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Due to the nature of the deficiencies, the facility failed to comply with the Condition of Governing Body. The governing body of the hospital failed to ensure that the the roles of the Chief Executive Officer, the Medical Director and the Medical Staff were clarified in terms of their oversight of hospital activities and accountability to the governing body. The governing body also failed to adequately monitor contracted services and emergency medical response services within the hospital.

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

A 048 - Governing Body - Medical Staff Bylaws and Rules and Regulations
The governing body failed to ensure that the medical staff bylaws were enforced with regard to the role of the medical director involvement in policy/procedures and quality improvement activities related to the evaluation of patient care.

A 049 - Governing Body - Medical Staff Accountability
The governing body failed to ensure that the medical staff was engaged in policy/procedure development and review and quality reviews of the provision of quality patient care in the facility.

A 057 - Governing Body - Chief Executive Officers
The governing body of the hospital failed to ensure that the hospital's senior clinical manager (Chief Operating Officer) was clearly identified as the Chief Executive Officer, who was accountable to the governing body for the management of the hospital.

A 085 - Governing Body - Contracted Services - Contract List
The governing body failed to ensure that the hospital maintained a complete and accurate list of all contracted services that included the nature of the services provided under contract.

Based on the manner and degree of deficiencies, the Facility failed to comply with the condition of Quality Assessment and Performance Improvement (QAPI).

The Facility failed to ensure its QAPI program reflected the complexity of the Facility's services, involved all hospital departments and focused on prevention and reduction of harm to patients.

The Facility failed to meet the following standards under the Condition of QAPI

A 0264 QAPI - Program Scope
The Facility did not set priorities for performance improvement that focused on indicators related to adverse patient events such as medication errors, infections and emergent transfers.

A 0267 - The Facility did not measure, analyze and track quality indicators that assess processes of care, hospital services and operations.

A 0275 - The Facility did not use the data collected to identify opportunities for improvement and changes that would lead to improvement.

A 0309 482.21 (e) EXECUTIVE RESPONSIBILITIES
The Facility's governing body, medical staff and administrative officials did not ensure that the Facility's QAPI priorities were defined, implemented and maintained to decrease adverse events and improve patient safety.

Due to the manner and degree of the deficiencies, the Facility failed to comply with the Condition of Nursing Services. The Facility failed to ensure that nursing care was provided by qualified and adequately trained nurses, operating with policies and procedures appropriate to the needs of the patients.

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

A 394 - Nursing Services - Licensure of Nursing Staff
The Facility failed to provide qualified, trained staff to respond to each patient's nursing needs in a safe and effective manner.

A 409 - Nursing Services - Blood Transfusions and IV Medications
The Facility failed to have current policies and procedures on blood transfusions.

A 410 - Nursing Services - Hospital Procedures
The Facility failed to have a procedure for reporting and reviewing transfusion reactions, adverse drug reactions, and errors in administration of drugs and regularly monitoring these reports through the Facilities QAPI program.

Based on the manner and degree of deficiencies, the Facility failed to comply with the Condition of Infection Control. The Facility failed to develop and implement an active program for the prevention, control, and investigation of infections and communicable diseases.

The Facility failed to meet the following standards under the Condition of Infection Control:

A 0749 - INFECTION CONTROL OFFICER(S) RESPONSIBILITIES:
The infection control officer or officers must develop a system for identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel.

A 0756 - RESPONSIBILITIES OF CHIEF EXECUTIVE OFFICER, MEDICAL STAFF, AND DIRECTOR OF NURSING SERVICES:
The chief executive officer, the medical staff, and the director of nursing must ensure that the hospital-wide quality assurance program and training programs address problems identified by the infection control officer or officers and be responsible for the implementation of successful corrective action plans in affected problem areas.

Due to the manner and degree of the deficiencies, the Facility failed to comply with the Condition of Organ, Tissue and Eye Procurement. The hospital failed to ensure the development, implementation and evaluation of the organ, tissue, and eye procurement requirements are met.

The Facility failed to meet the following standard under the Condition of Organ, Tissue and Eye Procurement.

A 886 - Organ, Tissue and Eye Procurement - OPO Agreement
The Facility failed to demonstrate the development, implementation and evaluation of a written agreement with an Organ Procurement Organization (OPO).

A 887 - Organ, Tissue and Eye Procurement - Tissue and Eye Bank Agreement
The Facility did not demonstrate the development, implementation and evaluation of a written agreement with at least one tissue bank and at least one eye bank to cooperate in the retrieval, processing, preservation, storage and distribution of tissues and eyes.

A 888 - Organ, Tissue and Eye Procurement - Informed Family
The Facility failed to demonstrate the development, implementation and evaluation of a mechanisms to ensure the families of all potential donors are informed of their options to donate organs, tissues, or eyes, or to decline to donate.

A 889 - Organ, Tissue and Eye Procurement - Designated Requestor
The Facility failed to demonstrate the development, implementation and evaluation of a individual designated by the hospital who has completed a course to initiate requests to families for organ, tissue and eye procurement, also known as a designated requestor.

