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Based on the number and nature of deficiencies, the facility failed to be in compliance with the Condition of Participation of Governing Body. Specifically, the governing body failed to ensure that the facility was in compliance with the other Conditions of Participation of Nursing Services and Quality Assurance/Performance Improvement (QAPI). In addition, the Governing Body failed to ensure that all practitioners providing or consulting around patient care were appointed to the medical staff. The Governing Body also failed to ensure that all contracted employees providing services to patients, or having direct contact with patients, were adequately screened, oriented, trained and evaluated to ensure a safe environment for patients. The Governing Body failed to ensure that adverse events identified during the survey involving surgical cases met acceptable standards of practice. In these cases, several months had lapsed since the events and completion dates for corrective actions in a timely manner, had not been met.

The facility failed to meet the following Standards under the Condition of Governing Body:

A 0046 Medical Staff Appointments. The governing body must appoint members of the medical staff after considering the recommendations of the existing members of the medical staff.

A 0084 Contracted Services. The governing body must ensure that the services performed under a contract are provided in a safe and effective manner.

In addition, the Governing Body of the facility failed to ensure the following other Conditions of Participation:

Tag A 0263 - Condition of Quality Assurance/Performance Improvement (QAPI)

Tag A 0385 - Condition of Nursing Services, including an Immediate Jeopardy (IJ) declaration on Day 3 of the survey

Also reference the following Standard deficiency:

Tag A 0118 - Grievances, under the Condition of Patient Rights
Tag A 0290 - A 0291 QAPI Sustained Improvement Measurements to implement actions taken and to track performance to ensure improvements were sustained.

Based on staff/physician interviews and review of facility documents, the governing body of the facility failed to ensure that the psychiatrists that provided phone consultation to the contracted emergency psychiatric evaluators were appointed to the medical staff through a process that involved evaluation of credentials, delineation of privileges and evaluation of care through peer review, as outlined in the medical staff bylaws and rules and regulations. The failure created the potential for a negative patient outcome.

The findings were:

1. Review of medical staff and allied health professional staff rosters during an interview with the director of medical staff services on 7/20/10 at approximately 9 a.m., revealed the following information, in pertinent parts: The medical staff roster contained only one psychiatrist. S/he stated the psychiatrist had been appointed to the medical staff approximately three months prior to the survey to provide medical staff sponsorship/consultation to the psychiatric clinical nurse specialist who was appointed to the allied health professional staff to provide psychiatric evaluation and consultation for the inpatient areas.

2. On 7/20/10 at approximately 1:30 p.m., an interview was conducted with the director of human resources and the on-site program manager for a contracted security services team for the facility. The findings were, in pertinent parts:
The on-site program manager for a contracted security services team clarified that the psychiatric evaluations were conducted in the emergency department (ED) by a group of contracted emergency psychiatric evaluators, referred to as the PEPCS (PorterCare Emergency Psychiatric Consultation Services) team, that were employees of an associated health system hospital (operating under a separate license and medicare provider number). S/he stated that the evaluators came to the facility to conduct evaluations on most psychiatric patients who were placed on a mental health hold (M-1). S/he stated that they were in the ED on at least a daily basis conducting evaluations.

3. On 7/21/10 a copy of the contract for the PEPCS team was requested for review. In response to the request, a document titled "Placement Facility Memorandum of Understanding" was provided. The document was reviewed and revealed the following, in pertinent parts: The document was an agreement between the facility and an associated health system hospital (operating under a separate license and medicare provider number) to provide psychiatric services and to receive psychiatric patients requiring inpatient care when bed space was available.

4. Interview with the director of ED/cardiovascular services on 7/21/10 at approximately 3:30 p.m., revealed that the PEPCS team conducted the psychiatric evaluations in the emergency department and that they utilize the psychiatrists that they work with on the staff of the other hospital for phone consultation, when conducting patient evaluations.

5. Interviews with the director of medical staff services and the chief medical officer at approximately 3:45 p.m. on 7/21/10, confirmed that the psychiatrists affiliated with the other hospital and the PEPCS team had not been appointed to the staff of the facility being surveyed.

Based on review of personnel files, facility documents and staff/physician interviews the governing body failed to ensure that patient care provided by contracted services within the facility were provided in a safe and effective manner. Specifically, the facility failed to ensure that emergency psychiatric evaluators and psychiatric sitters, who provided patient care services in the emergency department (ED) under contractual agreements, were provided in a safe and effective manner. In addition, the facility failed to ensure that contracted employees of a vendor who collected and emptied sharps containers in patient areas, including individual patient rooms, were adequately screened, oriented, trained and evaluated to ensure a safe environment for patients. These failures created the potential for negative patient outcomes.

The findings were:

1. During a tour of the intensive care units, telemetry and general surgery units on 7/19/10 at approximately 2:30 p.m., the director of acute care services confirmed that the sharps containers, including those in the patient rooms, were collected and emptied by employees of a contracted vendor. S/he confirmed that these employees routinely entered patient rooms unattended/supervised by facility staff in the course of performing their duties.

2. On 7/20/10 at approximately 1:30 p.m., an interview was conducted with the director of acute care services/staffing office, the director of human resources and the on-site program manager for a contracted security services team for the facility. The findings were, in pertinent parts:
- Emergency Psychiatric Evaluators
The on-site program manager for a contracted security services team clarified that the psychiatric evaluations were conducted in the emergency department (ED) by a group of contracted emergency psychiatric evaluators, referred to as the PEPCS (PorterCare Emergency Psychiatric Consultation Services) team, that were employees of an associated health system hospital (operating under a separate license and medicare provider number). S/he stated that the evaluators came to the facility to conduct evaluations on most psychiatric patients who were placed on a mental health hold (M-1). S/he stated that they were in the ED on at least a daily basis conducting evaluations. The director of human resources confirmed that the facility did not maintain personnel files on the PEPCS team clinicians.

- Psychiatric Sitters
The on-site program manager for a contracted security services team clarified that contracted psychiatric sitters were utilized to provide one-to-one supervision of some psychiatric patients in the emergency department. S/he stated that the sitters were from another department of his/her entity, and s/he did not have direct supervisory authority over those sitters. The director of human resources confirmed that the facility did not maintain personnel files on the sitters.

