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Based on observation, interview and record review, the hospital's Governing Body failed to oversee the following:

These deficient practices resulted in the possibility of harm to patients and staff.

Findings:

1. The hospital's governing body failed to ensure that the QAPI program reflected the complexity of the hospital's organization and services and involved all hospital departments and services. (see Tag A-263, A-273, and A-283)

2. The Governing Body failed to ensure that nursing services were well organized and properly supervised. (see Tag A-385)

3. The Governing Body failed to ensure that the Pharmaceutical service was fully responsible for developing policies and procedures that minimize drug errors. (see Tag A-489)

4. The Governing Body failed to ensure that Food Services were properly supervised and staffed by adequate qualified personnel. (see Tag A-615)

5. The hospital failed to provide a sanitary environment to avoid sources and transmission of infections and communicable diseases. (see Tag A-747)

6. The Governing Body failed to ensure that the hospital had in effect a discharge planning process that applies to all patients. (see Tag A-799)

These deficient practices resulted in the Condition of Participation for Governing Body being NOT MET.

Based on interview and record review, the hospital failed to ensure the Quality Assurance Performance Improvement Plan (QAPI) program maintained consistent oversight of discharge planning, sanitary environment and tracking of overdue medication.

This resulted in the possibility of harm to patients and staff.

Findings:

1. The Quality/Patient Safety Committee failed ensure oversight of the processes for Emergency Department patient census and the inpatient discharge census. (See A-283, A-810 and A-820)

2. The hospital failed to take actions timely to improve performance related to the accountability of controlled substances (medications subject to potentials of abuse). In addition, the hospital did not ensure the implemented actions to correct the identified issues related to heparin (high-risk medication, which can cause death if not used correctly) administration were monitored hospital-wide to prevent reoccurrences of medication errors. (See A-283)

3. The hospital failed to ensure data related to overdue medications was collected in an effort to measure, analyze, and track quality indicators in accordance with their own QAPI. As a results, the lack of data collection for overdue medications failed to monitored and sustain medication error reduction rates and improve patient health outcomes. (See A-263).

4. The Food and Nutrition Services department interview and departmental document review the hospital failed to ensure an effective performance improvement program when there was no analysis of collected data that demonstrated opportunities for improvement. Additionally, there were no action plans developed for the identified issues. Failure to analyze data and develop performance improvement action plans may result in provision of inadequate dietetic service which had the potential to compromise the nutritional status of patients. (See A-620, A-629, A-701 and A-749)

These failures, together, resulted in the condition of QAPI being NOT MET.

Based on Food and Nutrition Services and Nursing and Pharmacy departmental interview and departmental document review the hospital failed to:

1. Ensure an effective performance improvement program when there was no analysis of collected data that demonstrated opportunities for improvement. Additionally, there were no action plans developed for the identified issues. Failure to analyze data and develop performance improvement action plans may result in provision of inadequate dietetic service which had the potential to compromise the nutritional status of patients; and

2. Ensure data related to overdue medications was collected in an effort to measure, analyze, and track quality indicators in accordance with their own QAPI. As a result, the lack of data collection for overdue medications failed to monitored and sustain medication error reduction rates and improve patient health outcomes.

Findings:

1. On August 18, 2017 beginning at 9:50 a.m., Food and Nutrition Services (FANS) performance improvement program was reviewed with the Clinical Nutrition Manager (CNM). Review of the audit tools for food services beginning 5/2017 revealed that while the department was completing audits, there was no data analysis that could have identified potential opportunities for improvement. As an example a Kitchen Sanitation Audit of the West campus was conducted the week of 5/29/17 which reviewed the cleanliness of the catering storage area. Two of the five areas were reviewed as non-compliant; however the resolution of the issue was to clean areas, rather than determining whether the lack of cleanliness could rise to the level of a performance improvement program.

Similarly the hospital presented another audit titled "Nourishment Room Audit" dated 8/12/17. Rather than an audit of the status of the nourishment room it resembled a task list for staff to follow. As an example the tasks listed included "clean shelves and door interior ...instruct floor stocker to utilize FIFO [first in first out] and place soon to expire milk in front ..." The audit did not delineate whether the task were completed as outlined.

The FANS department also presented an undated audit titled "Test Tray Audit/Taste Test Summary." The audit listed food items and whether temperatures were met or not met as well as potential actions to mitigate identified issues. There was no pre-determined level of acceptable parameters. Review of the data revealed the percentage of time food temperatures were met ranged from 0-85%. The majority of the indicators were below 50%. It was also noted that the tray accuracy assessment included only temperatures. It did not incorporate the accuracy in relationship to the physician ordered diet. The department did not develop a performance improvement project, despite identified issues on the test tray summary.

The hospital did not have any performance improvement programs specific to overall kitchen cleanliness, food safety, tray accuracy, staff competence, equipment maintenance or departmental infection control (Cross Reference A 620, A-629, A-701 and A-749).



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2. Patient 2 was admitted to the hospital on 7/30/17 per the Face Sheet.

On 8/14/17 at 11:30 A.M., a review of Patient 2's medical record was conducted with a Registered Nurse (RN)1 and the Surgical Acute Care unit, Nurse Manager (NM)1.

The physician order, dated 8/1/17 through 8/31/17, indicated, Patient 2 was to receive potassium phosphate -sodium phosphate (KPhos-acidifying supplement), 1 packet by mouth four times a day.

The Medication Administration Record (MAR), dated 8/14/17 at 6 A.M., indicated, Patient 2's scheduled KPhos was not given. There was no documented evidence which indicated a reason Patient 2 had not received the KPhos.

During the record review on 8/14/17 at 11:30 A.M., RN 1 stated, the previous shift RN informed her, the KPhos had not been given and endorsed the medication administration for follow up, however, RN 1 acknowledged she had not administered the KPhos.

3. Patient 3 was admitted to the hospital on 8/10/17 per the Face Sheet.

On 8/17/17 at 8:30 A.M., Patient 3's medical record was reviewed with the Orthopedic/Neurological unit, Nurse Manager (NM) 2.

The physician order, dated 8/13/17 through 9/11/17, indicated, Patient 3 was to receive insulin lispro (combination of fast and intermediate acting administered at mealtime to prevent high blood sugar levels) 2 units, subcutaneous injection with breakfast, lunch, dinner, and bedtime.

Patient 3's Medication Administration Record (MAR) dated 8/15/17 indicated, insulin lispro 8 A.M. dose was not given related to "Not appropriate at this time."

On 8/17/17 at 8:45 A.M., an interview was conducted with RN 2. RN 2 stated, she held the insulin lispro because the patient was nauseated. In addition she stated she had not informed the Physician the insulin had been held.

On 8/17/17 at 9:30 A.M., an interview was conducted with NM 1 and 2, the Manager of Medication Safety (Pharm) 1, the Director of Clinical Operations Improvement (DCOI), and a Clinical Nurse Specialist (CNS) 1, related to the hospital's process for overdue medications. NM 1 stated there was no process in place to identify overdue medications and it would be good to have a tracking method in place. NM 2 stated there were no processes in place which would identify overdue medications or a real time alert system. NM 2 stated it would be good to have a tracking method in place. NM 2 stated overdue medications were captured by a chart check, once identified a 1:1 supervisory nursing education was provided. Pharm 1 stated she had knowledge overdue medications and 1:1 education had occurred. Pharm 1 was unable to provide documented evidence of any overdue medications that were monitored to sustain medication error reduction rates and improve patient health outcomes.

On 8/17/17 at 10 A.M., an interview with the DCOI was conducted. The DCOI stated he had been informed of the hospital's document titled Medication Overdue Report during the survey. The DCOI stated he had attended Medication Safety Committee meetings and was not aware of this report. In addition he stated he and the hospital staff had not received education related to the implementation for the use of the report.

The hospital's 2017 Quality Assurance Performance Improvement (QAPI) Plan indicated its approach examined how quality standards of patient care were delivered. In addition, its approach decreased the likelihood of problems by identifying underlying causes of systemic problems. The hospital's QAPI plan was not implemented when, there was no hospital wide data collected to ensure overdue medications were monitored in an effort to sustain medication error reduction rates and improve patient health outcomes.

The Quality/Patient Safety Committee failed ensure oversight of the processes for Emergency Department patient census and the inpatient discharge census and the hospital failed to take actions timely to improve performance related to the accountability of controlled substances (medications subject to potentials of abuse). In addition, the hospital did not ensure the implemented actions to correct the identified issues related to heparin (high-risk medication, which can cause death if not used correctly) administration were monitored hospital-wide to prevent reoccurrences of medication errors.

Findings:

1a. Eight Case Management/Discharge Planning Social Workers were interviewed on 8/16/17 at 2:30 PM. Several points were brought up that indicated there were delays in the discharge process. During the interview, a contributing factor was due to lighter staffing on weekends, which resulted in initial patient assessments were completed after the weekend. This contributing factor caused delays for many patient discharges. On weekends, one social worker would cover 3 floors instead of 1. It was stated there were 3 times the number of discharges on weekend days. The social workers also stated that a 7 day hospital should be fully staffed 7 days a week. Another issue delaying discharge was the fact that the outpatient pharmacy, used to fill discharge medications, is closed on weekends. The social workers voiced they were "Backlogged on Mondays" and had to prioritize and act in a "Reactive way instead of a proactive way." Another delay in getting patients to move through their inpatient stay quickly was the frequent long waits for a preoperative MRI (Radiology/imaging study). They were also concerned about the merger of the discharge nurse and social work functions into one nursing role and were under the impression the decision to implement this plan was already made. The Case Manage/Discharge Planning Social Workers were particularly concerned that traveling nurses were going to be put in this role. The social workers felt a traveling nurse would not know the resources in the community which would delay discharge further. In addition, the Director of the department, who had been a strong advocate for the discharge social workers, had left 6 weeks prior to survey and the staff were "Without a voice" to the administration.

1b. CRM 22 was interviewed on 8/16/17 at 3:30 PM, and had the dual role as Case Manger/Discharge Planner on an inpatient nursing unit. She had been in this role for approximately four months. She stated she "Had to do all of it" for 15 patients, including the initial assessment, utilization review and discharge planning. For this reason, some shortcuts were implemented. Instead of trying to find placement for homeless patients, she would give them a list of shelters and food banks. When asked to tell us about an example patient, she stated "I can't remember them all." She cannot request help from a social worker unless there is substance abuse or a mental health issue. She was asked about a specific patient who had been on her unit for about 6 days and stated she "hadn't gotten to her yet." She further stated she received only one day of training in her new role. She felt that the contracted service for developing a new discharge system had expectations that were not "Realistic".

1c. Three members of the governing body were interviewed on 8/17/17 at 9 A.M. The governing body was asked if they were aware of the number of requests made to the State Agency for patient accommodations in the Emergency Department. They mentioned that the rehabilitation unit at the downtown campus of the hospital had a more complete discharge process and they had not considered implementing a similar process at the main hospital.

1d. Ten utilization review/discharge planning nurses were interviewed on 8/17/17 at 1:30 PM. The nurses felt traveler nurses were not trained enough about patient placement resources in the community. They felt staff had been leaving since the contracted services began. They said that no one had been communicating with them about the new discharge system. Some of the utilization review/discharge planning nurses believed they were doing well with discharges before the contracted service was brought in. They also stated "We should have been involved in the process."

A Quality/Patient Safety meeting was held 8/18/17 at 10:10 AM. The committee confirmed they were unaware whether leadership had spoken to the Case worker/Social Worker or the Discharge Planning/Utilization Review Nurses regarding the ongoing evaluation of the discharge planning process.


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2. An interview was conducted with the hospital Quality Assessment and Performance Improvement (QAPI) committee members on 8/18/17 at 10:10 A.M. The committee members indicated heparin infusion would require two licensed nurses to double check hospital-wide prior to administration, as a corrective action, following a severe adverse medication event. Audit was started in January 2017, in the Interventional Radiology area only. The members acknowledged the audit was not performed hospital-wide to ensure the corrective action was effectively implemented hospital-wide to prevent reoccurrences.

3. An interview was conducted with the hospital Quality Assessment and Performance Improvement (QAPI) committee members on 8/18/17 at 10:10 A.M. The process to ensure all controlled substances were accounted for included the physical count weekly for each Automated Dispensing Cabinet (ADC, an automated system used in medication distribution) station by two nurses, as required by the hospital's policy. Pharmacy staff would check to ensure the weekly count was performed.

According to the hospital's policy, [ADC] MedStations, effective date 2/22/17, "Weekly, two licensed nurses will sign on any open unit and initiate a narcotic [controlled substance] inventory of all scheduled drugs [controlled substances]. This weekly count will be done regardless if the unit is open or closed."

The weekly inventory count for 2017, from January to August, was reviewed. The hospital had 68 ADC stations. During this time period, the weekly inventory was performed for every ADC station in the hospital twice, the weeks of 7/19/17 and 8/8/17. The inventory was not performed for every ADC station during other weeks, for example, 28 out of 68 stations were not inventoried for the week of 2/8/17.

Pharm 3 stated they "need[ed] to do something tougher" to improve compliance. Pharm 2 acknowledged, in 2016, the compliance rate was between 80 to 90 % (meaning 80 to 90% of 68 stations were inventoried weekly, and 10 to 20% were not). Pharm 3 stated they have sent emails to nursing managers to improve compliance, but there was no improvement.

Pharm 1 and Pharm 3 stated they have started to talk to Nursing Leadership "three months ago."

The hospital did not take any progressive corrective action to improve the compliance with the weekly physical count for controlled substances in the medication storage areas outside of the pharmacy for approximately 18 months, until three months ago.

The committee members acknowledged progressive corrective action should have been taken earlier.

According to the hospital's policy, Quality Assurance Performance Improvement (QAPI) Plan, effective date 8/5/17, Purpose section, "To outline the framework for a leadership driven, systemic, interdisciplinary approach to continuous improvement using our performance improvement model known as Plan, Do, Check, Act (PDCA)... That an ongoing program for patient safety, including the reduction of medical errors, is defined, implemented, and maintained. That the organization-wide quality assessment and performance improvement efforts address priorities for improved quality of care, and patient safety and that all improvement actions are evaluated." The PDCA, a continuous process, and included the following definitions: "Check" element included Action Results: Performance results of trial; Conclusions: Evaluate results of action.

Based on observation, interview and record review the hospital's Nursing Services failed to:

1. Maintain "Line of sight" (continuous surveillance of a patient) for critically ill patients in the Intensive Care Unit. (See A-392);

2. Perform re-assessment for patients after the administration of a pain medication and perform accurate assessment of pressure ulcer staging (See A-396 and A-397); and

3. Ensure Charge Nurses maintained oversight of CNAs (See A-397); and

4. Ensure LNs conducted patient handoff at time of transfer and/or discharge (A-397)

These failures, together, resulted in the condition of Nursing Services being NOT MET.

Based on interview and record review, the Licensed Nurse failed to maintain "line of sight" (continuous monitoring of a patient) for 1 of 40 sampled patients (11) in the Intensive Care Unit (ICU).

As a result, Patient 11 was left unattended for 30 minutes.