A 891 - Organ, Tissue and Eye Procurement - Staff Education
The Facility failed to demonstrate the development, implementation and evaluation of an educational process for staff on organ, tissue and eye donation and designated requestor training.

A 892 - Organ, Tissue and Eye Procurement - Death Record Reviews
The Facility failed to demonstrate the development, implementation and evaluation of an educational process for staff on organ,tissue and eye donation, including reviewing death records to identify potential donors.

Based on staff interviews and review of facility documents, the governing body failed to ensure that the medical staff bylaws were enforced with regard to the role of the medical director involvement in policy/procedures and quality improvement activities related to the evaluation of patient care. The failure created the potential for negative patient outcome.

Findings:

1. The governing body failed to enforce the Medical Staff Bylaws related to the role of the medical director to oversee the quality of care and the review and development of policies/procedures related to patient care.

a) Review on 06/19/13 of the Medical Staff Bylaws revealed the following, in part:
"ARTICLE 9
CLINICAL ORGANIZATION OF THE MEDICAL STAFF
9.3 MEDICAL DIRECTORS
B. RESPONSIBILITIES:
Each Medical Director shall:
4. Continuously assess and improve the quality of care, treatment and services, and maintain quality improvement programs as appropriate.
11. Assist in developing and enforcing hospital policies and procedures that guide and support the provision of care, treatment and services; the Medical Staff Bylaws, Rules and Regulations; and the requirements and Rules and Regulations (if any) of the Program."

b) Review on 06/20/13 of the meeting minutes for the Medical Executive Committee (MEC) and the Governing Body for the past year revealed that there was no evidence of Medical Staff or Medical Director collaboration and active involvement in review of patient care quality data or in policy/procedure review/revision/development.

c) An interview with the Medical Director was conducted on 06/21/13 at 11:49 p.m.. S/he acknowledged that s/he and other medical staff members were not consistently included in quality improvement activities, including attending the Quality Council meetings. Review of the meeting minutes for the past year also confirmed that. The Medical Director also stated that the s/he and other medical staff members were not involved in development or review of policies/procedures.

Based on staff interviews and review of facility documents, the governing body failed to ensure that the medical staff was engaged in policy/procedure development and review and quality reviews of the provision of quality patient care in the facility. The failure created the potential for negative patient outcome.

Findings:


1. The governing body failed to ensure that there was active medical staff involvement in the development and review of patient care policies and procedures and quality of care reviews for the facility.

a) Review on 06/20/13 of the meeting minutes for the Medical Executive Committee (MEC) and the Governing Body for the past year revealed that there was no evidence of Medical Staff or Medical Director collaboration and active involvement in review of patient care quality data or in policy/procedure review/revision/development.

b) An interview with the Medical Director was conducted on 06/21/13 at 11:49 p.m.. S/he acknowledged that s/he and other medical staff members were not consistently included in quality improvement activities, including attending the Quality Council meetings. Review of the meeting minutes for the past year also confirmed that. The Medical Director also stated that the s/he and other medical staff members were not involved in development or review of policies/procedures. The Medical Director confirmed that s/he was one of the three hospitalist physicians that functioned as the primary physicians for the patients.

c) An interview with another hospitalist physician was conducted on 06/21/13 at 9:50 a.m.. The physician acknowledged that s/he had not attended any Quality Council meetings and had not participated in any formal quality review or policy/procedure development review activities at the facility. S/he confirmed that s/he was one of the three hospitalists that staffed the hospital as primary physicians for the patients.

Based on staff interviews and review of facility documents, the governing body of the hospital failed to ensure that the hospital's senior clinical manager (Chief Operations Officer) was clearly identified as the Chief Executive Officer, who was accountable to the governing body for the management of the hospital.

Findings:

1. The governing body failed to ensure that a Chief Executive Officer (CEO), who was accountable to the governing body for the management of the hospital was clearly identified and appointed, as required.

a) During the entrance conference on 06/17/13 at 10:00 a.m., the Chief Operations Officer (COO), was identified as the CEO for the facility by the COO, the Director of Compliance and the Director of Nursing Operations (DNO).

b) On 06/18/13 the job description for the COO was reviewed and was found to contain no statements that that position also served as the CEO or administrator, there was no language clarifying that the COO was appointed by the governing body, and it stated that the COO reported to the "Area Director of Operations/Senior Vice President of Operations (name of the hospital's owner corporate entity)."

c) Review of the website for the facility on 06/18/13 revealed that there was no COO listed on the list of managers, and the COO was listed as being the Director of Nursing. The current DNO was listed on the website as the Nurse Manager. The top manager listed on the list of the "Management Team" was a Chief Financial Officer.

d) Review of other facility documents, such as the complaint, patient rights and grievance policies/procedures referred the patients to the "Hospital Administrator." No COO was mentioned.

e) During an interview with the Medical Records manager on 06/19/13 at 4:30 p.m., s/he stated that there was one CEO for the entire building that housed the hospital being surveyed and an affiliated rehabilitation hospital. S/he stated that there was a COO in each hospital and both reported to the corporate owner's CEO located in the building.

f) Review on 06/19/13 of the Organizational Chart for the hospital revealed the COO, but no CEO or administrator for the hospital. It appeared that the hospital managers reported to the governing body, not the COO.

