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Based on the manner and degree of the deficiency cited, the facility failed to be in compliance with the Condition of Participation of Governing Body. The Governing Body failed to exert adequate oversight of the facility related to contracted services, medical staff appointment/privileging, quality assurance/performance improvement (QAPI) activities and to ensure compliance with other CMS Conditions of Participation and related standards.

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

Reference Tag A 49 Medical Staff Accountability:
The medical staff failed to delineate what tasks/activities/procedures the practitioners were granted privileges to perform.

Reference Tag A 83 Contracted Services - Compliance with CMS Conditions of Participation and Related Standards:
The governing body failed to ensure that all contracted services permitted the hospital to comply with all applicable conditions of participation and standards for the contracted services related to mental health evaluations and laundry/linen services and that the contracted elevator inspector completed timely inspections and maintenance.

Reference Tag A 84 Contracted Services - Services Safe and Effective:
The Governing Body failed ensure that all contracted services were compliant with all CMS Conditions of Participation and standards and that all contracted services were evaluated for safety, effectiveness and contract performance.

Reference Tag A 85 Contracted Services - List of Contracted Services:
The facility failed to maintain a complete and accurate list of contracts that included the scope and nature of services provided, as required.

Reference Tag A 57 Chief Executive Officer:
The governing body failed to ensure that their appointed chief executive officer (CEO) exerted adequate oversight and provided effective leadership in the management of the hospital.

Based on review of credential files and staff/physician interviews and review of other facility documents, the governing body failed to ensure that the medical staff adequately delineated the privileges for each category of medical staff practice, as required.

The findings were:

Reference Tag A 355 Medical Staff Privileges - for findings related to the medical staff failure to delineate what tasks/activities/procedures the practitioners were granted privileges to perform.

Based on tours/observations, review of medical records, facility documents and staff/physician interviews, the governing body failed to ensure that their appointed chief executive officer (CEO) exerted adequate oversight and provided effective leadership in the management of the hospital. Specifically, the chief executive officer failed to ensure that adequate resources, organizational structure, coordination of staff/departmental skills and resources were in place to ensure the safe and effective operation of the facility. The failure created the potential for negative patient outcomes and contributed to standard and condition level non-compliance with the CMS acute care hospital regulations.

The findings were:

Reference the following findings of deficient practice related to governing body functions and shared responsibility with the CEO:

Reference Tag A 49 Medical Staff Accountability:
The medical staff failed to delineate what tasks/activities/procedures the practitioners were granted privileges to perform.

Reference Tag A 83 Contracted Services - Compliance with CMS Conditions of Participation and Related Standards:
The governing body failed to ensure that all contracted services permitted the hospital to comply with all applicable conditions of participation and standards for the contracted services related to mental health evaluations and laundry/linen services and that the contracted elevator inspector completed timely inspections and maintenance.

Reference Tag A 84 Contracted Services - Services Safe and Effective:
The Governing Body failed ensure that all contracted services were compliant with all CMS Conditions of Participation and standards and that all contracted services were evaluated for safety, effectiveness and contract performance.

Reference Tag A 85 Contracted Services - List of Contracted Services:
The facility failed to maintain a complete and accurate list of contracts that included the scope and nature of services provided, as required.

Reference Tag A 355 Medical Staff Privileging:
The facility failed to ensure that practitioners were granted specific privileges when placed on the medical staff. Specifically, the facility failed to delineate what tasks/activities/procedures the practitioners were granted privileges to perform.

Reference the following findings of deficient practice related to the other CMS Conditions of Participation and related standards for compliance:

The facility failed to meet the following standards under the Condition of Patient Rights:

Reference Tag A 0118 Grievances:
The facility failed to ensure that the facility's policy for prompt resolution of patient grievances was adhered to. Specifically, the facility failed to ensure that patients' complaints/grievances were referred timely to facility administration or designee or that documentation of complaints/grievances were retained when considered resolved.

Reference Tag A 0132 Advanced Directives:
The facility failed to document advance directive information in 14 (#1, #2, #3, #5, #6, #7, #8, #9, #11, #13, #14, #15, #17, and #20) of 21 inpatient, open and closed, medical records reviewed. Specifically, the facility failed to document the patient's decision in the formulation of advance directives, so the hospital staff and practitioners who provide care would comply with these directives.

Reference Tag A 0144 Care in a Safe Setting:
The facility failed to ensure that patients received care in a safe setting. Specifically, the facility failed to ensure that expired supplies were not used for patient care and that oxygen tanks were stored in a safe manner. The facility failed to ensure that temperatures for medications and food were monitored for safety.

The facility failed to meet the Condition of Participation for Quality Assurance Performance Improvement:
Reference Tag A 0265 QAPI Health Outcomes
The facility failed to ensure that the facility performance improvement and patient safety plan was implemented to ensure patients were provided the highest quality of care in a safe environment, that department audits were tracked, analyzed and monitored to improve health outcomes and ensure patient safety.

Reference Tag A 0267 QAPI Quality Indicators
The facility failed to track adverse patient events, grievances and complaints and ensure that each event was thoroughly investigated and followed by the appropriate department to ensure proper measures were put in place to prevent recurrence.

Reference Tag A 0273 QAPI Program Data
The facility failed to monitor and track that all facility departments were entering data related to their quality projects into the computer data system on a monthly basis.

Reference Tag A 0285 QAPI Patient Safety
The facility failed to ensure that event reporting in the recently acquired QSTATIM computer system was consistent with all departments reporting events take could possibly be of patient safety concerns.

The facility failed to be in compliance with the Condition of Participation of Nursing Services:

Reference Tag A 0386 Organization of Nursing Services: for findings related to the facility's failure to maintain a well-organized service.

Reference Tag A 0392 Staffing and Delivery of Care: for findings related to the facility's failure to ensure there was immediate availability of nursing staff for bedside care of each patient.

Reference Tag A 0396 Nursing Care Plan: for findings related to the facility's failure to ensure the nursing staff developed and kept current a nursing care plan for each patient that was easily identifiable and provided continuity of patient care.

Reference Tag A 442 Medical Records - Security of Medical Records:
The facility failed to assure that unauthorized individuals could gain access to or alter patient records. Specifically, the following areas failed to maintain adequate security and confidentiality of patient medical records:
1. Outpatient clinics failed to secure medical records.
2. Nurse servers on the nursing units were not locked secured to protect medical records.

Reference Tag A 464 Medical Records - Content of Records - Consults:
The facility failed to ensure that contracted mental health consultants provided documentation of all consultative patient evaluations in the medical record.

Reference Tag A 505 Pharmaceutical Services - Unusable Drugs Not Used:
The facility failed to assure that outdated or otherwise unusable drugs were not available for patient use. Specifically, the outpatient clinics failed to have a consistent inventory management system that ensured that outdated medications were removed from stock.

Reference Tag A 582 Laboratory Services - Adequacy of Laboratory Services:
The facility failed to provide adequate laboratory services in the outpatient service areas. Specifically, the facility failed to have a comprehensive system in place that would keep outdated laboratory supplies unavailable for staff use. The facility also failed to ensure that specimen handling/tracking in the outpatient clinics complied with facility standards.

Reference Tag A 585 Laboratory Services - Written Protocols for Tissue Specimens:
The facility failed to ensure its laboratory made provisions for the proper reporting of tissues specimens. Specifically, the facility had no oversight of tissue specimens not located within the laboratory and the nursing department failed to ensure specimens under their care were secure and stored in an organized manner.

The facility failed to meet the following standards under the Condition of Physical Environment:

Reference Tag A 703 Emergency Gas and Water
The facility failed to maintain an emergency supply of water, as required.

Reference Tag A 713 Disposal of Trash
The facility failed to comply with state hospital licensure requirements that the trash stored outside the facility, awaiting pick-up, must be stored in covered containers in a paved storage area.

Reference Tag A 724 Facilities, Supplies, Equipment Maintenance
The facility failed to conduct periodic preventive maintenance inspections of equipment and to review supplies and equipment for efficacy and to remove expired supplies/equipment from patient care delivery areas.

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

Reference Tag A 750 Infection Control - Infection Control Log
The hospital failed to maintain an infection control log, as required.

Reference Tag A 756 Infection Control- Leadership Responsibilities
The hospital failed to ensure that the outpatient clinics utilized the infection control, surgical services and central processing resources and expertise to ensure that the outpatient clinic staff adequately cleaned exam/procedure rooms and equipment between patients and cleaned and processed instruments appropriately to ensure patient safety.

Reference Tag A 945 Surgical Services - Surgical Privileges:
The facility failed to ensure that surgical privileges were delineated for all practitioners performing surgery in accordance with the competencies of each practitioner. The facility failed to ensure that the surgical service was able to maintain a roster of practitioners specifying the specific surgical privileges of each practitioner. Specifically, the facility granted general "core privileges" that only specified the type of practitioner (such as General Surgery, Orthopedic Surgery, etc.) category.

The facility failed to meet the following standard under the Condition of Anesthesia Services:

Reference Tag A 1001 Organization of Anesthesia Services:
The facility failed to ensure that anesthesia was administered only by a qualified anesthetist. Specifically, the facility allowed nurses in the Emergency Department (ED) to administer a general anesthetic for minor procedures without an anesthetist present. Furthermore, the nurses that were administering the anesthetic had no documented training/competencies on the performance of procedural sedation. This failure had the potential to cause patient harm.

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

Reference Tag A 1077 Integration of Outpatient Services
The facility failed to ensure that outpatient services were appropriately organized and integrated with inpatient services, particularly in the areas of infection control, nursing, pharmacy, laboratory, medical records, preventive maintenance and environment of care rounds.

Reference Tag A 1079 Outpatient Services Personnel
The facility failed to ensure that the outpatient services department was accountable to a single individual who directs the overall operation of the hospital's entire outpatient services (all locations, all outpatient services).

Based on staff/physician interviews and review of facility documents and medical records, the governing body failed to ensure that all contracted services permitted the hospital to comply with all applicable conditions of participation and standards for the contracted services.

The findings were:

Reference the following standards under the Conditions of Participation of Medical Records and Physical Environment:

Reference Tag A 464 Medical Records - Content of Medical Records -Consultations - for findings related to failure to ensure that mental health consultation reports, conducted by contract mental health clinicians, were contained in the medical record.

Reference Tag A 724 Physical Environment - Facilities, Supplies, Equipment Maintenance - for findings related to failure to ensure that the contracted laundry/linen services was adequately cleaning laundry, including removal of stains, inspecting all laundry and discarding linen that was damaged or stained and that the contracted elevator inspector completed timely inspections and maintenance.

Based on a review of facility documents and staff interviews, the Governing Body failed to ensure that all services performed under a contract were provided in a safe and effective manner. Specifically, the Governing Body failed ensure that all contracted services were compliant with all CMS Conditions of Participation and standards and that all contracted services were evaluated for safety, effectiveness and contract performance.

The findings were:

1. During an interview with the director of risk management on 6/22/11, at approximately 8:30 a.m., s/he acknowledged that the hospital did not currently have a system in place for ensuring that each contracted service was evaluated for performance on a regular basis and that the results of evaluations were submitted to the governing body for review, as required, to ensure the safety and effectiveness of contracted services.

2. Review of governing body meeting minutes on 6/22/11, revealed no evidence of regular evaluation of the contracts for the facility for safety, effective and contract performance.

3. Reference Tag A 464 Medical Records - Content of Medical Records -Consultations - for findings related to failure to ensure that mental health consultation reports, conducted by contract mental health clinicians, were contained in the medical record.

4. Reference Tag A 724 Physical Environment - Facilities, Supplies, Equipment Maintenance - for findings related to failure to ensure that the contracted laundry/linen services was adequately cleaning laundry, including removal of stains, inspecting all laundry and discarding linen that was damaged or stained and that the contracted elevator inspector completed timely inspections and maintenance.

Based on a review of facility documents and staff interviews, the facility failed to maintain a complete and accurate list of contracts that included the scope and nature of services provided, as required.

The findings were:

Review on 6/21/11 of the hospital's list of contracted services, revealed that the list did not include the scope and nature of services provided, as required. In addition, multiple interviews with the risk manager and the director of quality, identified that the facility provided services by contract to other entities, including other smaller hospitals in the area. Since the contract list did not contain clear information about the scope and nature of services provided, in some instances, it was unclear from the list whether a service was being provided by contract to the hospital being surveyed, or being provided by the hospital to the other entities.

Based on the manner and degree of deficiencies cited, the hospital failed to be in compliance with the Condition of Participation of Patient Rights. The hospital failed to protect and promote each patient's rights.

The facility failed to meet the following standards under the Condition of Patient Rights:

Reference Tag A 0118 Grievances:
The facility failed to ensure that the facility's policy for prompt resolution of patient grievances was adhered to. Specifically, the facility failed to ensure that patients' complaints/grievances were referred timely to facility administration or designee or that documentation of complaints/grievances were retained when considered resolved.

Reference Tag A 0132 Advanced Directives:
The facility failed to document advance directive information in 14 (#1, #2, #3, #5, #6, #7, #8, #9, #11, #13, #14, #15, #17, and #20) of 21 inpatient, open and closed, medical records reviewed. Specifically, the facility failed to document the patient's decision in the formulation of advance directives, so the hospital staff and practitioners who provide care would comply with these directives.

Reference Tag A 0144 Care in a Safe Setting
The facility failed to ensure that patients received care in a safe setting. Specifically, the facility failed to ensure that expired supplies were not used for patient care and that oxygen tanks were stored in a safe manner. The facility failed to ensure that temperatures for medications and food were monitored for safety.

Based on staff interview, facility document review, and review of the facility's policies/procedures, the facility failed to ensure that the facility's policy for prompt resolution of patient grievances was adhered to. Specifically, the facility failed to ensure that patients' complaints/grievances were referred timely to facility administration or designee or that documentation of complaints/grievances were retained when considered resolved.

The findings were:

A review of the facility's policies/procedures, revealed the following in pertinent parts:
"Patient Complaint/Grievance...
Step 1: Prompt Resolution for Verbal Complaint...
Step 2: Filing a Grievance
If a verbal complaint is not promptly resolved to the patient's satisfaction by the SLVRMC Staff under Step 1, or if a patient submits a written complaint, the SLVRMC staff member will forward the complaint to the SLVRMC Risk Manager by the next working day..."

An interview with the facility's Director of Acute Care Services (DACS) on 6/20/2011, at approximately 2:45 p.m., revealed that when complaints arise on the units under his/her direction, s/he is notified and given a form with the complaint documented. S/he stated that "I take the complaint form with me and address it. I put it in the nurses file" if appropriate. When asked if complaints are forwarded on to the facility's Risk Manager, s/he stated that "if it is a significant complaint, I would put it into the event reporting system" which would go to the Risk Manager.

A subsequent interview with the facility's DACS, the facility's Risk Manager, and the facility's Chief Nursing Officer (CNO) on 6/21/2011, at approximately 7:30 a.m., revealed that the expectation of the facility's Risk Manager was that all patient complaints "should be coming to [the Risk Manager], the nurses should be putting them in the event reporting system. Maybe [the DACS] is just not aware of the process."

