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Based on observation and interview, the hospital failed to have emergency medications readily available for treating emergencies when the malignant hyperthermia (MH-life threatening condition triggered by exposure to anesthesia drugs) cart was locked, which prevented immediate access in case of an emergency.

Findings:

An observation on 5/24/16, at 2:56 PM, revealed that the emergency medication supply for MH cart was locked. The Director of Pharmacy (DOP) tried to open the MH cart with one of his keys. The DOP unlocked the cart after about 3-5 minutes.

During an interview with the DOP, on 5/24/16, at 3:01 PM, the DOP stated that it did take him a little while to open the MH cart. He acknowledged that in case of an emergency the extra few minutes it would take to unlock the cart could have a delayed response in responding to an emergency.

Based on observation, interview, and medical record review, the hospital failed to provide a safe and sanitary environment to provide patient care as evidenced by the hospital's failure to:

1. Separate sharps and medication from other medical waste. (Refer to C-0223)

2. Appropriately store medications and secure one oxygen tank in the Radiology department. (Refer to C-0224)

3. Maintain a clean and orderly environment in the dietary, radiology, housekeeping and maintenance departments and the closed surgical area. (Refer to C-0225)

4. Ensure emergency food was nutritionally adequate for patients. (Refer to C-0230)

The cumulative effective of these systemic failures resulted in the hospitals inability to ensure a safe and sanitary environment, placing all patients and staff at risk of being exposed to infectious and communicable diseases.

Based on observation, interview, and record review, the hospital failed to separate sharps and medication from other medical waste. This failure had the potential to place all patients and staff at risk of being exposed to infectious and communicable diseases.

Findings:

During a concurrent observation and interview with Radiology Technician (RADT) 1 and Manager Environmental Services (MEVS), on 5/23/16, at 12:05 PM, in Radiology Room One, it was noted a red bag inside a biohazard waste container (any waste with infectious materials or potentially infectious substances such as blood). The following items were observed inside the red bag: six syringes (two without needles and four with needles attached), one empty vial of Lidocaine (medication used to numb the skin) injectable; several used paper towels, an used drinking cup, and three blue disposable gloves. Both RADT 1 and MEVS stated biohazard waste such as any dressing soaked in blood should be placed in the biohazard containers. The MEVS stated needles or syringes should not be discarded in the biohazard waste.

During a concurrent observation and interview with the Manager of Med-Surg (MMS) and Intensive Care Unit (ICU), on 5/25/16, at 1:30 PM, in the ICU, it was noted a red biohazard waste container lined with a red plastic bag contained an empty glove box, package wrappers for patient care items, a bottle cap, one used diaper, and two syringes with normal saline flush solution (a salt solution used to flush tubes to prevent blockage and remove medicine left in the tube). The MMS stated the syringes should not be disposed of in the container.

The hospital policy and procedure titled "Medical Waste Management Plan", dated 9/14/15, was reviewed. It indicated: "Sharps waste (needles, syringes, blades) are to be segregated from all other types of medical waste and placed in a rigid, puncture resistant sharps container. Sharps shall not be placed into any red bags. Pharmacy waste (medications) shall be placed in a blue pharmacy bag."

Based on observations, interviews, and document reviews, the hospital failed to ensure medication were stored at an appropriate temperature as evidence by:

1. The hospital pharmacy staff could not ensure the temperatures in the medication refrigerator were kept accordance to the hospital's policy: between 2.2 degrees Celsius (C) and 7.7 C.

2. The hospital staff did not store Dinoprostone (also called Cervidil, a medication used to induce labor) in accordance with the manufacturer's recommendations of -4 degrees Fahrenheit (F) and 14 F.

3. The hospital operating room (OR) staff did not record and monitor refrigerator temperatures daily in accordance with the hospital policy.

4. Patient medication was not stored according to the manufacturer's instructions. Staff medications were stored with patient care supplies and chemicals.

5. Intravenous solutions for patient use were not stored in a safe and sanitary manner.

6. One oxygen tank in the radiology department was not properly secured.

These failures had the potential for the hospital staff to administer compromised and/or deteriorated medications to the patients. Unsecured oxygen tank had the potential to assist combustion in case of fire.

Findings:

1. A review on 5/23/16 of the hospital policy titled "Monitoring of Temperature of Food and Medication Refrigerators", dated 10/27/15, indicated "All medications which require storage under refrigeration shall have those storage conditions continually monitored to ensure that those storage conditions are met. Refrigerator temperature shall be between 2.2 degrees C (26 degrees F) and 7.7 degree C (46 degrees F)..."

During an observation on 5/23/16, at 4:45 PM, in the pharmacy, the medication refrigerator thermometer temperature recorded 11.4 C. The refrigerator door was slightly opened and staff walked by without noticing the refrigerator temperature excursion.

During an observation on 5/24/16, at 9:30 AM, in the pharmacy, the medication refrigerator door alarm was tested and the refrigerator door was left opened. The alarm never went off.

During an interview with the Director of Pharmacy (DOP), on 5/24/16, at 9:30 AM, the DOP stated it looked like the alarm was not working. He also stated the alarm was disabled and he did not know why it was disabled.

2. A review on 5/23/16 of the manufactures' insert for Dinoprostone (Cervidil - a medication used to soften a cervix), indicated "Cervidil is a vaginal insert...store in a freezer: between...-4 F and 14 F...Cervidil is packed in foil and is stable when stored in a freezer ..."