Based on staff interviews and review of facility documents, the governing body failed to ensure that the hospital maintained a complete and accurate list of all contracted services, that included the nature of the services provided under contract.

Findings:

1. The hospital failed to maintain a complete and accurate contract list, as required.

a) At the entrance conference on 06/17/13 at 10 a.m., the complete list of contracted services was requested. Separate versions of the list were received on 06/17/13 and 06/18/13. Review of both lists revealed that the "description" column for the list was left blank for most of the contracts. In the column titled "contract type," the descriptions were very general. For example, the adjacent affiliated rehabilitation hospital that provided contract rehabilitation therapy services/gym, food and dietary support and a cafeteria for patient use, and the medical records department and human resources for the hospital, there were no entries in the "description" columns and "contract type" stated "professional services. Although the facility being surveyed also had a contract dialysis program, the only entry that pertained to that service was an entry for a nephrology clinic with the "description" column blank and the "contract type" column reading "physician: services agreement. It contained no description of the dialysis services, equipment and supplies and dialysis nurse that were provided by contract.

b) On 06/18/13 at 9:50 a.m., the compliance officer confirmed that the second contract list was the most up-to-date and accurate contract available.

32704

Based on staff interviews and review of facility documents, the Facility failed to ensure systems and processes were developed, implemented and evaluated supporting the patients' rights concerning the grievance process.

This failure created the potential for ineffective resolution of conflicts due to lack of a consistant grievance process.

Findings:

1. The hospital failed to maintain a grievance process for patients and families that included a prompt and documented resolution process.

a) A review of the Facility's Grievance Log and supporting documents revealed only two grievances were documented.

b) In an interview on 06/21/13 at 9:30 a.m., the Clinical Compliance Specialist (CCS) responsible for quality stated that s/he had been tracking grievances since 04/2013. Before this time, there was no tracking system in place. S/he also stated there was no consist follow up being done on grievances. S/he also confirmed there was no quality committee in place and the Facility's Governing Body did not review grievances.

c) In an interview on 06/21/13 at 9:40 a.m., a staff nurse described the process of filing a grievance starts at the bedside. The staff then puts the information into the computer system. The case manager then gets the email. The staff member stated that is as far into the process staff gets to do. S/he said there is no follow up with staff and staff does not see the end result of the grievance.

32704

Based on staff interviews and review of facility documents, the Facility failed to ensure systems and processes were developed, implemented and evaluated supporting the patients' rights concerning the grievance process.

This failure created the potential for ineffective resolution of conflicts due to lack of a grievance process.

Findings:

1. The hospital failed to maintain a complete and accurate grievance log.

a) A review of the Facility's Grievance Log and supporting documents revealed only two grievances were documented.

b) In an interview on 06/21/13 at 9:30 a.m., the Clinical Compliance Specialist (CCS) responsible for quality stated that s/he had been tracking grievances since 04/2013. Before this time, there was no tracking system in place. S/he also stated there was no consist follow up being done on grievances.

32704

Based on staff interviews and review of facility documents, the Facility failed to ensure that systems and processes were developed, implemented and evaluated supporting the patients' rights concerning the use of restraint or seclusion.

This failure created the potential for negative patient outcomes due to lack of evaluation of use of restraints or seclusion.

Findings:

1. The hospital failed to maintain a complete and accurate restraint log.

a) A review of the Facility's Restraint log on 06/17/13 at 10 a.m. showed only two restraints were documented.

b) On 06/19/13 at 9:08 a.m., review of the medical records showed 4 of 30 charts had restraint forms but the restraints were not logged in the Restraint Log. Patients #3, #21, #27 and #30 had restraints placed and documented on in the chart but were not documented on the log.

c) In an interview on 06/21/13 the Clinical Compliance Specialist (CCS) responsible for quality confirmed that only 2 instances of restraints were documented in the Restraint log.

Based on record review and interviews the Facility failed to develop and implement a Quality Assessment and Performance Improvement (QAPI) program designed to incorporate quality indicator data specific to the Facility, including patient care data and other relevant data.

This failure resulted in the potential for negative patient outcomes.

FINDINGS:

1. The Facility did not use data collected to identify opportunities for improvement in the delivery of patient care services.

a) A review of Facility documents revealed multiple medication administration errors. The Facility's PI Score Board Summarys (summarys) for 04/12 - 04/13 were reviewed. There was no evidence that a methodology aimed at reducing medication administration errors was developed or implemented.

b) In an interview on 06/20/13 at 2:26 p.m. the Clinical Compliance Specialist (CCS), Director of Nursing Operations (DNO) and staff Pharmacist described the process for reporting and reviewing the medication errors. They acknowledged that the quality process lacked an effective "drill down" into the reasons for the medication errors and a mechanism to reduce the medication errors.

c) A review of Facility documents revealed unexpected emergent transfers from the Facility to area emergency departments (ED). There was no evidence that the Facility evaluated the appropriateness of care for patients prior to an unexpected emergent transfer out of the hospital.

