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Based on interviews with the facilities quality personnel and review of the facilities grievance policy, the requirement for CFR 482.13 , A-0118 was NOT met .
Findings include:
A review of the facilities grievance policy documented that the governing body of hospital delegated the responsibility for grievance investigation and resolution to the grievance committee. The policy documented the process for filing and responding to grievances.
On 3/30/11 at 2:25 P.M an interview was conducted with the risk manager. He presented a file which he stated was 2009/2010 grievances and written responses. The surveyors were not allowed to view these files. He proceeded to open a note book which he stated was his grievance log and written responses for 2011. The surveyors were not allowed to view the content of these pages, just watch as he flipped through pages of the notebook. He stated that he reports to the QI group monthly regarding grievances.
He stated that the facility has identified issues through the grievances that have been used as QI monitors and that they have been monitoring laboratory issues regarding labs ordered versus specimens actually received in the lab. He stated that here have been no issues identified from grievances regarding patient rights and that nursing is involved in nonstop monitoring from information received from grievances.
The facility refused to provide the grievance log and written responses as well as evidence of the QI involvement with grievances citing " Patient safety work product ". The surveyors were unable to establish compliance due to lack of evidence.
The compliance with this policy was unable to be verified as the facility refused to provide the grievance log and the response letters citing " Patient safety work product ".

Based on staff interview and review of the policy and procedures it was determined the facility failed to provide documentation that the patient was provided with a written notice of its decision that contained the name of the hospital contact person, the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process, and the date of completion.

Findings include:

On 3/30/11 during the entrance conference the patient's grievance log was requested. On 3/30/11 at 2:25 p.m an interview was conducted with the Risk Manager. He presented a file which he stated was 2009/2010 grievances and written responses. The surveyors were not allowed to view these files. The Risk Manager proceeded to open a note book which he stated was his grievance log and written responses for 2011. The surveyors were not allowed to view the content of these pages only watch as he flipped through pages of the notebook. He stated that he reports to the QI group monthly regarding grievances.
He stated that the facility has identified issues through the grievances that have been used as QI monitors and that they have been monitoring laboratory issues regarding labs ordered versus specimens actually received in the lab. He stated that here have been no issues identified from grievances regarding patient rights and that nursing is involved in nonstop monitoring from information received from grievances.
The facility refused to provide the grievance log and written responses as well as evidence of the QI involvement with grievances citing " Patient safety work product " . The surveyors were unable to establish compliance due to lack of evidence.
A review of the facilities grievance policy documented that the governing body of hospital delegated the responsibility for grievance investigation and resolution to the grievance committee. The policy documented the process for filing and responding to grievances.
The compliance with this policy and regulation could not be verified as the facility refused to provide the grievance log and the response letters citing " Patient safety work product".

Based on staff interview, review of administrative documentation, and review of policy and procedures it was determined the facility failed to comply with the death reporting requirements for six of six deaths reported. The facility failed to document in the patient's medical record the date and time the death was reported to CMS.

Findings include:

Documentation of CMS reporting of deaths associated with the use of seclusion or restraint was requested upon entrance. The documentation was provided and reviewed. Review of the documentation revealed forms were completed and faxed to the CMS central office within 24 hours of the death.
A sample of medical records were requested to verify documentation in the record of the date and time CMS was notified. The Risk Manager was interviewed on 3/30/11 at 3:06 p.m. and stated there is no documentation in the medical records. He stated he would be the only one that would document this information and he has never done it since he has been employed as Risk Manager for the facility. Review of the facility ' s policy requires that CMS notification be documented in the patient ' s record. The Risk Manager stated he was not aware of the facility ' s policy or the federal regulation which requires the documentation.

Based on staff interviews, review of clinical records, and review of policy and procedures it was determined that a registered nurse failed to supervise and evaluate the nursing care for one (#7) of eight patients sampled.