The facility's DACS stated that, "after I resolve [the complaints/grievances], actually no, I did not save those. If I resolve them, they don't go to quality...If I resolve it, I honestly don't keep them. I don't put those in the system. If they [the patient or patient's representative] say 'I want to file a formal complaint' I get that to [the Risk Manager]."

The DACS stated that if the complaint is with another department within the facility, s/he forwarded the complaint form to the specific department manager/director and that the complaints do not get filtered on to the Risk Manager.

The facility's Risk Manager stated that complaints for other departments are taken "to Quality Assurance if I'm aware of them."

The DACS stated that if "[the patient or the patient's representative with a complaint] is not satisfied, [the complaint] goes to the AOC (Administrator on Call)."

The CNO stated that if the complaint goes to the AOC, the resolution hasn't been documented "as well" as it had been in the past when paper forms had been used. S/he stated that "I keep notes, but once [the complaint] is resolved, I destroy the notes. I wouldn't be able to support the investigation with documentation."

The facility was unable to provide documentation when requested to support investigation of complaints that were brought to the attention of the DACS that s/he considered resolved and that were not placed into the electronic system.

Based on staff interview, medical record and facility policy and procedure review, the facility failed to document advance directive information in 14 (#1, #2, #3, #5, #6, #7, #8, #9, #11, #13, #14, #15, #17, and #20) of 21 inpatient, open and closed, medical records reviewed. Specifically, the facility failed to document the patient's decision in the formulation of advance directives, so the hospital staff and practitioners who provide care would comply with these directives.

The findings were:

The facility's policy entitled, "Advance Directives" Reference #MS-1015, stated the following, in pertinent part:

"An inquiry will be made by the Admitting Department during the admissions process of the patient, or if the patient is incapacitated, to the patient's significant other, as to whether or not the patient has completed an advance directive..."

"Admitting Department personnel will document in the medical record whether the patient has completed an advance directive and that information concerning advance directives has been given to the patient/significant other during the admission process."

The facility's "Admission Agreement and Consent for Medical Treatment" form in the medical record, contained the "Advance Directive Acknowledgment/Organ Donation" choices. The advance directive choices were a "Living will - yes or no" and "Power of attorney for Health Care - yes or no." The yes or no questions had boxes that facility staff were to check when the form was completed with the patient.

The medical records were reviewed at various times during the survey from 6/20/11 through 6/23/11. The 14 medical records that were referenced in the opening statement all contained the "Admission Agreement and Consent for Medical Treatment" form; however, the area of the form that contained the "Advance Directive Acknowledgement/Organ Donation" documentation was completely blank.

An interview was conducted on 6/22/11, at approximately 12:30 p.m., with the staff social worker that supervised discharge planning for the facility. The social worker stated that in recent months s/he had noticed the advance directives portion of the consent form was not being consistently completed as it should be. There were too many medical records that contained uncompleted forms.

Based on staff interviews, facility tour, and review of policies/procedures, the facility failed to ensure that patients received care in a safe setting. Specifically, the facility failed to ensure that expired supplies were not used for patient care and that oxygen tanks were stored in a safe manner. The facility failed to ensure that temperatures for medications and food were monitored for safety.

The findings were:

Reference to A 0386 Organization of Nursing Services - for findings related to the facility's failure to maintain a well-organized service. Specifically, the facility did not ensure medications and intravenous fluids were stored appropriately, placenta tissue specimens were secure, medication and patient nourishment refrigerators were monitored regularly, oxygen tanks were stored safely, and that expired supplies were discarded and replaced timely. These failures created the potential for negative patient outcomes.

Reference Tag A 505 Pharmaceutical Services - Unusable Drugs Not Used - for findings related to the outpatient clinics failure to have a consistent inventory management system that ensured that outdated medications were removed from stock, so they would not be available for use with patients.

Reference Tag A 582 Laboratory Services - Adequacy of Laboratory Services - for findings related failure of the outpatient clinics to have a consistent inventory management system that ensured that outdated laboratory testing supplies/equipment was removed from stock, so that they would not be available for use with patients.

Reference Tag A 724 Physical Environment - Facilities, Supplies, Equipment Maintenance - for findings related to the hospital's failure to conduct periodic preventive maintenance inspections of equipment and to review supplies and equipment for efficacy and to remove expired supplies/equipment from patient care delivery areas and that the contracted elevator inspector completed timely inspections and maintenance.

Reference Tag A 756 Infection Control - Leadership Responsibilities - for findings related to the hospital failure to ensure that the outpatient clinics utilized the infection control, surgical services and central processing resources and expertise to ensure that the outpatient clinic staff adequately cleaned exam/procedure rooms and equipment between patients and cleaned and processed instruments appropriately to ensure patient safety.


29147

Based on staff interviews, review of facility documents, meeting minutes, computer incident reporting review and computer department data information, the facility failed to maintain an ongoing quality improvement and patient safety program to ensure that the facility developed, implemented and maintained an effective, ongoing, hospital wide, data driven quality and patient safety program.

The facility failed to ensure that the problems/issues/complaints were addressed and corrected, that plans were implemented and monitored to assure compliance. Failure to maintain an effective quality assurance program and implement preventive actions, put patient's safety at risk and a cause for potential negative outcome.

Based on the manner and degree of deficiencies cited, the facility failed to meet the Condition of Participation for Quality Assurance Performance Improvement.

Reference Tag A 0265 QAPI Health Outcomes
The facility failed to ensure that the facility performance improvement and patient safety plan was implemented to ensure patients were provided the highest quality of care in a safe environment, that department audits were tracked, analyzed and monitored to improve health outcomes and ensure patient safety.

Reference Tag A 0267 QAPI Quality Indicators
The facility failed to track adverse patient events, grievances and complaints and ensure that each event was thoroughly investigated and followed by the appropriate department to ensure that proper measures were put in place to prevent recurrence.
Reference Tag A 0273 QAPI Program Data
The facility failed to monitor and track that all facility departments were entering data related to their quality projects into the computer data system on a monthly basis.

Reference Tag A 0285 QAPI Patient Safety
The facility failed to ensure that event reporting in the recently acquired QSTATIM computer system, was consistent with all departments reporting events take could possibly be of patient safety concerns.

Based on staff interviews and facility meeting minutes and reports, the facility failed to ensure that the facility performance improvement and patient safety plan was implemented to ensure patients were provided the highest quality of care in a safe environment, that department audits were tracked, analyzed and monitored to improve health outcomes and ensure patient safety.

Findings are:

The San Luis Valley Regional Medical Center (SLVRMC) Performance Improvement and Safety plan was noted as follows in pertinent part:

"PURPOSE
The purpose of the Performance Improvement Plan is to assure that patients are provided the highest quality care in an environment of minimal risk. The main goal of improving organizational performance is to be at a Six Sigma level of quality and patient safety. The program provides a non-punitive process that encourages the reporting of medical errors, the use of quality and system analysis to identify, analyze and design measures to prevent medical errors from occurring, the creation of knowledge from accident learning and the sharing of that knowledge to improve patient safety.

The Performance Improvement Plan is developed by the leaders and medical staff with assistance from multiple departments and support from the Board of trustees. The Board of trustees holds ultimate responsibility for monitoring provision of patient care and resolving any breakdowns that may result in suboptimal patient care and safety while striving to improve patient health outcomes. SLVRMC (San Luis Valley Regional Medical Center) through the Board of Trustees, Medical Staff and Administration, is committed to delivering high quality care to all of its patients within the scope of available resources and consistent with established goals of the Medical Center."

"GOAL" (of the Performance Improvement and Patient Safety Plan)
"In order to accomplish this goal, objective and systemic criteria are developed on an ongoing basis. Information regarding patient care is utilized to assure that problems affecting patient care are identified, corrected by appropriate action, and monitored to maintain continued performance. The data gathered by various personnel, work teams, medical staff committees and services will be integrated to assure that trends, patterns of undesired performance or potential problems that affect more than one department or service will be detected and will result in the improvement of patient care."

On 07/21/2011, the meeting minutes were reviewed from July 2010. In October 2010, the medical surgery unit, the laboratory, the emergency department, obstetrics, cardiopulmonary, physician services, information systems and PT/OT/ST (physical therapy, occupational therapy, speech therapy) departments all had auditing projects to be completed. Meetings held in November 2010 through February 2011, failed to re-address these projects/issues. There was no documentation that the individual project for each department was measured, analyzed, tracked or monitored in this time frame.

An interview was conducted on 6/21/11, at approximately 10:00 a.m., with the Director of Quality Performance Improvement (QPI) and Patient Safety and also on 6/22/11, at approximately 9:15 a.m., with the QPI director and the newly appointed clinical excellence (CE) person. Per the Director, approximately five months earlier, the former Director of Quality transferred to another department within the hospital. The clinical excellence person also left the department. The clinical excellence person was responsible to review all quality assurance issues and give the quality issues to the appropriate supervisors for review and follow up. The QA and CE directors would meet monthly with each department for approximately 30 minutes to discuss QA issues. This has not been done for the past five months since the clinical excellence position was vacant and the present director assumed the position at that time. S/he stated that although quality meetings were held over the past few months, no meeting minutes were documented. Per interview, the QPI director stated the Quality meetings are to be held monthly and the day before the meeting three departments are notified to report their quality project progress. Review of the available meeting minutes does not reflect this has occurred. No meeting minutes were available for January 2011, March 2011, April 2011 or May 2011. The Quality director is presently spending approximately 50 percent of her/his time as an Interim CEO (Chief executive officer) at a nearby critical access hospital, therefore the Quality person is not available to maintain the program at this facility on a regular, consistent basis. Based on the lack of documentation available for review, the facility has failed to ensure that the purpose, goal and objectives of the SLVRMC Performance Improvement and Patient Safety Plan are being met. As a result quality issues/problems have had no follow up or activities monitored to ensure patient safety and quality of care.

There was also a computer program in place for each department to add data regarding quality issues monthly, but the director confirmed this was not always completed and there has been no follow up between the QA department and the individual hospital departments.

The Director discussed three instances s/he was made aware of that were followed through with the individual department and quality.

1. A family member reported an unknown substance was found on a patient's dietary tray. Nursing removed the substance and sent it to the lab for analysis. Dietary followed up and determined is was a food particle. Quality was notified, but there was no documentation of the incident, follow up or resolution.

2. Following a surgical procedure, a patient in the operating room was found to have a burn to the labia. Follow up determined the operating physician failed to allow the skin cleanser to dry, prior to initiating the surgical procedure, thus causing the burn. Per the Quality director, there was no documentation regarding this incident or follow up.

3. There were patient and staff complaints regarding laundry being returned "dirty" from the linen contractor. Although, several administrative persons were aware of the complaints and the laundry contractor was consulted, there was no documentation that the "dirty" laundry issue was resolved, what follow up was determined and how this issue will be monitored.

In summary, due to changes within the facility and the quality department, they failed to ensure that the facility maintained an ongoing, hospital wide data driven QAPI program to meet the needs of the hospital, staff and patients, that identified problems were addressed, documented and resolved and that areas of concern were being monitored and preventive measure implemented to ensure no recurrence.

Based on staff interviews and review of facility documents, the facility failed to track adverse patient events, grievances and complaints and ensure that each event was thoroughly investigated and followed by the appropriate department to ensure proper measures were put in place to prevent recurrence.

Findings are:

An interview with the facility's Director of Acute Care Services (DACS) on 6/20/2011, at approximately 2:45 p.m., revealed that when complaints arise on the units under his/her direction, s/he is notified and given a form with the complaint documented. S/he stated that "I take the complaint form with me and address it. I put it in the nurses file" if appropriate. When asked if complaints are forwarded on to the facility's Risk Manager, s/he stated that "if it is a significant complaint, I would put it into the event reporting system" which would go to the Risk Manager.

A subsequent interview with the facility's DACS, the facility's Risk Manager, and the facility's Chief Nursing Officer (CNO) on 6/21/2011, at approximately 7:30 a.m., revealed that the expectation of the facility's Risk Manager was that all patient complaints "should be coming to [the Risk Manager], the nurses should be putting them in the event reporting system. Maybe [the DACS] is just not aware of the process."

The facility's DACS stated that, "after I resolve [the complaints/grievances], actually no, I did not save those. If I resolve them, they don't go to quality...If I resolve it, I honestly don't keep them. I don't put those in the system. If they [the patient or patient's representative] say 'I want to file a formal complaint' I get that to [the Risk Manager]."

The DACS stated that if the complaint is with another department within the facility, s/he forwarded the complaint form to the specific department manager/director and that the complaints do not get filtered on to the Risk Manager.

The facility's Risk Manager stated that complaints for other departments are taken "to Quality Assurance if I'm aware of them."

The DACS stated that if "[the patient or the patient's representative with a complaint] is not satisfied, [the complaint] goes to the AOC (Administrator on Call)."

The CNO stated that if the complaint goes to the AOC, the resolution hasn't been documented "as well" as it had been in the past when paper forms had been used. S/he stated that "I keep notes, but once [the complaint] is resolved, I destroy the notes. I wouldn't be able to support the investigation with documentation."

The Risk Manager stated the complaint/issue should be put into the computer system (QSTATIM), so that the risk manager and the quality director was made aware of the issue and that documentation would be maintained and follow up monitored and resolutions achieved.

The facility was unable to provide documentation when requested to support investigation of complaints that were brought to the attention of the DACS that s/he considered resolved and that were not placed into the electronic system for follow up and monitoring of processes put in place to prevent recurrence.

The RM on the other hand stated the complaint/issue should be put into the computer system (QSTATIM), so that the RM and QA was made aware of the issue and that documentation was maintained and follow up monitored and resolutions achieved.

In summary,the facility staff failed to have a uniform system, which tracked any complaints/grievances or patient issues. No documentation was maintained to determine if the issues had been reviewed, investigated, resolved and reported to the appropriate departments including Risk management and quality. As a result there were no preventive measures implemented or performance improvement activities initiated to oversee the quality program.

Based on staff interviews and review of computer documentation, it was determined that all facility departments are not entering data related to their quality projects into the computer data system on a monthly basis.

Findings are:

An interview was conducted on 6/21/11, at approximately 10:00 a.m., with the Director of Quality Performance Improvement (QPI) and Patient Safety and on 6/22/11, at approximately 9:15 a.m., with the QPI director and the newly appointed clinical excellence (CE) person. Approximately five months earlier, the former Director of Quality transferred to another department within the hospital. The clinical excellence person also left the department. The clinical excellence person was responsible to review all quality assurance issues and give the quality issues to the appropriate supervisors for review and follow up. The QA and CE directors would meet monthly with each department for approximately 30 minutes to discuss QA issues. This has not been done for the past five months since the clinical excellence position was vacant and the present director assumed the position at that time. S/he stated that although quality meetings were held over the past few months, no meeting minutes were documented. Per interview, the QPI director stated the Quality meetings are to be held monthly and the day before the meeting three departments are notified to report their quality project progress. Review of the available meeting minutes does not reflect this is occurring. No meeting minutes were available for January 2011, March 2011, April 2011, or May 2011. The Quality director is presently spending approximately 50 percent of her/his time as an Interim CEO (Chief executive officer) at a nearby critical access hospital, therefore the Quality person is not available to maintain the program at this facility on a regular, consistent basis.