- Contract Staff to Empty "Sharps" Disposal Containers
The director of acute care services/staffing office and the director of human resources confirmed that the facility did not maintain personnel files on the contracted employees of a vendor who collected and emptied sharps containers in patient areas, including individual patient rooms.

Based on review of grievances, policies/procedures, and staff interviews, it was determined that the hospital did not have a process for prompt resolution of patient grievances in one (#21) of 21 sample patient records. This failure did not ensure this regulation was met and created the potential for a negative patient outcome.

The findings were:

The facility's policy titled "PATIENT COMPLAINTS AND GRIEVANCES" was reviewed on 7/20/2010. It revealed the following, in pertinent part:

"2. A 'patient grievance' is a written or verbal complaint (when the verbal complaint about the patient care is not resolved at the time of the complaint by staff present) by a patient, or the patient's representative, regarding the patient's care, abuse or neglect, issues related to the hospital's compliance with the CMS (Centers for Medicare and Medicaid Services) Hospital Conditions of Participation (CoPs), or a Medicare beneficiary billing complaint related to rights and limitations...
PROCEDURE...
3. Patient Representative
a. Document the complaint in the Complaints Database. Document a grievance in the Grievance Database and refer to the appropriate department manager (s) for investigation and resolution in a timely fashion.
b. If unable to resolve, refer the issue to the CEO or designee..."

On 7/19/2010 the facility's grievance log was reviewed and two random grievances were chosen for further review. Further review of one grievance revealed the following:
The patient filed the grievance with the Patient Representative on 5/17/2010. The patient stated that s/he came to the hospital because of a dizzy spell and hearing loss and that s/he never received prednisone or an ENT (Ear, Nose, and Throat physician) consultation. The patient received two letters from the hospital, one dated 5/17 which informed that the investigation may take over seven days and a second dated 7/16 which stated the hospital was still reviewing the investigation. As of 7/19, the grievance had not yet been resolved.

Review of the "Patient Quality and Safety Committee" meeting minutes from July 14, 2010 revealed that complaints and grievances had been addressed by the Patient Representative, but there was no evidence that this specific patient (#21) was addressed in the meeting.

An interview with the Patient Representative was conducted on 7/20/2010 at approximately 10:15 a.m. S/he stated that s/he did notify the CEO (Chief Executive Officer) about the grievance. S/he stated that the grievance was referred to a hospitalist for review as the patient was cared for by another physician in that hospitalist practice that no longer works at the facility.

An interview with the hospitalist physician (the Chief Officer for the Patient Quality and Safety Committee) who was reviewing sample patient #21's grievance was conducted on 7/21/2010 at approximately 8:20 a.m. S/he stated that the grievance would normally go to the physician involved, but that physician no longer works at the facility. S/he stated that there was a delay in obtaining the medical record and that the Patient Representative eventually obtained the record. After review of the record, the hospitalist stated that he contacted his practice's legal department out of state in regards to formulating a response to the patient. When asked if peer review would have been a faster process, s/he stated, "Peer review is a much slower process than when I look at the incident myself." When asked why the grievance has not been resolved after two months, s/he stated, "I'm clinical and there are time delays with this. The physician is already gone, it is a busy time with our group: we have a new boss, new colleagues, and our hospital nurse is gone..."

An interview with the facility's CMO (Chief Medical Officer) was conducted on 7/21/2010 at approximately 12:15 p.m. In regards to the grievance made by sample patient #21, s/he stated, "I've heard a little bit about it, but I have not investigated it." When asked why s/he had not investigated it instead of the hospitalist who stated s/he has a very demanding schedule, s/he stated, "My approach is to get someone involved. (The physician reviewing it) is a hospitalist and can give me thoughts on how the patient would have been treated." The CMO stated that since s/he was not a hospitalist, the grievance is best investigated by someone other than s/he. When it was addressed that the grievance is still not resolved after two months, s/he stated, "That sounds like something we need to work on."

An interview with the facility's Director of Quality/Patient Safety was conducted on 7/21/2010 at approximately 12:45 p.m. S/he stated that this grievance went to the Quality meeting in July. In regards to timeliness, s/he stated, "We did discuss this one. We knew it wasn't necessarily meeting our expectations." The Director confirmed that the hospitalist reviewing this grievance was also the chair of the Quality committee. When asked why this grievance wasn't expedited, s/he stated that they gave the hospitalist "more latitude that we would normally have because he was on vacation, the doctor is gone, and the hospitalist was dealing with another larger issue at the hospital." S/he stated, "I don't know if we can move forward in this case without some type of medical opinion" because it was care by a physician and not care by the hospital. When asked why s/he didn't take the grievance directly to an ENT physician, s/he stated that talking to an ENT would have been done through peer review. S/he also stated that s/he wanted to see what the hospitalist's legal department "says before I take it to our claims department." The Director had not sought guidance from other quality departments within the hospital's corporation and stated that this was the first grievance of its kind at this hospital.

In summary, the facility did not resolve sample patient #21's grievance in a timely matter. Upon exit from the facility, the grievance had still not been resolved, as the physician reviewing was still seeking legal counsel about it and it was then to be transferred to the hospital's corporate claims department. The facility did not have an effective process in which to establish prompt resolution of patient grievances.

Based on the nature and number of deficiencies cited, the hospital failed to comply with the Condition of Participation of Quality (QAPI). While onsite and after a thorough investigation of the Conditions of Participation (Quality, Nursing, Medical Staff, Emergency Services, Patient Rights, and Governing Body), an IJ (Immediate Jeopardy) was declared. It was determined that intensive care nursing staff did not activate a Code Blue appropriately when a patient was in need of resuscitation and did not document specific details (patient with or without pulse, time patient shocked) over a lengthy period of time (approximately one hour), and were not instructed to follow policy and procedure following a review of the event by the department director. Although the outcome for this particular patient was satisfactory, failure to follow policy and procedure, especially in an emergent situation, placed other patients at potential risk of negative patient harm.

Cross Reference A0386: Organization of Nursing Services for findings related to the Immediate Jeopardy.

Furthermore, the hospital failed to ensure there was an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. The hospital failed to ensure that all processes in the program were completed such that re-occurrences of sentinel events would be highly unlikely and the quality of care was superior in every way. The facility failed to meet the following standards under this Condition:

A0046 Medical Staff Appointments. The governing body must appoint members of the medical staff after considering the recommendations of the existing members of the medical staff.

