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Based on the manner and degree of deficiencies cited, the facility failed to be in compliance with the Condition of Participation of Quality Assurance/Performance Improvement (QAPI). The facility failed to ensure that complaints, grievances, reports of incidents/occurrences were consistently incorporated into their QAPI activities. In addition, the facility failed to ensure that quality activities were monitored and evaluated for efficacy and ongoing compliance.

The facility failed to be in compliance with the following standards under the Condition of Quality Assurance/Performance Improvement (QAPI):

A 0288 QAPI - Feedback and Learning
The facility failed to ensure that performance improvement activities tracked medical errors and adverse patient events, analyzed their causes and implement preventive actions and mechanisms that included feedback and learning throughout the hospital.

A 0291 QAPI - Sustained Improvement
The facility failed to consistently take actions aimed at performance improvement after adverse events, and, after implementing those actions, the hospital failed to consistently measure its success, and track performance to ensure that improvements were sustained.

Based on the manner and degree of deficiencies cited, the facility failed to be in compliance with the Condition of Participation of Nursing Services. The facility failed to ensure that it had an organized nursing service that included documented orientation and verification of competence of both in-house and agency nursing staff.

The facility failed to be in compliance with the following standards:

A 0386: Organization of Nursing Services - the facility failed to ensure that nurses caring for patients in the facility had documentation of orientation and validation of competencies.

A 0398: Supervision of Contract Staff - the facility failed to ensure that non-employee licensed nurses who were working in the hospital adhered to the policies and procedures of the hospital. The director of nursing service failed to provide for the adequate supervision and evaluation of the clinical activities of non-employee nursing personnel, which occurred within the responsibility of the nursing services of the facility. Specifically, the facility failed to maintain a complete personnel file that included an orientation to the facility, validation of the non-employee licensed nurses' competencies, and evaluation of the performance of the non-employee licensed nurses' care.

Based on personnel file review, staff interview, and review of the facility's policies/procedures, the facility failed to ensure that nurses caring for patients in the facility had documentation of orientation and validation of competencies.

The findings were:

A review of the facility's personnel files on 6/27/2011 revealed that the facility maintained two types of personnel files for the staff. One file contained pre-employment documentation and annual and periodic evaluations for staff. The second file contained other education and orientation documentation.

Staff member #6's file did not contain documentation of hospital orientation or unit orientation. The file did not contain documentation of verification of competencies. Staff member #6 began working at the facility in December 2010 and had not previously been employed as a registered nurse.

The facility's Director of Quality Management was requested, on 6/28/2011 at approximately 12:45 p.m., to provide facility policies/procedures that outlined orientation of new employees as well as documentation of training for new nurses. S/he provided a policy titled "General Hospital Orientation," which described the general orientation provided to all staff (clinical and non-clinical) upon hire. S/he stated that there was not any other policies/procedures that documented how new nurses or nurses new to the facility were oriented/trained.

An interview with the facility's Chief Nursing Officer (CNO) and the facility's Human Resource (HR) Generalist was conducted on 6/27/2011 at approximately 3:30 p.m. The personnel files were reviewed with both the CNO and HR Generalist. It was revealed that staff member #6's education file could not be located and there were "stacks of paper downstairs" that had not been incorporated into the respective personnel files that may have contained the missing documentation described above, however, was unable to be located prior to the exit conference on 6/28/2011 at approximately 4:00 p.m.

Cross Reference to A 0398: Supervision of Contract Staff - for findings related to the facility's failure to ensure that non-employee licensed nurses who were working in the hospital adhered to the policies and procedures of the hospital. The director of nursing service failed to provide for the adequate supervision and evaluation of the clinical activities of non-employee nursing personnel, which occurred within the responsibility of the nursing services of the facility. Specifically, the facility failed to maintain a complete personnel file that included an orientation to the facility, validation of the non-employee licensed nurses' competencies, and evaluation of the performance of the non-employee licensed nurses' care.

Based on personnel file review, staff interview, and review of the facility's policies/procedures, the facility failed to ensure that non-employee licensed nurses who were working in the hospital adhered to the policies and procedures of the hospital. The director of nursing service failed to provide for the adequate supervision and evaluation of the clinical activities of non-employee nursing personnel which occurred within the responsibility of the nursing services of the facility. Specifically, the facility failed to maintain a complete personnel file that included an orientation to the facility, validation of the non-employee licensed nurses' competencies, and evaluation of the performance of the non-employee licensed nurses' care.

