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Based on observation, interview, and record review, the facility's Governing Body (GB) failed to ensure the hospital's operation was conducted in an effective, safe, and organized manner by failing:

1. To ensure the organization and accountability of the Medical Staff to the Governing Body; and to ensure the medical staff was accountable to the GB for the quality of patient care provided at the facility (Refer to A048, A049, A338 A340, A347, A358);

2. To ensure nursing services and operations were provided in a safe and effective manner that would meet the patients' needs ( Refer to A385, A392, A395, A396, A397, A398, A405);

3. To ensure provision of pharmacy services were provided in a safe and effective manner to meet the patients' needs (Refer to A490, A500, A502, A503, A505);

4. To ensure a sanitary environment was maintained and an active program was in place to prevent infections for all patients (Refer A747, A749);

5. To ensure Surgical Services were provided in accordance with the facility policies and procedures and standards of practice (Refer to A940, A951); and

6. To ensure Anesthesia Services were provided in a well-organized manner under the direction of a qualified doctor of medicine or osteopathy (Refer to A1000, A1005).

The cumulative effect of these systemic problems resulted in failure of the Governing Body to ensure patients were receiving quality care in a safe and effective manner.

Based on observation, interview and record review, the facility's medical staff failed to submit a change in the rules and regulations to the Governing Body for approval. The Governing Body was unaware Emergency Department (ED) Physicians were required to contact the Chief of Staff prior to transferring a patient from the emergency department.

Findings:

On May 13, 2013, at 11 a.m., a tour of the facility's ED was conducted with the Chief Nursing Officer (CNO). The ED contained six patient care beds. Two patients were waiting for transfers to acute psychiatric facilities. All six beds were occupied.

In an interview with MD 8 on May 13, 2013, at 12:10 p.m., MD 8 stated the current ED physicians' contract was no longer valid, as the physician's group was concerned about requirements for patient transfers. MD 8 stated a new policy to notify the Chief of Staff prior to any patient transfer with an ETA (estimated time of arrival) transport greater than five minutes was implemented. According to MD 8, every transfer would require a call to the Chief of Staff, as all transport arrivals were more than five minutes away. MD 8 stated the mode of transfer for an ED patient should be determined by the transferring ED physician.

On May 16, 2013, at 7:40 a.m., a second tour of the ED was conducted. Staff 40 stated the newly admitted patient might need to be transferred to another facility.

In an interview with MD 9, on May 16, 2013, at 7:45 a.m., the MD stated, "Patients should be transferred in the quickest/safest way possible."

During an interview with Staff 40, on May 16, 2013, at 7:45 a.m., Staff 40 stated there was a new policy that required the Chief of Staff be notified about patient transport to another facility.

A Memorandum dated May 3, 2013, was reviewed. The memorandum addressed to "All ER Physicians," indicated "[Name of transfer company] transfer was arranged for a STEMI (heart attack that requires immediate intervention that can not be done at the facility) patient using (name of transport). An ETA of 22 minutes was originally given and immediately modified to 18 minutes by (name of transport). The actual length of time it took (name of transport) to arrive at the facility was 36 minutes which was double the final ETA provided. At the time that this transfer was arranged, there was a fixed wing available with an ETA of 5 minutes. Physicians who arrange a transfer using an undependable transfer agency causing a delay in patient care will be held responsible for the delay in care."

A second memorandum addressed to ED staff indicated: "When calling transport agencies for transport of a patient to another facility, if the estimated time of arrival given is more than five minutes the Chief of Staff must be notified. If the Chief of Staff is not available the Vice Chief of Staff should be contacted and notified. Please contact Nursing Administration with any questions you may have."

In an interview with the Chief Executive Officer (CEO) on May 16, 2013, at 11 a.m., the CEO stated the facility did not have a contract with a specific transportation company.

During an interview with two members of the Governing Body, on May 16, 2013, at 11 a.m., one member withdrew herself from the meeting due to a possible conflict, the other indicated there were issues with transports due to the closure of the helipad. The board member indicated she was unaware of the new rule regarding transports from the ED.

The facility's contract titled "Emergency Department Agreement," indicated it was an agreement between the emergency physician's medical group and the facility. In section 2.5 "Rules and Regulations. Professional services are to be rendered in accordance with Hospital's standards of quality and efficiency, California law, Medical Staff and Hospital bylaws, rules and regulations, policies and procedures and standards of practice in the community. Physicians shall at all times comply with the provisions of EMTALA [Emergency Medical Treatment and Labor Act] and applicable state law."

Federal EMTALA regulations at CFR 489 .24 (e) indicated a patient transfer from one facility to another, "is effected through qualified personnel and transportation equipment, as required, including the use of necessary and medically appropriate life support measures during the transfer."

On May 16, 2013, the facility's "Health Care District Bylaws," with a last revised date of January 28, 2009, were reviewed. In Article VIII, Medical Staff, it indicated the bylaws, rules and regulations would be periodically reviewed for consistency with Hospital policy and applicable legal or other requirements.

Based on interview and record review, the Governing Body/Board (GB) failed to ensure:

1. An effective Medical Staff peer review process was in place;
2. There was documented evidence of actions taken regarding peer review cases; and
3. The Medical staff was accountable to the GB for quality of patient care.

These failures increased the risk of poor health and safety outcomes for all facility patients.

Findings:

A review of the facility Quality Improvement Plan 2013 indicated, "The Medical Executive Committee (MEC)... evaluates the performance of individuals with delineated clinical privileges. Receives, reviews, and acts upon organization wide and clinical department specific performance improvement findings from committees and is accountable to the Governing Board for the overall quality of clinical care."

The facility policy, dated March 2010, and titled, "Peer Review," was reviewed. The policy indicated, "The Medical Staff of [facility name] conducts peer review as part of its quality improvement activities, which include: 1) use of operative and other procedures (through surgical case review), 2) medical assessment of patients and treatment of patients (through medical record review, utilization review and mortality review functions), 3) significant departures from established patterns of clinical practice (quality improvement reports, utilization review and physician profiles)... If significant patterns of inappropriate care are identified through quality improvement activities, the volume of records reviewed for the specific physician involved is increased to 100% to determine the extent of the problem."

During the inspection of a Peer Reviewer Final Report, completed by an outside reviewer on October 25, 2012, it was noted that the consultant reviewed three adverse patient events that involved the same physician (MD 1).

During inspection of the Peer Review Committee Meeting Minutes dated March 26, 2013, it was noted that there was no documented evidence that any action was recommended or taken by the committee for 30 (including 11 fatalities) peer review cases presented. Also, there was no documented evidence that the three cases (mentioned above), evaluated by an outside reviewer as medically unnecessary and not meeting the standard of care (quality), were addressed in the Peer Review Committee Meeting minutes.

Further review of the meeting minutes indicated that the committee Action/Recommendation for 30 cases reviewed was "Care and management was found to be appropriate- no further action required" or "Tabled for further review." This included the 11 mortality cases that were reviewed.

The only exception came when MD 1 presented three Anesthesia Referrals regarding the same anesthesia provider (MD 2), because he reportedly "refused to complete anesthesiology" on three patients. For these three cases, "The committee voted to approve a referral to the MEC (medical executive committee) for a six month track and trend on MD 2 in a previous motion."

A review of the medical records for the three Anesthesia Referrals (Patients 20, 21, and 22) indicated that an Anesthesia note was written for each patient, and the reason for delay or canceling of the operative case was explained as follows:

Patient 20, had anemia (low blood cell count) and was on a blood thinning medication that put him at risk for excessive bleeding. For safety reasons, the Anesthesiologist postponed the surgery until these conditions could be corrected. Per the medical record, Patient 20 also had heart problems and was transferred to another hospital for care.

Patient 21 had kidney and heart disease and the Anesthesiologist postponed surgery to allow time for the patient to be seen by a cardiologist and to be started on a beta blocker (heart medication). Per the medical record, Patient 21 was transferred to another hospital for care.

Patient 22 required a procedure, but had recently eaten, so the surgery was postponed to allow for the patient's stomach to be empty before surgery. Per the medical record, after waiting eight hours Patient 22 was taken to the Operating Room and surgery was performed safely.

A review of the Regular Board of Directors Meeting Minutes for the last three meetings (March 13, 2013, March 27, 2013, and April 10, 2013) indicated no documented evidence that any peer review information was requested by, or discussed with the Governing Body/Board.

During an interview with Governing Body/Board (GB) members, on May 16, 2013, at 10:40 a.m., they were asked, what their main concerns were. They stated they were concerned about "patient care, and policies and procedures," and making sure they were followed. One GB member stated she meets with the CEO weekly for updates, and to discuss and/or validate concerns that have been brought to her attention. When asked if they were aware of the negative external peer review reports regarding MD 1, one GB member stated she was aware and the other was not. When asked, the GB members stated the peer reviews had not been discussed at a GB meeting. When the GB was asked how they are holding the MEC (medical executive committee) accountable, the first response was, "We put it to a vote." Then the GB added, they were told the CEO is responsible for everybody, and expected him to fix it, then inform the GB. They thought the CEO was responsible for the result.

A letter addressed, "To our Community," signed by MD 5, Ethics Committee Chairman and MD 3, MEC Secretary (of the facility) was reviewed. The letter indicated, "Every hospital in the United States (including name of facility) must have a self-governing MEC (Medical Executive Committee) that is not beholden to the Board (Governing Body), so as to prevent any undue influence on them as to the quality of patient care. The MEC is required to review and evaluate the quality of care provided by its members, as long as it is kept absolutely confidential. The MEC is responsible to monitor and debate physicians' performance in order to protect the community. The MEC cannot debate these issues in public unless the physician waves these confidentiality rights. Our hospital physicians and the MEC have done almost everything that the (name of facility) Hospital Board has asked of them in the last four years..." The letter also indicated, "This lack of leadership by the Board and the CEO has cost the Hospital.. "

Based on observation, interview and record review, the facility Governing Body/Board (GB) failed to evaluate and ensure the quality of the linen provided to the facility by a contracted service. This practice increased the risk of a poor health outcome for all facility patients.

Findings:

1. During a tour of the surgical area on May 13, 2013, at 11:05 a.m., the Operating Room nurses' dressing room was observed to have very few surgical scrub pants and shirts available for staff use. There appeared to be less than ten pieces of surgical scrub clothing available to the surgical staff. During a concurrent interview, this finding was confirmed by Staff 2.

2. During a surgical case observation on May 14, 2013, at 8:10 a.m., it was observed that the Operating Table was draped with a folded sheet that had a three centimeter hole torn into the lower portion of the sheet. This observation was confirmed by the Staff 48.

A review of the facility Quality Improvement Plan 2013 indicated, "The Governing Board of [facility name] Acts strategically to ensure the delivery of high quality care and services."

During an interview with two Governing Body members, on May 16, 2013, at 10:40 a.m., they were asked if they were aware of the condition of some of the linen being used in the OR, (such as holes in the sheets), and that there were very few surgical scrubs available to the Operating Room staff. The GB members stated they were not aware of these concerns. When asked if the GB has evaluated the quality of the linen service, the GB responded, "No."

The facility policy and procedure titled "Evaluation of Patient Care Contract Services," with no effective or reviewed date, was reviewed on May 15, 2013. The policy indicated its purpose was to establish the organization's oversight of care, treatment, and services provided through contractual arrangements to patients, clients or residents. The policy indicated "when contractual agreements are renegotiated or terminated, the organization will assure that continuity of patient care is maintained." The policy indicated: "Contracted entities shall be evaluated in relation to the expectations placed upon them by the organization. In general, evaluations should be conducted on an annual basis; however longer or shorter time frames may be allowed based on the history and performance level of the entity."

Based on interview and record review, the facility failed to ensure a prompt resolution for two of three patient grievances reviewed (Patients A and B). This resulted in grievances not being investigated/resolved for greater than 60 days.

Findings:

On May 15, 2013, at 8:30 a.m., an interview was conducted with Staff 37 and Staff 38 in regards to the facility's grievance process.

a. The "Complaint & Grievance Log" for March 2013, was reviewed and indicated the following:

- Patient A's family member filed a grievance on February 20, 2013, in regards to Patient A's treatment in the Emergency Department (ED) and the ordering and administration of a medication which Patient A and Patient A's family member stated was contraindicated based on Patient A's medical condition. The date of response was February 23, 2013, and the grievance was resolved.

During a concurrent interview with Staff 37 and 38, they stated additional conversations had occurred with Patient A and his family member on April 11, 18, and 26, 2013, because they were not satisfied with the facility's investigation and response. Staff 38 stated no written notice had been sent to Patient A/Patient A's family member when the complaint was received on February 23, or when the investigation was closed on April 26, 2013. In addition, Staff 38 stated the grievance had not been sent to medical staff peer review even though the grievance involved the ordering and administration of a medication that the patient and the patient's family told the physician was contraindicated based on Patient A's medical condition.

Patient A's family member filed a grievance with the facility eighty four (84) days prio to the review, and no written notice of investigation process/resolution had been sent to Patient A/Patient A's family member.

b. The "Compliant & Grievance Log" for April 2013, was reviewed and indicated the following:

- Patient B's family member filed a grievance on April 28, 2013, in regards to Patient B's care and treatment in the Emergency Department (ED). Patient B's family member stated Patient B was discharged and the next day Patient B went to another acute care facility where surgery was performed. The facility responded to the grievance on April 30, 2013, and the grievance was not resolved.

During a concurrent interview with Staff 37 and 38, they stated the grievance was actually received by Staff 39 on February 8, 2013 (not on April 28, 2013, as documented on the log), and she notified the Quality Department of Patient B's grievance. Staff 38 stated she contacted Patient B's family member for the first time on May 1, 2013, about their concern with the care and treatment provided by the ED when Patient B was seen on December 28, 2012, and discharged. Staff 38 stated no written response had been sent to Patient B/Patient B's family member when the complaint was received, and the grievance was not closed. In addition, Staff 38 stated the grievance was not sent to medical staff peer review even though the grievance involved the physician's care and treatment, and the physician's decision to discharge Patient B home.

Patient B's family member filed a grievance with the facility ninety six (96) day ago, and no written notice of investigation process/resolution was sent to Patient B/Patient B's family member.

The facility policy and procedure titled "Patient Grievance Process" last reviewed/revised December 2009, revealed "... A complaint is considered resolved when the patient is satisfied with the actions taken on his/her behalf. All grievances receive immediate priority and must be investigated with efforts made toward resolution within 24 hours. ... This organization will make every attempt to provide a response within seven (7) days of receiving a grievance. ... The patient will be provided with written notice of: The name of the Quality Manager/Patient Advocate; The steps taken to investigate and resolve the grievance; The final result of the grievance; and The date of grievance completion. ..."

On May 16, 2013, at 10:40 a.m., an interview was conducted with members of the Governing Board. They stated they were not aware the Governing Board must delegate in writing the grievance process to a facility Grievance Committee if the Governing Board was not handling the grievance process themselves; there were grievances greater than 60 days old without a complete investigation and a response back to the patient/patient's responsible party of the facility's investigation or completed investigation; and the facility was not following their policy and procedure for the investigation and written response requirements to the patient/patient's responsible party.

Based on interview and record review, the facility failed to provide the patient/patient's responsible party with written notice of its resolution of the grievance that contained the name of the facility contact person, the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process, and the date of completion for one of two sampled grievances which had been closed (Patient A). This resulted in Patients A/Patient A's responsible party not being informed, in writing, who to contact if they had further concerns, steps taken in the investigation of their grievances, the results of the grievance process, and the completion date.

Findings:

On May 15, 2013, at 8:30 a.m., an interview was conducted with Staff 37 and Staff 38 in regards to the facility's grievance process.

The "Complaint & Grievance Log" for March 2013, was reviewed and indicated Patient A's family member filed a grievance on February 20, 2013, in regards to Patient A's treatment in the Emergency Department (ED) and the ordering and administration of a medication which Patient A and Patient A's family member stated was contraindicated based on Patient A's medical condition. The date of response was February 23, 2013, and the grievance was resolved.

During a concurrent interview with Staff 37 and 38, they stated additional conversations had occurred with Patient A and his family member on April 11, 18, and 26, 2013, because they were not satisfied with the facility's investigation and response. Staff 38 stated no written notice had been sent to Patient A/Patient A's family member when the complaint was received on February 23, 2013, or when the investigation was closed, April 26, 2013.

Patient A's family member filed a grievance with the facility eighty four (84) days prior to the interview, and no written notice of investigation process/resolution was sent to Patient A/Patient A's family member.

The facility policy and procedure titled "Patient Grievance Process" last reviewed/revised December 2009, revealed "... A complaint is considered resolved when the patient is satisfied with the actions taken on his/her behalf. All grievances receive immediate priority and must be investigated with efforts made toward resolution with 24 hours. ... This organization will make every attempt to provide a response within seven (7) days of receiving a grievance. ... The patient will be provided with written notice of: The name of the Quality Manager/Patient Advocate; The steps taken to investigate and resolve the grievance; The final result of the grievance; and The date of grievance completion. ..."

On May 16, 2013, at 10:40 a.m., an interview was conducted with members of the Governing Board. They stated they were not aware the Governing Board must delegate in writing the grievance process to a facility Grievance Committee if the Governing Board was not handling the grievance process themselves; there were grievances greater than 60 days old without a complete investigation and a response back to the patient/patient's responsible party of the facility's investigation or completed investigation; and the facility was not following their policy and procedure for the investigation and written response requirements to the patient/patient's responsible party.

Based on interview and record review, the facility Quality Assessment and Performance Improvement Program (QAPI) failed:

1. To ensure the Grievance Committee investigated, promptly resolved, and responded to the patient/patient's responsible party in writing per the facility's policy and procedure. (Refer to A118 and A123); and

2. To ensure the facility's compliance with the "Organ/Tissue/Eye Procurement Program" included obtaining the facility's statistics from the Organ Procurement Organization (OPO), comparing the statistics with death records, determining areas for improvement, and providing education to the staff.
(Refer to A891 and A892).

Findings:

On May 16, 2013, at 9 a.m., an interview was conducted with Quality Council Members.

When asked if the Quality Council Members were aware the Grievance Committee had grievances from patients/patients' responsible parties that were received by the facility greater than 60 days ago, the Quality Council Members responded by stating they were not aware there were grievances that had not been investigated and responded to for over 60 days.

When asked if the Quality Council Members were aware the facility had not provided the patients/patients' responsible parties with written notice of the facility's investigation or the facility's progress on the grievance investigation, the Quality Council Members responded by stating they were not familiar with the grievance process requirements and were not aware that there were any concerns.

When asked if the Quality Council Members had received information/quality data on the facility's "Organ/Tissue/Eye Procurement Program," the Quality Council Members responded by stating no data/statistics for compliance with the "Organ/Tissue/Eye Procurement Program" had been reported to the Quality Council Committee.

Based on interview and record review, the facility failed to ensure the Medical Staff was organized and accountable to the Governing Body/Board by failing to:

1. Ensure there was documented evidence of current competencies for two of four physician files reviewed (Refer to A340);

2. Ensure complete assessment at time of reappointment for one out of four physician credential files reviewed (Refer to A340);

3. Ensure an effective peer review process was in place and the Medical Staff was accountable to the Governing Body/Board (Refer to A347); and

4. Ensure there was documented evidence of actions taken regarding peer review cases (Refer to A347).

The cumulative effect of these practices increased the risk of substandard quality of care for all hospital patients.

Based on interview and record review the facility failed to ensure there was documented evidence of:

1. Current competencies for two of four physician credential files reviewed (MD 8 and MD 9); and
2. A complete assessment at time of reappointment to the medical staff for one of four physicians (MD 6).

Findings:

A review of the facility Medical Staff By-Laws dated September 28, 2010, indicated under 6.2-2 "Requests for clinical privileges shall be evaluated on the basis of the member's licensure, education, training, experience and current demonstrated professional competence and judgment, clinical performance, current health status, and the documented results of patient care and other quality review and monitoring which the medical staff deems appropriate." Further review of the facility Medical Staff By-Laws indicated under 5/5-1(c) Application Form, "peer references familiar with the applicant's professional competence and ethical character;"

1. A review of physician credential files on May 16, 2013, at 8:05 a.m., with Staff 16, indicated there was no documented evidence of current competencies for MD 8 at the time of reappointment to the medical staff on March 28, 2013. Further review indicated, the credential file for MD 9 also did not contain documented evidence of current competencies.