Findings:

Patient 11 was admitted to the Hospital on 5/11/17 with diagnoses which included congestive heart failure (inability of the heart to adequately pump blood to the body), acute respiratory failure on bipap (inability to breathe without mechanical assistance), and NSTEMI (a type of heart attack), per the History and Physical.

Patient 11's clinical record was reviewed.

In a Physician Progress Note dated 5/14/17 at 12:53 P.M., the physician documented, "Decision to move to ICU: 3 rapid responses (a team of health care providers that responds to hospitalized patients with early signs of deterioration on non-intensive care units to prevent respiratory or cardiac arrest) called on this patient in 2 days...often DESATS (has low blood oxygen concentrations), high risk ...needs to be monitored for the next 24 hours."

Per the Critical Care Consultation Note dated 5/14/17 at 5:52 P.M., Patient 11 was transferred to the ICU, for closer monitoring, after a rapid response was called for hypotension (very low blood pressure) and hemoptysis (coughing up blood).

While in the ICU, Patient 11's vital signs (blood pressure, heart rate, and oxygen saturations) were measured and documented at 15 minute increments in the electronic medical record (EMR) by LN 15. Administration of oxygen at 6 liters per minute via nasal cannula (oxygen provided through tubing with prongs positioned in the nose, to treat the patient's low blood oxygen concentrations), and the patient's respiratory rate were documented every hour, per the EMR.

The last set of vital signs for Patient 11 was documented in the EMR at 1:30 A.M.

Per the Physician Progress Note dated 5/15/17, "Code Blue (a medical emergency in which a team of medical personnel work to revive an individual in cardiac arrest) called over head at 2:05 A.M. because patient was found on the floor next to his bed. Staff had already initiated CPR ...I asked them to stop as he was a no chest compression status. When I checked, he was pulseless and looks like he had been without a pulse for some time. I pronounced him (time of death) at 2:10 A.M. ...Based on the tele monitor it looks like he had disconnected himself around 1:35 A.M. and gone to the bathroom. And it seems he may have fallen upon returning back to his bed."

Per the Nursing Narrative dated 5/15/17, LN 15 documented, "Late entry: Shift narrative for 5/14/17 night ...prior to event, last saw patient at 1:15 A.M. Patient was resting quietly ...last blood pressure reading at 1:30 A.M. ...approximately 2:07 A.M. found lying on floor ...unarousable."

In a telephone interview on 7/24/17 at 8 A.M., LN 15 said she returned from her break (did not remember the time) and checked on Patient 11, who was fast asleep. LN 15 then provided care to her other patient in the room next door. After LN 15 finished, she returned to her computer desk, situated between the two patient rooms, to enter vital signs. LN 15 said the last set of vitals did not register on the monitor so she went into Patient 11's room and found him on the floor. Patient 11's monitor leads had been removed from his chest and arms. LN 15 said she did not hear the alarm which indicated the leads were removed.

LN 16, the Director of Nursing for Critical Care, who was also present during the interview, said the leads off alarm is audible, but could not be heard while in another patient room.

In a group interview on 8/16/17 at 1:50 P.M., the Director of Clinical Operations (DCO) said the ICU LN's were notified of an alarm on their patient's monitor via an alert sent to a wireless phone, carried by each LN. DCO added, a committee formed in 2012 to analyze the quality and quantity of alarm alerts determined the "Leads off" alarm was over-alerting and disabled that alert to the LN phones.

The Director of Nursing for Critical Care (DNCC) said the monitors had an overview function, a "Safety net," which allowed the LN's to view their patient's vital signs in a "Picture-in-picture" format, while in another patient room, to maintain line of sight. DNCC said LN 15 did not use the monitor overview function for Patient 11 when she provided care in another patient room. DNCC added, during new hire orientation, the LN's are instructed in monitor set up and the required use of the monitor overview function.

In a second telephone interview on 8/17/17 at 10:12 A.M., LN 15 said she didn't remember being trained specifically in the use of the monitor overview function during new hire orientation. LN 15 said she was familiar with the monitor overview function, but did not use it for Patient 11 when she cared for a patient in another room.

Per the hospital policy titled Intensive and Coronary Care Units Scope of Service dated 1/30/17, "2. Maintenance of "line of sight" ...b. All members of the interdisciplinary team are expected to maintain continuous surveillance of critically ill patients. c. Staff are required to utilize the monitoring Overview function."

LN 15 failed to follow the hospital's policy and procedure related to "Line of sight", for critically ill patients.

Based on interview and record review, the LNs failed to ensure pain re-assessments were conducted and documented after the administration of pain medication for 1 of 56 sampled patients. In addition, the LNs failed to assess and stage a pressure ulcer

As a result, there was potential of inadequate pain control for the patient and the potential for a pressure ulcer to worsen.

Findings:

Patient 31 was admitted to the hospital on 6/24/17 according to the hospital's Face Sheet.

Patient 31's physician ordered on 7/15/17, Dilaudid (pain medication) intravenously pushed (IVP), every 3 hours as needed for pain.

According to the hospital's policy and procedure revised 8/10/17, entitled Pain Assessment and Management, IV. Steps of Procedure: "E.1. Reassessment of pain intensity level and sedation level will be within 30 minutes after IV opiod medication."

On 7/15/17 a concurrent interview and record review was conducted with LN 31. Patient 31 received the following:
7/2/17 at 6:24 P.M. - Dilaudid 0.8 mg IVP, Patient's 31 pain score at the time of the administration of Dilaudid was 7 out of 10 (severe). There was no reassessment by the LN;

7/3/17 at 6:24 P.M. - Dilaudid 0.8 mg IVP, Patient's 31 pain score at the time of the administration of Dilaudid was 8 out of 10 (severe). There was no reassessment by the LN;

8/2/17 at 4:22 P.M. - Dilaudid 0.8 mg IVP - Patient's 31 pain score at the time of the administration of Dilaudid was 8 out of 10 (severe). the reassessment was 50 minutes later;

8/3/17 at 5:25 P.M. - Dilaudid 0.8 mg IVP, Patient's 31 pain score at the time of the administration of Dilaudid was 10 out of 10 (severe). There was no reassessment by the LN.

In addition, there was no further documentation located throughout Patient 31's clinical record to indicate his reassessment of pain after the administration of the pain medications.

LN 31 stated the LNs were not following the hospital's policy and procedure.



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Findings:

Patient 12 was admitted to the hospital on 8/1/17 with diagnoses which included sepsis (wide spread infection in the body), osteomyelitis (infection in a bone), and quadriplegic (inability to move the body from the neck down), per admission orders.

On 8/1/17, Patient 12 was assessed with multiple pressure ulcers (localized damage to the skin and/or underlying tissue that usually occur over a bony prominence as a result of pressure). The pressure ulcers were staged (progress of ulcers are described in 4 stages, 1-4), measured, photographed, and documented in the clinical record by the LN.

A stage 3 pressure ulcer (a sore that extends into the tissue beneath the skin, forming a small crater, fat may show in the sore, but not muscle, tendon, or bone) was documented on the left heel 8/1/17 to 8/5/17. On 8/6/17, the ulcer was not assessed due to the dressing covering the wound. On 8/7/17, the heel ulcer was documented as unstageable (meaning the stage is not clear, the base of the sore is covered by a thick layer of other tissue and pus that may be yellow, gray, green, brown, or black). On 8/8/17, the ulcer was not assessed due to the dressing covering the wound. On 8/9/17, the ulcer was documented as a stage 1 (Stage 1 sores are not open wounds, the skin appears reddened and does not lose color briefly when you press your finger on it and then remove your finger).

A stage 2 pressure ulcer (the skin breaks open, or forms an ulcer, and the sore expands into deeper layers of the skin) was documented on the right and left big toes on 8/3/17. On 8/4/17, the wounds were not assessed due to the dressing covering the wounds. On 8/5/17, the right and left big toes wounds were documented as, "suspected deep tissue injury," (SDTI-when there isn't an open wound but the tissues beneath the surface have been damaged, the sore is called a deep tissue injury, may appear as a blood filled blister).

In an interview on 8/14/17 at 11:01 A.M., LN 16 said the LN's incorrectly staged the pressure ulcers when the left heel was first documented as stage 3, then later as stage 1, and when the toes were first documented as stage 2, then later as an SDTI. LN 16 acknowledged when ulcers improved, they were documented as an improved stage 3 or an improved stage 2, and said the LN's were trained to document this way.

Based on observation, interview, record and document review, the hospital failed to ensure:

1. A Charge Nurse maintained oversight related to the exchange of work telephones between CNAs at shift change. CNA 1 assigned to 1 of 56 sampled Patient's (1) with an order for constant observation (maintain constant sight of the patient until relieved by another staff) for a 5150/5250 status (involuntary hospital stay for 3 and 14 days due to danger to self or others), was without a work telephone.
As a result, the lack of oversight and possession of the work telephone, posed a risk for ineffective staff communication in the event of any potential emergent care needs which pertained to Patient 1.

2. The LN assessed and documented an initial pain assessment for 1 of 56 sampled patients.

3. The LNs documented handoff for 2 of 56 sampled patients (21, 34) during a transfer in level of care.
As a result, Patient 24 was at risk for unrelieved pain and there was potential for the miscommunication of Patient 21's and 34's plan of care.

Findings:

1. Patient 1 was admitted to the hospital on 8/11/17 per the Face Sheet. Patient 1's History and Physical dated 8/11/17, indicated, Patient 1 was placed on a 5150 for danger to self. In addition, a physician's order dated 8/13/17, indicated, Patient 1 was placed on a 5250 for danger to self.

On 8/14/17 at 9:45 A.M., during a tour of the Surgical Acute Care Unit with the Director of Home Health (DHH), two Clinical Nurse Specialist (CNS 1 and CNS 2), the Nurse Manager (NM), and the Nurse Supervisor (NS), CNA 1 was observed in Patient 1's room.

On 8/14/17 at 10:15 A.M., an interview was conducted with CNA 1. CNA 1 stated she received a handoff report from the previous night shift CNA. CNA 1 stated Patient 1 had an order for constant observation due to a 5150 status. CNA 1 accepted and provided constant observation for Patient 1. CNA 1 further stated CNA handoff included the following:
During the handoff report between the night shift and day shift, the night shift CNA's logged out of the work telephone and gave the telephone to the assigned day shift CNA; and
The day shift CNA then logged in as the assigned CNA.

CNA 1 stated work telephones were used by CNAs and RNs who provided care to patients, for the purpose of communication of care needs and emergencies. CNA 1 stated the night shift CNA did not have a work phone to exchange and therefore, she did not have a work phone for her shift.

CNA 1 acknowledged she did not utilize the work telephone and it posed a risk for ineffective staff communication in the event of any potential emergent care needs which pertained to Patient 1.

On 8/14/17 at 11:15 A.M., an interview was conducted with CNS 2 and the NM because the Charge Nurse was not available. CNS 2 stated the hospital provided work telephones to the unit CNAs and RNs at the beginning of each shift. The NM acknowledged the work telephone exchange between CNA 1 and the previous CNA had not occurred and the Hospital's expectation was staff were to inform the Charge Nurse in the event a work phone was not available. The NM stated it was the Charge Nurses responsibility to conduct unit rounds in order to verify direct care staff had their work telephones. In addition, the NM acknowledged the lack of oversight related to CNA 1 without the possession of the work telephone, posed a risk for ineffective staff communication, in the event of any potential emergent care needs which pertained to Patient 1.

On 8/15/17 at 8:30 A.M., an interview and review of the staff work telephone process titled "Logging Onto the (Name of Vendor) Wireless Device", undated, was conducted with CNS 1, the Director of Clinical Operations Improvement (DCOI) , and a Clinical Informatisist (CI) 1. During the interview, CN 1 stated all staff who provided direct patient care, received work telephone training in August 2012. A review of the training indicated how staff logged onto the wireless device and located healthcare personnel via an employee identification Directory. CI 1 stated staff who provided direct patient care obtained a work telephone at the beginning of each shift and were required to enter their employee identification number to activate the work phone.


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2. Patient 24 was admitted to the hospital on 6/4/17 with diagnoses which included meningitis, according to the admission H&P.

On 8/15/17 at 3:30 PM, Patient 24's record was reviewed with CNS 21.

According to the Emergency Physician's documentation dated 6/4/17 at 3:02 AM, Patient 24 was seen in the ED with signs and symptoms of meningitis on 6/3/17 at 3:53 PM and was admitted to the Medical/Surgical Unit on 6/4/17 at 3:54 AM.

According to the Initial Nursing Assessment dated 6/4/17 at 5 AM, the LN documented an assessment of Patient 24 when she arrived to the unit. There was no documentation in Patient 24's which indicated the LN assessed the patient for pain.

According to the Nursing Assessment dated 6/4/17 at 8 AM, the LN documented an assessment of Patient 24 at the beginning of the shift. There was no documentation in Patient 24's record which indicated the LN assessed the patient for pain.

CNS 21 confirmed, there was no documentation Patient 24 was assessed for pain unit 9:49 AM on 6/4/17 (approximately 5 hours after her arrival to the unit), at that time Patient 24 complained of a pain level of 7/10 (severe pain). CNS 21 stated, the LNs should have assessed Patient 24's pain with every assessment.

According to the hospital's policy entitled Pain Assessment and Management, effective 8/10/17, "...Perform an initial pain assessment... Pain is the 5th vital sign and will be screened routinely..."


3. Patient 21 was admitted to the hospital on 8/02/17 with diagnoses which included pneumonia and was admitted to the hospital's Medical/Surgical Unit, according to the admission H&P.

On 8/14/17, Patient 21's record was reviewed with CN 22.

According to the Physician's Procedure Notes dated 8/3/17 at 5:10 PM, Patient 21 had a chest tube placed in Interventional Radiology.

According to the transport log dated 8/3/17 at 6:15 PM, Patient 21 was transferred from the PACU after the chest tube procedure back to the Medical/Surgical Unit.

On 8/14/17 at 3:20 PM, CN 22 confirmed there was no documentation in Patient 21's record of handoff between the PACU nurse and the Medical/Surgical Unit nurse. CN 22 stated the nurses should have discussed the plan of care for Patient 21 during handoff and documented the handoff in the patient's record.


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4. Patient 34 was admitted to the hospital on 8/2/17, with diagnoses to include cervical and spine fractures, according to the hospital's Face Sheet.

On 8/16/17 at 8:45 A.M., a concurrent interview and record review was conducted.

Patient 34 underwent cervical and spinal surgery on 8/3/17. Patient 34 stabilized from the surgery and the physician ordered to transfer to the Acute Rehabilitation Unit for the remainder of his hospitalization.

On 8/18/17 at 8:45 A.M., a concurrent interview and record review was conducted with LN 32.
The "Patient Condition and Reason for Transfer" document was incomplete. LN 32 state he did not initiate the document and was unaware of the electronic form.

According to the hospital's revised policy and procedure dated 1/24/14, entitled Transfer of Patient to Other Facilities, 4. Steps of Procedure: "H. Nursing Staff...will...2. Initiate Transfer forms: a. Inter-Facility Transfer form..."

LN 32 stated he did not follow hospital policy and procedure.

