The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

SAN JOAQUIN GENERAL HOSPITAL 500 W HOSPITAL ROAD FRENCH CAMP, CA 95231 Jan. 27, 2017
VIOLATION: MEDICAL STAFF Tag No: A0052
Based on staff interview and document review, the hospital's governing body (GB) failed to grant privileges to physicians employed by the distant-site telemedicine entity, in one out of 22 providers reviewed.

This failure had the potential for the telemedicine physicians to perform unsuitable clinical tasks at the receiving hospital.

Findings:

During a concurrent interview and document review from 1/25/17 10 a.m. to 5 p.m., the credentialing files of 22 providers were reviewed. According to Medical Staff Coordinator (MSC) and Deputy Director of Medical Staff Services (DDMSS), MD 15 became a provisional medical staff after board approved MD 15's appointment in 10/16. A form titled, "Delineation of Privileges" in MD 15's file, was signed by the regional medical director of the distant telemedicine entity, in 2/16. There was no privilege form from the hospital stating clearly what procedures would be performed by MD 15 and which one was approved by the GB of the hospital.

On 1/27/17 at 11:15 a.m., the Chief Operating Officer acknowledged the above findings, during a concurrent interview and document review.

Review of the Medical Staff Bylaws, last revised in 1/16, indicated under Article V. "Clinical Privileges", 5.15 "Telemedicine Privileges", that " ... After consulting with the Medical Executive Committee, the Governing Body may approve specific types of telemedicine services to be utilized to provide clinical services to Hospital patients ..."
VIOLATION: CONTRACTED SERVICES Tag No: A0084
Based on document review and staff interview, the hospital failed to include contracted services into the hospital's quality assurance and performance improvement (QAPI) program.

This failure has the potential to put patients at risk for injuries or adverse outcomes resulting from the delivery of unsafe services.

Findings:

On 1/26/17 at approximately 11 a.m., the Deputy Director of Standards and Compliance (DSC) was asked to provide a list of all contracted services that provided services to the hospital. DSC also provided a list of all the clinical contracted services. When asked how the evaluation of the contracted services was performed, DSC stated that each contract owner would perform the evaluation for each contract service. When asked whether the hospital's QAPI plan or project included the contracted services, the DSC replied, "No."

On 1/26/17 at 1:30 p.m., during a concurrent interview and document review, the Chief Nursing Officer (CNO) was asked to explain how she had evaluated several contracted services. The CNO provided five forms that related to four contract services regarding temporary nursing staff and one contract services on plasmapheresis (the removal, treatment, and return or exchange of blood plasma or components thereof from and to the blood circulation). The CNO also stated that these contracted services were evaluated once a year and reported to Medical Executive Committee and Governing Body. When asked whether she had included the contracted services in QAPI project, the CNO replied, "Not yet."

On 1/27/17, the evaluation forms of five contracted services: neurology consults, lab services, pharmaceutical and medical waste disposal, temporary provider placement, and radiology, were received from the DSC and reviewed.

On 1/27/17 at approximately 11 a.m., during a concurrent interview and document review, the Chief Operating Officer acknowledged that the hospital's contracted services were not included in the hospital's QAPI program.

Review of the hospital's policy titled, "Contract Management of Clinical and Patient Care Services", dated 8/16, indicated under "Policy" that "[hospital] leadership will monitor the quality and safety of services provided pursuant to a Clinical Contract using appropriate methods, which consider risk reduction, safety, and staff competence and performance improvement."
VIOLATION: PROGRAM DATA, PROGRAM ACTIVITIES Tag No: A0283
Based on staff interviews and document review, the General Acute Care Hospital (GACH) failed to provide evidence the Integrated Quality Council (IQC), responsible for hospital wide performance improvement and patient safety, was aware of and responding to ongoing problem prone processes in the Trauma Service related to Trauma Surgeon (TS) response times, delays to the Operating Room (OR) and daily physician rounding in the Intensive Care Unit (ICU) in 2016.

The failure to report to the IQC on the incidence, prevalence and severity of high risk, high volume, problem prone areas of the Trauma Service resulted in the potential for a delay in the development and implementation of an effective action plan(s) with tracking mechanisms to prevent the delivery of substandard care.

Findings:

In review of the monthly minutes of the Multidisciplinary Trauma Services Committee and Trauma Services Peer Review for 2016 there were frequent, ongoing references to problems with the response of the Trauma Surgeon to Tier 2 trauma patients (not meeting stipulated three hour response time), delays to the OR due to unavailability of nursing staff, physician staff or operating room space and the lack of daily rounding and documentation of patient visits in the ICU. Discussions regarding Trauma Surgeon response time and the need for a plan of action occurred in June, delays to OR June and December, ICU rounding in February and a bypass plan for neuro[conditions related to the nervous system] transfers needing immediate surgery was discussed in June and July. In October there was a discussion of the development of a Trauma Services dashboard but there was no mention of this dashboard being presented to the committee for review and approval. None of the minutes included the presentation of formal action plans to address these critical items despite documentation of unexpected or less than optimal outcome due to the lack of physician or nursing resources.

The Director of Standards and Compliance (DSC), in an interview on 1/26/17 at 9:30 a.m., acknowledged Trauma Services and hospital leadership had met with the county Emergency Medical Services (EMS) on 5/16/16 to discuss ongoing deficiencies that had been unresolved following a consultative visit by the American College of Surgeons (ACS) in July of 2015. These deficiencies included:

1. Delays in the response of the Trauma Surgeon to the arrival of Tier 2 trauma patients in the Emergency Department (ED), and
2. Delays in trauma patients being taken to the OR, and
3. The lack of daily rounding by the Trauma Surgeon and Intensivists in the ICU.

The DSC revealed EMS had concluded the deficiencies noted impacted patient safety and the quality of care provided and mandated the GACH to provide evidence of correction of these deficiencies by 6/1/16 at which time auditing through site visits would be initiated to verify compliance with regulations.

The DSC confirmed three unannounced visits were made to the facility (7/13/16, 8/25/16, 9/1/16) and as a result of continuing non-compliance, the decision was made to re-route the destination of adult trauma patients until an acceptable plan of correction with evidence of compliance was presented to the county Board of Supervisors (which serves as Governing Body).

Full restoration of Trauma Services did not occur until 1/26/17 at which time previous deficiencies regarding response of Trauma Surgeon, delays to the OR and rounding by physicians in the ICU, in addition to other deficiencies identified, had been addressed.

In review of the 2016 minutes of the Integrated Quality Council (IQC), the Medical Executive Committee (MEC) and the Governing Body (GB) minutes there was no mention of ongoing problems with Trauma Services including physician availability in the ED, OR or ICU. There was no discussion of the unexpected patient outcomes due to lack of physician and nursing resources. The Chief Executive Officer (CEO), in an interview on 1/25/17 at 1 p.m., acknowledged there had been multiple issues which had been discussed in Medical Executive Committee and should have been documented. He stated many recommendations were made for changes in medical staff in Trauma Services and Surgery and the board took his recommendations. There were additional Trauma Surgeons hired with required EMS qualifications. In addition, the CEO reported
the nursing contract negotiated in October increased nursing salaries and recruitment and retention had significantly improved.