A0084 Contracted Services. The governing body must ensure that the services performed under a contract are provided in a safe and effective manner.

A0118 Patient Rights: Grievances. The hospital must establish a process for prompt resolution of patient grievances and must inform each patient whom to contact to file a grievance.

A0290 QAPI Improvement Measurements. The hospital must take actions aimed at performance improvement and, after implementing those actions, the hospital must measure its success.

A0291 QAPI Sustained Improvement. The hospital must take actions aimed at performance improvement and, after implementing those actions, the hospital must measure its success, and track performance to ensure that improvements are sustained.

A0313 Executive Responsibilities. Hospital-wide quality assessment and performance improvement efforts must address priorities for improved and continuous patient safety and that improvement actions are evaluated.

A0396 Nursing Care Plans. The hospital must ensure that the nursing staff develops, and keeps current, a nursing care plan for each patient.

Based on staff interviews and review of facility documentation, the hospital failed to measure its success after implementing changes as a result of three sentinel events. Failure to do so created the potential for future negative patient harm.

The findings were:

A review of sentinel events on 7/20/2010 revealed the following three incidents:

The first incident occurred in December 2009 and involved a retained uterus in a 31 year-old patient who was scheduled for a laparoscopic-assisted vaginal hysterectomy. On 12/29/2009 the surgeon excised the uterus and moved it to the left upper quadrant of the abdomen before proceeding with another aspect of the surgery. After the patient had been extubated and moved to the stretcher in the OR (operating room), it was determined that the specimen, uterus, had not been removed from the patient's abdomen. The patient required re-intubation and removal of cervical stitches to remove the uterus.

The second incident occurred in January 2010 and involved a retained surgical towel in a 65 year-old patient who underwent a sigmoid colectomy with colostomy. The patient returned on 4/14/2010 for a colostomy reversal and repair of colostomy with mesh at which time a surgical towel was discovered and removed.

The third incident involved a 54 year-old patient admitted on 3/15/2010 for a laparoscopic right hemicolectomy. The surgeon contacted pathology the day after surgery to obtain findings and discovered that no specimen had been received by this department. Approximately 12-16 inches of colon had been removed to be assessed for carcinoma.

An interview with the Director of Quality/Patient Safety and the Director of Peri-Operative Services (DOPS) on 7/21/2010 at approximately 12 noon revealed the following: the first and second cases were still under peer review process. Several factors were identified as contributing to the incident. Increased noise levels was one factor. Per the DOPS equipment to monitor noise levels was purchased. However, noise levels in the operating rooms have only been sporadically monitored without documentation. The department is considering a policy regarding noise level, but had not completed this to date.

A policy was revised to include surgical towels in the count process. The surgeon involved in the case was the only one who used towels in a retractor method. Prior to the survey there had not been any tracking or monitoring of counts with surgical towels for any procedures to determine whether this process was successful or not.

The surgeon in the third incident had completed a gross analysis of the resected colon while the patient was on the OR table and felt the margins were free of any cancerous tissue. The patient will be followed by colonoscopy at a future date with the procedure to be free of charge to the patient.

Ten (10) random cases had been reviewed by the DOPS for specimen process from 6/22/2010 to 7/19/2010. All were identified as correct. S/he stated that the facility performs approximately 360 surgeries per month not all of which require a specimen to be sent to pathology. A back-up system has been devised where a pathology tech receives and reviews the surgery schedule each day, identifies any cases that may have specimens, and calls the charge nurse to cross-reference cases for specimens. If a case is still in progress, the technician will follow up the next day to verify receipt of specimen. Signage, "Got specimen?" has been placed in each operating room. Informal staff discussions regarding specimens occurred during morning and afternoon huddles; no documentation was completed for these discussions. A revised policy for Tissue and Specimens was completed 6/21/2010 and provided to the surveyor. This policy further delineates responsibilities for all parties involved in the procedures/surgeries. Annual training for staff to include review of this policy and procedure is scheduled for next month. Both directors stated there had not been any further missing specimens.

It was further determined during interview that the facility had been tracking and monitoring approximately 10% of cases with specimens to determine the success of those corrective actions. There had not been any follow up with the pathology department to determine if the back-up system was effective or not. The peer review process is now into its seventh month for the retained uterus case and no definitive decision has been made as to the standard of care this patient received. In the meantime, the surgeon has continued to perform surgeries and verification of the new count process only recently started.

A review of the Quality & Patient Safety Plan 2009-2010 on 7/21/2010 revealed the following, in pertinent parts:

"XII. Improvement/Risk Reduction
The facility will utilize information from ongoing data analysis to make changes that will improve performance and patient safety and reduce the likelihood and risk of sentinel events and other adverse events. The facility will measure the success of the indicators on an ongoing basis and track improvements to ensure they are sustained. The following outlines how information from data analysis will be used to make changes:

Information is used to implement changes that will reduce risk of a sentinel event, or other adverse event.
The hospital will take actions aimed at performance improvement, and after implementing those actions; the hospital must measure its success, and track performance to ensure that improvements are sustained..."

A review of the Patient Quality and Safety Committee meeting minutes for the year 2010 revealed that the facility initiated a subcommittee of this one to address perioperative issues including process and quality issues and block scheduling. Although there was input by the subcommittee, there was no specific mention of quality and process concerns or outcome measurements regarding the three incidents in the minutes.

In summary, the hospital failed to demonstrate evidence of its success with changes that were implemented as a result of three sentinel events. Although policies were changed to tighten processes, no further retained foreign objects had been identified, and 10 cases demonstrated correct counts at the time of the survey, the surgery department performs approximately 360 surgeries per month and the potential for error is still present. Other factors (noise levels, staff changes for breaks and illness, rushing, communication between all parties, human errors, and lack of supplies) were identified in the investigations by the hospital as contributory to the adverse events. There was insufficient evidence that all factors had been addressed, monitored and tracked with communication by all parties to measure the success of any strategies.

Based on staff interviews and review of facility documentation, the facility failed to measure its success and track performance to ensure that improvements were sustained.