Based on interview, record and document review, the hospital failed to:

1. Ensure a Registered Nurse (RN) 1 administered medications in accordance with the Hospital's Medication Policies and Procedures for 1 of 56 sampled Patient's (2) and 1 randomly sampled Patient (3). The lack of policy implementation did not ensure guidelines were followed in an effort to safely administer medications to patients.

2. Implement policies and procedures on labeling one of one IV solution bags with the date and time hung. This occurred when undated and untimed IV solution fluid was observed being administered to Patient 85 in the patient's room. This failure had the potential to increase the patient's risk of infections.

Findings:

1a. Patient 2 was admitted to the hospital on 7/31/17 per the Face Sheet.

On 8/14/17 at 11:30 A.M., a review of Patient 2's Medical Record was reviewed with a Registered Nurse (RN)1.

The physician order, dated 8/1/17 through 8/31/17 indicated, Patient 2 was to receive potassium phosphate -sodium phosphate (KPhos-acidifying supplement), 1 packet by mouth four times a day.

The Medication Administration Record (MAR), dated 8/14/17 at 6 A.M., indicated, Patient 2's scheduled KPhos was not given. There was no documented evidence which indicated a reason Patient 2 had not received the KPhos.

During the record review on 8/14/17 at 11:30 A.M., RN 1 stated the previous shift RN informed her that the KPhos was not given and endorsed the medication administration for follow up. RN 1 stated she had not administered the KPhos. RN 1 stated she had been aware of the hospital's policy and failed to implement it.

The Hospital's Policy titled Administration Times for Medications, dated 3/11/16, indicated, "E. Document the reason if a scheduled medication is administered early, late, or omitted."

1b. Resident 3 was admitted to the hospital....

On 8/17/17 at 8:30 A.M., Patient 3's Medical Record was reviewed with the Orthopedic/Neurological unit, Nurse Manager (NM) 2.

The physician order, dated 8/13/17 through 9/11/17 indicated, Patient 3 was to receive insulin lispro (combination of fast and intermediate acting administered at mealtime to prevent high blood sugar levels) 2 units, subcutaneous injection with breakfast, lunch, dinner, and bedtime.

The Medication Administration Record (MAR), dated 8/15/17 at 8 A.M. indicated, insulin lispro was not given related to "Not appropriate at this time."

On 8/17/17 at 8:45 A.M., an interview was conducted with RN 2. RN 2 stated, she did not inform the Physician of the held insulin dose. In addition, RN 2 stated she had been aware of the hospital's policy and failed to implement it.

The Hospital's Policy titled Adult Insulin Administration, dated 3/9/16 indicated, " III. Standards of Practice: d. Do not hold insulin without provider order. Contact provider if you think a dose should be held or adjusted."



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2. On 8/16/17 at 8:50 A.M., a concurrent observation and interview was conducted in Room 486 accompanied by LN 85. An undated and untimed normal saline IV 1000 mLs solution bag was observed being administered to Patient 85 at a rate of 75 mLs per hour. LN 85 stated the IV solution bag should have been dated and timed.

On 8/16/17 at 9:05 A.M., record review was conducted with Pharmacist 1. Patient 85's clinical record indicated LN 86 documented the IV solution bag was last hung on 8/15/17 at 10:37 P.M.

LN 86 was not available for interview.

According to the facility's policy, entitled Standards of Patient Care for the Adult Inpatient, dated 1/25/17, "IV Solution Bags: Label IV solution bags with date and time hung."

Based on observation, interview, and document review, the hospital failed to ensure pharmaceutical services were provided to meet the needs of the patients. The hospital failed to:

1. Ensure:
a. Medications were protected from light as specified by the manufacturers.
b. Medication was refrigerated as specified by the manufacturer.
c. Medications were separated to prevent medication errors.
d. Medications were not stored in "dirty" containers.
e. The contents of the emergency medication carts (crash cart, medications used for medical emergencies) matched the inventory list posted outside. In addition, the medications in the Hemorrhage cart (emergency medication cart used for obstetrical emergency) were not checked and locked by the pharmacist.
f. Four medications in three of three RSI kits were stored in the temperature range in accordance with manufacturers' instructions. The four medications were lidocaine 2% syringe (medication to treat heart rhythm disorders), vecuronium dry powder (medication to prevent skeletal muscle movement), etomidate (an anesthetic medication), and lidocaine jelly 2% (topical numbing medication).
g. Two of two bottles of diphenhydramine (medication for serious allergic reactions) oral solution were stored in the temperature range in accordance with manufacturer's instructions.

As a result, the hospital could not ensure the integrity and potency (strength) of its medications. In addition, the hospital could not ensure medications needed during a medical emergencies would be readily available. (See A-491)

2. Maintain controlled substance (CS) records on the distribution, use, and disposition on 11 of 11 Vimpat injectable vials stored unlocked in the Medical Center Pharmacy Clean Room. In addition, the hospital failed to ensure the weekly count of controlled substances in the Automated Dispensing Cabinet (ADC, an automated system used in medication distribution) was performed as required. As a result, the hospital could not ensure diversion (unauthorized use of medication) of controlled substances was detected timely and reported to protect the patients, staff, and the surrounding community from misuse and abuse of controlled substances. (See A-494)

3. Ensure manufacturer's instructions were implemented for Sterile Water for Irrigation pour bottles. This occurred when water was observed to be stored in two of two Pharmacy Clean Rooms (Medical Center and Downtown Campus) for unknown time periods. This failure had the potential to expose patients to increased risk of infections. (See A-501)

4. Ensure medications were secure to prevent unauthorized access. As a result, the hospital was unable to ensure medications were safely stored to prevent misuse. (See A-502)

5. Store 11 of 11 controlled substance (CS) Vimpat (seizure medication) injectable vials in a locked manner. This failure had the potential to result in CS theft and diversion (use other than intended medical purpose). (See A-503)

6. Ensure:
a. Medications with shortened expiration date were labeled with the approriate beyond-use-date (BUD, a date after which a medication should not be used or stored) to ensure they were removed and discarded and not administered to patients.
b. Outdated diltiazem (medication for high blood pressure and chest pain) injectable vials were not available for patient use in a medication room refrigerator.

As a result, the hospital could not ensure the potency (strength) of its medications. Patients potentially could be administered deteriorated (reduced quality) medications which could lead to ineffective treatment. (See A-505)

The cumulative effect of these systemic issues resulted in the failure of the hospital to deliver pharmaceutical services in a safe manner.

Based on observation, interview, and document review, the hospital failed to ensure:

1. Medications were protected from light as specified by the manufacturers.

2. Medication was refrigerated as specified by the manufacturer.

3. Medications were separated to prevent medication errors.

4. Medications were not stored in "dirty" containers.

5. The contents of the emergency medication carts (crash cart, medications used for medical emergencies) matched the inventory list posted outside. In addition, the medications in the Hemorrhage cart (emergency medication cart used for obstetrical emergency) were not checked and locked by the pharmacist.

6. Four medications in three of three RSI kits were stored in the temperature range in accordance with manufacturers' instructions. The four medications were lidocaine 2% syringe (medication to treat heart rhythm disorders), vecuronium dry powder (medication to prevent skeletal muscle movement), etomidate (an anesthetic medication), and lidocaine jelly 2% (topical numbing medication).

7. Two of two bottles of diphenhydramine (medication for serious allergic reactions) oral solution were stored in the temperature range in accordance with manufacturer's instructions.

As a result, the hospital could not ensure the integrity and potency (strength) of its medications. In addition, the hospital could not ensure medications needed during a medical emergencies would be readily available.

Findings:

1a. A tour of the Pharmacy was conducted on 8/14/17 at 9:40 A.M. with Pharm 1.

Octreotide (medication to treat several conditions such as severe diarrhea) 100 mg per mL injection was stored exposed to ambient light in a clear plastic bag. The medication was labeled for Patient 81.

Pharm 2 indicated he verified the medication and it was ready to be sent to the nurse for administration to Patient 81. Pharm 2 acknowledged the manufacturer's specification indicated the medication should be, "Protect[ed] from light." Pharm 2 stated the medication should have been stored in a "brown bag" to protect from light.

Forty vials of dexamethasone (medication to treat swelling or inflammation) 10 mg per mL injection were exposed to ambient light; and

Thirty vials of ondansetron (medication to treat nausea) 4 mg per 2 mL injection were exposed to ambient light.

The manufacturers specified these medications should be protected from light.

1b. The medication storage in the Emergency Room Triage area was inspected with Pharm 1 on 8/14/17 at 10:35 A.M.

Nine vials of cefazolin (antibiotic) 1 g injection were exposed to ambient light.

The manufacturer specified the medication should be protected from light.

1c. The medication storage, Medication Room B, on the 7th floor (Ortho), was inspected on 8/14/17 at 11:45 A.M. with Pharm 1.

Avycaz (antibiotic) 2.5 g diluted in normal saline (salt water) was exposed to ambient light. The medication was labeled for Patient 82.

Pharm 1 agreed the medications were not protected from light.

According to the hospital's policy, Medication Storage and Safety, effective date 8/10/17, "Medications... are stored... according to the manufacturer's recommendations...."

2. The medication storage, Medication Room B, on the 7th floor (Neuro), was inspected on 8/14/17 at 11:54 A.M. with Pharm 1.

Zerbaxa (antibiotic) 1.5 g diluted in normal saline (salt water), labeled for Patient 83, was stored at room temperature. The medication contained a label, "Refrigerate." Pharm 1 was unsure how long the medication was at room temperature.

According to the hospital's policy, Medication Storage and Safety, effective date 8/10/17, "Medications...shall be stored under proper... temperature...."

3a. Medication room A on the Medical/Surgical floor was inspected with Pharm 1 on 8/14/17 at 4:02 P.M.

NS (normal saline, salt solution) 250 mL were stored together with NS 500 mL; and
LR (lactated ringer, electrolyte solution) 1,000 mL were stocked in the storage container labeled for NS 250 mL.

Pharm 1 acknowledged different medications should not have been stored together.

3b. Medication room C in the Post Partum/Medical Surgical unit was inspected with Pharm 1 on 8/14/17 at 4:20 P.M.

D5W (solution containing sugar) 1,000 mL and D5 1/2 NS (sugar and salt solution) were stored together;
NS (normal saline, salt solution) 1,000 mL and NS 500 mL were stored together; and
NS 500 mL and NS 250 mL were stored together.

Pharm 1 acknowledged different medications should not have been stored together.

According to the hospital's policy, Medication Storage and Safety, effective date 8/10/17, "Medication... shall be stored under proper... segregation...."

4. Medication room B on the Medical/Surgical floor was inspected with Pharm 1 on 8/14/17 at 4:10 P.M.

Pharm 1 acknowledged the storage bins for cefazolin (antibiotic) 1 g injection, and Hemabate (medication to treat bleeding after delivering a baby) 250 mcg, were "dirty."

According to the hospital's policy, Medication Storage and Safety, effective date 8/10/17, "Medication... shall be stored under proper sanitary...."

5a. The crash cart for pediatric in the Emergency Department Triage was inspected with Pharm 1 on 8/14/17 at 10:35 A.M.

Two D5W (solution containing sugar) 250 mL were stored inside, the content list posted outside indicated one should have been stocked.

Two NS (salt solution) 250 mL were stored inside, the content list posted outside indicated one should have been stocked.

Two naloxone (medication to treat opiate overdose) 2 mg per 2 mL were stocked, the content list posted outside included the description as 1 mg per mL, quantity of 2.

According to the hospital's policy, Pediatric Broselow Crash Cart, effective date 1/27/15, the Purpose section stated, "To establish guidelines for maintain (sic) and stocking Pediatric Crash Carts in order to provide consistency from area to area and to allow code team members to readily locate required items for the resuscitation of pediatric patients."

5b. The Hemorrhage cart in the Labor and Delivery unit was inspected with Pharm 1 on 8/14/17 at 3:15 P.M.

Pharm 1 stated the pharmacist only checked drawers 4 and 5, and used the tamper evident tape to seal the drawers, indicating they have been checked by a pharmacist.

Drawer 1 included normal saline (NS, salt solution) 1,000 mL (a medication). Drawer 1 did not have the tamper evident tape.

Drawer 6 included NS 500 mL and 1,000 mL (medications). Drawer 6 did not have the tamper evident tape.

Pharm 1 was interviewed on 8/15/17 at 11 A.M. Pharm 1 stated the pharmacist should have inspected all drawers containing medications and used the tamper evident tape to indicate they have been checked by a pharmacist.

According to the hospital's policy, Obstetrical Emergency: Postpartum Hemorrhage, effective date 12/7/16, "Pharmacist to perform final check of IV [intravenous, medication administered directly into the vein] drawer... Pharmacist... to check IV drawer and add tamper resistant tape to drawer and inspection sticker."

5c. The crash cart for adult in the Labor and Delivery unit was inspected with Pharm 1 on 8/14/17 at 3:15 P.M.

Three lidocaine (medication to treat heart issues) 100 mg per 5 mL were stocked, the content list posted outside indicated two should have been stocked.

One 500 mL bottle of sterile water for irrigation was stocked, the content list posted outside included the description as "sterile water 500 mL," therefore either the injectable or irrigation solution could have been stocked.

According to the Institute for Safe Medication Practices, sterile water 100 mL or more is considered a high-risk medication, and the consequence of a medication error could be devastating to patients, including death.

According to the hospital's policy, Adult Crash Cart - Contents and Procedures for Checking Contents, dated 1/23/16, "The Adult Crash Cart Contents are standardized and may not be altered by individual departments."



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5d. On 8/14/17 at 11:33 A.M., a concurrent observation and interview was conducted at the Adult crash cart outside of Medication Room 5 West #B accompanied by Pharmacist 3. Three lidocaine 2% syringes 100 mg in 5 mLs were observed stored inside the adult crash cart. Pharmacist 3 acknowledged the above observation.

According to the facility's policy, entitled Adult Crash Cart - Contents and Procedures for Checking Contents, dated 1/23/16, "The Adult Crash Cart Contents are standardized and may not be altered by individual departments." The approved policy indicated the contents of the adult crash cart for lidocaine 100 mg in 5 mLs was a quantity of 2 items.

6a. On 8/14/17 at 3:45 P.M., a concurrent observation and interview was conducted in Room CC # 3 accompanied by Pharmacist 3. The medication refrigerator indicated the temperature was 41°F. Two RSI kits were stored in the refrigerator containing the following medications: lidocaine 2% 100 mg in 5 mLs syringe from MFG B, etomidate 2 mg/mL injectable vial from MFG C, and lidocaine 2% jelly 5 mLs tube from MFG D, vecuronium 10 mg dry powder injectable vial from MFG E. Pharmacist 3 acknowledged the above four medications were stored in the medication refrigerator. Pharmacist 3 acknowledged the manufacturers' instructions for lidocaine 2% syringe, lidocaine 2% jelly tube, and etomidate 2 mg/mL injectable vial indicated to store at 68° to 77°F and the refrigerator temperature was observed to be 41°F.

According to the package insert (document to safely use medications) from MFG E, the manufacturer indicated to store the vecuronium 10 mg dry powder in the temperature range 68° to 77°F.

According to the facility's policy, entitled Medication Storage and Safety, dated 8/10/17, "Medications, chemicals and biologicals are stored, handled and disposed of according to the manufacturer's recommendations and state or federal law ...Medication and medication supplies shall be stored under proper sanitary, temperature..."