The DSC, in an interview on 1/26/17 at 2 p.m., stated the IQC, composed of physicians and hospital leadership, met bi-monthly and reviewed performance improvement and patient safety housewide. The DCS presented a document titled Quality Assessment, Performance Improvement (QAPI) and Patient Safety Plan for San Joaquin General Hospital, dated 2016-2017 and the following was noted:

1. "The purpose of the Quality Assessment, Performance Improvement (QAPI) and Patient Safety plan is to provide a formal mechanism by which [facility] utilizes objective measures to monitor and evaluate the quality of care provided to all patients. The Governing Board was designated as responsible for the quality of care provided."
2. "Quality is defined broadly to include all aspects of care consistent with care that strives to be safe, effective, patient centered, timely, efficient and equitable."
3. "The plan facilitates a multi disciplinary, systemic performance improvement approach to identify and pursue opportunities to improve patient outcomes and reduce the risks associated with patient safety...."
4. "The Governing Board is responsible for the quality of patient care provided."
5. "The Board ...delegates to the Chief Executive Officer (CEO), working with the Chief Medical Officer, the Performance Improvement Coordinator, and the Integrated Quality Council the responsibility to develop a systemic, integrated and continuous approach to assess and improve the performance of those functions and processes most directly related to the Mission of the hospital and quality patient outcomes, while addressing patient safety."
6. The Medical Executive Committee "functions as the primary authority over activities related to the functions of performance improvement" and "delegates the oversight responsibility for performance improvement activities, monitoring and analysis of data regarding patient care processes and outcomes throughout the facility to the Integrated Quality Council."

The plan included attachments for identifying high risk, high volume or problem prone processes as well as tools for monitoring activities and progress.

The plan included a list of the priorities identified for the fiscal year 2016-2017. This priority list did not include any priorities for performance improvement in Trauma Services.

In an interview with the DSC and the Trauma Services Nursing Director (TSND), on 1/26/17 at 10:30 a.m., the TSND stated she reported quarterly to the IQC. The TSND stated the Trauma Service was collecting and reporting data on 12 performance measures, four each for Trauma Admits, ICU Trauma Length of Stay and Vent Days, measured by indicator for "mild, moderate, great and severe injuries". The TSND acknowledged the problem prone processes for Trauma Surgeon Response, Delays to the OR and daily physician rounding in the ICU had not been taken to IQC as identified problem prone processes to be prioritized for consideration as performance improvement projects.

In review of the minutes of the IQC for 2017, the following was noted:

1/5/16 Trauma Quarterly Report "The Department was compliant in nine of the ten measures including Trauma Admissions, ICU Trauma Admissions and Length of Stay (LOS). In an area designated for Trauma - Attending Surgeon it was noted "Response times for Tier 1 being met, will "drop the measure" and replace with ICU Ventilator Days. There was no mention of the delay in the response of the Trauma Surgeon to the Tier 2 trauma patients.

6/7/16 Trauma Quarterly Report "[Name] presented the October 1 through December 31, 2015 Trauma Quarterly Report. The Department was compliant with 8 of 12 measures. Areas needing improvement were Trauma Admissions LOS, ICU admissions LOS and Vent Days. "All other measures were consistent and compliant as well". There was no mention of the ongoing challenges reported monthly in the Trauma Systems Committee and Trauma Peer Review regarding delay in response of the Trauma Surgeon to Tier 2, delays in getting to the OR due to insufficient availability of a surgical team or lack of rounding by physicians in the ICU.

8/2/16 Trauma Quarterly Report Again, only Trauma Admits, ICU Admits and LOS and Vent days were reported and the report noted "There were 6 indicators that were compliant and made improvements". There was no mentions of the continued lack of response by the TS to Tier 2, delays to OR or rounding by physicians in the ICU.

12/6/16 Trauma Quarterly Report. Reported eleven of twelve indicators were compliant. Does not refer to any actions taken to address the problem prone processes in the Trauma Services or actions being taken to resolve.

The DSC and the TSND acknowledged the response time of the Trauma Surgeon, the delay in taking patients to surgery and the daily rounding of physicians in the ICU had never been brought forward to the IQC as high risk, high volume, problem prone processes and no discussion had ensued on possible actions to be taken or monitoring to be conducted.

In review of the 2016 minutes of the Medical Executive Committee, there was never any discussion of problems or deficiencies in the Trauma Services that affected patient safety or outcomes.

Continuing with the interview, the TSND presented a document titled Trauma Audit Committee Quality Improvement Indicators, which noted fifteen measures which included Delay in Trauma Team Activation and Delay to the OR. The TSND stated this work was being done internally and reported only to the Trauma Services committees.

The TSND, in an interview on 1/27/17 at 9:30 a.m., presented data on the TS response to Tier 1 and Tier 2 trauma and daily ICU rounding from September through November with significant improvement noted. There was no plan to move this forward to IQC.

The Deputy Director of Medical Staff Services (DDMSS), in an interview on 1/27/16 at 11 a.m., stated there was no position on the Medical Executive Committee for the Trauma Service as this was a "stand alone" service line separate from hospital operations. The DDMSS stated actions had been taken to resolve the Trauma Services issues but they were "too political" and "too sensitive" to be discussed at tthe MEC meeting and recorded. The DDMSS acknowledged the Trauma Surgeon (TS) response had been resolved with a policy change for all TS to respond immediately to Tier 2 as well as Tier 1 trauma and additional TS had been hired. The DDMSS also stated a backup0 surgical team had been assigned to ensure all emergency trauma could be handled at any time 24/7.
VIOLATION: MEDICAL STAFF PERIODIC APPRAISALS Tag No: A0340
Based on staff interview and document review, the hospital failed to timely evaluate the performance of its providers on an ongoing basis, in six (MD 3, MD 4, MD 6, MD 7, MD 17, and MD 19) out of 22 providers reviewed.

This failure limited the ability of the hospital to adequately monitor its medical staff's competency on an ongoing basis, and put patients at risk for adverse outcomes related to care performed by underperforming providers.

Findings:

During concurrent interview and document reviews between 1/25/17 9:40 a.m. and 5 p.m., and 1/26/17 approximately 10 a.m., the credentialing files of MD 3, MD 4, MD 6, MD 7, MD 17, and MD 19 were reviewed together with Medical Staff Coordinator (MSC) and Deputy Director of Medical Staff Services (DDMSS).

According to MSC and DDMSS, all the medical staff was subjected to an ongoing professional practice evaluation (OPPE), which was set to occur every 9 months or at least annually, after the staff member became an active staff member. The OPPE would include gathering data to measure the provider's competency including, but not limited to areas of patient care, medical knowledge, and practice-based learning, etc. The information can be used to evaluate medical staff regularly, before the reappointment, so that problems can be caught before it was too late and quality work can be maintained. The OPPE was considered an important component in medical staff's reappraisal process.

MD 3 was initially appointed in 2006, and last reappointed in 5/15. MD 3's credentialing files did not contain any OPPE reports for year 2016.

MD 4 was initially appointed in 2014, and became an active staff member in 2015. MD 4's credentialing files did not contain any OPPE reports for year 2015 or 2016.

MD 6 was initially appointed in 2002, and last reappointed in 12/16. MD 6's credentialing files did not contain any OPPE reports for years 2015 and 2016.

MD 7 was initially appointed in 1984, and last reappointed in 3/16. MD 7's credentialing files did not contain any OPPE reports for year 2015.

MD 17 was initially appointed in 1991, and last reappointed in 7/16. MD 17's credentialing files did not contain any OPPE reports for year 2015.

MD 19 was initially appointed in 2014, and became an active staff member in 2/15. MD 19's credentialing files did not contain any OPPE reports for years 2015 and 2016.

Both MSC and DDMSS stated that during the years 2015 and 2016, the credentialing office did not have enough man power and resources to generate the data needed for the OPPE. The medical staff was expanding due to increased services provided in the hospital, yet certain measures related to OPPE were withdrawn from the medical staff monitoring process. This issue was brought to discussion involving various leaders, including the Chief Executive Officer (CEO), but was not adequately addressed.

During an interview with the CEO on 1/25/17 at approximately 1 p.m., the CEO acknowledged that he was aware of the facts that not all departments of medical staff had adequately OPPE and would aim to improve the process.

On 1/27/17, at approximately 11 a.m., during an interview with the Chief Operating Officer (COO), DDMSS, and MSC, the COO acknowledged that she was aware of the difficulties that the credentialing office faced with ensuring all departments have adequate OPPE, and that more support for the medical staff appraisal process would be provided.