During a concurrent interview, Staff 16 confirmed the absence of current competencies for both MD 8 and MD 9.

2. A review of the credential file of MD 6 on May 14, 2013, at 3:20 p.m., and 4:30 p.m., with Staff 37, contained two letters of recommendation from MD 1 and MD 7, supporting his reappointment on January 25, 2012. The letters of recommendation included questions about the applicant such as, "To your knowledge, has the applicant been involved in any professional liability suits (including claims made, pending, settled or decided)?" Both letters of recommendation from MD 1 and MD 7, signed and dated January 17, 2012, indicated, "No." However, upon further inspection of MD 6's file, it was noted there were two prior allegations against MD 6, dated 2004 and 2009. Upon inspection of the form titled, "California Participating Physician Application Addendum B, The Professional Liability Action Explanation" form, dated May 1997, MD 6 indicated that for the 2009 allegation, he checked the box "Lawsuit/arbitration was settled and payment made on my behalf" and the form was signed by MD 6 and dated December 17, 2011.

Based on interview and record review, the facility failed to ensure an effective Medical Staff peer review process was in place; there was documented evidence of actions taken regarding peer review cases; and the Medical Staff was accountable to the Governing Body/Board for quality of patient care.

This failure increased the risk of poor health and safety outcomes for all facility patients.

Findings:

A review of the facility Medical Staff By-Laws, dated September 28, 2010, indicated under Peer Review Committee 11.5-2 "The duties and responsibilities of the peer review committee shall be: to evaluate and improve the quality of care provided to hospital patients; to conduct patient care reviews for the purpose of analyzing and evaluating the quality and appropriateness of care and treatment provided by members of the medical staff holding clinical privileges and any allied health practitioners; to identify system problems requiring process improvement activities and refer such identified concerns to the performance improvement committee; and to submit written reports to the Medical Executive Committee concerning quality assessment and performance improvement activities and actions taken."

The facility policy, dated March 2010, and titled, "Peer Review", was reviewed. The policy indicated, "The Medical Staff of [name of entity] conducts peer review as part of its quality improvement activities, which include: 1) use of operative and other procedures (through surgical case review), 2) medical assessment of patients and treatment of patients (through medical record review, utilization review and mortality review functions), 3) significant departures from established patterns of clinical practice (quality improvement reports, utilization review and physician profiles)... If significant patterns of inappropriate care are identified through quality improvement activities the volume of records reviewed for the specific physician involved is increased to 100% to determine the extent of the problem."

A review of the facility Quality Improvement Plan 2013 indicated, "The Medical Execute Committee (MEC)... evaluates the performance of individuals with delineated clinical privileges. Receives, reviews, and acts upon organization wide and clinical department specific performance improvement findings from committees and is accountable to the governing Board for the overall quality of clinical care.

During the inspection of a Peer Reviewer Final Report, completed by an outside reviewer on October 25, 2012, it was noted that the consultant reviewed three adverse patient events that involved the same physician MD 1.

During inspection of the Peer Review Committee Meeting Minutes dated March 26, 2013, it was noted that there was no documented evidence that any action was taken or recommended by the committee for 30 (including 11 fatalities) peer review cases presented. Also, there was no documented evidence that the three cases, evaluated by an outside reviewer as medically unnecessary and not meeting the standard of care (quality), were addressed in the Peer Review Committee Meeting minutes.

Further review of the meeting minutes indicated that the committee Action/Recommendation for 30 cases reviewed was "Care and management was found to be appropriate- no further action required" or "Tabled for further review." This included the 11 mortality cases that were reviewed.

The only exception came when MD 1 presented three Anesthesia Referrals regarding the same anesthesia provider (MD 2), because he reportedly "refused to complete anesthesiology" on three patients. For these three cases, "The committee voted to approve a referral to the MEC (medical executive committee) for a six month track and trend on MD 2 in a previous motion."

A review of the Regular Board of Directors Meeting Minutes for the last three meetings (March 13, 2013, March 27, 2013 and April 10, 2013) indicated no documented evidence that any peer review information was requested by, or discussed with, the Governing Body/Board (GB).

During an interview the GB on May 16, 2013, at 10:40 a.m., they were asked, what was their main concerns. The reply was they were concerned about "patient care policies and procedures, and ensuring they were followed. The GB also stated when something unfavorable about the facility is brought to her attention, she would bring it to the ACEO to validate and/or discuss the matter. When asked if they were aware of the negative external peer review reports regarding MD 1, part of the GB said "yes" and part of the GB said "no." When asked if these peer reviews had been discussed at a GB meeting, the GB members stated they have not been discussed in public.

Later, during the interview with the GB members at 12:03 p.m., they were asked how they are holding the MEC (medical executive committee) accountable. The first response was, "We put it to a vote." They were asked again, "How do you hold them [the MEC] accountable?" They then replied, that they were told the CEO is responsible for everybody (including the MEC). They expect him to fix it, and then tell the GB. He was responsible for the result.

A letter addressed "To our Community," signed by MD 5, Ethics Committee Chairman and MD 3, MEC Secretary [of the facility] was reviewed. The letter indicated, "Every hospital in the United States (including [name of facility]) must have a self-governing MEC (Medical Executive Committee) that is not beholden to the Board (Governing Body), so as to prevent any undue influence on them as to the quality of patient care. The MEC is required to review and evaluate the quality of care provided by its members, as long as it is kept absolutely confidential. The MEC is responsible to monitor and debate physicians' performance in order to protect the community. The MEC cannot debate these issues in public unless the physician waves these confidentiality rights. Our Hospital physicians and the MEC have done almost everything that the [name of facility] Hospital Board has asked of them in the last four years..." The letter also indicated, "This lack of leadership by the Board and the CEO has cost the Hospital..."

Based on interview and record review, the facility failed to ensure the physician completed and documented a History and Physical (H&P) within 24 hours after admission for one of 32 sampled patient (Patient 4) who was admitted to the Intensive Care Unit (ICU). This resulted in staff and medical consultants not having Patient 4's H&P information available for review.

Finding:

On May 14, 2013, the record for Patient 4 was reviewed. Patient 4 was admitted to the ICU on May 12, 2013, at 1:15 a.m., with diagnoses including a strangulated hernia, pneumonia, and respiratory acidosis requiring mechanical ventilation.

On May 14, 2013, at 9 a.m., a facility form, which can be utilized by the physician to document Patient 4's admission H&P, was blank.

During a concurrent interview with Staff 31, she reviewed the record and was unable to find documentation of a physician's admission H&P.

On May 14, 2013, at 12 p.m., the record for Patient 4 was again reviewed, the form which can be utilized by the physician to document Patient 4's admission History and Physical was blank, and there was no dictated H&P in the record.

During a concurrent interview with Staff 32, she reviewed the record and was unable to find documentation of a physician's admission H&P. Staff 32 stated maybe the physician (MD 5) had dictated his H&P and she would check with medical records.

On May 14, 2013, at 2:15 p.m., the record for Patient 4 was again reviewed and MD 5's dictated H&P was found in the record (greater than 58 hours after Patient 4's admission to the facility's Intensive Care Unit).

MD 5's dictated H&P for Patient 4, indicated the H&P was dictated on May 13, 2013, at 7:30 a.m. (greater than 30 hours after Patient 4's admission to the facility's Intensive Care Unit), and transcribed on May 13, 2013, at 9:40 a.m.

On May 14, 2013, at 2:20 p.m., an interview was conducted with Staff 1. She stated MD 5's H&P for Patient 4 should of been in the record within 24 hours of the patient's admission to the facility.

The facility medical staff "Rules and Regulations" dated May 26, 2010, revealed "... A complete admission history and physical examination shall be recorded by the attending physician within twenty-four (24) hours of admission. ..."

Based on observation, interview, and record review, the facility failed to ensure it provided an organized nursing service to all patients by failing:

1. To ensure the discharge instructions reflected the patient's condition and a discharge medication reconciliation was completed and documented per facility policy and procedure. (Refer to A392);

2. To ensure Social Services was notified of a physician ordered referral. (Refer to A392);

3. To ensure Child Protective Services (CPS) was notified when a maternal positive urine drug screen was obtained for one sampled patient. (Refer to A392);

4. To ensure nursing staff implemented fluid restriction orders for Patient 3 in accordance with facility policy. (Refer to A395);

5. To ensure individualized nursing plans of care were developed and maintained for four sampled patients. (Refer to A396);

6. To ensure there was documented evidence nursing personnel were competent to perform their assigned duties. (Refer to A397);

7. To ensure a travel agency Registered Nurse (RN) had a current California RN license; and to ensure there was documented evidence travel agency RN's were competent to perform their assigned duties. (Refer to A398);

8. To ensure the physicians' orders for medication administration were followed; and to ensure safe administration of medications to patients in accordance with the facility policy and procedure. (Refer to A405);

The cumulative effects of these systemic problems resulted in the failure of the nursing department to ensure care was being provided in a safe and effective manner.

Based on interview and record review, the facility failed:

1. To ensure the discharge instructions reflected the patient's condition and a discharge medication reconciliation was completed and documented for one sampled patient (Patient 5) per facility policy and procedure. This failure had the potential to result in Patient 5 not being familiar with and/or educated about new medications being prescribed by her physician for her newly diagnosed condition.

2. To ensure Social Services was notified of physician ordered referral when the patient had a positive urine drug screen for one sampled patient (Patient 7). This resulted in Patient 7 not being seen by a case manager, social worker or social worker designee.

3. To ensure Child Protective Services (CPS) was notified when a maternal positive urine drug screen for one sampled patient (Patient 9). This resulted in Patient 10 being discharged home with Patient 9 without CPS being aware of the positive maternal urine drug screen.

4. To ensure the "Perinatal Department Daily Assignment" form accurately reflected the patients who were present in the Labor & Delivery (L&D), Obstetrics (OB), and Nursery and who was assigned to care for these patients. This resulted in inaccurate and incomplete documentation of nurse to patient care assignments.

Findings:

1. On May 14, 2013, the record for Patient 5 was reviewed. Patient 5 was admitted to the facility on March 26, 2013, with diagnoses including term pregnancy with an elevated blood pressure, headache, and chest pain.

The "History & Physical Update-Labor and Delivery" dated March 26, 2013, indicated Patient 5 had a blood pressure of 139/89 mmHg (millimeter of mercury) (normal range blood pressure: 90 to 119/ 60 to 79).

The "Medication Administration Record" dated March 26 through March 31, 2013, indicated Patient 5 was receiving Labetalol (used to treat high blood pressure)100 mg (milligrams) by mouth twice a day.

The "Progress Notes Physician" dated March 31, 2013, indicated Patient 5 was to be discharged home with Labetalol 100 mg by mouth twice a day for her elevated blood pressure.

The "Exitcare Patient Information" dated March 31, 2013, at 2:15 p.m., indicated "Postpartum Care After Vaginal Delivery" and "follow up in a week." There were no Exitcare instructions for Patient 5's new diagnosis of elevated blood pressure and the administration of Labetalol, a new medication for Patient 5.

The "Discharge Medication" form was blank.

During an interview with Staff 18, on May 15, 2013, at 9:55 a.m., she reviewed the record and was unable to find documentation of Exitcare instructions for Patient 5's newly diagnosed elevated blood pressure, the administration of Labetalol, and a completed "Discharge Medication" form. Staff 18 stated Patient 5's discharge instructions should have included information on her elevated blood pressure and the medication Labetalol. In addition, Staff 18 stated Patient 5 should have been given a "Discharge Medication" form that included the medication Labetalol.

On May 16, 2013, at 10:30 a.m., an interview was conducted with the Chief Nursing Officer. The CNO stated every patient discharged from the facility, who is being discharged with medications, received a "Discharge Medication" form which was computer generated. The CNO stated Patient 5 should have received a "Discharge Medication" form because she was discharged from the facility with Labetalol.

The facility policy and procedure titled "Discharge Planning" revised April 16, 2013, revealed "... Case Managers and nursing staff should instruct patients, families and significant others in needed aspects of patient care. Provide printed and/or electronic materials, as appropriate. ... On the day of discharge, complete discharge instructions, physician follow up and Medication Reconciliation Form for all patients. The discharging nurse must sign and complete and/or review the diet, activities, dressings, treatments, services and medications sections, including medication reconciliation. ..."

2. On May 14, 2013, the record for Patient 7 was reviewed. Patient 7 was admitted to the facility on April 11, 2013, with diagnoses of term pregnancy in labor, previous cesarean sections (abdominal birth of infant), and no prenatal care for this pregnancy.

On April 11, 2013, at 4:11 p.m., a urine drug screen was obtained and indicated Patient 7's urine was positive for opiates (powerful drugs derived from the poppy plant - heroin) and amphetamines (highly addictive commonly abused stimulant - cocaine).

Patient 7 underwent a repeat cesarean section and delivered a baby boy on April 11, 2013.

The "Post-Operative Cesarean Section" physician's orders dated April 11, 2013, indicated "Social Services consultation if indicated."

There was no indication in the record of a Social Services consultation.

During an interview with Staff 18, on May 15, 2013, at 10:05 a.m., she reviewed the record and was unable to find documentation of a Social Services referral or Patient 7 being evaluated by a case manager, social worker, or a social worker designee. When Staff 18 was asked what conditions/situations were referred to Social Services, Staff 18 stated she would refer patients who were homeless, had a positive urine drug screen, or there was a history of/current domestic violence. Staff 18 stated Patient 7 should have been seen and evaluated by the case manager.

On May 15, 2013, at 12:15 p.m., an interview was conducted with Staff 4. She stated the facility has not had a Social Worker or a Social Worker Designee for greater than one year. Staff 4 stated that when a Social Worker consultation was needed the referral was made to Case Management.

On May 15, 2013, at 1:45 p.m., an interview was conducted with Staff 4, Staff 29, Staff 35, and the Chief Nursing Officer (CNO). They stated Case Management never received the consultation order to see Patient 7. In addition, Staff 35 and the CNO stated the facility did not have a policy and procedure or list of what conditions/circumstances would trigger a Social Services consultation and would address the physician's order of "Social Services consultation if indicated."

The facility policy and procedure titled "Maternal Substance Abuse and Neonatal Withdrawal" last reviewed March 2010, revealed "... The birth of a baby to a mother currently abusing substances must be reported. ... Notify the attending physician and social worker of newborn's exposure. ..."

3. On May 14, 2013, the record for Patient 9 was reviewed. Patient 9 was admitted to the facility on April 10, 2013, with diagnosis of term pregnancy in active labor.

The prenatal drug screen urinalysis dated September 14, 2012, indicated Patient 9's urine was positive for cannabinoids (marijuana).

The "Labor Orders" dated April 10, 2013, at 7:45 a.m., indicated "Urine for Drug Screen and Urinalysis."

The urine drug screen dated April 10, 2013, at 6:38 a.m., indicated Patient 9's urine was positive for cannabinoids.

Patient 10 was born on April 10, 2013.

The "Post Partum Vaginal Delivery Orders" dated April 10, 2013, at 11:30 a.m., indicated "Social Services consultation if indicated."

Patient 9 was seen and evaluated by a case management registered nurse on April 11, 2013, at 9:15 a.m.

Patient 10 was discharged from the facility with Patient 9 on April 11, 2013, at 6:12 p.m.

There was no indication in Patient 10's record that the physician was aware Patient 10's mother had a positive drug screen and/or a urine drug screen was obtained on Patient 10.

There was no indication in Patient 9's or Patient 10's record that Child Protective Services (CPS) was notified of Patient 9's positive urine drug screen and Patient 10's exposure to cannabinoids.

During an interview with Staff 18, on May 15, 2013, at 10:40 a.m., she reviewed the records and was unable to find documentation of Patient 9 and/or Patient 10 being referred to CPS.

On May 15, 2013, at 1:45 p.m., an interview was conducted with Staff 4, Staff 29, Staff 35, and the Chief Nursing Officer (CNO). They stated Patient 9 was evaluated by case management, and generally it was the nurses responsibility to make the referral to CPS when there was a positive drug screen. They stated a referral to CPS should have occurred.

The facility policy and procedure titled "Maternal Substance Abuse and Neonatal Withdrawal" last reviewed March 2010, revealed "... The birth of a baby to a mother currently abusing substances must be reported. ... Notify the attending physician and social worker of newborn's exposure. Notify Manager or House Supervisor. In the absence of a social worker, the manager or supervisor will make a telephone report of the situation to the Department of Children Services as soon as possible. ..."

The facility policy and procedure titled "Neonatal Drug and Alcohol Exposure" last revised July 2010, revealed "... Determine whether a referral to the State Department of Children's Services is necessary. If positive screen exists, contact the hospital social worker who will report to DPSS. ... Child Protective Services shall be notified immediately when the assessment leads to suspicion of child endangerment due to the presence or interaction of the particular infant, parent and environmental risk factors. ..."

On May 16, 2013, at 10:50 a.m., an interview was conducted with members of the Governing Board. They stated they were not aware the facility did not have the services of a social worker or social worker designee for greater than one year.

4. On May 14, 2013, the "Perinatal Department Daily Assignments," "Delivery Log," "Outpatient Log," and "OB/Labor and Delivery Schedule" were reviewed.

a. The "Perinatal Department Daily Assignments" dated March 26, 2013, indicated there were no patients seen in Labor & Delivery (L&D) on the 7 a.m. to 7 p.m. shift (day shift).

The "Outpatient Log" dated March 26, 2013, indicated patients presented to L&D at 10:45 a.m.; 12:15 p.m., 12:50 p.m., and 6 p.m., for evaluation and possible admission to the facility.

There was no indication on the "Perinatal Department Daily Assignments" for March 26, 2013, day shift, as to who cared for the four patients who presented to L&D.

b. The "Perinatal Department Daily Assignments" dated March 29, 2013, indicated there were no patients seen in Labor & Delivery (L&D) on the 7 a.m. to 7 p.m. shift. In addition, the nurse assigned to L&D was also assigned to Postpartum/Nursery and was taking care of a mother and infant on the Obstetrics (OB) unit.

The "Outpatient Log" dated March 29, 2013, indicated a patient presented to L&D at 6:20 p.m., for evaluation and possible admission to the facility.

There was no indication on the "Perinatal Department Daily Assignments" for March 29, 2013, day shift, as to who cared for the patient who presented to L&D.

c. The "Perinatal Department Daily Assignments" dated April 9, 2013, indicated there were no patients seen in Labor & Delivery (L&D) on the 7 a.m. to 7 p.m. shift.

The "Outpatient Log" dated April 9, 2013, indicated a patient presented to L&D at 6:30 a.m., for a repeat cesarean section (abdominal delivery of an infant) and a second patient presented at 10 a.m., for evaluation and possible admission to the facility.

There was no indication on the "Perinatal Department Daily Assignments" for April 9, 2013, day shift, as to who cared for the two patients who presented to L&D.

d. The "Perinatal Department Daily Assignments" dated April 11, 2013, indicated there were no patients seen in Labor & Delivery (L&D) on the 7 a.m. to 7 p.m. shift. In addition, the nurse assigned to L&D was also assigned to Postpartum/Nursery and was taking care of three mothers and three infants on the Obstetrics (OB) unit.

The "Outpatient Log" dated April 11, 2013, indicated patients presented to L&D at 4:30 p.m. and 6:40 p.m., for evaluation and admission to the facility.

There was no indication on the "Perinatal Department Daily Assignments" for April 11, 2013, day shift, as to who cared for the two patients who presented to L&D.

On May 15, 2013, at 2:30 p.m., the "Perinatal Department Daily Assignments," "Delivery Log," "Outpatient Log," and "OB/Labor and Delivery Schedule" were reviewed with Staff 18 and Staff 35. They did not know why the "Perinatal Department Daily Assignments" did not accurately reflect the patients who were seen in the units, who was assigned to care for the patients, and who actually cared for the patients. Staff 35 stated the "Perinatal Department Daily Assignments" should accurately reflect who cared for each patient each shift. In addition, Staff 35 stated on April 11, 2013, one nurse should not have been caring for three mothers, three infants, and two patients who presented to L&D.

