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Based on interview and record review, the facility failed to ensure data was collected, measured, analyzed, and tracked to monitor the effectiveness and safety of services and quality of care provided by the Food and Nutrition Services department. This failed practice resulted in missed opportunities to identify processes for improvement, and the potential for unsafe practices to go unnoticed and unchanged in the Food and Nutrition Services department.

Findings:

During a review of the Food and Nutrition Services (FANS)'s Quality Assurance and Performance Improvement (QAPI) plan and concurrent interview with the Director of FANS (DFANS) on March 11, 2015, at 12:40 p.m., the DFANS, stated they were just starting their QAPI plan. They had two projects they wanted to study, but they hadn't started to collect data. Neither of the projects addressed the deficient practice observed during this survey.

A review of the FANS's QAPI projects, undated, indicated the department QAPI Project #1 was, "To provide training for Food and Nutrition Department staff to ensure food safety, food quality and customer/patient service." The plan did not indicate what data was going to be collected for analysis. There was no data collected.

The department's QAPI Project #2 was, "Food and Nutrition Services will meet the nutrition needs of the population during the incidence of a disaster as specified by recent AFL (All Facilities Letter) 14-32 released by the California Department of Public Health on December 4, 2014." There no indication in the plan what data was to be collected to study any performance improvement. There was no data collected to analyze.

During a concurrent interview with the DFANS, he stated they were working on developing their QAPI plan. He stated the current plan did not include collecting data related to the issues found during this survey.

Based on record review and interviews, the hospital failed to ensure that nursing followed a physician order when one of 49 sampled patients (Patient 601) had a physician order for daily weights which were not measured on seven of nine days. This failure had the potential to result in inaccurate medication dosage for medications and feedings in which dosages were calculated based on the patient weight. It also had the potential to result in inaccurate nutrition assessments in a patient on TPN (total parenteral nutrition - nutrition delivered directly into the blood).

Findings:

The medical record for Patient 601 was reviewed. The patient was admitted to the hospital on February 22, 2015, with diagnoses including small bowel obstruction, abdominal pain, nausea, vomiting Crohn's disease (an inflammatory bowel disease that is associated with inflammation of the lining of the digestive tract) and colitis (an inflammation of the large intestine).

A review of the physician orders dated March 2, 2015, indicated TPN was ordered because the patient was unable to tolerate oral feeding. Also on March 2, 2015, was an order for nursing to measure weight daily. The patient continued on TPN and daily weights from March 2, 2015, through the review of the medical record on March 11, 2015.

A review of the measured patient weights indicated there was no weight on March 2, 2015. On March 3, 2015, the weight was 49.5 kilograms (kg), on March 4 the weight was 48.6 kg. There was no weights measured on March 5 through 10, 2015.

During an interview with the patient's registered nurse (RN 600), on March 11, 2015, at 9:10 a.m., she stated she was not aware Patient 601 was on daily weights. She stated she would weigh the patient. She returned after weighing the patient and stated the weight was 45.4 kg.

There was a 3.2 kg weight loss between March 4 and 11, 2015. This was equivalent to a seven pound loss during the time Patient 601 was not being weighed, even though there was an order for daily weights.

A review of Patient 601's Nutrition Progress Note (Reassessment), dated March 10, 2015, indicated the patient's estimated daily nutrition needs were based on actual body weight. In addition the glucose infusion rate (a measure of how quickly the patient receives carbohydrates, measured in milligram per kg per minute, in order to prevent elevated blood sugar) was calculated based on the patient's weight. The nutrition reassessment also stated, "Weight has been fairly stable, down about 1 kg in the past week. Meeting previous nutrition goal. Will continue to monitor weight status and tolerance to TPN." On the same day the reassessment was written, the patient had not been weighed for six days.

Based on observation, interview, and record review, the facility failed to ensure one Intensive Care Unit (ICU) Registered Nurse (RN) (ICU RN 1) was competent to care for a mechanically ventilated patient on a propofol drip (a patient requiring a machine to assist with breathing and sedation to manage the level of sedation) prior to assigning the nurse to a patient requiring that level of care (Patient 45). This failed practice resulted in the potential for Patient 45 to receive too little propofol (with potential for increased anxiety and self extubation [pulling out the breathing tube]) or too much propofol (with potential for cardiovascular depression [critically low blood pressure and cardiac arrest]), harm, or death.

Findings:

The Richmond Agitation Sedation Scale (RASS) is a medical scale used to measure the agitation or sedation level of a patient, mostly in mechanically ventilated patients to avoid over and under-sedation. The scale is scored as follows:

(4) Combative - Overtly combative or violent, immediate danger to self;

(3) Very agitated - Pulls on or removes tubes or catheters or has aggressive behavior towards staff;

(2) Agitated - Frequent nonpurposeful movement or patient-ventilator dyssynchrony (breathing against the ventilator);

(1) Restless - Anxious or apprehensive but movements not aggressive or vigorous;

(0) Alert and calm;

(-1) Drowsy - Not fully alert, but has sustained (more than 10 seconds) awakening, with eye contact, to voice;

(-2) Light sedation - Briefly (less than 10 seconds) awakens with eye contact to voice;

(-3) Moderate sedation - Any movement (but no eye contact) to voice;

(-4) Deep sedation - No response to voice, but any movement to physical stimulation; and,

(-5) Unarousable - No response to voice or physical stimulation.

