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Based on interview and record review, the hospital failed to follow their policy and procedure related to informed consent (permission granted for treatment with full knowledge of possible risks and benefits) when the "Conditions of Admission" (COA) (form used for patient/legal guardian to sign indicating informed consent was given) form was not signed within 24 hours of admission to the facility for five of 30 sampled patients (Pts) Pts 11, 12, 13, 18, and 25.

This failure had the potential for Pts 11, 12, 13, 18, and 25 or his/her legal guardian to be denied their rights for information needed to make informed health care decisions.

Findings:

Review of Pt 11's clinical record indicated she was admitted to the hospital 7/17/18. Clinical records indicated Pt 11's COA form signed 7/20/18, three days after admission.

Review of Pt 12's clinical record indicated she was admitted to the hospital 7/18/18. Clinical records indicated Pt 12's COA form was signed 7/25/18, seven days after admission.

Review of Pt 13's clinical record indicated Pt 13 was admitted to the hospital 8/4/18. Clinical records indicated Pt 13's COA form was signed 8/12/18, eight days after admission.

Review of Pt 18's clinical record indicated he was admitted to the hospital 8/12/18. Staff was requested but unable to locate Pt 18's COA form.

Review of pt 25's clinical record indicated Pt 25 was admitted to the hospital 8/9/18. Pt 25's COA form was signed 8/11/18, two days after admission.

On 8/16/18 at 8:55 a.m., during an interview, the Director of Inpatient Services (DIS) stated the Admissions Department is responsible to ensure the COA forms are signed in a timely manner. The DIS stated the nursing staff assists the Admissions Department by sending legal guardians of direct admits to admissions to sign the informed consent within 24 hours of admission but it is not the responsibility of the bedside team to obtain informed consent.

On 8/16/18 at 9:05 a.m., during an interview, the Director of Patient Access (DPA) stated it is her expectation that the Admissions Department staff get all informed consents signed on transfers, emergency room admits, and clinic admits in the admissions office within 24 hours of admission. The DPA stated, for patients' legal guardians who miss the admissions office, the Admissions Department staff go to the patient bedside. The DPA stated a report is run every shift to look for unsigned COA forms. The DPA stated the Admissions Department staff document any attempts to contact the legal guardian in the notes in the "Registration Management Desktop". The DPA stated, "It's disturbing but it does happen; we don't always get [informed consent] signed within 24 hours."

On 8/16/18 at 3:05 p.m., during an interview, the DPA stated the staff could and should be doing verbal consents. The DPA stated, "It is a gap...we miss a lot of these..." The DPA stated her expectation is for the COA forms to be signed within 24 hours.

The hospital policy and procedure titled, "Admissions, Conditions of Admission Form" dated 8/16 indicated, "Policy: All inpatient admissions require the COA [Conditions of Admission] form be signed by the patient or his/her legal guardian at the time of admission. Should the patient be unable to sign or the legal guardian is not immediately available, the consent should be signed at the earliest opportunity and no later than 24 hours of admission... The patient's or his/her legal guardian signature is obtained, confirming his/her consent for care, billing information, and Notice of Privacy Practices [describes how health information may be disclosed for specific reasons]..."

Based on observation, interview, and record review, the hospital failed to protect Patient (Pt) 27's confidential medical information when his clinical information was displayed on a computer screen in the hallway on a portable workstation on wheels.

This failure resulted in Pt 27's confidential medical information being visible to the public and had the potential for a breach in privacy.

Findings:

On 8/15/18 at 8:50 a.m., during an observation, Respiratory Therapist (RT) 1 and RT 2 were observed in Pt 27's room providing care. The portable workstation was sitting in the hallway outside the room, with the computer screen visible. Pt 27's medical record was open and displayed.

On 8/15/18 at 8:55 a.m., during an interview, Charge Nurse (CN) 3 stated it was normal policy to turn off the computer when stepping away from the workstation. CN 3 stated, if the computer screen needed to remain opened to Pt 27's medical information, the workstation could be pulled into the doorway of the room, to prevent viewing Pt 27's information from the hallway and avoid a HIPAA (Health Insurance Portability and Accountability Act-Privacy- regulations which require hospitals to ensure the confidentiality and security of protected health information) violation. CN 3 stated he would expect the computer to be turned off.

On 8/15/18 at 9 a.m., during an interview, RT 1 stated he had received HIPAA training during orientation to the hospital and was told to turn off the computer when leaving the workstation. RT 1 stated, "That's my bad, that's on me, I was trained, and I have a lot to learn."

The hospital policy and procedure titled, "Information Technology Acceptable Use Policy" dated 4/18, indicated, "Purpose Statement [the hospital] is committed to protect the confidentiality, integrity, and availability of IT [information technology] systems and data as well as complying with federal and state health regulation, including HIPAA and security Rules...Policy...Users are expected to use the computer and network resources in a responsible manner...Users shall lock or logoff from workstations, if leaving the workstation unattended for any period of time..."

Based on observation, interview, and record review, the hospital failed to ensure quality indicators for food services were measured, analyzed, and tracked when the department of food services did not report any quality studies or activities to the hospital's quality committee.

This failure had the potential to allow practices to continue without remediation.

Findings:

On 8/15/18 at 10:25 a.m., during an interview with the Director of Food Services (DFS), the department's Food Service Quality Assurance and Performance Improvement (QAPI) program was discussed. The DFS stated she was not a part of the hospital QAPI committee and did not report anything to quality committee. There were no sanitation audits being conducted in the kitchen. They were monitoring hand washing, labeling, and dating; however, the DFS stated her issue was not washing hands but more about the use of gloves. The DFS stated it was an old audit form for hand washing and needed to be updated to capture the actual problem. She stated they do well with the hand washing audit and acknowledged it was not an actual performance improvement activity, since they were doing well at it. There were some internal audits being done (hand washing, test tray and tray delivery audits); however, they were monitoring activities not performance improvement activities.

On 8/15/18 at 1:50 p.m., during an interview with the Director of Quality and Patient Safety (DQPS), Infection Prevention Manager (IPM) and the Infection Control Preventionist (ICP), the DQPS stated all directors are responsible to bring their issues or performance improvement plans to the committee. The DQPS stated he was unsure if the DFS was a part of this. The DQPS acknowledged the quality department should help all departments identify areas for performance improvement.

On 8/15/18 at 2:35 p.m., an interview was conducted with the IPM, in the presence of the DQPS. The IPM confirmed Food Services was not a part of the QAPI committee at this time.

There was no data monitored or reported in 2017 or 2018 to the subcommittee.

Review of the hospital's policy and procedure titled, "Food Services CQI and PI" dated 05/18, indicated the quality indicators are selected in measure regulatory compliance and food quality. It indicated, "The Director of the Department will be actively involved in the monitoring for any QAPI projects in the department" and would be "included in the Organizational Wide Performance Improvement Program".

Review of the hospital's Performance Improvement (PI) Plan dated 07/18, indicated the PI program allows all departments and services to collaboratively perform improvement activities. It showed the scope of the PI Plan is all services and departments throughout the facility utilize the established PI Plan.

Based on observation, interview, and record review, the hospital failed to follow the policy and procedure, "Emergency Medical Response Program" when, crash cart (stocked with emergency medical equipment, supplies, and drugs for use by medical personnel during efforts to revive a patient) maintenance was not performed by nursing staff every 12 hours.

This failure had the potential for crash carts to have malfunctioning equipment and/or missing supplies necessary in an emergency.

Findings:

On 8/13/18 at 9:30 a.m., an initial tour of the emergency department (ED) was conducted. The crash cart in Zone 1 was observed. A review of the "Crash Cart Check Log" revealed maintenance checks had not been documented for 8/1/18, night shift (7 p.m.-7 a.m.), 8/3/18, night shift, and 8/12/18, night shift. The crash cart in Zone 2 was observed. A review of the "Crash Cart Check log revealed maintenance checks had not been documented for 8/5/18, day shift (7 a.m.-7 p.m.), and 8/12/18, night shift.