Review of the policy titled, "Medical Staff Policy and Procedure-Professional Practice Evaluation", last revised 11/10, indicated that under "III. Definitions", that OPPE is "a mechanism for the medical staff to identify professional practice trends that impact quality of care and patient safety on an ongoing basis ... Information from OPPE may also be used to determine whether to continue, limit or revoke any existing privilege(s)."
VIOLATION: STAFFING AND DELIVERY OF CARE Tag No: A0392
Based


a) Review of 1/21/17 and 1/22/17 " Maternal Child Towers Activity and Acuity " for the 7 p.m. to 7 a.m. shift reflected the patients in the units, their location, their corresponding acuity, and the initials of the nurse assigned to care for them.

Review of the 1/21/17 and 1/22/17 staffing assignment sheet for the Maternal Child Towers (MCT) for the 7 p.m. to 7 a.m. shift reflected the nurses scheduled to work, title, patient assignment and other assigned duties, and assigned rest breaks and meals. Further review of the document revealed the specific time breaks were assigned. There was no documentation of when breaks were actually taken and who cared for those patients during the breaks. Additionally, the charge nurse was noted on 1/21/17 to have care of three patients and then later admit and care for a fourth patient, and on 1/22/17 to have care of two patients.

In an interview on 1/26/17 at 1:30 p.m., Charge Nurse 2 (CN 2), the assigned charge nurse on for the day shift on the MCT, stated the dayshift sometimes uses nurses assigned from other maternal child towers to cover lunches and further stated 15 minute breaks are " usually cover by each other. We try to keep the charge from having patients so charge can cover breaks. "

During a concurrent interview and record review on 1/27/17 at 8:30 a.m. on the MCT, Deputy Director of Standards and Compliance (DSC) concurred there was no documentation of when breaks were actually taken and who care for the patients during the breaks

b) During a concurrent record review and interview with Interim Manager, Med/Surg/Tele 1(Mgr 1) and Interim Manager, Med/Surg/Tele 2 (Mgr 2) on 1/26/17 at 10:35 a.m., Mgr 1 stated, " It ' s [staffing] better ...we still have some 1:5 assignments at times. The nurses do ADO ' s (Assignment Despite Objection form) when breaks are missed ...when trauma was closed, it was really good. The LVN ' s (Licensed Vocational Nurse) are doing break relief ...we don ' t always list them on the staffing sheet. "

Record of the staffing sheets for the inclusive dates of 1/18/17 to 1/25/17 for the 3B and 3C units (Med/Surg/Tele) were evaluated for nursing ratio compliance, brake coverage, and break times assigned. This review revealed no days during this period where the two units were compliant with these regulations.
VIOLATION: RN SUPERVISION OF NURSING CARE Tag No: A0395
Based on staff interview, medical record and facility document review, the hospital's Emergency Department failed to 1) Accurately establish the prioritization of care needs for 2 patients (Patients 14 and 16), and 2) Reassess patient needs for 3 patients (Patients 3, 14 and 16) per policy.

These failures had the potential to prevent the timely provision of care and prevent the deterioriation of patients' conditions.

Findings:

Review of the hospital's February, 2015 "Initial Nursing Assessment - Triage" policy indicated, "[The] Emergency Department (ED) provides an initial nursing assessment (triage) to all patients presenting to the facility by a qualified Registered Nurse (RN). The goal of the initial nursing assessment is to determine acuity [how much care a patient requires] level, priority in receiving a medical screening exam (MSE) by a provider, and appropriate utilization of resources in the ED...The Registered Nurse will assess and categorize each patient upon arrival to the ED into ESI Levels 1 - 5 ... ESI Levels 3 - 5: These levels are based on the number of resources the triage RN anticipates the patient needing... ESI Level 3: 2 or more resources, ESI Level 4: 1 resource, ESI Level 5: No resources... Examples of ESI resources in the ED...X-rays, nebulized medications [medications administered in the form of a mist inhaled into the lungs]...Vital signs [measurements that indicate the status of the body's vital functions] are an essential component of a patient's triage assessment and can assist in determining the acuity of patients. If the patient's vital signs are outside of normal parameters... the RN should consider upgrading the patient to an ESI Level 2... dependent on many factors including presenting complaint, previous medical history, and subjective and objective data...Normal vital signs by age: 1 -3 years...Heart Rate 90 -120, normal temperature 98.6 F or 37 C..."

1A. A review of Patient 14's 1/21/17 at 7:07 p.m. triage "Initial Nursing Assessment" form reflected vital signs were taken at 7:13 p.m. The patient had a heart rate of 179 and a temperature of 38.2 C. ESI Level 5 was marked.

A review of Patient 14's medical record "Treatment Record - Order Sheet" indicated a chest x-ray was ordered at 10:00 p.m.

A review of Patient 14's medical record "Physician Medication Order" indicated an Albuterol Respiratory treatment at 1:30 a.m., 1/22/17.

During a 1/26/17 at 8:30 a.m. concurrent interview and medical record review, the Interim ED Manager (EDM) stated a service or resource would include any medication given, labs needed, any radiology services (the medical specialty which diagnoses and treats diseases and injuries using medical imaging techniques such as x-rays) needed, or an intravenous start (tube within the blood vessel system). After reviewing Patient 14's medical record, she said, "[Patient 14] should have been an ESI 3."

1B. A review of Patient 16's 3:25 a.m., 1/24/17 triage "Initial Nursing Assessment" reflected no assigned ESI level.

During a 10:47 a.m., 1/24/17 concurrent medical record review and interview, the Interim Emergency Department Manager (EDM) stated, "[The triage nurse] should have marked it. He would have been a Level 2."


2. Review of the hospital's 6/1/13 "Reassessment of the Patients in the Emergency Department" policy indicated, "Reassessments of patients in the waiting room shall be conducted based on triage category or more often as necessary... ESI Level 2...patients: Continuous reassessment with vital signs [blood pressure, heart and respiratory rates, temperature and pain rating] every 2 hours or more frequently based upon the patient's clinical condition....ESI Level 3 patients...vital signs and reassessment shall be based on the following criteria...every four hours, or more often as needed, after any interventions are conducted in triage (i.e. splinting, ice packs, antipyrectics [sic, fever-reducing measurees], etc.), any interventions and/ or reassessments shall be documented in the patient's medical record... ESI Level 4 and 5 vital signs and reassessment shall be based on the following criteria... every four hours, or more often as needed, after any interventions are conducted in triage (i.e. splinting, ice packs, antipyrectics [sic], etc.), any interventions and/ or reassessments shall be documented in the patient's medical record."

2A. A review of Patient 14's 1/21/17 at 7:07 p.m. triage "Initial Nursing Assessment" form reflected vital signs were taken at 7:13 p.m. and the patient had a heart rate of 179 and a temperature of 38.2 C. ESI Level 5 was marked.

A review of Patient 14's medical record "ER/ACS Physician Medication Order" indicated Tylenol 6 ml (milliliters, a unit of liquid measure) was ordered and given on 1/21/17 at 7:20 p.m. for fever and Albuterol was ordered and administered on 1/22/17 at 1:30 a.m.

A review of the medical record "Emergency Department Secondary Nursing Assessment" Flowsheet" for Patient 14 reflected vital signs and an assessment were not retaken until 3:00 a.m. on 1/22/17 when the patient was admitted to the hospital.

During a 1/26/17 at 8:30 a.m. concurrent interview and medical record review, the Interim Emergency Department Manager (EDM) concurred there were no additional assessments or vital signs documented on the flowsheet between 7:07 p.m., 1/21/17 and 3:00 a.m., 1/22/17. She further stated patients in the Rapid Medical Evaluation waiting room should be assessed at least every 4 hours and the temperature should have been rechecked 1 to 2 hours after the Tylenol was given.