The facility policy and procedure titled "Staffing - Nursing Services Plan With Patient Classification System" last revised/reviewed April 2010, revealed "... Staffing is done based on patient acuity according to ACOG (American Congress of Obstetricians and Gynecologists), AWHONN (Association of Women's Health, Obstetrics and Neonatal Nurses) and AAP's (American Academy of Pediatrics) recommended Perinatal Guidelines to assure that there is safe and effective nursing care with qualified nurses in adequate numbers to meet the needs of each patient in accordance with the care setting. ..."

Based on observation, interview, and record review, the facility failed to ensure nursing staff accurately supervised and evaluated the nursing care for one sampled patient (Patient 3) by failing to implement fluid restriction orders for Patient 3 in accordance with facility policy.

Findings:

On May 15, 2013, at 11:45 a.m., observation of the lunch trayline showed Patient 3 received eight ounces of iced tea on the lunch tray. The dietary aide explained the patient was prescribed a 1600 cc (cubic centimeter) fluid restriction, and could only receive 8 ounces of fluid on each tray (240 cc), for a total of 720 cc supplied by the dietary department.

On May 15, 2013, at 2:45 p.m., review of the record for Patient 3 indicated the physician prescribed a 1600 cc fluid restriction on May 14, 2013. Patient 3 had diagnoses that included end stage liver disease with ascites (accumulation of fluid in the peritoneal cavity). In a concurrent interview with the Registered Dietitian (RD), she stated fluid restriction orders applied to oral intake of fluids only, and it was the facility policy to split the provision of fluid between the dietary and nursing departments. So for Patient 3, dietary was to provide 800 cc per day and nursing would provide 800 cc per day for a total of 1600 cc per day. The RD stated the fluid restriction was independent of any intravenous fluids provided to the patient, and she had not received direction from nursing regarding the total amount of intravenous fluid Patient 3 was receiving.

On May 15, 2013, at 3:20 p.m., in an interview with Staff 23, she stated Patient 3's prescribed fluid restriction encompassed both oral fluids and any fluids provided via intravenous methods. Staff 23 stated Patient 3 was receiving intravenous fluid at a rate of 40 cc per hour for a total of 960 cc per day. Staff 23 stated the balance of fluid available for oral intake was 640 cc per day. Staff 23 was unsure how that amount would be split up between dietary and nursing.

A review of the facility policy titled, "Fluid Restrictions" dated February 1, 2011, indicated the purpose of the policy was, "To ensure that the correct fluid allowance is provided." The procedure in the policy included, "The distribution of daily fluid allowance will be determined by Nursing in conjunction with the clinical dietitian."

Based on interview and record review, the facility failed to ensure individualized nursing plans of care were developed and maintained for four sampled patients (Patients 4, 5, 8, and 11). This had the potential to result in care and treatment not being provided to Patients 4, 5, 8, and 11, as needed.

Findings:

1. On May 14, 2013, the record for Patient 4 was reviewed. Patient 4 was admitted to the facility's Intensive Care Unit (ICU), on May 12, 2013, at 1:15 a.m., with diagnoses including strangulated hernia, pneumonia, and respiratory acidosis requiring mechanical ventilation.

No plans of care had been developed and documented for Patient 4, who had been in the ICU for greater than 60 hours.

During an interview with Staff 1, on May 14, 2013, at 2:20 p.m., she reviewed the record and was unable to find documentation of plans of care being developed and implemented for Patient 4. Staff 1 stated plans of care should be initiated at the time of admission and updated as needed based on the patient's condition. Staff 1 stated plans of care should have been developed, implemented and maintained for Patient 4.

2. On May 14, 2013, the record for Patient 5 was reviewed. Patient 5 was admitted to the facility on March 26, 2013, with diagnoses including term pregnancy with an elevated blood pressure, headache, and chest pain.

The "History & Physical Update-Labor and Delivery" dated March 26, 2013, indicated Patient 5 had a blood pressure of 139/89 mmHg (millimeter of mercury) (normal range is 90 to 119/ 60 to 79).

The "Medication Administration Record" dated March 26 through March 31, 2013, indicated Patient 5 was receiving Labetalol (medication used to treat an elevated/high blood pressure) 100 mg (milligrams)

The plans of care developed for Patient 5 included "acute pain" and "potential fetal (infant) intolerance to labor." There was no plan of care related to Patient 5's elevated blood pressure and the administration of a medication to decrease Patient 5's elevated blood pressure.

During an interview with Staff 18, on May 15, 2013, at 9:55 a.m., she reviewed the record and was unable to find documentation of a plan of care addressing Patient 5's elevated blood pressure and the need for medication to treat Patient 5's elevated blood pressure. Staff 18 stated a plan of care should have been initiated because this was a new diagnosis and a new medication for Patient 5.

3. On May 14, 2013, the record for Patient 8 was reviewed. Patient 8 was admitted to the facility on April 11, 2013, at 7:23 p.m., with diagnoses including newborn infant, maternal hepatitis status unknown, and an exposure to opiates and amphetamines (non-prescribed addictive substances/drugs).

The "Newborn Orders" dated April 11, 2013, indicated "If mother's HBsAg (the surface antigen of the hepatitis B virus) is positive or unknown, with risk factors (i.e., history or Hepatitis B, IV drug use, native to Southeast Asia), obtain consent: - give hepatitis B vaccine (vaccine developed for the prevention of hepatitis B virus infection) 0.5 ml (milliliters), IM (intramuscularly) within 1 hour of delivery. - Give HBIG (Hepatitis B Immunoglobulin - serves as a bridge in the control of the hepatitis B virus until the innate immune system can mount an adequate response) 0.5 ml IM within 1 hour of delivery in the opposite thigh."

The "Medication Administration Record" dated April 11 through 15, 2013, indicated Patient 8 received the "hepatitis B vaccine" but did not receive the "HBIG" as ordered.

The urine drug screen obtained on April 12, 2013, at 6 a.m., indicated the urine was positive for opiates and amphetamines.

Child Protective Services (CPS) was informed, and on May 13, 2013, at 3 p.m., Patient 8 was placed on a "temporary hold on baby until CPS makes final decision."

Patient 8 was discharged from the facility on April 15, 2013, to CPS/foster care.

There were no plans of care related to Patient 8's exposure to opiates and amphetamines, possible drug withdrawal, being released to CPS rather then being discharged with the mother, and the need to receive both hepatitis B vaccine and HBIG vaccine because the mother's hepatitis status was unknown with risk factors.

During an interview with Staff 18, on May 15, 2013, at 10:20 a.m., she reviewed the record and was unable to find documentation of plans of care being developed and maintained for Patient 8's exposure to opiates and amphetamines, possible drug withdrawal, being released to CPS, and the need to receive both hepatitis B vaccine and HBIG. Staff 18 stated plans of care should have been developed and implemented related to possible drug withdrawal, "boarder" baby care (baby being cared for in the nursery as opposed to in the room with the mother) and release to CPS, and the need for both hepatitis B vaccine and HBIG because the mother's hepatitis status was unknown.

4. On May 14, 2013, the record for Patient 11 was reviewed. Patient 11 was admitted to the facility on April 11, 2013, with a diagnosis of term pregnancy in labor.

The physician's "History and Physical Exam" dated April 11, 2013, indicated Patient 11 had received her prenatal care in another country, the physician had no records of the care received, and her first visit with the physician had been March 18, 2013.

The "Labor Orders" dated April 11, 2013, at 6:50 p.m., indicated "Urine for Drug Screen and Urinalysis." The "urine for drug screen and urinalysis" was subsequently canceled in the computer system on April 12, 2013, at 7:10 a.m., but there was no physician's order to cancel the "urine for drug screen and urinalysis."

There were no plans of care developed and documented for Patient 11.

During an interview with Staff 18, on May 15, 2013, at 11:15 a.m., she reviewed the record and was unable to find documentation of plans of care for Patient 11. Staff 18 stated plans of care should have been developed and implemented for Patient 11 based on Patient 11's diagnosis, assessments and condition.

The facility policy and procedure titled "Patient Plan of Care Nursing and Interdisciplinary (Care Plan)" last revised/reviewed June 2010, revealed "... The Registered Nurse initiates the plan of care based on the admission assessment findings and/or the patient medical diagnoses and/or treatment orders. ... The admitting Registered Nurse ... will complete the initial plan of care. ... Every 12 hours, based on the shift to shift reassessment and reassessment findings, the Registered Nurse and multidisciplinary team documents any review or revisions to the plan of care through outcomes or interventions and charting in the plan of care. ..."

Based on interview and record review, the facility failed:

1. To ensure there was documented evidence nursing personnel were competent to perform their assigned duties for one of three employee files reviewed (Staff 41). This resulted in the facility not knowing if the staff assigned to care for patients were clinically competent.

2. To ensure the requirements to assume a patient care assignment in Obstetrics (OB) were met by Staff 40 prior to being assigned to care for newborn infants. This had the potential to result in Staff 40 not knowing how to care for a newborn infant.

3. To ensure the performance of an employee was evaluated annually per facility policy and procedure for one of three employee files reviewed (Staff 41).

4. To ensure the certification requirements were met by one of three staff (Staff 57) caring for the pediatric population in the Emergency Department and three of five staff (Staff 10, 15, and 54) assigned to the surgical services department.

5. To ensure the performance of an employee was evaluated annually per facility policy and procedure for one of three ED employee files reviewed (Staff 55).

6. To ensure there was documented evidence three of five operating room personnel were competent to perform their assigned duties (Staff 52, 54, and 59).

Findings:

1. The "OB/Labor and Delivery Schedule" dated March 3, through April 13, 2013, indicated Staff 41 was assigned to care for patients in Labor & Delivery and Obstetrics on April 4, 5, and 6, 2013.

The employee file for Staff 41 was reviewed on May 15, 2013. Staff 41 had a hire date of August 24, 2011, and was assigned to the Emergency Department (ED).

There were no initial clinical skills competencies for Labor & Delivery and Obstetrics in Staff 41's employee file.

During an interview with the Chief Nursing Officer (CNO), on May 15, 2013, at 4 p.m., she reviewed the employee file for Staff 41, and was unable to find documentation of an initial orientation/clinical skills competencies. The CNO stated any nurse who worked more than one unit was required to complete and be signed off on an initial orientation/clinical skills competency for each unit.

2. The "Perinatal Department Daily Assignments" dated April 11, 2013, indicated Staff 40 was assigned and cared for two newborn infants, and on April 14, 2013, Staff 40 was assigned to care for a newborn infant in the Nursery.

The employee file for Staff 40 was reviewed on May 15, 2013. Staff 40 had a hire date of July 3, 2004, and was assigned to the Medical/Surgical Unit.

There was no indication Staff 40 had signed a "Registered Nurse - OB" job description, and there was no indication Staff 40 was current with her Neonatal Resuscitation Program Certification.

The facility job description "Registered Nurse - OB" last revised March 2013, revealed "Education, Experience & Skills Required: ... Current American Heart Association NRP (Neonatal Resuscitation Program) Certification. ..."

During an interview with the Chief Nursing Officer (CNO), on May 15, 2013, at 4 p.m., she reviewed the employee file for Staff 40, and was unable to find documentation of current NRP certification. The CNO stated any nurse who worked more than one unit was required to meet and maintain the education, experience and skills required for each unit. The CNO stated Staff 40's last NRP certification had expired in 2009, and she should not have been caring for newborn infants without current NRP certification.

3. The employee file for Staff 41 was reviewed on May 15, 2013. Staff 41 had a hire date of August 24, 2011, and was assigned to the Emergency Department (ED).

There were no performance reviews and competency assessments in Staff 41's employee file.

During an interview with the Chief Nursing Officer (CNO), on May 15, 2013, at 4 p.m., she reviewed the employee file for Staff 41, and was unable to find documentation of a performance review and competency assessment. The CNO stated a review of the employee's performance and competency should be conducted annually, and an annual performance and competency evaluation should have been completed for Staff 41 in 2012.

The facility policy and procedure titled "Performance Evaluations - Competency" reviewed/revised March 24, 2010, revealed "... All employees will receive an annual evaluation for purposes of wage increases, performance review and competency assessment. ... Unit specific orientation conducted by the Department Director/designee is carried out for all new employees, including employees being cross-trained. The unit preceptor or the department director will assess the individual's unit specific proficiency as outlined on the unit-specific skills checklist. ... Documentation of mastery of unit specific skills will be recorded on the Unit-Specific Skills checklist. At the conclusion of the 90-day introductory period, the Department Director/Supervisor will conduct a performance evaluation of the new employee. ... Documentation of satisfactory performance for current competencies will be placed in the employee's file. ... The Department Director/Supervisor assures all required competencies have been satisfactorily completed within the allowed time frame. ... Required employee documentation: Clinical Initial skills competency, due the first 90 days of employment, if an employee works multiple units there must be a competency for each unit. ..."

The facility policy and procedure titled "Education and Licensure Requirements" last reviewed/revised April 2013, revealed "... Human Resources shall verify and obtain documented proof of employee's educational credentials including current License numbers and/or credential(s) and certifications (where applicable) at the time of employment and at the renewal date. ... In addition, current employees must submit the original of the renewed Licenses/Credentials information to Human Resources prior to the expiration date or after any change therein. ..."



18918

4a. On May 13, 2013, at 11:10 a.m., a tour of the ED was conducted with the Chief Nursing Officer (CNO). The ED included an area to triage (assign a severity of illness) and six ED beds. All six beds were occupied. Current staff included one triage Registered Nurse (RN), two staff RNs, one ED technician, and one admitting clerk (Staff 55, Staff 57 and Staff 58.).

During observation in the ED, a Pediatric Crash cart was observed. The crash cart was a color coded nine drawer cabinet on wheels, based on the Broselow Method for pediatric emergency care.

In an interview with Staff 55, on May 13, 2013, at 11:30 a.m., Staff 55 stated the licensed nurses rotated, performing both triage and patient care activities.

In an interview with Staff 58, on May 13, 2013, at 11:45 a.m., Staff 58 stated she had been here 3 weeks; she had undergone two weeks of orientation. Staff 58 stated she was assigned four beds (patients) today.

On May 13, 2013, at 2:10 p.m., Staff 57 was observed taking care of Patient 24. Patient 24 was intubated (tube placed in the throat) and undergoing mechanical ventilation.

On May 13, 2013, at 2:40 p.m., MD 8 asked ED staff if there was a "baby in the waiting room." When the response was "yes," MD 8 ordered an abdominal series.

On May 15, 2013, ED personnel files were reviewed. The following was noted:

Staff 55's personnel file contained a job description titled "ER RN." The job description indicated the ER (ED) RN would care for patient populations from neonate (newborns) to geriatric (the elderly). The job description indicated the ER RN would have current American Heart Association PALS (pediatric advanced life support.)

PALS was developed by the American Heart Association in conjunction with the American Academy of Pediatrics to equip health care professionals with the essential skills to effectively recognize and react to critical injuries or conditions in children and infants.

Staff 55 had evidence of current PALS certification.

Staff 57's personnel file did not contain the same job description as Staff 55, but the job description did indicate Staff 57 would be caring for the same patient population, neonate to geriatric. There was no evidence in Staff 57's file that the employee had current PALS certification.

During an interview with the Chief Nursing Officer (CNO), on May 15, 2013, 3:45 p.m., the CNO stated all ED licensed personnel should have PALS certification. New hires are given a six month grace period, but current personnel should have the certification. The CNO stated requirements in the ED have changed and they were in the process of training staff.

b. The employee file for Staff 10 was reviewed on May 15, 2013. Staff 10, a scrub technician assigned to the operating room, requires current Cardiopulmonary Resuscitation (CPR) certification. There was evidence in the record Staff 10's CPR certification expired prior to being renewed.

c. The employee file for Staff 15 was reviewed on May 15, 2013. Staff 15 was assigned to the operating room and the post anesthesia care unit. There was evidence in the employee file that Staff 15's CRP certification expired prior to being renewed.

d. The employee file for Staff 54 was reviewed on May 15, 2013. Staff 54 was assigned to the operating room as a pre op nurse. Staff 54 started this position in August 2012. A job description in Staff 54's file indicated ACLS (Advanced Cardiac Life Support) was a requirement for this position. There was no evidence in the employee's file that ACLS certification had been obtained or was current.

During an interview with the CNO, on May 13, 2013, at 4:30 p.m., the CNO stated Human Resources tracked licenses and certifications, and notified managers about licenses and certifications that were close to expiring. The CNO stated every effort was made to ensure certificates were renewed prior to expiration.

The facility policy and procedure titled "Education and Licensure Requirements" last reviewed/revised April 2013, revealed "... Human Resources shall verify and obtain documented proof of employee's educational credentials including current License numbers and/or credential(s) and certifications (where applicable) at the time of employment and at the renewal date. ... In addition, current employees must submit the original of the renewed Licenses/Credentials information to Human Resources prior to the expiration date or after any change therein. ..."

5. The employee file for Staff 55 was reviewed on May 15, 2013. Staff 55 had a hire date of February 6, 2006 and was assigned to the ED. According to the documentation in the file, Staff 55's last performance evaluation was conducted in August 2011.

The facility policy and procedure titled "Performance Evaluations - Competency" reviewed/revised March 24, 2010, revealed "... All employees will receive an annual evaluation for purposes of wage increases, performance review and competency assessment. ... "

6a. The employee file for Staff 52 was reviewed on May 15, 2013. Staff 52 had a hire date in March 2013, and was assigned to the facility's operating room. There was no initial clinical skills competencies in Staff 52's employee record.

b. The employee file for Staff 54 was reviewed on May 15, 2013. Staff 54 had a hire date of April 19, 2010. Staff 54 was initally assigned to the emergency department, but changed to the surgical services department, as a pre-operative nurse, on August 1, 2012. There was no clinical skills competencies for Staff 54's new position, in the employee record.

c. The employee file for Staff 59, was reviewed on May 15, 2013. Staff 59 had a hire date of April 10, 2013, and was assigned to the facility's operating room. There was no initial clinical skills competencies in Staff 59's record.

The facility policy and procedure titled "Performance Evaluations - Competency" reviewed/revised March 24, 2010, revealed "... All employees will receive an annual evaluation for purposes of wage increases, performance review and competency assessment. ... Unit specific orientation conducted by the Department Director/designee is carried out for all new employees, including employees being cross-trained. The unit preceptor or the department director will assess the individual's unit specific proficiency as outlined on the unit-specific skills checklist. ... Documentation of mastery of unit specific skills will be recorded on the Unit-Specific Skills checklist. At the conclusion of the 90-day introductory period, the Department Director/Supervisor will conduct a performance evaluation of the new employee. ... Documentation of satisfactory performance for current competencies will be placed in the employee's file. ... The Department Director/Supervisor assures all required competencies have been satisfactorily completed within the allowed time frame. ... Required employee documentation: Clinical Initial skills competency, due the first 90 days of employment, if an employee works multiple units there must be a competency for each unit. ..."

Based on interview and record review, the facility failed:

1. To ensure a travel agency Registered Nurse (RN) had a current California RN license for one of two travel agency RN files reviewed (Staff 43). This resulted in Staff 43 caring for patients without verification of current licensure.

2. To ensure there was documented evidence travel agency Registered Nurses (RN) were competent to perform their assigned duties for two of two travel agency RN files reviewed (Staff 42 and 43). This resulted in the facility not knowing if the travel agency RNs assigned to care for patients were clinically competent.

3. To ensure there was documented evidence of an evaluation of the travel agency Registered Nurse (RN) clinical performance for one of two travel agency RN files reviewed (Staff 43). This had the potential to result in the facility not being aware of Staff 43's overall performance capabilities.

Findings:

1. The travel agency file for Staff 43 was reviewed on May 15, 2013. Staff 43 had a start date of February 14, 2013, and was assigned to Labor & Delivery/Obstetrics.

Staff 43's RN license had expired on March 31, 2013.

There was no documented evidence the facility had verified if Staff 43's RN license was current after March 31, 2013.

Staff 43 worked and cared for patients in Labor & Delivery and Obstetrics on April 11, 12, 13, 14, and 15, 2013.

Staff 43 was terminated by the facility on April 16, 2013.