On 8/13/18 at 9:40 a.m., during an interview, Charge Nurse (CN) 1 stated the charge nurse on duty for each shift assigns crash cart maintenance to the Registered Nurse (RN) in each Zone. CN 1 stated it is the responsibility of the assigned RN to perform the check and document on the log every shift. CN 1 stated there were gaps in the documentation for the logs in Zone 1 and 2, and it was the responsibility of the charge nurse on duty to make sure the checks were completed.

On 8/13/18 at 9:55 a.m., during an interview, the ED manager stated it was her expectation the ED crash carts were checked twice daily, per policy and procedure. The ED manager stated the charge nurses are responsible to follow up on crash cart checks after the task are assigned to the RN. The ED manager stated the RNs need to know what supplies are in the cart, where the supplies are located and the equipment is functioning properly.

On 8/13/18 at 2:22 p.m., an initial tour of the Craycroft and Voyager units was conducted. The crash cart in each unit was observed. A review of the "Crash Cart Check Log" revealed maintenance checks had not been documented on Craycroft for 8/9/18, day shift and 8/10/18, night shift and on Voyager on 8/6/18, night shift.

On 8/13/18 at 2:30, during an interview, CN 2 stated the charge nurse on each shift is responsible for going through the check list and checking the crash cart. CN 2 stated the charge nurses do not assign the task out, they perform the checks themselves. CN 2 stated the charge nurses need to ensure the crash carts are ready for an emergency, and the lack of charting for the missing dates show the charge nurse forgot to check the crash cart.

On 8/13/18 at 2:35 p.m., during an interview, the Director of Inpatient Services stated the staff need to know where supplies are in the crash cart; she stated it was her expectation the crash carts were checked every shift, to make sure they are in case of an emergency.

The hospital policy and procedure titled "Emergency Medical Response Program" dated 1/16 indicated, "...Maintenance of the Crash Cart...3. Crash Cart CHECKS each shift A. Check the integrity of the external seal on the crash cart... B. Check proper function of the suction machine... C. Check the oxygen tank level... D. Verify monitor/defibrillator functions...E. Verify that the content list of the emergency drug and IV supplies is attached to the cart...5. Crash cart checks and/or lock replacement when crash cart has NOT been utilized A. Each crash cart will be checked once during every 12 hour shift by assigned department staff..."

Based on interview and record review, the facility failed to provide nursing care in accordance with the hospital policy and procedure titled, "Pulse Oximetry [test used to measure the oxygen level in the blood]," when the nursing staff did not provide skin assessments every four hours for one of 30 sampled patients (Pt 14).

This failure had the potential for skin breakdown (bedsore) to go undetected.

Findings:

Review of Pt 14's clinical record titled, "Care Activity- Assessments" dated 7/22 - 7/25/2018, indicated ten occurrences in which the completion of skin assessments exceeded four hours, as follows:

A. On 7/22, skin assessment was completed at 4 p.m. and the next assessment was completed at 11 p.m., a seven hour difference.

B. On 7/23, skin assessment was completed at 12 a.m. and the next assessment was completed at 5 a.m., a five hour difference; the next assessment was completed at 10:45 a.m., a difference of five hours and forty-five minutes; and the next assessment was completed at 4:45 p.m., a six hour difference.

C. On 7/23, skin assessment was completed at 8 p.m. and the next assessment was completed 7/24 at 3 a.m., a seven hour difference.

D. On 7/24, skin assessment was completed at 3 a.m. and the next assessment was completed at 8 a.m., a five hour difference; the next assessment was completed at 2 p.m., a six hour difference; and the next assessment was completed at 9 p.m., a seven hour difference.

E. On 7/24, skin assessment was completed at 9 p.m. and the next assessment was completed 7/25 at 3 a.m., a six hour difference.

F. On 7/25, skin assessment was completed at 3 a.m. and the next assessment was at 2:54 p.m., a difference of 11 hours and fifty-four minutes.

On 5/16/18 at 10:05 a.m., during a concurrent interview and record review, the Clinical Nurse Specialist (CNS) confirmed the occurrences where skin assessments exceeded four hours. The CNS stated the pulse oximetry assessments are for pressure ulcer (bed sore) prevention and skin inspection. The CNS stated the assessments are completed by the Registered Nurse (RN) or simultaneously with the RN and Respiratory Therapist. The CNS stated it is her expectation for staff to follow the facility's policy and procedure to assess the skin at least every 4 hours.

The hospital policy and procedure, titled "Pulse Oximetry" dated 12/2015, indicated "...Monitoring- the following should be monitored to ensure safe and effective use of pulse oximetry: The sensor site [place on the body where a clip-like probe is placed to measure oxygen level] should be assessed at least every 4 hours for color changes, bruising, erythema, etc. More frequent checks are indicated in the following: A... neonates [babies from birth to four weeks] B. Patients with poor peripheral perfusion...."

Based on observation, interview, and record review, the hospital failed to ensure medications were administered according to facility policy when:

1. Intravenous (IV - directly into the vein) tubings connected to two IV fluid bags were labeled with changed date, in accordance with hospital policy and procedure.

2. Medication was not scanned (process used by nurses prior to administering bedside medications to prevent errors) by a nurse prior to administration, in accordance with hospital policy and procedure.

These failures could increase the risk of microbial (germs that cause disease) contamination and bypass safeguards to prevent medication errors.

Findings:

1. On 8/14/18 starting at 9:10 a.m., medication pass observation was conducted with three nurses on the medical surgical unit of the hospital. During the medication pass with RN 6, it was noted that her patient (Patient 42) had an IV infusion of potassium chloride (a form of mineral found in the human body) 20 meq (milliequivalents - unit of measure) in a 1000 ml (milliliters - one thousandth of a liter) bag of sodium chloride (normal saline) and dextrose (a form of sugar) fluid for electrolyte replacement. The IV tubing attached to the bag was not labeled with the date it was changed.

At the 9:38 a.m. during medication pass with RN 5, while observing an IV antibiotic administration, it was noted Patient 43's IV tubing attached to a 500 ml bag of 0.9% sodium chloride solution was also not dated.

On 8/14/18, during a concurrent interview following their retrospective medication pass, both RN 5 and RN 6 acknowledged the IV tubings for their respective patients would need to be labeled with a changed date.

A review of the hospital policy titled, "Intravenous Catheters" dated 4/2016, under Line Management, indicated "Line Management - Document all IV line and bag changes... Appendix A - IV Tubing change: General IV solutions... Every 96 hours."


2. During a medication pass on 8/14/18 starting at 9:38 a.m., RN 5 was observed administrating an IV bag of cefazolin (antibiotic to treat bacterial infection) to Patient 43 in the medical surgical unit of the hospital. After scanning the barcode on the antibiotic medication with the clinical documentation device (bedside medication verification scanner), RN 5 proceeded to hang the IV medication by connecting an IV line to the bag and programmed the IV pump to start the infusion. RN 5 then went back to the patient and scanned her hospital wrist band with the same clinical documentation device. While in the patient room observing the medication pass, it was noted that one of the patient's IV tubings attached to a 500 ml bag of 0.9% sodium chloride solution was not dated by a nurse.

On 8/14/18 at 9:50 a.m., during an interview, RN 5 acknowledged she should have scanned Pt 43's wrist band prior to starting the IV antibiotic infusion.

Review of the physician orders for Patient 43 with the Medical Surgical Nurse Manager (MSNM) revealed that the patient also had an order for 1000 ml bag of IV 0.9% sodium chloride solution, however, the 500 ml bag of 0.9% sodium chloride solution found administering to the same patient in the room was not ordered by her prescriber.

On 8/14/18 at 10:10 a.m., during a concurrent interview and record review of the medication administration record (MAR), when asked how the wrong size bag of normal saline was administered to Patient 43, MSNM stated RN 5 failed to scan both the patient's wrist band and the barcode on the 500 ml bag of 0.9% sodium chloride solution during the course of administering the IV fluid.