During a tour of the Intensive Care Unit (ICU) on March 9, 2015, at 12:45 p.m., accompanied by the ICU Manager and the ICU Charge Nurse (CN), Patient 45 was observed laying in a bed in room 1112 (a private room) with a sign on the door that read, "Airborne Precautions." Patient 45 was intubated (a tube placed into his mouth, through his vocal chords, and into his trachea to provide an airway) and on a ventilator (a breathing machine). According to the ICU CN, due to the suspicious nature of Patient 45's symptoms, he had been tested for tuberculosis (TB), and was placed in isolation pending the results of the tests. Multiple intravenous (IV) containers were observed hanging on IV pumps, with one container being a glass bottle with a milky white substance (propofol).

A record review indicated Patient 45, a 79 year old male, was admitted to the facility on March 3, 2015, with diagnoses that included respiratory failure and rule out TB. According to the record, Patient 45 was intubated on March 8, 2015, and placed on a ventilator. The record contained two physician's orders dated March 8, 2015, for the use of propofol as follows:

a. Start at 5 mcg/kg/min (micrograms per kilogram per minute), and increase by 5 mcg/kg/min every 5 minutes to a maximum of 100 mcg/kg/min until the RASS target is achieved. Once RASS target is achieved, check RASS (every two hours) and adjust as follows:

b. If RASS is less than the target (patient oversedated), decrease propofol by 5 mcg/kg/min every 5 minutes until target is achieved;

c. If RASS is greater than the target (patient undersedated), increase propofol by 5 mcg/kg/min every 5 minutes until target is achieved; and,

d. Desired RASS target score: negative (-) 2, briefly awakens with eye contact to voice (<10 seconds).

The ICU nurses notes, completed by ICU RN 1, indicated the RASS was measured and propofol was titrated as follows:

1. March 8, 2015, 10 p.m., Patient 45 was intubated and a propofol infusion was started at 5 mcg/kg/min;

2. 10:10 p.m., the RASS was -2 (at target), but the propofol was titrated up to 10 mcg/kg/min;

3. 10:20 p.m., the RASS was -2 (at target), but the propofol was titrated up to 15 mcg/kg/min;

4. 10:41 p.m., the RASS was -2 (at target), but the propofol was titrated up to 20 mcg/kg/min;

5. 11:30 p.m., the RASS was -2 (at target), but the propofol was titrated up to 25 mcg/kg/min;

6. 11:45 p.m., the RASS was -2 (at target), but the propofol was titrated up to 30 mcg/kg/min;

7. March 9, 2015, 3:25 a.m., the RASS was -2 (at target), but the propofol was titrated down to 25 mcg/kg/min;

8. 3:29 a.m., the RASS was -2 (at target), but the propofol was titrated down to 20 mcg/kg/min;

9. 4:03 a.m., the RASS was -2 (at target), but the propofol was titrated down to 15 mcg/kg/min;

10. 4:39 a.m., the RASS was -2 (at target), but the propofol was titrated down to 10 mcg/kg/min;

11. 5:30 a.m., the RASS was -2 (at target), but the propofol was titrated down to 5 mcg/kg/min; and,

12. 7:15 a.m., care of Patient 45 was handed off to the next (day shift) nurse (ICU RN 2).

According to the notes written by ICU RN 1, Patient 45 was at the RASS target (-2) since the time of intubation and initiation of the propofol infusion, but the propofol was titrated multiple times by the nurse anyway, without apparent rationale.

During a concurrent interview with the ICU CN and manager, they stated if the RASS was at -2, the propofol should not have been titrated. They stated if ICU RN 1 had to titrate the propofol up or down, the RASS should have reflected a change in the level of sedation to necessitate the titration.

During an interview with ICU RN 2 (who took over care of Patient 45) on March 9, 2015, at 2:20 p.m., the RN stated Patient 45 was alert and writing notes to him when he first made contact with him that morning. He stated the RASS was 0, not -2 as ICU RN 1 had documented. The RN stated he increased the propofol to get the RASS to the target of -2, which required a rate of 20 mcg/kg/min.

The employee file for ICU RN 1 was reviewed on March 12, 2015. According to the file, the orientation and training received by ICU RN 1 while working at the facility did not include training on use of the RASS or propofol for sedation of a mechanically ventilated patient. There was no evidence ICU RN 1 was competent to care for Patient 45.

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

1. Propofol (a medication used for continuous sedation in critically ill patients while they are on a ventilator [breathing machine]) was titrated (increased and decreased) appropriately to achieve the desired clinical effect according to physician's orders for one patient (Patient 45). This failed practice resulted in the potential for Patient 45 to receive too little propofol (with potential for increased anxiety and self extubation [pulling out the breathing tube]) or too much propofol (with potential for cardiovascular depression [critically low blood pressure and cardiac arrest]), harm, or death; and,

2. Medications were administered in accordance with the facility policy and accepted standards of practice for one patient (Patient 30) who was unable to swallow tablets and had a physician's order for a mechanical soft diet. This failed practice resulted in the potential harm due to choking.

