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Based on observation, interview, and record review, the facility failed to ensure emergency care services met the needs for three of 30 sampled patients (Patients 5, 6, and 7) when the emergency department (ED) did not have a staffing plan sufficient to address shift by shift changes in the flow of patients (and their needs) and when nursing staff did not have access to an accurate pediatric (60 days to 13 years old) assessment tool, as evidenced by:

1. There was no plan in place to increase staffing personnel if needed based on patient volume or complexity of patients.

2. A licensed vocational nurse (LVN) providing care in the ED lacked the proper qualifications.

3. An emergency medical technician (EMT, unqualified to take verbal orders per hospital policy and procedures) took verbal orders for Patient 5 and entered them into the electronic medical record (EMR).

4. The systemic inflammatory response system (SIRS) screening tool (for identifying patients with sepsis, a life threatening infection), used for Patient 7, a pediatric patient, was for an adult.

5. There was insufficient staff to provide continuous cardiac monitoring.

6. There was insufficient staff on duty to provide care for four patients, including a critically ill patient (Patient 5), in the ED.

The cumulative effect of these systemic problems resulted in the facility's inability to comply with the statutorily mandated Condition of Participation: Emergency Services. These failures put patients at risk for substandard care and poor outcomes.

Findings:

1. During the initial tour of the ED with the Emergency Department Nurse Manager (EDNM) 1 on 5/14/18 at 10 am, she stated that year round there was one registered nurse (RN) on duty all the time. She stated that from May through September another nurse was scheduled to work 10 am to 10 pm and that they "try to staff." EDNM 1 stated they also staff one EMT or paramedic eight hours a day, although the EMTs leave to take emergency calls. EDNM 1 stated that when a patient comes in, "whoever is at the desk does a visual triage." (Triage is the process of sorting people based on their need for immediate medical treatment.) EDNM 1 identified the desk where the EMT sat and the nurses desk adjacent to it. EDNM 1 was unable to explain who would triage or escort a patient to the registration if the nurse was busy with a patient and there was no EMT present. EDNM 1 stated that the night shift staffing consisted of one RN, no EMT, no technician, and no respiratory therapist (RT).

During an interview with EDNM 2, on 5/14/18 at 10:35 am, she stated the ED used Title 22 (State regulations) for their professional standards of practice.

A review of Title 22, 70217(b) revealed "the hospital shall implement a patient classification system as defined in Section 700053.2 above for determining nursing care needs of individual patients that reflects the assessment, made by a registered nurse as specified at subsection 70215(a)(1), of patient requirements and provides for shift-by-shift staffing based on those requirements."

During an interview on 5/14/18 at 3:39 pm, the Chief Nursing Officer (CNO) stated the ED had no policy for staffing the ED by acuity (measurement of the intensity of nursing care required by a patient) because they "had discussed it and decided not to use it." The CNO stated, "There is always someone around to help."

During an interview with the registration clerk (RC), on 5/14/8 at 9:30 am, she stated there was no registration clerk on duty three nights a week and that on those nights, registration duties fell to the night shift nurse.

During an interview with EDNM 2, on 5/15/18 at 10:45 am, she stated that a patient who was triaged as an ESI level 1(emergency services index, a standardized system for assigning resources, bed location, and staff to patients; level 1 being the most severe and level 5 the least severe) should have their own nurse, "but that is not done." EDNM 2 stated that if needed, the ED would pull a nurse from the floor to help out. EDNM 2 did not explain how that would affect floor staffing and patient care.

During an interview with the ER Medical Director (ERMD), on 5/16/18 at 10:50 am, she stated that in the month of April 2018, 390 patients where seen in the ED. The ERMD stated the number of patients seen per month ranged from 350 to 500 patients in July; 10 to 20 patients a day (with one to six of those on the night shift). The ERMD stated that there were approximately 10 to 17 level ones seen in the ED per month.

The ERMD stated that if a patient required conscious sedation (use of a combination of medicines to cause sedation and block pain), they would have to have a nurse available to provide a one to one (a nurse dedicated solely to the patient) for the procedure. The ERMD confirmed that a patient who needed to be transferred for critical care services qualified as a critical care patient, but the ED had chosen not to adjust staffing for these patients as they would be transported in the "next 20 minutes." The ERMD acknowledged that not all critical patients were actually transferred out that soon. The ERMD stated that when a pediatric patient was in the ED, staffing should be adjusted by their acuity.

2. During an interview with EDRN 1, on 5/14/18 at 3:05 pm, she stated that floor nurses needed to have ACLS/PALS (advanced training on adult and pediatric emergencies and lifesaving techniques) if they worked as the second nurse in the ED.

During an interview with Licensed Nurse (LN) A from the medical floor, on 5/14/18 at 3:30 pm, she confirmed that she worked as a "second nurse" in the ED. LN A stated that while working in the ED, she triaged patients. LN A stated that she did not have ACLS or PALS training. LN A was unable to state who watched her patients on the medical/surgical unit when she went to the ED to help, and was unable to recall what training she had received in order to be able to assist in the ED, stating it was so long ago.

A review of a letter provided by the hospital during the survey indicated, "Please note for the Med-Surg RNs, PALS is not a requirement of the job, and ACLS was recently added for our new hires to have or be willing to obtain within six months of hire (we have not yet rolled it out to existing staff as a new requirement to meet)."

During an interview with the EDMD, on 5/16/18, at 11:40 am, she confirmed LVNs cannot assess patients and cannot triage them while working in the ED.

A review of the hospital's ED Nurse job description titled "Competency-Based Assessment and Job Description," undated, indicated that "TNCC (Trauma Nursing Core Course, training in critical thinking skills, hands-on training for trauma patient) will be required for internal candidates who are cross training and do not have ER experience."

3. During the initial tour of the ED, on 5/14/18 at 10:25 am, EMT 1 was observed alone at the triage desk typing on the computer while EDRN 1 and the physician where at Patient 5's bedside.

A review of Patient 5's physician orders revealed on 5/14/18, EMT 1 entered eight separate verbal orders (for labs) with a note "I read back the order information to the Authorizing Provider and confirmed its accuracy" for each order.

During a concurrent interview and record review with ED nurse (EDN) 2, she reviewed Patient 5's physician orders and confirmed that EMT 1 had entered verbal orders. EDN 2 stated that EMT 1 did not have the authority to take and enter verbal orders in the ED.

A review of the facility's policy and procedure titled, "Verbal/Telephone orders," dated 2/2018, under the section "Scope" indicated EMTs were not authorized to take verbal orders.

4. Patient 7's clinical record was reviewed. Patient 7, a pediatric patient, was seen in the ED for a fever, wheezing, and increased work of breathing (using more muscles than normal to breathe) and was diagnosed with a sudden viral infection of the lungs and admitted to the medical unit.

A review of the "ED Pediatric Nursing Assessment 0-13 [years old]," dated 1/2/18, revealed Patient 7 was screened for SIRS using the adult SIRS criteria.

A review of the "Med-Surg Pediatric Admission Assessment one [month-13 years old]," dated 1/2/18, also revealed Patient 7 was screened for SIRS using the adult SIRS criteria. The criteria read "[respiratory rate] greater than 20 [beats per minute (bpm)] ... [heart rate (HR)] greater than 90 bpm." A normal respiratory rate for a 6 week old is 30 to 55 bpm and a normal HR is 90-160 (both readings are greater than a normal adult and cannot be used as normal levels for children).

During a concurrent interview and record review with EDNM 2, on 5/15/18 at 10:56 am, she confirmed the assessment was for an adult, and that the vital sign parameters were wrong and could not be correctly used by the nurses as written. EDNM 2 confirmed that a nurse, not well versed in pediatric vital signs, might not know she was using the wrong assessment tool. EDNM 2 stated the facility was aware of the need for a Pediatric SIRS and sepsis assessment and had not been able to find one.

During an interview with the EDMD, on 5/16/18 at 11:12 am, she reviewed the Pediatric Assessment Triangle (a tool used in emergency medicine to quickly assess a sick child) and confirmed that the SIRS criteria was for adult. The EDMD confirmed they had not found a source for a pediatric SIRS assessment, though they had been looking.

During an interview with the CNO, on 5/14/18 at 10:35 am, she acknowledged that the ED used the resources from "Up-to-Date (evidence-based clinical decision support resource )," when updating policies and procedures.

During a concurrent interview and record review with EDRN 2, on 5/17/18 at 9 am, she reviewed the page on Up-to-Date (https://www.uptodate.com/contents/systemic-inflammatory-response-syndrome-sirs-and-sepsis-in-children-definitions-epistemology-clinical-manifestations-and-diagnosis#H2745623) which indicated, "Sepsis is a clinical syndrome that complicates severe infection and is characterized by the systemic inflammatory response syndrome (SIRS)... Early recognition of sepsis is crucial to ensuring the best outcomes in children and is aided by a working knowledge of the children at particular risk, the common pathogens, and the clinical manifestations. The definition, epistemology, clinical manifestations, and diagnosis of the systematic inflammatory response syndrome and sepsis in children are discussed here." EDRN 2 confirmed that there was a section on SIRS response in different pediatric age groups which was available to the staff. EDRN 2 stated that the hospital had made the pediatric template for the SIRS criteria and that it should be an easy fix.

5. During a tour of the ED with EDNM 1, on 5/14/18 at 10 am, she stated that the ED population served increased substantially in the summer, and that the nearby lake-based outdoor activities often resulted in accident victims being seen in the ED.

During a concurrent observation and interview with EDNM 1, on 5/14/18 at 11:40 am, she confirmed that one nurse could not directly visualize all the patients he or she was responsible for if all the ED beds were filled. The ED had beds 1 and 2 in one room, and beds 3 and 4 down the hall in another room. Bed 5 was off of the registration desk area in a room of its own. EDNM 1 confirmed that bed 5 was not connected to the central monitoring system (CMS, system to monitor patients). EDNM 1 stated there was no plan for vital sign monitoring (heart rate, blood pressure, oxygen level, heart rhythms, all key signs of a patient health) for bed 5 because they would never put anyone in that bed who required monitoring.

EDNM 1 confirmed that a multiple car accident or trauma could result in all beds being filled. EDNM 1 also confirmed that as a mountain location, weather could also delay the transfer of critically ill patients, increasing the likelihood of more complex patients needing that bed.

During an interview with EDRN 1, on 5/14/18 at 2:05 pm, she stated that the ED staffed one RN for "all four beds, plus the overflow." EDRN 1 stated that they did not call in other nurses if a critically ill patient came to the ED. EDRN 1 stated it was "difficult" to care for a critically ill patient, watch the patients in the other four beds, and triage new patients to the ED.

During an interview with the CNO, on 5/14/18 at 3:39 pm, she confirmed that the facility did not have a policy for staffing by acuity in the ED. The CNO stated, "they had discussed it" and decided they did not need one as there was "always someone around to help."

During an observation on 5/15/18 at 9:45 am, a patient entered the ED, was vomiting, and was escorted down the hall toward ED beds 3, 4, and 5, where EDRN 1 was stationed. There was nobody at the nurses desk, triage desk, and no one watching the CMS. The CMS showed no one in bed 1, a patient in bed 2 with a pulse oximeter (a device that measures the oxygen level in the blood) attached with no cardiac leads (for cardiac monitoring), a patient with cardiac leads in bed 3, and no one with cardiac leads in bed 4. There was no one with the patient in bed 2.

During a concurrent interview, the CNO acknowledged the hospital did not have a telemetry monitoring (cardiac monitoring) policy and procedure.

6. Patient 5's clinical record was reviewed. Patient 5 was admitted to the ED on 5/14/18 at 9:59 am, with a chief complaint of "ativan (an antianxiety medication that causes sedation) overdose" and a secondary diagnoses of alcohol abuse. During the course of Patient 5's ED stay, she was intubated (placement of a tube into the lungs to maintain an open airway and that is attached to a life support machine to breathe for the patient) and transferred to a higher level of care at 11:20 am.

Patient 6's clinical record was reviewed. Patient 6 was admitted to the ED on 5/14/18 at 10:52 am, for acute respiratory distress syndrome (sudden severe difficulty breathing), shortness of breath, and chronic obstructive pulmonary disease (long term difficulty breathing that reshapes the airways and leaves a patient susceptible to airway infections and difficulties), and dehydration. Patient 6 was transferred to a higher level of care at 1:52 pm.

During an observation in the ED, on 5/14/18, at 10 am, Patient 5 was in bed 2 and there was a patient in bed 1.

A review of the ED log revealed a third patient was admitted to bed 3 on 5/14/18 at 10:13 am.

During an observation on 5/14/18 at 10:52 am, Patient 6 was admitted to the ED in bed 4 (in another room down the hall), which brought the total number of patients EDRN 1 was caring for up to four.

During an interview with EDRN 1, on 5/14/18 at 2:05 pm, she stated that she was responsible for all four ED beds "plus the overflow room (bed 5)." EDRN 1 stated that if a critical patient was admitted to the ED, the hospital did not call another nurse in; although sometimes a floor nurse would come over to help. EDRN 1 confirmed that it was "difficult" to triage new patients while caring for a critical patient. EDRN 1 reviewed the ESI levels and confirmed that Patient 5 was a level 1 (most severe) and Patient 6 was a level 2.

Based on observation, interview, and record review, the facility failed to ensure the designated suction equipment was operating at a functional level for emergency department (ED) beds 3, 4, and 5 and for one of 30 sampled patients (Patient 6, a critical patient who was having difficulty breathing).

This failure had the potential to result in delayed lifesaving procedures, such as clearing the airway of debris or mucus, and ensuring proper set up of a ventilator (a life support machine that breathes for a patient via a tube in the lungs).

Findings:

Patient 6's clinical record was reviewed. Patient 6 was admitted to the ED on 5/14/18 at 10:52 am, for acute respiratory distress syndrome (sudden severe difficulty breathing), shortness of breath, chronic obstructive pulmonary disease (a group of lung diseases that block airflow and make it difficult to breathe, and increase a patient's susceptibility to airway infections and other difficulties), and dehydration. Patient 6 was transferred to a higher level of care at 1:52 pm.