The findings were:

A review of sentinel events on 7/20/2010 revealed the following three incidents:

The first incident occurred in December 2009 and involved a retained uterus in a 31 year-old patient who was scheduled for a laparoscopic-assisted vaginal hysterectomy. On 12/29/2009 the surgeon excised the uterus and moved it to the left upper quadrant of the abdomen before proceeding with another aspect of the surgery. After the patient had been extubated and moved to the stretcher in the OR (operating room), it was determined that the specimen, uterus, had not been removed from the patient's abdomen. The patient required re-intubation and removal of cervical stitches to remove the uterus.

The second incident occurred in January 2010 and involved a retained surgical towel in a 65 year-old patient who underwent a sigmoid colectomy with colostomy. The patient returned on 4/14/2010 for a colostomy reversal and repair of colostomy with mesh at which time a surgical towel was discovered and removed.

The third incident involved a 54 year-old patient admitted on 3/15/2010 for a laparoscopic right hemicolectomy. The surgeon contacted pathology the day after surgery to obtain findings and discovered that no specimen had been received by this department. Approximately 12-16 inches of colon had been removed to be assessed for carcinoma.

An interview with the Director of Quality/Patient Safety and the Director of Peri-Operative Services (DOPS) on 7/21/2010 at approximately 12 noon revealed the following: the first and second cases were still under peer review process. Several factors were identified as contributing to the incident. Increased noise levels was one factor. Per the DOPS equipment to monitor noise levels was purchased. However, noise levels in the operating rooms have only been sporadically monitored without documentation. The department is considering a policy regarding noise level, but had not completed this to date.

A policy was revised to include surgical towels in the count process. The surgeon involved in the case was the only one who used towels in a retractor method.

The surgeon in the third incident had completed a gross analysis of the resected colon while the patient was on the OR table and felt the margins were free of any cancerous tissue. The patient will be followed by colonoscopy at a future date with the procedure to be free of charge to the patient.

Ten (10) random cases had been reviewed by the DOPS for specimen process from 6/22/2010 to 7/19/2010. All were identified as correct. S/he stated that the facility performs approximately 360 surgeries per month not all of which require a specimen to be sent to pathology. A back-up system has been devised where a pathology tech receives and reviews the surgery schedule each day, identifies any cases that may have specimens, and calls the charge nurse to cross-reference cases for specimens. If a case is still in progress, the technician will follow up the next day to verify receipt of specimen. Signage, "Got specimen?" has been placed in each operating room. Informal staff discussions regarding specimens occurred during morning and afternoon huddles; no documentation was completed for these discussions. A revised policy for Tissue and Specimens was completed 6/21/2010 and provided to the surveyor. This policy further delineates responsibilities for all parties involved in the procedures/surgeries. Annual training for staff to include review of this policy and procedure is scheduled for next month. Both directors stated there had not been any further missing specimens.

It was further determined during interview that the facility had been tracking and monitoring approximately 10% of cases with specimens to determine the success of those corrective actions. There had not been any follow up with the pathology department to determine if the back-up system was effective or not. The peer review process is now into its seventh month for the retained uterus case and no definitive decision has been made as to the standard of care this patient received. In the meantime, the surgeon has continued to perform surgeries and verification of the new count process only recently started.

A review of the Quality & Patient Safety Plan 2009-2010 on 7/21/2010 revealed the following, in pertinent parts:
"III. Objectives
The overall objectives are as follows:
Challenge leaders of the organization to be responsible for fostering a safe environment
Target high risk activities for proactive review to reduce likelihood of future and recurring errors
Utilize internal and external data-driven, knowledge-based information to reduce the risk of sentinel events, adverse outcomes, and medical errors...

VIII. Data Collection and Use of Data
In addition to the medical staff performance measures, data are collected in the following areas:
Operative or other procedures that place patients at risk of disability or death
Patient safety activities including but not limited to: sentinel events, medical errors, and adverse patient events, root cause analyses done, and actions taken...

XII. Improvement/Risk Reduction
The facility will utilize information from ongoing data analysis to make changes that will improve performance and patient safety and reduce the likelihood and risk of sentinel events and other adverse events. The facility will measure the success of the indicators on an ongoing basis and track improvements to ensure they are sustained. The following outlines how information from data analysis will be used to make changes:

Information is used to implement changes that will reduce risk of a sentinel event, or other adverse event.
The hospital will take actions aimed at performance improvement, and after implementing those actions; the hospital must measure its success, and track performance to ensure that improvements are sustained..."

A review of the Patient Quality and Safety Committee meeting minutes for the year 2010 revealed that the facility initiated a subcommittee of this one to address perioperative issues including process and quality issues and block scheduling. Although there was input by the subcommittee, there was no specific mention of quality and process concerns regarding the three incidents in the minutes.

In summary, the facility failed to follow its Quality and Patient Safety Plan by not verifying with observed and factual data the success of its corrective actions for the following: correct counts of towels with sponges in a significant number of cases versus a small number completed several months after two incidents of retained foreign objects, tracking the specimen process including the efficacy of the pathology department's assistance, documenting that 100% of staff have received the appropriate training for revised policies and procedures, tracking and making a final determination and/or policy regarding noise levels in the operating rooms that were determined to have contributed to an adverse event, and not ensuring a timely peer review process for an adverse event that resulted in a re-intubation, removal of stitches and pathologic tissue that was the main focus of the surgery in the first place and a second event involving a retained surgical towel.

Based on staff interviews and review of facility documentation, the chief medical officer (CMO) and medical staff failed to perform peer review in a timely manner for two sentinel events and one grievance.

The findings were:

A review of sentinel events on 7/20/2010 revealed the following incidents:

A 31 year-old patient was admitted on 12/29/2009 for a laparoscopic-assisted vaginal hysterectomy. The surgeon excised the uterus and moved it to the left upper quadrant of the abdomen before proceeding with another aspect of the surgery. After the patient had been extubated and moved to the stretcher in the OR (operating room), it was determined that the specimen, uterus, had not been removed from the patient's abdomen. The patient required re-intubation, additional anesthesia, and removal of cervical stitches to remove the uterus.

The second incident occurred in January 2010 and involved a retained surgical towel in a 65 year-old patient who underwent a sigmoid colectomy with colostomy. The patient returned on 4/14/2010 for a colostomy reversal and repair of colostomy with mesh at which time a surgical towel was discovered and removed.