Findings:

1. The Richmond Agitation Sedation Scale (RASS) is a medical scale used to measure the agitation or sedation level of a patient, mostly in mechanically ventilated patients to avoid over and under-sedation. The scale is scored as follows:

(4) Combative - Overtly combative or violent, immediate danger to self;

(3) Very agitated - Pulls on or removes tubes or catheters or has aggressive behavior towards staff;

(2) Agitated - Frequent nonpurposeful movement or patient-ventilator dyssynchrony (breathing against the ventilator);

(1) Restless - Anxious or apprehensive but movements not aggressive or vigorous;

(0) Alert and calm;

(-1) Drowsy - Not fully alert, but has sustained (more than 10 seconds) awakening, with eye contact, to voice;

(-2) Light sedation - Briefly (less than 10 seconds) awakens with eye contact to voice;

(-3) Moderate sedation - Any movement (but no eye contact) to voice;

(-4) Deep sedation - No response to voice, but any movement to physical stimulation; and,

(-5) Unarousable - No response to voice or physical stimulation.

During a tour of the Intensive Care Unit (ICU) on March 9, 2015, at 12:45 p.m., accompanied by the ICU Manager and the ICU Charge Nurse (CN), Patient 45 was observed laying in a bed in room 1112 (a private room) with a sign on the door that read, "Airborne Precautions." Patient 45 was intubated (a tube placed into his mouth, through his vocal chords, and into his trachea to provide an airway) and on a ventilator (a breathing machine). According to the ICU CN, due to the suspicious nature of Patient 45's symptoms, he had been tested for tuberculosis (TB), and was placed in isolation pending the results of the tests. Multiple intravenous (IV) containers were observed hanging on IV pumps, with one container being a glass bottle with a milky white substance (propofol).

A record review indicated Patient 45 was admitted to the facility on March 3, 2015, with diagnoses that included respiratory failure and rule out TB. Patient 45 was intubated on March 8, 2015, and placed on a ventilator. The record contained two physician's orders dated March 8, 2015, for the use of propofol as follows:

a. Start at 5 mcg/kg/min (micrograms per kilogram per minute), and increase by 5 mcg/kg/min every 5 minutes to a maximum of 100 mcg/kg/min until the RASS target is achieved. Once RASS target is achieved, check RASS (every two hours) and adjust as follows:

b. If RASS is less than the target (patient oversedated), decrease propofol by 5 mcg/kg/min every 5 minutes until target is achieved;

c. If RASS is greater than the target (patient undersedated), increase propofol by 5 mcg/kg/min every 5 minutes until target is achieved; and,

d. Desired RASS target score: negative (-) 2, briefly awakens with eye contact to voice (<10 seconds).

The ICU nurses notes, completed by ICU RN 1, indicated the RASS was measured and propofol was titrated as follows:

A. March 8, 2015, 10 p.m., Patient 45 was intubated and a propofol infusion was started at 5 mcg/kg/min;

B. 10:10 p.m., the RASS was -2 (at target), but the propofol was titrated up to 10 mcg/kg/min;

C. 10:20 p.m., the RASS was -2 (at target), but the propofol was titrated up to 15 mcg/kg/min;

D. 10:41 p.m., the RASS was -2 (at target), but the propofol was titrated up to 20 mcg/kg/min;

E. 11:30 p.m., the RASS was -2 (at target), but the propofol was titrated up to 25 mcg/kg/min;

F. 11:45 p.m., the RASS was -2 (at target), but the propofol was titrated up to 30 mcg/kg/min;

G. March 9, 2015, 3:25 a.m., the RASS was -2 (at target), but the propofol was titrated down to 25 mcg/kg/min;

H. 3:29 a.m., the RASS was -2 (at target), but the propofol was titrated down to 20 mcg/kg/min;

I. 4:03 a.m., the RASS was -2 (at target), but the propofol was titrated down to 15 mcg/kg/min;

J. 4:39 a.m., the RASS was -2 (at target), but the propofol was titrated down to 10 mcg/kg/min;

K. 5:30 a.m., the RASS was -2 (at target), but the propofol was titrated down to 5 mcg/kg/min; and,

L. 7:15 a.m., care of Patient 45 was handed off to the next (day shift) nurse (ICU RN 2).

According to the notes written by ICU RN 1, Patient 45 was at the RASS target (-2) since the time of intubation and initiation of the propofol infusion, but the propofol was titrated multiple times by the nurse anyway, without apparent rationale.

During a concurrent interview with the ICU CN and manager, they stated if the RASS was at -2, the propofol should not have been titrated. They stated if ICU RN 1 had to titrate the propofol up or down, the RASS should have reflected a change in the level of sedation to necessitate the titration.

During an interview with ICU RN 2 (who took over care of Patient 45) on March 9, 2015, at 2:20 p.m., the RN stated Patient 45 was alert and writing notes to him when he first made contact with the patient that morning. He stated the RASS was 0, not -2 as ICU RN 1 had documented. The RN stated he increased the propofol to get the RASS to the target of -2, which required a rate of 20 mcg/kg/min.

2. During an inspection of the Step-Down Unit Medication Room March 10, 2015, at 10:20 a.m., the tray holding medications for Patient 30 was observed with the following:

a. Eight prefilled medication cups, each containing valproic acid oral solution (liquid medication used to treat seizure disorders) 250 mg (milligrams)/5 ml (milliliters); and,

b. Two tablets of divalproex 30 mg (pill form medication used to treat seizure disorders).