Patient 6's triage (sorting of people based on their need for immediate medical treatment) note, dated 5/14/18 at 11 am, was reviewed. The note revealed Patient 6 was triaged as an ESI level 2 (emergent), and was "in acute distress" with a respiratory rate of 24 breaths per minute (bpm, normal is 12 to 20), a pulse oxygen level (measurement of how much oxygen is in the blood, normal levels range from 88 to 100%) of 84% on room air, and "accessory muscle use" (using chest muscles to help breathe). ESI (emergency services index) is a standardized system for rating the most severe emergencies (level 1) to the least severe (level 5). Patient 6's blood pressure was 78/46 (BP, normal ranges from 90/60 to 120/80). Patient 6's triage note further revealed that he was given oxygen via nasal cannula (thin tube in the nose) and then via BiPAP (a mask covering the nose and mouth that helps force air into the lungs at a set rate).

During the initial tour of the ED with Emergency Department Nurse Manager (EDNM) 1, on 5/14/18 at 11:40 am, beds 3, 4, and 5 were observed to be in a separate room down the hall from the nurses station, triage desk, doctors room, and ED beds 1 and 2. On the far counter (next to bed 4) was a suction machine with tubing and a Yankauer suction head (used to reach into the mouth to suction). EDNM 1 turned on the suction machine (that was plugged in and not battery operated) to test the suction. EDNM 1 confirmed the level of suction was too weak to suction a patient effectively and could not be adjusted to increase the level of suction. EDNM 1 confirmed that a ventilator or chest tube would not be able to be set up for patients in these beds, and stated "We don't use these rooms for that."

A review of a nursing progress note and pain reassessment note, dated 5/14/18 at 11 am, indicated Patient 6 was "Triaged to ED bed 4, then bed 2 when available."

During an interview with EDRN 1, on 5/14/18 at 2:05 pm, she confirmed that Patient 6 had almost required intubation (placement of a tube into the lungs to maintain an open airway).

During a concurrent observation and interview with EDNM 2, on 5/15/18 at 9:35 am, she stated if Patient 6 had required intubation the previous day, staff would have needed to get another portable suction machine to complete the ventilator set up and intubation. EDNM 2 stated she "did not know" if there was a second portable suction machine available anywhere in the hospital.

Based on observation, interview, and policy review, the hospital failed to ensure medical equipment was maintained in safe operating condition for patients when:

1. The batteries for the heart telemetry monitors (a device that is attached to a patient that allows continuous monitoring of their heart rhythm and pattern) were identified as only lasting for approximately six hours and the facility did not have a policy and procedure in place for use of the telemetry monitors.

This failure had the potential to result in a mechanical failure and for dangerous heart rhythms to go undetected when batteries had to be changed frequently.

2. Biomedical (relating to both biology and medicine) preventive maintenance checks were not performed as required for the Contrast (a solution used to enhance the visibility of internal structures in X-ray-based imaging techniques) Warmer (used to warm contrast solution used during computerized tomography [CT scan], a diagnostic radiology procedure).

This had the potential for equipment malfunction to go unidentified.

Findings :

1. On 5/14/18 at 10 am, a tour of the Medical/Surgical unit was conducted with Nurse Manager (NM) 1. NM 1 stated there were nine patients currently on the unit.

During an observation, on 5/14/18 at 10:10 am, Licensed Nurse (LN) 1 was sitting at the nursing station in front of the telemetry monitors. LN 1 stated three of the nine patients were currently connected to a telemetry monitor.

During an interview with LN 1, on 5/14/14 at 3:15 pm, she stated the rechargeable batteries for the telemetry monitors only lasted approximately six hours and that she was constantly changing them.

On 5/16/18 at 11:50 am, Emergency Medical Technician (EMT) 1 was observed at the nursing station near the telemetry monitors. EMT 1 confirmed the rechargeable batteries for the patient devices only lasted approximately six hours.

During an interview with the Director of Support Services (DSS), on 5/16/18 at 10 am, he stated he had previously informed the Chief Nursing Officer (CNO) that he would like to order lithium pack batteries for the telemetry monitors, but that he needed to ask the Material Management Manager. The DSS stated they did not have a tracking or monitoring system for how long the batteries held a charge.

The operator's manual for the BeneVision TMS60 telemetry monitoring system was reviewed. Under the section regarding batteries, it indicated a lithium-ion battery pack would provide the longest runtime.

During an interview on 5/17/18 at 9:35 am, the DSS was asked if the Biomedical Equipment Inspection had identified problems with the telemetry monitor batteries. The DSS stated that it was not identified during their inspection.

During an interview on 5/17/18 at 9:40 am, the CNO acknowledged the facility did not have a policy and procedure related to the use of the telemetry monitoring devices.


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2. On 5/17/18 at 9:25 am, during a tour of the CT Room, the RAD Tech (Radiology Technician) confirmed the Contrast Warmer had a biomed sticker that indicated a preventive biomedical maintenance check had been performed 1/2013. The sticker indicated the next check was due 1/2014.

On 5/17/18 at 1:40 pm, during an interview, the Director of Maintenance (DM) programs stated the Contrast Warmer was required to have yearly biomedical maintenance checks. The DM confirmed the Contrast Warmer did not have biomedical maintenance checks as required. The DM explained the facility had changed companies that provided this service, and the Contrast Warmer had inadvertently been left off the list of equipment maintained by the contract company.

A review of the facility's policy titled, "Medical Equipment Management Plan," dated 12/2017, indicated the policy's purpose. "The mission is to ensure that equipment used in patient care is safe .... The hospital maintains a written inventory of all medical equipment identified in the medical equipment management plan .... The hospital identifies the activities and associated frequencies, in writing, for maintaining, inspecting and testing all medical equipment on the inventory ...."

Based on observation, interview, and record review, the hospital failed to have a Governing Body that assumed full legal responsibility for ensuring compliance with state and federal regulations and quality of care in a safe environment as evidenced by:

1. Failure to ensure oversight when paramedics (PMs) and emergency medical technicians (EMTs) were used in the emergency department (ED). (Refer to C 271)

2. Failure to oversee pharmacy operations and the implementation of the automated dispensing system (ADS) to ensure drug safety and security in the ED. (Refer to C 271)

The ADS means "a mechanical system that performs operations or activities, other than compounding or administration, relative to the storage, packaging, counting, labeling, and dispensing of medications, and which collects, controls, and maintains all transaction information."

These failures had the potential to negatively affect the quality of care provided and to jeopardize the health and safety of patients.

Findings:

1. The facility's "Governing Body By-laws," approved 10/2/12, were reviewed and indicated the following:

"only an appropriately licensed practitioner with clinical privileges shall be directly responsible for a patient's diagnosis and treatment within the area of his/her privileges ... that other direct medical care of patients provided by allied health professionals shall be under the appropriate degree of supervision by a licensed practitioner with clinical privileges."

"All individuals responsible for the assessment, treatment or care of patients are competent to take care of the ages of the patients served."

"The Board of Directors shall have and exercise all the powers ... to control and be responsible for the management of all operations and affairs of the District (facility)."

A review of the facility's "Medical Staff Meeting Minutes (MSMM)" for September 2017, indicated the ADS would be implemented on [October] 2nd and that the ED would be considered a physician-controlled location.

The MSMM for October 2017 were reviewed and indicated the ADS was scheduled to go live in November 2017.

The MSMM for November 2017 and December 2017 were reviewed. The minutes contained no documentation regarding the ADS or Emergency Medical Services (EMS, PMs and EMTs).

A review of the MSMM for January 2018 indicated the EMS crew was working in the ED once again. The minutes contained no documentation regarding the ADS.

The MSMM for February 2018 were reviewed and revealed no documentation about the ADS or EMS.

A review of the facility's "Quality Oversight Committee" minutes for October 2017 through January 2018, and for March 2018, revealed no documentation of the EMS contract/implementation, or of the ADS.

A review of the facility's "Minutes from the regular meeting of the Board of Directors" from April 2017 through February 2018 (excepting December which was not available for review) revealed the only mention of the ADS was in September and October; and the only mention of EMS implementation was in the November 2017 Nursing report, which indicated, "The ER and Careflight merge is happening ...."

During an interview with the Emergency Department Medical Director (EDMD), on 5/16/18 at 11:50 am, she stated she was not involved in the decision, or policy formation of the EMS services in the ED.

Based on observation, interview, and record review, the hospital failed to ensure that the provision of services was performed in a safe manner, as evidenced by:

1. Failure to ensure drug security of medications in an Automated Dispensing System (ADS) in the Emergency Department (ED) and to limit staff access to an after-hours supply of medications to registered nurses. (Refer to C 271, items 1 and 3)

The term automated dispensing system means "a mechanical system that performs operations or activities, other than compounding or administration, relative to the storage, packaging, counting, labeling, and dispensing of medications, and which collects, controls, and maintains all transaction information." [Reference: 21 CFR 1300.01 (45) [Title 21 Food and Drugs; Chapter II Drug Enforcement Administration, Department of Justice; Part 1300 Definitions]

2. Failure to ensure drug safety for patients in accordance with their policy, High Risk/High-Alert Medications, when paramedics and emergency medical technicians were furnished access to 14 High-Alert medications (e.g. hypertonic saline) which were not within their scope of practice to initiate or administer. (Refer to C 271, item 2)

The Institute of Safe Medication Practices (ISMP) is a nationally recognized professional organization dedicated to patient safety. They defined High-Alert medications as, "High-alert medications are drugs that bear a heightened risk of causing significant patient harm when they are used in error."

3. Failure to ensure the implementation of patient care policies when:

IV (administration of solutions directly into a vein) insertion sites were not dated and IV tubing was not dated when changed for six of 30 sampled patients (Patients 1, 2, 3, 10, 11, and 31).

A blood sample was obtained from an implanted port (a port placed under the skin, used for giving medicines, food, and fluids, and for taking blood samples) without a physician's order for one of 30 sampled patients (Patient 3).

Licensed nurses and other health care professionals did not check the emergency crash cart seal (locking seal with number) every shift.

Patient care supplies were stored in a room that was not identified as a clean area and the items were not labeled as clean.

(Refer to C 271, item 4)

4. Failure to ensure the verbal order policy was followed when Emergency Department Nurse (EDRN) 1 entered a verbal order into the electronic medical record (EMR) that she had not received for one of 30 sampled patients (Patient 5). (Refer to C 271, item 5)

5. Failure to ensure a system for controlling sources of infections was implemented in accordance with internal policies and procedures, nationally recognized infection control practices and guidelines, and regulations. (Refer to C 278)

The cumulative effect of these systemic problems resulted in the facility's inability to ensure the provision of services were in compliance with the statutorily mandated Condition of Participation: Provision of Services.

Based on observation, interview, and record review, the hospital failed to ensure that the provision of services was performed in a safe manner for seven of 30 sampled patients (Patients 1, 2, 3, 5, 10, 11, and 31) and hospital inpatient census of six, as evidenced by:

1. Failure to ensure drug security of medications in an Automated Dispensing System (ADS) in the Emergency Department (ED) and to limit staff access to an after-hours supply of medications to registered nurses. (Refer to items 1 and 3)

The term automated dispensing system means "a mechanical system that performs operations or activities, other than compounding or administration, relative to the storage, packaging, counting, labeling, and dispensing of medications, and which collects, controls, and maintains all transaction information." [Reference: 21 CFR 1300.01 (45) [Title 21 Food and Drugs; Chapter II Drug Enforcement Administration, Department of Justice; Part 1300 Definitions]

2. Failure to ensure drug safety for patients in accordance with their policy, High Risk/High-Alert Medications, when paramedics and emergency medical technicians were furnished access to 14 High-Alert medications (e.g. hypertonic saline) which were not within their scope of practice to initiate or administer. (Refer to item 2)

The Institute of Safe Medication Practices (ISMP) is a nationally recognized professional organization dedicated to patient safety. They defined High-Alert medications as, "High-alert medications are drugs that bear a heightened risk of causing significant patient harm when they are used in error."

The hospital's failure placed all patients receiving pharmaceutical services in the hospital at risk for adverse outcomes as a result of preventable medication errors. The hospital inpatient census was six patients.

3. Failure to ensure the implementation of patient care policies when:

a. IV (administration of solutions directly into a vein) insertion sites were not dated and IV tubing was not dated when changed for Patients 1, 2, 3, 10, 11, and 31.

b. A blood sample was obtained from an implanted port (a surgically placed catheter into a large vein for giving medicines, fluids, food, or taking blood samples) without a physician's order for Patient 3.

c. Licensed nurses and other health care professionals did not check the emergency crash cart seal (locking seal with number) every shift.

d. Patient care supplies were stored in a room that was not identified as a clean area and the items were not labeled as clean.

(Refer to item 4)

The hospital's failure had the potential to result in the spread of infection, and for needed medications and supplies to not be readily available in an emergency.

4. Failure to ensure the verbal order policy was followed when Emergency Department Nurse (EDRN) 1 entered a verbal order into the electronic medical record (EMR) that she had not recieved for Patient 5. (Refer to item 5)

This failure had the potential to result in an inaccurate accounting of Patient 5's medication orders, and to affect care provider decision making.

Findings:

1. A review of the hospital's Pharmacy and Therapeutics Committee (P&T) minutes, dated 12/1/17, showed the Consultant Pharmacist (CP), physicians (MD 1 and MD 2), registered nurses (RN 1, RN 2, RN 55, and LN 5) and the Chief Nursing Officer were in attendance. P&T is a medical staff committee. The CP presented the topic "Med Select Policy and Procedure Review" and the discussion showed, "MedSelect Policy and Procedure was felt to be comprehensive and clear." No further action was mentioned. MedSelect is the software associated with the Arxium ADS.

MedSelect is the software for the hospital's Arxium ADS.

A review of the hospital's contract with the Nevada contractor specified, "[Hospital A] will grant CONTRACTOR [from Nevada] prehospital personnel access to its electronic health record system and MedSelect medication dispensing system will all permissions deemed necessary by [Hospital A] to perform duties in the Emergency Department, and in accordance with scope of practice." Contractor A was a Nevada contractor and the contract did not specify whether or not services were to be provided "in accordance with scope of practice" as authorized by the state of Nevada or the state of California.

