluded the completion of the analysis for the perioperative and perinatal areas. The action was referred to the Directors of Perioperative Services and the Perinatal Department to conduct an analysis.

During the PSRC on September 17, 2014, the discussion regarding preventing unintended retained foreign bodies indicated the Operating Room Director will meet with the Director of Perioperative services to discuss standardizing the counting process...The operating room had ongoing audits on counts and they need to focus on the process in labor and delivery..."Greatest Risk."

During the PSRC on November 19, 2014, the discussion regarding preventing unintended retained foreign bodies was pending due to the absence of a Director of Perioperative Services.

During the PSRC on January 21, 2015, the discussion regarding preventing unintended retained foreign bodies indicated a "Formal recommendation to the committee for review of (needle) counts facility wide. Director of Obstetrics identified information...at the recent Patient Safety collaborative on retained foreign objects Identified two recent events during chart review in which we had the inability to locate two needles. Granted x-rays were performed per process however we were unable to locate the needles in both cases even though all measures to locate were implemented...the two recently found were found out of happen stance of a chart review for information unrelated to these events."

Further document review failed to show the facility reviewed the issue of preventing unintended retained foreign bodies. The documentation also failed to indicate that the facility analyzed the potential underlying causes or contributing factors involved in the inability to locate the two missing needles or initiated performance improvement activities based on the analysis.

An interview was conducted with the Physician Obstetric Chair of Quality on May 28, 2015, at 12 p.m. She stated no one had notified her about the quality issues surrounding unintended retained foreign bodies in the labor and delivery department.

Based on interview and document review, the facility failed to ensure the quality assessment and performance improvement (QAPI) program reflected all departments within the facility by failing to have a formal analysis of blood transfusion reactions. This failure had the potential to result in missed opportunities to improve patient care outcomes.

Findings:

A review of the laboratory's blood bank post transfusion investigations for the year 2014 was conducted. There was a total of 19 investigations regarding untoward results from the infusion of blood or a blood component.

A review of the facility's Quality and Performance Improvement Plan (Board approval: 6/17/2014) was conducted. The scope of the plan indicated, "Information for quality activities will be obtained from, but not limited to: multidisciplinary teams, hospital wide and departmental indicators and projects..."

Further document review failed to show that the laboratory's post transfusion investigations were brought to the QAPI committee for review.

An interview was conducted with the interim Quality Director (QD) on May 28, 2015, at 2:30 p.m. The QD stated there was no evidence to show the results of the 19 investigations by the blood bank personnel in 2014, were reviewed with the QAPI committee.

Based on interview and record review, the facility failed to ensure there was documented evidence of current Ongoing Professional Practice Evaluation's (OPPE) for nine out of eleven members of the Medical Staff reviewed (Physicians 1, 2, 3, 4, 5, 6, 7, 9, 11). This failed practice had the potential for the risk of substandard healthcare for patients receiving services from these physicians.

Findings:

A review of the medical staff files was conducted on May 26, 2015. Nine of the eleven physician credentialing files did not contain current OPPE.

During an interview with the Coordinator of Medical Staff on May 26, 2015, at 1:20 p.m., she stated current OPPE had not been completed for the nine physicians. The most recent period completed was Jan-June 2014. She stated OPPEs were to occur every six months.

During an interview with the Chief of staff-elect on May 28, 2015, at 12:30 p.m., he agreed that the OPPEs were not current and stated they are working on getting them up to date.

The facility policy, Professional Practice Evaluation, (revised November, 2014), was reviewed on May 26, 2015. The policy defined ongoing professional practice evaluation as "The routine monitoring and evaluation of current competency for members of the medical staff, and the use of that information for ongoing evaluation for the purposes of determining whether to continue, limit or revoke any existing privileges and reappointment."

The criteria listed included," Inpatient and outpatient data for both the individual physician and comparison with the aggregate of the physicians in that specialty as available and event specific information such as Risk related occurrences, quality indicator related occurrences, etc."

The policy further indicated, "The Quality and Safety Department will generate OPPE profiles for a defined 6 month period - generally January through June and July through December. OPPE profiles will be completed and available for the defined 6 month period no later than 90 days after the 6 month period ends. "

Based on interview and record review, Surgical Services failed to ensure services were provided in accordance with acceptable standards of practice by failing to:

1. Ensure surgical counts were completed and documented (A0951);

2. Ensure an analysis was conducted, preventative actions, and interventions were implemented for two identified potential adverse events. Two needles were unable to be located during a surgical procedures (A0286);

3. Ensure acceptable standards and recommendations by a facility adopted nationally recognized professional organization were implemented regarding the formation of policies and procedures for Robotic assisted surgery (A0951), and;

The cumulative effect of these systemic problems resulted in the failure of the Surgical Services to ensure patients' were receiving safe and effective care in the operative department.

29542

Based on interview and record review, the facility failed to ensure surgical services were consistent with needs and resources for multiple patients undergoing surgical procedures by:

A. Ensuring surgical counts were completed and documented for 20 of 34 patients (Patients 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16, 17, 18, 24, 31, 33, and 34) and ;

B. Ensuring policy and procedures were developed and implemented for Robotic assisted procedures.

These failures had the potential to result in:

A. Unintended retained objects during surgical procedures.

B. Staff to be unaware of what surgical care, precautions, and safeguards were to be provided during Robotic assisted procedures.