The electronic Medical Record (eMR) for Patient 30 was reviewed on March 10, 2015. The record contained the following physician's orders:

March 7, 2015,

A. 9 a.m., start divalproex DR (delayed release) tablet 1000 mg (2x500 mg tablets) by mouth twice a day (tablet form);

B. 5:18 p.m., discontinue divalproex tablets (tablet form);

C. 5:30 p.m., valproic acid oral solution 1000 mg (20 ml) by mouth three times a day (change to liquid form);

March 9, 2015,

D. 12:02 p.m., discontinue valproic acid oral solution (liquid form); and,

E. Divalproex DR tablet 1000 mg (2x500 mg tablet) by mouth twice a day to start at 5 p.m. (change back to tablet form).

There was a physician's order on March 8, 2015, for mechanical soft (chopped meat) diet with Nectar-thick liquid (indicating Patient 30 had difficulty swallowing).

The instructions for administration of divalproex DR tablets indicated they were not to be chewed or crushed.

The electronic Medication Administration Record (eMAR) indicated valproic acid oral solution (liquid form) 1000 mg was given to Patient 30 three times on March 8 and once on March 9, 2015, as ordered.

The eMAR also indicated that divalproex DR tablet 1000 mg (tablet form) was given to Patient 30 once (at 5:10 p.m.) on March 9 and once (at 8:19 a.m.) on March 10, 2015.

During a concurrent interview, RN 30 stated she assessed Patient 30 that morning to be unable to swallow tablets, and she administered the oral liquid solution instead of the tablets that were currently ordered.

During a concurrent interview, Patient 30 stated she could not swallow tablets, and that all medications were crushed before she took them the day before.

During a concurrent interview, the Inpatient Pharmacy Supervisor (IPS) acknowledged divalproex (that was administered to Patient 30 the previous day) should not be crushed.

A review of the facility's document titled, "Oral Dosages, Forms That Should Not be Crushed" included divalproex Delayed Release tablets.



25281

Based on observation, interview, and document review, the facility failed to safely control medications and biologicals by failing to ensure:

1. Proper temperature range was maintained and the integrity of medications assured by the Pharmacy within 2 Malignant Hyperthermia (MH) Carts (carts containing medications and supplies to treat a life-threatening increase in body temperature ) The medication Refrigerators were located in the Operating room (OR) and the obstetrics (OB) OR;

2. Two Malignant Hyperthermia (MH) Carts located in Operating Room (OR) and Obstetrics Unit Operating Room (OB/OR) were sealed by a pharmacist after they were opened;

3. The Medication Freezer, located in the pharmacy, had a temperature range that addressed the proper temperatures of all medications stored within the freezer as per the facility's policy and procedure;

4. The Pharmacy 's controlled substance (CS) area , that stored controlled substances, had a chain-linked fenced roof which did not allow access to CS by non-authorized staff; and,

5. Discontinued medications were not available for patient use in the patient medication trays located in the Medication Room. Discontinued medications were not available and mixed with active (current) medications.

These failed practices had the potential for patients to receive ineffective medication and the potential for theft of controlled substances.


Findings:

1. An inspection of the MH Cart was conducted in the OR on March 9, 2015, at 2:45 p.m. The MH medication refrigerator was observed to have ice and frost formation. The observed temperature on the external thermometer read 42°Fahrenheit (F).

During an interview on March 9, 2015, at 3:25 p.m., Facility Services Manager (FSM) stated, the reason for the formation of ice and frost was due to the constant cooling of warm air entering and cold air exiting from the door. The FSM stated, the door was not tightly sealed and the refrigerator door was open for an unknown period of time.

During an interview on March 9, 2015, at 11:40 a.m., the Director of Technical Services (DTS) stated, the medication refrigerators and freezer were monitored by a continuous temperature monitoring system called, Awarepoint. The system alerted the Engineering Department and the Pharmacy when the temperature fell out of a set range.

A review was conducted of the Awarepoint Temperature Regulatory Reports for the MH medication refrigerators. The OR and the OB/OR refrigerators were inspected on March 9, 2015, and the following were noted:

The temperature range for the OR MH medication refrigerator:

February 10, 2015, changed from 36-46°F to 36-47°F.

Since February 27, 2015, temperature reading was consistently higher than 46°F.

March 2, 2015, changed from 36-47°F to 36-48°F.



The temperature range for OB/OR MH medication refrigerator:

Changed numerous times in February 2015

February 9, 36-51°F
February 10, 36-53°F
February 13, 30-54°F
February 19, 35-48°F
February 22, 35-55°F
February 25, 30-48°F


Temperature range for OB/OR MH medication refrigerator March 2015:

March 9, 35-48°F

Other temperature range settings after March 9, 2015, were not consistent with the facility's policy and procedure.

The Awarepoint written Report for OB/OR indicated the temperature was outside the 36-46°F range on many occasions. The set temperature range at the time, did not create an alert or notification to the Engineering Department or the Pharmacy.

The Awarepoint written Report for the OR indicated that since March 2, 2015, the temperature was outside of the 36-46°F range. No alert was created with Awarepoint because the temperature range was set to 36-48°F instead. This range was set higher than the accepted parameters of facility policy.