A review of the hospital policy titled, "Medication Administration" dated 4/2018, indicated "Medication Administration Procedures - "E. Scan medication barcode with the clinical documentation device... H. Verify that the armband has the correct account number by scanning the armband barcode with the clinical documentation device... K. Administer the medication(s) following guidelines..."

Based on observation, interview, and administrative document review, the facility failed to have a well-exercised downtime backup (a switchover to written documentation of clinical care) process should the electronic health record (E.H.R.) fail. Failure to conduct downtime exercises did not prepare clinical staff to document medical records as part of emergency preparedness and to avoid preventable delays in the delivery of care to patients in a disaster. For disaster preparedness when patients are likely to be transferred to other hospitals, the exchange of medical record information would be critical to patient safety.

Findings:

On 8/14/18 at 11:15 a.m., during an interview with the Chief Information Security Officer (CISO), he stated the last scheduled downtime exercise for the facility occurred on 7/18/18. CISO stated that scheduled downtime exercises were conducted during the evening shift, between 1 a.m. - 4 a.m.

The facility's downtime log report titled, "Critical Incident Management - Downtime". The report showed incidents from 7/20/15 to 7/20/18. No scheduled downtime event for 7/18/18 was documented on the report, and there were no scheduled exercises documented between 2015 to 2018.

The IT (Information Technology) Disaster Recovery Plan (IT DRP) indicated in the Policy Statement dated August 2018 that:
· The disaster recovery plan should cover the essential and critical infrastructure elements, systems, and networks, in accordance with key business activities.
· The disaster recovery plan should be periodically tested in a simulated environment to ensure that it can be implemented in emergency situations and the management and staff understand how it is to be executed.

On 8/14/18 at 10:00 a.m., during a tour of the Emergency Department, Charge Nurse (CN) 1 was interviewed, while accompanied by the Director of Clinical Documentation and Coding (CDI/Code Dir). CN 1 stated there were 6 zones for emergency patient treatment with a total of 38 licensed beds, ranging from triage (the sorting of patients according to the urgency of their need for care) screening to assigned areas for critical care level treatment of emergency patients. When asked about nurse staffing, CN 1 stated that with a full house of patients in all 38 beds of the ED, there could be up to 20 nurses on duty.

On 8/14/18 at 10:30 a.m., during an observation, CN 1 was asked what would happen if the electronic health record (E.H.R.) system was not working, such as a situation with complete electric power failure or a catastrophic event such as large earthquake which could create an extended downtime of the E.H.R. When requested, CN 1 could not locate a copy of the Emergency Department Downtime Policy (DP-7010.053). When asked for the manual medical record documents that would be needed for each patient being treated in the emergency department, it took 5 minutes to gather the documents for one patient, which included:
· Emergency Department Downtown Form (also known as, "flow sheet")
· Emergency Department Physician Order's Sheet
· Physician's Orders Sheet
· Imaging Down Time Requisition (not in medical record format)
· Lab orders sheet (not in medical record format, no item number)
There were no packets of documents for each emergency department patient prepared in advance and it was observed that the forms were loosely stacked on shelves in a room for zone 5/6. The documents provided in the packet did not include a Medication Administration Record.

When asked how there would be tracking of patient movement from one room to another as the emergency patient was relocated from zone to zone, CN 1 provided a document with a table with headings of "Room, Acuity, Patient label, and Chief Complaint". CN 1 was asked if there was a document that could manually track patient location and it was provided. CN 1 was asked if there was a procedure to track multiple patient relocations in the ED and he stated that there was none. CN 1 could not recall participating in an scheduled E.H.R. outage exercise during the dayshift in the E.D.

A copy of policy and procedure titled "Emergency Delivery of Care" (DP-7010.053) was provided by CN 1 on 8/16/18 at 9:30 a.m. A review of the document indicated, "... Procedure, Process 1. Pre-Downtime preparation A. Downtime packets consisting of the ED flow sheet, discharge instruction form and physician order sheet will be pulled from the zone 5/6 storage room and placed in each zone for existing patients". No packets had been prepared in readiness for a disaster ready situation for the ED's 38 beds to assure immediate documentation would be accomplished quickly should an E.H.R. downtime occur.

On 8/15/18 at 9:45 a.m., during an interview with the Clinical Documentation Improvement/Code Director (CDI/Code DIR), and the Director of Medical Staff Services (MSS DIR), 6 different facility policies and procedures for emergency and disaster preparedness were shared. When asked which policy and procedure provided the main instruction for a unplanned E.H.R. downtime for the pateitn care information system, CDI/Code DIR stated "Hospital Downtime Procedure" (RC-1022).

A review of RC-1022, indicated for Procedure, 4) Clinical Documentation, the forms needed in a E.H.R. downtime were listed as:
a. Emergency Department Management (EDM) - Nursing Documentation ...
b. Patient Care System (PCS) Inpatient Nursing and Ancillary documentation
Utilize paper form of:
* Patient care flowsheets
* Pediatric Admission Database (PADB)
* Interdisciplinary Plan of Care (IDPC)
* Order Sheet
* Progress Notes
* Teaching forms
* Medication Administration Record

On 8/15/18 at 11:30 a.m., during a concurrent observation of the Pediatric Intensive Care Unit (PICU) and interview, the Head Unit Coordinator (HUC) 1 was asked what actions would take place in a downtime outage of the E.H.R. system. HUC 1 was observed to locate a binder of nursing unit policies and procedures known as "Code Purple" and went to a file cabinet which had folders of paper forms to retrieve required medical record forms. The packet created included: PICU 24 hour Critical Care Flowsheet, Physician's Order Sheet, Progress Note form, an unnamed form "Downtime for lab test orders and Point of Care Testing.

On 8/16/18 at 9:30 a.m., during an observation of PICU staff, the forms gathered for a patient packet in a downtime outage by PICU HUC 2 failed to include a Medical Administration Record.

On 8/15/18 at 11:45 am, during a concurrent observation in the Neonatal Intensive Care Unit (NICU) and interview, NICU Head Unit Coordinator (HUC) 3 was asked and responded that the total number of patient beds that could be treated on the unit was 85. HUC 3 was able to demonstrate use of the E.H.R. backup system for view-only known as Downtime Reporting System (DRS). HUC NICU could not recreate the Medical Administration Record (MAR). An effort to print out individual medication sheets which would be needed for patients transferred to other facilities in an emergency situation took approximately 15 minutes for 6 out of 30 patients that were currently on the nursing unit, which showed the potential for delay of patient care during an E.H.R. outage as well as lack of readiness for immediate patient transferring to other facilties.

On 8/16/18, at 10:15 a.m., during an interview, the E.D. policy and procedures on triage assessment and manual back up processes were requested. A copy of Emergency Delivery of Care (DP-7010.043) was provided as the ED's policy for downtime documentation which was inconsistent with RC 1022.

Based on interview and administrative document review, there was failure of the facility to secure authentication of verbal orders by physicians within 48 hours as required by federal regulation, state regulation and hospital policy in 20% of inpatient discharge records over the course of the most recent calendar year. Prompt co-signing of verbal orders must be done to prevent risk of medication order errors, provide clear specifications for treatments, interventions and other patient care, and for the accountability of orders issued by licensed providers in order to assure patient safety.

FINDINGS:

In an interview on 8/15/18 at 1:30 p.m. with the Director of Medical Staff Services (MSS DIR) and the Chief Medical information Officer (CMIO) the Medical Staff Rules and Regulations (MS R&R) regarding medical record completion were reviewed. The rule in Section VIII Medical Records, J. Orders, specified that Verbal Orders "must be countersigned by the ordering practitioner or the attending physician responsible for the patient's care at the time the medication are given to the patient ... within 48 hours". Medical record deficiencies were reported to the Health Information Management Committee, which met monthly as part of the Medical Staff activities. The minutes of the Health Information Management Committee for the past year were reviewed with the MSS DIR and the unsigned verbal orders reported in the minutes were:
· May 2018 84% signed
· April 2018 84% signed
· March 2018 84% signed
· February 2018 85% signed
· January 2018 85% signed
The MSS DIR showed a bar graph (a diagram consisting of vertical bars to show representation of amounts) for June 2017 - May 2018, which showed that the signing of verbal orders averaged 80% completion for the past calendar year, and ranging from 70-74% in June 2017 - December 2017. MSS DIR explained that physicians could have privileges suspended due to incomplete medical records and in May 2018 there were 9 physicians with suspended privileges and April 2018 there were 18 suspensions.