On 5/15/18 at 9:10 am during an observation in the ED, a paramedic (PM 1) demonstrated he had access to over 1,500 medication doses in all shelves of the ED Arxium ADS tower, the medication refrigerator, and all drawers in Cabinet 1 and 2 except for a few that contained controlled substances. Classes of medications included (e.g. anesthetics, antacids, antibiotics, anticoagulants, anticonvulsants, antidotes, antifungals, antipsychotics, antivirals, electrolytes, heparin, unfractionated heparin, anti-migraine, plasma expanders, snake antivenin, steroids, vaccines, and vasoconstrictors etc.). A detail follows:

Acetaminophen Children's oral suspension 160 mg/five mL quantity nine;
Acetaminophen rectal suppositories 120 mg quantity 5;
Acetaminophen rectal suppository 325 mg quantity 2;
Acetaminophen rectal suppository 650 mg quantity 8;
Acetylcysteine 20% solution IV 200 mg/mL 30 mL quantity two;
Acetylcysteine inhalation/PO solution 10% 100 mg/mL quantity 12;
Acyclovir capsule 200 mg quantity 10;
Albuterol Sulfate inhalation 90 mcg multidose inhaler quantity two;
Alteplase IV for reconstitution 100 mg quantity two;
Aluminum/Magnesium/Simethacone suspension 1200/1200/120 mg 30 mL quantity eight;
Aminocaproic Acid IV 250 mg/mL 20 mL single dose vial quantity six;
Amoxicillin oral suspension 250 mg/5mL 100mL bottle quantity 2;
Amoxicillin tablet 500 mg 9-Pack quantity one;
Amoxicillin Trihydrate for oral suspension 125 mg/5 mL quantity two;
Amoxicillin-Potassium Clavulanate oral suspension 400-57 mg/5 mL quantity one;
Amoxicillin-Potassium Clavulanate oral suspension 400-57mg/5mL quantity 3;
Amoxicillin-Potassium Clavulanate suspension 400-57 mg 50 mL bottle quantity six;
Ampicillin-Sulbactam injection 3 g quantity three;
Antivenin Crotalidae Polyvalent injection solution 1g quantity two;
Aspirin Rectal Suppository 300 mg quantity 12;
Azithromycin 500 mg dose pack quantity three;
Azithromycin IV 500 mg quantity 11;
Azithromycin oral suspension 200 mg/5mL quantity two;
Azithromycin tablet 250 mg quantity 17;
Baclofen tablets 10 mg quantity 18;
Bisacodyl rectal suppositories 10 mg quantity 9;
Budesonide inhalation nebulizer 0.25 mg/2 mL quantity four;
Bupivacaine 0.5% injection 5 mg/mL 30 ml preservative free single-dose vial quantity 10;
Bupivacaine 0.5% with epinephrine injection quantity three;
Calcium Carbonate chewable tablets 500 mg quantity 8;
Calcium Gluconate injection preservative free 10% quantity five;
Cefazolin injection 1 g quantity four;
Cefazolin Sodium IV premix 1 g/Dextrose 50 mL quantity seven;
Cefotetan 2g IV quantity six;
Ceftriaxone injection 1 g quantity 11;
Ceftriaxone injection 2 g quantity five;
Cephalexin 250 mg/5mL suspension quantity four;
Cephalexin 500 mg 2-Pack quantity three;
Cephalexin capsule 250 mg quantity 20;
Cephalexin oral suspension 50 mg/5 mL 200 mL quantity two;
Cetirizine tablet 10 mg quantity 10;
Ciprofloxacin IV premix 400 mg/200 mL D5W 400 mg quantity two;
Ciprofloxacin tablet 500 mg quantity 21;
Clindamycin capsule 150 mg a pack quantity three;
Clindamycin Hydrochloride capsule 150 mg quantity 30;
Clindamycin injection 150 mg/2 mL quantity seven;
Clindamycin Phosphate IV premix 600 mg/D5W 25mg/50mL quantity one;
Clonidine tablet 0.1 mg quantity 32;
Clopidogrel tablet 75 mg quantity 30;
Cyclobenzaprine tablet 10 mg quantity 10;
Dexamethasone Sodium Phosphate injection 4 mg/mL quantity 8;
Dexamethasone tablet 4 mg quantity 12;
Diamox IV 500 mg quantity two;
Diltiazem Hydrochloride IV 5 mg/mL 25 mL single dose vial quantity four;
Diltiazem Hydrochloride IV 5 mg/mL 5 mL single dose vial quantity four;
Diphenhydramine capsule 25 mg 10-Pack quantity five;
Dobutamine/D5W [Dextrose 5% in water] IV premix 250mg/250 mL bag quantity four;
Docusate Sodium capsule 100 mg softgel quantity 18;
Doxycycline IV 100 mg quantity two;
Electrolyte powder packet quantity 4;
Enalaprilat Dihydrate IV 1.25 mg/mL vial quantity nine;
Enoxaparin SQ 40 mg injection syringe quantity 4;
Enoxaparin SQ injection 100 mg syringe quantity 10;
Enoxaparin SQ injection 30 mg syringe quantity 6;
Enoxaparin SQ injection 40 mg syringe quantity 4;
Erythromycin ophthalmic ointment at 5 mg/g [gram] quantity 7;
Ethyl Chloride aerosol spray quantity one;
Etomidate IV 2 mg/mL 10 mL single dose vial quantity two;
Famotidine IV premix 20 mg/50 mL in 0.9% Sodium Chloride quantity five;
Fluconazole IV piggyback 200 mg/100 mL quantity one;
Fluconazole tablet 100 mg quantity 15;
Flumazenil IV 0.1 mg/mL vial quantity 3;
Fluorescein ophthalmic strip 1 mg quantity one;
Fluticasone Propionate nasal spray 50 mcg quantity one;
Folic Acid injection 5 mg/mL 10 mL multidose vial quantity one;
Gentamicin injection 80 mg/2 mL quantity five;
Gentamicin ophthalmic ointment 0.3% tube quantity six;
Gentamicin Sulfate ophthalmic solution 3 mg/mL 5mL bottle, quantity one;
Glycerin adult rectal suppositories quantity 9;
Glycerin infant/child rectal suppository quantity 10;
Guaifenesin/Dextromethorphan oral syrup 100-10 mg/5 mL quantity 10;
Haloperidol Lactate injection 5 mg/mL quantity 9;
Heparin 25,000 units/D5W 250 mL IV premix 100 units/mL quantity three;
Heparin Sodium injection 5000 units/mL [milliliter] quantity 11;
Hetastarch 6% in 0.9% Sodium Chloride IV solution 500 mL quantity three.
Hurricane Spray 20% inhalation quantity four;
Hydralazine Hydrochloride IV 20 mg/mL single dose vial quantity eight;
Hydrocortisone injection 100 mg/2 mL powder vial quantity four;
Hydroxyzine tablets quantity 20;
Ibuprofen tablets 600 mg quantity 15;
Ibuprofen tablets 800 mg quantity 24;
Insulin Regular Human injection solution 100 units/mL quantity two;
Ketorolac injection 30 mg/mL single doe vial quantity nine;
Ketorolac intramuscular injection 60 mg/2 mL vial quantity 7;
Labetalol IV 5 g/mL 40 mL vial quantity two;
Levalbuterol Hydrochloride nebulizer solution 1.25 mg/0.5 mL quantity eight;
Levetiracetam IV 100 mg/mL single dose vial quantity three;
Levetiracetam tablet 500 mg quantity 16;
Levofloxacin IV piggyback 500 mg/100 mL quantity five;
Levofloxacin IV piggyback 750 mg/150 mL quantity three;
Levofloxacin tablet 250 mg 3-Pack quantity four;
Levofloxacin tablet 250 mg quantity 36;
Lidocaine Hydrochloride injection 4% 5 mL ampoule quantity 10;
Lidocaine Viscous Hydrochloride 2% 15 mL solution quantity five;
Lidocaine-Epinephrine 2-0.001% injection quantity eight;
Lidocaine-Prilocaine topical cream 2.5-2.5% tube quantity 6;
Loperamide capsule 2 mg quantity 16;
Magnesium Citrate oral laxative solution 296 quantity one;
Magnesium Hydroxide Oral Suspension 400 mg/5 mL quantity seven;
Meclizine chewable tablets 25 mg quantity 20;
Methylene Blue injection 1% 10 mL single dose vial quantity one;
Methylprednisolone injection 125 mg/2 mL vial quantity 7;
Metoclopramide injection preservative-free 5 mg/mL 2 mL single dose vial quantity 15;
Metoprolol Tartrate IV [intravenous] 1 mg/mL 5 mL vial quantity 6;
Metoprolol Tartrate tablet 50 mg quantity 25;
Metronidazole Sodium Chloride IV piggyback 500 mg/100 mL quantity four;
Mineral oil or rectal enema 135 mL quantity two;
Montelukast tablet 10 mg quantity 20;
Neomycin-Polymyxin-Hydrocortisone otic drops 1% quantity one;
Nicardipine IV 2.5 mg/mL 10 mL single dose vial quantity three;
Nitroglycerin/D5W IV liquid premix 25 mg/250 mL (100 mcg/mL) in glass bottle quantity two;
Norepinephrine IV 1 mg/mL 4 mL ampule quantity 2;
Nystatin oral suspension 100 units/5 mL bottle quantity 4;
Ondansetron tablet 4 mg 6-Pack quantity one;
Oseltamivir capsule 45 mg quantity 12;
Oseltamivir capsule 75 mg [milligram] quantity 16;
Pantoprazole IV 40 mg vile quantity 10;
Pantoprazole tablet 40 mg quantity 17;
Penicillin G Benzathine intramuscular 1.2 million units/2 mL syringe quantity seven;
Penicillin G Potassium injection 5 million units quantity three;
Penicillin V Potassium oral suspension 125 mg/5 mL quantity three;
Penicillin V Potassium tablet 500 mg quantity 10;
Penicillin VK suspension 250 mg quantity three;
Penicillin VK suspension 500 mg 10-Pack quantity four;
Phenazopyridine Hydrochloride tablet 100 mg quantity 12;
Phenobarbital-Hyocosamine-Atropine-Scopolamine Elixir 6.20 mg/mL quantity one;
Phenol throat spray 1.4% quantity one;
Phenylephrine Hydrochloride 1% nasal spray 15 mL quantity one;
Phenylephrine Hydrochloride ophthalmic drops 2.5% 2 mL bottle quantity three;
Phenylephrine injection 10 mg/mL quantity four;
Phenytoin Sodium IV 50 mg/mL 5 ml single dose vial quantity six;
Physostigmine Salicylate injection 1 mg/mL 2 mL ampoule the quantity 10;
Piperacillin-Tazobactam 4.5 g quantity three;
Piperacillin-Tazobactam IV 3.375 g quantity three;
Potassium Chloride extended release tablet 8 mEq (milliequivalent) quantity 27;
Potassium Chloride IV premix 10 mEq/50 mL quantity 10;
Potassium Chloride tablet 20 mEq quantity six;
Pralidoxime IV 1 gram quantity six;
Prednisolone Acetate 1% ophthalmic drops quantity three;
Prednisolone oral Solution 15 mg/5mL quantity three;
Prednisolone tablet 20 mg 8-Pack quantity five;
Prednisone tablet 20 mg quantity 20;
Prochlorperazine rectal suppositories 25 mg quantity 6;
Promethazine injection 25 mg/mL Single dose vials quantity 13;
Promethazine oral syrup 6.25 mg/mL 118 mL quantity five;
Proparacaine 0.5% ophthalmic drops 0.5% quantity one;
Rabies Immune Globulin intramuscular injection 150 units/mL 10 mL preservative free vial quantity six;
Rabies vaccine intramuscular injection 2.5 unit preservative-free quantity two;
Rocuronium IV 10 mg/mL 5 mL multidose vial quantity two;
Silver Nitrate topical applicator stick quantity 8;
Silver Sulfadine topical 1% cream quantity three;
Sodium Chloride 3% IV 500 ml quantity five;
Sodium Nitrate IV 30 mg/mL 10 mL single dose vial quantity two;
Sodium Phosphate rectal enema 133 mL quantity one;
Sodium Polystyrene Sulfate oral suspension 15 g quantity two;
Sodium Thiosulfate IV 250 mg/mL 50 mL single dose vial quantity two;
Succinylcholine Chloride IV 20 mg/mL 10 mL multidose vial quantity two;
Sucralfate oral suspension 1 g/10 mL quantity 10;
Sulfacetamide Sodium ophthalmic drops 10% 50 mL quantity five;
Sulfacetamide Sodium ophthalmic drops 10% 50 mL quantity five;
Sulfamethoxazole-Trimethoprim double strength 800/160 mg tablet 6-Pack quantity four;
Sulfamethoxazole-Trimethoprim double strength 800/160 mg tablet 6-Pack quantity four;
Sulfamethoxazole-Trimethoprim double strength tablet 800 mg/160 mg quantity 21;
Sulfamethoxazole-Trimethoprim double strength tablet 800 mg/160 mg quantity 21;
Sumatriptan Succinate SQ [subcutaneous] injection 6 mg/0.5 mL Single dose vial quantity four;
Tamsulosin Hydrochloride capsule 0.4 mg quantity 14;
Tdap vaccine intramuscular 0.5 mL syringe quantity 11;
Tenecteplase IV kit 50 mg quantity one;
Thiamine IV 100mg/ml/ml multidose vial quantity seven;
Timolol Maleate ophthalmic drops 0.5% quantity three;
Tranexamic Acid 100 mg/mL single dose vial quantity four;
Triamcinolone Acetonide topical cream 0.1% quantity one;
Triamcinolone injection 40 mg/mL quantity 8;
Tropicamide 1% ophthalmic solution 10 mg/mL 15 mL quantity one;
Valproic Acid Oral Syrup 250 mg/5 mL quantity four;
Vancomycin injection for IV piggyback 1 g quantity 4;
Vancomycin injection for IV piggyback 500 mg quantity nine;
Verapamil IV 2.5 mg/mL ampule quantity 19;
Warfarin tablet 5 mg quantity eight;

On 5/15/18 at 1:47 pm, during an interview in the ED, PM 1 described Contractor A staff had 24 hour access to medications in the ADS since December 2017 which were outside their scope of practice. He said, "Access was granted by the hospital when we started in December." He described the only medications he personally removed from the ADS were those within his scope of practice and he administered them to patients in the hospital. PM 1 explained that prior to the survey he had not noticed he had access to medications outside his scope of practice.