During an interview with the Chief Nursing Officer (CNO), on May 15, 2013, at 4 p.m., she reviewed the travel agency file for Staff 43 and was unable to find a current California RN license. The CNO stated Human Resources was responsible to verify and maintain current licensure records for all employees and agency personnel. The CNO stated Staff 43 should not have been allowed to work without verification of a current California RN license.

The facility policy and procedure titled "Education and Licensure Requirements" last reviewed/revised April 2013, revealed "... Human Resources shall verify and obtain documented proof of employee's educational credentials including current License numbers and/or credential(s) and certifications (where applicable) at the time of employment and at the renewal date. ... If an applicant or employee allows his/her license to lapse or become revoked he/she will not be eligible for employment and/or will be suspended and/or terminated based upon the circumstances. ..."

2a. The travel agency RN file for Staff 42 was reviewed on May 15, 2013. Staff 42 had a start date of January 29, 2013, and was assigned to Labor & Delivery/Obstetrics.

There were no initial clinical skills competencies in Staff 42's travel agency file.

b. The travel agency RN file for Staff 43 was reviewed on May 15, 2013. Staff 43 had a start date of February 14, 2013, and was assigned to Labor & Delivery/Obstetrics.

There were no initial clinical skills competencies in Staff 43's travel agency file.

During an interview with the Chief Nursing Officer (CNO), on May 15, 2013, at 4 p.m., she reviewed the travel agency files for Staff 42 and 43, and was unable to find documentation of an initial orientation/clinical skills competencies. The CNO stated travel agency RNs were required to complete and be signed off on an initial orientation/clinical skills competency. The CNO stated the files for both Staff 42 and 43 should have contained documented evidence of their initial orientation/clinical skills competencies.

The facility policy and procedure titled "Performance Evaluations - Competency" last reviewed/revised March 24, 2010, revealed "... Unit specific orientation conducted by the Department Director/designee is carried out for all new employees, including employees being cross-trained. The unit preceptor or the department director will assess the individual's unit specific proficiency as outlined on the unit-specific skills checklist. ... Documentation of satisfactory performance for current competencies will be placed in the employee's file. ... The Department Director/Supervisor assures all required competencies have been satisfactorily completed within the allowed time frame. ..."

3. The travel agency file for Staff 43 was reviewed on May 15, 2013. Staff 43 had a start date of February 14, 2013, and was assigned to Labor & Delivery/Obstetrics.

Staff 43's RN license had expired on March 31, 2013.

There was no documented evidence the facility had verified if Staff 43's RN license was current after March 31, 2013.

Staff 43 worked and cared for patients in Labor & Delivery and Obstetrics on April 11, 12, 13, 14, and 15, 2013.

There was no job performance evaluation in Staff 43's travel agency file.

Staff 43 was terminated by the facility on April 16, 2013.

During an interview with the Chief Nursing Officer (CNO), on May 15, 2013, at 4 p.m., she reviewed the travel agency file for Staff 43 and was unable to find documentation of a job performance evaluation. The CNO stated Staff 43 no longer worked at the facility, was terminated by the facility on April 16, 2013, and a performance evaluation should of been completed.

Based on interview and record review, the facility failed:

1. To ensure the physicians' orders for medication administration were followed for three sampled patients (Patients 4, 8, and 9). This resulted in medication being discontinued prior to a physician's order for Patient 4, and medications not being given to Patient 8 and Patient 9 as ordered by the physicians.

2. To ensure a "urine for drug screen and urinalysis was obtained per physician's order for one sampled patient (Patient 11). This resulted in a "urine for drug screen and urinalysis" not being obtained as ordered by the physician.

3. To ensure safe administration of medication to a patient (Patient 3) in accordance with the facility policy and procedure.

Findings:

1a. On May 14, 2013, the record for Patient 4 was reviewed. Patient 4 was admitted to the facility's Intensive Care Unit (ICU), on May 12, 2013, at 1:15 a.m., with diagnoses including strangulated hernia, pneumonia, and respiratory acidosis requiring mechanical ventilation.

The "Physician's Orders" dated May 12, 2013, at 1:15 a.m., indicated "Levophed (medication used to treat acute low blood pressure) 4 mg (milligrams)/250 (milliliters) D5W (5% dextrose water) 5 mcg (micrograms)/min (ute) and titrate to MAP (mean arterial pressure) > (greater than or equal to) 65, as tolerated (with) HR (heart rate) < 125 SBP (systolic blood pressure) > 90."

The "Intakes/Outputs" dated May 13, 2013, at 7 a.m., indicated the Levophed drip was stopped.

There was no physician's order to discontinue the Levophed drip until 8:10 a.m., when the nurse contacted the physician and obtained a telephone order to discontinue the Levophed drip.

During an interview with Staff 1, on May 14, 2013, at 2:15 p.m., she reviewed the record and was unable to find documentation of a physician's order to discontinue the Levophed prior to the Levophed being discontinued. Staff 1 stated the night shift nurse discontinued the Levophed and the day shift nurse obtained the physician's order to discontinue the Levophed. Staff 1 stated the night shift nurse should have obtained a physician's order to discontinue the Levophed prior to stopping the medication.

b. On May 14, 2013, the record for Patient 8 was reviewed. Patient 8 was admitted to the facility on April 11, 2013, at 7:23 p.m., with diagnoses including newborn infant, maternal hepatitis status unknown, and an exposure to opiates and amphetamines (non-prescribed addictive substances/drugs).

The "Newborn Orders" dated April 11, 2013, indicated "If mother's HBsAg (the surface antigen of the hepatitis B virus) is positive or unknown, with risk factors (i.e., history or Hepatitis B, IV drug use, native to Southeast Asia), obtain consent: - give hepatitis B vaccine (vaccine developed for the prevention of hepatitis B virus infection) 0.5 ml (milliliters), IM (intramuscularly) within 1 hour of delivery. - Give HBIG (Hepatitis B Immunoglobulin - serves as a bridge in the control of the hepatitis B virus until the innate immune system can mount an adequate response) 0.5 mL IM within 1 hour of delivery in the opposite thigh."

The "Medication Administration Record" dated April 11 through 15, 2013, indicated Patient 8 received the "hepatitis B vaccine" on April 11, 2013, at 8:50 p.m.

There was no indication Patient 8 received the "HBIG" as ordered by the physician.

Patient 8 was discharged from the facility on April 15, 2013, to California Protective Services (CPS)/foster care without receiving the "HBIG" and with the maternal hepatitis status still unknown.

During an interview with Staff 18, on May 15, 2013, at 10:20 a.m., she reviewed the record and was unable to find documentation of Patient 8 receiving "HBIG" as ordered by the physician. Staff 18 stated the "HBIG" was not entered into the computer system as a physician's order. Staff 18 stated since the mother's hepatitis status was unknown at the time of delivery, Patient 8 should have been given the "HBIG" and the "hepatitis B vaccine" as ordered by the physician at the time of delivery.

c. On May 14, 2013, the record for Patient 9 was reviewed. Patient 9 was admitted to the facility on April 10, 2013, with diagnoses including term pregnancy in active labor.

The "Physician's Orders" dated April 11, 2013, at 5:20 p.m., indicated Patient 9 was to receive the Tdap vaccine (protects against diphtheria, tetanus, and pertussis - serious, potentially deadly illnesses caused by bacteria) prior to discharge from the facility.

Patient 9 was discharged from the facility on April 11, 2013, at 6 p.m.

There was no indication in the record that Patient 9 received the Tdap vaccine as ordered by the physician.

During an interview with Staff 18, on May 15, 2013, at 10:40 a.m., she reviewed the record and was unable to find documentation Patient 9 received the Tdap vaccine as ordered by the physician. Staff 18 stated the order for the Tdap vaccine was never entered into the computer system. Staff 18 stated Patient 9 should have received the Tdap vaccine prior to being discharged as ordered by the physician.

The facility policy and procedure titled "Chart Quality Control Check by Licensed Nursing Staff" dated December 17, 2012, revealed "... The night shift nurse; either RN (Registered Nurse) or LVN (Licensed Vocational Nurse), shall compare MD (Physician) orders with computer record and medication profile."

The facility policy and procedure titled "Orders, Processing by Nursing" last reviewed March 2010, revealed "... Send or deliver a direct copy of the order to the pharmacy. ... The medication is entered by a qualified nurse into the patient's eMar (electronic medication administration record) into HMS (health management system - computer system/order entry). ..."

2. On May 14, 2013, the record for Patient 11 was reviewed. Patient 11 was admitted to the facility on April 11, 2013, with diagnosis of term pregnancy in labor.

The physician's "History and Physical Exam" dated April 11, 2013, indicated Patient 11 had received her prenatal care in another country, the physician had no records of the care received, and her first visit with the physician had been March 18, 2013.

The "Labor Orders" dated April 11, 2013, at 6:50 p.m., indicated "Urine for Drug Screen and Urinalysis."

The "urine for drug screen and urinalysis" was subsequently canceled in the computer system on April 12, 2013, at 7:10 a.m., but there was no physician's order to cancel the "urine for drug screen and urinalysis."

During an interview with Staff 18, on May 15, 2013, at 11:15 a.m., she reviewed the record and was unable to find documentation of a physician's order canceling the "urine for drug screen and urinalysis" ordered by the physician on April 11, 2013, at 6:50 p.m. Staff 18 stated a physician's order to cancel the "urine for drug screen and urinalysis" was needed prior to canceling the order in the computer system. Staff 18 stated the "urine for drug screen and urinalysis" should have been done if there was no order to cancel the test.




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3a. Medication pass observation was conducted with Staff 31 in the ICU (Intensive Care Unit) on May 14, 2013 for Patient 3. During the observation, it was noted that Staff 31 mixed the powder inside the injectable Protonix (a stomach acid reducer) 40 mg vial with a 10-ml normal saline flush syringe with a final volume inside the syringe indicating 8 ml. Staff 31 also retrieved from the Pyxis MedStation (Automated Dispensing Cabinet: ADC) two 10-ml normal saline flush syringes.

It was also observed that Staff 31 prepared 100-mg Solu-Cortef (injectable steroid to decrease swelling) after mixing the powder with the manufacturer supplied diluent in a 3-ml syringe.

Prior to administration of the prepared injectable medications it was observed that none of the syringes were marked or labeled to indicate what was in each syringes.

During the administration of the mixed Protonix 40 mg, it was observed that Staff 31 administered the injectable medications in the following sequence into patient's IV line.

10-ml flush syringe followed by 10-mg flush syringe followed by 3-ml Solu-Cortef syringe followed by 8-ml Protonix syringe.

During a concurrent interview, Staff 31 stated that she intended to administer the medications in the following manner:

8-ml Protonix syringe followed by 10-ml flush syringe followed by 3-ml Solu-Cortef syringe followed by 10-ml flush syringe.

Staff 31 stated that she might have given the medication in the observed order and acknowledged that the wrong order of medication administration could have been due to not labeling the syringes.

b. Medication pass observation was conducted with Staff 31 in the ICU on May 14, 2013 for Patient 3. During the observation, it was noted that Staff 31 mixed the powder inside the injectable Protonix (a stomach acid reducer) 40 mg vial with a 10-ml normal saline flush syringe with a final volume inside the syringe indicating 8 ml. Staff 31 also retrieved from the Pyxis MedStation (Automated Dispensing Cabinet: ADC) two 10-ml normal saline flush syringes.

It was also observed that Staff 31 prepared 100-mg Solu-Cortef (injectable steroid to decrease swelling) after mixing the powder with the manufacturer supplied diluent in a 3-ml syringe.

It was noted that the Protonix syringe and the Solu-Cortef syringe were administered in approximately 10 seconds each.

According to the manufacturer's package insert for Solu-Cortef, "Therapy is initiated by administering SOLU-CORTEF sterile Powder intravenously over a period of 30 seconds..."

Based on observation, interview, and record review, the facility failed to provide pharmaceutical services that met the needs of the patients as evidenced by the facility's failure to:

1. Ensure duplicate medication therapy was reviewed and detected before the medication error reached the patient care unit (Refer to A500);

2. Ensure periodic sterility testing of compounded IV(intravenous) medications prepared in the Pharmacy IV Hood as outlined in the state regulation (Refer to A500);

3. Evaluate consistently on an annual basis the job performance and competency of all Pharmacy staff (Refer to A500);

4. Develop and establish in the facility's policy and procedure, content of Malignant Hyperthermia (MH) Cart, location of medications used for MH, and procedure for use of MH medications. In addition, the facility failed to ensure all staff was aware of the location of the MH Cart (Refer to A500);

5. Ensure Heparin protocol was initiated and monitored by the Pharmacy in accordance with the facility's policy and procedure (Refer to A500);

6. Ensure controlled substance accountability included monitoring of controlled substance use throughout the facility and not just one unit (Refer to A500);

7. Keep the medication content list outside all emergency supplies carts (adult, pediatric, and neonatal crash carts) (Refer to A500);

8. Ensure standardization of the medication content of the Intubation Boxes located throughout the facility for provision of emergent medications in a timely manner (Refer to A500);

9. Ensure all medications were secured to prevent unauthorized access (Refer to A502);

10. Ensure Scheduled IV Controlled substance stored in the Pharmacy Medication Refrigerator was locked (Refer to A503); and

11. Ensure unusable medications were not available for patient use (Refer to A505).

The cumulative effect of these systemic problems resulted in the hospital's failure to ensure the provision of pharmaceutical services in a safe environment that met the needs of the patients

Based on observation, interview, and document review, the facility failed to effectively control drugs and biological's to ensure patient safety by failing to:

1. Ensure duplicate medication therapy was reviewed and detected before the medication error reached the patient care unit;

2. Ensure periodic sterility testing of compounded IV medications prepared in the Pharmacy IV Hood as outlined in the state regulation;

3. Evaluate consistently on an annual basis the job performance and competency of all Pharmacy staff;

4. Develop and establish in the facility's policy and procedure, defined contents of Malignant Hyperthermia (MH) Cart, location of medications used for MH, and procedure for use of MH medications. In addition, the facility failed to ensure all staff were aware of the location of the MH Cart;

5. Ensure Heparin protocol was initiated and monitored by the Pharmacy in accordance with the facility's policy and procedure;

6. Ensure controlled substance accountability included monitoring of controlled substance use throughout the facility;

7. Keep the medication content list outside all emergency supplies carts (adult, pediatric, and neonatal crash carts); and

8. Ensure standardization of the medication content of the Intubation Boxes located throughout the facility for provision of emergent medications in a timely manner.

Findings:

1. A medication pass observation was conducted with Staff 31 in the ICU on May 14, 2013, for Patient 3. During the observation, it was noted that the printed Medication Administration Record had duplicated the medication orders for Proscar (medication used for enlarged prostate) 5 mg to be given orally once a day.

During an interview on May 14, 2013, at 10:30 a.m., the Director of Pharmacy (DOP) explained that the Proscar order was processed and verified by the pharmacist on May 11, 2013, at the time of the patient admission, and then another order for the same medication (Proscar) was processed and verified by the pharmacist on May 14, 2013.

The DOP demonstrated that the Pharmacy computer system informed the verifying pharmacist if there were any duplication of medication order and acknowledged that the duplication of Proscar order should have been caught and clarified.

The facility's policy and procedure titled, "Verification/Clarification of Orders" was reviewed. The policy indicated ... "If there is any question regarding a drug prescribed, dose, or strength...a nurse or pharmacist shall contact the prescriber. Questionable orders shall be verified/clarified prior to dispensing the drugs."

The facility's policy and procedure titled, "High Alert Medication Management Plan" was reviewed. The policy indicated, "All new or requested medication orders are sent to the Pharmacy for review. Pharmacist must review all medication orders for appropriateness."

2. During an interview on May 15, 2013 at 10:30 a.m., the DOP stated that the Pharmacy did not conduct an audit of sterile product preparation by the Pharmacy Staff (end product testing) as a part of the Pharmacy quality assurance program.

The facility's policy and procedure titled, "Sterile Products, End Product (Final) Examination Related" was reviewed. The policy indicated, "The purpose of this policy is to ensure that a Pharmacist shall perform an end product (final) examination of all compounded sterile products prior to their release from the Pharmacy."

The facility's policy and procedure titled, "Sterile Products, Quality Control" was reviewed. The policy indicated, "The Pharmacy's quality control program for sterile product preparation shall include monitoring of personnel qualifications, training, performance, equipment, and facilities... The Director of Pharmacy shall verify that personnel who prepare sterile products are properly educated and trained and/or demonstrate proficiency in preparing sterile products...The Director of Pharmacy or a qualified designee will monitor personnel performance to ensure adherence to the following quality control procedures and in-process checks..."

3. During an interview on May 15, 2013, at 10:30 a.m., the DOP was not able to produce requested evidence that showed Pharmacy staff were evaluated annually on the demonstration of the staff's competencies as they relate to the job performance.

The facility's policy and procedure titled, "Sterile Products: Orientation, Education, and Training Related" was reviewed. The policy indicated, "The Director of Pharmacy shall participate in the initial orientation and subsequent education and training of all Pharmacy and non-pharmacy personnel in the preparation and administration of sterile products... The facility shall ensure that all personnel who prepare or administer sterile products are properly oriented, educated, and trained, and/or demonstrate proficiency. Individuals who prepare sterile products shall be familiar with and skilled in: Pharmacy policy and procedures for preparing sterile products, Aseptic technique, Compounding... Incompatibilities, Detection of defective products... Storage and stability... The Pharmacy shall maintain appropriate records of its participation in the orientation, education, and training of personnel who prepare sterile products."

4. During a tour of the facility's Surgical Services Department, on May 15, 2013, at 9 a.m., the Malignant Hyperthermia (MH) Medication Box was observed. (Malignant hyperthermia is a rare genetic condition that occurs when affected individuals are exposed to triggering anesthetic agents and a muscle relaxant). The box contained 36 vials of Dantrium IV (dantrolene IV is a medication required for the immediate treatment of malignant hyperthermia) 20 milligrams and 2000 milliters of sterile water.

Instructions indicated each vial of Dantrium IV should be reconstituted by adding 60 milliters of sterile water for injection. To reconstitute all 36 vials, 2160 milliters of sterile water was required.

The facility's policy and procedure titled, "Malignant Hyperthermia Drugs," was reviewed. The policy indicated, "The purpose of this policy is to define having drugs available for Malignant Hyperthermia... Pharmacy will provide, and keep in stock Dantrolene 20 mg/vial, #36 vials, used to treat Malignant Hyperthermia... Sterile Water for injection 1000 ml, stored in refrigerator."

The facility's policy and procedure titled "Management of the Patient with Malignant Hyperthermia (MH)," with a last revised date of January 2010, was reviewed. The policy indicated surgical services clinical staff would receive education regarding malignant hyperthermia and the management of a patient with MH. The policy indicated each vial of Dantrolene was dissolved with 60 millilters of sterile, preservative free water for injection. The policy indicated "As a large quantity may be necessary, a sufficient supply must be available." The policy's references included the Malignant Hyperthermia Association of the United State (MHAUS), and the Association of periOperative Registered Nurses (AORN).

The Malignant Hyperthermia Association of the United State (MHAUS), a leading nationally recognized organization with the mission to promote optimum care and scientific understanding of MH, recommends a minimum of 36 vials of Dantrolene should be available within 5 minutes of the initial diagnosis of MH.

Inspection of the MH Medication Refrigerator in the Surgical Services Department indicated there was no regular insulin stored in the refrigerator. Regular insulin is a medication used in the treatment of MH.

During an interview on May 15, 2013, at 9:30 a.m., Staff 7 was not able to locate the MH Medication Box.

5. A review of Patient 18's medical record was conducted on May 13, 2013. The medical record had a physician order dated, May 9, 2013 at 12:30 p.m., that indicated "Hep(arin) 5000 units IV now, start protocol drip for DVT (deep vein thrombosis - blood clot)"

There was a form titled, "Heparin/PTT Sliding Scale Protocol" that was completed by a nurse and signed by a physician.

During an interview on May 15, 2013, at 11:20 a.m., Staff 23 stated that a physician-ordered heparin protocol was carried out by the nurses who completed the Heparin Sliding Scale Protocol form, and the sliding scale protocol on the form was followed.