An interview with the Director of Quality/Patient Safety and the Director of Peri-Operative Services (DOPS) on 7/21/2010 at approximately 12 noon revealed the following: the two cases were still under peer review process. Several factors were identified as contributing to the first incident. Increased noise levels was one factor. Per the DOPS equipment to monitor noise levels was purchased. However, noise levels in the operating rooms have only been sporadically monitored without documentation. The department is considering a policy regarding noise level, but had not completed this to date. Unusual staff changes during procedures (e.g., breaks, circulating nurse leaving the room to obtain supplies, illness, etc.) and poor communication including a lack of respect were identified as contributory to the events.

A policy was revised to include surgical towels in the count process. The surgeon involved in the case was the only one who used towels in a retractor method.

Ten (10) random cases had been reviewed by the DOPS for specimen process from 6/22/2010 to 7/19/2010. All were identified as correct. S/he stated that the facility performs approximately 360 surgeries per month not all of which require a specimen to be sent to pathology. A back-up system has been devised where a pathology tech receives and reviews the surgery schedule each day, identifies any cases that may have specimens, and calls the charge nurse to cross-reference cases for specimens. If a case is still in progress, the technician will follow up the next day to verify receipt of specimen.

A revised policy for Tissue and Specimens was completed 6/21/2010 and provided to the surveyor. This policy further delineates responsibilities for all parties involved in the procedures/surgeries. Both directors stated there had not been any further missing specimens.

It was further determined during interview that the facility had been tracking and monitoring approximately 10% of cases with specimens to determine the success of those corrective actions. The peer review process is now into its seventh month for the retained uterus case and no definitive decision has been made as to the standard of care this patient received. In the meantime, the surgeon has continued to perform surgeries and verification of the new count process only recently started.

A review of the Quality & Patient Safety Plan 2009-2010 on 7/21/2010 revealed the following, in pertinent parts:
"III. Objectives
The overall objectives are as follows:
Challenge leaders of the organization to be responsible for fostering a safe environment
Target high risk activities for proactive review to reduce likelihood of future and recurring errors
Utilize internal and external data-driven, knowledge-based information to reduce the risk of sentinel events, adverse outcomes, and medical errors...

VIII. Data Collection and Use of Data
In addition to the medical staff performance measures, data are collected in the following areas:
Operative or other procedures that place patients at risk of disability or death
Patient safety activities including but not limited to: sentinel events, medical errors, and adverse patient events, root cause analyses done, and actions taken...

XII. Improvement/Risk Reduction
The facility will utilize information from ongoing data analysis to make changes that will improve performance and patient safety and reduce the likelihood and risk of sentinel events and other adverse events. The facility will measure the success of the indicators on an ongoing basis and track improvements to ensure they are sustained. The following outlines how information from data analysis will be used to make changes:

Information is used to implement changes that will reduce risk of a sentinel event, or other adverse event...
The hospital will take actions aimed at performance improvement, and after implementing those actions; the hospital must measure its success, and track performance to ensure that improvements are sustained..."

A review of the Patient Quality and Safety Committee meeting minutes for the year 2010 revealed that the facility initiated a subcommittee of this one to address perioperative issues including process and quality issues and block scheduling. Although there was input by the subcommittee, there was no specific mention of quality and process concerns regarding the three incidents in the minutes. For example, there was no mention of accountability in the peer review process, accountability of noise levels in the operating rooms by either physician or nursing staff, accountability in the count process for sponges, towels, and specimens, or any further discussion regarding flow and communication between physicians and nursing staff in the OR.

On 7/19/2010 the facility's grievance log was reviewed and two random grievances were chosen for further review. Further review of one grievance revealed the following:
The patient filed the grievance with the Patient Representative on 5/17/2010. The patient stated that s/he came to the hospital because of a dizzy spell and hearing loss and that s/he never received prednisone or an ENT (Ear, Nose, and Throat physician) consultation. The patient received two letters from the hospital, one dated 5/17/10 which informed that the investigation may take over seven days and a second dated 7/16/10 which stated the hospital was still reviewing the investigation. As of 7/19/2010, the grievance had not yet been resolved and the physician reviewing it was awaiting legal counsel in regards to how to proceed.

In summary, the CMO and medical staff as leaders in the facility failed to follow the Quality and Patient Safety Plan to protect patients and ensure their safety by not completing actions that were designed to oversee medical care to patients in a timely manner. Specifically, they failed to ensure tracking and monitoring of corrective actions following adverse events, accountability issues in the department, and a timely peer review process for sentinel events and a grievance concerning provider care were completed.

Based on the nature of deficiency A0386 cited, the facility failed to meet the Condition of Participation of Nursing Services. The hospital failed to have an organized nursing service in which appropriate care was determined by critical care nurses and delineated to the Code Blue team on an unstable patient in one (#18) of 21 sample patient records. In addition, it failed to ensure that nursing care plans were initiated and maintained for each patient.

On Day 3 of the survey (7/21/10), an Immediate Jeopardy situation was declared. Specifically, it was determined that intensive care nursing staff did not activate a Code Blue appropriately when a patient (Sample Patient #18) was in need of resuscitation and did not document specific details (patient with or without pulse, time patient shocked) over a lengthy period of time (approximately one hour). No corrective actions were put in place, including staff instruction to follow the Code Blue policy and procedure, following a review of the event by the department director. Although the outcome for that particular patient was satisfactory, failure to follow policy and procedure, especially in an emergent situation, placed other patients at potential risk of negative patient harm. The facility management team was notified in a meeting that an IJ (Immediate Jeopardy) had been declared and directed to begin to formulate an immediate plan to correct the situation. The administrative team provided and began to implement an acceptable plan to correct the IJ situation, prior to the survey team's exit of the facility at the end of Survey Day 3.

The facility provided an acceptable plan of correction to remove the Immediate Jeopardy situation identified during the survey. The plan included in part, a change/revision in the Code Blue Policy to more clearly define activation triggers, to be more in alignment with the ACLS protocols and identified how the changes/revisions in the Code Blue Policy would be communicated to clinical staff, associates and medical staff. This plan of correction was presented and approved by the survey team on July 21,2010. The Immediate jeopardy situation was removed.



The facility failed to meet the following standards under the condition of Nursing Services:

A0386: Organization of Nursing Services - The hospital must have a well-organized service with a plan of administrative authority and delineation of responsibilities for patient care. The director of the nursing service must be a licensed registered nurse. He or she is responsible for the operation of the service, including determining the types and numbers of nursing personnel and staff necessary to provide nursing care for all areas of the hospital.