6b. On 8/16/17 at 12:15 P.M., a concurrent observation and interview was conducted in the Behavioral Health Unit (BHU) Medication Room A accompanied by Pharmacist 4. The medication room refrigerator indicated the temperature was 39°F. One RSI kit was stored in the refrigerator containing the following medications: lidocaine 2% 100 mg in 5 mLs syringe from MFG B, etomidate 2 mg/mL injectable vial from MFG B, lidocaine 2% jelly 5 mLs tube from MFG D, and vecuronium 10 mg dry powder injectable vial from MFG E. Pharmacist 4 acknowledged the above four medications were stored in the medication refrigerator. Pharmacist 4 acknowledged the manufacturers' instructions for lidocaine 2% syringe and lidocaine 2% jelly tube indicated to store at 68° to 77°F and the refrigerator temperature was observed to be 39°F.

According to the package insert from MFG B, the manufacturer indicated to store etomidate 2 mg/mL injectable vial in the temperature range 68° to 77°F.

According to the package insert from MFG E, the manufacturer indicated to store the vecuronium 10 mg dry powder injectable vial in the temperature range 68° to 77°F.

According to the facility's policy, entitled Medication Storage and Safety, dated 8/10/17, "Medications, chemicals and biologicals are stored, handled and disposed of according to the manufacturer's recommendations and state or federal law ...Medication and medication supplies shall be stored under proper sanitary, temperature..."

7. On 8/16/17 at 2:50 P.M., a concurrent observation and interview was conducted at the facility's Express Care accompanied by Nurse Practitioner 87 (NP 87). The medication refrigerator indicated temperature was 42°F. Inside the refrigerator, two bottles of diphenhydramine oral solution from MFG F indicated to store in the temperature range 59° to 86°F. NP 87 acknowledged the two bottles diphenhydramine oral solutions were not stored in accordance with manufacturer instructions and the refrigerator temperature was observed to be 42°F.

According to the facility's policy, entitled Medication Storage and Safety, dated 8/10/17, "Medications, chemicals and biologicals are stored, handled and disposed of according to the manufacturer's recommendations and state or federal law ...Medication and medication supplies shall be stored under proper sanitary, temperature..."

Based on observation, interview, and document review, the hospital failed to maintain controlled substance (CS) records on the distribution, use, and disposition on 11 of 11 Vimpat injectable vials stored unlocked in the Medical Center Pharmacy Clean Room. In addition, the hospital failed to ensure the weekly count of controlled substances in the Automated Dispensing Cabinet (ADC, an automated system used in medication distribution) was performed as required.

As a result, the hospital could not ensure diversion (unauthorized use of medication) of controlled substances was detected timely and reported to protect the patients, staff, and the surrounding community from misuse and abuse of controlled substances.

Findings:

1. On 8/14/17 at 10:22 A.M., a concurrent observation and interview in the Medical Center Pharmacy Clean Room was conducted accompanied by Pharmacist 3. Eleven vials of Vimpat 200 mg in 20 mLs injectable vials labeled CS Schedule V (five) were observed stored unlocked in the Pharmacy Clean Room. Pharmacist 3 acknowledged Vimpat was a Schedule V CS and the distribution and use of Vimpat injectable vials were not tracked in and out of the Pharmacy Clean Room.

On 8/16/17 at 10:10 A.M., Pharmacist 3 acknowledged there was no narcotic log on the 11 Vimpat injectable vials that were observed stored in the Medical Center Pharmacy Clean Room.

According to the facility's policy, entitled Medication Storage and Safety, dated 8/10/17, " ...the distribution and administration of controlled substances must be documented in accordance with state and federal statutes regulating controlled substances."

According to the facility's policy, entitled Pharmacy Sterile Compounding Service, dated 8/14/17, "Controlled Drug Admixtures: The narcotic control procedure will be followed concerning dispensing of admixtures containing controlled drugs."

According to the ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals dated 2013, on page 6, indicated "Controlled Substances. There shall be policies and procedures to ensure control of the distribution and use of controlled substances and other medications with a potential for abuse. These policies and procedures shall be consistent with applicable laws and regulations and shall include methods for preventing and detecting diversion."

According to Title 21 Code of Federal Regulations Section Part 1301.71 (a) indicated all Drug Enforcement Administration (DEA) registrants (those registered to handle CS) "shall provide effective controls and procedures to guard against theft and diversion of controlled substances."



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2. Concurrent interview and document review was conducted with Pharm 1 and Pharm 3 on 8/16/17 at 8:30 A.M. regarding accountability for controlled substances.

The process to ensure all controlled substances were accounted for included the physical count weekly for each ADC station by two nurses. Pharmacy staff would check to ensure the weekly count was performed.

According to the hospital's policy, [ADC] MedStations, effective date 2/22/17, "Weekly, two licensed nurses will sign on any open unit and initiate a narcotic [controlled substance] inventory of all scheduled drugs [controlled substances]. This weekly count will be done regardless if the unit is open or closed."

The weekly inventory count for 2017, from January to August, was reviewed. The hospital had 68 ADC stations. During this time period, the weekly inventory was performed for every ADC station in the hospital twice, the weeks of 7/19/17 and 8/8/17. The inventory was not performed for every ADC station during other weeks, for example, 28 out of 68 stations were not inventoried for the week of 2/8/17.

Pharm 3 stated they "need[ed] to do something tougher" to improve compliance. Pharm 2 acknowledged, in 2016, the compliance rate was between 80 to 90 % (meaning 80 to 90% of 68 stations were inventoried weekly, and 10 to 20% were not). Pharm 3 stated they have sent emails to nursing managers to improve compliance, but there was no improvement.

Pharm 1 and Pharm 3 stated they have started to talk to Nursing Leadership "three months ago."

Based on observation, interview, and record review, the hospital failed to ensure manufacturer's instructions were implemented for Sterile Water for Irrigation pour bottles. This occurred when water was observed to be stored in two of two Pharmacy Clean Rooms (Medical Center and Downtown Campus) for unknown time periods. This failure had the potential to expose patients to increased risk of infections.

Findings:

1a. On 8/14/17 at 10:12 A.M., a concurrent observation and interview was conducted in the Medical Center Pharmacy Clean Room accompanied by Pharmacist 3, Rx Tech 5, and Rx Tech 6. A spray bottle filled with clear liquid was observed on the top of the left compounding hood (area to mix medications). The spray bottle was observed to be labeled "SWFI" and did not indicate an expiration time. Rx Tech 5 stated the spray bottle contained water. When asked how long the water had been in the spray bottle, Rx Tech 5 stated "I don't know." Rx Tech 6 stated the spray bottle was refilled with the Sterile Water for Irrigation pour bottles in the Pharmacy. Pharmacist 3 acknowledged the Sterile Water for Irrigation pour bottles labeling from MFG A indicated no antimicrobial agents (preservatives).

On 8/18/17 at 9:15 A.M., Pharmacist 1 acknowledged the manufacturer's instructions for Sterile Water for Irrigation pour bottles from MFG A indicated "Discard used portion".

According to the facility's policy, entitled Medication Storage and Safety, dated 8/10/17, "Medications, chemicals and biologicals are stored, handled, and disposed of according to manufacturer's recommendations and state or federal law ..."

According to the manufacturer's labeling on the Sterile Water for Irrigation pour bottle from MFG A, "No antimicrobial agent or other substance has been added ...Sterile ...Discard unused portion."

1b. On 8/16/17 at 11:45 A.M., a concurrent observation and interview was conducted in the Downtown Campus Pharmacy Clean Room accompanied by Pharmacist 4. An opened 1000 mLs Sterile Water for Irrigation pour bottle from MFG A was observed stored on the counter and did not indicate an expiration time. Pharmacist 4 acknowledged the opened Sterile Water for Irrigation pour bottle on the counter. He acknowledged the water should not be reused for cleaning the compounding hood.

On 8/18/17 at 9:15 A.M., Pharmacist 1 acknowledged the manufacturer's instructions for Sterile Water for Irrigation pour bottles from MFG A indicated "Discard used portion".

According to the facility's policy, entitled Medication Storage and Safety, dated 8/10/17, "Medications, chemicals and biologicals are stored, handled, and disposed of according to manufacturer's recommendations and state or federal law ..."

According to the manufacturer's labeling on the Sterile Water for Irrigation pour bottle from MFG A, "No antimicrobial agent or other substance has been added ...Sterile ...Discard unused portion."

Based on observation, interview, and document review, the hospital failed to ensure medications were secure to prevent unauthorized access.

As a result, the hospital was unable to ensure medications were safely stored to prevent misuse.

Findings:

The medication storage in Trauma was inspected with Pharm 1 on 8/14/17 at 11:24 A.M.

The Trauma room was empty and unlocked, with no staff in attendance.

NS (normal saline, salt solution, a medication) 1,000 mL injection was stored in an unlocked cabinet;
NS 1,000 mL injection and NS 1,000 mL bottles were stored in an unlocked warmer.

LN 80 was interviewed and stated the public could access the room and the medications.

According to the hospital's policy, Medication Storage and Safety, effective date 8/10/17, "Medications are secured at all times.... Medication carts and medication rooms must be locked at all times while unattended.... Medication... shall be stored under proper... security conditions...."

Based on observation, interview, and record review, the hospital failed to store 11 of 11 controlled substance (CS) Vimpat (seizure medication) injectable vials in a locked manner. This failure had the potential to result in CS theft and diversion (use other than intended medical purpose).

Findings:

On 8/14/17 at 10:22 A.M., a concurrent observation and interview in the Medical Center Pharmacy Clean Room was conducted accompanied by Pharmacist 3. Eleven vials of Vimpat 200 mg in 20 mLs injectable vials labeled CS Schedule V (five) were observed stored unlocked in the Pharmacy Clean Room. Pharmacist 3 acknowledged the 11 Vimpat vials were labeled CS Schedule V and stored unlocked at the time of inspection.

According to the facility's policy, entitled Controlled Substances, dated 8/11/17, "Storing of Controlled Substances ...All controlled substances are stored in the Pharmacy in the Controlled Substance Vault or similar locked area."

According to the ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals dated 2013, on page 6, indicated "Controlled Substances. There shall be policies and procedures to ensure control of the distribution and use of controlled substances and other medications with a potential for abuse. These policies and procedures shall be consistent with applicable laws and regulations and shall include methods for preventing and detecting diversion."

According to Title 21 Code of Federal Regulations Section Part 1301.71 (a) indicated all Drug Enforcement Administration (DEA) registrants (those registered to handle CS) "shall provide effective controls and procedures to guard against theft and diversion of controlled substances."

Based on observation, interview, and document review, the hospital failed to ensure:

1. Medications with shortened expiration date were labeled with the appropriate beyond-use-date (BUD, a date after which a medication should not be used or stored) to ensure they were removed and discarded and not administered to patients.

2. Outdated diltiazem (medication for high blood pressure and chest pain) injectable vials were not available for patient use in a medication room refrigerator.

As a result, the hospital could not ensure the potency (strength) of its medications. Patients potentially could be administered deteriorated (reduced quality) medications which could lead to ineffective treatment.

Findings:

1. The Utility Room on the 8th floor, where some medications were stored, was inspected with Pharm 1 on 8/14/17 at 3:54 P.M.

The Utility Room also had a warmer, where some medications (solutions) were stored. The warmer contained sterile water for irrigation bottles, and 14 bottles did not contain the BUD.

Pharm 1 acknowledged the bottles did not contain the BUD, but should have had the appropriate BUD.

According to the manufacturer's specification, the solution could be warmed for a maximum of 60 days, then discarded.

According to the hospital's policy, Medication Storage and Safety, effective date 8/10/17, "Medications... are stored, handled and disposed of according to the manufacturer's recommendations...."

According to the hospital's policy, Time Allowance of Solution in Temperature Controlled Storage, "All solutions in the warming cabinet will be labeled prior to storage with an expiration date for the manufacturer's warming time allowance."


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2. On 8/14/17 at 10:58 A.M., a concurrent observation and interview was conducted in the Medication Room 4 West #C accompanied by Pharmacist 3. The medication room refrigerator contained 5 outdated diltiazem of the 13 diltiazem 25 mg per 5 mLs injectable vials. Four diltiazem vials indicated an expiration date of 9/15 (calculated to be expired approximately 684 days at the time of inspection). One diltiazem vial indicated an expiration date of 7/17 (calculated to be expired approximately 15 days at the time of inspection). Pharmacist 3 acknowledged the five expired diltiazem injectable vials in the medication room refrigerator.

According to the facility's policy, entitled Medication Storage and Safety, dated 8/10/17, " ...11. All outdated and deteriorated medications from all areas of the hospital will be returned to pharmacy."

Based on observation, review of hospital documents, manufacturer's instructions and staff interviews, the hospital failed to:

1. Develop an effective performance improvement program for dietetic services when survey data was not analyzed. There were no action plans when areas for improvement were identified (refer A273);

2. Designate a full-time Director of Hospitality when the position was shared between Dietetic and Environmental services and ensure the Director of Hospitality implemented an effective system for food storage (refer A620);

3. Ensure menu substitutions met the nutritional needs of patients when the grilled cheese entrée was not of equal nutritional value of the regular entrée (refer A629);

4. Develop a diet manual that fully reflected the physician ordered diets when the manual was not modified to reflect the hospitals menu and the diet manual did not describe the menus nutrient adequacies and inadequacies (refer A631);

5. Ensure maintenance of equipment in accordance with manufacturers' guidance (refer A701);

6. Ensure ware washing machine operated according to manufacturer's instructions resulting in the equipments' ability to convey sufficient heat to utensil surface, resulting in inadequate sanitization of the dish surface (refer A701);

7. Ensure effective implementation of dietetic services in a safe and sanitary manner and in accordance with current standards of practice when the facility failed to a) identify unsanitary conditions in the dish washing room, pots and pans and cart washing area in the kitchen; b) time/temperature control for foods capable of supporting bacterial growth associated with foodborne illness; c) maintain ice and soda machines in a sanitary manner; d) ensure quality of food ingredients; e) ensure overall departmental cleanliness; and f) ensure proper hand hygiene (refer A749).

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the Condition of Participation for Dietetic Services was met.

Based on observation, review of hospital documents, manufacturer's instructions and staff interviews, the hospital failed to:

1. Develop an effective performance improvement program for dietetic services when survey data was not analyzed. There were no action plans when areas for improvement were identified (refer A273);

2. Designate a full-time Director of Hospitality when the position was shared between Dietetic and Environmental services and ensure the Director of Hospitality implemented an effective system for food storage (refer A620);

3. Ensure menu substitutions met the nutritional needs of patients when the grilled cheese entrée was not of equal nutritional value of the regular entrée (refer A629);

4. Develop a diet manual that fully reflected the physician ordered diets when the manual was not modified to reflect the hospitals menu and the diet manual did not describe the menus nutrient adequacies and inadequacies (refer A631);

5. Ensure maintenance of equipment in accordance with manufacturers' guidance (refer A701);

6. Ensure ware washing machine operated according to manufacturer's instructions resulting in the equipment's' ability to convey sufficient heat to utensil surface, resulting in inadequate sanitization of the dish surface (refer A701);

7. Ensure effective implementation of dietetic services in a safe and sanitary manner and in accordance with current standards of practice when the facility failed to a) identify unsanitary conditions in the dish washing room, pots and pans and cart washing area in the kitchen; b) time/temperature control for foods capable of supporting bacterial growth associated with foodborne illness; c) maintain ice and soda machines in a sanitary manner; d) ensure quality of food ingredients; e) ensure overall departmental cleanliness; and f) ensure proper hand hygiene (refer A749).