In an interview on 06/21/13 the Chief Operating Officer stated that the Clinical Compliance Specialist kept a log of transfers with data related to reason for transfer. S/he could not produce the transfer log or describe quality initiatives that would investigate the appropriateness of care prior to emergent transfer.

2. The Facility did not take actions aimed at performance improvement, measure the success of the actions after implementation and track performance to ensure that improvements are sustained.

a) A review of Facility documents revealed multiple medication errors and other adverse patient events. From April 2013 to June 2013 there were 23 reported "medication variances" and 27 incidents identified as 'other' ranging from patients pulling lines and tubes out to patients having emergent conditions or being found unresponsive.

b) The Facility's PI Score Board Summarys (summarys) for 04/12 - 04/13 were reviewed. The Summarys listed areas for measurement which did not include issues specific to the Facility's reported incidents.

Quality Council meeting minutes from 04/2012 - 04/2013 were reviewed. Medical Executive Committee meeting minutes and department staff meeting minutes were also reviewed.

The meeting minutes did not reflect any tracking, trending or analysis of issues reported. The minutes did not reflect implementation of corrective actions or evaluation of the effectiveness of the corrective actions. There was no evidence that the Clinical Compliance Specialist (CCS) set the reported medication errors and other adverse events as priorities for performance improvement.

c) In an interview on 06/20/13, the CCS stated that, while s/he had pieces of the quality initiatives, there was no separate quality department and s/he confirmed that the issues reported as adverse events in the Facility were not added to the dash board summary to be tracked and trended. S/he admitted that the quality improvement process was incomplete and that there is a lack of followup, education and evaluation of reported issues.

d) Education department training documentation for 2013 was reviewed.
While the checklist contained 31 training areas for all disciplines, there was no evidence of training on medication errors or other reported issues.

In an interview on 06/19/13 the Director of Nursing Operations (DNO) confirmed that the list was for new hire orientation and annual skills evaluation. S/he admitted that there was no ongoing scheduled training on reported issues.

Based on Facility document review and interviews the Facility's governing body, medical staff and administrative officials failed to ensure that the Facility's quality improvement program defined priorities and was implemented and maintained to reduce adverse events and improve patient safety.

This failure resulted in the potential for negative patient outcomes.

FINDINGS:

1. The Facility's governing body, medical staff and administrative officials were not involved in the Quality Assessment and Performance Improvement (QAPI) program to ensure that an ongoing program for patient safety was implemented, maintained and evaluated.

a) The Quality Council meeting minutes from 04/2012-04/2013 were reviewed. The meeting minutes did not reference a schedule for reporting to the governing body and there was no standing agenda item listed for the Chief Executive Officer (CEO). The minutes did not list the CEO or Medical Director as members present or as guests.

There was no documentary or other evidence that the governing body, Medical Director, Medical Executive committee (MEC), CEO or CCO defined, monitored or otherwise maintained the QAPI program's priorities.

b) In an interview on 06/20/13 the Clinical Compliance Specialist (CCS) responsible for some quality intiatives stated that s/he reported to the Director of Clinical Compliance (DCC). S/he stated that the DCC was a resource and that they met to review performance improvement plans. The current DCC was newly hired and was just finishing hospital orientation.

c) In an interview on 06/21/13 the Medical Director admitted that s/he had not attended Quality Council meetings unless requested. S/he acknowledged that Quality Council meeting minutes were not covered in the MEC meetings.

Based on observation, interviews and record review the Facility failed to provide qualified, trained staff to respond to each patient's nursing needs in a safe and effective manner.

The failure created the potential for negative patient outcomes.

FINDINGS:

1. The Facility failed to provide adequately trained staff to monitor and protect patients during a Rapid Response situation.

a) In an interview conducted on 06/17/13 at 1:25 p.m. with the Director of Nursing Operations (DNO) and the Clinical Compliance Specialist (CCS), the DNO stated they do not have a policy for the Rapid Response Team (RRT) in situations where a patient would experience a deterioration in condition.

b) A review of the Facilities Policy and Procedures list on 06/17/13 at 2:45 p.m., showed there was no policy regarding a Rapid Response or a RRT.

2. The Facility failed to provide adequately trained staff to monitor and protect patients during a code blue situation.

a) During the facility tour and observations on 06/17/13 at 1:25 p.m. with the DNO and the CCS, the DNO was unable to open the crash cart or properly operate the Zoll Defibrillator. The DNO asked a nurse at the desk to open the crash cart, and the nurse was unable to do so. The Respiratory Team Lead then arrived and opened the crash cart.

b) In an interview on 06/17/13 at 1:25 p.m. the DNO and the Respiratory Team Lead, stated that Respiratory is responsible for nightly code cart checks. The Respiratory Team Lead stated the night respiratory therapist (RT) checks the Zoll nightly.

c) The Facility documents Mock Code were reviewed on 06/18/13 at 3:05 p.m. One document was dated 05/22/13 and was type written. It reviewed when the code blue was activated and the response of the staff. It had no follow up included. The second document was dated 06/14/13 and was hand written. It reviewed how to attach pads, analyze rhythm, shock, correct joules and intervention with patients in cardiac or respiratory arrest. It also stated "It was very busy tonight so didn ' t have a lot of time to go over mock codes. I'll do another mock code this weekend. [respiratory therapist] RT". There were no other Mock Code documents to review.