Findings include:

Review of patient #7's medical record revealed on 3/20/11 at 7:00 p.m. a LPN (Licensed Practical Nurse) was assigned to the care of the patient. Documentation revealed on 3/20/11 at 9:30 p.m. the LPN performed a nursing assessment of the patient. There was no evidence an RN (Registered Nurse) supervised or evaluated the nursing care of the patient. On 3/21/11 at 7:00 a.m. the care of the patient was transferred to another LPN. Documentation revealed on 3/21/11 at 8:00 a.m. the LPN performed a nursing assessment of the patient. There was no evidence an RN supervised or evaluated the nursing care of the patient. On 3/21/11 at 7:00 p.m. the care of the patient was transferred to another LPN. On 3/21/11 at 7:20 p.m. the LPN performed a nursing assessment of the patient. There was no evidence an RN supervised or evaluated the nursing care of the patient. On 3/22/11 at 7:00 a.m. the care of the patient was transferred to another LPN. On 3/22/11 at 8:00 a.m. the LPN performed a nursing assessment of the patient. There was no evidence an RN supervised or evaluated the nursing care of the patient. On 3/22/11 at 7:00 p.m. the care of the patient was transferred to an RN.
Review of the documentation revealed an RN did not supervise or evaluate the nursing care of the patient for 48 hours. Review of the facility ' s policy, " Assessment of Patients " , last reviewed 6/2010, stated the patient will be reassessed at least every 8 hours with an RN performing the assessment at least once in each 24 hour period.
On 4/01/11 at 1:30 p.m. the risk manager confirmed the findings. Interview with the CNO revealed LPN and RN's rotate each shift so that the patient is assessed by an RN at least once in each 24 hour period.

Based on staff interview, review of personnel files, and review of policy and procedures it was determined the Chief Nursing Officer failed to provide for adequate supervision and evaluation of the clinical activities for one non employee licensed nurse.

Findings include:

A tour of the ICU was conducted on 3/31/11 at 2:40 p.m. An agency nurse currently working on the unit was interviewed. The nurse stated he had been working in the facility for approximately 3 months. He was asked about the orientation he received at the facility. He stated on his first shift he was to be oriented with the charge nurse but she walked off the unit so he did not receive an orientation. He stated that he just started caring for the patients. The CNO (Chief Nursing Officer) interrupted the agency nurse to tell him this was a surveyor with AHCA and here on a complaint. She stated the surveyor was not here about the other situation. The agency nurse stated that he received about four hours of orientation on his first shift. Review of the facility's policy, "Agency Personnel, Orientation", last reviewed 11/2009, states each agency nurse will receive one shift of orientation on an appropriate unit. The policy also states the agency nurse will work with a facility employee on a one-to-one basis for the shift to become familiar with the facilities' routines and policy and procedures.

On 4/01/11 the personnel file for the agency nurse interviewed was requested and reviewed. Review of the file revealed a completed orientation form dated 3/31/11. The form stated " the above individual has oriented with me and has demonstrated the behavior, competency and understanding of the above " . The form was signed by the agency nurse and the Chief Nursing Officer and dated 3/31/11. The Chief Nursing Officer was interviewed on 4/01/11 at 1:00 p.m. The CNO confirmed the form was completed and signed on 3/31/11. The CNO was questioned if she oriented and observed the agency nurses competencies. She denied she oriented or observed the nurses competencies. Review of the facility's policy, "Agency Personnel Evaluation", last reviewed 6/2010, states an evaluation form will be completed at the end of the orientation shift, first shift and whenever deemed necessary. It was determined the chief nursing officer failed to ensure adequate supervision and evaluation of the clinical activities of a non-employee licensed nurse.

Based on staff interview and review of policy and procedures it was determined the facility failed to ensure nursing staff supervised the administration of medication. This practice does not ensure medications are administered according to physician orders.

Findings include:

On 3/30/11 at 2:40 p.m. the risk manager was interviewed. The risk manager was interviewed regarding a patient concern that medications were left by nursing at the patient's bedside. The risk manager stated nursing will leave a medication in a medication cup at the patient's bedside if the patient requests to take the medication with a meal. Review of the facility's policy, "Medication Administration, General Guidelines", last revised 2/2011, states medications are not to be left in patient rooms. Pyxis medications are to be returned to Pyxis when not administered.