A review of the physician suspension reports with the MSS DIR and CMIO showed that most of the suspensions for unsigned verbal orders involved orthopedic surgical staff.

On 8/16/18 at 11:00 a.m. in the Health Information Management department, the HIM Supervisor (HIMS) was interviewed on his role in managing and reporting medical record completion. HIMS was requested to show the current medical record deficiencies for unsigned verbal orders on the electronic health record (EHR) system for inpatient records. While verbal orders were to be signed within 48 hours, the medical staff was allowed an extended 14 days following discharge of an inpatient to complete the deficiencies. For discharges prior to 8/2/18, when medical records were delinquent past the allowed 14 days for completion per the MS R&R, HIMS demonstrated that the EHR system showed that the total number of unsigned verbal orders was 386 for the medical records beyond 14 days following discharge.

Based on interview and record review, the facility failed to assure that a patient had a current and complete medical history and physical examination that was no more than 30 days prior to inpatient admission for a surgery. The history and physical was necessary for information to be available to all care providers for awareness of the patient's overall condition to reduce risk prior to surgery.

FINDINGS:

In an interview on 8/13/18 at 10:45 a.m. with Charge Nurse (CN) 1, the need for prompt availability of patient information in the electronic health record (EHR) was discussed. When asked which patients were likely to return to the hospital via the emergency department, CN 1 stated that pediatric patients with tonsillectomy and adenoidectomy (excision removal of the tonsil and adenoid lymph tissue in the throat) procedures often returned with bleeding complications.

The surgical schedule of 8/7/18 was requested and provided, and a surgical case of a tonsillectomy with adenoidectomy was randomly picked from the schedule.

The EHR of patient 31, a 17 year old male, was reviewed at the computer station with CN 1. The patient had multiple diagnoses of Obstructive Sleep Apnea (blocked airway causing periodic episodes of inability to breathe, hypertrophy of tonsils and adenoids (unusual growth of tissue at the back of the nose), obesity, and Klinefelter syndrome (a genetic disorder that affects physical development in males). When the history and physical was searched in the EHR there was a brief and incompletely documented history and physical (H&P) dated 8/7/18, that did not indicate a full examination and did not include the standard documentation elements for a H&P for examination of the neck and chest and "current and/or recent medications". A full history and physical examination was documented on 3/28/18 in the outpatient medical records, more than four months prior to surgery which took place on 8/7/18.

Based on interview and record review, the facility failed to have discharge summary documentation which provided detailed medication listing for patients at the time of transfer to a higher level of care facility or at discharge to home with parents. The information regarding active medications could not be easily secured, creating a hurdle for continuity of care for the patient which could delay delivery of care, increase risk from medication error, and create potential harm to patients.

This failure had the potential for patients to not receive the correct medications.

Findings:

On 8/15/18 at 10:00 a.m., during an interview with four members of the Utilization Review department, led by the Medical Director of Hospitalists, a discussion was held about the Interfacility Transfer process. A copy of the facility's policy and procedure on interfacility transfers of patients was requested.

A review of an additional document titled, "Interfacility Transfer Checklist", with a footnote "updated 12/28/09", used by the Head Unit Coordinator (HUC) of each patient care area, indicated the HUC was responsible for preparing a document package for patients to be transferred to other health care facilities. According to the checklist, a transfer envelope was to include, with other medical record documents:
· Dictated or electronic Transfer Summary
· MAR (Medication Administration Record)
· Medication Reconciliation Form

During interviews of the PACU HUC 1 on 8/15/18 at 11:45 a.m.and NICU HUC 3 on 8/16/18 at 9:45 a.m. during observation tours, when asked what medical records would be produced for a transfer facility, and they provided the form titled "Interfacility Transfer Report (Advanced Clinical Systems)". The document package was to include: a transfer report, " Ventilator settings ..., H&P, Consult and Progress notes, Radiology Reports and CD's of CT, ECHO, CSR,MRI, CTSCN". Medications were not mentioned on this list which was provided by the HUC 1 and HUC 3 from the PICU or NICU.

During a medical record review of patient 35, a female infant was born prematurely at another facility and admitted 7/5/17 through 7/27/17. Patient 35 was diagnosed with a staphylococcus aureus infection (bacterial infection) , sepsis (life-threatening condition in which the body is fighting a severe infection that has spread via the bloodstream) and bacterial meningitis (inflammation of the membranes [meninges] surrounding the brain and spinal cord due to bacteria) which required 14 days of antibiotic therapy. The discharge summary included a closing statement instructing a parent or guardian to "give a list of the medicines to your doctor(s) and bring the list with you to all appointments". A medication list was unable to be provided as a list in the medical record, and in the discharge summary of 7/27/17 it mentioned that Patient 35 was discharged with "Home Medications: Poli-Visol (a child vitamin solution) 0.5 ml by mouth Q24h (once a day)".

During a medical record review of patient 40, an 8 year old female patient admitted with a high fever over 4 days was admitted on 6/6/18 with diagnoses of necrotizing fasciitis (bacterial infection of the tissue under the skin that surrounds muscles, nerves, fat, and blood vessels, spreading quickly and destroy the tissue infected.) A stack of medical records printed by the Utilization Review team consisting of >200 pages of documentation for patient 40 was briefly reviewed to determine what medications had been administered and needed to be continued when transferred on 6/13/ 18 to a higher level care pediatric hospital. A medication list was not included in the transfer packet.

On 8/16/18 at 11:30 a.m., during an interview with the Chief Medical Information Officer (CMIO) the difficulty of determining the medications for the highly complex care delivery for the facility patients was discussed. CMIO also reviewed the records of patient 40, including the large Interfacility Transfer packet of printed medical records and could not determine a quick summation of a patient medication list at the point of discharge. CMIO identified this issue as an opportunity for performance improvement.


A review of the policy and procedure titled "Interfacility Transfer" provided by MD Hosp indicated copies of all medical records including the Medication Administration Record (MAR) was to be provided for all patients upon transfer

Based on observation, interview and document review, the facility failed to ensure patient safety in the delivery of drugs when an accurate listing of medications posted for an emergency crash cart (portable vehicle on wheels, used to transport supplies and equipment to the site of a medical emergency) in the Pediatric Intensive Care Unit (PICU).

This failure could potentially increase the risk of adverse outcome for patients receiving treatment during medical emergencies.

Findings:

On 8/14/18 at 3:00 p.m., during a concurrent interview and inspection of the emergency crash cart in the PICU, the medication tray inside an emergency crash cart was opened with the assistance of Pharmacist (Pharm) 2, in order to examine the content within. The medications found in the tray were then compared with the content list posted outside of the emergency crash cart. Pharm 2 confirmed the medication list indicated the medication tray should have one 30 ml (milliliter - unit of measure) vial of epinephrine (medication used for emergency treatment of severe allergic reactions) with concentration of 1 mg (milligram) /ml. However, a physical inventory of the tray revealed there were only five (1 ml) ampules (total 5 ml) of epinephrine 1 mg/ml which were different than the one listed on the medication content list in term of the total volume.

On 8/14/18 at 3:11 p.m., during an interview, acknowledged the medication content list for this emergency crash cart was outdated and needed to be updated.

The hospital policy and procedure titled "Emergency Medical Response Program" dated 1/16 indicated, "...Maintenance of the Crash Cart... Verify that the content list of the emergency drug and IV supplies is attached to the cart... Each crash cart will be checked once during every 12 hour shift by assigned department staff..."

Based on observation, interview, and record review, the facility failed to ensure only authorized personnel had access to the room where medications were being stored when a unit aide (Unit Aide 1) was observed in the locked medication room on a nursing unit without the supevision of authorized personnel.