The facility's policy and procedure titled, "Anticoagulation: Heparin Infusion" was reviewed. The policy indicated, "The Heparin Protocol shall provide guidelines for Pharmacists to run the Heparin Protocol, which is initiated by a physician's order for "heparin Protocol" or "Heparin Per Pharmacy" and monitor administration of Heparin IVPB-Continuous Infusion with safety and efficacy..."

During an interview on May 15, 2013, at 2:30 p.m., Staff 3 stated that she filled out the heparin protocol form and followed the recommendation by the pharmacist to administer the loading dose from the Heparin infusion bag 5000 units or 100 ml to run for one hour.

During a concurrent interview, the DOP acknowledged that the heparin protocol needed to be initiated by the pharmacist upon receipt of the order by a physician and subsequently monitored. The DOP also acknowledged the available Heparin injectable vials that contained 5000 units in 1 ml volume should have been used for quickly reaching the therapeutic blood level rather than slower infusion of the loading dose over one hour.

During an interview on May 16, 2013, at 8:30 a.m., Pharmacist 1 stated that Heparin was not initiated and monitored by the pharmacist.

6. During an interview on May 15, 2013, at 3:45 p.m., the DOP stated that controlled substance use from the Pyxis MedStation (Automated Dispensing Cabinet: ADC) by facility's authorized staff was monitored by conducting quarterly audits of five anesthesia records.

The DOP stated that the Pharmacy received reports of all after-hour overrides of all medications from the Pyxis after pharmacy closed but indicated the audit of overrides was not done.

The DOP also stated that there were nursing units, namely ED, PACU, and outpatient, that have non-patient profiled Pyxis MedStations from which any stocked medications could be accessed by authorized staff and controlled substance access would not be reported on the override report.

The DOP stated that the Pharmacy did not conduct chart reviews for appropriate controlled substance use and proper documentation of controlled substance use and that current system in place for controlled substance audit did not include all nursing units.

The facility's policy and procedure titled, "Pyxis Automated Medstation Use" was reviewed. The policy indicated, "The following reports will automatically print daily... Daily all station events... Weekly C-II usage (all station events for C-II's by user...)
Monthly quality checks... Pharmacy will review randomly selected charts to verify proper wastages of controlled substances on a monthly basis..."

The facility's policy and procedure titled, "Controlled Drugs, Distributed and Accountability (General)" was reviewed. The policy indicated, "The Director of Pharmacy, acting as the facility's agent, shall ensure that the distribution and administration of controlled drugs are documented adequately by the pharmacy, nursing service, and other involved services or personnel in accordance with federal law and the laws of this state."

According to published guideline by American Society of Health-Systems Pharmacists (ASHP), a nationally recognized pharmacy organization, titled, "ASHP Guidelines on the Safe Use of Automated Dispensing Devices" :

"The organization should have a written plan for the monitoring and surveillance of medications accessed through automated pharmacy systems. The plan should be developed by the pharmacy, with input from nursing staff and other clinicians, and communicated to staff members responsible for its implementation. The plan should include:

Identification of the data to be captured and the reports to be generated for monitoring medication use, waste reconciliation, and discrepancies... Assignment of responsibility for reviewing reports, scheduling the frequency of report reviews, and reporting discrepancies... Assignment of reviewing overrides to ensure the function is being used appropriately."

7. During a tour of the facility's Medical/Surgical Nursing Unit (Med/Surg) on May 13, 2013, at 3 p.m., it was noted that the Adult Crash Cart and the Pediatric Crash Cart did not have a content list outside the carts.

During a concurrent interview, the DOP acknowledged that there were no content lists for the Crash Carts.

During a tour of the facility's Labor and Delivery Unit (L&D) on May 13, 2013 at 4 p.m., it was noted that the Neonatal Crash Cart did not contain a content list outside the cart.

During a concurrent interview, the DOP acknowledged that there was no content list placed outside the Neonatal Crash Cart.

8. During a tour of the facility's Medical/Surgical Nursing Unit (Med/Surg) on May 13, 2013, at 3 p.m., it was noted that the Intubation Box had a content list that indicated there were two injectable vials of etomidate 2 mg/ml without having any actual vials placed inside the box.

During a concurrent interview, the DOP acknowledged that the list did not match the content of the Intubation Box and explained that the Box for Med/Surg correctly should not have any etomidate vials.

During a tour of the facility's Emergency Department (ED) on May 13, 2013, at 3:30 p.m., it was noted that the Intubation Box located in ED had two vials of etomidate as correctly indicated on the content list found inside the box.

It was also noted the Intubation Box did not have holes to seal the box with a breakable lock.

During a tour of the facility's Intensive Care Unit (ICU) on May 13, 2013, at 4 p.m., it was noted that the intubation Box located in ICU only contained one vial of etomidate.

All three Intubation Boxes inspected were not labeled in any way specific to any one unit.

During a concurrent interview, the DOP acknowledged that the box was used during an emergency intubation and could not explain why each nursing unit required different amount of etomidate in the Intubation box.

The DOP was not able to provide documents that established the content of the Intubation Box for each nursing units and acknowledged that mistakes could be made as in the above case without one standardized content list.

Based on observation and interview, the facility failed to ensure all medications were secured to prevent unauthorized access.

Findings:

1. A medication pass observation was conducted with Staff 31 in the ICU on May 14, 2013, for Patient 3. During the observation, it was noted Staff 31 mixed the powder inside the injectable Protonix (a stomach acid reducer) 40 mg vial with a 10-ml normal saline flush syringe with a final volume inside the syringe indicating 8 ml.

It was also observed Staff 31 prepared 100-mg Solu-Cortef (injectable steroid to decrease swelling) after mixing the powder with the manufacturer supplied diluent in a 3-ml syringe and four other patient's oral medications.

Staff 31 was observed to place all medications on the bedside tray next to the bed in which the patient laid and left them there unattended and vacated the patient area to retrieve two 10-ml normal saline flush syringes from the Pyxis MedStation.

During a concurrent interview, Staff 31 acknowledged that she left the medications on the bedside tray in the patient area unattended and she should not have done that.

2. During a medication pass observation on May 14, 2013 starting at 8:50 a.m., it was noted there was an injectable bag of Levaquin (antibiotic) IV 500 mg Pre-Mix left unattended on the WOW (Workstation-on-Wheel) which was parked just outside an ICU room where Staff 33 was administering medication to a patient.

During a concurrent interview, Staff 33 stated she had placed the Levaquin bag after receiving it from the Pharmacy so that she could administer it to the next patient for which the Levaquin was intended.

Based on observation and interview, the facility failed to ensure Scheduled IV Controlled substance stored in the Pharmacy Medication Refrigerator was locked.

Findings:

During a tour of the facility's Pharmacy Department on May 13, 2013, at 1:50 p.m., it was observed in the Pharmacy Medication Refrigerator, a lockable compartment containing one hundred ninety-five (195) 1 ml vials of 2 mg Ativan, (a Scheduled 4 Controlled Substance used for anxiety). The compartment was not locked.

During a concurrent interview, the DOP agreed that the compartment should have remained locked and all controlled substances needed to be locked and secured.

Based on observation, interview, and document review, the facility failed to ensure unusable medications were not available for patient use.

Findings:

During a tour of the facility's Pharmacy Department on May 13, 2013, at 1:50 p.m., it was observed in the Pharmacy Medication Refrigerator the following pharmacy compounded IVPB injectable bags that were expired:

- One bag containing gentamicin (an antibiotic) 130 mg in 100 ml of normal saline with the expiration date of 5/7/13@2200; and

- One bag containing vancomycin (an antibiotic) 2 gm in 500 ml of normal saline with the expiration date of 5/9/13@1000.

During a concurrent interview, the DOP acknowledged the bags were expired and they should have been removed from the medication refrigerator.

The facility's policy and procedure titled, "Unusable Drugs and Medical Devices" was reviewed. The policy indicated, "Unusable drugs and medical devices include those that are expired... Otherwise unusable for administration or use... The Pharmacy shall store unusable drugs and medical devices in a specially designated area to prevent their distribution or administration. They shall not be returned to the active Pharmacy or patient stocks."

Based on interview and record review, the facility failed to ensure corrective measures were taken, per the facility's policy and procedure, when the blood bank refrigerator temperature was out of compliance for two consecutive days in April 2013. This had the potential to result in blood and blood products not being stored and maintained at an acceptable temperature and the possibility of contamination of the blood/blood products.

Findings:

Refer to 42 CFR 493.1252(b): "The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. ..."

The facility policy and procedure titled "Blood Bank Refrigerator Visual Temperature Monitoring" last revised May 2004, revealed "An NIST Blood Bank thermometer placed in the blood bank refrigerator, a Jewett digital temperature monitor, and a continuous temperature chart recorder provide verification and accuracy of the refrigerator's internal temperature. ... A Lab (oratory) Aide is to record the temperatures of the internal thermometer, the digital thermometer and the recording chart on a daily basis. ... The temperature of all three must be within 1?C (celcius) of each other. The temperature of the internal thermometer must be within 1?C of both the chart recorder and the digital thermometer. The temperature of the digital thermometer must be within 1?C of the recording chart. Notify the lab manager or a CLS (Clinical Laboratory Scientist) of any discrepancies. All discrepancies must be investigated and corrective action taken. Record corrective action taken on the Daily Temperature Log.

On May 13, 2013, at 3:25 p.m., a tour of the Clinical Laboratory was conducted with Staff 49.

The "(Facility) Laboratory Temperature Log" for April 16, 2013, was reviewed as follows:
? The internal thermometer reading was 5?C;
? The digital thermometer reading was 2.8?C ; and
? The chart recording was 4?C

The "(Facility) Laboratory Temperature Log" for April 17, 2013, was reviewed as follows:
? The internal thermometer reading was 4?C;
? The digital thermometer reading was 2.9?C; and
? The chart recording was 3?C.

There was no indication the manager or the Clinical Laboratory Scientist were informed, the temperature discrepancies were investigated, or corrective actions were taken.

During a concurrent interview with Staff 49, she reviewed the "(Facility) Laboratory Temperature Log" and verified there was more than 1?C difference between the three temperatures recorded for April 16, and 17, 2013. Staff 49 stated the Laboratory Aide who recorded the temperatures should have notified the CLS, rechecked the temperatures for accuracy, determined why the temperatures were out of range, and documented what was done to include corrective actions.

Based on interview and record review, the facility failed to ensure the medical staff and a pathologist determined which tissue specimens required a macroscopic (gross) examination and which specimens required both a macroscopic and a microscopic examination.

This had the potential to result in specimens receiving a macroscopic examination when the specimen should have received both a macroscopic and a microscopic examination.

Findings:

On May 16, 2013, at 7:45 a.m., the Chief Nursing Officer (CNO) was asked and unable to provide a facility policy and procedure, outlining which specimens required a macroscopic examination, and which specimens required both a macroscopic and a microscopic examination, as determined by the medical staff and pathologist.

The facility was unable to provide a policy and procedure, or a list of tissue specimens that required a macroscopic examination and a list of tissue specimens that required both a macroscopic and a microscopic examination.

On May 16, 2013, at 1:45 p.m., Staff 48 was interviewed. Staff 48 stated the medical staff with a pathologist had not determined which specimens required a macroscopic examination and which specimens required both a macroscopic and a microscopic examination.

Based on observation, interview and record review, the facility failed to ensure the General Manager of Food and Nutrition Services (GMFS), a Registered Dietitian (RD), developed and monitored written procedures for the provision of disaster food supplies for patients prescribed puree diets and for pediatric patients.

Findings:

On May 15, 2013, at 9:25 a.m., an observation of the disaster food supply was conducted. A disaster meal plan was posted next to the stored food supply and delineated the service of disaster foods for patients prescribed regular, renal and diabetic diets. There were no directions as to whether the menu was appropriate for service to patients prescribed puree diets and for pediatric patients. The "4-Day Disaster Menu" included food items such as dry cereal, bread, crackers, pop tarts, and peanut butter. There were no provisions for patients prescribed puree diets or for pediatric patients.

The GMFS, present at the time of the observation, acknowledged the absence of directions and provisions for the service of appropriate food items, in the case of a disaster, to patients prescribed puree or pediatric diets.

A review of the job description for the GMFS included the following as one of the duties of the GMFS: "Directs daily food service operations including: menu evaluation and planning, purchasing, inventory, receiving, food preparation, and storage."

Based on interview and personnel file review, the facility failed to ensure staff competency was documented for the Registered Dietitian (RD) who also served as the General Manager of Food Service (GMFS).

Findings:

On May 15, 2013, at 4:00 p.m., in an interview with the RD, she stated she had assumed the role of GMFS for approximately two months, since March 2013. The RD stated her personnel file was not available at the facility since she was a contracted employee, and the personnel file had to be recreated.

On May 16, 2013, at 7:50 a.m., review of the recreated personnel file for the RD revealed the "Initial & Annual Competency Assessment and Validation" form was blank. The management skills competencies were blank and there was no evaluation of the RD's clinical skills or age-appropriate competencies. There was also no evidence of orientation of the RD to the facility.

On May 16, 2013, at 9:15 a.m., during the Quality Assurance (QA) interview with facility staff, the Human Resources Manager (HRM) stated she was not allowed to maintain personnel files for contracted employees and relied on management staff within the contract company to ensure appropriate competencies were completed. The HRM stated she maintained a file at the facility for orientation and training that employees completed on site. No record was available for the RD.

A review of the facility policy titled, "Assessment of Competency" dated February 1, 2011, indicated the purpose of the policy was to "..Ensure the competence of all staff members is assessed, maintained, demonstrated, and improved continually." The procedure included
"Complete the competency assessment development and training checklist for all new employees ...Include age-appropriate skills competency for designated positions."

A review of the facility policy titled, "Orientation," dated February 1, 2011, indicated the purpose of the policy was, "The Orientation Process provides initial job training and information as well as assessing the staff's ability to fulfill specific responsibilities."

Based on staff interview and record review, the facility failed:

1. To ensure standard menus were comprehensively analyzed for the nutritional components to meet the current national standards including the RDA (Recommended Dietary Allowances) and the DRI (Dietary Reference Intake) of the Food and Nutrition Board of the National Research Council for all diets/populations served at the facility, and adjusted for the nutritional needs of the populations served by the hospital.

2. To ensure patient diets were prepared and served as planned and in accordance with prescribed orders and the planned menu.

3. To ensure dietary staff comprehensively addressed the nutritional status of one sampled patient (Patient 22) in accordance with the physician plan of care and facility diet manual recommendations.

This had the potential for the patients in the hospital to not receive adequate nutrition to meet the estimated recommended dietary allowances, and in accordance with prescribed physician orders.

Findings:

1a. The DRI/RDA consists of nutrient based references whose purpose is to plan diets for individuals, focusing on optimizing health status, disease prevention and ensuring consumption of nutrients in adequate amounts. The provisions of the Dietary Reference Intakes, which include the Recommended Dietary Allowances (RDA's), Adequate intake, and Acceptable Macro and Micronutrient distribution ranges, developed by the Food and Nutrition Board under the auspice of the Institute of Medicine are used to evaluate nutritional adequacy of patient menus.

On May 15, 2013, at 10:15 a.m., review of the facility's nutrient analysis for the hospital diets revealed it did not include an analysis of the fiber content of the menu, or all macro and micronutrients specified in the RDA or DRI such as copper, selenium, biotin, pantothenic acid, Vitamin B, Vitamin D, Vitamin E, etc..

Further review of the nutrition analysis, indicated, there was no analysis of what would be provided on the facility's hepatic/low protein diet. In addition, there was no comparison of the facility menu nutrition analysis with the nutritional needs of target groups served by the facility to determine adequacy of the planned menu in meeting the needs of the patients served.

A review of the facility policy titled, "Menu Nutrient Analysis" dated February 1, 2011, revealed, "The Food and Nutrition Services Department will maintain current nutrient analysis of patient menus."

b. On May 15, 2013, at 10:15 a.m., review of the planned menus showed there was no special consideration for patients who were pregnant or lactating.

A review of the facility Nutrition Care Manual guidelines for the Lactation, revealed, "Additional energy needs for an exclusively breastfeeding woman are approximately 670 Kcal (calories)/day." Guidelines for pregnancy included increased calories as well as the provision of at least one serving per day of fruits, vegetables, or grains high in folic acid/folate, high in vitamin A and vitamin C.

c. Further review of the planned menus showed no menus had been designed for the pediatric population served by the hospital which ranged in age from 0 to 18 years of age.

In a concurrent interview with the Registered Dietitian (RD), she confirmed the menus were not adjusted calorically for pregnant or post-partum patients. She stated that patients were offered regular diets and the non-select regular menu mirrors the menu that would be sent to any patient prescribed a regular diet at the facility. The RD further acknowledged the absence of planned menus to serve the pediatric population served by the facility.

2. On May 15, 2013, at 11:45 a.m., during an observation of the lunch trayline process, beef tips with mushrooms and gravy were noted to be the main entree served to patients utilizing a three ounce ladle. Review of the menu spreadsheet and the recipe for beef tips with mushrooms revealed the portion size should have been six ounces.

Further review of the lunch trayline revealed, two patient menus indicated prescribed diets of 2000 ADA (diabetic). Review of the menu spreadsheet indicated those patients should have received two servings of noodles and two servings of angel food cake. Observation of the meal served to the residents showed the residents prescribed 2000 ADA diets received only one serving of angel food cake and one serving of noodles.

On May 15, 2013, at 11:55 a.m., in an interview with Staff 50, she acknowledged the serving size of the beef tips with mushrooms should have been 6 ounces, and confirmed the extra servings of noodles and angel food cake should have been served on the 2000 ADA diets.

A review of the facility policy titled, "Patient Menus - Tray Identification" dated February 1, 2011, revealed "Patient trays are assembled in accordance with the menu spreadsheet or pattern written by the dietitian."

3. On May 15, 2013, at 10:30 a.m., review of the record for Patient 3 indicated the patient was admitted on May 14, 2013, with diagnoses that included end stage liver disease, ascites (accumulation of fluid in the peritoneal cavity), and chronic confusion.

On May 14, 2013, the physician prescribed a low protein, 2000 calorie diet with a 1800 cc (cubic centimeter) fluid restriction. The diet order was changed the same day to a hepatic diet, 2000 ADA (diabetic), with a 1600 cc fluid restriction. A nutrition consultant was also requested.

On May 14, 2013, the patient's percent meal intake was documented as 90% for breakfast, 45% for lunch and 100% for dinner. Patient 3's ammonia levels were initially documented as 220 mcg/dl (micrograms per deciliter) and gradually decreased to 50 mcg/dl.

A nutrition assessment was completed on May 14, 2013, by a Registered Dietitian (RD). The RD documented the patient was 5 feet 5 inches tall and weighed 126 pounds. The RD noted the patient had weighed 170 pounds over the "distant past" and had experienced progressive weight loss over an unknown amount of time. The RD documented Patient 3's abdomen was noted to be distended. The RD assessed the patient's nutritional needs at 1431-1718 calories and 57-74 grams of protein (1-1.3 grams of protein per kilogram). The RD recommended supplementation of the diet with two cans of Ensure Plus (nutritional supplement providing 480 cc of fluid and 26 grams of protein), multivitamins and a daily probiotic.

A review of the facility policy titled "Interpretation of Diet Orders - Non-Specific Diet Orders" dated February 1, 2011, indicated a "Hepatic/Liver Diet" was to be interpreted as: 2 gm (gram) Na (sodium), 60 gm protein. This diet provided protein needs within the range recommended by the RD.

On May 15, 2013, at 2:45 p.m., in an interview with the General Manager of Food Service (GMFS), she stated the RD who completed the assessment was from Arizona and was being oriented to the facility. The GMFS stated, "He may be used to ordering probiotics at the hospital he works for in Arizona, but we don't provide that here." With regards to the RD recommendations for increased protein needs via nutrition supplement, the GMFS stated the RD was working within the guidelines of the Nutrition Care Manual.

A review of the Nutrition Care Manual recommendations for liver disease included, "Protein requirements may also change over time as the liver disease progresses ...nutrition prescription for cirrhosis include the following: ... Modest protein intake for those with protein-sensitive hepatic encephalopathy ...Goals for nutrition intervention for cirrhosis include the following ... Protein at 0.8 g/kg (grams per kilogram) to 1.2 g/kg dry or appropriate weight for height."