The Facility's Cardiopulmonary Resuscitation/Code Blue Critique Forms were reviewed on 06/18/13 at 3:05 p.m. No followup was documented in 5 of 5 documents reviewed. Three of five of the documents did not include the Code Blue Critique Form. A fifth Facility document titled Nursing Progress Note was provided and included a nursing note from a Code Blue situation. No other documentation on this event was provided.

3. The facility failed to provide adequately trained staff to monitor and protect patients who are monitored by telemetry for cardiac events.

a) In an interview on 06/17/13 at 1:25 p.m. the Director of Nursing Operations (DNO) and the Clinical Compliance Specialist (CCS), the DNO admitted that the Facility had no cardiac telemetry monitoring policy.

b) A review of the Facilities Policy and Procedures list on 06/20/13 at 2:25 p.m., showed there was no policy regarding cardiac telemetry monitoring.

c) During the facility tour and observations on 06/20/13 at 1:25 p.m. with the DNO and the CCS, cardiac telemetry monitors at both nursing stations were observed and there was no staff monitoring the telemetry. Staff was unable to describe a process for monitoring telemetry. The DNO confirmed there was no staff watching the monitors to determine if patients were having telemetry issues.

Based on staff interviews and review of facility documents, the Facility failed to have current policies and procedures pertaining to blood transfusions and reactions.

The failure created the potential for negative patient outcome for patients receiving blood or blood products.

Findings:

1. The Facility did not review or update policies related to Blood Product Administration.

a) A review of the Facility's Policy Blood Product Administration was reviewed on 06/18/13. The policy had an effective date of 06/07 and a revision date of 08/08.

b) In an interview on 06/20/13 the Director of Nursing Operations (DNO) stated the education related to blood product and administration happens at new hire orientation and annually. The DNO confirmed that the policy had not been updated since 08/08.

In an interview on 6/20/13 the Clinical Compliance Specialist confirmed that the policy for blood products and administration had not been revised since 08/08.

Based on interviews and Facility document review the Facility failed to have a procedure for reporting and reviewing transfusion reactions, adverse drug reactions, and errors in administration of drugs and regularly monitoring these reports through the Facilities QAPI program.

This failure resulted in a lack of focus on issues reported as impacting patient outcomes.

FINDINGS:

1. The Facility did not use data collected to identify opportunities for improvement in the delivery of patient care services.

a) A review of Facility documents revealed multiple medication administration errors. The Facility's PI Score Board Summarys (summarys) for 04/12 - 04/13 were reviewed. There was no evidence that a methodology aimed at reducing medication administration errors was developed or implemented.

b) In an interview on 06/20/13 at 2:26 p.m. the Clinical Compliance Specialist (CCS), Director of Nursing Operations (DNO) and staff Pharmacist described the process for reporting and reviewing the medication errors. They acknowledged that the quality process lacked an effective "drill down" into the reasons for the medication errors and a mechanism to reduce the medication errors.

c) A review of Facility documents revealed unexpected emergent transfers from the Facility to area emergency departments (ED). There was no evidence that the Facility evaluated the appropriateness of care for patients prior to an unexpected emergent transfer out of the hospital.

In an interview on 06/21/13 the Chief Operating Officer stated that the Clinical Compliance Specialist kept a log of transfers with data related to reason for transfer. S/he could not produce the transfer log or describe quality initiatives that would investigate the appropriateness of care prior to emergent transfer.

2. The hospital did not take actions aimed at performance improvement, measure the success of the actions after implementation and track performance to ensure that improvements are sustained.

a) A review of Facility documents revealed multiple medication errors and other adverse patient events. From April 2013 to June 2013 there were 23 reported "medication variances" and 27 incidents identified as 'other' ranging from patients pulling lines and tubes out to patients having emergent conditions or being found unresponsive.

b) The Facility's PI Score Board Summarys (summarys) for 04/12 - 04/13 were reviewed. The Summarys listed areas for measurement which did not include issues specific to the Facility's reported incidents.

Quality Council meeting minutes from 04/2012 - 04/2013 were reviewed. Medical Executive Committee meeting minutes and department staff meeting minutes were also reviewed.

The meeting minutes did not reflect any tracking, trending or analysis of issues reported. The minutes did not reflect implementation of corrective actions or evaluation of the effectiveness of the corrective actions. There was no evidence that the Clinical Compliance Specialist (CCS) set the reported medication errors and other adverse events as priorities for performance improvement.

c) In an interview on 06/20/13, the CCS stated that, while she had pieces of the quality initiatives, there was no separate quality department and s/he confirmed that the issues reported as adverse events in the Facility were not added to the dash board summary to be tracked and trended. S/he admitted that the quality improvement process was incomplete and that there is a lack of followup, education and evaluation of reported issues.

d) Education department training documentation for 2013 was reviewed.
While the checklist contained 31 training areas for all disciplines, there was no evidence of training on medication errors or other reported issues.