This failure had the potential for unauthorized personnel gaining access to pharmaceuticals stored in the locked medication room.

Findings:

On 8/13/18 at 3:30 p.m., during a concurrent observation and interview, Unit Aide 1 was observed stocking supplies in the medication room on the Explorer Unit, without the supervision of authorized personnel. The Director of Inpatient Services (DIS) 2 acknowledged the unit aide staff should be supervised by the authorized personnel when stocking the medication room. DIS 2 stated the unit aide's employee badge did not have access privileges to the locked medication room.

The facilities policy and procedure titled, "Pharmacy, Drug Storage and Control" dated 02/2017, indicated "... Procedure 1 ...drugs must me secured and kept in a medication room, a locked cabinet ...in a secure area ...8. Only licensed personnel ... shall have access to these drugs..."

39150

Based on observation, interview, and record review, the facility failed to eliminate outdated, or otherwise unusable medications, from patient use when:

1. Expired medication used for bowel cleansing before a procedure was found in the medication room;

2. An opened multi-dose (more than one dose) vial of Lidocaine (medication use for numbing) was found in the drug storage cabinet located in the Ear, Nose, Throat (ENT) clinic.

3. Two outdated bags of intravenous (IV - directly into the vein) fluid were found in a warmer located in the hospital surgical department.

These failures resulted in the potential for patients to receive outdated, ineffective medications.

Findings:

1. On 8/13/18 at 10:30 a.m., during a concurrent interview and observation of the medication room in the Discovery Unit, Registered Nurse (RN) 1 confirmed a container of (brand name) (medication for bowel cleansing before a procedure) had an expiration date of 8/12/18 8 p.m. RN 1 stated, the expired (brand name) should not be on the medication room counter for patient use.

On 8/16/18 at 2:10 p.m., during an interview, Director of Inpatient Services (DIS) 1 stated, it is her expectation that expired medication would be placed in the pharmacy waste bin. DIS 1 stated, a negative outcome of using expired (brand name) is the bowel will not get cleansed fully.

The facility policy and procedure titled, "Pharmaceutical Inspection Service" dated 2/2018, indicated "...A drug is considered to be expired at the end of the month/year dating or at midnight..."

2. On 8/13/18 at 11:26 a.m., during a concurrent observation and interview in the ENT clinic, the Nurse Practitioner (NP) confirmed there was an opened, multi-dose vial of Lidocaine stored in the medication cabinet without a date written on the vial to indicate when it was opened. The NP stated there should have been a date on the vial for the staff to determine how long the vial had been opened.

On 8/13/18 at 11:32 a.m., during an interview, the Manager of ENT (MENT), stated multi-dose vials that are opened should have a date on the vial indicating when it was opened. The MENT stated his expectation is for the staff to have dated the multi-dose vial.

On 8/16/18 at 2:45 p.m., during an interview, the Director of Pharmacy (DP) stated multi-dose vials that are opened should be dated with the expiration date, which is 28 days from the time it has been opened. The DP stated, "...We don't want to use medications that are not stable or sterile [free of germs]..."

The facility policy and procedure titled, "Pharmaceutical Inspection Services" dated 2/18, indicated "Inspections will be documented on Pharmaceutical Services Inspection Form by pharmacists, pharmacy technicians who will check for and remove all outdated medications and supplies...Procedure...4. Steps to complete the inspection are as follows...B...Multi-dose vials are to be dated upon opening with the date of initial use. Any opened vial without a date will be discarded..."

The facility policy and procedure titled, "Medication Stability" dated 5/18, indicated "Purpose Statement: Provides guidelines for the appropriate use of single use and multi-use medication containers on patient care units to ensure they are used in a manner that assures sterility and stability of their contents while complying...Procedure...1. General policies that apply to ALL multiple use medication containers on patient care unit...A. Multi-use medication containers to be used parentally (administered not through the mouth)...will be dated and initialed upon first use...Multi-dose vials will be labeled with a revised expiration date once the multi-dose vial is opened or punctured..."

3. On 8/14/18 starting at 2:10 p.m., during a concurrent observation and interview in the hospital surgical department, with the DP and the Director of Perioperative Services (DPS) in attendance, two 500 ml (milliliter) bags of 0.9% sodium chloride (normal saline - salt solution) IV solution were found inside the fluid warmer B in the operating room with expiration dates of 8/13/18.

On 8/14/18 at 2:30 p.m., during an interview, the DPS confirmed the two bags of 500 ml 0.9% sodium chloride IV solution that were found in the warmer had already expired on 8/13/18, and should be taken out of the fluid warmer.

The facility policy and procedure titled, "Periop, Warming Cabinets" dated 12/2015 on page 2, indicated "C. ...IV fluids can be warmed in their plastic over-wraps for a period no longer than 14 days. Once they have been in the warming cabinet for their maximum time period, the containers must be removed from the warming cabinet ..."

Based on observation, interview, and record review, the failed to ensure dietary services was were organized and directed by adequate, qualified personnel when:

1. The hospital failed to ensure that the Director of Food Services was effective in the daily management of the dietetic services (Refer A 620);

2. There was not a comprehensive disaster menu and plan to feed all of the patients, staff and visitors or adequate food supplies to fully implement the planned disaster menu were on hand at all times (Cross Refer A 620);

3. Correct portion sizes were not followed in the patient menu for 22 patients when the Registered Dietitian (RD) did not oversee patient meal service operations. (Refer A 621);

4. The hospital did not ensure the dietetic service employees were competent in serving the patient menu with the correct portion sizes during the lunch meal service. (Refer to A 622)

5. An effective performance improvement program for food and dietetic services was not developed when there was no monitoring of performance improvement activities or participation with the hospital QAPI committee for the department (Refer A 273);

6. Safe and effective food and ice storage/production practices were not integrated in the facility's Infection Control surveillance system (Refer to A 749, findings 6,7, and 8).

The cumulative effect of these systemic problems resulted in the inability of the facility's food and dietetic services to direct staff in such a manner to ensure that the nutritional needs of the patients were met in accordance with practitioners' orders and acceptable standards of practice.

Based on observation, interview, and record review, the hospital failed to ensure effective oversight and daily management of the Food and Nutrition Services by the Director of Food Services (DFS) when:

1) There was not a comprehensive disaster menu or plan to feed all of the patients, staff, and visitors or adequate food supplies to fully implement the planned disaster menu at all times; and

2) The DFS failed to ensure the food service employees were competent in serving the patient menu the correct portion sizes during the lunch meal service on 8/14/18.

These failures had the potential to affect the safe provision of patient care.

Findings:

1. On 8/13/18 beginning at 3:09 p.m., during a concurrent observation, interview, and record review, the hospital's food services emergency response plan was reviewed in the presence of the DFS. The DFS stated, the hospital was planning to provide food for 1315 people a day, for a total of seven day, in the event of a disaster. The DFS stated they planned to serve the non-patients survivor meal bars (food product used in emergencies that requires no preparation) but they have not gotten these in at this time and she was not sure of their nutritional adequacy. The plan indicated there were 1315 non-patients and 394 patients, for a total of 1709. Further review of the food plan indicated the first 3 days of the plan to feed the total of people was not written into the plan; there was a menu for the patients for the additional four days with a nutrient analysis. The plan included 58 boxes with 25 servings (1450 servings total) of dehydrated foods.

On 8/14/18 at 9:41 a.m., during a concurrent observation and interview, the DFS and the Dietetic Staff 3 confirmed the food supply for the four day patient menu was short pureed green beans; Salisbury steak; sugar free jello; (product name) survivor meal bars; and four cases of chicken meat. The DFS stated she was not sure how much water would be needed for her dehydrated foods or any other part of her menu.

On 8/15/18 at 8:16 a.m., during an interview, the Clinical Nutrition Manager (CNM) was asked what the plan would be to feed everyone, if there was a disaster at 4 a.m. The CNM stated they would use the patient menu and cafe menu for the first 72 hours to use up the perishable food items.