A0396: Nursing Care Plan - The hospital must ensure that the nursing staff develops, and keeps current, a nursing care plan for each patient.

Based on review of medical record, staff interview, and review of facility documents/policies, it was determined that the Director of Nursing and support staff failed to ensure nurses made appropriate clinical decisions within a critical care environment as evidenced by failure to call a CODE BLUE on an unstable patient in one (#18) of 21 sample patient records. This failure created a potential negative outcome.

The findings were:

Sample patient record #18 was reviewed on 7/20/2010 on revealed the following:

The patient was a 69 year old adult admitted to the hospital though the Emergency Department (ED) on 7/8/2010 at approximately 5:00 p.m. after cardiac arrest which necessitated defibrillation (shocking) by paramedics prior to arrival. The patient had a cardiac history of cardiomyopathy, hypertension, hyperlipidemia. S/he was transferred to the Intensive Care Unit (ICU) at approximately 5:40 p.m. On 7/9/2010, between 9:57 p.m. and 10:51 p.m. the patient received multiple electrical shocks administered by Registered Nurses in the ICU for an abnormal heart rhythm. The patient had a complicated hospital course, which included respiratory failure and pneumonia, mechanical respiratory ventilation from 7/11/10 through 7/14/10, a fall, multiple radiological studies, and an echocardiogram that revealed the patient's heart was not pumping ideally. S/he had placement of an automated implantable cardioverter-defibrillator on 7/16/10 to prevent further cardiac arrests if the patient should experience life-threatening heart arrhythmias. The patient was eventually discharged home the afternoon of 7/19/10.

On 7/9/10, while the patient remained in the ICU, at 8:00 p.m. it was documented that the patient's level of consciousness was "Lethargic/Drowsy, Awake." The patient had documented heart arrhythmias (irregular heartbeats) which initiated at approximately 7:59 p.m. according to monitor recordings. These heart beats were initially infrequent and then progressed to extended amounts of time classified at Ventricular Tachycardia (VTach), which is a life-threatening heart rhythm. According to monitor recordings placed in the permanent medical record, sustained VTach began at approximately 9:57 p.m. and continued on and off until at least 10:51 p.m. It was not documented when the patient was shocked. The last extended episode of VTach (approximately 20 seconds duration) was at approximately 10:51 p.m. The next documented monitor recording was timed midnight and was then a normal perfusing heart rhythm. The monitor recordings revealed that the patient's arterial line (a catheter usually placed the patient's artery reflecting real-time blood pressure) was decreased frequently when the patient was having episodes of VTach, indicating that the heart was not perfusing well. There was no additional documentation to determine if the patient was with or without a pulse during the episodes of VTach.

According to physician orders and progress notes, a cardiologist was called by the patient's nurse at 9:12 p.m. for cardiac medication orders and again at 10:00 p.m. A hospitalist was called for a pain medication order at 10:10 p.m. and the hospitalist was by to see the patient thereafter, although it is unknown what time as the physician's order and progress note are not timed. The hospitalist also wrote additional orders on another page, which are timed "11 PM." One of the orders stated, in pertinent part: "If VTACH recurs, shock only if loses consciousness & Give another Amiodarone #3 150 mg Bolus & cont. drip." The untimed progress note, stated the following, in pertinent part: "Called re analgesia request. Pt having V. Tach. & shocked by RN. In & out of V. Tach...."

The nurse's notes in regards to this time period revealed that s/he called the cardiologist at 9:45 p.m. and the hospitalist at 10:00 p.m. The nurse's documentation of the patient's cardiac rhythm varies between a normal heart rhythm and VTach.

The only nurse's narrative note for the night shift of 7/9/10 to the morning of 7/10/10 stated the following, in pertinent part: "Pt with increased ectopy and hypertension during evening hours, labs sent, notify Dr... about pt change in status. Orders received for more potassium, magnesium replacements and an amiodarone bolus. K 3.4 copious amounts of urine. Amiodarone bolus infusing and pt went into sustained VTach rhythm @ 2200 turned pale gray and became unresponsive. Shock administered per ACLS protocol. Sinus rhythm returned and pt became responsive, refer to rhythm strips in chart. Pt then proceeded to go into VTach we shocked 10 times during the next hour to keep the pt in a perfusing rhythm. Dr... at bedside to assist orders received and finally 5 mg IV lopressor helped break him out of VTach. Pt resting in bed in a sinus rhythm in the 70s blood pressure in the 150-170s and continue to replace electrolytes as ordered will cont to monitor."

A physician's dictated "INTERIM SUMMARY REPORT" in the chart dated 7/12/10 stated the following regarding the events, in pertinent part: "He was doing okay here in the hospital. Plans were to place a cardiac defibrillator and pacemaker in him, but on the evening of July 10, 2010 he went into several runs of what sounds like either ectopy or V-tach. He was shocked 10 times over the course of an hour. According to the spouse, the patient was awake and screaming during these events..." However, the date of July 10th was not when the patient experienced this event, but the evening of 7/9/10.

In a telephone interview on 7/22/10 at approximately 3:42 p.m. with the nurse that cared for sample patient #18 the night of July 9th, s/he stated that the patient was "in and out of VTach." When asked if the patient was with or without a pulse, s/he stated, "The A-line would dampen and he would lose consciousness. We never stopped to check a pulse." When asked why a Code Blue was not called, s/he stated, "It wasn't necessarily a code." S/he continued, "If something else would have changed in the situation, we would have called a code... For example if he would have become apneic or there was a need with any of the other patient on the unit." S/he stated that s/he thought there were six ICU patients that night with three nurses. S/he confirmed that the charge nurse and another nurse were helping continually with the patient's care.

The night shift ICU charge nurse who worked on July 9th was interviewed via telephone on 7/22/10 at approximately 6:00 p.m. The nurse stated that the patient never lost consciousness during the runs of VTach. When asked if the patient yelled out, s/he stated "When we had to shock him, he screamed ouch..." When asked if the patient had a pulse, s/he stated, "He had a pulse because he was talking to us. I didn't sit there and check his pulse when he was in VTach, we shocked him right away." S/he continued, "I normally wouldn't call a code in that situation. I felt very comfortable with that situation. If we shocked him and he didn't respond, I would have called a code." The nurse confirmed that the patient was defibrillated, not cardioverted when he was shocked. S/he also stated, "We wouldn't let things get into a bad situation."