A review of ADS dispensing records titled, Supply Usage, showed user-specific access and removal of several hundred medications by PM/EMT staff between December 2017 and May 2018.

On 5/16/18 at 3:31 pm, during an interview with the CP, the Chief Nursing Officer and registered nurse (CNO), RN 55, and surveyors (Surveyor 2 and Surveyor 3), hospital staff discussed the role of the PMs and EMTs in the hospital conducting medication-related activities as follows:

*The CNO said, "There is an agreement. There was a formal process." The CNO explained the PMs and EMTs were not recognized as Allied Health Professionals with privileges in the hospital's bylaws.

*The CP explained the hospital planned to limit the PM/EMTs access to the ADS in the ED. He said, "I have oversight ... it hasn't been a high priority. He said, "You should have seen this place six months ago." The CP explained he was the Pharmacist-in-Charge and responsible for oversight of the hospital's pharmacy services and the Drug Room." He described the hospital's priority was to limit the PM/EMTs access to controlled substances and the hospital had done a good job of that. CP explained that all medications in the ED are for emergencies and that PMs and EMTs were trained for that and supervised. He said, "The emergency room is always an emergency." The CP explained that to his knowledge the hospital did not provide training on ED protocols or policies related to medication use in the ED prior to commencing medication-related activities.

*RN 55 explained she gave the PM/EMTs access to the ADS in the ED after consulting the CP.

2. The hospital's policy titled, High Risk/High-Alert Medications, revised 4/2017, defined High-Alert medications as, "high alert, also called high risk medications are drugs that have an increased risk of causing significant harm to a patient when used in error. Because the consequences of an error associated with use of these medications can result in significant patient injury, special precautions will be employed with their overall management throughout the institution." The policy stipulated, "The Pharmacy and Therapeutics Committee will review this list of High-Alert medications every six (6) months and as needed to evaluate the specific precautions implemented by the medication room and in patient care units to reduce the errors associated with these medications, and to determine necessary additions or deletions from the list."

A review of the hospital's inventory record titled, Arxium Inventory Summary, dated 5/15/18 and cross-referenced to the hospital's High Risk/High-Alert Medications policy, showed 14 of the medications available to PM 1 in the ED ADS matched those on the hospital's High-Alert medication list and included:

Alteplase IV is a thrombolytic agent used to break up or dissolve blood clots, which are the main cause of heart attacks and strokes. [Reference: www.dailymed.nlm.nih.gov and medlineplus.gov]

Bupivacaine is used to provide local, regional and spinal anesthesia. [Reference: www.dailymed.nlm.nih.gov]

Dobutamine IV is a direct inotrope that improves heart output by increasing the force of the contraction of ventricle muscles in the heart. It is used to support a failing heart (cardiac decompensation) resulting from heart disease or after heart surgery. [Reference: www.dailymed.nlm.nih.gov and medlineplus.gov]

Enoxaparin is an anticoagulant used to hinder the formation of blood clots and prevent pulmonary embolism (PE). PE is a condition that can be fatal and occurs when clots form in deep veins then break off and obstruct a blood vessel in the lungs blocking a coronary artery. [Reference: www.dailymed.nlm.nih.gov and www.medicaldictionary.thefreedictionary.com]

Heparin IV is an anticoagulant used to hinder the formation of blood clots in people with heart disease, heart valves, or conditions that predispose them to forming blood clots which could cause a stroke or heart attack. [Reference: www.dailymed.nlm.nih.gov]

Insulin Regular Human injection is a hormone used to lower blood glucose levels and treat diabetes. [Reference: www.dailymed.nlm.nih.gov]

Labetalol IV is an adrenergic antagonist. [Reference: www.dailymed.nlm.nih.gov]

Lidocaine Hydrochloride IV is an antiarrhythmic [arrhythmias are dangerous heart rhythms]. [Reference: www.dailymed.nlm.nih.gov]

Metoprolol tartrate IV is an adrenergic antagonist used to decrease the rate and force of heart contractions to treat hypertension [high blood pressure], angina [chest pain], and arrhythmias dangerous heart rhythms]. [Reference: www.dailymed.nlm.nih.gov]

Norepinephrine IV is an adrenergic agonist (peripheral vasoconstrictor alpha-adrenergic action) and an inotropic stimulator of the heart and dilator of coronary arteries used to control low blood pressure (e.g., spinal anesthesia, myocardial infarction, and septicemia). [Reference: www.dailymed.nlm.nih.gov]

Phenylephrine IV is an alpha-1 adrenergic receptor agonist indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. [Reference: www.dailymed.nlm.nih.gov]

Promethazine IV is a phenothiazine derivative used to treat allergic reactions to blood or plasma, in combination to treat anaphylactic shock, to cause sedation or alleviate motion sickness. [Reference: www.dailymed.nlm.nih.gov]

Rocuronium IV is a neuromuscular blocking agent used to paralyze smooth muscles during placement of an artificial airway into the windpipe to maintain an open airway. [Reference: www.dailymed.nlm.nih.gov and www.medicaldictionary.thefreedictionary.com]

Sodium Chloride 3% IV is a hypertonic saline solution used to treat severe salt depletion. The low salt syndrome may occur in the presence of heart failure, renal impairment, during surgery, and postoperatively. [Reference: www.dailymed.nlm.nih.gov] [www.drugs.com]

Warfarin tablet is an anticoagulant. [Reference: www.dailymed.nlm.nih.gov]

On 5/15/18 at 3:31 pm, during an interview, RN 55 explained how, after consulting the CP, she used her administrator rights the computer's MedSelect software to furnish all the PM/EMTs 24 hour access to the ADS in the ED.

A review of the hospital's policy titled, Automated Drug Distribution System-Medication Order and override; and pick list dispensing, approved 12/2017, stipulated, "All State and Federal regulations will be observed in strict accountability will be exercised." Under the section "Access", the policy stipulated, "Authorized Access will be given after user reads and signs the MedSelect Personal Identification Number (PIN) Verification Statement. Access will be strictly controlled to ensure proper security of all medications, proper documentation and accountability for medication use, and confidentiality of patient information. Only individuals authorized to use the system shall be granted access to it."


23083


3. On 5/14/18 beginning at 10 am, a tour of the Medical/Surgical Unit (MSU) was conducted with Nurse Manager (NM) 1. NM 1 stated there were nine patients currently on the unit.

a. During the initial tour, the following observations were made:

On 5/14/18 at 10:10 am, Patient 1 was observed with an IV in her right hand. She was receiving D5-0.45 with 20 milliequivalent (mEq, a unit of measure) of potassium chloride (KCL, electrolyte replacement solution) at a rate of 125 milliliters (ml) per hour via an infusion pump (a device used to deliver fluids in a controlled manner). Patient 1's IV site dressing and tubing were not dated.

On 5/14/18 at 10:45 am, Patient 31 was observed with a saline lock (a capped off IV for future use) to her right arm that was not dated when inserted. There was an IV pump next to Patient 31's bed with a bag of 0.9% Normal Saline (NS, hydration solution) that had no date on the tubing. Patient 31 stated the saline lock was placed the previous night, and that staff disconnected the IV solution at that time. During a concurrent interview, NM 1 stated IV site dressings and tubing were to be dated and changed every three days.

On 5/14/18 at 11:10 am, Patient 3 was observed with an implanted port (used for giving IV medicines, fluids, food, or taking blood samples) in her chest. She was receiving D5-0.45 solution at 100 ml per hour. There was a clear op-site (transparent) dressing over the port that was not dated. The tubing to the solution was not dated.

On 5/14/18 at 11:20 am, Patient 10 was observed with a saline lock to her left wrist. There was no date written on the site dressing that indicated when the saline lock was inserted.

On 5/14/18 at 11:25 am, Patient 11 was observed. There was an IV pump in her room with tubing attached and an empty bag of Rocephin (antibiotic). The Rocephin tubing was not labeled. During a concurrent interview, Licensed Nurse (LN) 2, Patient 11's nurse, stated that Patient 11 received a Rocephin IV every day, and acknowledged that the IV tubing was not dated. LN 2 stated the tubing was supposed to be changed and dated every three days.

On 5/14/18 at 11:30 am, Patient 2 was observed with a saline lock on her left wrist that was dangling and not secured with a dressing or tape. On her right wrist area she had an IV that was wrapped with a coban dressing (elastic type of dressing). Patient 2 was receiving 0.9% NS with 20 mEq of KCL at 100 ml per hour through this site. During a concurrent interview, NM 1 confirmed the IV sites and tubing were not dated.

During an interview, on 5/16/18 at 9:30 am, the CNO stated that the electronic record did not keep track of when IV sites and tubing were changed.

A review of the hospital's "Vascular Access Guidelines," undated, indicated peripheral IV sites, injection ports, saline locks, and dressings to the sites were to be changed every 72 hours or sooner if they became infiltrated, red or tender. The guidelines indicated that all IV tubing was to be changed every 72 hours unless the patient had received blood, lipids or total parenteral nutrition (feeding a person through an IV).

b. A review of the hospital's policy titled, "Central Line Care and Prevention of Infection," dated 10/17, indicated the policy was to reduce the risk of complications and infections. The policy indicated it was imperative that the Central Venous Catheter (a catheter placed into a large vein, such as in the chest) be handled and maintained correctly. Under the section titled, "Orders," the policy directed that there must be physician orders in place for fluid administration and blood draws.

During an observation on 5/14/18 at 11:10 am, Patient 3 had an implanted port in her chest and was receiving D5 0.45 solution at 100 ml per hour. There was a clear op-site dressing over the port that was not dated when it was last changed. The tubing to the solution was not dated.

A review of Patient 3's record was conducted on 5/15/18 with LN 2. Patient 3's record contained an undated nursing progress note that indicated LN 3 had drawn blood from Patient 3's port at 6 am on 5/15/18.

During an interview on 5/15/18 at 11:50 am, Patient 3 confirmed the facility staff had drawn blood from her port site on two separate occasions.

During an interview and record review with the CNO, on 5/16/18 at 9:30 am, she stated there was no physician's order in place to draw blood from Patient 3's implanted port.

c. A review of the hospital's policy titled, "Emergency Medications Crash Carts," revised 4/2016, indicated the hospital would maintain mobile supplies of emergency equipment and medications locked in the crash cart in patient care areas. Under the procedure section of the policy, it indicated a Registered Nurse would maintain a record of which break away lock numbers had been assigned to the emergency medication containers in the crash cart. It indicated a nurse or a licensed healthcare professional would inspect the seals integrity on every shift. Additionally, the policy indicated the Consulting Pharmacist would inspect the drug supply as part of a monthly unit inspection.

On 5/14/18 at 3:20 pm, the crash cart was observed with NM 1. A "Crash Cart/Defibrillator Check Sheet," dated 5/1/18, instructed staff to check the crash cart seal every shift. A handwritten mark on the check sheet had scratched out "every shift" and "every day" was added to the instructions. There was no documentation that the seal was checked by a healthcare professional on 5/11/18. During a concurrent interview, NM 1 acknowledged there were also many missing entries for the previous months.

A review of the check sheets for the previous four months indicated the following:

In 1/18, 3/18, and 4/18, the crash cart seal was only checked once a shift. There was no documentation the seal was checked on two days in each of these months, and there was no record the seal was checked for the entire month of 2/18.

On 5/14/18 at 3:30 pm, the "Crash Cart Checklist" was reviewed and indicated the cart contents had not been checked since 3/11/18. During a concurrent interview, NM 1 stated she did not know why the crash cart had not been checked for four months.

During an interview with NM 1, on 5/15/18 at 11:29 am, she acknowledged that the facility policy instructed staff to check the crash cart seal every shift and that this was not followed.

d. A review of the hospital's policy titled, "IV Poles and Infusion Pumps," dated 4/4/12, indicated the purpose for the policy was to ensure patient safety and prevent cross contamination (the spread of bacteria from one surface to another). The policy instructed that Housekeeping would clean the IV pole and pump with a germicidal solution and return them to the clean utility room with a sticker that was dated and indicated "Unit Cleaned."

On 5/14/18 at 10:30 am, a room on the MSU was observed with NM 1. The room contained seven IV poles, a Sara Lift (a hydraulic device used to lift patients), a blood pressure cuff on a rolling stand, two carts with supplies for patients on isolation, and nine slings used with the lift that were hanging on the wall. NM 1 stated the supplies in the room were clean items. NM 1 acknowledged none of the items contained stickers to indicate they had been cleaned.


36893

4. Patient 5's clinical record was reviewed. Patient 5 was admitted to the ED on 5/14/18 at 9:59 am with a chief complaint of "ativan (an antianxiety medication that causes sedation) overdose." During the course of Patient 5's ED stay, she was intubated (placement of a tube into the lungs to maintain an open airway and that is attached to a life support machine to breathe for the patient) and was transferred to a higher level of care at 11:20 am.

During an observation at the ED nurses station, on 5/14/18 at 10:48 am, the physician gave a verbal order to the ED Nurse Manager (EDNM) 1 for "one milligram (mG) of versed (brand name midazolam, a sedating medication used to keep patients asleep while undergoing procedures or on life support) push (rapid administration of medication) and start a drip (IV) at two mG."

During an observation, on 5/14/18 at 10:49 am, EDNM 1 withdrew three vials of medication from the ADS and printed a label with the patient's name on it. When emergency department nurse (EDRN) 1 entered the room, EDNM 1 asked EDRN 1 if the proper ratio of midazolam was 25 milligrams (mG) in 50 milliliters (mL) of IV fluid. EDRN 1 confirmed the ratio/concentration.