Based on staff interviews, review of clinical records, and observations it was determined the facility failed to provide documentation the infection control officer maintained a log of incidents related to infections and communicable diseases (refer to A750). The facility failed to ensure the chief executive officer, the medical staff, and the chief nursing officer addressed problems identified by the infection control officer and implemented the problems identified into the hospital wide quality assurance program and training programs. The facility failed to ensure the chief executive officer, the medical staff, and the chief nursing officer were responsible for the implementation of successful corrective action plans in affected problem areas (refer to A756). Lack of documentation provided by the facility failed to ensure the facility maintained an infection control program for the prevention, control, and investigations of infections and communicable diseases. This does not ensure the provision of quality health care in a safe environment.

Based on staff interview and requested infection control log it was determined the facility failed to maintain a log of incidents related to infections and communicable diseases, including healthcare associated infections and infections identified through employee health services.

Findings include:

On 3/30/11 during the entrance conference the infection control log was requested. The administrative staff stated the facility is a PSO (Patient Safety Organization) and upon advice from legal counsel the facility could not provide the infection control log stating the log was patient safety work product.

In reference to 73 FR 70743, November 21, 2008:

" Information is not patient safety work product if it is collected to comply with external reporting, such as ..... certification or licensing records for compliance with health oversight agency requirements .....compliance with required disclosures by particular providers or suppliers pursuant to Medicare ' s Condition of Participation or Conditions of Coverage ..... "

In reference to 73 FR 70742, November 21, 2008

" Providers have the flexibility to protect this information as patient safety work product within their patient safety evaluation system while they consider whether the information is needed to meet external reporting obligations. Information can be removed from the patient safety evaluation system before it is reported to a PSO to fulfill external reporting obligations."

An interview was conducted with the IC (Infection Control) Officer on 3/31/11 at 1:15 p.m. The log of incidents related to infections and communicable diseases was requested. The IC Officer denied access to the information. She stated she was informed by administration this was protected information. Furthermore, she stated she maintains a log, monitors the program and reports finding to corporate and to hospital administration. She stated the reports are taken to the infection control committee, quality committee, and then to the Board. Infection control meeting minutes were requested but the facility refused to provide them.

It could not be determined if the facility was in compliance with the Condition of Participation for Infection Control based on the lack of documentation.

Based on staff interview and requested QAPI documentation it was determined the facility failed to ensure the chief executive officer, the medical staff, and the chief nursing officer were responsible for the implementation of successful corrective action plans in affected problems identified through the infection prevention and control program.

Findings include:

On 3/30/11 during the entrance conference the QAPI documentation and meeting minutes were requested. The administrative staff stated the facility is a PSO (Patient Safety Organization) and upon advice from legal counsel the facility could not provide the requested documentation stating the information is patient safety work product.

73 FR 70743, November 21, 2008 states:

" Information is not patient safety work product if it is collected to comply with external reporting, such as ..... certification or licensing records for compliance with health oversight agency requirements .....compliance with required disclosures by particular providers or suppliers pursuant to Medicare ' s Condition of Participation or Conditions of Coverage ..... "

73 FR 70742, November 21, 2008 states:

" Providers have the flexibility to protect this information as patient safety work product within their patient safety evaluation system while they consider whether the information is needed to meet external reporting obligations. Information can be removed from the patient safety evaluation system before it is reported to a PSO to fulfill external reporting obligations."

An interview was conducted with the IC (Infection Control) Officer on 3/31/11 at 1:15 p.m. She revealed the facility uses a program called Medmined to identify, track and trend the facility's infections including HAI (healthcare associated infections) and multiple drug resistant organisms. The IC Officer stated she monitors the program and reports findings to corporate and to hospital administration. She stated the reports are taken to the infection control committee, quality committee, and then to the Board. Infection control meeting minutes were requested but the facility refused to provide them. The facility's QAPI could not be reviewed to determine that the hospital wide QAPI program addressed problems identified through the infection prevention and control program. It could not be determined if the facility was in compliance with the Condition of Participation for Infection Control based on the lack of documentation.