In an interview on 06/19/13 the Director of Nursing Operations (DNO) confirmed that the list was for new hire orientation and annual skills evaluation. S/he admitted that there was no ongoing scheduled training on reported issues.

Based on observation, interviews and document reviews the Facility failed to ensure that pharmaceutical services promoted a safe medication use process that substantially reduced or eliminated adverse drug events.

This failure resulted in the potential for patient harm related to adverse drug events.

FINDINGS:

1. The Facility did not ensure that the Pharmacy Director received input from appropriate staff and committees for the development and implementation of pharmacy quality initiatives.

a) During an interview on 06/21/13 at 2:00 p.m., a staff pharmacist confirmed that pharmacy did not conduct meetings and that there were no meeting minutes to review.

Based on interviews and Facility document review the infection control officer did not demonstrate the development, implementation and evaluation of a system for identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel.

This failure led to the potential exposure of patients to infectious and communicable diseases and those infections and diseases not being tracked and controlled.

FINDINGS:

1. The infection control officer did not demonstrate a method or mechanism for identifying, investigating, reporting and preventing infections.

a) The Facility's infection control policy was reviewed. The policy stated that the "Infection Control Department oversees a hospital-wide interdisciplinary program, which encompasses all hospital departments and services." The policy describes the procedure for risk assessment, priorities, surveillance methodologies, analysis, reporting and evaluation of infections.

The Facility could not demonstrate that it followed its policy. There was no evidence of formal meetings with members in attendance and no meeting minutes to capture discussions related to infection control/prevention issues.

b) On 06/21/13 the Clinical Compliance Specialist (CCS) was interviewed. Per job description, the Clinical Compliance Specialist was responsible for the infection control risk assessment, data collection, analysis, reporting and the facilitation of improvement processes related to infection control. The job description further stated that the CCS was responsible for the education of staff regarding infection control issues.

The CCS admitted that, although informal discussions regarding infections were conducted, no formalized committee was developed, and no meeting minutes were available for review. There was no evidence that the CCS developed or conducted staff training regarding infection control/prevention issues as is required by regulation.

c) In an interview on 06/21/13 a Facility staff physician confirmed that there were informal discussions about infections routinely, however, s/he had not been involved in a formal committee where he/she would make recommendations regarding infection control/prevention and s/he was not aware of any meetings having been conducted.

d) In an interview on 06/20/13 the Director of Nursing Operations (DNO) stated that education related to infection control was conducted at new hire orientation and annually. The single education topic related to infection control was "handwashing."

e) There was no evidence of ongoing education regarding infection control/prevention.

Based on interviews and Facility document review the Facility failed to demonstrate the development, implementation and evaluation of a written agreement with an Organ Procurement Organization (OPO).

This failure led to potentially viable organs not being donated.

FINDINGS:

1. The Facility failed to demonstrate a method or mechanism for development, implementation and evaluation of a written agreement with an Organ Procurement Organization (OPO).

a) On 06/17/13 at 12:22 p.m. the Clinical Compliance Specialist (CCS) was interviewed. S/he stated there was no designated requestor program. The Donor Alliance (DA) and Rocky Mountain Lions Eye Bank (RMLEB) were contacted when there was an imminent death. The nurses would notify the DA and RMLEB when a death was imminent.

On 06/18/13 at 9:43 a.m. interviews were conducted with the Faciliy's staff on duty at that time. Staff stated any nurse on duty could contact patients and families when DA or RMLEB needed to be contacted due to a dying patient. Staff stated all nurses recieved training when oriented to the facility on hire. Staff stated there was no annual education provided.

In an interview on 06/20/13 the Director of Nursing Operations (DNO) stated that education related to Organ, Tissue and Eye Donation and the designated requestor program was conducted at new hire orientation. The single education topic related to Organ, Tissue and Eye Donation and the designated requestor program was the "Organ and Tissue Donation" policy printed in the book titled "New Employee Nursing Orientation". No other training was provided.

b) The Facility's Organ and Tissue Donation (Anatomical Gifts) policy was reviewed on 06/18/13 at 9:55 a.m. The policy does not mention a designated requestor program. The policy had an effective date of 06/07 with no revision date provided.

c) The Facility did not provide the contract for the OPO it has an agreement with after requests were made on 06/20/13 at 8:30 a.m. and 2:08 p.m.

d) On 06/20/13 at 10:25 a.m. human resource files and job descriptions were reviewed. The facility failed to provide a job description or file on the Facility's designated requestor.

Based on interviews and Facility document review the Facility did not demonstrate the development, implementation and evaluation of a written agreement with at least one tissue bank and at least one eye bank to cooperate in the retrieval, processing, preservation, storage and distribution of tissues and eyes.

This failure led to potentially tissue and eyes not being donated.

FINDINGS:

The Facility failed to demonstrate a method or mechanism for development, implementation and evaluation of a written agreement with at least one tissue bank and at least one eye bank.

a) On 06/17/13 at 12:22 p.m. the Clinical Compliance Specialist (CCS) was interviewed. S/he stated there was no designated requestor program. The Donor Alliance (DA) and Rocky Mountain Lions Eye Bank (RMLEB) were contacted when there was an imminent death. The nurses would notify the DA and RMLEB when a death was imminent.