Based on staff interview and hospital document review the hospital failed to ensure effective oversight of dietetic services as evidenced by: 1) the Director of Food Services was not full-time to dietetic services. In addition to foodservice responsibilities the Director also had managerial responsibilities to another department; 2) food storage practices that were not in accordance with hospital procedures or standard of practice.
Failure to ensure staffing levels in accordance with regulatory requirements may result in ineffective operations within the Food and Nutrition Services putting patients at risk for issues associated with safety and sanitation, meal delivery systems that do not meet patient nutritional needs and lack of effective staff training, all of which directly or indirectly can affect the medical and nutritional status of inpatients.

Findings:

Staffing
In an interview on 8/14/17 at 9:30 a.m., the Director of Hospitality (DOH) stated he was recently appointed as the Interim Director. The DOH stated that until 3 weeks ago he was the Director of Operations at the downtown location. Review of the position summary dated 2/11/17 revealed that this position was responsible for the provision of not only Nutrition services but also included administrative responsibilities for Environmental services. The responsibilities included assessing, planning, implementing and evaluating all aspects of the services delivered.

Review of undated organizational chart for Hospitality and Facilities revealed that the DOH had a direct supervisory relationship to the Manger of Environmental Services. It was also noted that job requirements included "required" certifications such as hotel administrator which was not relevant to the position of Director of Food and Nutrition Services.

Food Storage
Palomar Campus: During review of dry storage practices on 8/7/14 at 11 a.m., in the large dry storage nearest the kitchen exit there were 1-gallon containers of Worcester sauce, molasses and pancake syrup that were opened and sticky outside. In a concurrent interview with the Clinical Nutrition Manager (CNM) she acknowledged the items should have been cleaned prior to returning to storage.

Hospital policy titled "Infection Control Overview in FANS [Food and Nutrition Services]" dated 4/22/16 had a section titled "Food Products and Storage; did not provide guidance on cleaning soiled containers prior to storage. The standard of practice would be to ensure cleanliness of the food establishment to minimize attractants for insects and rodents, aid in preventing the contamination of food and equipment, and prevent nuisance conditions (Food Code, 2013).

Downtown Campus: The standard of practice for food quality would include the development of a first in first out system. Product rotation is important for both quality and safety reasons. "First-In-First-Out" (FIFO) means that the first batch of product prepared and placed in storage should be the first one sold or used. Date marking foods as required by the Food Code facilitates the use of a FIFO procedure in refrigerated, ready-to-eat, TCS foods. The FIFO concept limits the potential for pathogen growth and encourages product rotation (Food Code, 2013).

During initial tour of the dry storage area on August 17, 2017 at 9 a.m., it was noted there were 5-four pound bags of pickles with no receipt date; 1-four pound can of tuna with a dent on the top seam, 6-27 ounce cans of Chile Verde sauce, no delivery date; 1 can of Spanish artichoke hearts with a rim dent and no delivery date; greater than five-28 ounce cans of diced pimentos with no expiration or receipt date and five-#10 cans of canned mushrooms with no delivery or discard date.

While the hospital policy titled "Infection Control Overview in FANS" dated 4/22/16 provided guidance for labeling/dating of prepared foods and opened containers for food safety it did not include a procedure that ensured food quality.

Based on observation, review of hospital menu and hospital documents and staff interviews, the hospital failed to ensure the nutritional needs of one unsampled patient was met in accordance with recognized dietary practices. The unsampled patient had requested a grilled cheese sandwich in place of the entrée served for lunch. The grilled cheese sandwich that was planned for the patient would have contained less protein than was provided to other patients who received the main entrée.

Findings:

According to the menu on August 17, 2017, at the Downtown campus, the following items were offered for lunch: Seasonal Mixed Green salad with ranch dressing, ½ cup orange juice, 6 ounces Minestrone soup, 3 ounces Chicken fried steak, ½ cup steamed rice with gravy, ½ cup broccoli, wheat roll and apple pie.

During trayline observation starting at 10:10 am on August 17, 2017, an unsampled patient's tray was prepared with instructions to prepare grilled cheese prior to service. Review of the tray card showed grilled cheese hand written, the diet was regular. FSS 3 was interviewed on the preparation of grilled cheese at 10:15 am, FSS3 stated the item is prepared on the grill in the café area using a recipe.

Review of the recipe book did not include one for a grilled cheese sandwich. Cook 2 was interviewed on how he would prepare the grilled cheese for this patient. Cook 2 explained the process and the use of 2 slices of American Cheese between 2 slices of bread.
Review of the Nutrition Facts on the package of cheese that would be used in the preparation indicated that 2 slices of cheese would provide 5 grams of protein (approximately 3/4 ounces of protein). Three ounces of chicken steak would provide at a minimum 21 grams of protein. One gram of protein is 7 grams. The two cheese slices with the bread will provide approximately 6 additional grams of protein for a total of 11 grams of protein. This is less protein than was offered to patients on the regular diet.
FSD stated at 10: 17 am on August 17, 2017 that the hospital had not reviewed the difference in protein the substitution would make.

Based on dietary staff and Clinical Nutrition Manager interview and departmental document review the hospital failed to develop and utilize a diet manual that was specific to the hospital, including diets routinely ordered and guidance for ordering and preparing patient meals in accordance with the hospitals' menu. This failure had the potential to result in a lack of consistency and communication concerning the diets among medical nursing and dietary staff. This failure had the potential to affect the patient census of 288.

Findings:

Diet manuals establish a common language and practice for physicians and other healthcare professionals to use when providing nutrition care to patients. The diet manual includes the purpose and principles of each diet, the meal pattern, the foods allowed and foods to avoid and describes the nutritional adequacy and/or inadequacy of each diet. The diet manual and diets offered by the hospital should mirror the nutritional care provided by the hospital (California Department of Public Health, 2013).

During meal plating observation on August 14, 2017beginning at 11:30 a.m., it was noted there were multiple patients with physician ordered carbohydrate consistent diets. In an interview on August 15, 2017 at 9:25 a.m., with Nutrition Care Assistant (NCA) 7 she was asked to describe how the diet was determined if patients selected their own meals. NCA 7 stated she had a grid that described three levels of carbohydrate for this particular diet order. The levels were listed as low, average and high carbohydrate. The levels of carbohydrate were listed as 60, 75 and 90 grams (a metric unit of measure) of carbohydrate per meal. NCA 7 also stated there was an additional diet manual document; however she was unsure of where to locate it.

In a concurrent interview with the CNM she stated that the hospital developed a document to that described the diets in relationship to the hospital menu to be utilized in an adjunct to the diet manual published by the Academy of Nutrition and Dietetics.

The Academy of Nutrition and Dietetics Nutrition Care Manual® (NCM) is an Internet-based diet manual and professional practice manual for registered dietitian nutritionists; nutrition and dietetics technicians, registered; and allied health professionals. While the manual had some elements of a diet manual it is not specific to the hospitals ordering practices or menus. As an example the section that intended to describe the diabetic diet revealed the information was limited to patient education materials describing the importance of carbohydrate counting, listed foods that have carbohydrates, meal planning tips and label reading tips. The section did not describe the nutritional adequacy/inadequacy of the diet, foods to use and foods to avoid or a sample meal pattern that is consistent with the hospitals' menu. The bottom of each page also notes that the "handout may be duplicated for client education." The format in the Nutrition Care Manual was similar for the remaining diets.

Hospital document titled "Diet Interpretation Guideline of Commonly Ordered Diets" dated 8/4/17 listed the diet orders, purpose of the diet and alterations. As an example the cardiac diet listed eliminating salt packets and limiting cured meats as alterations. It was also noted that while the document listed some of the macronutrients such as calories, protein and fat the document did not comprehensively address the requirements of a diet manual. The documents presented did not comprehensively evaluate the nutritional adequacy of the commonly ordered diets.

Based on observation and staff interviews, the hospital failed to ensure that:
1. The dish washing machines on both campuses were maintained in good working order and according to manufacturer's specifications;

2. The freezer part of the refrigerator in the nourishment room on the main campus was maintained in good working when the edges of the freeze showed evidence of condensation;

3. The rubber gaskets on the door of two refrigerators in the kitchen at the downtown campus were warped causing an incomplete closure of the doors allowing warm kitchen air in the refrigerators as evidenced by condensation around the doors. This had the potential to affect the safety and well-being of patients all patients in both campuses. The census was 288.

Finding:

During inspection of the dish washing procedure on August 16, 2017 starting at 9:20 am, the final water temperature of the final rinse cycle of the dish machine, over many wash cycles, ranged from 201.5 degrees Fahrenheit (F) to 202.4 degrees F. The manufacturer's label around final rinse cycle gauge read 180 -195 degrees F. This implied the final rinse temperatures should be at this range.

A concurrent observation and interview was conducted with FSS 2 at 9:37 am on August 16, 2017, FSS 2 stated he did not know what the highest temperature the final rinse should be. He left the area for a minute and then returned stating "185 - 200" degrees F. FSS stated at 9:40 am on August 16, 2017 he got the final rinse temperature from the "vendor". At 9:57 am on August 16, 2017, FSS 2 stated that the third party vendor is called when the temperature of the final rinse cycle is low.

A review of the hospital document Titled "Dish washing Machine Temperature Record for August 2017, showed four instances where the final rinse temperature recorded at 195 degrees or 200 degrees F.
On August 17, 2017 at starting at 2:38 pm at the Downtown Campus, the final wash temperature was 204 degrees F. The label around the final rinse cycle indicated 180 - 195 degrees F. A test of the water temperature using an irreversible registering temperature stick (160 degrees F) showed an uneven color change. Two subsequent tests showed a complete color change. The use of a holding thermometer showed similar inconsistent temperature recording. The first test showed a temperature of less than 160 degrees F, on the second try, the temperature was 161 degrees F.

According to the 2013 Food Code Section 4. 501.112 (A)" ... in a mechanical operation, the temperature of the fresh hot water sanitizing rinse as it enters the manifold may not be more than 194 degrees F". The temperature of the hot water delivered from a ware washing sanitizing manifold must be maintained according to the equipment manufacturer's specifications and temperature limits ..... to ensure surfaces of multi-use utensils such as kitchenware and tableware accumulate enough heat to destroy pathogens that may remain on such surfaces after cleaning ... ... When the sanitizing rinse temperature exceeds 194 degrees F at the manifold, the water becomes volatile and begin to vaporize reducing its ability to convey sufficient heat to utensil surface (2013 Food Code Annex).
According to the 2013 Food Code Annex, "proper maintenance of equipment to manufacturer specifications helps ensure that it will continue to operate as designed ..... Adequate cleaning and sanitization of dishes and utensils using a ware washing machine is directly dependent on the exposure time during the wash, rinse and sanitizing cycles. Failure to meet manufacturer and Code for cycle times could result in failure to clean and sanitize. For example, high temperature machines depend on the build-up of heat on the surface of the dishes to accomplish sanitization. If the exposure time during any of the cycles is not met, the surface of the items may not reach the time- temperature required for sanitization".


High Water Pressure

During inspection of the kitchen on August 16, 2017 starting at 9:20 am, there was a loud clinking noise coming from the dish washing machine as it was operating. Food service workers operating the machine did not appear concerned about the noise as evidenced by the lack of action of the Food Service Supervisor 2 who was present, continued operation of the machine, continued scraping, loading and unloading of dishes and food service equipment by the food service workers.
The water pressure gauge during the same wash cycles observed on August 16, 2017 starting at 9:20 am showed the needle on the pressure gauge moving away from the green section (normal 10 - 25 psi (pound per square inch), unit of measure for pressure) to the 45 to 50 psi range. High water pressure results in plumbing problems including banging pipes.
In an interview on August 16, 2017 with FSW 3 stated he did not know what it meant if the pressure gauge was outside of the normal as depicted by green shading on the dial. He replied "that's a maintenance thing."
Section 4-501. 113 states "The flow pressure of the fresh hot water sanitizing rinse in a ware washing machine .... shall be within the range specified on the machine manufacturer's data plate and may not be less than 5psi or more than 30 psi".

A review of the hospital policy and procedure (P/P) manual was reviewed. The P/P manual did not address high water temperature and /or high water pressure.
In an interview on August 18, 2017 at 1:50 pm, the Maintenance Supervisor (MS) and VP Hospitality stated the water pressure in the different sections of the hospital was regulated. The water pressure that comes into the hospital from the city is increased from 50 - 65 psi to about 120 to 160 psi; through the use of boost pumpers the water is distributed to different areas of the hospital at about 120 psi. Neither MS nor VP Hospitality stated in the concurrent interview they were aware of the water pressure requirements for the dish washing machine.
According to the Food Code Annex, if temperature or measuring devices are not maintained in good repair, the accuracy of the readings is questionable". The actual wash and rinse temperatures and rinse pressure should be consistent with the manufacturer's operating instructions and within limits.

Refrigerators

On August 15, 2017 starting at 10:15 am, the refrigerators in the nourishment rooms on the patient units were inspected. At 10:22 am, ice crystals were observed on the upper part around the rim of the freezer door of the refrigerator of one of the 9th floor refrigerators.
On August 17, 2017 at 8:50 am, condensation was observed around the door of the refrigerator described by Food Service Supervisor (FSS) 3 as entrée refrigerator. At 9:25 am, condensation was observed around the door of the three door refrigerator labeled "#2". Inspection of the rubber gaskets, revealed the gaskets to be warped. A check of the internal temperature of the compartment on the left side showed 50 degrees Fahrenheit.
The FSD who was present during the observation stated at 9:25 am, the rubber gaskets will be replaced.
4-501.11 (B) "Equipment components such as doors, seals, ..... shall be kept intact, tight and adjusted in accordance with manufacturer's specifications." (Food Code, 2013)

Based on observation, interview, and document review, the hospital failed to ensure patient care equipment was maintained in good repair in accordance with their Medical Equipment Management Plan (MEMP) and Biomedical Engineering Service Request Policy. Nine suction canisters (equipment utilized to extract oral secretions via a thin catheter attached to a suction compartment) were observed in an equipment room on the Neurological unit. Three of nine suction canisters had missing gauge covers which, exposed the gauge to open air and prevented proper cleaning and disinfection.

In addition, all nine suction canisters were labeled with a preventative maintenance (PM) sticker, dated 12/16/16 which was, inconsistent with the hospital's data. The data indicated, six of nine suction canisters were identified "Retired" from patient care use. The lack of maintaining and labeling the equipment in good repair, posed a risk for the spread of microorganisms to patients who had contact with the compromised canisters.