2B. Review of Patient 16 ' s "Initial Nursing Assessment" form reflected vital signs taken at 3:25 a.m., 1/24/17 during triage. The 1/24/17 "Emergency Department Secondary Nursing Assessment and Flowsheet" indicated a reassessment including vital signs was not completed until 8:30 a.m.

In a 9:45 a.m., 1/26/17 concurrent interview and medical record review, the EDM stated that at least every two hours Level 2 patients should have focused reassessments related to their chief complaints including vital signs.

2C. Review of Patient 3's 1/1/17 "ER/ACS [emergency room /Acute Coronary Syndrome] Physician Medication Order" form reflected a 3:22 p.m. order for 3 doses of nitroglycerin (a medication used for chest pain) every 5 minutes. The form indicated it was given once at 3:43 p.m., 1/1/17.

Nursing progress notes documented Patient 3 was experiencing "arm tingling" on both sides at 3:30 p.m., 1/1/17. Vital signs taken did not reflect pain assessment and a pain rating was not charted until 3:50 p.m., 1/1/17, after the nitroglycerin was given ("0").

In a 9:50 a.m., 1/26/17 interview, the EDM stated a pain assessment prior to the nitroglycerin administration would have been expected.
VIOLATION: PATIENT CARE ASSIGMENTS Tag No: A0397
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observations, interviews, medical record and document review, the facility failed to 1) Ensure that Registered Nurses (RNs) assigned to adult patients in Intensive Care Unit (ICU) were qualified and competent to provide patient care during the immediate postoperative period, and 2) Ensure the competency of a Post-Anesthesia Care Unit (PACU) Registered Nurse 1 when he was unable to discharge the defibrillator correctly.

This failure had the potential to lead to compromised patient care and safety.

Findings:

1) During an initial tour of the ICU on 1/24/17 at 2 p.m., Patient 21 was observed in a bed being transported down the hall to a patient room. Several staff accompanied the patient, including an anesthesiologist. In a concurrent interview, the ICU Charge Nurse (ICU CN) explained Patient 21 went to surgery from the ICU earlier that day. Patient 21 was now returning from the operating room directly to the ICU, bypassing the Post-Anesthesia Care Unit (PACU), or recovery room.

In a group interview on 1/25/17 at 3 p.m., the ICU Educator (ICUE) stated the unit had been receiving patients directly from surgery for a long time; it was their standard practice. The ICUE revealed the ICU RNs, upon hire, received an initial orientation which covered minimal information about post-anesthesia patient care. Education specific to the care of the postoperative patient did not go further than this, he said. The ICUE stated the ICU RNs were not evaluated annually for specific post-anesthesia care competencies.

In the same group interview, the Interim Perioperative Services Director (IPD) stated the PACU nurses had annual competency evaluations specific to the care of the post-anesthesia patient. Training was ongoing and included mock codes for [DIAGNOSES REDACTED] (MH), a rare life-threatening condition usually triggered by exposure to anesthetic gases and succinylcholine, a neuromuscular blocking agent.

During an interview with the Interim Assistant Nurse Manager (IANM) of the ICU on 1/26/17 at 11:15 a.m., she stated the "2C" nurses (medical/surgical/telemetry) that float to ICU were provided the same limited education regarding the post-anesthesia patient the ICU nurses received. Neither participated in mock MH codes. The IANM stated she personally would not be able to identify a MH crisis if it happened. She said she would, "Give Tylenol", assuming the patient had a fever. Furthermore, the IANM had limited knowledge of the crucial drug Dantrolene, a medication, if used promptly, can reverse a MH crisis.

A staff nurse (ICU RN) from 2C was interviewed in the ICU. ICU RN was assigned two patients in the ICU. When asked what he would do if his patient had showed signs and symptoms of [DIAGNOSES REDACTED]

On 1/27/17 at 10 a.m., the Administrative Department Manager of Short Stay Surgery and the Post-Anesthesia Care Unit (ADM SSS PACU) was interviewed. The ADM SSS PACU explained the PACU RN was required to demonstrate he or she was fully competent to care for a patient received directly from surgery. The nurses complete a preceptorship, numerous inservices and training modules all specific to care of the post-anesthesia patient. The ADM SSS PACU explained PACU RNs had specialized knowledge of, but not limited to, the types of anesthesia (examples including local, regional, monitored anesthesia care, and general), Aldrete scoring, and Phases I and II of recovery). Staff must have a good understanding of MH, the ADM SSS PACU stated. MH training and mock codes were scheduled regularly. When asked if any of the ICU RNs have trained in the PACU, the ADM SSS PACU said, "I haven't seen anyone from ICU train in the PACU."

The Departmental personnel files for ICUE and ICU RN were reviewed. The most recent documentation of competency for both employees was limited to a 2015-2016 ICU/2C Checklist-Evaluation Registered Nurse with a box checked indicating, "Demonstrates knowledge of post-anesthesia complications."

According to Chapter 42 The Perianesthesia Patient of a facility reference titled, Elsevier "Critical Care Nursing, 7th Edition (2014)", "Caring for the critically ill patient who is emerging from anesthesia requires diligent monitoring of the patient's physical and psychologic status to prevent potential complications that may occur as a result of the anesthetic gases or techniques. To provide safe and competent patient care, the critical care nurse needs knowledge of anesthetic agents and techniques and the physiologic and psychologic responses of patients who receive anesthesia."

The Department was provided with an additional publication by the ICU staff. This reference from the American Association of Critical Care Nurses was titled, Critical Care Nursing, 6th Edition (2011). The book made no reference to the perianesthesia patient.
2) During a concurrent observation in the PACU on 1/24/17 at 9:15 a.m., and interview with the Perioperative Director (POD), PACU Registered Nurse 1 (PACU 1) was unable to discharge the defibrillator, even with a directional sheet he was reading. The POD acknowledged the observation and confirmed PACU 1 did not know how to use the defibrillator, and it concerned her.

Review of the hospital Policy and Procedure titled, "Anesthesia Responsibilities" dated 7/08 indicated, "Staffing of Nursing Personnel: A Registered Nurse qualified by relevant education, training, experience, and documented competence, is responsible for planning and directing the nursing care of patients who undergo surgery and other invasive procedures when patients are receiving anesthesia."
VIOLATION: WRITTEN MEDICAL ODERS FOR DRUGS Tag No: A0406
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on staff interview, medical record and facility document review, the hospital failed to obtain physician orders or authenticate verbal orders for medications for 5 of 30 sampled patients (Patients 1, 2, 3, 13 and 18).

This failure prevented care team members from having access to accurate medical information for these 5 patients.

Findings:

A. Review of the 11/14/16 "Nursing Progress Notes" revealed the medication hydralazine
was given at 1:49 p.m. and 1:53 p.m. to lower Patient 2's blood pressure.

In an 8:11 a.m., 1/27/17 concurrent interview and medical record review, the Emergency Department Charge Nurse (CN 1) was unable to find a physician order for the hydralazine. CN 1 stated an order should have been written on the physician medication order sheet.

B. Review of 1/25/17 "Trauma Flowsheet" revealed at 1720 (5:20 p.m.) Patient 18 received Morphine (a narcotic pain reliever used to treat moderate to severe pain) 4 mg (milligrams, a unit of measure) IVP (a technique deliver medication directly into a vein) and Zofran (ondansetron a medication used to prevent nausea and vomiting) 4 mg IVP. Further review of the medical record revealed no verbal or written orders for the medications.

In an 8:11 a.m., 1/27/17 interview CN 1 stated an order should have been written on the physician medication order sheet.

C. Review of the 8/9/16 "ER/ACS Physician Medication Order" revealed orders for Patient 13 for DTAP (a vaccine), Ancef (an antibiotic), Mannitol (a medication to treat high pressures in the head), Keppra (a medication used to treat seizures) and Rocuronium (a muscle relaxant used during medical procedures). Further review of form reflected only a nurse's signature.