During a concurrent interview and record review with EDRN 1, on 5/15/18 at 2:07 pm, she reviewed Patient 5's physicians orders, which revealed a verbal order placed by EDRN 1 on 5/14/18 at 7:58 pm, for "Midazolam in dextrose 5% IV solution 30 mG @ Rate 2 mL [per] hour." EDRN 1 confirmed that she had placed the verbal order, even though she did not receive the order from the physician and did not overhear it. EDRN 1 acknowledged she did not know the concentration of the midazolam drip that was ordered, and could not confirm that it matched the original verbal order given to EDNM 1. EDRN 1 stated that the ED nurses usually had to place verbal orders received by other nurses when they where helping the ED nurse.

A review of the facility's policy and procedure titled, "Verbal/Telephone Orders," approved 2/2018 by the CNO and Medical Staff committee indicated, "Safety in the overriding principle in accepting verbal or telephone orders ... [as they] have a higher potential for errors as these orders can be misheard, misinterpreted and/or mis-t

Based on interview and record review, the hospital failed to ensure that policies regarding the provision of pharmaceutical services were reviewed by professional staff at least annually.

The hospital's failure placed patients at risk for adverse outcomes resulting from preventable medication errors. The hospital inpatient census was six patients.

Findings:

1. A review of the hospital's policy titled, Patient Controlled Analgesia [PCA], revised 04/2012, described the policy was assigned to the Emergency, Surgical Services, Medical Surgical Department. The Pharmacy and Therapeutics (P&T) Committee, a medical staff committee responsible for developing policies and procedures to ensure the safe use of medications and the hospital, did not review the policy by the annual due date of 4/30/13.

PCA is a method for control of pain based on use of a pump for the constant intravenous or, less frequently, epidural infusion of a dilute narcotic solution that includes a mechanism for the self-administration at predetermined intervals of a predetermined amount of the narcotic solution if the infusion fails to relieve pain. [Reference: www.medicaldictionary.thefreedictionary.com]

2. A review of the hospital's policy titled, Emergency Medications/Crash Carts, revised 4/2016, described the policy was assigned to the Pharmacy Department. The P&T Committee did not review the policy by the annual due date of 4/30/17.

3. A review of the hospital's policy titled, Fentanyl Transdermal Patch, revised 10/2016, described the policy was assigned to the Pharmacy Department. The P&T Committee did not review the policy by the annual due date of 10/31/17.

Fentanyl Transdermal System (FTS), administered as a patch applied to the skin, is a long-acting opiate indicated for the management of pain in opioid-tolerant patients, severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. [Reference: dailymed.nih.gov]

DailyMed is a nationally-recognized publication of the National Institute of Health in the U.S. National Library of Medicine and includes references to drug information submitted to the Food and Drug Administration. [Reference: dailymed.nlm.nih.gov]

4. A review of the hospital's policy titled, High Risk/High-Alert Medications, revised 4/2017, described the policy was assigned to the Pharmacy Department and the policy review was the responsibility of the P&T Committee. The "Policy" section showed, "The Pharmacy and Therapeutics Committee will review this list of High-Alert medications every six (6) months and as needed to evaluate the specific precautions implemented by the medication room in patient care units to reduce the errors associated with these medications, and to determine necessary additions or deletions from the list." The P&T Committee did not review the policy by the annual due date of 10/31/17.

According to the Institute for Safe Medication Practices (ISMP), a nationally-recognized patient safety organization, "High Alert Medications are drugs that bear a heightened risk of causing significant patient harm when they are used in error." [Reference: www.ISMP.org]

5. A review of the hospital's policy titled, Medication Administration, revised 06/2016, described the policy was assigned to the Pharmacy Department. The P&T Committee did not review the policy by the annual due date of 6/30/17.

6. A review of the hospital's policy titled, Preparation of Compounded Sterile Products (CSPs) for Immediate Use, revised 9/2016, described the policy was assigned to the Pharmacy Department. The P&T Committee did not review the policy by the annual due date of 9/30/17.

CSP is a sterile drug product that has been prepared by compounding by a qualified individual in a sterile environment. CSPs are not explicitly defined in the United States Pharmacopeia (USP) Chapter 797. [Reference: www.usp.org]

7. A review of the hospital's policy titled, Medication Distribution, revised 11/16, showed the responsibility for policy review was assigned to the Pharmacy Department. The policy did not specify an approver or reviewer. The policy was not reviewed by the due date of 11/30/17.

8. A review of the hospital's policy titled, Refrigerated Drug Storage, revised 11/16, showed the policy was assigned to the Pharmacy Department. The P&T Committee did not review the policy by the annual due date of 11/30/17.

9. A review of the hospital's policy titled, Unit Inspection Policy, revised 1/15/2016, showed the policy was assigned to the Pharmacy Department. The P&T Committee did not review the policy by the annual due date of 11/30/17.

On 5/16/18 at 9:15 am, during an interview and concurrent review of the policies and P&T minutes, the Consultant Pharmacist (CP) described the above policies and procedures were related to the safe provision of pharmaceutical services to patients in the hospital and were intended to reduce the potential for medication errors. He said, "These are the most current policies."

Based on interview and record review, the facility failed to implement its Assessment and Reassessment policy, during the management of changing conditions in status, for one of 30 sampled patients (Patient 30, a newborn infant) when:

a. Vital signs (VS, temperature, heart rate, respirations and blood pressure) were not assessed per facility practice or as ordered.

b. Vital signs and oxygenation status (includes pulse oximeter readings) that were outside of normal parameters were not reassessed timely.

c. The facility did not have a policy regarding patient vital sign/pulse oximeter requirements, when to notify the physician of abnormal findings, or nursing directives if a physician would not come in to assess a patient after repeated requests.

This had the potential to result in an avoidable serious and rapid decline in the condition of Patient 30.

Findings:

The facility's policy, "Assessment and Reassessment of Patients," dated 10/2017, was reviewed. The policy indicated "Reassessment will occur whenever there is a significant change in the patient's physical ... status ...." The policy indicated assessment included "Body systems review including parameters for vital signs, oxygenation ... lab values ... response to medications and interventions .... Throughout the process, it is important to include the patient, other health care workers, the provider and others as appropriate in identifying patient needs. Reassessment. A. Each patient will be reassessed as necessary based on his or her plan for care or changes in his or her condition, diagnosis, treatment, response to previous care ... and his or her setting requirements .... C. Assess each patient at the time of admission and continuously throughout the patient's hospitalization as warranted by changes in the patient's care needs through the systematic collection of data ...."

The facility's Age-Specific Competencies - Direct Patient Care module, dated 2017, indicated the education module was part of the annual education requirement. The module objectives indicated, "The goal of this course is to provide health care providers with an understanding of the competencies required to provide care to patients of different age groups. After studying the information presented here, you will be able to .... 2. Identify the nursing considerations applicable to each of the age ranges discussed. 3. List the significant age ranges that require different nursing competencies to address patient needs and care issues ...." The module included a section titled, "The Healthy Newborn (0-1 years)" that indicated, "Expected vital signs in this age group: Newborns 0-6 weeks: respiratory rate of 30-50, pulse rate 120-160, blood pressure 75-100/50-68 .... The nurse should follow the hospital's policy on taking vital signs in newborns ...."

On 5/16/18 at 11 am, during an interview and concurrent employee file review, the Human Resources Manager provided evidence that all direct care staff, and the department manager responsible for Patient 30's care, had completed the Age-Specific Competency module within the past year as required.

A review of the physician's Newborn Birth Summary for Patient 30 indicated Patient 30 had, "Transient tachypnea (rapid respiratory rate) ... requiring O2 (oxygen) supplementation for two hours and back to room air with oxygenation saturations 91-95%, and heart rate 100-120. Patient nursing vigorously .... Now 41 hours of age and patient maintain heart rate on average 70-90 with O2 saturations 91% on 0.25 (liters of oxygen) nasal cannula ...." The summary indicated a telemedicine neonatology (a subspecialty of pediatrics that consists of the medical care of newborn infants, especially the ill or premature newborn) consult and review of an EKG (diagnostic heart analysis report) with pediatric cardiology and agree with sinus bradycardia (abnormally slow heart rate with a regular rhythm). The summary indicated Patient 30 was "Appropriate for gestation age ... with respiratory cardiac (heart) and hypoxia (insufficient oxygenation). #1 transfer to tertiary care center (hospital that provides higher level of care) for further management of sinus bradycardia and hypoxia. Will need pediatric cardiac echo (diagnostic ultrasound of the heart) .... #2 Hypoxia blood gas (analysis of oxygenation and respiratory status) with normal limits. Concern for cardiogenic (heart related) cause versus neurogenic (related to the nervous system) cause ...." The summary indicated results of a chest x-ray performed on 3/30/18 included "diffuse density in lungs may represent retained fetal lung fluid with no local infiltrate..." A chest x-ray performed on 4/1/18 indicated, minimal increased markings at lung base consistent with atelectasis (from excess fluid in the lungs) and possibly pneumonia."

A concurrent interview and record review was conducted with the Peri-Natal Nursing Manager (NM 1) on 5/15/18 starting at 3:15 pm, which revealed that the assessment/reassessment during the management of Patient 30's changing conditions, including interventions and assessment of the patient's response to these interventions was not adequate. Patient 30's record was reviewed with the following findings.

On 3/30/18, nursing documentation indicated:

At 3:10 pm, Patient 30 was placed on oxygen (02) in response to having dusky skin (can be an indicator of poor oxygenation), and a pulse oximeter (PO, an indicator of oxygenation status) reading of 88% (no policy or orders in place for expected normal PO readings). Supplemental 02 was given and PO was 95%.

At 3:15 pm, 02 was started per nasal cannula. Patient 30 remained on oxygen until 6:30 pm when the oxygen was discontinued and the PO was re-assessed at 94%. No follow-up PO checks (to validate the baby's response to removing the oxygen) were done until 7:55 pm (one hour and 25 minutes after placing the baby on room air).

At 7:55 pm, the oxygen was restarted in response to Patient 30 having an episode of lower PO readings averaging in the high 80's (%) with occasional bradycardia (low heart rate - rate not indicated). The physician (MD) was consulted at 8:25 pm and ordered VS every 30 minutes x two, and if VS were within normal limits (WNL), return to VS every four hours. The VS were repeated frequently and WNL until 10 pm (so that the next VS were then due every four hours).

Follow-up VS and PO assessments were not done every four hours, per order, as follows:
On 3/31/18:
4:14 am, (over six hours later), VS were WNL and PO was 97%.
9 am, (almost five hours later) VS were WNL, but no PO check was done.
4 pm, (seven hours later) VS were WNL, but no PO check was done.
4:30 pm, Patient 30 was assessed by the physician and no concerns were noted.
8:30 pm, VS indicated Patient 30 had a change in condition when the heart rate (HR) was assessed at 90 beats per minute (bpm), indicating an abnormally low heart rate (facility's age-specific competencies indicated normal newborn HR was 120-160).
8:32 pm, the HR was 102, no PO check was done.
8:34 pm, the HR was 88, no PO check was done.
8:45 pm, the nurses notes indicated, "(Other RN) and (MD) notified of abnormal low heart rates. MD ordered monitoring every 2 hours and to be notified of HR less than 90. (RN) recommended possible transfer (to higher level of care) of baby with the low HR. MD would like monitoring at this time." The nurse's notes indicated that a heart monitor was applied.
9:55 pm, nursing note remarks indicated, "MD notified of ... heart rate dropping to 82 with quick return to mid-90's. (RN) requested bedside evaluation, (MD) will come in if clinical assessment changes" (baby with good tone, nursing well, crying strong). No assessment of Patient 30's oxygenation status was found when no PO check was done.
10:13 pm, the nursing note remarks indicated, "Requested bedside evaluation by MD. MD orders cardiac monitoring with every two hour vital assessments. If clinical assessment changes with a heart rate below 90 or saturation less than 91%, he (MD) will come in for bedside eval (evaluation)."
10:35 pm, PO and VS were WNL.

On 4/1/18:
12:36 am, PO and VS were WNL.
2:36 am, PO and VS were WNL.
4:35 am, the VS assessment included a HR of 83 (indicating bradycardia). No reassessment of these abnormal VS was done, and no assessment of Patient 30's oxygenation status was found (when no PO check was done) until 5 am (25 minutes after the low heart rate was documented).
5 am, the nurses notes indicated Patient 30 was crying, had a HR less than 80 and PO 96%. No reassessment of these abnormal VS or a repeat PO check was done until 5:45 am, (45 minutes after documentation of a HR less than 80 and over three hours after the last normal heart rate was recorded) when the nurses notes indicated the PO was consistently 87-88%, and the HR was 112.
6 am, (25 minutes after the HR of 112 was recorded), the nurse's notes indicated Patient 30 was started on supplemental oxygen when the PO remained at 87% and the HR was 84. The notes indicated Patient 30 responded to this intervention with a PO of 96%.
6:36 am, the nurses notes indicated a pulse oximetry sensor was on and continuous oxygen supplementation was in place. The 6:36 VS assessment indicated Patient 30 had a HR of 94 and PO of 97%.