In a further interview with the GMFS, she was not sure whether the RD had discussed his recommendations (to provide the patient with approximately 86 grams of protein per day) with the physician who had recommended a low protein/hepatic diet for the patient. The GMFS also acknowledged the provision of liquid supplements would have to be subtracted from the patient's fluid restriction which would limit the amount of other fluids that could be provided on the patient's tray.

A review of the facility policy titled, "Nutrition Assessment, Reassessment" dated February 1, 2011, indicated "Physicians assume the responsibility for the overall nutritional management of the patient ....The Clinical Nutrition Team uses the information from other disciplines to continually monitor patient needs and response to nutrition care."

Based on interview and document review, the facility failed to ensure that the diet manual included guidance for the service of pediatric diets that were served at the facility, and was individualized to reflect the diet orders as prescribed at the facility.

Findings:

On May 15, 2013, at 10:15 a.m., in an interview with the Registered Dietitian (RD), she indicated the facility utilized the Nutrition Care Manual as the facility diet manual. The RD stated the Nutrition Care Manual was available online and in a hard copy format.

A concurrent review of the diet manual revealed there were no guidelines provided related to the nutritional needs of pediatric patients (Age 0-18).

A review of the facility policy titled "Diet Manual" dated February 1, 2011, indicated "Food and Nutrition Services Registered Dietitians are responsible for the identifying and recommending of a diet manual that will include diets that will meet the needs of the patients at (name of facility)".

A review of the facility policy titled "Interpretation of Diet Orders - Non-specific Diet Orders" dated February 1, 2011, revealed "Nonspecific diet orders or orders not specified in the hospital approved Diet Manual will be interpreted and provided as listed."

Further review of the online and hard copy versions of the Diet Manual revealed a copy of this policy/interpretation of diet orders was not added as an addendum, and was therefore not available for reference by medical and nursing personnel.

Based on observation, interview, and record review, the facility failed:

1. To ensure expired supplies and single use opened bottles of scrub solution were not available for patient care use. This had the potential to result in expired products being used for patient care.

2. To ensure content lists, to include supplies and medications with quantities, for the adult, pediatric and infant emergency carts were easily accessible. This resulted in staff being unaware of what supplies or supply quantities, and where the supplies would be located in the emergency carts.

3. To ensure the emergency department warming cabinets were monitored according to instructions on the temperature control charts and facility practices. This had the potential for overheated blankets and solutions being used for patient care.

Findings:

On May 13, 2013, at 11 a.m., a tour of Labor & Delivery (L&D) was conducted with Staff 35.

The following was observed in L&D:
- Four (4), 3-0 Vicryl sutures, with a CT Taper needle, with an expiration date of January 2011.
- One, four fluid ounce single use bottle of Povidone-Iodine Scrub opened with one half of the fluid gone.
- One gallon of Sparkletts water with a best by date of February 10, 2012.
- Eight packets of E-Z Lubricating Jelly with an expiration date of March 2013.

The following was observed in the Nursery:
- One bottle of 1650 milliliters of Sterile Water used for respiratory therapy equipment with an expiration date of March 2012.
- One packet of Povidone-Iodine Swabstick (3's) with an expiration date of January 2011.

During a concurrent interview with Staff 35, she stated the sutures, gallon of water, lubricating jelly, sterile water and povidone-iodine swabsticks were expired and should have been discarded. In addition, Staff 35 stated the povidone-iodine scrub was a single use item and once the scrub had been opened it should have been discarded.

On May 14, 2013, at 8 a.m., a tour of the Intensive Care Unit (ICU) was conducted with Staff 1.

The following was observed in the ICU, "Cart #1:"
- Six (6), blue top vaccutainer laboratory tubes with an expiration date of January 2013.
- Two (2), yellow top vaccutainer laboratory tubes with an expiration date of February 2013.
- Two (2), blue top vaccutainer laboratory tubes with an expiration date of March 2013.

During a concurrent interview with Staff 1, she stated the blue and yellow vaccutainer laboratory tubes were expired and should have been returned to the laboratory and new vaccutainer tubes obtained.

The facility policy and procedure titled "Sterile Manufactured Supplies Expiration Process" reviewed May 5, 2009, revealed "... All sterile items throughout the hospital must be checked for expiration dates on a routine basis. This is the responsibility of each department; however the Materials Management Department retains oversight responsibility. Items that have reached the marked expiration date will be immediately removed from patient care areas and returned to the Materials Management Department. ... Each department must have a method of regularly checking their sterile supplies for outdates and documenting it..."

2. On May 13, 2013, at 11:30 a.m., a tour of Labor & Delivery/Obstetrics/Nursery was conducted with Staff 35.

In Labor & Delivery, on top of the Neonatal Crash Cart was a red binder with a daily check off sheet. The cart had multiple drawers and was locked. The red binder did not contain a list of the supplies/medications with quantities or where the supplies/medications would be located in the cart.

In Labor & Delivery, on top of the Adult Crash Cart was a red binder with a daily check off sheet. The cart had multiple drawers and was locked. The red binder did not contain a list of the supplies/medications with quantities or where the supplies/medications would be located in the cart.

During a concurrent interview with Staff 35, she verified there were no content lists of supplies/medications for the emergency carts available. Staff 35 stated she did not know what specific medications/supplies were in the carts. In addition, Staff 35 stated the Respiratory Therapy Department was responsible for maintaining the emergency carts.

On May 13, 2013, at 2:12 p.m., an observation was made of the Pediatric and Adult Crash Carts located in the Medical/Surgical/Telemetry Unit.

On top of the Pediatric Crash Cart was a red binder with a daily check off sheet. The cart had multiple drawers and was locked. The red binder did not contain a list of the supplies/medications with quantities or where the supplies/medications would be located in the cart.

On top of the Adult Crash Cart was a red binder with a daily check off sheet. The cart had multiple drawers and was locked. The red binder did not contain a list of the supplies/medications with quantities or where the supplies/medications would be located in the cart.

During an interview with the Chief Nursing Officer (CNO), on May 13, 2013, at 4:30 p.m., she verified the Pediatric Crash Cart and the Adult Crash Cart in the Medical/Surgical/Telemetry Unit did not have a content list available for staff. The CNO stated the crash carts/emergency carts should all have a list of the supplies/medications in the cart to include quantities and location, and the list should be located in the red binder on top of each cart.

The facility policy and procedure titled "Crash Cart - Standardized Arrangements" last revised/reviewed May 2013, revealed "...Crash Carts should be arranged according to this form and a crash cart supplies checklist will be checked for accuracy every month by clinical staff designee. ..."



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3. On May 13, 2013, at 12:15 p.m., a tour of the Emergency Department (ED) was conducted with the Chief Nursing Officer (CNO). A two tiered warming cabinet (a cabinet designed to warm blankets and/or solutions) was observed. The cabinet was divided into sections, each with its own temperature display.

The cabinet's lower section contained hospital linens, including bath sheets and blankets . The external digital display for the temperature in the lower section of the warmer read 140? F (Fahrenheit).

The upper section of the cabinet contained two 1000 millilters bags of intravenous normal saline solution and multiple "Ready Bath Luxe," body cleansing wipes. The upper section's digital display indicated a temperature of 122 ?F. One of the bags of normal saline was picked up. The bag, as verified by the CNO, was very warm to touch.

During an interview with Staff 39, on May 13, 2013, at 12:20 p.m., Staff 39 stated, ED staff check the temperature of the cabinet warmer and if not within range they increased or decreased the temperature. Staff 39 stated she did not know why the intravenous solution was placed in the warmer.

Two logs sheets attached to the warming unit were reviewed. The first log titled "Blanket Warmer Temperature Monitor Control Chart," indicated facility staff were to record the temperature, daily by placing a dot in the box that corresponded with the appropriate temperature for that day. The instructions indicated if the temperature fell outside the acceptable range of 120-130 ? F, corrective actions would be recorded on the form. Written documentation would include initials, actions taken to correct out of range temperatures, and the results of a repeat temperature taken after the problem was corrected. The Blanket warmer chart for May 2013 contained one entry. The entry for May 1, 2013, one dot at 145 ?F. There was no further documentation about corrective actions or repeat temperature readings.

The second log, titled "Ready Bath Warmer Temperature Monitor Control Chart," contained the same instructions, but indicated acceptable temperature ranges would be between 122-128?F.

The facility policy and procedure for blanket and fluid warming in the ED was requested.

A policy titled "Perinatal Unit Warmer/Blanket Warmer," revised June 2006, was reviewed. The policy indicated its purpose:

"Irrigant is kept in the blanket warmer to be used in labor and delivery as well as surgery.
a. The temperatures of the blanket warmer (upper part of the cabinet) are to be kept within 85-105 degrees Fahrenheit - in the upper compartment for warming irrigants, and
b. 85-110 degrees Fahrenheit for warming blankets on the lower compartments.
Thermometers are internal and are checked every 24 hours by the LDRP [Labor Delivery Recovery Postpartum] and OR [Operating Room] staff."

The policy also indicated the temperature of the blanket warmer was logged daily by assigned shift.

On May 14, 2013, the CNO indicated there was no policy and procedure for the ED's blanket/fluid warmer. The CNO also stated there was no policy for the "Ready Bath Luxe," prepackaged cleansing wipes.

Based on observation, interview and record review, the facility failed to ensure a sanitary environment was maintained and an active program was in place to prevent infections for all patients as evidenced by failure:

1. To ensure reusable head covering, used by surgical staff inside of the Operating Room (OR), were professionally laundered. (Refer to A749);

2. To ensure Surgical staff did not wear masks outside of the OR. (Refer to A749);

3. To ensure unpackaged syringes, (with and without needles) and lip balms, (opened and undated) were not available for use on and in an anesthesia cart in the OR. (Refer to A749);

5. To ensure the distal tips of two endoscopes were not touching a towel at the bottom of the storage cabinet in the OR. (Refer to A749);

6. To ensure dust was not on top of the endoscope storage cabinet in the OR corridor. (Refer to A749);

7. To ensure staff and visitors used personal protective equipment (PPE), and/or washed their hands while caring and/or visiting patients on contact isolation. (Refer to A749);

8. To ensure manufacturer's disinfecting wet contact time was met during the turnover cleaning of an OR suite. (Refer to A749);

9. To ensure the ice machine in the dietary department was sanitized using the manufacturer's recommended process. (Refer to A749);

10. To ensure food items were not kept past the manufacturer's suggested "Best By" dates. (Refer to A749); and

11. To ensure open tube feeding systems were hung in accordance with facility policy to prevent possible contamination and infections. (Refer to A749).

The cumulative effects of these systemic problems resulted in the failure of the infection control program to ensure care was being provided in a safe and effective manner.

Based on observation, document review, and staff interview, the hospital failed to maintain a system for controlling sources of infections in accordance with internal policies and procedures, nationally recognized infection control practices and guidelines, and applicable regulations, when:

1. Reusable head covering, used by surgical staff inside of the Operating Room (OR), were not professionally laundered.

2. Surgical staff wore masks outside of the OR.

3. Unpackaged syringes, with and without needles, were observed on and in an anesthesia cart in the OR.

4. Three lip balms, opened and undated, were observed in an anesthesia cart in the OR.

5. The distal tips of two endoscopes were touching a towel at the bottom of the storage cabinet in the OR.

6. Dust was observed on top of the endoscope storage cabinet in the OR corridor.

7. A Physician and a nurse were observed entering a contact isolation room in the ICU without the use of personal protective equipment (PPE),and/or washing their hands. In addition, visitors did not use PPE while visiting a patient on contact isolation.

8. Manufacturer's disinfecting wet contact time was not met during the turnover cleaning of an OR suite.

9a. The ice machine in the dietary department was not sanitized using the manufacturer's recommended process.
b. Food items were kept past manufacturer's suggested "Best By" dates.
c. Open tubefeeding systems were not hung in accordance with facility policy to prevent possible contamination and infections.

Findings:

1. From May 13 through May 16, 2013, during intermittent observations, three surgical staff were observed wearing reusable head coverings outside of the OR.

On May 15, 2013, at 2:50 p.m., during an interview with Staff 52, she stated that she takes her reusable head coverings home and launders them.

On May 13, 2013, at 11:05 a.m., during an interview with Staff 2, she stated the facility follows APIC (Association for Professionals in Infection Control and Epidemiology), AORN (Association of Perioperative Registered Nurses), and CDC (Centers for Disease Control and Prevention) standards.

The undated facility policy titled, "Infection Prevention & Control Program," was reviewed, and revealed the following:

? Authority & Responsibility: The Infection Preventionist develops and implements Palo Verde Hospital Infection Prevention and Control policies and procedures using, at minimum, the following as resources:
o APIC
o CDC
o The Society for Healthcare Epidemiology of America
o The Joint Commission
o The County of Riverside
o State of California Department of Public Health

The facility policy, dated March 2010, and titled, "Surgical Services, Attire in the Operating Room," was reviewed and revealed, "A clean surgical cap or bouffant should be worn prior to entering a semirestricted or restricted area ...The headgear is to be properly disposed of in designated receptacles after use."

According to the AORN, Perioperative Standards and Recommended Practices, Recommended Practices for Surgical Attire (2013):
? Clean surgical attire, including shoes, head covering, masks, jackets, and identification badges should be worn in the semirestricted areas (includes the peripheral support areas of the surgical suite and has storage areas for sterile and clean supplies, work areas for storage and processing instruments, and corridors leading to the restricted areas of the surgical suite) and restricted areas (includes the OR and procedure room, the clean core, and scrub sink areas. People in this area are required to wear full surgical attire and cover all head and facial hair, including sideburns, beards, and necklines) of the surgical or invasive procedure setting.
? All individuals who enter the semirestricted and restricted areas should wear freshly laundered surgical attire that is laundered at a health care-accredited laundry facility or disposable surgical attire provided by the facility and intended for use within the perioperative setting.
? Surgical attire should be changed daily or at the end of the shift.
? Reusable head coverings should be laundered in a health care-accredited laundry facility after each daily use.
? Surgical attire should be laundered in a health care-accredited laundry facility.
? Home laundering is not monitored for quality, consistency, or safety. Exposure of health care personnel and their family members to blood and other potentially infectious materials may result from improper handling and decontamination of surgical attire.
? Home laundering may not meet the specified measures necessary to achieve a reduction in microbial levels in soiled surgical attire.

2. From May 13 through May 16, 2013, during intermittent observations, four surgical staff were observed wearing masks outside of the OR, one of which hung from the neck and touched the staff's scrub top.

The facility policy, dated March 2010, and titled, "Surgical Services, Attire in the Operating Room," was reviewed and revealed, "A single use surgical mask is to be worn at all times when open sterile items and equipment are present ...The mask should be discarded immediately after each use in a designated receptacle."

According to the AORN, Perioperative Standards and Recommended Practices, Recommended Practices for Surgical Attire (2013):
? All individuals entering the restricted areas should wear a surgical mask when open sterile supplies and equipment are present.
? A fresh, clean surgical mask should be worn for every procedure. The mask should be replaced and discarded whenever it becomes wet or soiled.
? Masks should not be worn hanging down from the neck. The filter portion of a surgical mask harbors bacteria collected from the nasopharyngeal airway. The contaminated mask may cross-contaminate the surgical attire top.
? Surgical masks should be discarded after each procedure. Masks should be removed carefully by handling only the mask ties. Hand hygiene should be performed after removal of masks.

3. On May 13, 2013, at 11:25 a.m., during observation and concurrent interviews with Staff 2 and Staff 52, an empty 20 ml syringe (unpackaged and unlabeled) was observed on top of an anesthesia cart in the OR.

Staff 2 stated she was not sure why the syringe was there. Staff 52 stated the syringe was used to test laryngeal mask airways (an airway device that enable the passage of oxygen or anesthesia gas into a patient's lungs).

On May 15, 2013, at 8:30 a.m., four empty syringes with needles (a 5 ml and 3 ml with a Fentanyl label, a 10 ml with a Neostigmine/ Glycopyrrolate label, and a 5 ml unlabeled) were observed in an anesthesia cart drawer.

The facility policy, dated March 2010, and titled, "Pharmacy, Infection Control, single-use sterile drugs and services", indicated, "Single-use sterile ...devices (e.g., syringes) shall be used when economically feasible... Single-use sterile ...devices shall not be reused."

According to the AORN, Perioperative Standards and Recommended Practices, Recommended Practices for Prevention of Transmissible Infections in the Perioperative Practice Setting (2013):
? A syringe and needle should be used only once to administer a medication to a single patient, after which the syringe and needle should be discarded. The syringe should never be left unattended and should be discarded immediately at the end of the procedure.

According to the APIC position paper: Safe injection, infusion, and medication vial practices in health care (April 2010), retrieved from the American Journal of Infection Control:

SYRINGES
? Remove the sterile needle/cannulas and/or syringe from the package immediately before use.
? Never use a syringe for more than 1 patient even if the needle has been changed between patients.
? Use a new syringe and a new needle for each entry into a vial or IV bag.
? Discard syringes, needles, and cannulas after use directly on an individual patient or in an IV administration system.
? Never store or transport syringes in clothing or pockets.
? Prepare syringes as close to administration as feasible.

According to the California Department of Public Health, Licensing and Certification, All Facilities Letter (AFL) 08-11, Multi-Dose Medication and Reuse of Syringes:
? Healthcare providers should never reuse a needle or syringe ...both needle and syringe must be discarded once they have been used.

According to the Centers for Disease Control and Prevention (CDC)/Healthcare Infection Control Practices Advisory Committee (HICPAC), Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings (2007):
? Syringes are sterile, single-use items; they should not be reused for another patient or to access a medication or solution that might be used for a subsequent patient.

4. On May 13, 2013, at 11:25 a.m., during observation and concurrent interviews with Staff 2 and Staff 52, three lip balms, opened and undated, were observed in an anesthesia cart in the OR. Staff 52 stated the lip balm was applied to pediatric anesthesia masks during procedures. Staff 2 stated the lip balms should be for single use.

The facility policy, dated July 2011, and titled, "Infection Control, Transmission Based (Isolation) Precautions" was reviewed. The policy revealed, "Patient Care Equipment - The use of noncritical patient care equipment should be dedicated to a single patient whenever possible. If use of common patient or equipment or items is unavoidable, the equipment or items must be adequately cleaned and disinfected prior to use on another patient."

According to the CDC/HICPAC, Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings (2007):
? Indirect contact transmission: Indirect transmission involves the transfer of an infectious agent through a contaminated intermediate object or person.
Precautions to Prevent Transmission of Infectious Agents
? Standard Precautions are intended to be applied to the care of all patients in all healthcare settings, regardless of the suspected or confirmed presence of an infectious agent. Implementation of Standard Precautions constitutes the primary strategy for the prevention of healthcare-associated transmission of infectious agents among patients and healthcare personnel.
? Standard Precautions include a group of infection prevention practices that apply to all patients, regardless of suspected or confirmed infection status, in any setting in which healthcare is delivered. The recommendations are considered a standard of care and are based on the principle that all blood, body fluids, secretions, and mucous membranes may contain transmissible infectious agents. Equipment or items in the patient environment likely to have been contaminated with infectious body fluids must be handled in a manner to prevent transmission of infectious agents.

According to the AORN, Perioperative Standards and Recommended Practices, Recommended Practices for Prevention of Transmissible Infections in the Perioperative Practice Setting (2013):
? All noncritical equipment, items that come in contact with intact skin but not mucous membranes, should be cleaned and disinfected before use on another patient and should be handled in a manner to prevent health care provider or environmental contact with potentially infectious materials.

5. During observations on May 13, 2013, at 11:05 a.m., and on May 14, 2013, at 9:45 a.m., the distal tips of two endoscopes (a device that is used to look inside a body cavity or organ) were touching a towel at the bottom of the storage cabinet in the OR corridor.

During concurrent interview on 5/14/13, at 9:45 am, Staff 2 and Staff 53 stated the endoscopes should not touch the towel at the bottom of the cabinet.