There was also a computer program in place for each department to add data regarding quality issues monthly, but the director confirmed this was not always completed and there has been no follow up between the QA department and the individual hospital departments to ensure that the data was entered into the computer system. This failure was indicative of the lack of oversight by the quality department to assure quality improvement and patient safety concerns were identified.

Based on staff interviews and review of facility reports and meeting minutes, the facility failed to ensure that event reporting in the recently acquired QSTATIM computer system was consistent with all departments reporting events take could possibly be of patient safety concerns. Due to the lack of reporting, investigation and follow up, there was a potential for negative patient outcomes.

The findings are:

San Luis Valley Regional Medical Center Patient Safety Plan was reviewed and in pertinent part stated:

"The Patient Safety Office plays a key role in identifying opportunities for reducing medical errors. In addition to the role and responsibilities listed in the job description, the Patient Safety Officer, in collaboration with the Best in Safety Committee, performs the following:

1. Proactively focuses on processes and systems rather than blame individuals

2. Works with consultants and information services to provide a user-friendly incident reporting system for reporting patient safety issues

3. receives and reviews reports related to patient safety from associates, departments, teams or committees charged with quality improvement, patient complaints and advocacy, clinical safety, and facility or environmental safety."

On 6/2/11, at approximately 1:50 p.m., an interview and review of the incident reporting system was conducted with the Risk manager (RM). The facility utilizes a computer incident reporting system, QSTATIM. Per the RM, the system permits any staff member to enter an incident when it occurs and takes approximately three minutes. The RM and the Quality Director always get copied and depending on the department, the department head gets notified by email. The purpose is to have the department head review and follow up on the incident, enter data into the computer and alert the RM and Quality director that the incident has been reviewed/resolved or that more follow up is required.

Many of the incidents reviewed had no follow up documented to demonstrate the incident was reviewed, investigated, resolved or completed. The areas for follow up by the department heads or appropriate staff were blank. The QSTATIM system appeared difficult to locate specific incidents and did not automatically notify the RM or quality director that the incident had been reviewed or resolved.

1. Following review of the computer report, the surveyor questioned the RM why a transfusion issue was not seen in the incident reporting system. The RM was unaware of any transfusion issues.

Specifically, on 8/11/10, a patient received one unit of PRBCs (Packed Red Blood Cells) without a prior physician order. The RM was given
the Laboratory Meeting Minutes dated 8/27/10. The following paragraph was documented in the meeting minutes regarding an error in blood administration: "When issuing blood products to nurses taking care of inpatients, it is imperative and absolutely required for the RNs to have the label and the printed form with them. They are not allowed to check out blood with just a piece of paper with the patients name and arm band number any longer. This is a HARD STOP process. The reason is that an RN came down to the lab with just a piece of paper with the information on it and checked out 2 units which were transfused. The physician did not order the units to be transfused, he only ordered the XM2 (cross match 2 units). If the RN would have had the label and printed form, then we can be assured the patient's physician has written the order to give 2 units."

The medical record of sample patient #21 was reviewed on 6/23/11. The patient was admitted to the hospital on 8/10/10, with diagnoses of autoimmune hepatitis and hematuria and discharged on 8/15/10.

The physician admission orders written on 8/10/10, included the following order: "Cross type 2 units of washed PRBCs (packed red blood cells)." The order was sent to the laboratory on 8/10/10, for "XM2 - Crossmatch 2 units PRBC."

The nurse that was caring for the patient went to the laboratory to pick up the blood on 8/11/10 ,with a sheet of 8 1/2" x 11" paper that had a handwritten note which stated: "Blood transfusion #1 washed cells - Typenex #GXG9231" with the patient's admission sticker on the bottom of the page. The laboratory, contrary to their own protocol, gave the nurse the one unit of blood without the proper requisition with the understanding the nurse would drop off the printed form later; however, this was not done. The nurse began the transfusion at 3:20 p.m. At 3:43 p.m., an order from the nursing unit was sent to the laboratory for "PRBC - Leukoreduced packed cells."

The nurse caring for the patient on the 7p to 7a shift was given information by the 7a to 7p nurse that another unit of PRBCs needed to be given. The nurse picked up the blood from the laboratory and began the transfusion. After beginning the transfusion, the nurse decided to check the physician's order and could not find one. The nurse called the physician and the following telephone order was received on 8/11/10 at 8:25 p.m.: "OK to transfuse 1 unit washed PRBCs (done @1520 (3:20 p.m.)). Stop 2nd unit now."

The RN stated he was not aware of this transfusion issue after reviewing the laboratory meeting minutes, produced an incident report shortly after being notified of the error. An incident report by the 7p to 7a nurse was written on 8/12/10, to the clinical director regarding the sequence of events that occurred on 8/11/10. The following are excerpts from the report: "(Nurse name) reported to me that the first unit was finished and handed me "the reqs for the 2nd unit." I got my other patients squared away, verified consent was signed, and picked up the 2nd unit at 1947 (7:47 p.m.), started it at 1955 (7:55 p.m.) after double-checking with (nurse name). After the first 15 minutes, I returned to the desk and found new, blank reqs for a unit of blood had just printed up. I called lab to clarify, and (lab tech name) told me she had released that unit to me based on the reqs for the first unit, which (nurse name) had never brought down. She went to lab with a handwritten form containing a patient sticker and her typenex number and asked them where she got the form to get blood. They released the blood to her and told her to get the order into the computer and drop off the other forms. She did have (proper name) enter the order, but kept the printouts and handed them to me as being for the second unit. (Lab tech name) then entered the order for the second unit when she realized that only one had been entered in the computer. I did a more thorough chart check at this point (beyond the past 12 hours) and found that there had never been an order to transfuse, only to cross match. I called Dr. (name), gave him (patient name) labs from the morning, and he said he only wanted one unit transfused. I stopped the transfusion at 2025 (8:25 p.m.)..."

An interview was conducted on 6/22/11, at approximately 3:00 p.m., with the Risk Manager. The Manager stated this was the first s/he had heard of this incident.

An interview was conducted on 6/23/11, at approximately 9:30 a.m., with the former Laboratory Director and the interim Laboratory Director. They stated that an internal occurrence report was not generated, because this incident was considered a nursing error.

Neither the nursing staff nor laboratory staff followed the facility's protocol when the blood was dispensed and administered, nor were these failures internally reported as mandated. Neither Risk or quality was aware of the transfusion incident.

2. A possible drug diversion incident was identified as explained below. On 11/3/2010, on the charges and credits report for 11/3/2010, there were drugs pulled under "monte amb beds5". The nurse that pulled the drugs believes that it was for a specific patient. The facility has no documentation that the patient received the medication. Review of the medical record on 11/8/10, did not indicate the medication was given to the patient. "This is still under investigation." Staff have been instructed they can not use any other service such as "monte amb" for the name of any way of retrieving meds from Pyxis. There was no indication that any further follow up was conducted, that issues were resolved or that the possibility of this reoccurring was not a possibility. No risk or quality involvement was documented.

3. Review of the facility QSTATIM document from October 15, 2010 through June 19, 2011, determined that the documentation was incomplete with no follow up after the initial report. There was no documentation to determine if the reporter or the department head conducted any follow up or resolution to the incidents reported. Many of the incidents during individual review were lacking appropriate resolution including Risk and quality involvement. There was no indication that the data collected was analyzed, tracked and monitored to assure patient safety and improve healthcare outcomes.

Based on credential file review, review of the facility's Medical Staff Bylaws, Rules/Regulations, and staff interview, the facility failed to ensure that practitioners were granted specific privileges when placed on the medical staff. Specifically, the facility failed to delineate what tasks/activities/procedures the practitioners were granted privileges to perform.

The findings were:

A review of the facility's Medical Staff Bylaws, last revised 9/29/2010, revealed the following, in pertinent parts:

"Definitions...
4. Clinical Privileges or Privileges means the rights that may be granted to a Medical Staff Appointee or Independent AHP to provide those diagnostic, therapeutic, medical, surgical, dental or podiatric services specifically delineated to him or her, and includes Temporary and Disastrous Emergency Privileges...
3.3 Term of Appointment...
3.3-3 Procedures for Appointment and Reappointment:
The procedures for appointment, reappointment and the granting of Clinical Privileges to the Medical Staff are outlines in the Credentials and Hearing and Appellate Review Policy and Procedure Manual and are incorporated herein by reference...
Article IV: Medical Staff Categories...
4.2 Active Category...
4.2-3 Prerogatives: Appointees to this category:...
D. may exercise such Clinical Privileges as are granted to him or her...
4.3 Active-Outpatient Category...
4.3-3 Prerogatives: Appointees to this category:...
G. may exercise such Clinical Privileges as are granted to him or her in the Hospital outpatient department...
4.4 Courtesy Medical Staff...
4.4-3 Prerogatives: Appointees to this category:...
B. may exercise such Clinical Privileges as are granted to the appointee...
4.5 Consulting Category...
4.5-3 Prerogatives: Appointees to this category may:...
A. exercise such Clinical Privileges as are granted to the appointee..."

A review of the facility's "Credentials and Hearing and Appellate Review Policy and Procedure Manual", adopted 7/27/2005, revealed the following, in pertinent parts:
"...Article V: Clinical Privileges
5.1 Exercise of Privileges: A Practitioner providing clinical services at the Hospital may exercise only those privileges granted to him/her by the Board or emergency privileges as described herein.
5.2 Privileges in General
5.2-1 Requests: Each application for appointment or reappointment to the Medical Staff must contain a request for specific Clinical Privileges desired by the applicant. Specific requests must also be submitted for temporary privileges and for modification of privileges in the interim between reappointment evaluations.
5.2-2 Basis for Privileges Determination: Requests for Clinical Privileges will be considered only when accompanied by evidence of education, training, and demonstrated competence as specified by the Hospital. In the event a request is submitted for which no criteria have been created or for a privilege that is not currently available the request may be tabled for a reasonable period of time during which the Board shall, after consultation with the MEC, formulate the necessary criteria and/or make the decision whether the privilege is available at the Hospital...
Valid, complete request for Clinical Privileges shall be evaluated on the basis of education, training, experience demonstrated competence, ability and judgment and other qualifications the Hospital deems applicable..."

A review of a sample of seven credential files that were reviewed on 6/22/2011, revealed that all seven credential files contained a privilege request form for "Core Privileges", which did not indicate that individual privileges were granted to practitioners.

A review of the "General Surgery Privilege Request Form", revealed that any applicant that was granted "Core Privileges in General Surgery" would include: "...the performance of surgical procedures (including related admission, consultation, work up, pre- and post-operative care) to correct or treat various conditions, illnesses, and injuries of the alimentary tract, abdomen and its contents, breasts, skin and soft tissue, head and neck, endocrine system and vascular system, excluding the intercranial vessels, the heart, and those vessels intrinsic and immediately adjacent thereto. Included within this Core of privileges: minor extremity surgery (biopsy, I&D, varicose veins, foreign body removal and skin grafts), laparoscopic surgery for removal of gall bladder, appendix, ventral hernia, or inguinal hernia, comprehensive management of trauma, including musculoskeletal, hand and head injuries, and complete care of critically ill patients with underlying surgical conditions in the emergency department, intensive care unit, and the trauma/burn units. Also, included within this CORE is Vascular Surgery as follows: being able to admit, work-up, diagnose, and provide surgical and non-surgical treatment and consultative services to patients with vascular disease and disorders. These privileges do not include and special requests...
Special General Surgery Requests...
If you meet the above criteria, you may request privileges by checking the appropriate box(es) below...
Conscious Sedation...
Bronchoscopy...
ERCP...
Endoscopy...
Laparoscopic Nissen Fundoplication...
Bariatric Surgery...
Additional Laparoscopic Surgery beyond the 4 listed in the CORE privileges..."

An interview with the facility's Credentialing Specialist on 6/22/2011, at approximately 9:39 a.m., during the review of the facility's Credential files, revealed that in the evaluation of practitioners for "Core Privileges" it was expected that "in [the practitioner's] training it is expected to have learned [the contents of the core privileges]."

An interview with the facility's Chief Medical Officer on 6/23/2011, at approximately 8:45 a.m., revealed that the facility granted "core privileges" and that specifying the procedures that surgeons could perform would include 600-700 procedures. S/he did confirm that not all procedures that a surgeon is trained to perform would necessarily be performed at the facility.

Based on the manner and degree of the deficiencies cited, the facility failed to be in compliance with the Condition of Participation of Nursing Services.

The findings were:

Cross Reference to A0386 - Organization of Nursing Services: for findings related to the facility's failure to maintain a well-organized service.

Cross Reference to A0392 - Staffing and Delivery of Care: for findings related to the facility's failure to ensure there was immediate availability of nursing staff for bedside care of each patient.

Cross Reference to A0396 - Nursing Care Plan: for findings related to the facility's failure to ensure the nursing staff developed and kept current a nursing care plan for each patient that was easily identifiable and provided continuity of patient care.

Based on staff interviews, facility tour, and review of policies/procedures, the facility failed to maintain a well-organized service. Specifically, the facility did not ensure medications and intravenous fluids were stored appropriately, placenta tissue specimens were secure, medication and patient nourishment refrigerators were monitored regularly, oxygen tanks were stored safely, and that expired supplies were discarded and replaced timely. These failures created the potential for negative patient outcomes.

The findings were:

1. Review on 6/22/11 of the nursing policy/procedure "Use of Multiple Dose Vials (MVDs)," revealed a that the standard was for an expiration date of 28-days after opening. The policy was in the process of being revised per the director of nursing, so it contained hand-written notes modifying the policy to state that all multiple dose vials should be discarded 28 days after opening, regardless of the manufacturer's expiration date.

Reference Tag A 505 for findings related to the failure of nursing to ensure that the policies/procedures for nursing, including those for multi-dose vials, were consistently applied in the outpatient areas.


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2. Medication Storage
Facility tour of the Medical/Surgical unit and Intensive Care Unit (ICU) was conducted on 6/20/11 at approximately 1:30 p.m. with the Director of Acute Care Services (DACS). Tour of the ICU medication room revealed an open 25 mg metoprolol tablet wrapping in patient specific drawer 302. One half of the tablet was gone, but the other half remained in the wrapping, however, the wrapper was not in a patient medication bag, labeled, or secured in any manner. The DACS stated that when the ICU gets a new patient, the nurses will override the pyxis to get medications and the nurses are supposed to get a "double check." However, there was no way to determine what medication still remained in the open wrapping and if the nurse planned to use it again, despite its lack of secure storage.

When the above findings were explained to the Director of Pharmacy on 6/22 at approximately 8:00 a.m., s/he stated that the remainder of the pill should have been destroyed.