On 8/15/18 at 8:42 a.m., during a concurrent observation and interview with the DFS, Kitchen Production Manager (KPM), and CNM in attendance, a review was conducted as to how they could feed the 1709 patients, staff and visitors and to determine if they had enough food on hand. The DFS, KPM, and CNM confirmed they were expecting a food order the next day and some food items on the menus were not currently at the facility. The DFS acknowledged they used to keep a two day perishable food supply on hand and they got away from doing that but they will need to change that practice back. The DFS acknowledged their par levels are too low on the day before their order comes in and this would affect their disaster plan. The DFS acknowledged they need to have a better plan in writing both for the first three days and for non-patients for seven days. It was determined the hospital had enough food on hand to feed 1709 for 4 days, rather than for seven days.

On 8/15/18 at 9:32 a.m., during an interview, the Emergency Management Coordinator (EMC) stated she relies on the DFS to be responsible for the emergency plan for feeding the patients, staff, and visitors. She stated the DFS is a part of the committee and that they were consistently working on the menu. The EMC stated she relies on the DFS and CNM to have this complete and the last time it was reviewed was in June or July of this year.

Review of the DFS job description showed the DFS is responsible for the hospital's Food Service operations including management of the service, implementing training and coaching programs for dietary staff, and assuring policies and procedures are maintained.

2. On 8/14/18 starting at 11:38 a.m., an observation of the lunch meal service was conducted, in the presence of the DFS. The broccoli was being served with a three ounce spoodle (serving spoon) and a #12 green scoop (1/3 cup) for the cooked rice and macaroni and cheese. A two ounce spoodle was in the corn, peas and carrots, carrots, and green beans that was used to serve the patients. The Dietetic Staff (DS) 2 was observed serving the mentioned food items and serving spoons to the patients during the lunch meal service.

Review of the lunch menu indicated the serving size of the foods depended on the age of the patients. Review of each of the patient meal tickets indicated the portion sizes of each food item each patient was to receive. Twenty-two patients received amounts less than what was posted on their tray tickets; some contained three food items and others just one food item that were served incorrectly.

On 8/14/18 at 12:21 p.m., a concurrent interview was conducted with DS 2 in the presence of the DFS regarding lunch meal service. DS 2 confirmed she used the #12 scoop for macaroni and cheese and the rice; a three ounce spoodle for the broccoli and the two ounce spoodle for the corn and other vegetables on the lunch tray line. DS 2 stated she would only use one level scoop of each scooper and put on each plate for the patients. The DFS confirmed DS 2 should give the amount listed on each tray ticket and, if it stated 1/2 cup, then they should have gotten two scoops of the 2-ounce spoodle or used a different scoop size depending on the food item served. DS 2 confirmed there were some incorrect scoop sizes in the food items.

On 8/15/18 at 10:01 a.m. an interview was conducted with the DFS regarding training and competencies for Dietetic Staff. The DFS stated she has individual on job training when they get hired for new hires however no competencies on the dietetic staff on their job duties.

Review of dietary staff in-services from 2016-2018 did not indicate any were conducted relating to following the menu or using the correct portion sizes.

Review of the personnel file for DS 2 indicated there was only a department orientation checklist and there was no competencies related to her job position.

Review of the hospital policy and procedure titled Food Services, Competency, dated 3/18, indicated each position has a competency checklist of the skills needed to perform their positions and that competency checklists are completed during orientation, during probationary period and annually effective June, 2015.

Review of the DFS job description showed the DFS is responsible for the hospital's Food Service operations including management of the service, implementing training and coaching programs for dietary staff, and assuring policies and procedures are maintained.

Based on observation, interview and record review, the hospital failed to ensure the qualified dietitian adequately supervised the nutritional aspects of patient care when 22 patients were served amounts less then the menu.

This resulted in a failure to follow correct portion sizes in the patient menu when the Registered Dietitian (RD) did not oversee patient meal service operations.

Findings:

On 8/14/18 starting at 11:38 a.m. an observation of the lunch meal service was conducted in the presence of the Director of Food Services (DFS). The broccoli was being served with a three (3) ounce spoodle (serving spoon) and a #12 green scoop (1/3 cup) for the cooked rice and macaroni and cheese. There was a two (2) ounce spoodle in the corn, peas and carrots, carrots, and green beans that was used to serve the patients. The Dietetic Staff (DS) 2 was observed serving the mentioned food items and serving spoons to the patients during the lunch meal service.

Review of the lunch menu, showed that the serving size of the foods depended on the age of the patients. Review of each of the patient meal tickets showed the portion sizes of each food item each patient was to receive. Twenty-two (22) patients received amounts less than what was posted on their tray tickets. Some of which contained three food items that were served incorrectly and others just one food item.

On 8/14/18 at 12:21 p.m. an interview was conducted with DS 2 in the presence of the DFS regarding the lunch meal service. DS 2 confirmed she used the #12 scoop for macaroni and cheese and the rice, a 3 ounce spoodle for the broccoli and the 2 ounce spoodle for the corn and other vegetables on the lunch tray line. DS 2 stated she would only use one level scoop and put on each plate. The DFS confirmed DS 2 should give the amount listed on each tray ticket so if stated 1/2 cup then they should have gotten two scoops of the 2 ounce spoodle. She confirmed there was some incorrect scoop sizes of the food items given to the patients.

On 8/15/18 at 8:16 a.m., an interview was conducted with the Clinical Nutrition Manager (CNM) regarding her job responsibilities. The CNM is a Registered Dietitian (RD). The CNM stated she is responsible for the formula room and all the recipes for infant feedings, the diet manual and patient menus along with the nutritional analysis of those. The CNM stated she has not participated in tray line (meal service) or done any kind of audits; she stated she gives consultation in regards to special diets.

On 8/15/18 at 10:05 a.m., during an interview, the DFS stated the Food Service Supervisor-Patient Care (FSSPC) oversees the patient tray line and meal services and does audits. At 10:10 a.m. the FSSPC joined the interview. The FSSPC stated she performs test tray and tray delivery audits. She stated she observes the meal service line at times but does not do any kind of audit for accuracy or check to see if correct portion sizes are being used. She stated the Dietetic Staff (DS) 2 was a relief for that position and has been doing it for about 10-12 months since she was covering for someone's maternity leave. The FSSPC stated the RD's do in-services for the whole staff about four times a year.

On 8/15/18 at 11:48 a.m., during an interview, the CNM stated the FSSPC reports to the DFS and she works closely with the FSSPC. The CNM acknowledged the diet office has clinical functions to ensure they are meeting the patient needs by following the menu. She stated she has not ever reviewed any of the audits done by the FSSPC. She stated her schedule varies in clinic coverage each week, depending on the RD coverage or availability. She stated the dotted line (to indicate an indirect relationship) to the DFS is how she supports the menus and therapeutic diets.

On 8/15/18 at 3:50 p.m., during a telephone interview, the CNM acknowledged the diet office was a clerical element with a therapeutic background and they needed to follow the approved menus to ensure patient needs are met.

Review of the job description of the CNM indicated she oversees regulatory compliance. It did not indicate what the CNM responsibilities were regarding the patient menu, nutrition analysis of the menu or ensuring the patient menu is carried out to meet the nutrition needs of the patients.

Based on observation, interview, and record review, the hospital failed to ensure the dietetic staff were competent in their job duties when serving the patient menu the incorrect portion sizes during the lunch meal service on 8/14/18


This failure had the potential to result in inadequate nutrition for the patients for 206 of 206 patients.

Findings:

On 8/14/18 at 11:38 a.m., during a concurrent observation of the lunch meal service and interview with the Director of Food Services (DFS), the broccoli was being served with a three (3) ounce spoodle (serving spoon) and a #12 green scoop (1/3 cup) for the cooked rice and macaroni and cheese. There was a two (2) ounce spoodle in the corn, peas and carrots, carrots, and green beans that was used to serve the patient. The Dietetic Staff (DS) 2 scooped the mentioned food items on to the trays to be served to the patients during the lunch meal service.