The findings were:

A review of the facility's policies/procedures on 6/28/2011 revealed the following, in pertinent parts:
"Agency/Contract Labor Staffing and Clinical Purchased Services Use...
Purpose: To ensure all patient care services under contract are subject to the same quality assurance as other services and to outline the process for use of agency/contract labor and clinical purchased services (hereinafter referred to as 'Contract Staff'.) This policy also, defines the role of these individuals as members of the healthcare team, and defines the process for orientation, timekeeping, file requirements and evaluation of the quality of care delivered by Contract Staff...
Procedure...
F. Contract Staff files are maintained and updated by the Scheduler or individual designated by the department leader. It will be the responsibility of the department supervisor to assure personnel files are maintained and to provide orientation to contracted personnel...
Contract Staff Personnel File Contents
Prior to a shift being worked a file on Contract Staff member will be created and will include:
Credentials Provided by the Agency...
Information Prepared by LifeCare:
a. Contract Staff File Checklist (sample attached
b. Primary source verification of credentials, including licensure/certification,
c. "Contract Staff Orientation and Evaluation" form (Sample RN form attached) which includes: Job duties; department orientation checklist and first shift evaluation
d. LifeCare's role specific competency checklist, including age specific competency verified by department designee
e. 90 day and annual evaluation if applicable
f. Verified and copied photo ID
LifeCare Hospital General Hospital Orientation Self-Study packet and test.
General Hospital and Department Orientation
A. All Contract Staff will be required to complete General Hospital Orientation self study and test.
B. Department Orientation will be provided on the assigned unit by designated team members by using the 'Contract Staff Orientation and Evaluation' form (Sample of RN form attached)...
Evaluations
A. Contract Staff will be evaluated by the department supervisor or designee after the first shift worked by using the 'Contract Staff Orientation and Evaluation' form (Sample of RN form attached)..."

A review of the facility's personnel files revealed the following:
The facility furnished a list of non-employee licensed nurses and nurse aides that had provided care for patients in the facility since 4/1/2011 when requested to do so. A sample of personnel files were reviewed on 6/27/2011 for four of the non-employee licensed nurses and nurse aides (staff members #2, #3, #4, and #5). When the sample was requested, the facility was unable to locate a file within the facility for staff member #2 and had the staff member's agency fax the information that would have been contained in the file. Staff member #2's file contained only forms from the fax received from the staff member's agency that were date/time stamped 6/27/2011 and 11:09 a.m.

All four (personnel records #2, #3, #4, and #5) of the four personnel records for the non-employee nursing staff did not contain the forms referred to the facility's policy outlining expectations of "Contract Staff" personnel files. None of the four personnel files contained a Job Description from the facility that would outline expectations and requirements of the assigned duties and responsibilities. None of the four personnel files contained an orientation to the facility or to the unit the staff was assigned to. The files did contain a test administered to the staff member by the agency that the staff members worked for that was faxed to the facility, however, the faxes often made it impossible to read half of the answers due to the print being obscured by the fax quality. Only one (staff member #5) of the four personnel files contained a "New Employee Self-paced Orientation Quiz," but it was not completed in it's entirety and it had not been checked for accuracy of the answers provided by the staff member. None of the files contained recent evaluations of the performance of the staff members. Only staff member #3's file contained an evaluation, however, the last evaluation was completed 3/31/2010 and the staff member's last shift in the facility according to the facility's Chief Nursing Officer was on 4/28/2011.

An interview with the Director of Quality Management on 6/27/2011 at approximately 11:55 a.m., revealed that the facility could not locate a file on staff member #2 within the facility and was having the staff member's agency fax documentation to the facility.

An interview with the facility's Chief Nursing Officer (CNO) and the facility's Human Resource (HR) Generalist was conducted on 6/27/2011 at approximately 3:30 p.m. The personnel files were reviewed with both the CNO and HR Generalist. It was revealed that there were "stacks of paper downstairs" that had not been incorporated into the respective personnel files that may have contained the missing documentation described above, however, was unable to be located prior to the exit conference on 6/28/2011 at approximately 4:00 p.m.

A subsequent interview with the facility's CNO on 6/28/2011 at approximately 3:05 p.m. revealed that the individual that was responsible for the maintenance of the personnel files and documentation of orientation/competencies was part-time and was unable to do what was expected of him/her in the limited time that the individual was in the facility and that the lack of documentation was an issue that was identified and was currently a priority to improve. S/he stated that s/he had recently been hired within the last two months.

An interview with the facility's Director of Quality Management on 6/28/2011 at approximately 3:15 p.m., revealed that the personnel files should have contained an evaluation after the shift worked. S/he also stated that the facility's "Nurse Agency Orientation Post Test Answer Key" that was faxed to the facility from the staff member's agency prior to the first shift worked was graded by the agency, but should have been verified by the facility's staff. When shown Staff Member #2's post-test, s/he confirmed that the even-numbered questions' answers could not be read due to the quality of the fax.

Based on a review of medical records, staff interviews and review of facility documents, the facility failed to ensure that performance improvement activities tracked medical errors and adverse patient events, analyzed their causes and implement preventive actions and mechanisms that included feedback and learning throughout the hospital. Specifically, the facility failed to ensure that all adverse events were documented through their incident reporting system, so that the events could be reviewed and incorporated into the facilities performance improvement activities. The facility also failed to consistently incorporate information from the complaint/grievance process into those activities. Finally, once adverse events/complaints/grievance were addressed in the QAPI process, the facility failed to consistently take action to further investigate the underlying causes of the problems, to implement changes in processes (including institutional feedback and learning) and to monitor effectiveness of the changes.