In an 8:11 a.m., 1/27/17 concurrent interview and medical record review CN 1 stated that Patient 13's nurse had not documented the above medications and vaccine as physician verbal orders prior to the patient being sent to surgery. CN 1 indicated that the physician would cosign the nurse ' s notation of the verbal orders.

D. During a concurrent interview and medical record review on 1/27/17 at 10:45 a.m., the
medical records of Patients 1 and 3 were reviewed together with the Administrative Department Manager of Short Stay Surgery and Post Anesthesia Care Unit (ADM SSS PACU) and Perioperative Director (PeriOp Dir).

Patient 1 was admitted on [DATE]. The chart review indicated that on 7/19/16, 7/23/16, and 7/24/16, three verbal orders from various physicians were taken by registered nurses and not authenticated by physicians later.

Patient 3 was admitted on [DATE], after discharge from outpatient surgery on the same day. Review of the chart indicated that on 2/26/16 and 2/28/16, two verbal orders were taken by registered nurses and not authenticated by physicians later.

When asked whether those verbal orders should have been signed by physicians in a timely manner, both the ADM SSS PACU and PeriOp Dir replied, "Yes."

On 1/27/17 at approximately 11 a.m., the Chief Operating Officer (COO), Deputy Director of Medical Staff Services (DDMSS), and Medical Staff Coordinator (MSC) acknowledged the above findings. The DDMSS also stated that the issue of physicians not signing verbal orders timely was recognized in the past, and the hospital made efforts to address such issue.
Review of the Medical Staff Rules and Regulations, last revised in 3/13, indicated under Article 8, "Medical Records", that "All verbal orders, including telephone orders, must be countersigned (authenticated) within forty-eight hours, except that verbal orders for restraints must be countersigned within twenty-four hours. All signatures must be dated and timed."
VIOLATION: OPERATING ROOM POLICIES Tag No: A0951
Based on observation, staff interview, hospital document review and hospital Policy and Procedure review, the hospital failed to ensure staff adhered to Policy and Procedures related to the following concerns:
1. Traffic patterns, restricted and semirestricted surgical attire;

2. Aseptic (technique used to prevent infection) practices;

3. Housekeeping requirements;

4. Surgical instruments;

5. Safety related to environmental temperature, blanket warmer temperature and air changes per hour in Perioperative services;

6. Medication safety; and

7. Expired supplies available for use.

These failures had the potential for the spread of infection, wrong laboratory results and patient harm.

Findings:

1. On 1/26/17 from 10 a.m.-11:30 a.m. a concurrent observation of the restricted areas of the Perioperative Department with the Interim Perioperaive Director (IPD) and the Perioperative Director (POD) was conducted.

1a. Operating room 4 (OR 4), a restricted area, had open sterile instruments on a table. The patient had been prepped and draped for surgery. An unidentified medical student was observed in the OR with no cover jacket (special OR designated jacket used to cover bare arms and protect against infection) or mask on, talking to an anesthesiologist, who also had no mask on. Surgeon 1 (S 1) entered the OR without scrubbing his hands, no cover jacket and an untied mask held over S 1's face with his left hand. S 1 tied the mask inside the OR while talking to other staff. S 1 exited the OR and proceeded to scrub. S 1 reentered the OR and walked around the OR waving his arms around while talking to staff. S 1 exited the OR suite. The POD acknowledged and confirmed the observations. POD stated MS 1 and S 1 should have worn cover jackets and a properly worn mask. The anesthesiologist should have been wearing a mask;

1b. A staff member was observed in the semirestricted area walking to a changing room, an unrestricted area, with a mask tied around her neck. The staff member exited the changing room after a couple of minutes, walked to OR 7, entered the OR without hand hygiene and proceeded to chart on the computer. POD acknowledged and confirmed the observation and stated the staff member should have changed her mask and used hand hygiene prior to reentry to OR 7;

1c. A Certified Registered Nurse Anesthetist 1 (CRNA 1) was observed in OR 4 with a mask not covering his nose and was loose fitting, not tight to the face. The IPD acknowledged and confirmed the observation and stated the mask should be worn above the nose, pinched to the nose and tight on the face with no gaps.

1d. An Attending Surgeon 1 (AS 1) was observed in the semirestriced area with a mask tied around his neck. The IPD and POD acknowledged and confirmed the observation and stated his mask should not be tied around his neck while walking through the semirestricted area.

Review of the hospitals Policy and Procedure titled, "Traffic Patterns in the Operating Room" dated 7/08, indicated the following:
A. "Procedure: 1. The semirestricted area includes the peripheral support areas of the surgical suite. It has storage areas for clean and sterile supplies, work areas for storage and processing of instruments, scrub sink areas, and corridors leading to restricted areas of the surgical suite. Personnel are required to wear surgical attire and cover all head and facial hair. The restricted area includes the ORs, procedure rooms and the clean core area. Surgical attire and hair coverings are required. Masks are required where open sterile supplies or scrubbed persons are located"; and

B. "C. Movement of personnel will be kept to a minimum while invasive and noninvasive procedures are in progress:... 2. Doors to the operating or procedure room will be closed except during movement of patients, personnel, supplies and equipment. Traffic in and out of the OR will be minimized during the procedure or when sterile supplies are opened".

Review of the hospital's Policy and Procedure titled, "Attire in Surgery" dated 6/14, indicated:
A. "Procedure: A. All individuals who enter the semirestricted and restricted areas of the surgical suite should wear freshly laundered surgical attire intended for use only within the surgical suite. ...10. Nonscrubbed personnel should wear long-sleeved disposable jackets that are buttoned or snapped closed during use"; and

B. "C. All individuals entering restricted areas of the OR suite will wear a mask when open sterile items and equipment are present. 1. A mask should fully cover both mouth and nose and be secured in a manner that prevents venting; 2. Masks should be removed carefully by handling only the ties, and they should be discarded immediately. Masks should not be saved by hanging them around the neck or tucking them into a pocket for future use".

C. "3. Talking and the number of people present will be minimized during procedures. An increase in airborne microorganisms can occur with an increased number of people present. Movement, talking, and uncovered skin areas can contribute to airborne contamination".

2. A used cover jacket was observed hanging on a clean/sterile utility cart with supplies in the semirestricted area. The POD confirmed the observation and stated the dirty cover jacket should not be hung on the clean/sterile supply utility cart.

3. During a concurrent observation in the Post Anesthesia Care Unit (PACU) on 1/24/17 at 3 p.m. with the POD, a student nurse (SN) was observed cleaning a gurney between patients. The SN used a cleaning product that required a dwell time of two (2) minutes and let dry. The SN cleaned the front of the gurney pad, but not the back side of the pad. The SN placed new sheets on the gurney when the pad was visibly wet, and placed a patient on the gurney.

3a. At 3:10 p.m. a staff member was observed cleaning a gurney pad between patients. The backside of the pad was not cleaned and fresh linen was placed on the gurney pad. The POD acknowledged the observations and stated the back side of the gurney pad should have been cleaned and the SN should not have placed clean sheets on a wet gurney pad.

Review of the hospital's Policy and Procedure titled, "Housekeeping Cleaning in Perioperative services" dated 7/08 indicated:
A. "Purpose:...12. After cleaning and disinfection, all surfaces should be dry before patient contact".

4. During a concurrent observation of the semiresticted area on 1/24/17 at 10:50 a.m. with the POD, a staff member was observed placing surgical instruments into the immediate use steam sterilizer, also know as flash sterilization. The POD stated the instruments were arthroscopy forceps (a surgical scope used to hold and manipulate tissue). The POD stated they had six (6) arthroscopy cased scheduled today with only two (2) arthroscopy forceps available, so the surgical instruments had to be sterilized immediately for the next case, and acknowledged the hospital did not have enough equipment for the scheduled cases.