The pharmacy policy titled, "Administration of Medications- General" and numbered 13-01, stated the following, in pertinent part, "MEDICATION ADMINISTRATION PROCEDURE... Keep unit-dose packages intact until just prior to administration... Destroy unusable refused medication..." The Director of Nursing stated on 6/21/11 at approximately 5:05 p.m., that the policy titled "MEDICATION ADMINISTRATION" was for the entire hospital, although the department on the policy stated perioperative services. The policy stated, in pertinent part: "...If a medication has been opened and is refused by the patient, it is to be destroyed. This also applies to medications held because of nurse discretion..."

Facility tour of the Obstetrics Unit (OB) was conducted at approximately 3:15 p.m. with the Director. The blanket warmer contained one 500 ml bag of intravenous Lactated Ringers and one 1500 ml bottle of sterile water. Neither were labeled with the date in which they should be removed and the plastic outside covering bag of Lactated Ringers bag was tight and appeared as though it was going to break open. The Director stated, "They aren't supposed to have anything in there (except blankets)." Inspection of one of the hall cabinets that open into the patient room revealed an open unlabeled 1000 ml bottle of Sodium Chloride. The Director stated that is used for placentas but that "it should be thrown away."

The policy titled, "BLANKET WARMING UNITS" stated the following, in pertinent part: "The blanket warmer must be used to warm blankets, sheets, towels, and other linen, as indicated. Fluids must not be placed in the blanket warmer..."

3. Placenta Specimen Storage and Security
Upon further tour of the OB unit, it was discovered that patients' placentas were stored in an unlocked dirty storage room within an unsecured refrigerator. The Director explained that each placenta was kept for a week. Observations revealed a pink bucket/bath basin labeled with each day of the week and several placentas in each basin except the Sunday and Monday labeled ones. The placentas were stored in two plastic biohazard bags with the mother's patient label affixed to the outside. When asked about the procedure with the placentas, the Director stated that the "techs" check everyday and dispose of them after a week. S/he stated that their insurance company "recommended we keep them." S/he stated after a week's time, the placentas are disposed of in a biohazard container. In further interview with the Director on 6/21/11 at approximately 4:20 p.m., s/he stated, "Insurance says it is a routine thing to keep them for a week and then toss them." S/he clarified that the insurance carrier was the hospital's insurance. S/he confirmed that neither the room or the refrigerator locked and that no log of the contents/storage was maintained. When asked about the use of the placentas during that week, s/he stated they are kept in case they need to be examined later due to a physician's concern, but that it "has never happened." Instead, s/he stated that they are "always examined immediately after surgery" and that if the mother chooses to take the placenta home, she "usually takes it when [she] discharges." S/he stated that the process of storing the placentas within the OB unit instead of the lab began about five years ago due to the preference of the laboratory.

An interview with the hospital's Lab Director was conducted on 6/21/11 at approximately 1:45 p.m. When asked about the storage of patients' placentas within the OB unit, s/he commented on the previous storage of the placentas within the lab and stated "there were so many placentas that storage was an issue." S/he stated, "What was happening was that they [OB staff] would bring them [the placentas] to the lab and sit in the fridge and you would say 'Doctor, you need to say what you are going to do with this." In regards to samples obtained from the placentas currently stored in the OB unit, s/he stated, "We only accept if it is labeled correctly and has a tissue form..." S/he explained that pathology then takes the sample and "moves it forward" for processing per the physician's order. When asked if the lab department had identified a concern with the current placenta storage practice, s/he stated that the storage was up to the OB unit.

The facility's laboratory policy titled, "SURGICAL PATHOLOGY, version 11/26/2010, stated the following, in pertinent part: "Cytology Specimen Handling & Transport... Specimen Type - Placentas: Upon the request of the physician, placentas should be labeled according to policy and presented to the Pathology Dept. Complete Tissue Submission Forms and reason for exam must accompany the specimen. Action to Take - Keep refrigerated, take to Pathology Lab in a timely manner."

In contrast, the policy provided by the OB nursing department, titled "PATHOLOGY POLICIES AND PROCEDURES, SPECIAL PROCEDURE" with "Routine Placenta Storage" handwritten below and in parenthesis, was last reviewed 9/02. It stated the facility's previous practice and, therefore, the nursing unit had no policy or direct instruction and procedure in which to follow for its handling and storage of patients's placentas. The policy stated the following, in pertinent part: "1. Effective October 9, 1996, placentas from all deliveries (regardless of gestational age...) will be stored and kept for pathologic evaluation for 7 days following delivery... 3. The specimen bag/container should be labeled with the date of delivery and with the patient's identification information. 4. A Pathology Tissue Submission Form should be completed on each placenta, and must list... 5. If the clinician would like the placenta processed for gross and microscopic evaluation by Pathology... If no such note is made, the placenta will not be examined by Pathology. 6. The appropriately dated and labeled specimen and the corresponding completed Pathology Tissue Submission Form will then be transported within 4 hours of delivery to the designated placenta refrigerator in the washroom of the hospital Laboratory. 7. The dated and labeled specimen, in saline solution, will be placed inside the designated placenta refrigerator... 9. The Pathology Department will be responsible for discarding placentas. Unless the Pathology Department is otherwise instructed, the placenta will be discarded on the eighth day following delivery..."

4. Refrigerator Temperature Monitoring
Each of the three toured nursing units had similar issues in that there was no consistent monitoring of the patient nourishment refrigerator temperatures and often the medication refrigerator temperatures were also not monitored. For example, the medication refrigerator in the ICU had a monitoring form on the front, however, the last date of documentation was 12/21/08. The DACS stated the refrigerator "alarms if it goes out of range" and that facilities is then notified and staff then document on the form. Daily documentation was not conducted in the ICU, however, daily documentation was noted on both medication refrigerators on the Medical/Surgical unit. The patient nourishment refrigerator for Med/Surg monitoring form was absent and for ICU was present but without documentation. Tour of the medication refrigerator on the OB unit revealed that a temperature log was being utilized with a color wheel and "changed weekly," according to the Director, but no documentation of such was maintained. The OB patient nourishment refrigerator did not have a log and the Director stated, "It is supposed to alarm if it goes out of range." The Director acknowledged that they were supposed to maintain a log, but s/he thought that the kitchen also looked at temperatures. Additionally, inconsistency of storage of items in patient refrigerators was noted. The patient nourishment refrigerator contained the following items: an open unlabeled milk container, an unlabeled Gatorade bottle, an unlabeled plastic bag full of asparagus, and an unlabeled Tupperware container filled with a creamy substance. Three soda cans were present in the breast milk refrigerator, located in the nursery on the OB unit. That refrigerator had a sign on the front that stated in was to be used only for breast milk storage.

When the Director of Acute Care Services was asked about temperature monitoring of refrigerators on the units (Med/Surg and ICU), s/he stated that some recent conversation had taken place between her/himself and the Director of Dietary. Ultimately, s/he stated that s/he was informed the patient nourishment refrigerators were the nursing unit's responsibility. S/he stated the plan going forward it to have each fridge temperature checked daily. Both the Director of Acute Care Services and the Director of OB acknowledged that it was the floors responsibility to monitor the medication refrigerator temperatures, not the pharmacy's responsibility.

The "Med-Surg Meeting" minutes, dated 3/24/11, stated the following, in pertinent part: "3. Refrigerators and temps - I am looking into a different type of refrigerator temp control. It uses graph paper, and every 24 hours we change out the paper and the documentation is done for us..." The meeting minutes from 4/21/11 stated the following, in pertinent part: "... Also, I am looking into thermometers that track our fridge temps continually so that we have constant documentation on temps for refrigerators."

An interview with the facility's Director of Nursing was conducted on 6/21/11 at approximately 4:50 p.m. When asked about a policy for the monitoring of refrigerator temperatures, s/he stated, "We do not have a policy for monitoring temperatures of medication or nourishment fridges."

The policy titled "Breastfeeding," last approved 9/24/07, stated the following, in pertinent part: "In the hospital, milk may be refrigerated for 48 hours or frozen for 2 weeks in Nursery refrigerator freezer..."

The dietary policies did not clearly delineate the responsibility for monitoring nourishment refrigerator temperatures. The policy titled "Kitchenettes and Pantries" stated, in pertinent part: "The food service staff will deliver items daily to the appropriate kitchenette or pantry... - Check the temperatures of the refrigerators/ freezers in kitchenettes or pantries weekly - Check the internal food temperatures randomly to assure proper temperatures..." The policy titled "Personal Food Storage" stated, in pertinent part: "Food or beverage brought in from outside sources for storage in facility pantries, refrigeration units, or personal room refrigeration units will be monitored by designated facility staff for food safety... Designated facility staff will be assigned to monitor individual room storage and refrigeration units for food or beverage disposal... All refrigeration units will have internal thermometers to monitor for safe food storage temperatures. Units must maintain safe internal temperatures in accordance with state and federal standards for safe food storage temperatures."

5. Oxygen Tank Storage
A second prevalent issue on two nursing units was unsafe storage of oxygen tanks. On tour of the ICU, two tanks were observed setting in a corner on the floor in the clean utility storage room. The tanks were not secured in holders or carts. A third oxygen tank was observed on the OB floor near the nurses station. This tank was also without a holder or cart. The OB Director stated that sometimes surgery staff leave the tanks behind after they bring a patient to her room.

An interview with the Director of Cardiopulmonary Services, which encompasses respiratory care, was conducted on 6/22/11 at approximately 8:00 a.m. The Director confirmed that safe storage of the oxygen tanks is necessary and is the responsibility of the staff who last used the tank.

The policy titled "Oxygen Tank Preparation," date reviewed 6/2009, stated the following, in pertinent part: "Safety Notes: 1. Keep tanks with regulators stored in tank trucks or cylinder carts in an upright position unless secured on an appropriate stretcher (i.e. - ED, ambulance or radiology stretchers)..."

6. Crash Cart Supplies
Each nursing unit "Crash Cart" was inspected upon tour. The ICU Pediatric Crash Cart contained three (pink coded) "Pediatric Emergency System" kits which were expired on the following dates: 7/2009, 3/2011, and 5/2011. The Pediatric Crash Cart on the Medical/Surgical unit contained one (blue coded) "Pediatric Emergency System" kit which had expired on 3/2011. It also contained an infant lumbar puncture tray, which had expired on 2/2011. The OB unit's Adult Crash Cart contained two sets of 3M brand defibrillator pads which both expired 10/2009. Three Medline "IV Start Kits" contained an expiration date of 8/2010. The Crash Cart also contained sets of 3M brand Red Dot electrodes which expired 4/2010. The Infant Crash Cart, located within the nursery, contained four expired uncuffed tracheal tubes, which were dated the following: 11/2005, 8/2009, 1/2010, and 8/2010.

Each crash cart contained a medication box which was sealed and locked by the pharmacy department. Upon tour in the ICU, the Director of Acute Care Services stated, "Nursing checks the rest of the supplies in the crash cart. It is done after each use and once a month." Additionally, upon tour of the OB floor, the OB Director stated, "Pharmacy goes through medications and the rest of it the nurses are supposed to keep up."

The facility's policy titled, "Crash Cart," last reviewed 3/03, stated the following, in pertinent part: "Users (e.g. nurses) should inspect the crash carts once daily, including a defibrillator test while unplugged, and after use to ensure that all drugs and supplies are present and usable. A determination that a seal is intact is sufficient user inspection... In the event that the crash cart has been opened, it is the nurse's responsibility to itemize the necessary equipment needed to supply and restock the cart. Careful attention should be paid to expiration dates..."

Based on observations of care within the facility, review of policies/procedures and facility documents, and staff interview, the facility failed to ensure there was immediate availability of nursing staff for bedside care of each patient. Although staffing on nursing units, specifically Medical/Surgical, was adequate, an issue of call light response had been identified by the Director. Despite that, no changes had been implemented or education provided to further ensure patient satisfaction, comfort, or prompt availability of bedside care. This failure created the potential for a negative outcome.

The findings were:

Observations on the Medical Surgical nursing unit were conducted on 6/21/11 at approximately 10:00 a.m. Two separate patient call lights were noted to be sounding on two different occasions for several minutes each. While the call lights were sounding, two Nursing Assistants were observed walking in and out of other patient rooms while completing documentation and two nurses and a secretary were noted sitting at the nurses station. One of the nurses was completing patient charting while the second was lightly engaging in conversation with two physicians. During one of the call light instances, the nurse sitting near the physicians was asked who's responsibility it is to answer call lights. S/he responded, "All of ours." At that point, the nurse departed the nurses station and responded to the call light.

A review of nursing staffing for each unit for the previous week was conducted on 6/21/11. Each unit was staffed appropriately based upon the facility's staffing matrix.

"Med-Surg Staff Meeting" minutes from the 4/21/11 meeting stated the following, in pertinent part: "3. Patient Satisfaction - I shared some concerns that patients have written about. Their experiences were not positive. We discussed how that can be difficult when we are very very busy, but everyone acknowledges this is something we have to continually work on."

An interview was conducted on 6/22/11 at approximately 1:00 p.m. with the Director of Acute Care Services (DACS). The DACS explained the patient satisfaction scores that were noted in the Nursing Meeting Minutes. S/he stated, "PressGaney sends results to us monthly. It is not specific feedback. Our biggest complaint is that we aren't getting many back." When asked what changes or actions had been formulated from the survey results, s/he stated that they had "talked at length amongst ourselves." When asked what issues had been noted, s/he stated pain medication, side effects of medications, responsiveness to call light, and the patients' feelings in regards to being equipped to go home. When asked what had been done to address the patients' perspective on call light response, s/he referenced a specific family complaint and stated, "We can actually track the time a call light is put on and the time it is turned off. There were two times it was longer than ten minutes. We can pull a report for the call light system. One patient complained and we saw that is was answered the first time within seven minutes." When asked what an acceptable time was to answer a call light, the DACS stated, "Right now," indicating that an immediate response would be expected. S/he continued that the response is "usually within three to five minutes... three minutes is probably our average." When asked if any future plans were in production to address call light responses the DACS stated that s/he would address the issue with the charge nurses, but that such a discussion had not yet been planned. Little evidenced actions had been done to address the three other issues identified from the PressGaney surveys. An additional interview was conducted with the DACS at approximately 2:15 p.m. When asked if any education had been provided to the nursing staff in regards to call light response, s/he stated, "Other than to tell them they need to answer when they go off? No." The DACS did emphasize the fall risk program they had implemented and that all high fall risk patients are placed in rooms around the nurses station. S/he stated that the bed alarm response time "is as low as it is because we have done so much education on falls with our fall program." When asked if the patient satisfaction scores or issues had been implemented into the facility's Quality Assessment and Performance Improvement Program, s/he stated they were not but were looked at in staff meetings.