On 06/18/13 at 9:43 a.m. interviews were conducted with the Faciliy's staff on duty at that time. Staff stated any nurse on duty could contact patients and families when DA or RMLEB needed to be contacted due to a dying patient. Staff stated all nurses recieved training when oriented to the facility on hire. Staff stated there was no annual education provided.

In an interview on 06/20/13 the Director of Nursing Operations (DNO) stated that education related to Organ, Tissue and Eye Donation and the designated requestor program was conducted at new hire orientation. The single education topic related to Organ, Tissue and Eye Donation and the designated requestor program was the "Organ and Tissue Donation" policy printed in the book titled "New Employee Nursing Orientation". No other training was provided.

b) The Facility's Organ and Tissue Donation (Anatomical Gifts) policy was reviewed on 06/18/13 at 9:55 a.m. The policy does not mention a designated requestor program. The policy had an effective date of 06/07 with no revision date provided.

c) The Facility did not provide the contract for a tissue bank and an eye bank it has an agreement with after requests were made on 06/20/13 at 8:30 a.m. and 2:08 p.m.

d) On 06/20/13 at 10:25 a.m. human resource files and job descriptions were reviewed. The facility failed to provide a job description or file on the Facility's designated requestor.

Based on interviews and Facility document review the Facility failed to demonstrate the development, implementation and evaluation of a mechanisms to ensure the families of all potential donors are informed of their options to donate organs, tissues, or eyes, or to decline to donate.

This failure led to potentially viable tissue and eyes not being donated.

FINDINGS:

The Facility failed to demonstrate a method or mechanism for development, implementation and evaluation of an educational process for staff on donation issues, including a mechanisms to ensure the families of all potential donors are informed of their options to donate organs, tissues, or eyes, or to decline to donate.

a) On 06/17/13 at 12:22 p.m. the Clinical Compliance Specialist (CCS) was interviewed. S/he stated there was no educational process for staff on donation issues, including a mechanisms to ensure the families of all potential donors are informed of their options to donate organs, tissues, or eyes, or to decline to donate. The Donor Alliance (DA) and Rocky Mountain Lions Eye Bank (RMLEB) are contacted by the nurse when a death is imminent.

On 06/18/13 at 9:43 a.m. interviews were conducted with the Facility's staff on duty at that time. Staff stated any nurse on duty could contact patients and families when DA or RMLEB needed to be contacted related to a dying patient. Staff stated all nurses received training when oriented to the facility on hire. Staff stated there was no annual education provided related to organ, tissue and eye donation or for reviewing that potential donors are informed of their options to donate organs, tissues, or eyes, or to decline to donate.

In an interview on 06/20/13 the Director of Nursing Operations (DNO) stated that education related to Organ, Tissue and Eye Donation and educational process for staff on donation issues was conducted at new hire orientation.

b) The Facility's Organ and Tissue Donation (Anatomical Gifts) policy was reviewed on 06/18/13 at 9:55 a.m. The policy does not mention a educational process for staff on donation issues, including a mechanisms to ensure the families of all potential donors are informed of their options to donate organs, tissues, or eyes, or to decline to donate. The policy had an effective date of 06/07 with no revision date provided.

c) On 06/20/13 at 10:25 a.m. human resource files and job descriptions were reviewed there was no evidence of a job description or file for the Facility's designated requestor.

Based on interviews and Facility document review the Facility failed to demonstrate the development, implementation and evaluation of a individual designated by the hospital who has completed a course to initiate requests to families for organ and tissue procurement, also known as a designated requestor.

This failure led to potentially viable organ,tissue and eye donors being missed and viable tissue and eyes not being donated.

FINDINGS:

1. The Facility failed to demonstrate a method or mechanism for development, implementation and evaluation of a individual designated by the hospital who has completed a course to initiate requests to families for organ, tissue and eye procurement, also known as a designated requestor.

a) On 06/17/13 at 12:22 p.m. the Clinical Compliance Specialist (CCS) was interviewed. S/he stated there was no designated requestor program. The Donor Alliance (DA) and Rocky Mountain Lions Eye Bank (RMLEB) were contacted by the nurses who would notify the DA and RMLEB when a death was imminent.

On 06/18/13 at 9:43 a.m. interviews were conducted with the Facility's staff on duty at that time. Staff stated any nurse on duty could contact patients and families when DA or RMLEB needed to be contacted related to a dying patient. Staff stated all nurses received training when oriented to the facility on hire. Staff stated there was no annual education provided related to organ, tissue and eye donation.

In an interview on 06/20/13 the Director of Nursing Operations (DNO) stated that education related to Organ, Tissue and Eye Donation and the designated requestor program was conducted at new hire orientation. The single education topic related to Organ, Tissue and Eye Donation and the designated requestor program was the "Organ and Tissue Donation" policy printed in the book titled "New Employee Nursing Orientation". No other training was provided.

b) The Facility's Organ and Tissue Donation (Anatomical Gifts) policy was reviewed on 06/18/13 at 9:55 a.m. The policy does not mention a designated requestor program. The policy had an effective date of 06/07 with no revision date provided.

c) On 06/20/13 at 10:25 a.m. human resource files and job descriptions were reviewed. The facility failed to provide a job description or file on the Facility's designated requestor.