According to the CDC/HICPAC, Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings (2007):
? More healthcare-associated outbreaks have been linked to contaminated endoscopes than to any other medical device.
? Store the endoscope in a way that prevents recontamination and promotes drying (e.g., hung vertically). Drying the endoscope is essential to greatly reduce the chance of recontamination of the endoscope by microorganisms that can be present in the rinse water.

According to the AORN, Perioperative Standards and Recommended Practices, Recommended Practices for Cleaning and Processing Flexible Endoscopes and Endoscope Accessories (2013):
? Flexible endoscopes should be stored in a manner that protects the device from damage and minimizes microbial contamination. Flexible endoscopes should be stored in a closed cabinet with venting that allows air circulation around the flexible endoscopes and adequate height to allow flexible endoscopes to hang without touching the bottom of the cabinet.
? Proper storage facilitates drying and decreases potential for contamination, coiling or kinking may prevent remaining moisture to drain out of the endoscope and increase the potential development of an environment conducive to microbial growth in the endoscope.

6. During observation and concurrent interview on May 14, 2013, at 9:50 a.m., dust was observed on top of the endoscope storage cabinet in the OR corridor. Staff 53 confirmed the presence of dust and stated that the surface should be cleaned daily.

The facility policy, dated October 2008, and titled, "Housekeeping, Surgery Cleaning Procedure," was reviewed. The policy revealed, "The purpose of this policy is to ensure an aseptically clean environment for staff and for the processing through strict adherence to post case cleaning and terminal cleaning procedures and schedules... It is the policy of the Housekeeping Department at [Facility Name] that Surgery and related areas directly connected to its operation are to be cleaned in accordance with a strict daily and weekly schedule... Areas of responsibility...Corridors ...Surgery Units (2)... All corridors are to be dust mopped damp mopped daily once each shift, using disinfectant solution."

According to the AORN, Perioperative Standards and Recommended Practices, Recommended Practices for Environmental Cleaning in the Perioperative Setting (2013):
? The patient should be provided a clean, safe environment. Cleanliness means the absence of visible dust, debris, soil, or body substances.
? All horizontal surfaces in the OR should be damp dusted before the first scheduled surgical procedure of the day.
? Dust is known to contain human skin and hair, fabric fibers, pollens, mold, fungi, insect parts, glove powder, and paper fibers among other things.
? Growth of bacteria and fungus has been found in dust.
? Terminal cleaning and disinfection of the perioperative environment decreases the number of pathogens, dust, and debris that is created during the day.

According to the CDC/HICPAC, Guidelines for Environmental Infection Control in Health-Care Facilities (2011), Environmental Services, Cleaning and Disinfecting Strategies for Environmental Surfaces in Patient-Care Areas:
? Wet-dust horizontal surfaces daily by moistening a cloth with a small amount of an EPA-registered hospital detergent/disinfectant.

7a. On May 14, 2013, at 8:15 a.m., the following observation was made in the Intensive Care Unit (ICU) with Staff 1:

- A florescent/bright green "Contact Precautions" sign was posted on the curtain cubicle occupied by Patient 4.
- Physician (MD) 6 was observed entering the ICU and Patient 4's cubicle.
- MD 6 did not wash his hands, proceeded to apply gloves and examined Patient 4.
- MD 6 removed his gloves and left the ICU without washing his hands or using a waterless antiseptic agent.

During a concurrent interview with Staff 1, she stated Patient 4 was on "Contact Precautions" for a history of and possible MRSA (Methicillin-resistant Staphylococcus aureus - a bacterium responsible for several difficult-to-treat infections), MD 6 should have worn a cover gown (personal protective equipment) when he examined Patient 4, and MD 6 should have washed his hands or used a waterless antiseptic agent after removing his gloves and before leaving the ICU.

b. On May 14, 2013, at 8:30 a.m., the following observation was made in the Intensive Care Unit (ICU):
- A florescent/bright green "Contact Precautions" sign was posted on the door of the room occupied by Patient 16.
- Staff 33 entered Patient 16's room and applied gloves once she was in the room.
- Staff 33 leaned over Patient 16's bed rail and proceeded to adjust the patient's tubes, lines, bed linens, and re-apply Patient 16's restraints moving from one side of the bed to the other during this process. Staff 33 was not wearing a cover gown (personal protective equipment).
- At 8:32 a.m., Staff 33 put on a cover gown and removed the cover gown 15 seconds later when she left Patient 16's room.

On May 14, 2013, at 9:20 a.m., an interview was conducted with Staff 33. She stated if a patient was on "Contact Isolation," the individual entering the room should put on gloves and a cover gown any time the individual was touching the patient or items that may or have come in contact with the patient. Staff 33 stated Patient 16 was on "Contact Precautions" for a history of and possible MRSA (Methicillin-resistant Staphylococcus aureus - a bacterium responsible for several difficult-to-treat infections). When Staff 33 was asked why she did not wear a cover gown when caring for Patient 16, at 8:30 a.m., Staff 33 stated she should have worn a cover gown when she was working with Patient 16 because she was touching the patient, re-applying her restraints, and moving her bed linens.

The facility florescent/bright green "Contact Precautions" sign, indicated "... Gowns are required, not optional, when you enter a room. WASH YOUR HANDS immediately with antimicrobial agent before leaving the patient's room. ..."

The facility policy and procedure titled "Transmission Based (Isolation) Precautions" revised July 2011, revealed "... Contact Precautions include the following: ... Always remove gloves prior to leaving the patient's environment and wash hands promptly with an antimicrobial agent or a waterless antiseptic agent. ... Wear an isolation gown as outlined under Standard Precautions prior to entering the room of a patient on contact precautions. ... Examples of Diseases or Conditions Requiring Contact Precautions: ... MRSA ..."

c. On May 13, 2013, at 11:10 a.m., Staff 34 was observed placing a gown and gloves on herself as she prepared to enter Patient 14's room. A green sticker was observed on the door indicating the patient was on "Contact isolation." There were three visitors in the room with the patient, and none were wearing a gown or gloves.

In a concurrent interview with Staff 34, she stated visitors are required to follow the same precautions as the staff when entering the room of a patient on contact isolation. Staff 34 further stated, visitors of any patient on contact isolation are instructed to wear gown and gloves anytime they enter the patient room.

Further review of the instructions on the green isolation sticker revealed, "Wear gloves when entering the room... Gowns are required, not optional, when you enter a room..."

The record for Patient 14 was reviewed with Staff 36. Patient 14 was admitted to the facility on May 9, 2013, with diagnoses that included back infection. In addition, Patient 14 had a history of MRSA. Staff 36 stated any patient that comes in with a history of MRSA is automatically placed on contact isolation by nursing. She stated Patient 14 did have a history, but also had a current MRSA infection in the wound on his back.

The nursing notes for Patient 14 was reviewed with Staff 36, and she was unable to find documentation the patient and/or family members were provided education or instructions on the proper procedures for contact isolation.

On May 13, 2013, one of the visitors for Patient 14 was interviewed. The visitor stated she was the spouse for Patient 14, and had visited daily since his admission four days earlier. The spouse stated she was never advised to wear a gown and gloves while visiting with Patient 14.

According to the Centers for Disease Control and Prevention (CDC)/Healthcare Infection Control Practices Advisory Committee (HICPAC), Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings (2007):
? Personal protective equipment (PPE) for healthcare personnel: Hand hygiene is always the final step after removing and disposing of PPE.
? Gloves are used to prevent contamination of healthcare personnel hands when anticipating direct contact with potentially infectious material; having direct contact with patients who are colonized or infected with pathogens transmitted by the contact route.
? Isolation gowns are used as specified by Standard and Transmission-Based Precautions, to protect the HCW ' s arms and exposed body areas and prevent contamination of clothing with blood, body fluids, and other potentially infectious material.
? Clinical and laboratory coats or jackets worn over personal clothing for comfort and/or purposes of identity are not considered PPE.
? Isolation gowns are always worn in combination with gloves, and with other PPE when indicated.
? When Contact Precautions are used, donning of both gown and gloves upon room entry is indicated to address unintentional contact with contaminated environmental surfaces.

8. During observation on May 14, 2013, at 10:18 a.m., Oasis 499 HBV Disinfectant was applied to the procedure table and padding in OR #1. At 10:25 a.m. (7 minutes later), the procedure table and padding were approximately half-dry, verified by Staff 2.

In a concurrent interview with Environmental Services Staff (EVS 1), regarding the manufacturer's disinfecting wet contact time, she stated surfaces must remain wet for 10 minutes.

The facility policy, dated October 2008, and titled, "Housekeeping, Surgery Cleaning Procedure," was reviewed. The policy revealed, "Disinfectant Solutions: Oasis 499 HBV Disinfectant - use for cleaning, disinfecting of all surfaces ...Note: Manufacture Instructions for Oasis 499 HBV Disinfectant ...Treated surfaces must remain wet for 10 minutes... Wipe down all equipment with disinfectant solution ensuring that all surfaces remain wet for disinfection contact time in accordance [sic] manufacturer instructions.

According to CDC/HICPAC, Guideline for Disinfection and Sterilization in Healthcare Facilities (2008):
EPA and FDA
? Antimicrobials are regulated by the EPA and FDA, under the authority of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Food, Drug and Cosmetic Act. Any substance or mixture of substances intended to prevent, destroy, repel, or mitigate any pest (including microorganisms) must be registered and users must explicitly follow the labeling directions on each product, i.e., " It is a violation of federal law to use this product in a manner inconsistent with its labeling. " Thus, health-care workers must follow the safety precautions and use directions on the labeling of each registered product. Failure to follow the specified use-dilution, contact time, method of application, or any other condition of use is considered a misuse of the product and potentially subject to enforcement action.

According to the CDC/HICPAC, Guidelines for Environmental Infection Control in Health-Care Facilities (2011), Cleaning and Disinfecting Strategies for Environmental Surfaces in Patient-Care Areas:
? Cleaning and Disinfecting Strategies for Environmental Surfaces in Patient-Care Areas: Select EPA-registered disinfectants, if available, and use them in accordance with the manufacturer's instructions.



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9a. On May 15, 2013, at 10:30 a.m., Staff 46 was interviewed regarding the process for cleaning and sanitizing the ice machine located in the dietary department. Staff 46 stated he was cleaning the ice machine quarterly, but has just switched to a monthly process. Staff 46 stated he utilized a "Nickel Safe" product and water to clean the machine, but did not utilize any sanitizer. Staff 46 was unsure of the manufacturer's recommendations for cleaning and sanitizing the ice machine.

Staff 46 provided a preventative maintenance record for the ice machine that indicated the ice machine had not been sanitized in two years.

On May 16, 2013 at 12:30 p.m., the facility provided the manufacturer's recommendations for cleaning and sanitizing the ice machine. The recommendations included: "(Manufacturer name) recommends cleaning this unit at least twice a year. More frequent cleaning, however, may be required in some existing water conditions ... ...Sanitizing solution - Dilute 2.5 fl (fluid) oz (ounces) of IMS-II Sanitizer or a 5.25% sodium hypochlorite solution (chlorine bleach) with 5 gallons of warm water."

In a concurrent interview with Staff 2, she acknowledged she was unaware the engineering staff was not sanitizing the ice machine per manufacturer's instructions.

b. On May 15, 2013, at 9:25 a.m., during an inspection of the dry storage area, 15 cans of Nepro (nutritional supplement) were noted stored on a shelf designed for daily food circulation. The cans were imprinted with a manufacturer "Use By" date of May 1, 2013. In the disaster food storage area, two cases of low sodium tuna were noted to be imprinted with a manufacturer "Best By" date of April 2013.

In a concurrent interview with the Registered Dietitian (RD), she acknowledged the food products were outdated, and stated they should be discarded.

A review of the facility policy titled "Expired/Recalled Products" dated February 1, 2011, indicated, "Discard outdated or recalled products immediately or return them to the manufacturer for credit."

c. On May 15, 2013, at 3:33 p.m., an observation of Patient 16 showed the patient in bed with a tubefeeding infusing at bedside. The tubefeeding bag (open system - whereby cans of formula are poured into the bag) was not labeled with the patient's name, when it was hung and what type of tubefeeding formula it contained. The tubefeeding pump indicated the formula was infusing at 20 cc (cubic centimeters) per hour. There was approximately 400-500 cc of formula remaining in the bag.

The RD, present at the time of the observation, stated she delivered three cans of tubefeeding formula in the morning to meet the needs of the patient for 24 hours.

In a concurrent interview with Staff 51, she acknowledged the tubefeeding bag and tubing were not labeled. Upon referencing the computer, Staff 51 stated the tubefeeding was started at 10 a.m. Staff 51 stated the patients tubefeeding order was for a "continuous feeding," and the formula would continue to infuse until the bag was empty. Staff 51 was not sure what the facility policy recommended with regards to the hang time of open system tubefeedings, but she stated she would try to change the bag and tubing during her shift.

A review of the facility policy titled "Enteral Formulary," dated February 1, 2011, indicated " ...Closed systems are safer from a HACCP (Hazard Analysis Critical Control Point) standpoint and are utilized whenever possible. Maximum hang time for diluted formula is 4 hours. Hang times for closed feedings are 48 hours." The policy did not address the hang time for open tubefeeding systems for undiluted formulas.

A review of the facility policy titled "Feeding and Medicating via a Gastrostomy Tube" dated February 1, 2011, indicated "Continuous Gavage: ...Add prescribed amount of formula to bag for a 4-hour period; dilute with water if prescribed."

Based on interview and record review, the facility failed to ensure the staff were educated regarding the facility Organ/Tissue/Eye Donor Program, to include the requirements of the program, the facility's statistics, and identification of ways to enhance the Organ/Tissue/Eye Donor Program. This had the potential to result in the staff being unaware of the Organ/Tissue/Eye Donor Program requirements, and the facility's compliance with the program requirements.

Findings:

On May 15, 2013, at 8:15 a.m., an interview was conducted with Staff 17 and Staff 37. They stated the issue of the facility's Organ/Tissue/Eye Donor Program "surfaced last week" and they were scheduled to meet with an Organ Procurement Organization (OPO), on May 17, 2013. Staff 17 and Staff 37 stated the facility's last organ donation dashboard data was from May of 2012, and they currently had a request out to the OPO for the facility's statistics/data for the first quarter of 2013. They stated there were no facility quality projects currently in place regarding the Organ/Tissue/Eye Donor Program. Staff 17 and 37 stated the facility did not have any "Designated Requestor(s)" in the facility as stated in the facility's policy and procedure.

In addition, Staff 17 and Staff 37, stated the staff had not been educated within the last year about the program or donation issues because the facility did not have any organ donation data/statistics from the OPO and the facility had no quality projects in place regarding the Organ/Tissue/Eye Donor Program.

The facility policy and procedure titled "Organ- Tissue-Eye Donation" dated March 2010, revealed "The intent of this procedure is to provide information and processes to facilitate organ and tissue donations, and to ensure that the option of donation be provided to families. This policy also establishes the guidelines for the referral of all deaths ... Duties and responsibilities of hospital staff ... The Nurse making the referral or his/her designee is responsible for notifying the Designated Requestor in the hospital to approach the family. The referring nurse will determine who is a Designated Requestor from a list his/her nurse manager and house supervisor will keep. The Designated Requestor will document on the Record of Death Form the outcome of the family discussion. ..."

Based on interview and record review, the facility failed to ensure facility personnel worked with the designated Organ Procurement Organization (OPO) to review death records and improve the identification of potential donors. This had the potential to result in an ineffective Organ/Tissue/Eye Donor Program.

Findings:

On May 15, 2013, at 8:15 a.m., an interview was conducted with Staff 17 and Staff 37. They stated the issue of the facility's Organ/Tissue/Eye Donor Program "surfaced last week" and they were scheduled to meet with an Organ Procurement Organization (OPO), on May 17, 2013. Staff 17 and Staff 37 stated the facility's last organ donation dashboard data was from May of 2012, and they currently had a request out to the OPO for the facility's statistics/data for the first quarter of 2013. They stated there were no facility quality projects currently in place regarding the Organ/Tissue/Eye Donor Program.

In addition, Staff 17 and Staff 37, stated the staff had not been educated within the last year about the program or donation issues because the facility did not have any organ donation data/statistics from the OPO and the facility had no quality projects in place regarding the Organ/Tissue/Eye Donor Program.

The facility policy and procedure titled "Organ- Tissue-Eye Donation" dated March 2010, revealed "The intent of this procedure is to provide information and processes to facilitate organ and tissue donations, and to ensure that the option of donation be provided to families. This policy also establishes the guidelines for the referral of all deaths ... Duties and responsibilities of hospital staff ..."

Based on observation, interview, and record review, the facility failed to ensure organized surgical services was provided to all patients by failing:


1. To ensure surgical services were supplied in a safe manner using patient safety protocols to protect patients and staff from fire danger. The facility failed to ensure an alcohol based surgical scrub was used according to policy (Refer to A951);

2. To ensure there was sufficient quantities of medication to treat malignant hyperthermia, (a rare life threatening condition triggered by certain medications and general anesthesia) available for immediate use in the operating room (Refer to A951);

3. To ensure medications used in the emergency treatment of malignant hyperthermia were available for immediate use and included in the facility's policy and procedure (Refer to A951);

4. To ensure three operating room staff wore head covers according to policy and procedures and standards of practice (Refer to A749, A951);

5. To ensure four operating room staff discarded used surgical masks according to policy and procedure and standards of practice (Refer to A749, A951); and,

6. To ensure hard surfaces in the operating room were cleaned and disinfected according to facility policy (Refer to A749, A951).


The cumulative effects of these systemic problems resulted in the failure of surgical services to ensure care was being provided in a safe and effective manner.

Based on observation, interview and record review, the facility failed:

1. To ensure surgical services were supplied in a safe manner using patient safety protocols to protect patients and staff from fire danger. The facility failed to ensure an alcohol based surgical scrub was used according to policy.

2. To ensure there was sufficient quantities of medication to treat malignant hyperthermia, (a rare life threatening condition triggered by certain medications and general anesthesia) available for immediate use in the operating room.

3. To ensure medications used in the emergency treatment of malignant hyperthermia were available for immediate use and included in the facility's policy and procedure.

4. To ensure three operating room staff wore head covers according to policy and procedures and standards of practice.

5. To ensure four operating room staff discarded used surgical masks according to policy and procedure and standards of practice.

6. To ensure hard surfaces in the operating room were cleaned and disinfected according to facility policy.

Findings:

1. On May 13, 2013, Patient 32 was observed in the post anesthesia care unit (PACU) where she was undergoing preoperative assessment. Patient 32 was he surgery schedule was reviewed. Patient 32 was asked and gave permission for observation of her upcoming surgical procedure.

Patient 32's record was reviewed on May 14, 2013. According to the consent, Patient 32 was scheduled to undergo "Bilateral Temporal Artery Biopsy." (A temporal artery biopsy is a procedure in which a small piece of tissue is removed from the temporal artery (near the temple) and then studied under a microscope to check for signs of inflammation and damage.)

Patient 32 was transferred to Operating Room 1, on May 14, 2013, at 8:10 a.m. After being placed on the OR table, MD (Physician) 1, shaved the patient's hair around the ear, and applied an alcohol based skin preparation to the temporal region (side of the forehead and near the ear), to reduce the risk of post-operative infection. MD 1 used a large size applicator. Solution from the alcohol based skin preparation was noted to be pooling in the patient's left ear.

At 8:30 a.m., Patient 32 was draped (linens placed on the patient or around the field to delineate sterile areas.) The staff was alerted to the pooling of the alcohol based skin preparation, and in response, made sure the liquid did not travel deeper into the ear canal.

During a concurrent interview, Staff 52 was asked what MD 1 intended to use for coagulation (to stop bleeding) during the procedure. Staff 52 replied, "Needle point bovie (electrosurgical energy conducted through a pen like device to stop bleeding)."

At that moment the procedure was halted and the staff was asked if they had considered and implemented all surgical fire precautions in this case. After discussion, and reading of the skin preparation warning label, the team decided to clean the patient off and repeat the skin preparation with a non-alcohol based liquid, for safety, and draped the patient again for surgery.

A review of the skin preparation solution indicated ingredients included 70% Isopropyl Alcohol.