Review of the lunch menu showed that the serving size of the foods depended on the age of the patients. Review of each of the patient meal tickets showed the portion sizes of each food item each patient was to receive. Twenty-two (22) patients received amounts less than what was posted on their tray tickets.

On 8/14/18 at 12:21 p.m., during an interview with DS 2 in the presence of the DFS regarding lunch meal service, DS 2 confirmed she used the #12 scoop for macaroni and cheese and the rice, a 3 ounce spoodle for the broccoli and the 2 ounce spoodle for the corn and other vegetables on the lunch tray line. DS 2 stated she would only use one level scoop of each scooper and put on each plate for the patients. The DFS confirmed DS 2 should give the amount listed on each tray ticket so if stated 1/2 cup then they should have gotten two scoops of the 2-ounce spoodle or used a different scoop size depending on the food item served. She confirmed there were some incorrect scoop sizes in the food items.

Review of the in-services from 2016-2018, did not indicate any were conducted relating to following the menu or using the correct portion sizes.

On 8/15/18 at 10:01 a.m., an interview was conducted with the DFS regarding training and competencies for Dietetic Staff. The DFS stated she provides individual on the job training when staff get hired; however no competencies for the staff on their job position or duties.

Review of the hospital policy and procedure titled "Food Services, Competency", dated 3/18, showed that each position has a competency checklist of the skills needed to perform their positions and that competency checklists are completed during orientation, during probationary period and annually effective June, 2015. It also showed that individuals receive in-service education programs but not limited to the following topics: proper serving of food, sanitation procedures, and portion control.

Based on observation, interview, and record review, the hospital failed to monitor the internal temperature of the medication refrigerator in the Pediatric Intensive Care Unit (PICU) when the medication refrigerator located on the East side of the unit was not within the desired temperature of 2 to 8 degrees Celsius (C), per the hospital's policy and procedure.

This failure had the potential to affect the integrity and/or potency of medications stored in the refrigerator.

Findings:

On 8/13/18 at 9:37 a.m., during a concurrent observation and interview on the second floor East side, Registered Nurse (RN) 2 stated the internal temperature of the medication refrigerator was 10.5 degrees C. RN 1 stated the refrigerator was supposed to be between 2-8 degrees C.

On 8/13/18 at 10:00 a.m., during an interview, the lead PICU Pharmacist (Pharm) 1 stated the internal temperature of the medication refrigerator was 10.4 degrees C. Pharm 1 stated, "It's [the refrigerator temperature] not within range." Pharm 1 stated the acceptable temperature range is 2-8 degrees C. Pharm 1 stated this range needed to be maintained for stability and sterility of medications inside the refrigerator.

On 8/16/18 at 2:45 p.m., during an interview, the Director of Pharmacy (DP) stated the internal medication refrigerator is supposed to be at 2-8 degrees C.

The hospital record titled, "Temperature History" dated 8/14/18 indicated, "....PICU East Med [Medication] Refrigerator...Range: 2.0 C to 8.0 C... 8/13/18 2:53 PM Temperature 9.09... 8/13/18 1:52 PM Temperature 9.34... 8/13/18 12:52 PM Temperature 9.78... 8/13/18 11:51 AM 10.09..."

The hospital policy and procedure titled, "Refrigerator Policy" dated 9/15, indicated "Purpose Statement: To ensure that medications...are stored at the appropriate temperatures to ensure medication integrity and patient safety...Policy: All refrigerators used for the purpose of storing...medications shall be maintained within a specified temperature range by the United States Pharmacopoeia... Refrigerated medication range 2 degrees C to 8 degrees C (36 degrees F [Fahrenheit] to 46 degrees F)...1. Medication Refrigerators/Freezers...A. All refrigerators used to store medications shall be maintained at a temperature range between 2 degrees and 8 degrees C (36 F to 46 F)..."

39156

Based on observation, interview, and record review, the facility failed to ensure staff implemented measures to prevent the spread of infection or the growth of microorganisms when:

1. Registered Nurse (RN) 3 did not use gloves on both hands when he started an intravenous (IV) catheter (small, flexible tube placed into a vein in order to administer medication or fluids) on Patient (Pt) 2 in Operating Room (OR) 2;

2. RN 3 did not perform hand hygiene prior to donning (putting on) gloves and after the removal of gloves in Operating Room (OR) 2;

3. RN 3 did not use gloves when handling a syringe filled with blood in Operating Room (OR) 2;

4. RN 4 did not perform hand hygiene after removal of gloves in Operating Room (OR) 3.

5. An expired bottle of (brand name) (nutritious supplement for children falling behind on growth) was in the nourishment refrigerator located in the Discovery unit.

6. The kitchen flooring was not smooth and easily cleanable in multiple areas including the dish machine area, pot washing area, around one of the deep fryers, and aisles.

7. The ice machine located in the (company name) within the hospital, contained a white substance on the ice machine chute.

8. Scoop handles stored in flour in the kitchen.

These failures had the potential for patients, staff and visitors to be placed at risk of being exposed to infectious diseases and the growth of microorganisms which could lead to food borne illnesses.

Findings:

1. On 8/14/18 at 10:13 a.m., during an observation, RN 3 placed a glove on his left hand. RN 3 did not place a glove on the right hand. RN 3 inserted an IV into Patient (Pt) 2's left arm.

On 8/14/18 at 2:51 p.m., during an interview, RN 3 stated when he inserted the IV into Pt 2's arm, he only had a glove on his left hand. RN 3 stated he does not use a glove on his right hand. RN 3 stated the facility policy indicates to use gloves on both hands when starting an IV. RN 3 stated the importance of donning gloves on both hands is, "...some IV sticks can lead to copious (large quantity) amounts of blood."

On 8/14/18 at 3:05 p.m., during an interview, the Manager of the Surgery Department (MSD) stated her expectation is for the staff to follow the infection control policy and have gloves on both hands when starting an IV. The MSD stated, when starting the IV, there is a potential for exposure of bloodborne pathogens (diseases that can be spread through contamination by blood and other body fluids) on both ends to patient and/or staff.

On 8/14/18 at 3:19 p.m., during an interview, the Director of the Surgery Department (DSD) stated her expectation for staff to use gloves on both hands when starting IVs. The DSD stated it is, "...Good aseptic [free from contamination caused by harmful bacteria, viruses, or other microorganisms] technique." The DSD stated the use of gloves will protect the staff and patients from bloodborne pathogen exposure.

The hospital policy and procedure titled, "Intravenous Catheters" dated 6/16, indicated "Purpose Statement: This procedure outlines the nursing responsibilities related to management of the patient with a peripheral intravenous (IV) catheter...Procedure...C. Hand Hygiene/Gloves...3...Note: Gloves must be work during all infusion procedures that will potentially expose the care provider to blood and body fluids (e.g., inserting or removing IV cannula, obtaining blood specimen)..."

2. During observations in OR 2 on 8/14/18, four occurrences were observed when staff did not perform hand hygiene, as follows:

A. At 11:29 a.m., RN 3 donned gloves without performing hand hygiene prior.

B. At 11:31 a.m., RN 3 removed gloves and did not perform hand hygiene.

C. At 11:33 a.m., RN 3 did not perform hand hygiene prior to putting a glove on his right hand; then, he did not perform hand hygiene after removing the glove from his right hand.

On 8/14/18 a.m. at 2:51 p.m., during an interview, RN 3 stated throughout Pt 2's surgery in OR 2, he did not perform hand hygiene prior to donning gloves and after the removal of gloves. RN 3 stated, "...I got a little busy, careless..." RN 3 stated the importance of performing hand hygiene prior to donning gloves and after the removal of gloves is there can be a tear in the glove and without performing hand hygiene in between glove use, there can be a potential for transmission of viruses and/or bacterial to someone else.

On 8/14/18 at 3:05 p.m., during an interview, the Manager of the Surgery Department (MSD) stated her expectation is for the staff to follow the infection control policy and perform hand hygiene prior to donning gloves and after the removal of gloves. The MSD stated the importance of performing hand hygiene is to prevent passing bacteria from the staff's skin to the patient's skin.