The subsequent frequent VS assessments/nursing notes were as follows:
7:10 am, HR 90's at rest, monitor on, PO 94% on 0.25 liters NC (nasal cannula), EKG (a heart assessment test) ordered.
7:45 am, EKG being done by RT (Respiratory Therapist).
7:47 am, O2 increased to 3 liters per minute (LPM) by RT
8:05 am, PO 95%, (body) system assessment done.
8:10 am, patient moved to Room 101 for tele-med consult (video assisted exam by specialist from another facility).
8:19 am, MD at bedside (no documentation regarding MD notification was found during the abnormal VS assessments that started three hours and 45 minutes earlier, at 4:35 am).
8:31 am, PO 93%, T (temperature) 36.9, HR 86, respiratory rate (RR) 42, blood pressure (B/P) 77/49 (This was the only B/P obtained for Patient 30)
8:32 am, MD and RT at bedside
8:36 am, tele-med consult in progress
8:50 am, blood gas drawn (blood test, assessed actual oxygenation of blood), on 02 at 3 LPM, PO 94%
9:05 am, T 36.9 Celsius (C, temperature scale), HR 96, RR 46
9:36 am, blood gas drawn, O2 at 3 LPM, PO 96% and no S/S resp (respiratory) distress (difficulty breathing)
9:46 am, decision to transfer to consulting hospital
10:05 am, T 36.8, HR 102, RR 33
10:36 am, T 36.9 C, HR 99, RR 38
10:50 am, Ampicillin (an antibiotic medication) administered.
11:05 am, T 37, HR 124, RR 48, Remarks: lower than normal PO to 87-88%, RT increased FiO2 (fraction of oxygen) from 30% to 40% at 3 liters, now 96% pink, no tachypnea/apnea or retractions, flaring or grunting
11:07 am, Gentamicin (an antibiotic medication) administered.
11:36 am, T 37, HR 94, RR 34
12 pm, Transfer team at bedside. Transport crew assuming care.
12:05 pm, T 36.8 C, HR 128, RR 44
12:45 pm, Patient 30 d/c'd (discharged) with transport team.

On 5/16/18 at 3:30 pm, NM 1 confirmed the assessments/reassessments of VS and PO assessments were not done as required (by MD orders and in response to interventions and/or abnormal findings) for Patient 30. When asked about specifics for abnormal vital signs that would require MD notification, NM 1 stated the facility did not have a policy regarding specific parameters that would require physician notification, nor protocols for reassessments if abnormal findings were obtained. NM 1 stated the VS were to be taken per MD order, so if an abnormal finding was obtained, the nurse was to notify the MD and follow new orders for VS frequency. NM 1 could not state whether or not a baby heart rate of 90 would require notification of the MD, or how soon the heart rate should be re-assessed. NM 1 stated the facility did not have a policy for routine pulse oximeter monitoring and stated it would depend on the MD order. When asked what the normal expectation was for newborn PO assessments, NM 1 stated it would be dependent on what the MD ordered and stated the facility did not have any specific guidelines. Regarding the age-specific competency indicating the normal newborn HR range being 120-160, NM 1 indicated she wasn't sure if that was being followed. NM 1 stated this competency was an annual requirement, and indicated staff did complete the competency, but stated there were no guidelines in place for what to do if the baby's HR was outside these specific parameters. NM 1 confirmed the facility did not have a policy, or protocol, to indicate what a nurse was to do if a physician would not come in to perform a bedside assessment after repeated requests were made.

Based on observation, interview, and record review, the hospital failed to implement policies to ensure pharmaceutical services were administered in accordance with accepted professional principles related to medication security, storage, and handling for a hospital inpatient census of six, and to ensure medications were prepared and administered in accordance with hospital policy and procedures (P&P) for two of 30 sampled patients (Patients 5 and 6) as follows:

1. Medications in the Drug Room were crowded in a lateral file cabinet (Cabinet A);

2. Medications intended for internal use only were not stored separately from medications intended for external use only in Cabinet A;

3. A partially-filled bottle of Sterile Water for Irrigation, an irrigation solution, in Cabinet A was not discarded after it was opened as required by the manufacturer;

4. Nitroglycerin bottles, used to treat chest pain, in Cabinet A were stored without an overwrap to protect them from light as required by the manufacturer;

5. Lactated Ringers and 5% Dextrose injection 1000 mL (milliliter), a hydration solution, was stocked in a medication room (Med Room 1) on the Medical Surgical Unit (MSU) without the protective overwrap and an assigned expiration date;

6. Inspections of the Drug Room were not conducted at least every 30 days.

7. Emergency medications in the emergency department (ED) crash cart were accessible without breaking a tamper-evident seal. The crash cart was sealed by a registered nurse who was not authorized to seal the supply.

8. A crash cart in the ED did not have a content list on the outside container.

9. In a medication room (Med Room 1) on the MSU, furosemide, a diuretic, was stocked in an Automated Dispensing System (ADS) compartment assigned to stock gabapentin, used to treat neuralgia (nerve pain) and prevent seizures.

The term automated dispensing system means "a mechanical system that performs operations or activities, other than compounding or administration, relative to the storage, packaging, counting, labeling, and dispensing of medications, and which collects, controls, and maintains all transaction information." [Reference: 21 CFR 1300.01 (45) [Title 21 Food and Drugs; Chapter II Drug Enforcement Administration, Department of Justice; Part 1300 Definitions]

10. A syringe of ceftriaxone, an antibiotic, was left unattended in a hallway accessible by the general public.

11. An opened multidose vial of expired lidocaine hydrochloride, an anesthetic, was stocked in the ADS in the ED.

12. EDNM 1 did not follow the hospital's protocol during the preparation and administration of a midazolam (a sedating medication used to keep patients asleep while undergoing procedures on on life support) IV drip (delivery of medication directly into a vein) for Patient 5.

13. Respiratory Therapist (RT) did not obtain a physician's order for use of BiPAP (a mask that goes over the nose and mouth which forces oxygen [considered a medication] into the airways) for Patient 6.

14. The ED medication storage refrigerator was left unlocked.

The hospital's failure placed patients at risk for adverse outcomes as a result of preventable medication errors. The hospital inpatient census was six patients.

Findings:

1. On 5/14/18 at 1:38 pm, during a concurrent interview and observation of the Drug Room with a registered nurse Drug Room Supervisor (RN 55), there was one lateral file cabinet in the Drug Room (Cabinet A). The remainder of the medication stock was stored in open shelving. Cabinet A was stocked crowded and stacked bottom-to-top in a disorganized manner with drugs. RN 55 said, "These are overflow medications. We're short of space."

A review of the hospital's policy titled, Unit Inspection Policy, revised 1/15/2016, showed "Medication shall be stored in an orderly manner and well-lighted cabinets, shells, drawers or carts of sufficient size to prevent crowding."

2. On 5/14/18 at 1:38 pm, during a concurrent interview and observation of the Drug Room with RN 55, medications intended for internal use were not stored separately from medications intended for external use in Cabinet A. A bottle of Phenol 88-90% Liquefied 1 liter glass bottle, a solvent, was stored in Cabinet A next to medications intended for internal use. The label showed, "Toxic in contact with skin." According to the Material Safety Data Sheet (MSDS), "Phenol is a hazardous substance that is harmful if swallowed." [Reference: toxnet.nlh.nih.gov]

A review of the hospital's policy titled, Unit Inspection Policy, revised 1/15/2016, showed "Internal use medication in liquid, tablet, capsule or powder form shall be segregated from medications for external use." RN 55 said, "Adenosine injection is next to the sodium bicarbonate tablets." Adenosine is an endogenous nucleoside used to convert abnormal heart rhythms into normal sinus rhythm. Sodium Bicarbonate tables are used to treat heartburn. [Reference: www.dailymed.nlm.nih.gov]

3. On 5/14/18 at 1:38 pm, during a concurrent interview and observation of the Drug Room with RN 55, an opened partially-filled bottle of Sterile Water for Irrigation 500 mL NDC 0038-0004-03 was stored in Cabinet A. RN 55 said, "It's been opened. It actually has about 375 milliliters." The manufacturer's label stipulated, "Discard unused portion." [Reference: www.dailymed.nlm.nih.gov]

Drug products are identified and reported using a unique, three-segment number, called the National Drug Code (NDC), which serves as a universal product identifier for drugs. FDA publishes the listed NDC numbers and the information submitted as part of the listing information in the NDC Directory which is updated daily. [Reference: www.fda.gov]

4. On 5/14/18 at 1:38 pm, during an observation of the Drug Room with RN 55, two nitroglycerin bottles in the Drug Room were stored without an overwrap to protect them from light. The manufacturer's label showed, "Protect from light until time of use. Nitroglycerine is used to treat chest pain, heart failure, high blood pressure during surgery, or to induce necessary hypotension during surgery. [Reference: www.dailymed.nlm.nih.gov]

On 5/14/18 at 1:38 pm, during an interview, RN 55 gestured to Cabinet A and said, "This is excess stock medication." She walked over to a shelf in the Drug Room and retrieved an amber-colored bag and placed it over one of the bottles of nitroglycerine.

5. On 5/14/18 at 3:57 pm, during an observation of Med Room 1 with RN 55, a bag of Baxter brand Lactated Ringers and 5% dextrose injection 1000 mL, a hydration solution, was stored on a shelf without the manufacturer's protective overwrap. Concentration of the solution can occur through evaporative losses. It did not have an expiration date assigned supported by the manufacturer as storage conditions had changed. [Reference: www.dailymed.nlm.nih.gov]

6. On 5/14/18 at 3:57 pm, during an observation of the Drug Room with RN 55, the surveyor asked whether or not drug storage issues had been identified in the Drug Room prior to the survey. RN 55 said, "We don't inspect the Drug Room."

A review of the hospital's policy titled, Unit Inspection Policy, revised 1/15/2016, showed, "All drug storage areas within this hospital will be inspected every 30 days by the consultant pharmacist [CP]. The purpose is to ensure proper storage of medications. A written record of these inspections will be maintained."

On 5/17/18 at 2:40 pm, during an interview, the CP explained the hospital did not inspect or maintain records of inspections of the Drug Room every 30 days. On 5/24/18 at 10:30 am, during the exit conference, the CP indicated that the Board of Pharmacy had been inspecting the Drug Room quarterly for years. The hospital did not provide any written inspections of the Drug Room.

7. On 5/15/18 at 4:02 pm, during a concurrent observation and interview in the Emergency Department with RN 55 and a registered nurse (RN 57) an adult and pediatric crash cart was not sealed with a tamper-evident seal in the ED. The crash cart had a red plastic breakaway tamper-evident (zip tie) seal with a unique number 8277714. The surveyor accessed all the medications in the cart without breaking the seal.

On 5/15/18 at 4:02 pm, during an interview, RN 55 explained the seal should have been cinched tighter on the crash cart in order to make the cart tamper-evident. In the same interview, RN 57 indicated the crash cart was sealed by a registered nurse (RN 58) who worked night shift in the ED.

A review of the hospital's policy titled, Emergency Medications/Crash Carts, revised 4/2016, stipulated, "The emergency drug supply is stored in a clearly marked portable container, which is sealed by the Consulting Pharmacist or the Medication Room Nurse with a seal which made which must be broken to gain access to the drugs."

8. On 5/15/18 at 4:02 pm, during a concurrent observation and interview in the emergency Department with RN 55 and RN 57, an adult and pediatric crash cart did not have the content list of medications displayed on the outside container (crash cart) with the date of the earliest drug to expire. RN 55 explained the content list was inside a medication tray in a drawer in the cart instead of on the outside the container. RN 55 said, "It does not meet my expectation."

A review of the hospital's policy titled, Emergency Medications/Crash Carts, revised 4/2016, showed, "The contents of the container are listed on the outside cover and include the earliest expiration date of the drugs within."

9. On 5/14/18 at 3:08 pm, during a medication pass observation with a registered nurse (RN 56), she accessed the ADS in the Med Room 1 of the MSU and removed two unit dose gabapentin 100 mg capsules NDC 0904-5631-61 and one furosemide 20 mg tablet NDC 0904-5796-61.

On 5/14/18 at 3:26 pm, in an interview in the medication room, RN 56 said, "I grabbed the wrong pill. It was in the wrong drawer."

A review of the hospital's policy titled, Automated Drug Distribution System-Medication Order and override; and pick list dispensing, approved 12/2017, showed the procedures, "Select the desired medication and quantity. Touch the dispense button after all selections have been made. The appropriate door will open for each medication selected, or the appropriate quantity will be delivered from the unit for module."

10. On 5/14/18 at 3:21 pm, during a medication pass observation in the MSU, RN 56 left a syringe of ceftriaxone (an antibiotic) unattended and out of line-of-sight in a hallway accessible by the general public outside a patient room [Bed 8].

On 5/14/18 at 3:23 pm, in an interview, RN 56 explained it was not her habit to leave medications unattended. She said, "I never leave it. I had it in the back of my mind."

A review of the hospital's policy titled, Unit Inspection Policy, revised 1/15/2016, showed, "Medications shall be accessible only to responsible personnel designated by the hospital."

11. On 5/15/18 at 1:47 pm, during an observation of the emergency Department with a paramedic (PM 1), an opened multidose vial of lidocaine hydrochloride 400 mg per 20 mL 2% was observed with an expiration date 5/7/18. Lidocaine Hydrochloride IV is used as an anesthetic and antiarrhythmic [arrhythmias are dangerous heart rhythms]. [Reference: www.dailymed.nlm.nih.gov]

A review of the hospital's policy titled, Unit Inspection Policy, revised 1/15/2016, showed, "Medication shall not be kept in stock after the expiration date on the label and no contaminated or deteriorated drugs shall be available for use."


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12. Patient 5's clinical record was reviewed. Patient 5 was admitted to the ED on 5/14/18 at 9:59 am with a chief complaint of "ativan (an antianxiety medication that causes sedation) overdose." During the course of Patient 5's ED stay, she was intubated (placement of a tube into the lungs to maintain an open airway and that is attached to a life support machine to breathe for the patient) and transferred to a higher level of care at 11:20 am.

During an observation at the ED nurses station, on 5/14/18 at 10:48 am, the physician gave a verbal order to the ED Nurse Manager (EDNM) 1 for "one milligram (mG) of versed (brand name midazolam) push (rapid administration of medication) and start a drip (IV) at two mG."

During a concurrent observation and interview with EDNM 1, on 5/14/18 at 10:49 am, she withdrew three vials of medication from the ADS, and printed a label with the patient's name on it. EDNM 1 asked the ED Nurse (EDRN) 1 if the proper ratio of midazolam was 25 mG in 50 milliliters of intravenous (IV) fluid. EDRN 1 confirmed the ratio/concentration. EDNM 1 withdrew the medication from the vials and injected it into the IV bag without withdrawing the equivalent amount of IV fluid first (the standard procedure to ensure proper ratio of medication to IV fluid), without reviewing the protocol, and without having a second nurse observe the process and verify it had been done correctly.