The hospitalist caring for sample patient #18 the evening of July 9th was interviewed on 7/21/10. In regards to the patient, s/he stated that s/he was called by a nurse in the ICU requesting pain meds for the patient. The patient's nurse then got on the phone with the physician and stated, "I had to shock because he was in VTach and couldn't call a code because it was too fast." The physician then came up to see the patient, although the patient was "shocked more times prior to me getting there." The physician stated, "During one of the shocks it looked awfully quick in that I know you can shock people while awake, but this was in seconds. I asked if he had lost his pulse and the charge nurse said yes. When the rhythm got quieter, I went downstairs. It was busy at that time and I had multiple admissions. I got called again or the nurses on the first floor could see the rhythm..." The physician stated s/he then went back up to the patient due to the patient's continued VTach and consulted with the cardiologist via telephone, who was not planning to come in to see the patient since he was "non-ischemic". The physician continued, "I thought about calling a code and I didn't see what else they could do except add to confusion because the patient kept coming out of it... I had not been in this situation in a long time..." The physician stated s/he asked the Director of Acute Care to present this to the Code Committee. When the physician was asked if hospitalists come to Code Blues, s/he stated, "Yes, we do if in the vicinity... we don't run them. It is supposed to be the Emergency Department doctor, but often we are there first..." When the physician was asked why a code wasn't called s/he said, "The patient came out of it immediately but wouldn't stay out of it." When asked if anyone other than the Director of Acute Care had reviewed the case, the physician stated that it was being left up to them.

A telephone interview was conducted on 7/22/10 at approximately 2:50 p.m. with the cardiologist that was on-call the night sample patient #18 had VTach. When asked who was the primary physician caring for the patient during the VTach, s/he stated that it was her/his understanding that the hospitalist was caring for the patient as s/he was the critical care doctor.

The Educator of Acute Care was interviewed on 7/19/10 at approximately 2:40 p.m. S/he stated that should a Code Blue occur in the ICU, the Charge nurse would be the code lead until the physician arrived. The Educator stated that a provider of obstetric anesthesia is in hospital 24 hours a day, 7 days a week and would be the first physician to lead the code and that the Emergency Department physician, also in house 24/7, would be the second to lead the code.

In an interview with a Telemetry Technician on 7/19/10 at approximately 3:00 p.m., s/he stated in regards to a life-threatening arrythmia, "We don't have to take the time to call a nurse, we can call a code ourselves."

An interview with the Director of Acute Care was conducted on 7/21/10 at approximately 9:35 a.m. S/he stated that s/he had investigated the events which occurred on 7/9/10 with patient #18, however, the majority of the investigation was related to an outburst by a physician the next morning, not about care the patient received. S/he stated, "We felt everything was done correctly." S/he stated, "The issue of calling a code or not is on the agenda for the next Critical Care Committee." However, the next meeting isn't until mid August. At 9:55 a.m., s/he stated that the nurses' perceptions were that both physicians (the hospitalist and the cardiologist) were the captains of the ship. S/he stated, "He was not pulseless every time he was shocked, he was talking to them and one time he did yell out." S/he did acknowledge that the medical record contained no data in regards to the time the patient was shocked and if the patient was with or without a pulse prior to shocks. "A code sheet would have better data," s/he stated. When the Director was asked why this patient was on the agenda for review at the Code Blue Committee when a code was not called, s/he stated that this patient would have only been taken to the code blue committee because the hospitalist requested it. The Director confirmed that CPR (Cardiopulmonary Resuscitation) was not ever done. When asked why the nurses did not call a Code Blue, s/he stated "They felt that they followed ACLS protocol and they felt it was under control."

In an additional interview with the Educator of Acute Care on 7/21/10 at approximately 10:25 a.m., s/he stated, "We did speak about the lack of pulseless info and coached the nurses about it."

An interview was conducted with the chair of the Code Blue Committee on 7/21/10 at approximately 1:55 p.m. The May Code Blue Meeting Minutes were addressed with her/him. In response to the issue of "overcrowding issues in Rapid Response and Code Blues" s/he stated "People will just turn up for Code Blues. We've had a hard time pairing down people that should be there." S/he stated that now the ED nurse is responsible for eliminating extra people from the room. S/he also stated, "We try to get the staff to pause instead of being in a moment." Sample patient #18 had not yet been discussed at a Code Blue Committee meeting.

The facility's hospitalwide policy titled "CARDIOPULMONARY RESUSCITATION (CODE BLUE)" was reviewed on 7/19/2010.
The "POLICY" portion stated the following, in pertinent part:
"1. Code Blue will be initiated if a patient, visitor, associate, or other person on hospital premises needs resuscitation or if BLS is started..."

The "PROCEDURE" portion stated the following, in pertinent part:
"Resuscitation:
1. CODE BLUE should be called if BLS is started, with the exception of perioperative patients, immediate post-delivery neonates, and the Emergency Department when the appropriate healthcare providers are at the bedside.
2. Resuscitation should be initiated in accordance with AHA (American Heart Association) guidelines as appropriate, unless the patient has a Do Not Resuscitate (DNR) status ordered by a physician and/or the patient is wearing a DNR bracelet.
3. Any person in the facility can call a CODE BLUE by dialing "55" on any hospital telephone...
d. The Code Blue Team consists of the following:
(1) 1 Acute Care RN, 1 ED RN + 1 Admin Coordinator
(2) Neonatal Nurse Practitioner for Pediatric and NICU response
(3) Emergency Services Physician
(4) Respiratory Therapist
(5) Imaging personnel (called as needed)
(6) Lab personnel (called as needed)
(7) Pharmacist
(8) Chaplain
(9) Security
Procedures:
1. Initiating Code Blue alert for Adults and Pediatric Patients:
a. A person found unresponsive without a pulse and/or respirations is resuscitated unless there is a written order by the physician for "NO CODE" or "DNR" (Do Not Resuscitate)..."

The facility's "Emergency Response Plan" education, which is provided in General Hospital Orientation, was reviewed on 7/21/2010. The Code Blue portion of the education reflected the hospital's policy and stated, "A person found unresponsive without a pulse and/or respirations is resuscitated unless there is a written order by the physician for NO CODE or DNR."