Review of the hospital's Policy and Procedure titled, "Sterilization Practices dated 6/08, indicated:
A. "Procedure: ...2. ..b. Flash sterilization may be associated with an increased risk of infection to patients because of pressure on personnel to eliminate one or more steps in the cleaning and sterilization process; i. Flash sterilization will be used only when there is insufficient time to process by preferred wrapped or container method. Flash sterilization will not be used as a substitute for insufficient instrument inventory".

5. Review of hospital documents related to the environment of care in the Perioperative services indicated the temperature and air changes were out of compliance. OR 7 was out of compliance with temperature on 1/7-12/17 and the decontamination area of the Sterile Processing Department (SPD) were out of compliance 1/1-26/17. The air changes per hour were out of compliance in OR 3 on 1/9 & 10/17.

5a. Review of the blanket warmer temperature log indicated the temperature on the warmer was out of compliance the following days: 1/5-10, 13-16, 18-22, and 24/17.

In an interview on 1/27/17 at 8:35 a.m., the Facilities Manager (FM) confirmed the OR and SPD temperatures were out of compliance. The FM stated the blanket warmer was not centrally monitored and he relied on OR staff to put in a work order if the blanket warmer was out of compliance with temperatures. The FM checked for a work order but had none.

Review of the hospital's Policy and Procedure titled, "Environment of Care-Safety" dated 7/08, indicated the following:
A. "Purpose: E.V.c.1. Temperature should be maintained between 68 degrees Fahrenheit (F) to 73 degrees F within the operating room suite and general work areas in sterile processing"; and

B. "E. V.c.2. The decontamination area temperature should be maintained between 60 to 65 degrees F".

6. During a concurrent observation of the PACU with the POD on 1/24/17 at 9:20 a.m., several bags of intravenous (IV) fluid were observed to be pre-hung and ready for patient use. The POD acknowledged and confirmed the observation. The POD stated the fluid should not be available for patient use.

In an interview with the Pharmacy Director (PD) on 1/25/17 at 10:35 a.m., the PD stated IV fluid should not be pre-hung, that IV fluid should be spiked and hung at the time of administration.

7. During an observation in the clean utility room of the Perioperative area on 1/24/17 at 9:35 a.m., 19 red top blood laboratory tubes had expired. The assistant POD confirmed the observation and stated the expired laboratory tubes should not be available for patient use.

7a. During a concurrent observation in the SPD on 1/24/17 at 11 a.m. with the sterile processing supervisor (SPS), the SPS acknowledged one pre-sterilized vacuum delivery kit had expired 6/2016. The SPS stated staff were to check weekly for expired products and stated he did not have documentation of the weekly checks being performed.
VIOLATION: POST-OPERATIVE CARE Tag No: A0957
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observations, interviews, medical record and document review, the facility failed to ensure adequate provisions were made for immediate post-operative/post-anesthesia care of patients in the Intensive Care Unit (ICU) when:
a) The facility failed to develop and implement a policy and procedure to define the requirements, in accordance with acceptable standards of practice, to safely and adequately recover patients transferred directly from surgery to the ICU;
b) A [DIAGNOSES REDACTED] (MH) cart was not readily accessible and;
c) ICU staff were not adequately trained to provide immediate post-anesthesia care.
These failures could result in inadequate monitoring, a failure to identify complications and delays in treatment.
Findings:

a) During an initial tour of the ICU on 1/24/17 at 2:30 p.m., Patient 21 was observed in a bed being transported down the hall to a patient room. Several staff accompanied the patient, including an anesthesiologist. In a concurrent interview, the ICU Charge Nurse (ICU CN) explained Patient 21 went to surgery from the ICU earlier that day. Patient 21 was now returning from the operating room directly to the ICU, bypassing the Post-Anesthesia Care Unit (PACU), or recovery room. Patient 21 underwent thoracic surgery and the insertion of a chest tube.

In a concurrent observation and interview with the ICU Educator (ICUE) on 1/24/17 at 2:45 p.m., he stated the majority of surgical patients that originated in the ICU returned directly from the operating room to their rooms. This was a challenge for the ICU, he said. The ICUE stated the post-operative patient required increased monitoring and attention, making it challenging to meet staffing requirements. The ICUE drew the surveyor's attention to the number of staff in Patient 21's room. Three registered nurses, all assigned to other patients, were observed at Patient 21's bedside. Patient 21 was observed to be sedated, required a head tilt chin lift to maintain her airway and Narcan, a medication used to reverse the effect of a narcotic. The ICUE stated a critically ill post-operative patient, like Patient 21, required a 1:1 nurse to patient ratio. The facility didn't always have additional staff to accommadate such assignments.
The ICUE further explained the care of the post-operative patient in the ICU was different from the PACU, primarily because of the difference between physician orders. For example, in the PACU, physician orders were generally written by the anesthesiologist to address the period of time a patient recovered from anesthesia. When the post-operative patient was transferred straight to the unit, the surgeon or attending physician generally wrote the orders which did not address the recommended practice of post-anesthesia care. The ICUE added, the ICU did have its own standard of care and interventions for all its critically ill patients.
In a group interview with the Chief Nurse Officer, the Perioperative Director, the Interim Director of Surgical Services, the Interim Manager of ICU/2C, and the Risk Manager on 1/25/17 at 3 p.m., the ICU ED explained that all patients that go to surgery from the ICU return straight to the unit after surgery, bypassing the PACU. This was the standard practice at the facility and had been in effect a long time. When asked if the facility had a formalized process or policy that outlined specific criteria to ensure a post-anesthesia patient could be adequately and safely recovered in the ICU, the ICU ED said no. The group was asked what determined whether a patient was recovered in the PACU or ICU, they did not have an answer. The ICU ED acknowledged a post-operative/post-anesthesia patient was considered a hign risk patient. When asked if the standard of care in the ICU was the same as the PACU, the ICU ED said...
Later, during the group interview, the Perioperative Director said, "the equipment is the same, the medications are the same and the monitoring is the same, the only difference is the charting" when comparing the PACU to ICU.
The ICU Interim Assistant Manager (ICU IAM) was interviewed on 1/26/17 at 11:15 a.m. She indicated there were differences between the post-anesthesia care provided in the PACU and the ICU. The ICU IAM explained that certain medications were given to the recovering patient in PACU that wouldn't generally be given in the ICU, such as Fentanyl, a short-acting pain medication. In addition, the patient upon arrival to the unit after surgery was considered an admission with a new set of post-operative physician orders. If the patient went to the PACU from surgery, she stated, the anesthesiologist generally used a standardized order set for post-anesthesia care, including specific instructions for monitoring and criteria for discharge. The PACU staff also followed a "PACU protocol" as instructed by the anesthesiologist.
On 1/27/17 at 9:50 a.m., the PACU Assistant Manager (PACU AM) and the Perioperative Director (PD) were interviewed in the PACU. The PACU AM stated the PACU registered nurse can have 1 or 2 patients. A patient requiring a 1:1 nurse to patient ratio included any patient with an airway device, such as an endotracheal tube. The patient's acuity, she explained, was also dependent on his or her Aldrete score, gag reflex and pain. When asked what determined whether a post-operative patient was recovered in the PACU or ICU, the PACU AM stated if the patient required a ventilator after surgery, they are transferred directly to the ICU. The anesthesiologist or surgeon may have a preference where his or her patient is recovered. The PACU AM acknowledged order sets with specific pre-defined parameters were used by the majority of anesthesiologists. The orders included monitoring parameters, when to notify anesthesia and discharge/transfer criteria.
The Post Anesthesia Care Physician's Orders standardized order set was reviewed. Item 1. on the list read: "Admit to PACU, ICU, FMC for recovery [check one]". The orders included: monitoring parameters, MD notification instructions, diet orders, intravenous fluids and supplemental oxygen, medications for pain, nausea and vomiting, heart rate and shortness of breath and lastly criteria for discharge or transfer from the PACU.
As evident by a review of Patient 21's medical record, Patient 21 had thoracic surgery on 1/24/16. Post-operatively, Patient 21 returned to the ICU from the operating room. The physician post-operative orders, dated 1/24/17 at 2:20 p.m. were limited to: "Chest X-Ray now post-operatively, Chest X-Ray in am follow up, CBC at 4 p.m., CBC, BMP in am, Start Regular Diet when awake, Discontinue intravenous fluids, Downgrade to floor."
A review of the medical record revealed Patient 10 went to surgery on 1/14/17 at 2:00 p.m., for a revision of an extraventricular drain (EVD) status post intracerebral/intraventricular hemorrhage. In a concurrent review with the ICU IM, she acknowledged there was no futher post-operative physician orders in the chart other than what the surgeon wrote at 1/14/17 at 3:30 p.m., "Please open EVD at 15 cm above the ear level. Clamp for transporation. Non-contrast head CT at 6 a.m. tomorrow."
In an interview with 1/27/17 at 11:20 a.m., the ICU ED acknowledged anytime a patient goes to surgery under general anesthesia and returns to the ICU, the previous physician orders no longer apply and new orders must be written.
b) On 1/24/17 at 1 p.m., observations were made of the ICU. An MH cart (or kit), a rare life-threatening condition usually triggered by exposure to anesthetic gases and/or succinylcholine, was not observed on the unit.