During an observation on 5/14/19 at 10:49 am, EDNM 1 returned to the ADS and withdrew five additional mG of midazolam to add it to the IV bag, making the total 1 mG to mL IV fluid. EDNM 1 stated she was going to relabel the medication to read 50 mG in 50 mL. EDNM 1 added the medication, documented on the medication label, and gave it to EDRN 1.

A concurrent interview and record review was conducted with EDNM 1 and the Chief Nursing Officer (CNO), on 5/14/18 at 11 am. EDNM 1 reviewed the "Midazolam [Versed]" policy, dated 4/18, which indicated the correct "Medication Preparation:" was to "Mix 25 mG in 50 mL of NS or D5W (IV fluid/solutions). EDNM 1 confirmed that the midazolam drip was mixed incorrectly. The CNO confirmed the expectation was for nurses to withdraw the equivalent amount of fluid from the IV bag prior to adding the medication. EDNM 1 stated that midazolam did not require a witness when mixing.

A review of the Midazolam P&P revealed that too much of the medication administered too fast could cause "hypotension and seizures."

During a concurrent observation and interview with EDNM 1, on 5/14/18 at 5:07 pm, she reviewed Patient 5's pull log documentation, which revealed that 30 mG of midazolam had been pulled for Patient 5. EDRN 1 stated she thought that EDNM 1 made a 50 mG/50 mL bag by accident and had "corrected it somehow" before giving it to the transport crew.

During a concurrent interview and record review with EDNM 2, on 5/15/18 at 10:45 am, she confirmed that the verbal order entered by EDRN 1 on 5/14/18 at 7:58 pm (several hours after Patient 5 had been transferred) for 30 mG of midazolam in 50 mL did not match the hospital's P&P, and that the order did not contain a maximum dose or proof that the IV drip had been double checked (checked by two nurses). EDRN 1 confirmed that midazolam drips are high risk medications and are double checked when preparing the dose.

A review of the hospital's P&P titled, "HIGH RISK/HIGH ALERT MEDICATIONS," revised 4/2017, indicated requirements for "specific safeguards to reduce the risk of errors related to ordering and prescribing, transcribing, preparation, storage, distribution and administration." The requirements included "IV moderate sedation agents Midazolam" (review source for best practices).

13. Patient 6's clinical record was reviewed. Patient 6 was admitted to the ED on 5/14/18 at 10:52 am with a chief complaint of shortness of breath, and diagnoses that included respiratory distress syndrome (a severe condition when fluid collects in the lungs and decreases the ability to breathe) and chronic obstructive pulmonary disease (a group of lung diseases that block airflow and make it difficult to breathe). During Patient 6's stay in the ED, BiPAP was applied. Patient 6 received fluids, antibiotics, and steroids, and was transferred to a higher level of care at 1:52 pm.

During a concurrent interview and record review with EDNM 2, on 5/15/18 at 2:50 pm, she confirmed that Patient 6's "NON-INVASIVE VENTILATION (CPAP/BiPAP)" notes by the RT revealed that BiPAP was started at 12:15 pm. EDNM 2 reviewed the physician orders and confirmed a BiPAP order had not been entered by the RT or the physician.

During an interview with the RT on 5/15/18 at 3:15 pm, he confirmed that while the RT chooses the settings, BiPAP must have a physician's order for use.

During an interview with the ED Medical Director (EDMD), on 5/16/18 at 10:50 am, she confirmed oxygen was a medication and that the ultimate responsibility for its use was with the physician.

14. During the initial tour of the hospital with EDNM 1, on 5/14/18 at 10:27 am, an open door was observed in the ED, with a triage desk and a desk for nursing located directly inside the open door. A refrigerator was located next to the nursing desk and was left unlocked (with a key in the lock) and was accessible to anyone walking by.

During an interview with EDNM 1 and the CNO, on 5/14/18 at 10:29 am, EDNM 1 stated that rapid sequence intubation kits (RSI) with IV medications such as succicholine, etomodate, and roxinal (used to temporarily paralyze patients), as well as crofab (a very expensive rattlesnake antivenom) and diltiazem (an emergency medication used to stabilize the heart) were stored in refrigerator. The CNO confirmed that the medication refrigerator should not have been left unlocked with the key in it.

Based on observation, interview, and document review, the facility 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 regulations, when:

1. Terminal cleaning was not performed for Operating Room (OR) 1, Sterile Core, Surgery Decontamination, Endoscopy Procedure Room, Endoscopy Decontamination Room, and the Endoscopy Processing Room.

2. Temperature and humidity were not monitored on weekends, in areas where sterile supplies were stored.

3. Work surfaces in OR 1, Surgery Decontamination, and Surgical Processing Areas were made of unsuitable material or in a state of disrepair that prohibited surface disinfection.

4. Air vents in the Decontamination Room and in the Endoscopy Procedure Room were visibly soiled.

5. The temperature of the Endoscopy Procedure Room was not being monitored.

6. Clean, contaminated instruments were carried in an open container from Decontamination through the Sterile Core to the IUSS (Immediate Use Steam Sterilization) autoclave.

7. Required immunization status was not documented in employee health files.

8. Competencies were not evaluated or documented in employee files.

9. Hand hygiene was not performed, as required, during an endoscopy procedure (includes diagnostic visual inspection with tissue removal and biopsy as needed, of the upper and lower gastrointestinal [GI] tract - esophagus, stomach and intestines).

This could result in the spread of infectious germs and viruses to patients.

10. No lighted magnification was available during the surgical instrument cleaning process (included endoscopes used during endoscopy procedures). The cleaning process included visual inspection for instrument integrity and for residual visible contamination.

This lack of lighted magnification could result in incomplete removal of bioburden (number of bacteria living on a surface) from the instruments during the cleaning process and for instruments with compromised integrity to go unidentified.

11. The facility did not follow guidelines for pre-operative hair removal for Patient 12 having a right inguinal hernia repair with mesh.

This could result in a hospital associated surgical site infection.

Findings:

1. On 5/14/18 at 9:52 am, during an interview with Nurse Manager (NM) 3, she stated that the facility had adopted AORN (Association of peri-Operative Nurses) Guidelines for Perioperative Practice as one of the nationally recognized guidelines for their infection control program. During the same interview with the OR Director, she stated that housekeeping was responsible for cleaning in the surgery department and performed the turnover cleaning in between surgical cases and a deep cleaning once weekly.

On 5/16/18 at 9 am, during an interview with the Director of Support Services (DSS), he stated that the term "deep cleaning" had the same meaning as terminal cleaning and it was only performed once weekly in OR 1, Sterile Core, Decontamination, Endoscopy Procedure Room, Endoscopy Decontamination Room, and Endoscopy Processing Room.

According to AORN Guidelines for Perioperative Practice (2018), Guideline for Environmental Cleaning: Terminal cleaning and disinfection of perioperative areas, including sterile processing areas, should be performed daily when the areas are being used. Completion of terminal and scheduled cleaning procedures should be documented on a checklist or log sheet.

The Journal of Gastrointestinal Endoscopy, dated March 2014, 79(3): 363-372. States: Properly clean and disinfect surfaces that are frequently touched by personnel or dirty equipment in the endoscopic procedure area at the beginning of the day, between cases, and during terminal cleansing. Frequently touched surfaces may include endoscopy keyboards, video monitors and consoles. Terminal Cleansing-Terminal cleansing involves the cleaning of surfaces to physically remove soil and biofilm (bacteria that adhere to surfaces), followed by proper disinfection. Agents for terminal cleansing should have efficacy in spore removal, which may differ from requirements for agents used in sterile operating rooms. Before the first case of the day, staff should verify that all procedural and recovery areas have been properly cleansed.

2. On 5/14/18 at 9:52 am, during an interview, NM 3 stated that the facility had adopted AORN Guidelines for Perioperative Practice as one of the nationally recognized guidelines for their infection control program.

On 5/14/18 at 9:52 am, during a tour of the Sterile Core, the restricted area immediately adjacent to OR 1, where sterile supplies were stored, NM 3 stated that the temperature and humidity was recorded Monday through Friday but they were not recorded on weekends.

According to AORN Guidelines for Practice (2016), Guideline for Sterilization: Room temperature, humidity, and ventilation must be controlled and monitored in accordance with local, state, and federal policy and regulation ...Monitoring results should be readily retrievable. Monitoring and recording environmental controls in each area will assist in verification that minimum recommended parameters are met and maintained and will identify when corrective action needs to be taken. A mechanism with memory for history of temperature and humidity can alert personnel if there was a deviation during unmanned times. Sterilized materials should be labeled and stored in a manner to ensure sterility ...Limiting exposure to moisture, dust, excessive light or handling, and temperature and humidity extremes decreases potential contamination of sterilized items. Factors that contribute to contamination include air movement, humidity, temperature, and location of storage, presence of vermin, whether shelving is open or closed, and properties of the packaging material. The shelf life is dependent on packaging material, storage conditions, transport, and handling. An event must occur to compromise package content sterility. Events that may compromise the sterility of a package include moisture penetration.

3. On 5/14/18 at 9:52 am, during a tour of OR 1 and a concurrent interview with NM 3, she stated that the facility had adopted AORN Guidelines for Perioperative Practice as one of the nationally recognized guidelines for their infection control program. During the tour, it was observed that there were two areas of the ceiling that were peeling off. The surfaces of the wood door to OR 1 were observed to have exposed wood surfaces. This was verified by NM 3.

On 5/14/18 at 10:05 am, during a tour of the Surgery Decontamination Room, adjacent to the Sterile Core, a wood surfaced cabinet was observed in the corner of the room and a wood shelf was observed under the stainless steel counter adjacent to the sink. The stainless steel sink had tape attached to the inside to mark volume levels. The NM 3 confirmed this observation and agreed that these surfaces could not be disinfected.

On 5/14/18 at 10:45 am, during a tour of Sterile Processing, the floor was observed to have large sections of peeling red tape and a large floor pad with a porous surface adhered to the floor in front of the instrument preparation table. During a concurrent interview with Licensed Nurse (LN) 8, she stated that the floor under and around the tape, and the pad and the floor underneath the pad could not be properly cleaned or disinfected.

On 5/14/18 at 11:20 am, during a tour of the Endoscopy Decontamination Room, the stainless steel sink had tape attached to the inside to mark volume levels. This was validated by LN 8.

On 5/16/18 at 9 am, during an interview with the DSS, he stated that DMQ® was the product that was utilized for cleaning and disinfection in the facility.

According to AORN Guidelines for Perioperative Practice (2018), Environment of Care, Part 2: All surfaces (floors, walls, ceilings, cabinets) should be durable, smooth, and cleanable. Surfaces that are durable, smooth, and cleanable allow for ease of cleaning and assist in preventing buildup of dirt and debris in crevices. In the semi-restricted and restricted areas, surfaces should withstand cleaning chemicals; floors should have no seams or have sealed seams and a cove base; walls should be smooth with no seams or sealed seams; cabinets should have a smooth surface and be made of laminate, stainless steel, or glass; and absorbent material, such as exposed wood, should not be used. Ceilings in semi-restricted areas should be smooth and may be either monolithic or drop-in ceiling tiles.

According to Centers for Disease Control and Prevention Healthcare Infection Control Practices Advisory Committee (HICPAC) Guideline for Environmental Infection Control in Health-Care Facilities (2003): cost, safety, product-surface compatibility ... can be the main criteria for selecting a registered agent [disinfectant]. If using a proprietary detergent/disinfectant, the manufacturers' instructions for appropriate use of the product should be followed.

According to the DMQ® manufacturer's instructions for use: This product is a non-acid formulation designed to disinfect, sanitize, clean and deodorize countertops, floors, walls, glazed ceramic tile, glazed porcelain, shower walls, toilet bowls, urinals, chrome, ...bathtubs, showers, sinks, fiberglass, synthetic marble, stainless steel, glass, vinyl, other hard non-porous bathroom surfaces, [and] other hard non-porous environmental surfaces.

4. On 5/14/18 at 9:52 am, during an interview with NM 3, she stated that the facility has adopted AORN Guidelines for Perioperative Practice as one of the nationally recognized guidelines for their infection control program.

On 5/14/18 at 10:15 am, during a tour of the Surgery Decontamination Room, the air exchange vent was observed to be visibly soiled. This was validated by NM 3.

On 5/14/18 at 11:20 am, during a tour of the Endoscopy Procedure Room, the air exchange vent was observed to be visibly soiled. This observation was also validated by NM 3.

According to AORN Guidelines for Perioperative Practice (2018), Guidelines for Environmental Cleaning: Ventilation ducts, including air vents and grilles, should be cleaned and have their filters changed on a routine basis according to manufacturers' instructions for use. Clean ventilation ducts and filters support optimal performance of the ventilation system.

5. On 5/14/18 at 9:52 am, during an interview with NM 3, she stated that the facility has adopted AORN Guidelines for Perioperative Practice as one of the nationally recognized guidelines for their infection control program.

On 5/14/18 at 11:20 am, during a tour of the Endoscopy Procedure Room, the ambient temperature of the room was noted to be very warm. When asked where the thermometer was in the room, LN 8 could not locate a thermometer.

According to According to AORN Guidelines for Perioperative Practice (2018), Environment of Care Part 2: The temperature should be maintained within the limits recommended for each area (i.e., unrestricted, semi-restricted, restricted). The temperature of the room may be intentionally adjusted based on the individual needs of the patient. The temperature of an endoscopy procedure room should be between 68° F and 73° F (20° C and 23° C).

6. On 5/14/18 at 9:52 am, during an interview, NM 3 stated that the facility had adopted AORN Guidelines for Perioperative Practice as one of the nationally recognized guidelines for their infection control program. NM 3 also stated that after a contaminated case (where a bacterial infection was present), the clean, contaminated surgical instruments were carried from the decontamination room, uncovered on an open tray, through the sterile core to the IUSS (Immediate Use Steam Sterilization) Autoclave.