An interview was conducted on March 10, 2015, at 11 a.m., with the DTS. The DTS explained why the temperature range was adjusted to a wider range. The DTS stated the wider range was set to prevent the alarm from going off while the medication refrigerators were being serviced.

During an interview on March 11, 2015, at 2:30 p.m., the Director of Pharmacy (DOP) was unaware of the numerous changes in temperature range and the out of range temperature during the month of February and March. The DOP could not produce documented evidence pharmacy was notified of the out of range temperature readings for the MH medication refrigerators.

Review of the facility's policy and procedure titled, "Equipment Monitoring System," indicated,

"The Awarepoint Equipment Monitoring System was installed to track ...temperatures of temperature control equipment such as refrigerators and freezers ...

To ensure the proper monitoring, timely alert notification, responding to alert, corrective action and documentation in order to maintain patient, safety along with meeting regulatory compliance ...

A continuous monitoring and alert system that identifies situations when high and low temperature limits are exceeded, will be used for refrigerators, freezers, and other equipment that are used to store medications, vaccines ...that rely on proper temperature maintenance for efficacy and sterility ...

Temperature will be kept within the following ranges: (See Attachment B for References) ...

Medication Refrigerator ...Minimum Temperature ...36°F ...Maximum Temperature ...46°F."

2. An observation was conducted of the MH Cart in OR on March 9, 2015, at 2:45 p.m. A log titled, "Malignant Hyperthermia Cart Monthly Check," was on top of the MH Cart.

A review of the log, indicated on the following dates: January 15, and 17, and February 9 and 22, in the year 2015, the MH Cart was opened and sealed with new locks by nurses and Pharmacy Technicians.

During a concurrent interview, RN 2 stated the log had the signatures of the unit nurses indicating the cart was sealed with a new lock by non-pharmacist staff members.

During a concurrent interview, the DOP stated the final seal of the MH Carts needed to be completed by a pharmacist.

During a concurrent interview, the DOP was unaware the MH Cart was opened and sealed by nurses and Pharmacy Technicians.

Review of the facility's policy and procedure titled, "Malignant Hyperthermia Cart," indicated,

"The RN/anesthesia technician will inspect the cart once a month for inventory, expired drugs, and other needed equipment."

3. An inspection of the Pharmacy's IV Room, was conducted on March 9, 2015, at 11:10 a.m. An observation of the medication freezer temperature read -22.5 degree Celsius (C).

The medication freezer contained frozen Vancomycin (an antibiotic) in premixed bags and Cervidil (medication used to induce labor) in which the manufacturer recommended temperature range was -20 to -10 °C.

Concurrent interviews were conducted with the Inpatient Pharmacy Supervisor (IPS), and the DOP. The IPS confirmed the temperature of the medication freezer had read -22.5 degree C. The DOP acknowledged the temperature reading was below the range of -20 to -10 °C as required in the policy.

During an interview on March 9, 2015, at 11:40 a.m., the DTS stated the medication freezer in the Pharmacy was monitored by a continuous temperature monitoring system called, Awarepoint. The system contained an alarm to notify the Engineering Department when the temperature fell out of set range.

Review of the facility's policy and procedure titled, "Equipment Monitoring System" indicated,

"A continuous monitoring and alert system that identifies situations when high and low temperature limits are exceeded, will be used for refrigerators, freezers, and other equipment that are used to store medications, vaccines...that rely on proper temperature maintenance for efficacy and sterility.

Temperature will be kept within the following ranges...Medication Freezer ...Minimum Temperature (Celsius) ...-20°C ...Maximum Temperature (Celsius) ...-10°C. Inpt (Inpatient) Pharm(acy) Baxter Frozen Freezer ...Below -20°C"

4. An inspection of the Pharmacy was conducted on March 9, 2015, at 1:50 p.m. An area designated as CII Safe was used for storing controlled substances (CS). The area was enclosed by solid vertical walls and a lockable door within the Pharmacy. The ceiling of the enclosed area was covered with an iron chain-link fence. The top shelves of the CII Safe were stocked with various CS that were accessible from the ceiling through the holes in the fence.

During a concurrent interview, the DOP, and the Registered Pharmacist( RPH 1) stated only pharmacists have access to the CII Safe. The DOP and RPH 1 acknowledged controlled substances could be accessible from the open chain ceiling of the CII Safe.

Review of the facility's policy and procedure titled, "Controlled Substances" indicated,

"All Controlled Substances are stored in the Pharmacy narcotic vault."

Review of the facility's policy and procedure titled, "Medication Storage" indicated,
"All drugs and biologicals must be secure, and locked when appropriate. Drugs listed in Schedules II, III, IV, and V of the Comprehensive Drug Abuse Prevention and Control Act of 1970 must be locked at all times...Only authorized personnel may have access to locked areas."

5. During inspection of the Medication Room located in the Step-Down Unit on March 10, 2015, at 10:20 a.m., a patient-specific tray that contained medications for Patient 30 was observed. The tray included eight cups containing valproic acid oral solution (medication used to treat seizure disorder) 250 milligrams (mg- solid measurement)/5 milliters (ml-liquid measurement) and two tablets of divalproex 500 mg (medication used to treat seizure disorder).