It was requested that the DACS pull up the call light response times as s/he had previously done when investigating a complaint. S/he stated they were unable to do so that day but were able to pull up the response times to bathroom red lights and bed exit alarms. The average bathroom call light response was 1 minute, 9 seconds. The minimum was 5 seconds and the maximum was 7 minutes, 34 seconds. A total of 68 calls were averaged in this sampling. The average bed exit alarm response was 54 seconds. The minimum was 2 seconds and the maximum was 10 minutes, 41 seconds. A total of 134 calls/lights were averaged in this sampling.

Upon review of the facility's policies and procedures, the only policy that addressed call lights was titled "SAFETY GUIDELINES FOR PATIENT CARE SERVICES." It stated the following, in pertinent part: "Call lights will be placed within easy accessibility to the patient."

Based on review of medical records, facility policies/procedures, and staff interview, the facility failed to ensure the nursing staff developed and kept current a nursing care plan for each patient that was easily identifiable and provided continuity of patient care in six of 21 sample medical records. This failure created the potential for a negative patient outcome.

The findings were:

The "Nursing Policy and Procedure" for the Medical Surgical Department, titled Patient Care Planning and numbered MS-2009, stated the following, in pertinent part:
"- Each patient's nurse care is based on identified patient care needs and patient care standards and is consistent with the therapies of other disciplines.
-Each patient will have a multidisciplinary plan of care developed at the completion of admission assessment and documented in the medical record.
-The patient and significant other(s) will be included in the planning of care, as appropriate.
-The plan of care will be measurable, outcome-based and developed in collaboration with the medical plan of care.
-The plan of care will guide staff in providing care to the patient.
-When care is not planned for assessed needs, this documentation will be in the medical record.*"
Hand written below this text it stated, "- Care Planning will be documented on APIE/ Daily Nurse Notes." There was no evidence as to when this handwritten text had been added, but clearly it was not a formulized procedure at the time.

The "Nursing Policy and Procedure" for the Medical Surgical Department, titled "Standards of Practice - General Nursing" and numbered MS-2000, stated the following, in pertinent part: "... Planning consists of determining patient problems (nursing diagnoses) based on patient assessment data... Desired outcomes are identified and a plan of care developed to achieve those outcomes... The plan of care is developed in order to achieve the desired outcomes... The plan of care is implemented... Outcomes of nursing actions (interventions) are evaluated for further assessment and planning. This is evidenced by: - Evaluating the achievement of desired outcomes... - Reassessment of the Nursing Care Plan... - Further planning as directed by the reassessment... - Provides continuity of patient care through the dissemination of the results of the plan of care to the patient and other healthcare providers, per state and federal laws and regulations. - Results and modification of the plan of care are documented."

An interview with the Director of Acute Care Services was conducted on 6/20/11 at approximately 2:45 p.m. When asked about care plans, s/he stated, "We use APIE charting, which stands for Assessment, Plan, Intervention, and Explanation." S/he explained that nurses are expected to do a daily intervention and plan in the nurses notes, but that techs also chart within that section.

An additional interview was conducted with the Director on 6/21/2011 at approximately 4:30 p.m. When asked about a specific medical record's plan of care (sample #14), s/he stated, "We use APIE charting." S/he continued, It "should be there," referencing the column where the nurse would have indicated which nursing diagnosis/problem was being addressed, "but it is not." When asked if audits of nursing documentation was conducted, s/he stated, "We don't do audits of charting."

An Intensive Care Nurse was interviewed on 6/21/11 at approximately 9:20 a.m. about patients' plans of care. S/he stated, "I usually do it in my narrative note and designate the letter (APIE). MedSurg and overflow patients also have the boxed care plans we can use." The "boxed" care plans were also located within the four day flow sheet but had a more structured format. The APIE care planning process afforded space to choose patient problems as well as three priorities.

A Medical/Surgical Nurse was interviewed on 6/21/11 at approximately 9:40 a.m., about dates on the patients' four day flowsheets (which included the nurses' narrative notes and the plans of care). The nurse stated, "We usually are good about putting the date on (the flow sheets) but it is hard to figure out the day and you have to go back..." The nurse agreed that a person reviewing the medical record would have difficulty knowing the day of documentation.

Medical record review was conducted 6/22/11 and revealed the following:

Sample medical record #5, reviewed 6/21/2011, was a patient admitted on 6/18/11 for septic shock. The record contained no APIE charting within the nurses' flowsheets on 6/18 or 6/19.

Sample medical record #6, reviewed 6/21/2011, was a patient admitted on 6/16/11 for cholecystitis. The record contained no APIE charting by the night shift nurse on 6/18, as well as no APIE on either shifts of 6/16 or 6/17.

Sample medical record #11, reviewed 6/21/2011, was a patient admitted on 4/3/2011 for alcohol withdrawal. Nursing documentation on 4/3/2011 indicated the patient had the following patient problems/nursing diagnoses: "2. Anxiety, 4. Confusion, 14. Nutrition Alteration, and 19. Safety Risk." In the areas provided for prioritization of the patient's problems, there was no indication of what was the 1st priority, 2nd priority, or 3rd priority. The APIE charting did not indicate which problem was being addressed by the intervention or being evaluated. Nursing documentation on 4/4/2011 did not indicate which problems/ nursing diagnoses the patient had nor the prioritization. The APIE charting from 6:45 a.m. through 6:15 p.m. did not indicate which problem was being addressed. An entry at 7:45 p.m. stated that "19," which indicated the patient problem of safety risk, was being addressed with an intervention. Nursing documentation on 4/5/2011 at 12:40 a.m. did not indicate which problems/nursing diagnoses the patient had nor the prioritization. However, the patient problem of "16," which indicated the patient problem of "Pharmacy Intervention," was being addressed with an intervention. No further nursing documentation addressed which problem/nursing diagnosis was being addressed up to and including the time of the patient's leaving Against Medical Advice on 4/5/2011 at 8:20 a.m.

Sample #14, reviewed 6/21/11, was a patient admitted on 5/4/11 due to a fractured pubis. The record contained APIE charting within the nurses' flowsheets, but only during one shift within the approximately 53 hour admission did the nurses indicate which problem was being addressed by the intervention or being evaluated. Specifically, the night shift nurse on 4/5 to 4/6 addressed two problems/ priorities. All other documentation was without a problem or priority identification.

Sample #15, reviewed 6/22/11, was a patient admitted on 3/5/11 due to a pneumothorax. The record contained APIE charting within the nurses' flowsheets but nurses did not consistently indicate which problems and priorities were being addressed by the intervention or being evaluated.

Sample #17, reviewed 6/22/11, was a patient admitted on 4/3/11 with a diagnosis of gastrointestinal bleed. The record contained APIE charting within the nurses' flowsheets but nurses did not consistently indicate which problems and priorities were being addressed by the intervention or being evaluated.

Based on facility tour, staff interviews, and review of policies/ procedures, the facility failed to ensure drugs and biologicals were administered and stored under supervision of nursing staff and in accordance with approved standards. Specifically, improper and unsafe storage of medications was identified on nursing units. This failure created the potential for a negative outcome.

The findings were:

Cross Reference to A 0386, part 1 - Organization of Nursing Services: for findings related to the facility's failure to maintain a well-organized service.

Based on observations, staff interviews and review of the facility's policies and procedures, the facility failed to assure that unauthorized individuals could gain access to or alter patient records. Specifically, the following areas failed to maintain adequate security and confidentiality of patient medical records:
1. Outpatient clinics failed to secure medical records and maintain confidentiality during off business hours.
2. Nurse servers on the nursing units were not locked which allowed anyone passing by to gain access to a medical record.

The findings were:

The facility's Health Information Management (HIM) policy and procedure entitled, "General Policies," stated the following in pertinent part: "The policy of the HIM Department at the (hospital name) is to serve the other departments and Medical Staff of the hospital in providing high quality patient care through the maintenance of accurate, complete, secure and readily retrievable medical records...All records shall be kept in a secure area to assure maximum protection of records and to assure the confidentiality of the records contents..."

An interview was conducted with the Director of HIM on 6/22/11 at approximately 10:05 a.m. The Director stated that s/he goes to the outpatient clinics periodically, "obviously not enough," and constantly reminds them to be aware of the necessity of keeping medical records secure. They should not be left laying around in the physician offices or in the open clinic nursing areas during off business hours. The Director further stated that when the nursing units put in the Nurse Servers, s/he understood they would always be locked when not being used by the nurses. The Director requested that s/he wanted to go to the nursing units and check out the Nurse Servers. At 10:40 a.m., the Director returned from the nursing units and stated the Nurse Servers were not locked and that s/he planned to meet with the nursing director as soon as possible.


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During tours/observations of the outpatient clinics on 6/21/11, stacks of medical records were observed on shelves and counters in remote access hallways running between clinics. Medical records were also observed in physician offices and in the clinic nursing stations. During the tour, the practice manager for the physician services stated that the records were maintained in a locked medical records area and pulled the day before a patient visit and delivered to the various clinic for use at the patient visit and then returned to the medical records area after the visit. There were no provisions for overnight/weekend locked storage of the records in the clinic areas.

During a tour of the internal medicine clinic area on 6/21/11 at approximately 2 p.m., and large stacks of charts were observed on one of the counters across from the main part of the clinic desk/nursing station. A delivery person from the multi-clinic medical records department located on the first floor of the complex was seen to be delivering records to the clinic with a cart of records. The delivery person was introduced to the surveyor and was asked if all of the records s/he delivered and all of the records sitting around on counters, hallways and in doctors' offices were returned to the medical record department for storage each evening after the clinic closed each evening. S/he stated that s/he doubted that all of the records were returned to the medical records department each night. The medical director, who was part of the tour, was also questioned about physicians keeping medical records in their offices. S/he stated that it was probably a consistent practice of physicians to keep patient charts unsecured (unlocked) in their offices overnight or over a weekend until the paperwork was completed.

During a tour of the outpatient physical therapy area of the same complex, at approximately 1:45 p.m., a five-drawer lateral file cabinet was observed with patient records in it sitting in a hallway of the area outside the patient gym and right outside the doorway of the director of that clinic. The clinic director was asked about the records and stated that the records were kept there for convenience because the patients come for multiple appointments during the week, so sending the records back and forth to the multi-clinic medical records department on the first floor was impractical. When asked if the cabinet was locked at night to secure the records, the director stated "no," and also that they did not have a key to the lock on the cabinet. It was noted that the charts were in red and green manilla folders rather the buff colored patient files with coding labels on the margins, as seen in the rest of the hospital. The director also stated that the physical therapy clinic had a room full of additional files in the multi-clinical medical record area, but that the head of the medical records area was pushing the clinic to clear out all of their records and take custody of them, so that there would be more medical record storage for the rest of the complex. When asked if the medical records department had a master list of all of their files, s/he stated that s/he did not think so.

During a tour/observation of the outpatient clinic complex located in another town approximately 15 miles from the main hospital campus on 6/21/11 at approximately 3 p.m., it was determined that the clinic had previously been a private physician-owned family practice clinic until May 2011, when the hospital assumed control of the clinic and all patient records. The records were stored on the second floor of the clinic. When the administrator of physician services was asked if the medical records department of the hospital had taken an inventory of all of the records, s/he stated that s/he did not believe that had been done. At the time of the exit conference on 6/23/11 at approximately 12:30 p.m., the risk manager stated that the medical records department had just initiated/completed an inventory of the records at that clinic earlier that morning.

Review of the policy/procedure manual for the outpatient clinics on 6/21/11, revealed that the manual contained no standards or guidelines for overnight or weekend security/storage of medical records in the clinic areas. The manual also contained not directions for safe supervision or short-term storage of medical record that were located in isolated areas such as back access hallways, in which security of the records could not be assured.


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Facility tour of the Medical/Surgical unit and Intensive Care Unit (ICU) was conducted on 6/20/11 at approximately 1:30 p.m. with the Director of Acute Care Services (DACS). Nurse servers were observed on the wall outside each patient room in the Medical/Surgical and ICU areas. The servers were observed to be used by several disciplines, including physicians, respiratory, and nursing (nurse assistants and Registered Nurses). Items stored within the nurse servers included respiratory charting forms, four day nursing flow sheets (which contained nurses notes, vital signs, and intake/ output forms), fall risk assessments, and hourly patient checks forms. Each of the documents within the nurse servers contained the patient's label that included the patients names, date of birth, medical record number, and admission date. The servers were observed to be closed after use, but not locked. When the Director was asked about the nurse servers, s/he stated, "They are not locked. We have too many departments trying to get to stuff." S/he also stated, "Doctors notoriously leave them (nurse servers) open and I go around in the morning and close them."

Facility tour of the Obstetrics Unit (OB) was conducted at approximately 3:15 p.m. with the Director. Each room of the OB unit was observed to have a nurse server in use as well. The Director confirmed that they do use the nurse servers and that they are not locked.

An interview with the Director of Acute Care Services was conducted on 6/23/11 at approximately 8:30 a.m. S/he explained the plan going forward for use of the nurse servers. S/he stated that his/her units may just keep the vital signs and intake/output forms in the nurse servers with only the patients' room number and initials on the forms. When asked what the OB unit planned to do, s/he stated that s/he was unaware and was only planning the changes for his/her two units. The lack of continuity in a facility change opens potential for error when different disciplines (for example, respiratory) work on each floor.

Based on review of medical records, facility documents and staff/physician interviews, the facility failed to ensure that contracted mental health consultants provided documentation of all consultative patient evaluations in the medical record. This failure created the potential for a negative patient outcome.

The findings were:

1) Review of medical record sample #19, as part of the hospital survey on 6/22/11, revealed that the patient had been transferred to a psychiatric hospital for treatment of "acute psychosis." The medical record contained a nursing record for patient transfer to the mental health facility. The record contained no documentation of an assessment, findings or recommendations from a consultative visit with a mental health professional.

2) Review of the Health Information Management Policy and Procedure listed under General Policies with review date of 7/10 stated the following in pertinent part:
"a) the HIM department is to serve the facility by maintaining accurate, complete and readily retrievable medical records.
b) all records shall be kept in a secure area to assure maximum protection of records and to assure the confidentiality of the records contents.
c) all patients who are seen in this hospital have the right to assume that the information contained in their medical record will not be divulged without their expressed consent. It is the responsibility of the HIM personnel to maintain the confidentiality of each patient's medical information in accordance with hospital policy and sate and federal regulations including HIPPA."

3) Per the contractural agreement with the mental health consultant and the facility signed June 29, 2009, the mental health contractor was to provide mental health services for the hospital and the "staff will document these services in the hospital chart as is normal operating procedure."

4) In an interview with the Director of Acute Care Services on 6/22/11 at approximately 10:40 a.m., an inquiry was made regarding the documentation of the mental health consult. She stated, "A lot of times they will go back to their office to dictate; they will usually talk to the M.D. but sometimes the consult gets to us two days later."

5) In an interview with the Chief Medical Officer on 6/22/11 at approximately 12:20 p.m., when asked if there was a delay or refusal to submit mental health notes, he stated, "I can honestly say this is the first progress note I have ever seen." He noted that there is a mandate from the state that the contracted agency provide care, but the relationship is not ideal." We've asked that they please leave a note in our record... anything written in the chart would be helpful, but we can't get them to do that." He further noted that nearly 100% of these patients are seen in the Emergency Department, so the mental health consultants communicate verbally with the Emergency Room M.D., as to the recommended treatment plan for the patient. He further noted that the facility had been told that the contracted agency did not include consultative notes in the patient chart because they felt it would be a breech of patient confidentiality.