Findings:

A. The Robotic Coordinator/Charge Nurse (RCCN) was interviewed conduct on May 26, 2015, at 10:15 a.m. The RCCN stated the facility's policy and procedures followed the Association of Peri-Operative Nurses standards (AORN- an organization that provides nursing education, standards, and clinical practice guidelines for operating room nurses).

The RCCN stated the facility's policy and procedure was to count sharps (needles), and other surgical items to include sponges, prior to the surgical procedure, before wound closure, and at skin closure for a total of three counts. The RCCN stated in the case of a cavity within a cavity surgery, such as a cesarean section, an additional counting of instruments would be performed for a total of four counts.

The RCCN stated surgical items were counted to account for all items used in surgery, and to decrease the potential for a retained foreign body. The RCCN stated all counts would be documented in the patient's medical record.

The AORN guidelines for prevention of retained surgical items effective July 15, 2010 are as follows:
"...Retained surgical items (RSI) are considered preventable occurrences...Performing surgical item counts is one RSI prevention strategy...Counts of soft goods (sponges, towels), and sharps (needles,scalpels) should be performed:
*before the procedure
*when new items are added
*before closure of a cavity within a cavity (e.g.. uterus)
*at skin closure at the end of the procedure or at the end of the procedure when items are no longer in use, and
*at the time of permanent relief of either scrub person or circulating Registered Nurse (RN)."

1. A review of Patient 1's record was conducted. Patient 1 was admitted on May 22, 2015, for a left hip hemiarthroplasty (repair of a fracture), which was conducted on May 23, 2015.

The record indicated the initial instrument count was completed at 8:12 a.m. The final instrument count was completed at 9:25 a.m. There was no documentation to indicate a middle instrument count was conducted at the time of the skin closure.

2. A review of Patient 2's record was conducted. Patient 2 was admitted on May 21, 2015, and had a lumbar laminectomy (spinal surgery)

The record indicated the initial instrument count was completed at 7 p.m. The final instrument count was completed at 10:41 p.m. There was no documentation to indicate a middle instrument count was conducted at the time of the skin closure.

3. A review of Patient 3's record was conducted. Patient 3 was admitted on May 25, 2015, and had a cholecystectomy (removal of the gallbladder).

The record indicated the initial instrument count was completed at 3 p.m. The final instrument count was completed at 4:12 p.m. There was no documentation to indicate a middle instrument count was conducted at the time of the skin closure.

4. A review of Patient 4's record was conducted. Patient 4 was admitted on May 24, 2015. On May 26, 2015, and had a right total hip revision arthroplasty (revision of a prior surgical hip repair).

The initial instrument count was completed at 7 p.m. The final instrument count was completed at 9:52 p.m. There was no documentation to indicate a middle instrument count was conducted at the time of the skin closure.

5. A review of Patient 5's record was conducted. Patient 5 was admitted on May 24, 2015, and had a cholecystectomy.

The initial instrument count was completed at 10:31 a.m. The final instrument count was completed at 11:33 a.m. There was no documentation to indicate a middle instrument count was conducted at the time of the skin closure.

6. A review of Patient 6's record was conducted. Patient 6 was admitted on May 21, 2015, and had a colon resection (removal of part of the colon).

The initial instrument count was completed at 12:30 p.m. the final instrument count was completed at 2:30 p.m. There was no documentation to indicate a middle instrument count was conducted at the time of the skin closure.

7. A review of Patient 7's record was completed. Patient 7 was admitted on May 23, 2015, and had a left hip hemiarthroplasty.

The initial instrument count was completed at 2:28 p.m. The final instrument count was completed at 4:35 p.m. There was no documentation to indicate a middle instrument count was completed at the time of the skin closure.

8. A review of Patient 8's record was conducted. Patient 8 was admitted on February 3, 2015, for a robotic assisted removal of a lymph node (an organ which filters for foreign particles).

The initial instrument count was completed at 8:30 a.m. The final instrument count was completed at 10:26 a.m. There was no documentation to indicate a middle instrument count was conducted at the time of the skin closure.

9. A review of Patient 9's record was conducted. Patient 9 was admitted on February 21, 2015, in active labor. The patient had a caesarean section (surgical removal of a fetus from the uterus) on February 21, 2015.

The initial instrument count was completed at 8:10 p.m. The final instrument count was completed at 9:05 p.m. There was no documentation to indicate there were additional instrument counts done during the closure of the uterus or at the time of the skin closure.

10. A review of Patient 10's record was conducted. Patient 10 was admitted on February 16, 2015, for a scheduled caesarean section.

The initial instrument count was completed at 1:20 a.m. The final instrument count was completed at 2:08 a.m. There was no documentation to indicate there were additional instrument counts done during the closure of the uterus or at the time of the skin closure.

11. A review of Patient 11's record was conducted. Patient 11 was admitted on February 3, 2015, for a scheduled caesarean section.