On March 10, 2015, at 10:30 a.m., the patient's electronic Medical Record (eMR) was reviewed and the following were noted:

Patient 30 had a physician order dated on March 7, 2015, at 5:30 p.m. for valproic acid oral solution 1000 mg (20 ml) by mouth three times a day. The order was discontinued on March 9, 2015, at 12:02 p.m.

On March 9, 2015, Patient 500 had a physician's order for divalproex delayed release (DR) tablet 1000 (2x500 mg tablet) by mouth twice a day to start at 5 p.m.

During a concurrent interview, the Inpatient Pharmacy Supervisor (IPS), stated the Pharmacist made rounds once a day around 11 a.m. Each day discontinued medications from the patient-specific trays were removed and then filled with the active (current) medications for patients for the next 24 hours. All discontinued medications would be taken back to the pharmacy. The IPS acknowledged discontinued medications could be inside the patient's tray mixed with active medications for up to 24 hours because rounds were made only once a day.

Review of the facility's policy and procedure titled, "Medication Storage," indicated,

"All discontinued medications shall be returned daily from the nursing unit to the Inpatient Pharmacy."

Based on observations, interviews and record reviews the hospital failed to ensure the Director of Food and Nutrition Services (DFANS) was effective in the daily management of the dietary services when:

1. Unsafe food handling practices were observed in the department. (Cross refer A 749);

2. The hospital's diet manual was not made available to the nursing and medical staff. (Cross refer A 631); and

3. The dietary service department did not measure, track and analyze quality indicators for deficient and unsafe food handling practices identified during the survey to ensure high risk, problem prone processes were studied;

These failures had the potential to result in food borne illness and allow deficient practices to continue. These failures also had the potential to provide inaccurate diet information to the nursing and medical staff during their evaluation and assessment of a medically vulnerable patient population in a hospital with a licensed bed capacity of 131.

Findings:

1. During an observation of the kitchen and nursing unit nourishment room refrigerators throughout the day, on March 9, 2015, multiple unsafe food handling practices were identified:

a. Perishable patient food was not held at safe temperatures in two of three nursing unit refrigerators (2nd and 4th floors);

b. The ice machine in the kitchen was not clean;

c. Dietary Staff did not perform proper hand washing after placing a hair net on and before handling clean patient dishes;

d. During manual dishwashing, pots and pans were not completely submerged in the sanitizer per manufacturer's instructions;

e. In the walk-in refrigerator, raw beef was stored over liquid eggs in a way that did not prevent the juices from the beef from dripping on the egg product; and

f. The can opener blade was worn with a dried black residual around the cutting blade.

During an interview with the DFANS, on March 9, 2015, at 10 a.m., he stated he took over as Director in December, 2014. Before starting at the hospital in December 2014, he was the interim Director of FANS (Food and Nutrition Services) at a small community hospital for three months. Prior to that, he did clinical nutrition and did not have other director of dietary service experience. He stated he wanted to learn from this survey.

On March 9. 2015, throughout the day, the DFANS was unable to answer questions regarding the daily operations of the kitchen. When asked if there was a thermometer in the dry food storage room, he didn't know. When asked if the raw beef in the cook's walk-in refrigerator was stored correctly, he asked the executive chef to answer how it should be stored. He was unable to state the policy for cleaning of the can opener. He did not know how often the ice machine was cleaned by the engineering staff. He was not aware that the centralized refrigerator temperature monitoring system for the nursing unit nourishment refrigerators was set for an acceptable range of 34 to 42 °F before alarming, above the food safety range.

During an interview with the DFANS, on March 9, 2015, at 1:45 p.m., he stated the first month he was at this facility, the dietitian was on a leave of absence and he had to cover her clinical responsibilities. After that, he was focused on revising the department policy and procedures, scheduling staff, and working on the budget.

2. During an observation of the nursing units for the hospital's diet manual and concurrent interview with the DFANS, on March 12, 2015, between 8:40 and 9 a.m., the hospital's current diet manual was not available to the nursing and medical staff. The DFANS stated the manual that was present was the old diet manual. The manual indicated it was last revised July, 2009, greater than five years ago.

During an observation of the FANS office and concurrent interview with Dietary Staff 2, the same day, at 9 a.m., she was able to locate a manual and stated it was the hospital's current diet manual.

During a concurrent interview with the DFANS, he was unable to explain why the hospital's current diet manual was not available to the nursing and medical staff on the nursing units.

3. During a review of the FANS's QAPI (Quality Assurance and Performance Improvement) plan and concurrent interview with the DFANS on March 11, 2015, at 12:40 p.m., he stated they were just starting their QAPI plan. They had two projects they wanted to study, but they hadn't started to collect data. Neither of the projects addressed the deficient practice observed during this survey.

A review of the FANS's QAPI projects, undated, indicated the department QAPI Project #1 was, "To provide training for Food and Nutrition Department staff to ensure food safety, food quality and customer/patient service." The plan did not indicate what data was going to be collected for analysis. There was no data collected.

The department's QAPI Project #2 was, "Food and Nutrition Services will meet the nutrition needs of the population during the incidence of a disaster as specified by recent AFL (All Facilities Letter) 14-32 released by the California Department of Public Health on December 4, 2014." There no indication in the plan what data was to be collected to study any performance improvement. There was no data collected to analyze.

During a concurrent interview with the DFANS, he stated they were working on developing their QAPI plan. He stated the current plan did not include collecting data related to the issues found during this survey.