Findings:

On 8/15/17 at 3:15 P.M., an observation of the Neurological unit equipment room and joint interview was conducted with the Orthopedic/Neurological unit Nurse Manager (NM) 2, a Clinical Nurse Specialist (CNS) 1, and the contracted District Manager of Biomed (MGR-B). Nine suction canisters with visible PM stickers were observed in the equipment room. During the interview, MGR-B stated the PM stickers indicated, the canisters were ready for patient care use. In addition, MGR-B stated three of nine canisters had a missing gauge cover and prevented proper cleaning and disinfecting.

On 8/16/17 at 9:45 A.M., an interview was conducted with the Director of Biomed (DB) and NM 2. The DB stated during 12/2016, the hospital's medical vacuum (wall suction supply) was temporarily out of commission. As a result, portable suction canisters were transported to the hospital for emergency usage. The DB stated the nine canisters initially, were stored in the Biomed Engineering Department to undergo a full PM prior to patient use, and was not aware how the nine canisters ended up in the Neurological unit equipment room. NM 2 stated she recalled the canisters in the equipment room, however; there was no documented evidence of communication between the Neurological unit staff and the Biomed Department related to the identification of the patient care equipment.

On 8/16/17 at 10 A.M., an interview and review of the hospital's data related to the suction equipment devices, the "MEMP" dated 3/1/15, and the Biomedical Engineering Service Request Policy dated 10/31/16, were conducted with the DB and NM 2.

The suction equipment data indicated, six of nine canisters were "Retired." In addition, the data had not indicated any service orders for the three of nine canisters which had missing gauge covers or that a full PM was conducted on all of the canisters.

According to the MEMP, the process implemented by the hospital managed the effective, safe and reliable operation of medical equipment. Additionally, short term rental and non-hospital owned equipment received was uniquely numbered with a yellow inventory sticker; which identified it as temporary equipment.

The Policy indicated, all clinical Departments reported patient equipment concerns to Biomedical Engineering via a service order request and attached a red "Defective Device" tag.

The DB stated the canisters were not identified and tagged in the Biomed Engineering Department as rental equipment. He stated "Retired" equipment was not intended for patient use and when the data was documented as "Retired," the canisters should have been located and removed from their location. In addition, the DB stated a full PM was not conducted on all nine of the canisters.

The DB stated the hospital had not implemented their MEMP and Biomedical Engineering Service Request Policy, or had acted upon their own data collection to ensure the equipment was safe and did not pose a risk for the spread of microorganisms to patients who had contact with the compromised canisters.

On 8/17/17 at 3:10 P.M, an interview was conducted with the Infection Preventionist (IP). The IP was not aware of the suction canisters located in the equipment room of the Neurological unit. The IP had been aware of the hospital's Biomedical Engineering Service Request Policy and stated, the hospital expectation was all Departments entered work orders for any patient care equipment not in good repair. Additionally, the IP stated, the lack of maintaining and labeling the equipment in good repair, posed a risk for the spread of microorganisms to patients who had contact with the compromised canisters.

Based on observation, interview and record review, the hospital's Infection Control Program failed to oversee the following:

1. Provide a sanitary environment and oversee the compliance in the prevention, control and investigation of infections throughout the hospital. See A-0747; and

2. Provide oversight of a patient in the prevention, control and investigation of infections in the Emergency Waiting Room A-0749.


These failures, together, resulted in the condition of Governing body being NOT MET.

Based on observation, review of hospital documents, manufacturer's, and staff interviews, the hospital failed to ensure:

1. There was an effective system to identify unsanitary conditions in the dish washing room, pots and pans and cart washing areas in the kitchen. The kitchen and infection control staff did not identify a black substance on the walls and ceiling in the three areas. The black substance was observed along the length of walls from the floor to the ceiling, from one wall to the other, on the caulking that sealed the stainless steel three compartment sink in the pots and pans washing area, along the wall underneath the sink, on the grout lines of the wall tiles, on the dish machine, posters affixed on the walls and dish washing machines and containers of the soap dispensers. The black substance resembled mildew (mold). The presence of molds could result in the contamination of stored food products and allergic reactions in patients, visitors and patients who are allergic to mold. These failures had the potential to affect all kitchen staff, other hospital staff, visitors and 288 patients that were admitted to the hospital through cross contamination of surfaces and air transmission.
According to the University of Central Florida extension article titled "Mold Growth", "There are four critical requirements for mold growth - available mold spores, available mold food, appropriate temperatures and considerable amount of moisture. The removal of any one of these will prohibit mold growth". Although the hospital staff maintained they did not know what the substance was, all four of these requirements for mold growth were present in the areas were the black substance observed in the hospital kitchen. In addition, the cleaner used by the hospital to eliminate the black substance (mildew, mold) contained a mildewcide (an agent that destroys mildew) and fungicide (a substance that destroys fungus, mold is a form of fungus). (www.fsec.ucf.edu)
In the same UCF article "Mold Growth", Mold spores are described as being "everywhere" and cannot be completely eliminated. Oils from the skin or soap residue left from a good cleaning will provide sufficient nutrients to support the growth of some molds. Most molds require considerable moisture for growth. The dish room, pots and pans and cart washing areas had oils and soap from cooking and eating utensils and equipment that were being washed. The third requirement is moisture, all three areas have high moisture (water) and food service staff stated in interviews that they wash the walls down after every meal (three times a day). The fourth requirement is the high temperature. The dish machine uses water that is 180 degrees Fahrenheit (F.) hot water is also used in both the pots and pans and cart washing areas. The areas are generally warm and humid.
The lack of awareness, the failure of both infection control and food and nutrition staff to identify this black substance and eliminate the factors caused the growth of the substance resulted in an immediate threat to the health and safety of the hospital patients, staff and visitors. According to the CDC (Centers for Disease Control and Prevention), document "Molds in the Environment", "Some people are sensitive to molds. For these people molds can cause nasal stuffiness, throat irritation, coughing and wheezing, eye irritation and in some cases skin irritation. People with mold allergies may have more severe reactions. Immunocompromised people and people with chronic lung disease may get serious infections in their lungs when they are exposed to mold".

In the Molds in the Environment document, CDC indicated "In 2004, the Institute of Medicine (IOM) found there was sufficient evidence to link indoor exposure to mold with upper respiratory tract symptoms, cough and wheeze in otherwise healthy people. The IOM also found limited or suggestive evidence linking exposure to damp indoor environment in general to shortness of breath, to respiratory illness and to potential development of asthma in susceptible individuals".

Immediate jeopardy was declared on August 14, 2017at 4:10pm. The hospital's chief executive officer, vice president, chief infection control officer, vice president of operations, hospital and facilities vice president and interim hospitality and environmental services were informed of the black substance observed throughout the dish room, pots and pans area and cart washing areas. The extent, the lack of awareness and failure of staff to identify the substance was also discussed.

An acceptable plan of action was provided by the hospital administrator on August 14, 2017at 7:42 pm. The actions to remove the immediate jeopardy situation included: Inspection of other areas in the kitchen to identify other areas that the black substance may located; taking the areas affected from use until cleaning was completed; cleaning of the affected areas by an outside contractor specializing in restoration and the hospital EVS ( environmental services) staff. In addition, food service staff were to be educated on proper cleaning, an environmental testing company would test the area after cleaning to validate the absence of mold and finally, a an engineering company to evaluate the kitchen's mechanical system (exhaust and air supply) to focus on humidity and temperature. Patient meals were to be served on disposable ware to limit dish washing.

The immediate jeopardy was abated (reduced in amount, degree or intensity and immediacy) on August 16, 2017at 4:10 pm.
There were other deficient practices identified during the survey for both campus related to improper food storage , improper food cooling, poor ice machine cleaning practices and general uncleanliness of the foodservice area , storage and preparation of food that could result in food poisoning and food borne illness, improper dish washing practices.

In addition 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:

2. Employees in the perioperative services area did not wear appropriate surgical attire;
3. Isolation rooms were not disinfected on a daily basis or at the time of discharge; and
4. The hospital failed to protect patients and visitors in the ED waiting room from potential infection when they allowed 1 of 56 sampled patients (24) on droplet precautions to sit in the ED waiting room for 7 hours and did not ensure the patient wore a mask at all times. As a result, patients and visitors in the ED waiting room were potentially exposed to infectious disease.

Findings:

1. During the tour of the kitchen on August 14, 2017 at 11:02 am, a black substance was observed along the length of walls from the floor to the ceiling, from one wall to the other, on the caulking that sealed the stainless steel three compartment sink in the pots and pans washing area, along the wall underneath the sink, on the grout lines of the wall tiles, on the dish machine, posters affixed on the walls and dish washing machines, containers of the soap dispensers. The black substance resembled mildew (mold). The hospitals clinical nutrition manager and Food Service Director (FSD) who were present during the concurrent observation and interviews, both indicated neither had observed the black substance that was all over the walls and equipment in the dish room.
The Facilities manager (FM) who was called in stated in an interview on August 14, 2017 at 11:10 am, he was not aware and that no one had mentioned to him about the black substance. He was observed to scrape the substance off and said "mildew ".
On the floor in the dish room were two floor fans blowing. Food service Supervisor (FSS) 1 stated in an interview at 11: 15 am on August 14, 2107, the fans were being used to dry the floor. The clinical nutrition manager and FSD who were in the dish room stated the staff wash (hose) down the walls after every meal to remove food splatter.
On August 14, 2017 at 11: 20 am, Food service Supervisor (FSS) 2 indicated in an interview he had never observed the black substance that was present in the dish washing room and pots and pans area.
On August 14, 2017 at 3:15 pm, an interview was conducted with one of the hospital's infection preventionists, (IC 2) she indicated that she conducts an inspection of the food and nutrition department monthly and that her last inspection was on July 31, 2017. IC 2 indicated she did not observe the black substance during her last tour of the department.
On August 15, 2017 at 8:35 am, a tour of the kitchen was conducted. Two food service workers (FSW 3 and 4) were observed in the pots and pans area wiping down the three - compartment sink. The area had not been closed off as was promised by the infection control director. FSW 4 stated she was helping but her usual responsibility was working on the trayline. There were carts loaded with dirty dishes and food service equipment in the area adjacent to this area. The FSD stated in a concurrent observation and interview that the items were from the night before. FSD stated he was not aware that area needed to be closed off like the dish washing room. FSD and the Environmental Services director (DEVS) who were present stated the area had been cleaned overnight and that the crew of the restoration company had left except for the superintendent of the company. They indicated the environmental testing company had also come to test after the cleaning was done.
At 8:43 am on August 15, 2017, there was black substance observed underneath the sink in the pots and pans area. The black substance was against the wall along the seal above the floor tiles. It was also along the length of the seal that joined the pieces of the FRP (fiberglass reinforced plastic) panels the wall was made of. The superintendent of the contracted restoration company was interviewed (SRSC) on August 14, 2017 at 8:45 am. SRSC stated in the concurrent interview, the caulking in the pots and pans area had been removed and replaced and cleaned and treated any black substance with a product that was an antimicrobial. SRSC stated a general cleaning of the kitchen area was also conducted.
Review of the antimicrobial disinfectant used revealed it was also a mildewcide and fungicide.
At 9:00 am, on August 15, 2017, the Director of Infection control (DIC) was interviewed. DIC indicated the areas are still being cleaned and will continue to be cleaned until everything is completed. The pots and pans area and cart washing areas were then also contained to prevent spread of the substance and allow cleaning.
At 3:40 pm, on August 15, 2017, the dish room, 3-compartment sink and cart cleaning areas were inspected for compliance with the submitted Plan of Action. Observation of the dish room revealed there continued to multiple smaller areas where the black substance remained. In the dish room it included areas along the baseboards, exterior or the dishwasher and underneath a poster affixed to the dish machine. Additionally there was missing caulking along the ceiling vents. In the 3-compartment sink area staff did not remove all wall mounted dispensers prior to cleaning the FRP wall panels.
On August 16, 2017, starting at 9:20 am, the affected areas were re-inspected to ensure absence of the black substance. All areas inspected were free of the black substance. Document review from the remediation company hired to perform indoor air quality investigation was done. The report indicated the absence of mold spores on August 15, 2017 in six areas tested in the kitchen areas. The engineering company evaluating the ventilation has submitted a quote and description of proposed services.
Food service workers were interviewed on their knowledge of cleaning procedures that had been put in place. All of the FSWs interviewed were able to correctly state what the cleaning procedures were.
On August 16, 2017 at 4:10 pm, after inspection of all affected areas showed no more visible black substance, review of mold spore evaluation revealed absence of mold spores, engineering company plans for ventilation review and interviews of food service staff to validate training were completed, the immediate jeopardy situation was abated.
The following are the other deficient practices identified during the survey:
Potatoes
During the tour of the kitchen on August 14, 2017 at 9:45 am, a large plastic bin was inspected. The bin dated "8/10/17" was observed to have at least one potato that had spoiled. The surface of the potato was black and was soft to touch. There were a few potatoes that were green in color and others were sprouting. FSS 2 who was present during the observation stated the date was the date the bin was cleaned. FSS 2 could not state when the item was initially placed in the bin. He was observed giving instructions to an unidentified food service worker to clean the bin.
At 10:55 am on August 14, 2017, the unidentified food service worker was observed at one of the sinks near the freezer rinsing off the potatoes from the bin.
On August 16, 2017 at 9:57 am, a metal rack with four full trays of raw potatoes was observed next to the oven. There were at least three that were green. FSS 2 stated in the concurrent interview, it was put there by one of the cooks. Cook 1 was interviewed at 10:08 am. Cook 1 stated he was planning to bake it. FSS 2 who was present during the interview was asked what color the potatoes were. FSS 2 acknowledged it was green. Cook 1 also agreed some of the potatoes were green. Neither the FSS 2 nor Cook 1 knew the significance of the green potato; nor if there was a problem eating them. Cook 1 stated it probably could cause the potatoes to be tough. FSS 2 stated he did not know.
According to the University of Nebraska institute of Agriculture and Natural Resources article "Green Potatoes: The Problem", the greening in potatoes indicate an increase in the presence of the substance "solanine". When the potato greens, it as a result of exposure to light, solanine increases to potentially dangerous levels. The greening increases with the quality of light, duration and intensity. The Food Safety Authority of Ireland blames greening on improper storage. The formation of solanine in potato is localized to the skin, usually no deeper than an eighth of an inch (3 mm). Potatoes containing more than 0.1% solanine (.01 oz./10 oz. potato) are considered unfit for eating. There are a number of reports suggesting that ingestion of potatoes containing high levels of solanine have led to poisoning incidents where the main symptoms displayed are irritation of the gut and also drowsiness.
Improper cooling
"Non-continuous cooking" means the cooking of food in a food establishment using a process in which the initial heating of the food is intentionally halted so that it may be cooled and held for complete cooking at a later time prior to sale or service. Raw animal foods that are cooked using a non-continuous cooking process shall be: ...(B) Immediately after initial heating, cooled according to the time and temperature parameters specified for cooked time/temperature control for food safety (Food Code, 2013).