The initial instrument count was completed at 7:55 a.m. The final instrument count was completed at 8:20 a.m. There was no documentation to indicate there were additional instrument counts done during the closure of the uterus or at the time of the skin closure.

12. A review of Patient 12's record was conducted. Patient 12 was admitted on February 24, 2015, and had a caesarean section.

The initial instrument count was completed at 1:50 a.m. The final instrument count was completed at 2:30 a.m. There was no documentation to indicate there were additional instrument counts done during the closure of the uterus or at the time of the skin closure.

13. A review of Patient 13's record was conducted. Patient 13 was admitted on February 6, 2012, for a robotic assisted hernia (a condition in which part of an organ is displaced and protrudes through the wall of a cavity) surgery.

The initial instrument count was completed at 11:15 a.m. The final instrument count was completed at 12:13 p.m. There was no documentation to indicate an instrument count was conducted at the time of the skin closure.

14. A review of Patient 16's record was conducted on May 26, 2015. Patient 16 was admitted on April 15, 2015, for the purpose of a Robotic assisted surgical procedure. The record indicated there were two surgical counts performed during the procedure, an initial count and a final count.

There was no documentation to indicate a middle count was conducted at skin closure.

The record further indicated Patient 16 returned to the Operating Room (OR), on April 18, 2015, (three days after the Robotic surgical procedure), for removal of a retained needle.

15. A review of Patient 17's record was conducted on May 26, 2015. patient 17 was admitted on March 1, 2015, for a cesarean section. The record indicated there were two surgical counts performed during the procedure, an initial count and a final count.

There was no documentation to indicate a count was conducted at cavity closure, and at skin closure.

16. A review of Patient 18's record was conducted on May 26, 2015. Patient 18 was admitted on March 16, 2015, for the purposed of a total abdominal hysterectomy (removal of the uterus through an abdominal incision). The record indicated there were two surgical counts performed during the procedure, an initial count and a final count.

There was no documentation to indicated a count was conducted at cavity closure, and at skin closure.

17. A review of Patient 24's record was conducted on May 27, 2015. Patient 24 was admitted on April 3, 2015, for a cesarean section. The record indicated there were two surgical counts performed during the procedure, an initial count and a final count.

There was no documentation to indicate a count was conducted at cavity closure, and at skin closure.

18. A review of Patient 31's record was conducted on May 28, 2015. Patient 31 was admitted on May 22, 2015, for a cesarean section. The record indicated there were two surgical counts performed during the procedure, an initial count and a final count.

There was no documentation to indicate a count was conducted at cavity closure, and at skin closure.

19. A review of Patient 33's record was conducted on May 28, 2015. Patient 33 was admitted on May 22, 2015, for a cesarean section. The record indicated there were two surgical counts performed during the procedure, an initial count and a final count.

There was no documentation to indicate a count was conducted at cavity closure, and at skin closure.

20. A review of Patient 34's was conducted on May 28, 2015. Patient 34 was admitted on May 24, 2015. The record indicated the patient underwent a hip replacement surgery on May 25, 2015. The record indicated there were two surgical counts performed during the procedure, an initial count and a final count.

There was no documentation to indicate a middle count was conducted at skin closure.

The facility policy and procedure titled "Surgical Counts" dated November 12, 2013, indicated "Surgical Counts are performed to account for all items used in surgery and to decrease the potential for injury to patients as a result of a retained foreign body."

The policy further indicated "Sharps and miscellaneous counts are to be performed on all surgical procedures, before the procedure to establish a baseline, before closure of a cavity within a cavity, before wound closure, and at skin closure or end of procedure..."

B. An interview was conducted with the Robotic Coordinator/Charge Nurse (RCCN), on May 26, 2015, at 10:15 a.m.

The The RCCN stated the facility followed the Association of Peri-Operative Nurses recommendations regarding the development of surgical policies and procedures. (AORN- an organization that provides nursing education, standards, and clinical practice guidelines for operating room nurses).

The RCCN stated the facility provided Robotic assisted surgical services since 2014. The RCCN stated surgical staff were required to have extensive training regarding Robotic assisted surgical procedures because the procedures required different and sometimes complicated positioning of the patient, and an added emphasis on verbal communication between staff during the procedures.

The RCCN stated the facility did not have policies and procedures developed regarding Robotic assisted surgeries.

During an interview with the Interim Chief Nursing Officer (CNO), on May 28, 2015, at 10:30 a.m., the CNO stated the facility did not have a Nursing Director of Surgical Services. The CNO stated she was responsible for the nursing oversite of the surgical department.

The CNO stated the facility followed AORN's standards and recommendations. The CNO stated the facility did not have policies and procedures regarding Robotic assisted surgery.

During an interview with the Chief of Staff Elect (CSE), on May 28, 2015, at 12:30 p.m., the CSE stated the facility should have policies and procedures in place regarding Robotic assisted surgery in order to ensure surgical staff were aware of what protocols (rules) to follow during the procedures.

The AORN guideline for Minimally Invasive Surgery (MIS) effective December 2009, indicated "...Policies and procedures for MIS and computer assisted (Robotic) procedures should be developed, reviewed periodically, and readily available in the practice setting..."