6) At approximately 11:20 a.m. on 6/22/11 after the hospital's request, a faxed copy of a progress note report was received documenting the assessment, findings, and recommendations from the contracted mental health provider in regards to sample patient # 19.

Based on observations, staff interviews and review of the facility's policies and procedures, the facility failed to assure that outdated or otherwise unusable drugs were not available for patient use. Specifically, the outpatient clinics failed to have a consistent inventory management system that ensured that outdated medications were removed from stock.

The findings were:

The facility's policy and procedure for "Medication Management - Storage and Inspections in the Medication Areas" stated the following in pertinent part: "The Director of Pharmacy or qualified designee shall conduct routine (preferably monthly) inspections of all medication areas (e.g., nursing-care units, emergency medication containers, and other areas where medications are dispensed, administered, or stored). Inspections shall be by a pharmacist or an appropriately trained or experienced individual under the supervision of a pharmacist...Inspections shall include the main pharmacy, all nursing care units, medication storage units, emergency boxes and emergency carts, and all other areas of the facility (including off-site clinics and physicians' offices) where medications are dispensed, administered or stored (including medications in areas that do not obtain their stocks from the pharmacy)."

An interview was conducted with the Director of Pharmacy on 6/22/11 at approximately 8:00 a.m. The Director stated that in the past pharmacy was going to the outpatient clinics and doing the inspections. S/he did not know when that process was discontinued and the nurses in the outpatient clinics began doing the inspections. The Director further stated that a pharmacy tech would be going to all the outpatient clinics again and perform the inspections.


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Review of the Outpatient Clinics policy/procedures on 6/22/11, revealed the following policy/procedure related to storage of medications:
The policy/procedure titled "Stock Medications," revealed the following, in pertinent parts:
"...Storage of Drugs:
...Drugs shall not be kept in stock after the expiration date on the label. No contaminated or deteriorated drugs shall be used.
-Drugs shall be checked monthly, as well as each time a medication is dispensed, for outdates. Monthly checks of sample drugs shall be included.
-Multidose dials of injectable medications are to be dated and initialed when opened. The vials shall be destroyed when expired (per manufacturer) or if contamination is suspected. Multidose vials will be discarded if opened longer than 30 days or if no date on opened vial. Drugs used for local anesthesia shall be single use vials...
Emergency Drugs:
-Emergency drugs shall be checked and logged at least monthly to assure appropriate replenishment of drug supply and to assure that drugs are not outdated.
Disposal of Outdated Medications:
-Medications which become outdated are to be disposed of in the biohazardous waste or returned to the drug manufacturing representative..."

During a tour of the outpatient clinics on 6/21/11 at approximately 11 a.m., inspection of the medication storage area of the obstetrics/gynecology (OB/GYN) clinic revealed an open multidose vial with a date of expiration sticker, but no date of opening and no initials. When the nurse was questioned about the expiration date, s/he said it was 30 days after opening. When s/he and the chief nurse for outpatient were questioned about whether they were aware that the newest standard for discarding open multidose vials was 28 days, they were unaware of that standard. The chief nurse stated that nursing policies/procedures for the outpatient area were not always coordinated with the nursing standards set out in the inpatient nursing policies/procedures, but that s/he was trying to get in line with the regular nursing policies in the facility. Subsequent interviews with other outpatient nurses during the tours revealed that the understanding of the standards for labeling multidose vials and the discard date requirements varied among nurses.

During a tour of the occupational medicine clinic of the outpatient clinics on 6/21/11 at approximately 1 p.m., revealed multiple oral, injectable, and topical stock medications and eye drops that were outdated, with some as old as February 2009 and including a box of 30 vials of the emergency medication epinephrine that had expired in February 2011.

Tour of an outpatient Rehabilitation area of the hospital, located on the 3rd floor, was conducted with the Director of Acute Care Services on 6/21/11 at approximately 12:30 p.m. The Crash Cart, located adjacent the echocardiogram lab, contained the following expired supplies: one 500 ml bag of 2 g Lidocaine (0.4% Lidocaine with 5% Dextrose) with an expiration date of 11/10, two 1000 ml bags of Sodium Chloride with and expiration date of 4/2011, one 250 ml bag of 5% Dextrose with an expiration date of 3/2011, and packages of 3M brand Red Dot Electrodes with an expiration date of 4/11. The regular checks of the crash cart had been documented and the box of medications sealed with a pharmacy tag were not expired.

Based on observations and staff interview, the facility failed to provide adequate laboratory services in the outpatient service areas. Specifically, the facility failed to have a comprehensive system in place that would keep outdated laboratory supplies unavailable for staff use. The facility also failed to ensure that specimen handling/tracking in the outpatient clinics complied with facility standards. This failure created the potential for negative patient outcome.

The findings were:

An interview was conducted with the Laboratory Director on 6/22/11 at approximately 9:35 a.m., regarding the lack of oversight in the outpatient clinics in regards to expired laboratory supplies that were available for patient usage. The Director stated that s/he has a staff member that goes to the outpatient clinics periodically keeping up with supplies. Also, the nurses from the clinics have come to the main hospital blood draw area and have gotten supplies. Unfortunately, this has been very difficult to keep track of and monitor. The Director further stated that there have been donations of laboratory supplies from recent health fairs and these supplies may not have been monitored for expiration dates.


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During tours/observation of the outpatient clinics on 6/21/11, the chief nurse for outpatient and the physician services practice administrator stated that specimens for laboratory or pathology analysis were always logged into a computer system called "Tracker," which ensured that specimens were tracked from collection until final results were received, so that a specimen or test results did get lost in the system.

Review of the policy/procedure manual for the outpatient clinics on 6/21/11 revealed that several policies/procedures that would have routinely involved a specimen did state "Enter into Tracker system," but many others contained no directions to log the specimen into the "Tracker" system. Review of the policies/procedures titled "Lab Specimen Collection" and "Pathology Submission Form," which were the only policies/procedures specifically addressing the standards for handling specimens, contained no instructions to track or log the specimens in any way, including entering them into the "Tracker" system.

During the tour/observation of the outpatient clinics on 6/21/11, the occupational health clinic contained blood collection tubes that expired January 2011 and a centrifuge that had not had a preventive maintenance inspection since November, 2009. In addition, a tour of the clinic in another town 15 miles west of the main campus of the facility contained a large amount of blood collection tubes that were expired, some back to 2007. In addition, the clinic had a centrifuge that had not been inspected for preventive maintenance since May 2008. The clinic also had a bottle of urine dip sticks that was expired in June 2010 and a blood testing kit with a set of control solutions that expired 10/31/10.

Based on facility tour, staff interviews, and review of policies/procedures, the facility failed to ensure its laboratory made provisions for the proper reporting of tissues specimens. Specifically, the facility had no oversight of tissue specimens not located within the laboratory and the nursing department failed to ensure specimens under their care were secure and stored in an organized manner. This failure created the potential for a negative outcome.

The findings were:

Cross Reference to A 0386, part 2 - Organization of Nursing Services: for findings related to the facility's failure to maintain a well-organized service.

Based on the manner and degree of the deficiency cited, the facility failed to be in compliance with the Condition of Participation of Physical Environment. The facility failed to ensure that all equipment and supplies were appropriately maintained an periodically inspected for safety, efficacy and expiration dates, in order to ensure safe delivery of patient care. The facility also failed to comply with state hospital licensure requirements for outside storage of trash awaiting pick-up. In addition, the facility failed to ensure that an adequate supply of emergency water was maintained to meet the needs of the facility in an emergency situation.

The facility failed to meet the following standards under the Condition of Physical Environment:

Reference Tag A 703 Emergency Gas and Water
The facility failed to maintain an emergency supply of water, as required.

Reference Tag A 713 Disposal of Trash
The facility failed to comply with state hospital licensure requirements that the trash stored outside the facility, awaiting pick-up, must be stored in covered containers in a paved storage area.

Reference Tag A 724 Facilities, Supplies, Equipment Maintenance
The facility failed to conduct periodic preventive maintenance inspections of equipment and to review supplies and equipment for efficacy and to remove expired supplies/equipment from patient care delivery areas.

Based on review of facility documents and staff interviews, the facility failed to maintain an emergency water supply to meet the needs of the facility in an emergency situation, as required.

The findings were:

1. On 6/22/11 at approximately 10 a.m., during a tour of the offices of the plant operations manager, the manager was asked about an emergency water supply for the facility. The manager stated that the facility did not have an emergency water supply and had no contracts in place with a local supplier, such as a dairy or a water company, to provide/haul in emergency water. S/he stated that the facility had water lines that went to two different wells that were part of the town's seven-well water supply system.

2. Review of the facilities contract list on 6/22/11 revealed no contract to supply or store emergency water for the facility.

Based on tours/observation and staff interviews, the facility failed to comply with state hospital licensure requirements that the trash stored outside the facility, awaiting pick-up, must be stored in covered containers in a paved storage area.

The findings were:

1. On 6/22/11 at approximately 10:30 a.m., during a tour of the outside area of the facility, the trash storage area was observed. Multiple trash dumpsters with flip-down lids were observed lined up together in such a way that the lids could not be utilized unless they were pulled away from the adjacent dumpster. The dumpsters appeared empty or nearly empty and the director of plant operations stated that the city picked up the trash every day. An additional large dumpster, that would have been down-loaded off of a truck bed, was also sitting in the area and it contained a large quantity of cardboard and box materials. The dumpster was not covered and did not appear to have any kind of lid. Both the large and smaller dumpsters were located in an unpaved, non-enclosed area. The director of plant operations stated that/she was not aware of the requirement that trash needed to be stored in covered containers.

Based on facility tour, interviews, review of policies/procedures, the facility failed to ensure acceptable levels of safety and quality were maintained. Specifically, the facility did not maintain regular Preventative Maintenance (PM) checks on their equipment within their inpatient and outpatient settings. In addition, the facility failed to ensure that oxygen tanks were stored safely, that expired supplies were discarded and replaced timely and that laundry and linen were adequately laundered, free of stains and in good repair when available for patient use and that the contracted elevator inspector completed timely inspections and maintenance. This failure created the potential for a negative outcome.

The findings were:

1. During a review of patient complaints on 6/21/11, complaints were reviewed related to stained and torn patient linen and bedding. During an interview with the director of plant operations on 6/23/11 at approximately 10 a.m., the director of plant operations was interviewed and revealed that the facility had experienced ongoing problems with the contracted laundry service. They had multiple conversations with the laundry, but continued to have problems with stains and damaged linen and lost items. The risk manager, who was also present also stated that some of the staining problems were believed to be a chemical reaction between the laundry soaps/products and the Betadine used as a disinfectant. They both stated that the problems had been discussed at the environment of care and quality committees. The director of plant operations stated that the housekeeping staff had been charged with inspecting each piece of linen when it was returned from the laundry and asked to discard all stained and damaged linens. Despite this plan, stained and damaged linen continued to make to the patient care areas, causing ongoing concerns and complaints. The director of plant operations stated that the contract with the laundry had expired and they were looking at other options, including use of a laundry room at an adjacent motel purchased by the hospital. Despite the options discussed. No final decisions had been made that could establish a date by which the problem would be corrected.

2. During the meeting with the director of plant operations on 6/22/11 at approximately 10 a.m., additional problems with other contracts were discussed. S/he stated that the hospital had problems with the elevator maintenance contract. The contractor had apparently been late doing regular inspections and testing and when it finally occurred multiple problems were found. Review of the environment of care meeting minutes for the past year revealed at least one entry indicating an elevator inspection had occurred with problems identified. During the survey, the one of the elevators was out of service for part of the day on 6/22/11. Review of other event reports revealed at least one instance of elevator failure in the clinic areas on 1/27/11, which required staff help with escorting a patient to the main floor and assistance from EMT's to use a lift chair to move another patient to the main floor. The director of plant operations stated that they were looking for another option for elevator services, but were limited because of their isolated geographic location.

3. Reference Tag A 0386: Organization of Nursing Services - for findings related to the facility's failure to ensure that expired supplies were not used for patient care and that oxygen tanks were stored in a safe manner.

4. Reference Tag A 582 Adequacy of Laboratory Services - for findings related to expired blood tubes found in the outpatient clinics.


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5. Facility tour of the Medical/Surgical unit and Intensive Care Unit (ICU) was conducted on 6/20/11 at approximately 1:30 p.m. with the Director of Acute Care Services (DACS). The nursing storage room on the 3rd floor contained six Plum-A brand single chamber intravenous pumps that were last inspected 6/10. One of the same type of pumps was last inspected 5/10. Also present was a Flexo Quantum brand enteral feeding pump, which was last inspected 10/09 and a label that stated "clean" was affixed to its handle. Two portable radiant heaters were without a Biomedical PM sticker specifying a date of inspection. Additionally, the Medical/Surgical storage room contained a Sequential Compression Device (#19) that was last inspected 2/10.

6. Facility tour of the Obstetrics Unit (OB) was conducted at approximately 3:15 p.m. with the Director. The blanket warmer temperature was not monitored by the floor's nursing staff and the Director stated, "Biomed is supposed to check the temperature." A later interview conducted on 6/22/11 at approximately 1:15 p.m. with the Head of Facility Operations revealed that, although Biomed was responsible for monitoring the temperature of the OB blanket warmer, it had not been done.

Further tour of the OB unit revealed the following Preventative Maintenance expiration dates in the storage room: one Patient Care Analgesia pump (Lifecare 4100 brand), dated 7/08, five single chamber intravenous pumps (Plum-A brand), dated 6/10, one triple chamber intravenous pumps (Plum-A brand), dated 6/10, and one epidural pump (Abbott brand), dated 6/10. One portable radiant heater was observed in a patient room and was without a Biomedical PM sticker specifying a date of inspection. The nursery contained an infant respiratory ventilator, which was last inspected 6/09, that the Director stated could be used to keep infants stable prior to transfer. A back-up older version warmer, which the Director stated was used "in the past six months," was last inspected 6/09.

7. Tour of the inpatient Rehabilitation gym was conducted with the Rehab Director on 6/21/11 at approximately 3:00 p.m. The ParaCare brand hot wax machine was noted to have been last inspected 2/09.

8. Tour of the Respiratory storage room was conducted with the Director of CardioPulmonary Services on 6/22/11 at approximately 8:00 a.m. An oxygen analyzer was last inspected 2/09. Two different brands of BiPAP assistive breathing devices (Quantum and Vision Respironics) were both last inspected 4/09.

9. The facility's policy titled "Preventative Maintenance," last reviewed 12/10, stated the following, in pertinent part: "Maintain a comprehensive Preventative Program, which includes written testing and maintenance for all equipment/utility system included in the program at pre-established intervals, set by the standards of the hospital... If scheduled maintenance cannot be performed (i.e., part not available), the reason is documented on the work order and it is returned to the Lead Engineer. The work order is placed under "outstanding jobs," which will later be compiled as part of 30 or 60 day report..."