Based on observation, interviews and record reviews, the hospital failed to have a current therapeutic diet manual available on the nursing units for the medical and nursing staff. The diet manual in the nursing units was over five years old and was last approved by dietitian and medical staff in 2011. This failure had the potential to provide inaccurate diet information to the nursing and medical staff during their evaluation and assessment of patients.

Findings:

During an observation in the medical-surgical nurse's station and concurrent interview with RN 601, on March 12, 2015, at 8:40 a.m., RN 601 located the diet manual for the nurses station.

A review of the "Clinical Diet Manual ...15th Edition," indicated it was last revised in July, 2009. The signature sheet for the diet manual indicated, "This manual has been approved:" with signatures from various hospital leadership, including a former dietitian and the area Medical Director. The signature page was dated 2011.

During an observation in the ICU (Intensive Care Unit) nurse's station and a concurrent interview with RN 602, the same day, at 8:50 a.m., RN 602 located the same diet manual with the same signature page, that was found in the medical-surgical nurse's station.

During an observation and concurrent interview with Dietary Staff (DS)2, in the Food and Nutrition Services (FANS) office, on March 12, 2015, at 9 a.m., DS 2 located a different diet manual titled, "Manual of Clinical Nutrition Management © 2014." It contained a signature page that included the signature of the medical director and the dietitian, dated 2014.

During an interview with the Director of Food and Nutrition Services, on March 12, 2015, at 9 a.m., he was unable to state why the current diet manuals were not available to the nursing and medical staff, on the nursing units.

Diet Manuals provide information regarding the hospital's diets so the nursing and medical staff can perform accurate evaluations and assessments of the patients related to their diets.

Based on observation, interviews and record reviews, the hospital failed to develop an effective infection control surveillance system for identifying unsafe food handling practices when:

1. Perishable patient food was not held at safe temperatures in two of three nursing unit refrigerators (2nd and 4th floors);

2. The ice machine in the kitchen was not clean;

3. Dietary staff did not perform proper hand washing after placing a hair net on and before handling clean patient dishes;

4. During manual dishwashing, pots and pans were not completely submerged in the sanitizer per manufacturer's instructions;

5. In the walk-in refrigerator, raw beef was stored over liquid eggs in a way that did not prevent the juices from the beef from dripping on the egg product;

6. The can opener blade was worn with a dried black residual around the cutting blade; and

7. The patient nourishment rooms were not kept clean.

This failure to develop and an effective infection control surveillance system for safe food handling had the potential to result in food borne illness in a medically vulnerable patient population.

Findings:

1. During an observation of the patient nourishment refrigerator on the second floor, on March 9, 2015, at 3:25 p.m., the refrigerator was small and packed full with juices, milk cartons and meat sandwiches. It was filled full enough to prevent adequate air circulation and did not feel cold enough. There was no thermometer in the unit. The temperature of one of the milk cartons was taken which measured 44.4 °F (Fahrenheit). The temperature of a tuna salad sandwich was measured at 52.1 °F.

During an observation of the patient refrigerator on the fourth floor, the same day, at 3:40 p.m., the refrigerator was also small and packed full with juices, milk cartons and meat sandwiches. It was filled full enough to prevent adequate air circulation and did not feel cold enough. There was no thermometer in the unit. The temperature of one of the milk cartons was taken which measured 42.1 °F (Fahrenheit). The temperature of a tuna salad sandwich was measured at 51.1 °F.

According to the 2013 Food and Drug Administration (FDA) Food Code, cold holding for time and temperature controlled for safety (TCS) food (food that can cause food borne illness if not stored at proper temperatures) is 41 °F or less to prevent bacteria from growing to sufficient numbers to cause food borne illness.

During a concurrent interview with the Director of Food and Nutrition Services (DFANS), he stated one of his staff stocked the refrigerators with the food earlier that day. He didn't know the time the refrigerators were filled with the patient food, but he stated that the staff who stocked the refrigerator left at 2 p.m. During a follow-up interview with the DFANS the same day at 4 p.m., he stated his staff stocked the refrigerator at 1:30 p.m.

During an interview with Engineering Staff (ES) 1, on March 9, 2015, at 3:40 p.m., he stated the temperatures of the refrigerators were monitored remotely by a centralized system that monitored the temperatures every 7 minutes. ES 1 stated, the system alarmed if the temperature was out of range for 30 minutes or more. He further stated the temperature range set for the patient food refrigerators should be 34 to 41 °F and he had not received an alarm indicating the refrigerators were out of the temperature range. He verified the sensors used to measure the temperature in the refrigerators were at the back of the refrigerator adjacent to the condenser which was the coldest part of the unit. He verified the refrigerators were packed with food which did not allow for proper air circulation and may have prevented the patient food from reaching safe temperatures.

A review of the "Temperature History," report of the patient nourishment refrigerator on the fourth floor indicated, on February 25, 2015, the refrigeration temperature reached 42.5 °F. It remained above the acceptable maximum temperature of 41 °F for 4 hours. Also noted, the acceptable temperature range for the refrigerator was adjusted to alarm at 42 °F instead of 41 °F the same day.

The patient TCS food had been stored at unsafe temperatures for two hours when observed. The hospital did not have an effective system in place to ensure the temperature of the food in the refrigerators was maintained at 41 °F or below to prevent food borne illness.