In the group interview on 1/25/17 at 3 p.m., the ICU ED acknowledged the ICU did not have an MH cart. When asked if the ICU had a plan in place should a patient have an MH crisis, the ICU ED said no.
In an interview with the PACU AM on 1/27/17 at 10:30 a.m., she stated an MH cart must be maintained and accessible anywhere anesthetic gas and/or succinylcholine may be used. It is crucial, the PACU AM said, a plan is developed to ensure timely and competent care of a patient with MH.
According the Malignant Hyperthernia Association of the United States, 2017 website www.mhaus.org, "Stocking an MH Cart: All facilities...where MH triggering aesthesitic gases (isoflurane, desflurane, and sevoflurane) and depolarizing muscle relaxants (succinylcholine) are administered, should stock dantrolene (a skeletal muscle relaxant) along with the other drugs and devices necessary to treat an MH reaction. All anesthesia and perioperative staff should be aware of the location [of medications and supplies].
c) In a group interview on 1/25/17 at 3 p.m., the ICUE revealed the ICU RNs, upon hire, received an initial orientation which covered minimal information about post-anesthesia patient care. Education specific to the care of the postoperative patient did not go further than this, he said. The ICUE stated the ICU RNs were not evaluated annually for specific post-anesthesia care competencies.

In the same group interview, the Interim Director of Surgical Services (IDSS) stated the PACU nurses had annual competency evaluations specific to the care of the post-anesthesia patient. Training was ongoing and included mock codes for [DIAGNOSES REDACTED] (MH), a rare life-threatening condition usually triggered by exposure to anesthetic gases and succinylcholine, a neuromuscular blocking agent.

During an interview with the Interim Assistant Nurse Manager (IANM) of the ICU on 1/26/17 at 11:15 a.m., she stated the "2C" nurses (medical/surgical/telemetry) that float to ICU were provided the same limited education regarding the post-anesthesia patient the ICU nurses received. Neither participated in mock MH codes. The IANM stated she personally would not be able to identify a MH crisis if it happened. She said she would, "Give Tylenol", assuming the patient had a fever. Furthermore, the IANM had limited knowledge of the crucial drug Dantrolene, a medication, if used promptly, can reverse a MH crisis.

A staff nurse (ICU RN) from 2C was interviewed in the ICU. ICU RN was assigned two patients in the ICU. When asked what he would do if his patient had showed signs and symptoms of [DIAGNOSES REDACTED]

On 1/27/17 at 10 a.m., the Assistant Nurse Manager (ANM PACU) of the PACU was interviewed. The ANM PACU explained the PACU RN was required to demonstrate he or she was fully competent to care for a patient received directly from surgery. The nurses complete a preceptorship, numerous inservices and training modules all specific to care of the post-anesthesia patient. The ANM explained PACU RNs had specialized knowledge of, but not limited to, the types of anesthesia (examples including local, regional, monitored anesthesia care, and general), Aldrete scoring, and Phases I and II of recovery). Staff must have a good understanding of MH, the ANM stated. MH training and mock codes were scheduled regularly. When asked if any of the ICU RNs have trained in the PACU, the ANM PACU said, "I haven't seen anyone from ICU train in the PACU."

The Departmental personnel files for ICUE and ICU RN were reviewed. The most recent documentation of competency for both employees was limited to a 2015-2016 ICU/2C Checklist-Evaluation Registered Nurse with a box checked indicating, "Demonstrates knowledge of post-anesthesia complications."

According to Chapter 42 The Perianesthesia Patient of the facility reference titled, Elsevier Critical Care Nursing, 7th Edition (2014), "Caring for the critically ill patient who is emerging from anesthesia requires diligent monitoring of the patient's physical and psychologic status to prevent potential complications that may occur as a result of the anesthetic gases or techniques. To provide safe and competent patient care, the critical care nurse needs knowledge of anesthetic agents and techniques and the physiologic and psychologic responses of patients who receive anesthesia."

The Department was provided with an additional publication by the ICU staff. This reference from the American Association of Critical Care Nurses was titled, Critical Care Nursing, 6th Edition (2011). The book made no reference to the perianesthesia patient.

The ASPAN 2012-2014 Perianesthesia Nursing Standards, Practice Recommendations and Interpretative Statements include Practice Recommendation (#8) that addresses bypassing PACU Phase I and taking patients directly to Phase II recovery (p. 60-62). There is no parallel practice recommendation describing criteria for bypassing PACU with critical care patients who may require mechanical ventilation or other advanced monitoring. In some facilities ventilated patients go directly to ICU from the OR. In others, PACU nurses recover ventilated patients on a regular basis. In still other facilities, some ventilated patients go to PACU for care and observation until they meet criteria for extubation while others who will not be extubated within a short time go directly to ICU. Who decides? Is the decision based on space available or is it resource oriented? The primary responsibility for Phase I PACU is to provide the optimal standard of care to the Postanesthesia patient and to effectively maintain the flow of the surgery schedule. Phase I PACUs are by their nature critical care units, and as such staff should meet the competencies required for the critically ill patient. These competencies should include, but are not limited to, ventilator management, hemodynamic monitoring and medication administration, as appropriate to their patient population. Management should have a multidisciplinary plan to address appropriate utilization of ICU beds. Admission and discharge criteria should be utilized to evaluate the necessity for critical care and to determine the priority for admission. The important issues to keep in mind are these: 1. The same standard of care must be met for the patient recovering from anesthesia, regardless of where that process occurs. 2. Patient safety issues must always be at the forefront when considering the best location for the patient recovery. That being said, there are times when ventilated post-operative patients become the focus of turf wars. Many organizations have established policies to help guide and direct care givers in making appropriate decisions for patient placement in these situations. Input from the Anesthesia Provider, PACU charge nurse, and ICU Charge nurse can be valuable in determining where care can best be provided. PACU nurses generally contend that the patient will not be recovered if he is to remain intubated while ICU nurses argue staffing issues: one-to-one care for a specified length of time (ICU nurses may not be as well versed on anesthetic agents and recovery). Finally, anesthesia providers need to weigh in on the issue. Anesthesiologists often feel more comfortable when PACU nurses are directly involved in providing the initial postanesthesia care for all their patients, including those who will ultimately transfer to ICU. Summary: Developing a written policy to address the recovery of ICU patients helps resolve the criteria for transferring critical patients from OR to ICU and/or PACU. An existing policy promotes open communication and helps guide caregivers in determining the safest and best patient placement.
The facility was unable to provide a written policy or procedure for the standard of care for the immediate post-operative/post-anesthesia patient in the ICU.
According to the 2017 facility Plan for Providing Patient Care Services, "The patient can expect care that is based upon established policies and procedures...An ongoing review of the Plan [is to] assure a comparable level of care provided to patients no matter where they are in the hospital."
VIOLATION: PRE-ANESTHESIA EVALUATION Tag No: A1002
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, staff interview and hospital Policy and Procedure review, the facility failed to ensure safe anesthesia services when the following observations were made:
1. Inside the anesthesia cart: dirty/used magill forceps, two (2) open 50 milliliter (ml) bags of intravenous fluid (IVF) with medication inside the IVF, a 50 ml premixed antibiotic with a half torn patient label attached and an open 250 ml bottle of sevoflurane (inhaled anesthesia medication) that was half empty and available for use; and when the