According to AORN 2018 Guidelines for Perioperative Practice, Guideline for Cleaning and Care of Surgical Instruments: Contaminated instruments must be contained during transport to a decontamination area. Containment of contaminated instruments decreases the potential for injury to personnel or their exposure to blood, body fluids, or other potentially infectious materials and helps prevent damage to the instruments during transport. Contaminated instruments should be transported to the decontamination area as soon as possible after completion of the procedure. Transporting soiled instruments in a manner that prevents exposing personnel to bloodborne pathogens and other potentially infectious materials is an OSHA (Occupational Health and Safety Administration) requirement. Labeling the transport containment device communicates to others that the contents are potentially infectious.

7. On 5/15/18 at 2:10 pm, during an interview and review of employee health files with Human Resource Manager (HRM), the current status of health requirements for five employees (RDA, LN 4, Tech 2, LN 9, and IP) was reviewed. Two out of five did not have evidence of Measles and Mumps (LN 9, IP); four out of five did not have evidence of immunity to Varicella (Chickenpox) (RDA, LN 4, LN 9, and IP). Two out of five did not have evidence of Tdap immunization (t=Tetanus, a serious illness caused by bacteria that can enter the body through a deep cut; D=Diphtheria, a serious bacterial infection; and ap=acellular Pertussis, commonly known as Whooping Cough, an infectious bacterial disease that causes uncontrollable coughing) (RDA, LN 4).

According to the facility policy titled, "Immunizations," dated August 2012, Immunizations for Influenza, MMR (measles, mumps, and rubella), Hepatitis B, and Tdap will be made available to new employees, if needed upon hire. If the employee declines a vaccination offered, a Vaccine Information Sheet will be offered and a signed declination form will be retained in the Employee Health Record. The policy did not include Varicella.

On 5/14/18 at 9:52 am, during an interview with NM 3, she stated that the facility had adopted AORN Guidelines for Perioperative Practice as one of the nationally recognized guidelines for their infection control program.

According to AORN Guidelines for Perioperative Practice (2018), Guideline for Prevention of Transmissible Infections: Health care personnel should be immunized against vaccine-preventable diseases ... Health care organizations should review health care provider vaccination and immunity status at the time of hire and at least annually thereafter. Regularly reviewing vaccination and immunity status helps ensure that health care providers are up to date with respect to the recommended vaccines

For current California requirements, "Cal. Code Regs. tit. 8, § 5199, relating to "aerosol transmissible diseases." Cal. Code Regs. tit. 8, § 5199(h)(5) requires employers to make available to all susceptible healthcare workers with occupational exposure all vaccine doses listed in Appendix E. Doses listed in Appendix E include seasonal influenza vaccine, measles, mumps, and rubella vaccine, varicella vaccine, and tetanus-diphtheria-acellular pertussis (Tdap) vaccine. Employers are required to ensure that employees who decline to accept a recommended and offered vaccination sign the declination statement in Appendix C1 for each declined vaccine. Cal. Code Regs. tit. 8, § 5199 applies to hospitals, skilled nursing facilities, clinics, medical offices and other outpatient medical facilities, among others.

8. On 5/15/18 at 2:10 pm, during an interview and review of employee files with HRM, there was no documentation of annual competency for an Endoscopy Technician (LN 4) or a Sterile Processing Tech (LN 9). These findings were validated by HRM.

On 5/14/18 at 9:52 am, during an interview, NM 3 stated that the facility had adopted AORN Guidelines for Perioperative Practice as one of the nationally recognized guidelines for their infection control program.

According to AORN Guidelines for Perioperative Practice (2018), Guideline for a Safe Environment of Care, Part 1: Perioperative personnel should receive initial and ongoing education and complete competency verification activities for establishing and maintaining a safe environment of care. Initial and ongoing education of perioperative personnel on establishing and maintaining a safe environment of care facilitates the development of knowledge, skills, and attitudes that affect safe patient care. Periodic educational programs provide the opportunity to reinforce the knowledge of potential environmental hazards to patients and personnel, and to introduce new information on equipment or practice changes. Competency verification measures individual performance and provides a mechanism for documentation. Competency assessment verifies that perioperative personnel have an understanding of potential environmental hazards to patients and personnel.


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9. On 5/15/18 from 10 am to 10:45 am, an upper and lower endoscopy procedure was observed. LN 5 was observed using the same gloves throughout the procedure, with no performance of hand hygiene. LN 5 was observed filling out and affixing labels onto contaminated specimen containers (contained tissue excised from the intestinal tract), for multiple specimens. LN 5 then proceeded to complete computerized charting, touch the patient, and administer medications without changing gloves or performing hand hygiene. During a concurrent interview, LN 5 acknowledged that hand hygiene/glove changes were not done as required. LN 5 acknowledged gloves should be changed and hand hygiene performed after touching a contaminated surface and prior to performing the next clean process. During the same procedure, LN 4 was observed changing her gloves multiple times after they became contaminated with the patient's body fluids (from the patient's GI tract). LN 4 proceeded to obtain clean supplies without performing hand hygiene. No hand hygiene was performed by LN 4 throughout the procedure, which included multiple glove changes due to contamination with the patient's body fluids. During a concurrent interview, LN 4 acknowledged hand hygiene was not done as required and should be done each time contaminated gloves are removed and prior to proceeding with a clean process.

According to the Association of peri-Operative Nurses (AORN) Guideline for Hand Hygiene, effective 9/1/16, "... Hand hygiene is widely recognized as a primary method to prevent health care-associated infections and the transmission of pathogens in the health care setting. 1 Health care-associated infections can result in untoward patient outcomes, such as morbidity and mortality, pain and suffering, longer lengths of hospital stay, delayed wound healing, increased use of antibiotics, and higher costs of care. 2 Thus, prevention of health care-associated infections is a priority for all health care personnel. Hand hygiene and surgical hand antisepsis are effective and cost-efficient ways to prevent and control infections in the perioperative setting...

III.a.2. Hand hygiene should be performed before a clean or sterile task, including

-inserting an invasive device (eg, vascular catheter31 [peripheral,29,30,32-34 arterial,30 central22,23,32], urinary catheter35)1,3,4,10,27,36; [1: Strong Evidence]

-accessing a vascular device (eg, port,10 stopcock,19-21 IV tubing23,27,33,36)31; [1: Strong Evidence]

-moving from a contaminated body site (eg, perineum) to a clean body site (eg, face) on the same patient1,3,4; [1: Strong Evidence]

-administering or preparing medication, including delivery of medications to the sterile field and preparation of IV fluids1,3,27,30,33,36; [1: Strong Evidence] ...

-opening sterile supplies27,30,33,36; [3: Moderate Evidence] ...

III.a.3. Hand hygiene should be performed after risk for blood or body fluid exposure, including

-removing personal protective equipment (eg, gloves, mask)1,3,4,10,22,23; [1: Strong Evidence]

-having contact with blood, body fluids, excretions, mucous membranes, non-intact skin, or wound dressings1,3,4; [1: Strong Evidence]

-inserting or assessing an invasive device (ie, vascular catheter [peripheral, arterial, central], urinary catheter)27,30,32; [3: Moderate Evidence] ...

-handling specimens27; [3: Moderate Evidence] ...

III.a.5. When gloves are worn and hand hygiene is indicated, the gloves should be removed to perform hand hygiene.3,4 [1: Strong Evidence]

The use of gloves does not replace the need for hand hygiene.3,4 ..."

10. On 5/15/18 at 10:55 am, LN 4 was observed performing endoscope cleaning procedures. The procedures included wiping and/or brushing the scope and visually inspecting it (for any remaining visible bioburden and for any nicks or other evidence of compromise to the instrument). No magnification was available for use in the instrument cleaning room.

The AORN Guidelines for Processing Flexible Endoscopes, effective 2/1/16, was reviewed and indicated, "VII.c. Lighted magnification should be used to inspect endoscopes and accessories for cleanliness and damage. 12,13,65 [2: High Evidence]

An endoscope that appears clean may harbor debris that cannot be seen without magnification. Lighted magnification may increase the ability to identify residual soil or damage.

VII.c.1. Internal channels of flexible endoscopes may be inspected using an endoscopic camera or borescope. [2: High Evidence]

Endoscopic cameras and borescopes penetrate the lumen and allow for improved visual inspection. 12,58

VII. d. Defective endoscopes, accessories, and equipment should be removed from service and repaired or replaced. 1,13,58 [2: High Evidence]

Identification of defective endoscopes, accessories, and equipment and removal from service reduces the risk of a defective item being used and helps prevent further damage from use."


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11. During an interview on 5/14/18 at 10:20 am, NM 3 indicated the facility followed the AORN guidelines.

During an observation in the OR, on 5/17/18 at 8:50 am, Medical Doctor (MD) 2 clipped Patient 12's pubic hair immediately prior to the skin prep for surgery.

During an interview on 5/17/18 at 10:45 am, LN 8 stated the standard for patient hair removal was to be as close to the time of surgery as possible.

A review of the 2018 AORN Guideline for Preoperative Patient Skin Antisepsis, Recommendation II, provided by NM 3, indicated hair removal at the surgical site should be performed only in select clinical situations. Collective evidence supports that hair at the surgical site should be left in place. When necessary, hair at the surgical site should be removed by clipping or depilatory methods in a manner that minimizes injury to the skin. The patient's hair should be removed in a location outside the operating or procedure room.

A review of the facility's procedure titled, "Pre-Operative Skin Preparation of Patients," dated 5/18, indicated, "When hair removal is necessary, it should be performed as close to the time of surgery as possible."

Based on observation, interview, and document review, the facility failed to identify/prevent potential radiation hazards when Lead Apron #3 (LA #3) had surface damage and was not removed from service.

This had the potential for avoidable radiation exposure.

Findings:

On 5/17/18 at 9:25 am, during an observation of the CT Room (used for diagnostic radiology procedures), the RAD Tech (Radiology Technician) confirmed LA #3 had surface damage that included cracks, and was available for use. The RAD Tech stated the lead apron was used very rarely. The RAD Tech explained that if a CT scan was being done on a young child, the lead apron may be used by a parent accompanying the child.

On 5/17/18 at 9:35 am, during an observation and interview, the Assistant Chief Rad Tech (ACRT) confirmed the CT Room had a lead apron with surface damage that included cracks. ACRT stated he was responsible for evaluating the lead aprons, acknowledged the lead apron was very old, was in a deteriorated condition, and should be retired from use.

On 5/17/18 at 1:40 pm, the Director of Maintenance (DM) provided a copy of the facility's Lead Apron Check (LAC) document. The document indicated, "...Should you find any ... cracks on aprons ... dispose of that apron immediately." The DM confirmed this was not done as required for LA #3.

Based on observation, interview, and record review, the facility failed to ensure nursing services were provided per facility policy and that Licensed Nurse (LN) 3 was adequately trained and competent to meet the needs for one of 30 sampled patients (Patient 3).

This failure had the potential to result in adverse outcomes for Patient 3.

Findings:

During an observation on 5/14/18 at 11:10 am, Patient 3 had an implanted port (central line, a surgically placed catheter into a large vein for giving medicines, fluids, food, or taking blood samples) in her chest. She was receiving D5-0.45 (intravenous solution) at 100 milliliters per hour. There was a clear op-site (transparent) dressing over the port that was not dated when it was last changed. The tubing to the solution was not dated.

A review of Patient 3's record was conducted with LN 2. Patient 3's record contained an undated nursing progress note that indicated LN 3 had drawn blood from Patient 3's port at 6 am on 5/15/18.

During an interview on 5/15/18 at 11:50 am, Patient 3 confirmed that facility staff had drawn blood from her port on two separate occasions.

A review of the hospital's policy titled, "Central Line Care and Prevention of Infection," dated 10/17, indicated the policy was to reduce the risk of complications and infections. The policy indicated it was imperative that the Central Venous Catheter (a catheter placed into a large vein, such as in the chest) be handled and maintained correctly. Under the section titled, "Orders," the policy directed that there must be physician orders in place for fluid administration and blood draws.

On 5/16/18 at 9:25 am, LN 3's employee competencies were reviewed with the Human Resource Manager (HRM). HRM stated LN 3 was a traveling nurse and that her last competency test was completed on 6/6/17. HRM stated that the clinical competencies came from the traveling agency, and confirmed the facility had no documentation that LN 3 had been trained on how to draw blood from a patient's central line.

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

1. the emergency water supply was stored at an appropriate temperature and was not expired, and

2. the emergency preparedness policies and procedures included a plan on how to transport the emergency water supply from a locked shed across the street to the facility in an emergency and for water availability from an outside vendor.

These failures had the potential to result in the facility not being fully prepared to respond in an emergency.

Findings:

During the initial tour of the kitchen on 5/14/18 at 2:10 pm, the Dietary Supervisor (DS) stated the emergency water, 150 gallons, was kept across the street and was maintained by maintenance.

An observation of the facility's emergency water supply was conducted with the Maintenance Supervisor (MS) on 5/16/18 at 10:35 pm. The emergency water supply was stored in a locked aluminum shed across the street from the hospital, approximately 100 feet away. There were three steps uphill that led to the shed. Inside the locked shed were 30 five-gallon bottles of water (150 gallons total) with an expiration date of 5/3/17 on each of the containers. The MS stated the amount of water on hand was correct; however, acknowledged that it had not been rotated and that the water had expired. The MS stated the facility did have a contract with a local vender for water delivery, but was unable to locate and provide the contract information upon request. The MS also stated a thermometer was not kept in the shed to monitor the temperature, and acknowledged the aluminum shed would have increased temperatures during the summer months. The MS stated that maintenance staff were the only ones that had a key to the shed and that they were on call at all times.

During an interview, on 5/16/18 at 2:15 pm, the Registered Dietician (RD) stated she expected the emergency water to be rotated and not expired. She also stated she expected a thermometer to be in the shed to monitor the temperature.

During an interview, on 5/17/18 at 9:40 pm, the Director of Support Services (DSS) acknowledged the facility did not have a plan for how they would transport the emergency water from across the street to the hospital in an emergency.

A review of the facility's policy titled, "Disaster Plan Procedure," revised 11/17, indicated the facility would maintain water for 50 people for a three day period during a disaster and that 150 gallons or more would be stored for emergencies or disruption of services. The policy did not include a plan for transporting the water from across the street during an emergency or for water availability from an outside vendor.