The findings were:

1. On 6/27/11, the medical record of sample patient #3 was reviewed and revealed the following findings:
The patient was admitted to the hospital on 6/2/11 as a transfer from an acute care hospital. The patient had a PEG (percutaneous endoscopic gastrostomy) tube in place from the previous hospital related to nutritional needs. Nursing notes documented that the patient pulled out the PEG tube while bedding was being changed on the first night after admission. The on-call physician was notified and determined that the tube did not need to be re-inserted or replaced because the patient had begun to take oral food and fluids prior to transfer/admission.

In addition, the patient had a seizure disorder that was controlled with the medications Dilantin and Phenobarbital. Nursing notes documented a significant delay in the patient receiving the Phenobarbital on the night of admission because the medication was not available, there were delays in response time from on-call pharmacist and the nurse was unaware that the medication was available on another floor of the facility. The delay caused the family to verbalize concern and frustration to the nurse because the patient's seizure control was sensitive to the patient receiving his/her anti-seizure medications timely.

2. Review on 6/27/11 of a facility report of incident reports generated since the beginning of 2011 revealed that an incident report was generated to report the patient having pulled out the PEG tube, but no incident reports were generated related to the patient receiving late dose of the Phenobarbital or of the lack of response by the on-call pharmacist, which was a contributory factor to the delayed medication dose. The lack of incident reports for the lack of response by the on-call pharmacist and the delayed phenobarbital dose on 6/2/11 were confirmed by the director of pharmacy and the director of quality and risk during an interview on 6/27/11 at approximately 1 p.m.

3. During the 6/27/11 interview with the director of pharmacy and the director of quality and risk, the director of pharmacy stated that s/he had become aware of the problem the next morning when the on-call pharmacist from the previous night approached him/her apologizing for not responding to calls and stating that his/her cellular telephone had not sent the calls. The director stated that the on-call pharmacist had contacted his/her cellular telephone carrier to try to correct the problem to prevent future communication gaps. The on-call pharmacist had stated that the communication failure with his/her cellular telephone had not occurred before.

The director of pharmacy stated that the problem had been discussed with the director of nursing and they had determined that the nurse should have called the "back-up" pharmacist when the on-call pharmacist did not respond. In addition, they identified other actions that could have been taken to resolve the problem. When asked if any actions to prevent this were incorporated into current policies/procedures or if any new directives or written communication to staff had been generated to prevent the problem in the future, the director stated that the investigation with nursing and any recommended actions had not been documented in writing or communicated to nursing staff.

When asked about the lack of incident reports being generated regarding the delay of the medication dose for sample patient #3 and the related on-call pharmacist failure to respond timely, s/he stated that the incident reports are always to be generated by "the person(s) closest to the situation; the one(s) with first-hand knowledge of the episode." According to the director of pharmacy, based on that facility philosophy, the involved nurse should have generated the incident reports. S/he stated s/he would not generate a complaint in this situation, even if s/he became aware of the situation, because s/he "did not have first-hand knowledge of the situation." The director of quality and risk confirmed this philosophy and recognized that it could contribute to not consistently receiving notification of all reportable events. S/he stated that s/he had "recently identified" that not all reportable events were being consistently documented and submitted to administration for review, as required. S/he stated that s/he intended to have a training to address the issue with staff. At the time of the interviews/survey, no training program had been developed or scheduled.

4. Review of facility meeting minutes revealed that there were increases in incidents of lines/tubes being pulled out/dislodged and of patient falls with injuries. In addition there was documentation of various types of medication errors, including omitted doses, wrong time and doses. The minutes contained no evidence of planned actions to address the problems.

During an interview with the director of quality on 6/28/11 at approximately 1 p.m., s/he stated that the facility was planning to convene a committee to deal with medication issues. S/he stated that "last month" the facility had identified the need to have a performance improvement project group to address medication error and other related medication administration issues. S/he stated that the first meeting was schedule for "next week, after the holiday weekend and another (other facility-wide) training program had been completed." Review of meeting minutes from a medical staff subcommittee revealed that the creation of medication study group had been recommended on 4/12/11. S/he confirmed that a recommendation had been made at that referenced meeting on 4/12/11.

The director of quality and risk was also asked if any performance improvement task forces or groups had been developed to addressed other identified areas of concern, such as falls with injuries and tube/line dislodgements. S/he stated that no performance improvement task forces or groups had been developed to addressed other identified areas of concern.

5. Review on 6/27/11 of meeting minutes related performance improvement revealed no actions initiated to address complaints/grievances.

6. Review on 6/27/11 of documentation related to complaints/grievances revealed no evidence of referral or incorporation of complaints/grievances information into the QAPI process/activities.

The facility failed to consistently take actions aimed at performance improvement after adverse events, and, after implementing those actions, the hospital failed to consistently measure its success, and track performance to ensure that improvements were sustained. The facility failed to consistently take action to further investigate the underlying causes of the problems, to implement changes in processes (including institutional feedback and learning) and to monitor effectiveness of the changes.

The findings were:

Reference findings from Tag A 0288 QAPI - Feedback and Learning for additional findings related to failure to capture and incorporate all adverse patient events/complaints/grievances into the QAPI process, analyzed their causes and implement preventive actions and mechanisms and to monitor effectiveness to ensure sustained improvement.