2, During an observation of the ice machine in the kitchen, on March 9, 2015, at 10:15 a.m., a clean paper towel swipe of the bottom of the water trough, inside the ice maker, produced a moderate amount of peach/brown/black colored residue and a white crusty residue.

During a concurrent interview with Engineering Staff (ES) 2, he stated the last time he cleaned the ice machine was February 18, 2015. He couldn't explain why the ice machine had accumulated this residue in less than three weeks and the ice machine was scheduled for preventative maintenance (PM) every three months.

A review of the PM report for the ice machine indicated the last maintenance was completed on February 18, 2015. Steps for cleaning the ice machine were listed. Step number five indicated, "Clean trough and drain hole." Step number nine indicated, "Check unit for calcium deposits. Clean and/or replace as necessary."

According to the 2013 FDA Food Code, in equipment such as ice bins and enclosed components of equipment such as ice machines, surfaces shall be cleaned at a frequency necessary to preclude accumulation of soil or mold.

3. During an observation in the dishwashing room of the kitchen, on March 9, 2015, at 12:30 p.m., Dietary Staff 1 (DS 1) demonstrated how the dish machine worked. During the demonstration, her hairnet fell off so she replaced it. She then proceeded to handle clean patient dishes without washing her hands. After she was reminded by the Regional FANS Director to wash her hands, DS 1 washed her hands rubbing her hand with soap and water for approximately 3 to 5 seconds before rinsing and drying. She returned to handling clean dishes.

During a concurrent interview with DS 1, she said she should have rubbed her hands with soap and water for 20 seconds before rinsing. She stated she didn't wash her hands for the required amount of time.

A review of the hospital's "Associate Food Safety and Sanitation Handbook," (undated) indicated dietary staff must always wash their hands after touching hair. It also indicated the procedure was to wet hands, apply soap and water, vigorously scrub hands and arms for at least 20 seconds, rinse thoroughly and dry hands with a paper towel.

4. During an observation and concurrent interview with DS 1, on March 9, 2015, at 11 a.m., DS 1 was observed manually washing pots and pans used to cook patient food. Pots and pans were arranged in the sanitizer sink in such a way that many were above the water line or just touching it. DS 1 stated that the pans should be completely submerged in the sanitizer.

A review of the sanitizer manufacturer's instruction indicated dishes should be completely submerged in the sanitizer solution for 30 seconds for effective sanitizing.

During a concurrent interview with DFANS, he stated the pots and pans should be completely submerged in the sanitizing solutions. He was unable to state why the pots and pans were not submerged in the sanitizer.

5. During the tour of the kitchen in the walk-in cook's refrigerator on, March 9, 2015, at 10:45 a.m., a cardboard box containing raw beef roasts was observed on a shelf above a liquid egg product. There was no pan or tub under the beef to prevent it from dripping onto the shelf below.

During concurrent interviews with the DFANS and the Executive Chef, the DFANS stated the meat should be stored on the bottom shelf. The Executive Chef stated the beef should be stored on a sheet pan to prevent dripping onto the food below it.

A review of the hospital's policy titled, "Food and Supply Storage Procedures," dated January, 2014, indicated for refrigerated storage, "Separate refrigerated goods by category (meat, fish, poultry, dairy produce)." The beef should have been separated from the egg product.

6. During the tour of the kitchen and concurrent interview with the DFANS, on March 9, 2015, at 11:10 a.m., the can opener blade was noted to be worn with nicks on the surface and a black dried residual crusted on it. After asking the executive chef, the DFANS stated the can opener should be cleaned after each use. He stated the blade should be changed when it is worn. He could not explain why the can opener blade was worn and not clean.

A review of the FANS document titled, "2015 Facilities and Equipment Cleaning Schedule ..." indicated the can opener should be cleaned after each use.

According to the 2013 FDA Food Code, cutting or piercing part of can openers shall be kept sharp to minimize the creation of metal fragments that can contaminate food when the container is open. It further indicated multi-use food contact surfaces shall be smooth and free of crevices. Surfaces which have imperfections such as cracks, chips or pits allow microorganisms (bacteria) to attach and form biofilms (a thin layer of microorganisms adhering to the surface of a structure) that can release pathogens (disease causing bacteria) in the food. Biofilms are highly resistant to cleaning and sanitizing efforts.

7. During an observation in the first floor patient nourishment room, on March 9, 2015, at 3:15 p.m., a moderate amount of dust was noted on the top of the ice machine. Also noted was a significant amount of dust on top of the refrigerator where patient food was stored.

During a concurrent interview with the Director of Environmental Services, he stated the dust should have been cleaned by his staff. He stated, it was his responsibility to ensure his staff properly cleaned the nourishment area. He could not explain why there was a significant accumulation of dust on the refrigerator.

According to the 2013 FDA Food Code, nonfood-contact surfaces of equipment shall be kept free of an accumulation of dust, dirt, food residue, and other debris.

During an interview with the Infection Control Preventionist, on March 11, 2015, at 12:05 p.m., she stated she does quarterly surveys in the Food and Nutrition Services department and informal monitoring in between. She stated she had identified some issues in the past and the executive chef submitted a plan of correction immediately and the issues were corrected. She stated she had not found the issues that were found during this survey.