Based on interviews and Facility document review the Facility failed to demonstrate the development, implementation and evaluation of an educational process for staff on donation issues.

This failure led to potential issues with organ and tissue requests to patients and their families.

FINDINGS:

1. The Facility failed to demonstrate a method or mechanism for development, implementation and evaluation of a an educational process for staff on donation issues.

a) On 06/17/13 at 12:22 p.m. the Clinical Compliance Specialist (CCS) was interviewed. S/he stated there was no designated requestor program. The Donor Alliance (DA) and Rocky Mountain Lions Eye Bank (RMLEB) were contacted by the nurses who would notify the DA and RMLEB when a death was imminent.

On 06/18/13 at 9:43 a.m. interviews were conducted with the Faciliy's staff on duty at that time. Staff stated any nurse on duty could contact patients and families when DA or RMLEB needed to be contacted related to a dying patient. Staff stated all nurses recieved training when oriented to the facility on hire. Staff stated there was no annual education provided related to organ, tissue and eye donation.

In an interview on 06/20/13 the Director of Nursing Operations (DNO) stated that education related to Organ, Tissue and Eye Donation and the designated requestor program was conducted at new hire orientation.

b) The Facility's Organ and Tissue Donation (Anatomical Gifts) policy was reviewed on 06/18/13 at 9:55 a.m. The policy does not mention a designated requestor program. The policy had an effective date of 06/07 with no revision date provided.

c) On 06/20/13 at 10:25 a.m. human resource files and job descriptions were reviewed. The facility failed to provide a job description or file on the Facility's designated requestor.

d) On 06/20/13 at 2:08 p.m. the Facility training book titled "New Employee Nursing Orientation" was reviewed. The single education topic related to Organ, Tissue and Eye Donation and the designated requestor program was the "Organ and Tissue Donation" policy printed in the book. No other training was provided.

Based on interviews and Facility document review the Facility failed to demonstrate the development, implementation and evaluation of an educational process for staff on organ and tissue donation, including reviewing death records to identify potential donors.

This failure led to potential issues with organ and tissue requests to patients and their families.

FINDINGS:

The Facility failed to demonstrate a method or mechanism for development, implementation and evaluation of an educational process for staff on donation issues, including reviewing death records to identify potential donors.

a) On 06/17/13 at 12:22 p.m. the Clinical Compliance Specialist (CCS) was interviewed. S/he stated there was no educational process for staff on donation issues, including reviewing death records to identify potential donors. The Donor Alliance (DA) and Rocky Mountain Lions Eye Bank (RMLEB) were contacted by the nurses who would notify the DA and RMLEB when a death was imminent.

On 06/18/13 at 9:43 a.m. interviews were conducted with the Facility's staff on duty at that time. Staff stated any nurse on duty could contact patients and families when DA or RMLEB needed to be contacted related to a dying patient. Staff stated all nurses received training when oriented to the facility on hire. Staff stated there was no annual education provided related to organ, tissue and eye donation or for reviewing death records.

In an interview on 06/20/13 the Director of Nursing Operations (DNO) stated that education related to Organ, Tissue and Eye Donation and educational process for staff on donation issues was conducted at new hire orientation.

b) The Facility's Organ and Tissue Donation (Anatomical Gifts) policy was reviewed on 06/18/13 at 9:55 a.m. The policy does not mention a educational process for staff on donation issues, including review of the death record. The policy had an effective date of 06/07 with no revision date provided.

c) On 06/20/13 at 10:25 a.m. human resource files and job descriptions were reviewed. The facility failed to provide a job description or file on the Facility's designated requestor.

d) On 06/20/13 at 2:08 p.m. the Facility training book titled "New Employee Nursing Orientation" was reviewed. The single education topic related to Organ, Tissue and Eye Donation and the designated requestor program was the "Organ and Tissue Donation" policy printed in the book. No other training was provided.

Based on record review and interviews, the chief executive officer, the medical staff, and the director of nursing did not ensure that a hospital-wide Quality Assessment and Performance Improvement (QAPI) program and staff in-service training program addressed problems identified through an infection control program

This failure contributed to the exposure of patients to infectious and communicable diseases.

FINDINGS:

1. The Facility did not ensure the development and implementation of an infection control/prevention program including frequent collaboration with persons administratively and clinically responsible for inpatient departments and services and staff/practitioner education.

a) There was no evidence of a hospital-wide infection prevention and control program that included active surveillance, data collection and education to promote infection control measures.


b) There was no evidence that infection control committee meetings addressing data related to infection control/prevention issues were conducted.

c) In an interview on 06/21/13 the Clinical Compliance Specialist (CCS) admitted that, although informal discussions regarding infections were conducted, no formalized committee was developed, and no meeting minutes were available for review.

d) There was no evidence that the CCS developed or conducted staff training regarding infection control/prevention issues as is required by regulation.