2. [DIAGNOSES REDACTED] (MH: a rare life-threatening condition that is usually triggered by exposure to medication used for general anesthesia) cart did not have adequate supplies to treat an emergent condition and were not readily available to patients in the recovery process from anesthesia.

These failures had the potential for medication errors and patient harm.

Findings:

1. During a concurrent observation in OR 4 with the Interim Perioperative Director (IPD) on 1/24/17 at 10 a.m., the anesthesia cart was inspected. The following items were observed in the anesthesia cart:

1a. A used/dirty magill forceps (surgical instrument used to assist with intubation, an artificial airway);

1b. Two (2) 50 ml bags of IV fluid, one labled "neosynephrine" (also known as phenylephrine, used to augment blood pressure during anesthesia) and one labled "epinephrine" (medication used to increase profoundly low blood pressure). Neosynephrine and epinephrine are both high alert medications (medication that has the potential for patient harm if used incorrectly) emergency medications. Neither bag of IV fluid had a documented medication dosage or expiration time on the medication label;

1c. A premixed antibiotic with a half torn patient label attached.
The IPD acknowledged and confirmed all observations and stated the items listed above should not have been in the anesthesia cart.

1d. During a concurrent observation and interview with the Perioperative Director (POD) on 1/25/17 in OR two (2), the anesthesia cart was inspected. The following item was observed inside the anesthesia cart: an undated 250 ml bottle of sevoflurane (an inhaled anesthetic) that had been opened and was half full.

The POD acknowledged and confirmed the observation and stated the used anesthetic medication should not be in the anesthesia cart available for use.

In an interview with Anesthesiologist 1 (A 1) on 1/24/16 at 10:30 a.m., A 1 stated the premixed antibiotic, improperly labeled IV fluids and magill forceps were probably left over from a case last night. A1 stated staff were supposed to dispose of all medication after the case is over and acknowledged the observed items were not supposed to be in the anesthesia cart.

In an interview with Anesthesiologist 2 (A 2) on 1/25/17 at 10:15 a.m., A 2 confirmed the half full bottle of inhaled anesthesia should not be in the anesthesia cart available for use.

Review of the hospital's Policy and Procedure titled, "Anesthesia Safety Regulations" dated 6/08, indicated:
1. "Procedure: ...12. When medications are added to the intravenous solutions, they are labeled properly".

Review of the hospital's Policy and Procedure titled, "Medications" dated 5/2016, indicated:
A. "High Alert Medications: High alert medications are those that have been shown to have a narrow margin of safety, placing patient's at risk of significant harm when used in error. Enhanced awareness and safety practices are required to reduce the risk of errors with these medications. The following are considered High Alert Medications at [name of hospital]: ... Vasoactive medications such as epinephrine and neosynephrine ... High alert medications will be marked as such with a visual alert, such as a high alert sticker, on the medication itself ..."; and

B. "Medication Storage/Floor Stock: Medications requiring reconstitution are labeled with the date of reconstitution and discarded at the appropriate time specified by the manufacturer in the product information sheets. IV medications must be labeled with 2 patient identifiers, medication, dose and date of admixture".

In an interview with the Pharmacy Director (PD) on 1/25/17 at 10:35 a.m., the PD stated medication that is mixed by staff should have been labeled with the drug, dose, and expiration date. If the medication was not used during the case, it was to be discarded. The PD stated the antibiotic should have been returned to the pharmacy. The PD stated inhaled anesthetic should never be saved. After use, the inhaled anesthesia medication was supposed to be discarded.

3. Review of the hospital's Policy and Procedure titled, "[DIAGNOSES REDACTED]" dated 1/14, indicated the following supplies were required inside the MH cart:
3a. "Purpose: Drugs/Equipment/Supplies needed:

3b. Drugs: (6) 1000 ml .9% sodium chloride (saline) IV solution-cold;

3c. Four (4) 1000 ml .9% sodium chloride irrigation solution-cold;

3d. Equipment: (10) 60 ml syringes-to dilute dantrolene (medication used for [DIAGNOSES REDACTED]);

1d. Four (4) each intravenous catheters- 16g (gage), 18g, 20g, 24g (for IV access and arterial line)".

During a concurrent observation/inspection of anesthesia's [DIAGNOSES REDACTED] cart with the POD on 1/26/17 at 8:30 a.m., the following was observed to be missing from the MH cart:
3a. Two (2) liters of cold .9% saline;

3b. Four (4) bottles of cold .9% saline irrigation;

3c. Two (2) 16 g (gage) IV start catheters;

3d. Two 18g IV catheters;

3e. Three (3) IV start catheters;

3f. Two (2) 22g IV start catheters; and

3g. 10 60 ml syringes.
The POD acknowledged and confirmed the observations and stated the missing items should have been in the [DIAGNOSES REDACTED] cart.

During a concurrent observation and interview with the ICU Educator (ICUE) on 1/27/17 at 12 p.m., the ICUE stated, " We don't have a MH cart. We would have to get the cart from PACU." The MH cart was observed in the central core, a semirestricted area, and not in the PACU.
VIOLATION: OUTPATIENT POST-ANESTHESIA EVALUATION Tag No: A1005
Based on staff interview, medical record review and hospital Policy and Procedure review the hospital failed to ensure a post operative anesthesia assessment had been completed by an anestheseoligist prior to discharge from the hospital.

This failure had the potential for the patient to be discharged without an assessment by an anestheseologist to confirm the patient had recovered from anesthesia and there were no complications.

Findings:

Review of Patient 5's medical record on 1/24/17 at 11:07 a.m., indicated Patient 5 had a scheduled short stay (admission less than 24 hours) knee surgery. Patient 5 was discharged from the post anesthesia care unit (PACU) on 1/24/17 at 2 p.m. The post anesthesia assessment document was left blank.

Review of the hospital's Policy and Procedure titled, "Anesthesia Responsibilities" dated 7/08, indicated:
A. "J. Post-operative evaluation: 2. A post-operative note by the Anesthesiologist is entered into the patient's clinic record following emergence describing the anesthetic course and detailing any and all anesthetic complications. The post-operative status of the patient is evaluated prior to admission and discharge from the post-anesthesia recovery area".

Review of the hospital's Policy and Procedure titled, "Delivery of Anesthesia" dated 6/08, indicated:
A. "15. Post Anesthesia Care Unit (PACU): A. When patient is admitted or discharged from the PACU, the following should be documented: A Post anesthesia visit by a qualified physician

B. "B. Patient shall be discharged from PACU by an Anesthesiologist provider familiar with the patient or by criteria by the Anesthesia Department in discharge criteria policy".

In an interview with the Interim Perioperative Director (IPD), on 1/24/17 at 2 p.m., the IPD acknowledged the post anesthesia assessment for Patient 5 had not been documented.