10. An interview with the facility's Director of Biomedical/Maintenance was conducted on 6/22/11 at approximately 8:45 a.m. The Director explained that s/he had began as the Associate VP of Biomed the first week of December. S/he stated that her/his directive was to "prioritize and catch up" after the previous Director and Biomedical Engineer had resigned. S/he stated that the department "did a great job of doing that" but that one of the two technicians then resigned in May. S/he continued, "I evaluated what Biomed was doing. We had many outside contracts or verbal agreements to do Biomed." S/he listed the other commitments, which included two hospitals, outpatient services, eight to ten clinics, several nursing homes, and a local education facility. S/he stated, "I cancelled all outside contracts" except for the two hospitals, however, there is still only one tech and the Director in the department. S/he stated that the facility is now in the process of checking with two outside companies "to look at outsourcing Biomedical Engineering: they will bring on the equipment and team." S/he explained that this had been "presented to administration about six weeks ago." S/he stated that each company had signed a confidentiality agreement, but that nothing else was in writing and the facility was hoping to get quotes from both in "two to three weeks." S/he continued that "high priority needs are kept up, like the call system and items that don't have a back-up." S/he also stated, "I don't know of anything that has broken down due to no (Preventative Maintenance) checks." When asked about all the equipment that had expired PMs, s/he stated, "Knowing that [the tech] could stay on top of emergent needs, I don't think we could bring in someone for a month... contracted or another employee... and really catch up. We have records that show exactly when everything was done and due. The problem is: we are lacking staff." S/he stated the new process would be for each of the contracted hospitals to have their own separate contracts with the outside BM Engineering companies and that the companies had addressed the administrators of each of the hospitals. Going forward, s/he explained, "As soon as they give us a proposal, administration will meet and decide what we can do. Both companies said as soon as we sign a contract, they can get people out here right away."

In a later interview with the Director at approximately 10:45 a.m., s/he was asked how frequently Preventative Maintenance checks were required on equipment. S/he stated, "Every piece of equipment has a requirement based on manufacturer's guidelines and I think the minimum is usually a year..."

Based on the manner and degree of the deficiency cited, the facility failed to be in compliance with the Condition of Participation of Infection Control. The hospital failed to institute standards and surveillance mechanisms to ensure a consistently sanitary environment, including exam/procedure rooms, equipment, supplies and instruments in the outpatient clinics and by instituting an infection control log for the entire facility.

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

Reference Tag A 750 Infection Control - Infection Control Log
The hospital failed to maintain an infection control log, as required.

Reference Tag A 756 Infection Control- Leadership Responsibilities
The hospital failed to ensure that the outpatient clinics utilized the infection control, surgical services and central processing resources and expertise to ensure that the outpatient clinic staff adequately cleaned exam/procedure rooms and equipment between patients and cleaned and processed instruments appropriately to ensure patient safety.

Based on staff interview and review of the Infection Control documents provided by the facility, the facility failed to maintain an infection control log, failed to demonstrate that infections were being tracked, monitored and that the quality director was notified of any Infection Control issues/concerns and that departments and clinics had no individual quality improvement plans.

Findings are:

The policy and procedure in the Infection Control Department reads as follows in pertinent part:
"Title: Infection Control Plan
1. RESPONSIBILITY
The responsibility for the Infection Control Quality Improvement activity lies with the Infection Control Practitioner and the Chairperson of the Infection Control Committee. The Infection Control Practitioner oversees all Quality Improvement activities and initiates all monitoring activities with the input and cooperation of the Medical Staff, the Nursing Staff and the Department Heads. All hospital and clinic employees are delegated the responsibility for control and prevention of infections by following Infection Control Policies and Procedures.
2. SCOPE OF SERVICE
b. All departments within the hospital and clinic shall participate in the Infection Control Quality Improvement Program through their Individual Quality Improvement Plans."

An interview was conducted on June 22, 2011 at approximately 10:30 a.m. with the Infection Control Practitioner. S/he has been in that position for approximately two years. S/he reviews daily census reports to determine the patients on antibiotics, on ventilators, have catheters, have decubitus and central lines. S/he also pulls up lab reports to determine any infections. The laboratory also notifies her/him of any potential infections and positive laboratory results. S/he checks on patients presenting to the emergency department with fevers and diarrhea and follows them through their hospital stay. S/he educates the patients and families regarding handwashing and isolation at home if necessary. The Infection Control Practitioner also does new employee orientation and provides inservices with all hospital staff. S/he is involved in the Environment of Care rounds in the hospital and the outpatient areas. S/he stated that the outpatient departments are resistive to have oversight by the Infection Control department of the hospital.

The Infection Control Committee meets every two months and reports to the Quality Assurance Department. There was no documentation that the Quality Director had any oversight over the Infection Control Program at the facility.

The only Infection Control documentation provided was for hand hygiene compliance for specific nursing units in 2010. There was documentation for hand hygiene compliance for all of SLVRMC (no specific area) documented for the first three months of 2011. There was no evidence that foley catheter days, hospital acquired -urinary tract infections, central line infections, hospital acquired- blood stream infections or ventilator infections were tracked, monitored or that data was documented for 2011.

The facility failed to assure that Infection Control practices were identified other than hand washing in any of the hospital units and no department quality improvement plans were initiated in any of the hospital departments or clinics.

An Infection Control log was unable to be produced and during interview with the Infection Control Practitioner, s/he verified that no log was maintained.

Based on tours/observations, staff interviews and review of facility policies/procedures and documents, the facility failure to ensure that outpatient clinic policies/procedures and usual practice regarding infection control practices, including cleaning of procedure/exam rooms and procedure instruments and scopes, were consistent with the standards and oversight provided by the infection control, surgical services and central processing departments of the facility. The failure created the potential for negative patient outcomes.

The findings were:

1. During a tour of the outpatient clinics on 6/21/11 throughout the day with physician services practice administrator, the chief nurse for outpatient services, and the chief medical officer, multiple instruments were found sitting in the sink in exam/procedure rooms. When the cabinets under the sinks were examined, the were found to be completely empty. After the tour, a member of the environment of care committee stated that the outpatient clinics have consistently been keeping basins of unknown soaking solutions for soaking used instruments. S/he stated that there had been concern about keeping the chemical solution basins in a low cabinet where patients/families, including children, might have access to the potentially harmful soaking solution. The member stated his/her belief that the staff in the clinics had removed the basins, dumped the solution and left the instruments in the sinks, prior to the surveyor arriving at the clinics so that the surveyor would not see the soaking instruments. A second member of the committee expressed similar concerns about the practice of soaking instruments under the sinks in the clinics. On 6/22/11 at approximately 11:30 a.m., during an interview with the practice administrator for physician services, s/he stated that the staff did not have soaking solutions under the sinks for used instruments, as previously reported by other staff. At approximately 2 p.m. on 6/22/11, the practice administrator returned to report that the previous information was incorrect and that s/he had since become aware that the nurses in the obstetrics/gynecology (OB/GYN) clinic were, in fact soaking instruments in a chemical solutions under the sinks in the exam/procedure rooms, as previously reported.

2. When the chief nurse for the clinics was interviewed during the tours on 6/21/11, s/he stated that the clinic did not have a policy/procedure for cleaning, soaking and processing of instruments and scopes in the clinics. No instructions for type of solution or wipes, soaking liquid dilutions instructions, soaking times, rinsing and drying and storage instructions were found posted in any of the clinic areas were used instruments/scopes were found sitting in sinks or soaking in solution in closed plastic bins. On 6/22/11 at approximately 2 p.m., the physician services practice manager provided a draft of new policy/procedure titled "Contaminated Instrument Handling and Processing," which had been drafted in response to the findings on the tour that there was no guidance for cleaning and processing contaminated instruments. The draft policy/procedure was incomplete and did not contain instructions for the types of cleaning solutions to be used, dilution of liquids or soaking times. The last section titled "Initial Decontamination:" stop with the title and no content or instructions related to initial decontamination.

3. During the tour/observation of the outpatient clinics on 6/21/11, during a tour of an exam/procedure room in the OB/GYN clinic, a diagnostic scope was found to be soaking in a covered plastic bin containing a blue liquid. The bin was sitting on the counter to the right of the sink. The clinic nurse stated that the scope was to soak in the liquid. When asked about the dilution of the chemical, s/he was unaware of a dilution ratio for solution to water. There were no posted instruction for cleaning the scope or other instruments. The chief nurse for the outpatient clinics later (at 6/22/11, at approximately 11:45 a.m.) brought a package insert for the chemical used in the cleaning, stating that the reason the nurse did not know the dilutions ratio was because the chemical was to used full-strength. The infection control nurse, who was present during this interview, stated that the specific chemical was not safe to be used full-strength because in emitted fumes that were hazardous to the health of employees exposed to the fumes. S/he stated that s/he was unaware that the chemical was being utilized in the clinics.

4. During the tour/observations of the outpatient clinics, nurses were asked about use of disinfectant wipes to clean equipment, examination tables and other surfaces. Some nurses were unfamiliar with the concept of "contact times" for using the disinfectant wipes and none were found to be aware of the actual contact time required for effective disinfection with the product they were using. During an interview with the infection control nurse for the facility on 6/22/11 at approximately 10:30 a.m., s/he stated that the use of disinfectant wipes and the concept of contact time was something s/he stressed in infection training and information s/he sent out to all staff. S/he stated that the outpatient departments were resistive to having oversight by the Infection Control department of the hospital.

5. Review of the policy/procedure manual for the outpatient clinics/"Physician Services" on 6/22/11, revealed that procedures lacked detailed or specific instructions for cleaning of equipment, instruments, scopes and exam tables and other surface to ensure that everything was clean and ready for the next patient. Review of the manual revealed the following examples of incomplete or inconsistent policies/procedures, in pertinent parts:
-"General Surgery Anoscope" policy and procedure stated the following, in pertinent parts: "...7. Clean anoscope with Asepti-zyme. 8. Clean room in usual manner."
-"General Surgery Flexible Sigmoidoscopy" policy and procedure contained no instructions for cleaning the scope after the procedure. The only other cleaning instruction was "10". Clean room in usual manner."
-"General Surgery Hemorrhoid Banding" policy and procedure stated the following, in pertinent parts: "...8. Clean anoscope and banding gun with Asepti-zyme. 9. Clean room in usual manner."
-"Guidelines for Daily Nurse Duties for Internal Medicine" contained no instructions for cleaning instruments.
-"OB/GYN IUD (Intrauterine Device) Placement and Removal" policy and procedure stated the following, in pertinent parts: "...8. Clean room and equipment in usual manner."
-"OB/GYN LEEP" policy and procedure stated the following, in pertinent parts: "Policy Statement: LEEP removes abnormal cells from the cervix. It is an office procedure performed using a wire loop, which allows an electrical current to pass through, cutting away a thin layer of the cervix....Procedure:...13. Soak speculum in alcohol....16. Clean room and remaining equipment in the usual manner."
-"Removal of Cervical Cerclage Sutures" policy and procedure stated the following, in pertinent parts: "...7. Clean room and equipment."
-"OB/GYN Colposcopy" policy and procedure stated the following, in pertinent parts: "...13. Clean room and equipment in the usual manner..."
-"OB/GYN Cryosurgery" policy and procedure stated the following, in pertinent parts: "...11. Clean room and equipment
a. Speculum and table to be cleaned in the usual manner
b. Cryo tip to be washed with metrizyme and soaked in alcohol for at least 20 minutes. DO NOT AUTOCLAVE THE TIP.
c. Use extra caution to not loose the small rubber gasket that is in-between th Cryo tip and handle."
-"Endometrial Biopsy" policy and procedure stated the following, in pertinent parts: "...13. Clean room and equipment in the usual manner..."
-"Pediatric Circumcision" policy and procedure stated the following, in pertinent parts: "...8. Clean room and equipment in the usual manner."
-"Pediatric Lesion Removal" policy and procedure stated the following, in pertinent parts: "...6. Clean room and equipment in the usual manner and dispose of sharps..."
-"Pediatric Sutures" policy and procedure stated the following, in pertinent parts: "...5. Clean up in usual manner and dispose of sharps appropriately."
-"Pediatric Toenail Removal" policy and procedure stated the following, in pertinent parts: "...7. Clean room and equipment in the usual manner."
-"OB/GYN Polyp Removal" policy and procedure stated the following, in pertinent parts: "...8. Clean room and equipment in the usual manner..."
-"Proctoscopy" policy and procedure stated the following, in pertinent parts: "3. g. Clean the proctoscope, suction tip, anoscope and all other instruments with Asepti-zyme."
-"General Surgery Punch Biopsy" policy and procedure stated the following, in pertinent parts: "...6. Clean room in usual manner and dispose of sharps appropriately..."
-"Orthopedic Staple Removal" policy and procedure stated the following, in pertinent parts: "...10. Clean room in usual manner."
-Orthopedic Suture Removal" policy and procedure stated the following, in pertinent parts: "...10. Clean room in usual manner."

6. Review on 6/22/11 of the meeting minutes for the Environment of Care Committee and the associated environmental inspections of the departments of the facility revealed that environmental tours were not inspecting all areas of the two off-site clinic complexes for safety, compliance with facility policies/procedures and regarding routine up-keep and maintenance of the clinics. The meeting minutes also reflected a failure to correct problems that were found on the environmental inspections, since the same issues, such as supplies stored on the floor, overflowing sharps containers and instruments "soaking in unknown liquids under the sinks" in procedure rooms in outpatient clinics were cited repeatedly throughout the year of tours/minutes reviewed.

Based on credential file review, review of the facility's Medical Staff Bylaws, Rules/Regulations, and staff interview, the facility failed to ensure that surgical privileges were delineated for all practitioners performing surgery in accordance with the competencies of each practitioner. The facility failed to ensure that the surgical service was able to maintain a roster of practitioners specifying the specific surgical privileges of each practitioner. Specifically, the facility granted general "core privileges" that only specified the type of practitioner (such as General Surgery, Orthopedic Surgery, etc.) category.

The findings were:

Cross Reference to A 0355: Medical Staff Privileging - for findings related to the facility's failure to ensure that practitioners were granted specific privileges when placed on the medical staff. Specifically, the facility failed to delineate what tasks/activities/procedures the practitioners were granted privileges to do.

An interview with the Interim Director of Surgical Services on 6/21/2011 at approximately 2:40 p.m., revealed that the roster of practitioners that was maintained in the surgical department included a sheet of paper for each member of the Active Medical Staff that included the same language of the core privilege request form that was included in the practitioner's credential file. There was no further delineation of what specific procedures the practitioner was granted permission to perform at the facility.

Based on the manner and degree of the deficiency cited, the facility failed to be in compliance with the Condition of Participation of Anesthesia Services. The facility failed to ensure that when the hospital furnished anesthesia services, that they were provided by a representative of the anesthesia department and the service was responsible for all anesthesia administered in the hospital.