The December 13, 2005 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care published in Circulation, Volume 112, Issue 24 revealed the following data in regards to Advanced Cardiac Life Support (ACLS) algorithms:
Pulseless Arrest treatment for VTach or VFib includes CPR (Cardiopulmonary Resuscitation), shocking (defibrillation), and medication with Vasopressin or Epinephrine intravenous (IV). Treatment for tachycardia with a pulse that is unstable includes performing immediate synchronized cardioversion. Treatment for tachycardia with a pulse that is stable includes obtaining an ECG (electrocardiogram) to further examine the type of rhythm. Thereafter, regular wide QRS treatment includes medication with Amiodarone IV and preparation for synchronized cardioversion. Irregular wide QRS treatment includes medication with Amiodarone IV, possibly Magnesium, and expert consultation.

In summary, the hospital failed to ensure critical care nurses maintained clear delineation of responsibilities for patient care. The ICU nurses did not initiate a Code Blue when a patient (#18) was in need of resuscitation and therefore failed to follow the facility's Code Blue policy/procedure. Reluctancy to call Code Blues along with congestion during codes was evidenced, indicating the need for education in regards to the importance of Code Blue teams and their work. The Code Blue Committee would not have routinely investigated this patient's care, had a physician not drawn attention to it. Nursing documentation during a patient's critical event did not clearly reflect the status of the patient and interviews with staff did not clarify if the patient was with or without a pulse during a hour long event which included sustained VTach and approximately ten defibrillation shocks, not synchronized cardioversion shocks. There is no evidence that the patient's pulse was ever checked per ACLS protocol. ACLS protocol maintains clearly different algorithms for treating pulseless VTach and VTach with a pulse and it was not evidenced that these were followed. An Emergency Department physician, who is designated to lead codes, would be well practiced in treating such situations. Physician care was fragmented and not optimal as there was no direct lead during an ICU patient's life-threatening situation. Additionally, several ICU nurses were caring for one patient over the course of an hour, when there were other patients in the ICU. Although the outcome for this particular patient was satisfactory, failure to follow policy and procedure, especially in an emergent situation, placed other patients at potential risk of negative patient harm.

Based on a review of 21 medical records, the hospital failed to ensure there was a care plan in three (samples #6, #8, #16) of 21 medical records. Additionally, two (#18, #19) of 21 medical records had incomplete care plan entries.

On 7/20/2010 and 7/21/2010 two surveyors reviewed medical records. There was no evidence of a care plan in 3 randomly selected samples. Two medical records had problem lists, but no updated or current information by a nurse since the patients were admitted.

Sample #6 was a 42 year-old adult patient admitted May 2010 with diagnoses of upper gastrointestinal bleeding and duodenal ulcer. S/he was hospitalized for two days.

Sample #8 was a 19 year-old adult patient admitted in March 2010 with a spontaneous pneumothorax who was hospitalized for five days.

Sample #16 was a 16 year-old adolescent admitted in February 2010 with tetany secondary to hypocalcemia who was hospitalized for two days.

Sample #18 was a 69 year-old adult admitted in July 2010 as a cardiac alert. This patient's history included cardiomyopathy, hypertension, hyperlipidemia, and dysphagia secondary to radiation therapy for squamous cell carcinoma. S/he was hospitalized for eleven days between July 8th and 19th. Although a care plan was initiated on the 12th, there was no evidence of further documentation or updates for this patient.

Sample #19 was a 23 year-old adult admitted since July 12th for alcohol-related disease. The patient was placed on a mental health hold and required a sitter for four days. The patient remains hospitalized at the time of the survey seven days later. Although a care plan was initiated on admission, there were no updates by nursing. There was evidence by respiratory and physical therapies of documentation in the care plan two days prior.

A review of the facility's policy, "Plan of Care - Planning Care, Treatment and Service" on 7/21/2010 revealed the following, in pertinent parts:

"SCOPE
Nursing services, respiratory, pharmacy, case management/social work, dietary, spiritual care, physical and occupational therapy.

PURPOSE
To define the initial plan for care, treatment and services appropriate to the patient's specific assessed needs, and then revising or maintaining the plan, based on the patient's response.

POLICY STATEMENT
Planning care, treatment and services is a dynamic process that addresses the execution of care, treatment and services. This includes an interdisciplinary and collaborative approach, as appropriate to the patient's needs, and the hospital's scope of services, and uses measurable outcomes.

PROCEDURE
Planning care, treatment and services
1. Care, treatment and services are planned to ensure that they are individualized to the patient's needs...
3. Patient needs, goals and timeframes, settings, and services required to meet the patient needs and/or goals determine the plan for care, treatment and services...
5. The goals of care, treatment and services are revised as necessary..."

A review of the Care Plan Pilot, Phase Two, on 7/21/2010 revealed the following, in pertinent parts:
"OBJECTIVES
Be able to speak to the patient's plan using information at hand.
Use the Care Plan process to tell the patient's story.
Use the EMR (Electronic Medical Record) to look up more detailed info.
Document evaluation and revisions to the plan of care using the new PILOT- Care Plan intervention...

In 2009 Centura decided to embark on a journey to provide our nurses with a more meaningful, radically different, plan of care that will eliminate duplicate documentation and add value to our patient's care...

An individualized, interdisciplinary, plan of care should be evident in the medical record...

The nurse is the coordinator of this care, throughout the patient's stay...

Our five patient care goals are:
Implement the treatment plan
Keep the patient safe
Ensure patient comfort
Complete patient education
Plan for discharge...

Results of the Care Plan Pilot
Staff satisfaction with the pilot was significantly improved...
The new Care Plan process did not meet all the regulatory requirements for a plan of care which is:
Individualized
Interdisciplinary
Routinely evaluated
Revised as needed

How will we meet the regulatory requirements?
Re-educate associates on the requirements for care planning
Revise the policy to reflect desired practice
Employ unique solutions within Meditech to support an individualized, interdisciplinary, plan of care which is evaluated and revised as needed."

An interview with one of the facility's informatics nurses on 7/21/2010 during medical record review revealed the following:
S/he stated that the Pilot Program was initiated over the past six weeks and was to continue for another "few weeks", but s/he did not know the exact timeframe. Pilot program patients in particular were supposed to have a care plan using the new strategies, but this was not evident during the medical record review.