During initial tour on August 14, 2017 starting at 9:20 am, in the refrigerator listed as #3 it was noted there were greater than 2 full sized sheet pans of partially cooked chicken. In a concurrent interview Food Service Supervisor (FSS) 3 confirmed the chicken breast was partially grilled after which they were returned to the refrigerator. FSS 3 stated there was no temperature monitoring after the chicken was cooked. Department document titled "Chicken Breast Procedure (PAL West) guide staff " ...6. Place in blast chiller at 0 degrees F or lower until internal temperature reaches 41 degrees F or lower." Review of hospital document titled "Potentially Hazardous Food Cooling Log" from 6/11 - August 16, 2017confirmed that chicken was not an item that was regularly monitored for cooldown. Review of undated "patient menu" and hospital document titled "Garden Terrace Café" revealed grilled chicken was a regular item on both menus.

On August 14, 2017 at 11:40 am, a container of tuna salad was observed in one of the reach -in refrigerators. FSS 2 who was present during the observation, stated the tuna is prepared a day in advance and was prepared by FSW 5. In a concurrent observation, FSW 5 was interviewed about the preparation of the tuna salad. FSW 5 indicated the tuna was prepared the day before at 3:30 pm. The description of the preparation did not include a step to ensure that the tuna salad reached 41 degrees F within a specific time frame. FSS 3 who was also present during the observation and interview explained the tuna used to prepare the tuna salad was stored in the dry storage room at room temperature. Review of the hospital recipe titled "Tuna Salad" showed procedure indicated the tuna salad mixture should be chilled to 40 degrees F or below but did not indicate the time frame.
According to the 2013 Food Code Section 3-501.14 (B) " Time/Temperature Control For Safety Food (formerly potentially hazardous foods) shall be cooled within 4 hours to 41 degrees F or less if prepared from ingredients at ambient temperature such as reconstituted foods and canned tuna."
During the inspection of the kitchen on August 14, 2017 starting at 9:34 am, a blast chiller was one of the foodservice equipment observed in the kitchen. A blast chiller is a "safe contained refrigeration cabinet with a system designed to rapidly cool and uniformly decrease the temperature of hot food to either a chilled or frozen state to provide enhanced food safety and longer storage life". (Norlake.com) However, during the inspection, tuna salad and chicken breasts partially cooked were not appropriately cooled and or monitored to prevent food borne illness despite the availability of this piece of equipment.

Improper storage of food
During review of food storage practices on August 14, 2017 beginning at 10:40 a.m., the following was noted in the refrigerator labeled as "cold storage #3"

The standard of practice is to ensure food is protected from cross contamination by separating raw animal foods during storage, preparation and holding (Food Code 2013). There was raw bacon stored next to fully cooked ham; cooked eggs were stored below raw salmon. A concurrent interview with FSS 3 revealed he did not feel it was a problem since the cooked items were covered and/or sealed and the bacon and pancetta was a cured product. Observation in the food production area on August 14, 2017 at 11:35 a.m., noted there was guidance posted on the refrigerator that instructing staff to store ready to eat foods such as eggs above raw meat.

Pork like other muscle meats frequently contains bacteria (US Department of Agriculture, Food Safety Inspection Service, 2016). While the curing process may inhibit some bacterial growth bacteria such as halophiles may continue to grow under the decreased water (Scientific America, 2017).

On August 14, 2017 at 11:10 am, in the reach in refrigerator raw hamburger was stored over cooked chicken.
Hospital document titled "Infection Control Overview in FANS [Food and Nutrition Services]" dated 2016 did not include guidance on food storage with respect to raw and cooked foods.

Food Labeling
Date marking is the mechanism by which the food establishment demonstrates active managerial control of the temperature and time combinations for cold holding. Industry must implement a system of identifying the date or day by which the food must be consumed, sold, or discarded (Food Code 2013).

On August 14, 2017 starting at 9:40 am, in refrigerator #3 there was a case of partially frozen turkey breasts, each weighing greater than 5 pounds. It was noted that the receipt date was "7/31/17". On the exterior of the box there were printed instructions "keep frozen." In a concurrent interview FSS 3 was unable to demonstrate the date the turkeys were moved from the freezer to the refrigerator. FSS also stated the product required 7-8 days thawing time. Similarly there was ½ case of fully thawed rib eye steak wrapped individually in reduced oxygen packaging (packaging that extends the shelf life of products). The delivery date on the steak was 6/6/17. There was no thaw date listed.

Hospital policy dated 4/22/16 titled "Infection Control Overview in FANS" instructed staff under the subheading 13. Label and Dating a. "All ...packages will be labeled with a sticker that contains the following: II. after the frozen item is pulled for thawing, place the thawing label on the item. The label day the item was pulled and the date is to be used by ..." The policy also indicated that the thawing time for meats that were not protected by reduced oxygen packaging was 5 days. Items that had reduced oxygen packaging were to be discarded 14 days after pulling from freezer or receipt date.

During kitchen inspection on August 14, 2017 at 9:50 am, a container of orange juice was observed in the refrigerator. The "best by date" stamped on the container by the manufacturer was "8/8/17". There was a label by the hospital staff showing the container was opened on 8/10/17, (two days past the "best by date") and was good through "9/9/17", a month past when the manufacturer recommended.

Cutting Boards
On August 16, 2017 at 11:10 am, three cutting boards were observed hung on the drying racks in the pots and sink area. Closer inspection revealed the boards to be stained with black colored stains on the surface of these boards. FSS 2 who was present during the inspection stated the cutting boards are cleaned after every use and sanitized with the quat (quaternary) sanitizer.
On August 17, 2017 at 9:42 am at the Downtown Campus, the cutting boards stored away as clean were observed with the same black stains observed at the main campus kitchen, on the surface of the cutting boards. The FSS 4 who was present stated the boards will be discarded and replaced.
During interview with IC 2 on August 18, 2017 at 2:15 pm***, IC 2 indicated during the infection control rounds in the kitchen that IC 2 looks at the cutting boards to see if there are different colored boards; to ensure there is a different color cutting board used for different foods. IC 2 stated she never looks at the surface of cutting boards to evaluate if the boards could be source of infections through cross contamination. Review of the hospital documents titled "Sentact - FANS (Food and Nutrition Services) Infection Control Rounds" dated 6/29/17 and 7/31/17 revealed under the Subheading Food preparation Equipment the question was related to the use of the cutting boards not whether they can be sanitized. In both reports, the answer was "yes". The tool was not effective in identifying the black stains on the surface of the plastic cutting boards.
The knife marks and grooves created as a result of cutting can trap food residue that is not cleaned during regular dish washing and create source microbial and fungal contamination. Section 4-501.12 of the 2013 Food Code states, "Cutting surfaces such as cutting boards and blocks that become scratched and scored may be difficult to clean and sanitize. As a result, pathogenic (disease causing) microorganisms transmissible through food may build up or accumulate. These organisms may be transferred to foods that are prepared on that surface"

Food Blender
During the inspection tour of the kitchen on August 14, 2017 at 10:10 am, a stainless blender that was stored away as clean was inspected. The container of the blender did not appear dirty; it had a small amount of clear liquid at the bottom. The lid that covered the base however, had a light yellow mixture of semi solids and liquid covering the lid.
FSW 6 who was in the area, was interviewed about the use and cleaning of the blender. FSW 6 stated the she had used the blender to prepare soups: broccoli, chicken, tortilla and vegetable. FSW 6 stated she usually takes the blender to the dish room and cleans with sanitizer. FSW 6 provided no explanation on why the lid was not cleaned. The presence of liquid at the base of the container indicates it was not allowed to air dry as is the hospital policy.
Review of the hospital policy titled "Blender Sanitation - FANS" dated August 14, 2017 with a revision dated of 4/28/2017, indicates "rinse out the blender and break it down to its components, send the blender pitcher through the dish machine and /or 3 compartment sink .... Air dry and reassemble and return to appropriate kitchen area.
Ice Machine
During inspection of the kitchen at the downtown campus on August 17, 2017 at 9:58 am, the ice machine was inspected. A wipe of the surface where ice is dispensed revealed a light pink, and brown slimy substance. Inspection of the interior of the machine, the condenser and other interior components revealed a black substance covering the white pipe and tubing. There was also rust and white hard substance (similar to calcium) covering other areas inside and exterior of the machine.
Slime also known as yeast, mold, biofilm, organic growth and biological pollution. The precursors are naturally occurring in the air and contaminate ice machine as air is drawn in as part of its normal operation. The temperature, moisture, and environment in the kitchen make it an ideal environment for the growth of the yeast and/or bacteria. "Most times slime will take on a pinkish tone, if left untreated will turn to red, green, brown or even black." (Houston Department of Health and Human Services article on houstontx.gov).
If left untreated, the slime results in machine efficiency problems and contamination of ice production. There have been several published reports of infection outbreaks in hospitals traced back to contaminated ice machines. Infections include legionella pneumophilia, the bacteria which causes Legionnaire's disease; mycobacterium fortuitum, nontuberculous mycobacteria, which is a major cause of infections in immunocompromised patients. (BioZone Scientific International: Slime in Ice machine article)
The maintenance employee (ME) 1 who was present during the inspection indicated in an interview at 10:00 am that the machine had just been recently cleaned about two weeks earlier. ME 1 explained in the concurrent interview, the machines are cleaned by hospital staff using hospital supplied sanitizer. Review of the document titled "FANS Ice machine Cleaning Record 2017" showed the "internal" cleaning was done on 7/19/17 and another cleaning titled " Ice cleaning Cleaned monthly" was done 8/6/17.
Review of manufacturer's instructions and cleaning procedure revealed while the ice machine is sanitizing, other areas including inside of the hopper lid, stud assembly, baffle, wheel, inside storage area, dispense chutes, drain grill and drain pan be wiped down with damp cloth wrung out in sanitizing solution. The manufacturer also recommended a specific cleaner and sanitizer. According to the instructions on the bottle on the recommended cleaner it is "designed to prevent mold, mildew and bacteria growth inside the machine" and extend the life of ice machines. The active ingredient on this sanitizer is "quaternary ammonia"
Review of the hospital's policy titled "Ice machine Sanitation - FANS" dated August 14, 2017with revision date of 04/05/2016 revealed the interior of the machine should be sanitized with a solution sanitizer based on "FANS Chemical Use Chart". The document provided by the hospital titled Ice Machine Operations and Maintenance Program (prepared by the contract for the hospital use) was reviewed. The EVSD stated in an interview on August 18, 2017 at 3:50 pm the hospital staff and contractor use the chemicals stated in the document. The contractor recommended a sanitizing solution of 200 ppm (parts per million) available chlorine.
The industry standard is the use of solutions that do not harm the ice machine. The recommendation is that no chlorine based solution such as bleach, chlorine dioxide are not used. These chemicals can attack the surface of the evaporator as well as other metal components causing corrosion and flaking (Ice-O-Matic).
The interiors of other ice machine were not inspected during the survey however, documents provided for the ice machine maintenance titled "Ice Machine sanitation Service Log" revealed pictures of evaporators and evaporator trays that had evidence of corrosion. The evaporators in the ice machines in almost all the patient floors have been replaced according to the EVSD in the concurrent interview.

Improper cleaning and sanitizing
In an interview on 8/15/17 beginning at 8:50 a.m., Cook 1 stated the large steam kettle was regularly used for cooking soups and gravies. Cook 1 described the cleaning process as removing food debris, washing with detergent, draining the kettle then wiping the inside with a sanitizer. There was no distinct rinse step.
In an interview on August 16, 2017 beginning at 10:20 a.m., with Cook 1 the patient meal delivery cart cleaning process was described as follows: the cart would be sprayed down with the power wash hose, after spraying the interior would be wiped out and returned to meal service. Cook 1 stated this process was completed 2-3 days per week.

During the interview it was noted there was a black box with 2 dials mounted to the wall adjacent to the power wash hose. Cook 1 stated that this was the dispenser for the chemicals in the cart washing area. The dispenser was empty. FSW 8 stated that he had not seen chemicals in the dispenser "in the past month." In an interview on August 16, 2017 at 10:50 a.m., with FSS 2 he was unsure of the last time chemicals were ordered. There was no detergent use or sanitizing step.

If washing in the dishwasher or sink compartments is impractical washing shall be done by using alternative method with the following procedures. Equipment shall be washed then rinsed so that abrasives are removed and cleaning chemicals are removed or diluted through the use of water followed by a sanitation step (Food Code, 2013).
During review of food storage practices on August 17, 2017 beginning at 9:10 a.m., it was noted that the hospital had a beverage system referred to as "bag in a box." There were greater than 6 boxes on a rack. The bags contained soda and juice syrup. The syrup would be diluted, in a predetermined concentration, with water in the dispensing equipment. The bag was connected through a plastic connecting device which was in turn connected to the tubing leading to the dispensing equipment. It was noted that the exterior of the quick connect devices were covered with a sticky material. In a concurrent interview FSS 11 stated the system was maintained, including cleaning by the vendor. In an interview on August 17, 2017at 1:30 p.m. with Vendor 9 he stated he did not maintain the system, rather his primary function was to inventory the weekly supply and order the syrup. He also stated he would facilitate repair of the equipment should it be necessary. The Vendor provided no cleaning or preventive maintenance of the system. The manufacturers' guidance for maintenance was requested from Vendor 9. As of 8/22/17 the vendor did not supply information.

In equipment such as enclosed components of equipment such distribution lines, beverage and syrup dispensing lines or tubes shall be cleaned at a frequency specified by the manufacturer, or absent manufacturer specifications, at a frequency necessary to preclude accumulation of soil or mold (Food Code, 2013).

On August 17, 2017 at 9:15 am, an iced tea dispenser was observed on the counter in the kitchen in the Downtown campus. FSS 3 stated in a concurrent observation and interview, the ice tea is left out for two days and then cleaned.

General Uncleanliness
During the tour of the kitchen on August 14, 2017 starting at 9:34 am, the floor of the kitchen was observed to be dirty and grimy. At 9: 57 am, the lid of a large black food bin was dusty. A label attached to the side of the bin indicated Panko Bread Crumbs. This label titled "Monthly Bin Cleaning record Year 2017 showed the last time the bin was cleaned was 6/8/17. FSS 2 who was present during the observation acknowledged the bin had not been cleaned per the hospital policy.
At 10:03 am on August 14, 2017, a clear plastic container was observed on the shelf with parts of the food processor. FSS 2 who was present during the observation indicated the c

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

1. Ensure a timely discharge planning process for the patients (See A-810); and

2. Implement a discharge plan process for the patients (see A-820)

As a result, the hospital's policy and procedure did not specify in writing an effective discharge planning process for all patients.

These failures, together, resulted in the condition of Discharge Planning.

Based on interview and record review, the hospital failed to ensure the implementation of an effective discharge planning process. In additiona, the hospital failed to ensure discharge planning was initiated timely for 2 of 54 sampled patients.
As a result, there were delayed patient discharges throughout the hospital.