The facility failed to meet the following standard under the Condition of Anesthesia Services:

Reference Tag A 1001 - Organization of Anesthesia Services:
The facility failed to ensure that anesthesia was administered only by a qualified anesthetist. Specifically, the facility allowed nurses in the Emergency Department (ED) to administer a general anesthetic for minor procedures without an anesthetist present. Furthermore, the nurses that were administering the anesthetic had no documented training/competencies on the performance of procedural sedation. This failure had the potential to cause patient harm.

Based on review of the facility's policies/procedures, medical record review, personnel file review, and staff interview the facility failed to ensure that anesthesia was administered only by a qualified anesthetist. Specifically, the facility allowed nurses in the Emergency Department (ED) to administer a general anesthetic for minor procedures without an anesthetist present. Furthermore, the nurses that were administering the anesthetic had no documented training/competencies on the performance of procedural sedation. This failure had the potential to cause patient harm.

The findings were:

An interview with the facility's Director of Emergency Services on 6/20/2011 at approximately 1:30 p.m., revealed that when procedures within the ED required sedation, nurses within the ED administered and monitored the patients unless propofol (a general anesthetic) was given. S/he stated that if propofol was to be given, then a Certified Registered Nurse Anesthetist (CRNA) would come down to the department to administer the medications and monitor the patient.

An interview with the Director of Anesthesia Services on 6/21/2011 at approximately 12:45 p.m., revealed that CRNAs are not always involved in the administration of propofol in the ED. S/he stated that over the previous weekend, a patient in the ED received propofol for a shoulder reduction procedure and that a RN gave the propofol.

A review of sample patient #22's medical record on 6/21/2011 revealed the following, in pertinent parts:
The patient was an adult that presented to the ED on 6/18/2011 at approximately 8:17 a.m. with shoulder pain after a fall. S/he was diagnosed with an anterior shoulder dislocation and the physician performed a closed reduction with nurse administered propofol at approximately 9:30 a.m. Documentation by the RN that administered the propofol stated that 50 mg of propofol was administered at approximately 9:44 a.m. The patient was discharged home at approximately 11:45 a.m.

A review of the personnel file of the nurse that administered propofol revealed that the file did not contain documentation of demonstrated competency or education for the administration of anesthesia or conscious sedation.

An interview with the facility's Director of Emergency Services on 6/22/2011 at approximately 10:30 a.m., revealed that s/he was not aware that nurses in the ED were administering propofol and that the nurses in the ED did not have any documented education on the administration of conscious sedation. When asked if the ED had a policy on conscious sedation, s/he stated that the ED did not have such a policy.

A review of the facility's policies/procedures revealed that an Anesthesia Department policy existed titled "Sedation" that was last revised 10/10/10. The policy stated, in pertinent part:
"...It is the policy at SLV Regional Medical Center that these guidelines apply to all locations in the hospital where moderate and deep sedation is administered (specific departments described at end of this policy).
Only licensed independent practitioners (CRNA's) that are trained in professional standards and techniques to administer pharmacologic agents to predictably achieve desired levels of sedation and to monitor patients carefully in order to maintain them at the desired level of sedation, will provide sedation...
Specified Departments:
Surgery
Anesthesia
Outpatient Surgery/GI Laboratory
Imaging/Radiology
Emergency Department..."

The facility's Chief Nursing Officer provided a facility policy to the surveyors on 6/22/2011 at approximately 11:00 a.m., that was from the "GI LAB Policy and Procedure" manual that was titled "Intravenous Conscious Sedation (IVCS)." The policy did not have a policy number, effective date, review date, or final approval indicated in areas provided for such. The policy did, however, state in pertinent parts:
"Purpose: To provide guidelines for monitoring and management of patients receiving intravenous conscious sedation for invasive, manipulative or constraining procedures including...dislocation reduction...at San Luis Valley Regional Medical Center...
Procedure:
1. IVCS will be supervised by a physician or dentist credentialed for the specific procedure and for administration of IVCS...
5. A physician (other than the procedurist) RN or EMP-Paramedic (with ACLS experience) will continuously monitor the patient throughout the procedure...
6. A physician, dentist, CRNA may order the medications used in IVCS...
7. A physician, dentist, RN, or EMT-Paramedic trained in IVCS will administer IVCS...
Definitions
Intravenous conscious sedation (IVCS) is the administration of parenteral drugs such as narcotics and short acting benzodiazepines...
This policy does not apply to light sedation...or deep sedation..."

According to the United Stated Food and Drug Administration (http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019627s045lbl.pdf) the approved labeling for Diprivan/propofol contained the following warning: "...For general anesthesia or monitored anesthesia care (MAC) sedation, DIPRIVAN Injectable Emulsion should be administered only by persons trained in the administration of general anesthesia and not involved in the conduct of the surgical/diagnostic procedure..."

Based on the manner and degree of the deficiency cited, the facility failed to be in compliance with the Condition of Participation of Outpatient Services.

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

Reference Tag A 1077 Integration of Outpatient Services
The facility failed to ensure that outpatient services were appropriately organized and integrated with inpatient services, particularly in the areas of infection control, nursing, pharmacy, laboratory, medical records, preventive maintenance and environment of care rounds.

Reference Tag A 1079 Outpatient Services Personnel
The facility failed to ensure that the outpatient services department was accountable to a single individual who directs the overall operation of the hospital's entire outpatient services (all locations, all outpatient services).

Based on tours/observation, review of facility documents staff/physician interviews, the hospital failed to ensure that outpatient services were appropriately organized and integrated with inpatient services. The failure created the potential for negative patient outcomes.

The findings were:

Reference Tag A 386 - Nursing Services - Organization of Nursing - for findings related to the failure to ensure that nursing care and policies/procedures in the outpatient clinics were consistent with the standards and oversight provided by the organization of nursing for the facility.

Reference Tag A 442 Medical Records - Security of Records - for findings related to the failure to ensure that outpatient clinic medical record security and storage policies/procedures and usual practice were consistent with the standards and oversight provided by the medical records department for the facility.

Reference Tag A 505 Pharmaceutical Services - Unusable Drugs Not Used - for findings related to the failure to ensure that outpatient clinic policies/procedures and usual practice regarding medications that were expired, unsafely stored or otherwise unsafe for patient use were consistent with the standards and oversight provided by the pharmacy services department of the facility.

Reference Tag A 582 Laboratory Services - Adequacy of Laboratory Services - for findings related to the failure to ensure that outpatient clinic policies/procedures and usual practice regarding laboratory equipment, supplies and handling of specimens were consistent with the standards and oversight provided by the laboratory services department of the facility.

Reference Tag A 724 Physical Environment - Facilities, Supplies and Maintenance - for findings related to the failure to ensure that outpatient clinic supplies and equipment were inspected for safe storage, expiration dates and that preventive maintenance inspections were conducted to ensure patient safety.

Reference Tag A 756 Infection Control - Leadership Responsibilities - for findings related to the failure to ensure that outpatient clinic policies/procedures and usual practice regarding infection control practices, including cleaning of procedure/exam rooms and procedure instruments and scopes, were consistent with the standards and oversight provided by the infection control, surgical services and central processing departments of the facility.

Review on 6/22/11 of the meeting minutes for the Environment of Care Committee and the associated environmental inspections of the departments of the facility revealed that environmental tours were not inspecting all areas of the two off-site clinic complexes for safety, compliance with facility policies/procedures and regarding routine up-keep and maintenance of the clinics. The meeting minutes also reflected a failure to correct problems that were found on the environmental inspections, since the same issues, such as supplies stored on the floor, overflowing sharps containers and instruments "soaking in unknown liquids under the sinks" in procedure rooms in outpatient clinics were cited repeatedly throughout the year of tours/minutes reviewed.

Based on staff interviews and review of facility documents, the facility failed to ensure that the outpatient services department was accountable to a single individual who directs the overall operation of the hospital's entire outpatient services (all locations, all outpatient services).

The findings were:

Based on review of the organization chart on 6/21/11, the outpatient services were divided between at least three different managers. The organizational chart, which was labelled as an "Interim" document identified that physician services, all imaging services, inpatient and outpatient therapy services, all laboratory services and all cardiopulmonary services were under the vice president for physician and financial services.

The inpatient and outpatient surgery, women's services (including genetic counseling clinic), oncology (including outpatient infusion clinic) and clinical education (including diabetic clinic) were under the chief nursing officer.

Review of the pamphlet "Physician Services" revealed that physician services included the following outpatient clinics: Allergy, Audiology, Cardiopulmonary, ENT (Ear, Nose and Throat), General Surgery, Oncology/Infusion Therapy, Obstetrics/Gynecology, Pediatrics, Wound Care, Behavioral Health, Chiropractic Care, Family Practice, Internal Medicine, Occupational Medicine, Orthopedic Surgery, Physical Medicine and Rehabilitation.
Note: The family practice clinic complex in the town 15 miles from the main campus was not included in the pamphlet because it was recently acquired. Per interview with the administrator of the physician services on 6/20/11 at approximately 2 p.m., the clinic also contained a radiology department and a satellite phlebotomy site that the hospital had maintained at that location, even when the complex was physician-owned. The administrator also clarified during the outpatient clinics tour on 6/21/11 that the oncology/infusion center was not under physician services, but instead reported to the chief nursing officer. The administrator also clarified that the physical therapy, occupational therapy and speech therapy were under a therapies director that reported to the vice president for physician and financial services. The administrator also stated that outpatient services such as surgery, laboratory and imaging were not under the physician services.

During an interview with the vice president of physician and financial services, s/he stated that many of the clinics were currently under his/her responsibility on a temporary basis, because the current chief operating officer had taken on other responsibilities for quality and acting CEO (chief executive officer) of an affiliated Critical Access Hospital, so those reporting departments had been temporarily delegated to him/her. S/he acknowledged that not one single person was responsible for all of the outpatient services, as required.

Based on facility policies/procedures, staff interview, review of documents/personnel files, the facility failed to ensure that its Director of Rehabilitation maintained proper supervision and administration of the services. Specifically, the Director did not maintain ongoing meeting minutes and evidence of departmental education, conduct staff evaluations per the facility's policy/procedure, and ensure treatment plans were in place when speech therapy care was provided. These failures created the potential for a negative patient outcome.

The findings were:

The "Physical Therapy Director Job Description," located in the Director's personnel file, stated the following, in pertinent part: "Essential Duties, Function and Responsibilities: ...Supervise certified athletic trainers, certified occupational therapist assistants, occupational therapist, physical therapists, physical therapist assistants, program coordinators/directors, rehab services aides, secretarial staff, speech language pathologists, students... Provide knowledge, leadership, administrative guidance and advice in the day-to-day management of therapy programs."

1. The Rehabilitation Policy titled "PI Process for Rehabilitation," with an effective date of 8/1/05, stated the following, in pertinent part: "3. Competencies will be assessed using the discipline specific form for self assessment. Each discipline will identify areas of concern. Resources for training and competency evaluation will be identified and documented. 4. The scope of services document will be reviewed annually and the rehab department will follow the procedure for updating this document as outlined in the document..."

An interview with the Director of Inpatient Rehabilitation Services was conducted on 6/21/11 at approximately 3:00 p.m. When asked about the education provided to staff, s/he stated that, due to the budget plan, education primarily came from team meetings where "the staff put on presentations." When asked further about what education the Director provides to staff, s/he stated, "What I do is provide the CEUs (Continued Education Units) postings for everyone... People go to courses on their own." When asked further about topics covered in the monthly staff meetings, s/he stated, "I address the recovery plan, daily staffing reports, issues, department needs, and students present different things." Neither after the entrance conference nor at the time of the interview was the Director able to provide documentation of meeting minutes or education provided to staff.

In an additional interview with the Director on 6/22/11 at approximately 4:35 p.m., s/he provided documentation of meetings and education dates. When asked where the documentation was gathered and formulated from, s/he stated, "I got it from my notebook and other notes the Team Lead had. Some of it I had from before that I showed you this afternoon." It was discovered that the Director became Interim Manager in spring of 2010 and accepted the Director position in August of 2010.

The documentation provided included agendas, topics, brief minutes, or extended minutes from 16 meetings held over the past year, with the first on 4/14/10 and the most recent on 6/16/11. Staff education was documented to have been provided on the following dates: 5/26/11, 5/19/11, 5/12/11, 4/28/11, 8/10/10, 8/4/10, 7/28/10, 6/24/10, and 5/6/10. However, no notes or information on the education provided could be obtained. Additionally, the staff did not sign in for any of the documented meetings.

2. The Rehabilitation Policy titled "Rehabilitation Policy and Procedure" stated the following, in pertinent part: "The Rehabilitation Department will assess staff competencies with complete reassessments due every three years. Portions of the competency assessment will be completed each year."

In the interview with the Director of Inpatient Rehabilitation Services on 6/21/11 at approximately 3:00 p.m., s/he was asked about evaluation of staff and chart audits. The Director stated that s/he did not conduct chart audits on inpatients and that formal staff evaluations were not conducted by the Director. In an additional interview with the Director on 6/22/11 at approximately 4:35 p.m., s/he stated that s/he would begin going the competency evaluation of staff as stated in the policy going forward.

Review of two Rehab providers' personnel files revealed that an annual "SLVRMC Performance Appraisal" was annually conducted and documented on each. However, these hospital-wide appraisals did not address "competencies."

3. The Rehabilitation Policy titled "Evaluations/Assessments" stated the following, in pertinent part: "Each evaluation will included short and long term goals for treatment, a treatment plan, and frequency, intensity and duration of treatment... Who is responsible: Registered or Licensed PT, OT and/ or SLP." When this policy was brought to the attention of the Director, s/he stated that it referenced "outpatient" rehab care.

In the interview with the Director of inpatient Rehabilitation Services on 6/21/11 at approximately 3:00 p.m., s/he was asked if all disciplines formulate written treatment plans, which include the type, amount, frequency, duration, and goals expected of the treatment. The Director was the sole provider of Speech Therapy at the facility and s/he stated, "I don't see long-term treatment of ST [very often]. I would document it in the progress notes, not on the printed form." In an additional interview with the Director on 6/22/11 at approximately 4:35 p.m., s/he stated that s/he had not used a printed form or structured treatment plan at any of the previous hospitals s/he had worked.

An additional Rehabilitation Policy was reviewed, titled "Treatment Plans." It stated the following, in pertinent part: "2. Each Treatment Plan shall be completed for meeting the specific documentation criteria required for the served patient population... Acute inpatients will require following the documentation guidelines for APIE... 3. Long and short-term goals shall be based on the patient's needs and preferences. 4. Long-term goals shall reflect the patient's expected functional status at recertification or discharge. 5. Goals shall be objective, measurable, time-referenced, and meaningful to the patient. 6. All documentation shall be completed on approved forms. 7. Treatments shall consist of modalities and interventions that are within the scope of practice for each discipline and shall be within the guidelines for use as regulated by the APTA, AOTA, ASHA, JCAHO, and CMS."