On 8/14/18 at 3:19 p.m., during an interview, the Director of the Surgery Department (DSD) stated her expectation is for the staff to perform hand hygiene before donning gloves and after glove removal.

The hospital policy and procedure titled, "Periop-Surgery, Infection Control" dated 8/18, indicated "Purpose Statement: The intent of this policy is to provide staff with the tools necessary to prevent health care-associated infections...B. Hand Hygiene...Staff gel/wash their hands: Before donning gloves and after removing gloves..."

The hospital policy and procedure titled, "Hand Hygiene" dated 5/18, indicated "Purpose Statement: The hand hygiene policy outlines the specific hand hygiene practices required to minimize the risk of patients, visitors and staff acquiring healthcare-associated infections (HAIs)...Policy...1. Hand hygiene (hand washing or alcohol-based hand run) is the single most important procedure for preventing hospital acquired infections...Procedure...1. Hand Hygiene Indications...3)...Key Point-Hand hygiene should always occur before putting on gloves and immediately after them..."

3. On 8/14/18 at 10:20 a.m., during an observation in OR 2, RN 3 carried a 10 ml (milliliter - form of measurement) syringe filled with Pt 2's blood and walked from Pt 2's gurney to a desk located on the corner of the room without gloves on.

On 8/14/18 at 2:51 p.m., during an interview, RN 3 stated he was supposed to wear gloves when handling the syringe that was filled with Pt 2's blood. RN 3 stated the importance of glove use is to ensure staff does not get blood on themselves.

On 8/14/18 at 3:05 p.m., during an interview, the Manager of the Surgery Department (MSD) stated her expectation is for staff to use gloves when handling syringes filled with blood. The MSD stated the importance of wearing gloves is to protect the staff from potential blood exposure from splashes or spills.

On 8/14/18 at 3:19 p.m., during an interview, the Director of the Surgery Department (DSD) stated her expectation was for the staff to have gloves on when handling biohazards (blood or other bodily fluids that have the potential to carry diseases) to protect themselves from bloodborne pathogens (germs that are spread through contamination by blood).

The hospital policy and procedure titled, "Periop-Surgery, Infection Control" dated 8/18, indicated "Purpose Statement: The intent of this policy is to provide staff with the tools necessary to prevent health care-associated infections...Procedure...7. Blood-contaminated items...A. All blood shall be handled as infectious. B. At no time shall blood contaminated items be handled without gloves..."

The hospital policy and procedure titled, "Hand Hygiene" dated 5/18, indicated "Purpose Statement: The hand hygiene policy outlines the specific hand hygiene practices required to minimize the risk of patients, visitors and staff acquiring healthcare-associated infections (HAIs)...Procedure...3. Use of Gloves...B. Wear gloves when it can be reasonably anticipated that contact with blood..."

4. On 8/14/18 at 2:11 p.m., during an observation in OR 3, RN 4 removed her gloves, did not perform hand hygiene, and donned new gloves.

On 8/14/18 at 3:05 p.m., during an interview, the Manager of the Surgery Department (MSD) stated her expectation is for the staff to follow the infection control policy and perform hand hygiene prior to donning gloves and after the removal of gloves. The MSD stated the importance of performing hand hygiene is to prevent passing bacteria from the staff's skin to the patient's skin.

On 8/14/18 at 3:19 p.m., during an interview, the Director of the Surgery Department (DSD) stated her expectation is for the staff to perform hand hygiene before donning gloves and after glove removal.

On 8/14/18 at 3:23 p.m., during an interview, RN 4 stated hand hygiene is to one of the most important tasks to do to prevent infection. RN 4 stated she did not perform hand hygiene after she removed her gloves in OR 3 because she felt "rushed".

The hospital policy and procedure titled, "Periop-Surgery, Infection Control" dated 8/18, indicated "Purpose Statement: The intent of this policy is to provide staff with the tools necessary to prevent health care-associated infections...B. Hand Hygiene...Staff gel/wash their hands: Before donning gloves and after removing gloves..."

The hospital policy and procedure titled, "Hand Hygiene" dated 5/18, indicated "Purpose Statement: The hand hygiene policy outlines the specific hand hygiene practices required to minimize the risk of patients, visitors and staff acquiring healthcare-associated infections (HAIs)...Policy...1. Hand hygiene (hand washing or alcohol-based hand run) is the single most important procedure for preventing hospital acquired infections...Procedure...1. Hand Hygiene Indications...3)...Key Point-Hand hygiene should always occur before putting on gloves and immediately after them..."


5. On 8/13/18 at 10:00 a.m., during a concurrent observation and interview of a nourishment room, RN 1 confirmed a bottle of (brand name) (nutritious supplement for children falling behind on growth) was in the nourishment refrigerator dated 8/8/18. RN 1 stated, "The expiration date is 8/8/18 and the bottle should not be in the refrigerator, it should have been discarded."

On 8/16/18 at 9:05 a.m., during an interview, the Manager of Clinical Nutrition (MCN) stated, once (brand name) is opened, it is to be used or discarded within 24 hours. MCN stated it is her expectation staff discards expired formula.

On 8/16/18 at 10:10 a.m., during an interview, Director of Inpatient Services (DIS) 2 stated, it is her expectation staff will check the refrigerator daily and throw out any expired formula. DIS 2 stated, a possible outcome of serving an expired formula is gastric intestinal irritation (symptoms of a stomach or intestines include gas, pain, nausea, and vomiting) and diarrhea.

The hospital policy and procedure titled, "Food Service, Food Preparation and Storage, Food and Formulas" dated 7/18, indicated "...L. All food ...must be labeled and dated and indicate a Use by Date ...C. Formulating Preparing and Handling-...Each label...shall have ...expiration date and time...packaged in a high grade container for a 24 hour period...discard after 24 hrs. Expired prepared formulas on the unit will be checked daily..."

The hospital policy and procedure titled, "Nutrition NNN, Formula Procedure" dated, 12/17, indicated "...e. Formula will be refrigerated for up to 24 hours...F. Discard formula at the expiration time date ..."

6. Throughout the survey from 8/13/18-8/15/18, it was noted by observation that the kitchen flooring had many large holes, large grooves, cracks in multiple areas including, but not limited to: the dish machine area, pot washing area, back fryer, and aisle way the prominent path of travel from kitchen to the cafe. There was large amounts dirt and debris surrounding the fryer inside the grooves and holes.

On 8/14/18 at 8:40 a.m., during an interview an interview, the Director of Food Services (DFS) stated she was aware of the problems with the kitchen floors. The DFS stated on 9/1/18 they would be fixing the dish room flooring and the flooring in the fryer area. She stated for fiscal year 19 they would be discussing or planning on replacing the flooring but she has not picked anything out yet.

According to the Food and Drug Administration (FDA) 2017 Food Code, Section 6-201.11 Floors, Walls and Ceilings: "floors, floor coverings, walls, wall coverings, and ceilings shall be designed, constructed, and installed so they are smooth and easily cleanable."

7. On 8/14/18 at 9:32 a.m., during a concurrent observation of the ice machine located in (company name), and interview with the Plant Engineer (PE) and Director of Food Services (DFS), there was a white substance located on the chute inside the ice machine that was able to be wiped clean with a paper towel. There was a thick hard white substance located on the sides of the chute that were unable to be wiped off with a paper towel. The PE stated when he cleans the ice machine this substance is able to be removed. He confirmed he cleans and sanitizes all the ice machines on a quarterly basis using nickel safe cleaner and sanitizing concentrate.

8. On 8/13/18 at 12:24 p.m., during an observation of a bin of flour, the scoop was located inside the flour and the handle was immersed in the product. A concurrent interview was conducted with the Director of Food Services (DFS), she stated the scoop should not be in the product.

According to the Food and Drug Administration (FDA) Food Code 2017, Section 3-304.12 In-Use Utensils, Between-Use Storage, "In Food, that is not time/temperature control for safety food with their handles above the top of the food within containers or equipment that can be close, such as bins of sugar, flour or cinnamon."