Findings:

1a. Eight Case Management/Discharge Planning Social Workers were interviewed on 8/16/17 at 2:30 PM. Several points were brought up that indicated there were delays in the discharge process. During the interview, a contributing factor was due to lighter staffing on weekends, which resulted in initial patient assessments were completed after the weekend. This contributing factor caused delays for many patient discharges. On weekends, one social worker would cover 3 floors instead of 1. It was stated there were 3 times the number of discharges on weekend days. The social workers also stated that a 7 day hospital should be fully staffed 7 days a week. Another issue delaying discharge was the fact that the outpatient pharmacy, used to fill discharge medications, is closed on weekends. The social workers voiced they were "Backlogged on Mondays" and had to prioritize and act in a "Peactive way instead of a proactive way." Another delay in getting patients to move through their inpatient stay quickly was the frequent long waits for a preoperative MRI (Radiology/imaging study). They were also concerned about the merger of the discharge nurse and social work functions into one nursing role and were under the impression the decision to implement this plan was already made. The Case Manage/Discharge Planning Social Workers were particularly concerned that traveling nurses were going to be put in this role. The social workers felt a traveling nurse would not know the resources in the community which would delay discharge further. In addition, the Director of the department, who had been a strong advocate for the discharge social workers, had left 6 weeks prior to survey and the staff were "Without a voice" to the administration.

1b. CRM 22 was interviewed on 8/16/17 at 3:30 PM, and had the dual role as Case Manger/Discharge Planner on an inpatient nursing unit. She had been in this role for approximately four months. She stated she "Had to do all of it" for 15 patients, including the initial assessment, utilization review and discharge planning. For this reason, some shortcuts were implemented. Instead of trying to find placement for homeless patients, she would give them a list of shelters and food banks. When asked to tell us about an example patient, she stated "I can't remember them all." She cannot request help from a social worker unless there is substance abuse or a mental health issue. She was asked about a specific patient who had been on her unit for about 6 days and stated she "hadn't gotten to her yet." She further stated she received only one day of training in her new role. She felt that the contracted service for developing a new discharge system had expectations that were not "Realistic".

1c. Three members of the governing body were interviewed on 8/17/17 at 9 A.M. The governing body was asked if they were aware of the number of requests made to the State Agency for patient accomodations in the Emergency Department. They mentioned that the rehabilitation unit at the downtown campus of the hospital had a more complete discharge process and they had not considered implementing a similar process at the main hospital.

1d. Ten utilization review/discharge planning nurses were interviewed on 8/17/17 at 1:30 PM. The nurses felt traveler nurses were not trained enough about patient placement resources in the community. They felt staff had been leaving since the contracted services began. They said that no one had been communicating with them about the new discharge system. Some of the utilization review/discharge planning nurses believed they were doing well with discharges before the contracted service was brought in. They also stated "We should have been involved in the process."



33922

2a. Patient 21 was admitted to the hospital on 8/02/17 with diagnoses which included pneumonia, according to the admission H&P.

On 8/14/17, Patient 21's record was reviewed.

According to the Physician's Progress Note dated 8/4/17, Patient 21 had an empyema ( a condition in which pus gathers in the area between the lungs and the inner surface of the chest wall) and the MD placed a chest tube and ordered antibiotics to treat the infection.

According to the Physician's Progress Note dated 8/6/17, the MD plan was, "continue antibiotics, will likely need prolonged antibiotics for 3-4 weeks."

On 8/7/17, the CRM (CRM 21) completed the CRM Initial Assessment (5 days after the patient was admitted). Under the category of Resources/Referrals, CRM 21 documented Patient 21, "Could possibly need home O2." There was no documentation in CRM 21's assessment which indicated Patient 21 would require long term antibiotics at home."

During an interview on 8/17/17 at 9:25 AM, CRM 22 stated the CRM Initial Assessment should have been completed within 24 hours of Patient 21's admission. CRM 22 stated it was important to start the discharge planning process on admission to ensure a smooth discharge.

2b. Patient 31 was admitted to the hospital on 6/24/2017 with diagnoses to include bilateral testicular and lower back pain, according to the facility's Face Sheet.

A record review was conducted on 8/14/17. Patient 31 also has a history of IV drug abuse and developed abscesses during his hospitalization (6 drains). In addition, the patient is on routine and PRN (when necessary) pain medication.
A review of the interdisciplinary team meeting notes were reviewed, there was inconsistent documentation of the plan for Patient 31.

On 8/17/17 at 10:17 A.M., a concurrent interview and record review was conducted with LN 31. A note was documented by a discharge planner on 6/29/17 at 11:37 A.M., "Anticipated D/C (discharge) to SNF (Skilled Nursing Facility) with Abx (Antibiotics). When asked if the patient was ready to be discharged to a SNF who demonstrated consistent pain medication use amd continual wound drainage output, LN 31 stated, the patient was not ready. There was no documentation by the discharge planner as whether Patient 31 would be discharged to the SNF with wound drains and antibiotics.

According to the facility's policy and procedure dated 2/20/14, entitled Discharge Planning and Instructions, Documentaton of, III. Standards of Practice: "J. CRM assessments and recommendations to the physician and team members are intergrated into the plan for discharge..."

LN 31 stated the discharge nurse was not following the hospital's policy and procedure.

Based on interview, record, and document review, the hospital failed to ensure mechanisms for a transdisciplanary approach during the discharge of patients, was implemented. In addition, initial Case Management assessments (ICMAs) were not completed or within the hospital's expected timeframe for 8 of 56 sampled Patient's (2, 4, 5, 6, 7, 8, 9, 10). The lack of mechanisms and assessments, did not ensure therapeutic discharge goals were communicated across the continuum in an effort to maintain continuity of care in accordance with their own Discharge Planning Procedure.

Findings:

1. On 8/17/17 at 2:30 P.M., an interview, review of 8 sampled patient's ICMAs, and the hospital's Procedure titled Discharge Planning and Instructions, Documentation of, was conducted with a Medical Social Worker (MSW)1. The Procedure indicated, upon admission of each patient, Clinical Resource Management (CRM) staff initiated patient referrals and conducted and documented the ICMA.

Patient 2 was admitted to the hospital on 7/30/17 per the Face Sheet. Patient 2's ICMA was was conducted on 8/4/17.

Patient 4 was admitted to the hospital on 7/31/17 per the Face Sheet. Patient 4's ICMA wasn't conducted until 8/2/17.

Patient 5 was admitted to the hospital on 8/12/17 per the Face Sheet. There was no documented evidence that an ICMA was conducted for Patient 5.

Patient 6 was admitted to the hospital on 8/14/17 per the Face Sheet. There was no documented evidence that an ICMA was conducted for Patient 6.

Patient 7 was admitted to the hospital on 8/13/17 per the Face Sheet. There was no documented evidence that an ICMA was conducted for Patient 7.

Patient 8 was admitted to the hospital on 8/4/17 per the Face Sheet. Patient 8's ICMA wasn't conducted until 8/16/17.

Patient 9 was admitted to the hospital on 8/12/17 per the Face Sheet. Patient 9's ICMA wasn't conducted until 8/14/17.

Patient 10 was admitted to the hospital on 8/8/17 per the Face Sheet. There was no documented evidence that an ICMA was conducted for Patient 10.

2. On 8/15/17 at 10:15 A.M., an interview was conducted with RN 1, a Clinical Nurse Specialist (CNS) 1, the Surgical Acute Care Nurse Manager (NM) 1, and a Nurse Supervisor (NS). RN 1 stated when she discharged patients from the unit, she verified the Physician's order for discharge first and then she called the Physician. In addition, she stated after she called the Physician, the Physician and RN spoke with the patient/responsible party at the bedside and reviewed the discharge plan. Furthermore, RN 1 stated, if any durable medical equipment (DME-i.e wheelchair/walker/cane, bedside commode, portable oxygen, and/or assistance with medication) was needed, the Physician called the MSE who, ensured patients received the DME.

On 8/16/17 at 8:45 A.M., an interview was conducted with RN 3, CNS 1, and the Orthopedic/Neurology unit Manager (NM) 2. RN 3 stated when she discharged patients from the unit, she called a MSW to arrange the patient's disposition and transportation. In addition, RN 3 stated one of her assigned Patient's (8) was supposed to be discharged on 8/16/17, however; the patient's family called the nursing unit and questioned her about the discharge. RN 3 stated she informed the family how she obtained report from the previous night shift and the plan was for the patient to discharge to a nursing home. RN 3 further stated the family expressed concerns because the discharge was not discussed with them and at that point, RN 3 informed the family that a MSW would call the family later that day.

On 8/16/17 at 9:00 A.M., an interview and review of Patient 8's medical record was conducted with MSW 1, NM 2, and CNS 1. MSW 1 stated she had not obtained report from RN 3. During the record review, MSW 1 acknowledged Patient 8 had been admitted on 8/4/17, had a planned discharge for 8/16/17, and no documented evidence that an ICMA had been conducted. MSW 1 stated the hospital's expectation was, the ICMA be conducted and documented within 24 hours of admission and this had not occurred for Patient's 2, 4, 5, 6, 7, 8, 9, and 10. MSW 1 stated the lack of completed assessments did not ensure therapeutic discharge goals were communicated across the continuum in an effort to maintain continuity of care in accordance with their own Discharge Planning and Instructions, Documentation of, Procedure.

On 8/16/17 at 2:30 P.M., a MSW group interview was conducted. During the interview, the MSW's verbalized an increase of weekend patient admission and discharges in comparison with the MSW staffing resources and as a result, the ICMAs were not always completed or completed during the first 24 hours of admission. The MSW's agreed and stated the lack of mechanisms and assessments, did not ensure, therapeutic discharge goals were communicated across the continuum in an effort to maintain continuity of care in accordance with their own Discharge Planning Procedure.



33922

Based on interview and record review, the hospital failed to ensure the IDT coordinated, implemented, and revaluated a discharge plan for 2 of 56 sampled patients (22, 23). In addition, the hospital failed to communicate physician's discharge plan during the IDT meeting for 2 of 56 sampled patients (22,23).

As a result, patients were at risk for delayed discharge planning and prolonged hospital stays.

Findings:

1. Patient 22 was admitted to the hospital on 8/5/17 with diagnoses which included diabetes and an infected wound on her left foot, according the the admission H&P.

On 8/15/17 at 10 AM, Patient 22's record was reviewed.

According to the History and Physical dated 8/5/17, in addition to her infected foot wound, Patient 22 had not been taking her diabetic medication which caused her to have extremely high blood sugars and was severely dehydrated. MD 21 documented Patient 22's additional problems were "... Homelessness: This doesn't help any of her medical problems and my need addressing from social work...Methamphetamine Abuse: She last used methamphetamine about a week ago she says..."

According to the Physician's Progress Notes dated 8/8/17, "... [Patient 22] will need placement to skilled nursing facility with the wound VAC as well as likely long term antibiotics..."

According to the Physician's Progress Notes dated 8/13/17, "... soon to SNF for wound care, PT and OT and IV antibiotics..."

According to the Physician's Progress Notes dated 8/15/17 "... soon to SNF for wound care, PT and OT and antibiotics..."

On 8/6/17, CRM 23 completed Patient 22's CRM initial assessment. CRM 23 documented Patient 22's anticipated discharge needs were PT vs SNF. There was no documentation of Patient 22's methamphetamine abuse.

On 8/14/17, CRM 23 documented an address Patient 22 would be discharged to accompanied by her son.

On 8/16/17 at 2:15 PM, CRM 22 documented, "Current order for discharge to SNF. No accepting facilities at this time..."

There was no documentation in the record which indicated a social work consult was ordered.

On 8/16/17 at 9:35 AM, IDT Rounds were observed. Patient 22's nurse, the charge nurse, the unit Director, and CRM 22 attended IDT rounds. The IDT discussed Patient 22's discharge plan. Patient 22's nurse stated the patient's anticipated discharge date was 8/16/17 and she was unsure if Patient 22 was being discharged home or to a SNF. CRM 22 stated, "Well she has an address, so I think she's going home." The IDT did not discuss any potential discharge needs for Patient 22's substance abuse.

On 8/17/17 at 9:30 AM, IDT Rounds were observed. Patient 22's nurse, the charge nurse, the unit Director, and CRM 22 attended IDT rounds and discussed Patient 22's discharge plans. CRM 22 stated, "He [the patient's MD] decided he wanted her to go to a SNF yesterday and she doesn't want to go." The IDT did not discuss any potential discharge needs for Patient 22's substance abuse.

During a joint interview on 8/17/17 at 9:40 AM, the charge nurse (CN 21) and Unit Director (UD 21) were unaware Patient 22 used methamphetamines and confirmed this was not discussed in IDT Rounds. UM 21 stated Patient 22 had complex discharge needs including homelessness and substance abuse which should have been assessed by a social worker.

During an interview on 8/17/17 at 3:30 PM, CRM 22 stated, she gave Patient 22 a list of homeless shelters and a list of food banks to prepare for discharge. CRM 22 stated, she did not start discharge planning to find Patient 22 placement in a SNF until 8/17/17, 8 days after the MD indicated Patient 22 would need placement in a SNF. CRM 22 further stated, she was instructed not to request social work consults for patients.

2. Patient 23 was admitted to the hospital on 8/10/17 for a right radical mastectomy with placement of a wound VAC (removal of the breast and placement of a drain in the incision), according to the admission H&P.

According to the Physician's Progress Note, dated 8/12/17, "... She will require placement to a SNF and have to return to the operating room on a weekly basis as an outpatient to have the wound VAC change in the operating room."

According to the CRM Progress Note, dated 8/14/17, CRM 23 documented, "... This writer trying to reach her friend to see if patient can stay long enough for removal of wound VAC, then possible referral to recuperative care..."


On 8/16/17 at 9:35 AM, IDT Rounds were observed. Patient 23's nurse (LN 24), the charge nurse (CNN 24) , UD 21, and CRM 22 attended IDT rounds. The IDT discussed Patient 23's discharge plan. LN 24 stated she was concerned about Patient 23's discharge plans because the patient told her she was homeless and stayed with different friends. There was no discussion in IDT Rounds regarding the physician's note to plan for SNF placement or discussion of how Patient 23 would be transported to the hospital for weekly wound VAC changes in the operating room.

On 8/17/17 at 9:30 AM, IDT Rounds were observed. Patient 23's nurse (LN 25), CN 21, UD 21, and CRM 22 attended IDT rounds and discussed Patient 23's discharge plans. CRM 22 stated, "I found out she can go to a SNF." CRM 22 stated she planned to find SNF placement for Patient 23.

During an interview on 8/17/17 at 11:30 PM, CRM 23 stated Patient 23 was staying at a friends house and she attempted to call the friend to see if Patient 23 could return home with her upon discharge but was unable to reach her. CRM 23 confirmed she did not attempt to find Patient 23 placement in a SNF as the physician recommended on 8/12/17. CRM 23 stated she was unfamiliar with Patient 23's insurance plan and was unsure if she would qualify for SNF placement. CRM 23 stated she did not think she was allowed to request a social work referral for Patient 23. CRM 23 confirmed the discharge plan to find Patient 23 placement in a SNF was not initiated until 8/17/17 AM (5 days after the patient's MD indicated she would need to be discharged to a SNF)

According to the hospital's Scope of Service for Clinical Resource Management (CRM), effective 8/10/17, The Case Manager will, "...coordinate hospital unit's daily patient population to endure timely, safe discharges... initiate and coordinate daily patient focused rounds emphasizing follow-up and accountability for interventions including but not limited to MD... Identify avoidable delays in care..."

According to the same policy, "... Medical Social Workers/Case Managers shall be the subject matter experts for providing intensive one-to-one patient counseling for complex biophysical and high risk social issues with particular attention to the following high risk population...substance abusers...indigent/unfunded..."