During an interview with Staff 53 (not currently assigned to OR 1), on May 14, 2013, at 8:45 a.m., Staff 53 stated alcohol based skin preparation should not be used on the head when electric cautery was in use.

On May 14, 2013, at 10:45 a.m., Staff 15 was interviewed. Staff 15 stated there were ways to prevent pooling of skin prep solution. Staff 15 stated he would inform the physician of pooling as it was a fire hazard.

On May 14, 2013, the facility's policy and procedures for fire safety in the operating rooms were requested. The policy and procedure titled "Patient Safety in the Operating room," with a last revised date of March 2010, was reviewed. The policy documented its purpose was to identify and eliminate potential safety hazards. The section titled "Prevention of Burns/Fires," indicated: " Do not allow prep solutions to pool around the patient. Remove any pooling of prep solutions with a towel and remove the towel from the operating room before the start of surgery...Allow solutions...to dry completely and to dissipate before draping and before use of electrocautery... "

The facility's policy and procedure titled "Fire Safety in an Oxygen Rich Environment-Operating Room," with a last revised date of March 2010, indicated its purpose was to provide fire safety in an oxygen rich environment. The policy indicated the most common causes of fire stem from the use of electrosurgical equipment and the most common locations include the patient's airway and the head or face. The policy indicated fuels found in the Operating Room included alcohol used for prepping. Common ignition sources included electrocautery units. When using an electrocautery unit: "Do not allow prep solutions to pool." The policy indicated fire prevention practices are the most important tools in preventing a fire from starting; "Be careful with chemicals and aerosols that contain flammable ingredients. Do not use so much that they pool or soak into the patient's hair or drapes."

During an interview with the Governing Body/Board (GB) members, on May 16, 2013, at 10:40 a.m., the GB was asked if they were aware Operating Room staff was not following facility policy and procedure regarding alcohol based skin preparations. The GB members stated they were not aware of these concerns.



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2. During a tour of the facility's Surgical Services Department, on May 15, 2013, at 9 a.m., the Malignant Hyperthermia (MH) Medication Box was observed. (Malignant hyperthermia is a rare genetic condition that occurs when affected individuals are exposed to triggering anesthetic agents and a muscle relaxant). The box contained 36 vials of Dantrium IV (dantrolene IV is a medication required for the immediate treatment of malignant hyperthermia) 20 milligrams and 2000 milliters of sterile water.

Instructions indicated each vial of Dantrium IV should be reconstituted by adding 60 milliters of sterile water for injection. To reconstitute all 36 vials, 2160 milliters of sterile water was required.

The facility's policy and procedure titled, "Malignant Hyperthermia Drugs," was reviewed. The policy indicated, "The purpose of this policy is to define having drugs available for Malignant Hyperthermia... Pharmacy will provide, and keep in stock Dantrolene 20 mg/vial, #36 vials, used to treat Malignant Hyperthermia... Sterile Water for injection 1000 ml, stored in refrigerator."

The facility's policy ad procedure titled "Management of the Patient with Malignant Hyperthermia (MH)," with a last revised date of January 2010, was reviewed. The policy indicated surgical services clinical staff would receive education regarding malignant hyperthermia and the management of a patient with MH. The policy indicated each vial of Dantrolene was dissolved with 60 millilters of sterile, preservative free water for injection. The policy indicated "As a large quantity may be necessary, a sufficient supply must be available." The policy's references included the Malignant Hyperthermia Association of the United State (MHAUS), and the Association of periOperative Registered Nurses (AORN).

The Malignant Hyperthermia Association of the United State (MHAUS), a leading nationally recognized organization with the mission to promote optimum care and scientific understanding of MH, recommends a minimum of 36 vials of Dantrolene should be available within 5 minutes of the initial diagnosis of MH.

3. During a tour of the facility's Surgical Services Department, on May 15, 2013, at 9 a.m., the Malignant Hyperthermia (MH) Medication Box was observed. (Malignant hyperthermia is a rare genetic condition that occurs when affected individuals are exposed to triggering anesthetic agents and a muscle relaxant). The box contained Dantrium IV (an intravenous solution used to treat MH), but did not contain a vial of refrigerated Regular Insulin. In addition, the box did not include the location of a vial of refrigerated Regular Insulin.


The facility's policy and procedure titled, "Malignant Hyperthermia Drugs" was reviewed. This policy indicated its purpose was to define "having drugs available for Malignant Hyperthermia." The policy did not include a content list or identification of other medications used during the treatment of MH. The policy did not indicate other medications that were required in the MH Medication Box.

Inspection of the facility's MH Medication Refrigerator in SD indicated there was no refrigerated Regular Insulin stored in the refrigerator.

The facility's policy and procedure titled "Management of the Patient with Malignant Hyperthermia (MH)," with a last revised date of January 2010, was reviewed. The policy indicated surgical services clinical staff would receive education regarding malignant hyperthermia and the management of a patient with MH. The policy indicated "Administration of 50 ml (milliters) 50 % Dextrose and 10 units regular insulin, for adults, may be ordered to provide glucose for metabolism and reduce hyperkalemia..."

The policy's references included the Malignant Hyperthermia Association of the United State (MHAUS), and the Association of periOperative Registered Nurses (AORN).

Malignant Hyperthermia Association of the United State (MHAUS), a leading nationally recognized organization with the mission to promote optimum care and scientific understanding of MH, recommends a vial of Regular Insulin be included in the MH Cart.

4. On May 13 through May 16, 2013, during intermittent observations at the facility, three surgical staff were observed wearing reusable head coverings outside of the OR.

On May 13, 2013, at 11:05 a.m., during an interview with Staff 2, she stated the facility follows APIC (Association for Professionals in Infection Control and Epidemiology), AORN (Association of Perioperative Registered Nurses), and CDC (Centers for Disease Control and Prevention) standards.

On May 15, 2013, at 2:50 p.m., during an interview with Staff 52, Staff 52 stated she takes her reusable head coverings home and launders them.

The facility policy, dated March 2010, and titled, "Surgical Services, Attire in the Operating Room," was reviewed and revealed, "A clean surgical cap or bouffant should be worn prior to entering a semi-restricted or restricted area ...The headgear is to be properly disposed of in designated receptacles after use."

According to the AORN, Perioperative Standards and Recommended Practices, Recommended Practices for Surgical Attire (2013):

" Surgical attire should be changed daily or at the end of the shift ...Reusable head coverings should be laundered in a health care-accredited laundry facility after each daily use ...Home laundering is not monitored for quality, consistency, or safety. Exposure of health care personnel and their family members to blood and other potentially infectious materials may result from improper handling and decontamination of surgical attire ...Home laundering may not meet the specified measures necessary to achieve a reduction in microbial levels in soiled surgical attire. "

5. From May 13 through May 16, 2013, during intermittent observations, four surgical staff were observed wearing masks outside of the OR, one of which hung from the neck and touched the staff's scrub top.

The facility policy, dated March 2010, and titled, "Surgical Services, Attire in the Operating Room," was reviewed and revealed, "A single use surgical mask is to be worn at all times when open sterile items and equipment are present ...The mask should be discarded immediately after each use in a designated receptacle."

According to the AORN, Perioperative Standards and Recommended Practices, Recommended Practices for Surgical Attire (2013):

" All individuals entering the restricted areas should wear a surgical mask when open sterile supplies and equipment are present ...A fresh, clean surgical mask should be worn for every procedure. The mask should be replaced and discarded whenever it becomes wet or soiled ...Masks should not be worn hanging down from the neck. The filter portion of a surgical mask harbors bacteria collected from the nasopharyngeal airway. The contaminated mask may cross-contaminate the surgical attire top ...Surgical masks should be discarded after each procedure. Masks should be removed carefully by handling only the mask ties. Hand hygiene should be performed after removal of masks. "

6. During observation on May 14, 2013, at 10:18 a.m., Oasis 499 HBV Disinfectant was applied to the procedure table and padding in OR #1. At 10:25 a.m., (7 minutes later), the procedure table and padding were approximately half-dry, verified by Staff 2.

In a concurrent interview with Environmental Services Staff (EVS 1), regarding the manufacturer's disinfecting wet contact time; she stated surfaces must remain wet for 10 minutes.

The facility policy, dated October 2008, and titled, "Housekeeping, Surgery Cleaning Procedure," was reviewed. The policy revealed, "Disinfectant Solutions: Oasis 499 HBV Disinfectant - use for cleaning, disinfecting of all surfaces ...Note: Manufacture Instructions for Oasis 499 HBV Disinfectant ...Treated surfaces must remain wet for 10 minutes... Wipe down all equipment with disinfectant solution ensuring that all surfaces remain wet for disinfection contact time in accordance [sic] manufacturer instructions

Based on observation, interview and record review the facility failed to:

1. Ensure that Anesthesia Services were organized under the direction of a qualified physician; and

2. Ensure that a post-anesthesia evaluation was completed after surgery for one facility patient (Refer to A1005).

This practice increased the risk of poor anesthetic care for all patients receiving anesthesia.

Findings:

On May 13, 2013, the facility's surgery schedule was requested. The schedule indicated on May 14, and 17, 2013, four patients were undergoing surgery with general anesthesia (drug induced loss of consciousness).

On May 13, 2013, the following Memorandum was observed posted on the facility bulletin board:

"Effective immediately, until further notice, CRNA 1 [Certified Registered Nurse Anesthetist] would be providing anesthesia coverage for [name of facility}."

A CRNA is a registered nurse who has completed additional training to administer anesthesia.

On May 14, 2013, at 8:10 a.m., CRNA 1 was observed administering anesthesia to Patient 32.

During the initial tour of the facility on May 13, 2013, at 11:30 a.m., it was noted that MD 2 was not in the operative room area. When Staff 9 and Staff 10 were questioned regarding MD 2's whereabouts, they responded "His contract was not renewed." They stated the CRNA who usually covered for MD 2, while he was on vacation, had been providing anesthesia services since last week.

During a tour of the facility Post Anesthesia Care Unit (PACU) on May 13, 2013, at 2:45 p.m., the CRNA, who was a traveler from Minnesota, was asked who was providing Anesthesia Services in the hospital. The CRNA stated that she was providing anesthesia for the facility and that she was "five minutes away and available 24 hours a day, seven days a week." When asked if she had help, the CRNA replied, "no." When asked how long she will stay, the CRNA replied, "I will stay here until they find someone." The CRNA stated she did not know what happened to the Director of Anesthesia Services that was previously at the facility.

On May 14, 2013 at 4:30 p.m., the CRNA was interviewed. When the CRNA was asked who at the facility knows as much, or more, than she did about anesthesia, the CRNA replied, "no one." The CRNA stated if she was unable to continue with an anesthesia case, she did not know what would happen.

During an interview with the CEO on May 15, 2013, at 5 p.m., he was asked what would happens if the CRNA fainted in the middle of providing anesthesia in the operating room. The CEO answered, "I don't know."

In a concurrent phone interview with MD 2 he was asked who the current Director of Anesthesia was. MD 2 stated "I don't know."

A review of a letter sent from the facility to MD 2, dated March 20, 2013 indicated, "You are hereby informed that you have been placed on summary restriction or suspension according to Section 7.2 of the Medical Staff Bylaws." A second letter, also dated March 20, 2013, from the facility to MD 2 indicated, "As of 1:30 today, March 20, 2013, the MEC unanimously voted to discontinue your summary restriction of suspension."

Review of a letter, dated May 7, 2013, from the facility to MD 2 indicated "[name of facility] has attempted to secure a contractual agreement with you during the past two months with no success to this date... Since [name of facility] is required to maintain working contracts with all of its directors of hospital practices, the District finds it necessary to move forward in securing alternative Anesthesia services effective tomorrow, Wednesday May 8, 2013." Review of a letter from the facility to MD 2, dated May 8, 2013, indicated, "consider this a rescission of yesterday's letter."

The facility policy titled "Duties and Responsibilities of Chief Anesthesiologist," dated March 2010, was reviewed. The policy indicated, "The Chief of Anesthesia will have the following qualifications: Member of the active medical staff... Appointed by the Chief of Staff and/or Administration according to the medical staff bylaws of the hospital... The Chief of Anesthesia will fulfill the duties and qualifications of the position and have 24-hour accountability for all anesthesia coverage provided..." Also, "The duties of the Chief of Anesthesia will include, but not be limited to, the following: Directing the administration of all anesthesia throughout the hospital, continuing surveillance of professional performance of all individuals with clinical privileges in the Department of Anesthesia."

On May 16, 2013, at 10:40 a.m., the Governing Body/Board members (GB) were interviewed. One board member stated she was aware there was no longer a Director of Anesthesia. She stated, it has not been brought to the full Governing Board. They stated that no emergency meeting had been called to discuss this concern. When asked, what was the plan regarding a Director of Anesthesia, they replied, "I don't know."

The cumulative effect of the systemic problems resulted in the hospital's failure to ensure the provision of anesthesia services in a safe environment that met the needs of the patients.

Based on observation, interview and record review, the facility failed to ensure a post-anesthesia evaluation was completed after surgery for one patient. This practice increased the risk of poor anesthetic care for all patients receiving anesthesia.

Findings:

The facility policy, dated March 2010, and titled, "Guidelines for Administration of Anesthesia", was reviewed. The policy indicated, "The post anesthesia record shall be completed by the anesthetist immediately in the postoperative care..."

During the facility tour on May 13, 2013, at 12:15 p.m., of the pre-operative area, included a review of the pre-operative medical charts of the patients awaiting surgery for that day. Review of Patient 19's chart indicated a post- anesthesia evaluation was already documented, signed and dated, and filed in the medical record, even though the patient had not been taken to the operating room yet. Review of the facility form titled, "Pre-Anesthesia Evaluation," dated May 13, 2013, indicated "no" was checked for all of the boxes related to "Anesthetic Related Complications." And the box "F/U (follow up) Care Required?" was also checked "no."

During a concurrent interview with Staff 54, she confirmed the post-operative evaluation was already filled out, before the patient was transported to surgery and stated that it was not appropriate.

During an interview with the CRNA (Certified Registered Nurse Anesthetist) in the PACU(Post Anesthesia Care Unit) on May 13, 2013, at 2:30 p.m., a copy of Patient 19's "Pre-Anesthesia Evaluation," dated May 13, 2013, was shown to the CRNA. She indicated she did not see anything wrong with the form and said that she just signed and dated the Post-Op Note section. The CRNA was shown that the check boxes for all Anesthetic Related Complications had been already checked "no," before surgical procedure had started.

Based on observation, interview and record review, the facility failed:

1. To ensure the Emergency Department had qualified physician coverage after the contracted Emergency Physician's group terminated their contract and would no longer be staffing the emergency room. This had the potential to result in a lack of physician coverage in the ED.

2. To ensure there was documented evidence ED nursing personnel were qualified in emergency care. One of three ED employee files (Staff 57) reviewed had no evidence of current PALS (Pediatric Advanced Life Support) certification. This had the potential for unqualified staff caring for a pediatric patient in an emergency situation.

3. To ensure the performance of one ED staff (Staff 55) was evaluated annually per facility policy and procedure. This had the potential for unqualified personnel continuing to provide care to facility patients.

Findings:

1. On May 13, 2013, at 11:10 a.m., a tour of the ED was conducted with the Chief Nursing Officer (CNO). The ambulance entrance was identified and a sign posted indicated "Standby Emergency Medical Service Physician on Duty." The ED included an area to triage (assign a severity) and six ED beds. All six beds were occupied.

In a concurrent interview, the CNO stated the ED saw about 30 to 40 patients daily. The CNO stated there was no current ED Manager, she was overseeing the department.

On May 13, 2013, at 11:55 a.m., MD 8 was interviewed. MD 8 stated he was a member of the contracted physician's group. MD 8 stated some of the groups' physicians split a 24-hour shift, but he works a 24 hour shift. MD 8 stated the group recently terminated there contract with the hospital and would no longer be providing ED physicians to the facility at the end of this month.

On May 14, 2013, the ED physician's schedule for May 2013, was reviewed. On May 30, 2013, "OPEN," was documented. An ED physician was not scheduled for May 30, 2013.

During an interview with the Acting Chief Executive Officer (CEO), on May 14, 2013, at 2:30 p.m., the CEO stated they had negotiated a contract with the existing ED physician's group through June 1, 2013. The CEO stated the facility was in the process of hiring individual physicians to staff the ED.

On May 16, 2013, at 10:40 a.m., during an interview with two members of the Governing Body (GB), one board member stated she was aware the ED physicians' group was leaving, "It was their choice." This member stated she had not heard about any issues with the group, other than the occasional customer service/quality of care issue that was handled individually. This member stated the loss of ED physician coverage was not on the agenda for discussion at tonight's board meeting.

The second GB member stated she had heard there were issues in the ED, but had not heard the physicians group had terminated due to breach of contract. The GB member stated assuring the ED had physician coverage was a priority for the GB.

The facility policy and procedure titled "Evaluation of Patient Care Contract Services," with no effective or reviewed date, was reviewed on May 16, 2013. The policy indicated its purpose was to establish the organization's oversight of care, treatment, and services provided through contractual arrangements to patients, clients or residents. The policy indicated "when contractual agreements are renegotiated or terminated, the organization will assure that continuity of patient care is maintained."


2. On May 13, 2013, at 11:10 a.m., a tour of the ED was conducted with the Chief Nursing Officer (CNO). The ED included an area to triage (assign a severity of illness) and six ED beds. All six beds were occupied. Current staff included one triage Registered Nurse (RN), two staff RNs, one ED technician, and one admitting clerk (Staff 55, Staff 57 and Staff 58.).

During observation in the ED, a Pediatric Crash cart was observed. The crash cart was a color coded nine drawer cabinet on wheels, based on the Broselow Method for pediatric emergency care.

In an interview with Staff 55, on May 13, 2013, at 11:30 a.m., Staff 55 stated the licensed nurses rotated, performing both triage and patient care activities.

In an interview with Staff 58, on May 13, 2013, at 11:45 a.m., Staff 58 stated she had been here 3 weeks, she had undergone two weeks of orientation. Staff 58 stated she was assigned four beds (patients) today.

On May 13, 2013, at 2:10 p.m., Staff 57 was observed taking care of Patient 24. Patient 24 was intubated (tube placed in the throat) and undergoing mechanical ventilation.

On May 13, 2013, at 2:40 p.m., MD 8 asked ED staff if there was a "baby in the waiting room." When the response was "yes," MD 8 ordered an abdominal series.

On May 15, 2013, ED personnel files were reviewed. The following was noted:

Staff 55's personnel file contained a job description titled "ER RN." The job description indicated the ER (ED) RN would care for patient populations from neonate (newborns) to geriatric (the elderly). The job description indicated the ER RN would have current American Heart Association PALS (pediatric advanced life support.)

PALS was developed by the American Heart Association in conjunction with the American Academy of Pediatrics to equip health care professionals with the essential skills to effectively recognize and react to critical injuries or conditions in children and infants.

Staff 55 had evidence of current PALS certification.

Staff 57's personnel file did not contain the same job description as Staff 55, but the job description did indicate Staff 57 would be caring for the same patient population, neonate to geriatric. There was no evidence in Staff 57's file that the employee had current PALS certification.

During an interview with the Chief Nursing Officer (CNO), on May 15, 2013, 3:45 p.m., the CNO stated all ED licensed personnel should have PALS certification. New hires are given a six month grace period, but current personnel should have the certification. The CNO stated requirements in the ED have changed and they were in the process of training staff.

The facility policy and procedure titled "Education and Licensure Requirements" last reviewed/revised April 2013, revealed "... Human Resources shall verify and obtain documented proof of employee's educational credentials including current License numbers and/or credential(s) and certifications (where applicable) at the time of employment and at the renewal date. ... In addition, current employees must submit the original of the renewed Licenses/Credentials information to Human Resources prior to the expiration date or after any change therein. ..."

3. The employee file for Staff 55 was reviewed on May 15, 2013. Staff 55 had a hire date of February 6, 2006 and was assigned to the ED. According to the documentation in the file, Staff 55's last performance evaluation was conducted in August 2011.

The facility policy and procedure titled "Performance Evaluations - Competency" reviewed/revised March 24, 2010, revealed "... All employees will receive an annual evaluation for purposes of wage increases, performance review and competency assessment. ... "