During an observation on 5/24/16, at 2:15 PM, in the Obstetrics Department (OB), several boxes of Dinoprostone were in the freezer. There was a freezer thermometer with recorded temperature ranges of -10 F and 16 F. The boxes of Dinoprostone were stored between -10 F and 16 F since the last time the thermometer was reset. The Dinoprostone was stored in temperatures that were too cold and too warm.

During an observation on 5/24/16, at 3:22 PM, in the Pharmacy, several boxes of Dinoprostone were in the freezer. There was a freezer thermometer with recorded temperature ranges of -12 F and -8 F. The boxes of Dinoprostone were stored between -12 F to -8 F since the last time the thermometer was reset. The Dinoprostone was stored in temperatures that were too cold.

3. A review on 5/24/16 of the hospital policy titled "Monitoring of Temperature of Food and Medication Refrigerators", dated 10/29/15, indicated "The temperature of each medication refrigerator is checked and recorded daily when the units are open. Medication refrigerators that are used for the storage of vaccines must have temperatures recorded twice a day... All medication refrigerators will be monitored, and will have temperatures recorded."

A review on 5/24/16 of the OR refrigerator record for 4/2016 and 5/2016, indicated several un-documented medication refrigerator temperatures. On 4/5, 4/7, 4/12, 4/13, 4/14, 4/15, 4/18, 4/20, 4/22, 4/26, 4/28, and 4/29, there were no documented refrigerator temperatures. On 5/5, 5/16, 5/19, and 5/20, there were no documented refrigerator temperatures.

During an interview with the OR Manager (ORM), on 5/25/16, at 9 AM, the ORM stated all the medications that were in the refrigerator were mostly used for anesthesia. She also stated that her staff did not document the medication refrigerator temperatures. She said that she did not know why they did not document the daily medication refrigerator temperatures.



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4. During a concurrent observation and interview with the Radiology Supervisor (RADSUP), on 5/23/16, at 12:45 PM, in the Radiology storeroom/breakroom, approximately 20 containers for Barium Sulfate (a liquid that highlights certain areas of the body to create a clearer picture during X-rays) were found stored inside a countertop refrigerator. The instructions for use on the containers indicated the controlled storage room temperature range should be 68-77 degrees F and to protect the medication from freezing. The temperature of the refrigerator was 35.56 degrees F. The RADSUP stated the containers are kept cold so the Barium is easier for the patients to swallow. On two shelves in an unlocked cabinet, staff medications (Tylenol Extra Strength, Kaopectate, Pepto-Bismol Max) were stored next to Lemon Drops, Lifesavers, a salt shaker and a lint roller. Office supplies were stored together with reference books and a bottle of Soda Lime CO2 Absorber (a mixture of granules used to remove chemicals from certain gases). The RADSUP stated the personal staff medications should not be there and would be removed.

5. During a concurrent observation and interview with the Manager of Environmental Services (MEVS), on 5/25/16, at 3:30 PM, in the closed surgery/recovery area being used for general hospital storage, two dusty, corrugated cardboard shipping cases containing 24 bags of Lactated Ringers (a solution given to patients through the veins used to stabilize bleeding and replace body fluids after injury, surgery, or burns) intravenous fluid (a solution given to a patient directly into a vein) were on the floor and stacked on top of each other. The bottom case and three bags of intravenous fluid were crushed. The MEVS stated "the hospital never asked me to clean the closed surgery/recovery area."

During a concurrent observation and interview, with the Director of Obstetrics (DOB), on 5/24/16, at 2:30 PM, in the Obstetrics Department, two bags of Ceftriaxone (antibiotic) prepared by the pharmacy for intravenous use, were located on a shelf in an unlocked cabinet next to six boxes containing AA batteries, AAA batteries, four loose batteries, and three containers of baby powder. The DOB stated the medication should not be on the shelf and did not know why the Pharmacy left them there "when they know they go in the med room."

6. During a concurrent observation and interview with the Radiology Technician (RADT) 2 on 5/23/16, at 12:30 PM, in Radiology Room Two, one unsecured oxygen tank was found in a corner of the room. RADT 2 stated the oxygen tank should be secured in a tank holder or tank rack.

Based on observation, staff interviews, and review of hospital policies and procedures, the hospital failed to ensure the dietary, radiology, housekeeping and maintenance departments and the closed surgical/recovery area were maintained in a clean and orderly environment when:

1. The kitchen was not maintained in a clean and orderly fashion to enable staff to function safely. The equipment, floors and supplies in the kitchen were visibly soiled, grimy and unclean to touch. The finish of non-food contact surfaces were worn making them unable to be cleaned effectively, and there were rags on the floor and on pipes.

2. The radiology room and supply areas were not maintained in a clean, orderly and sanitary manner.

3. The staff in the clean linen storage area was not properly attired with their head coverings. The clean linen storage was unsanitary with dust, damaged ceiling, and air vents which were improperly secured.

4. The closed surgery/recovery unit on the second floor was not at an appropriate temperature, had an offensive odor; there was improper storage of sterile and unsterile items, staff items and safety equipment.

These failures had the potential to adversely affect all patients, staff and visitors because they posed the risk of fire; risk of falls to staff from unkept floors and cluttered access to areas; infection control risk; a source of pests that are disease causing, such as roaches and mice.

Findings:

1. During the tour of the hospital kitchen on 5/23/16, which began at 1:30 PM, the following was observed:

At 1:30 PM the microwave was visibly soiled with a dried-on bright yellow food spill on the roof of the microwave oven.

At 1:35 PM, an open plastic bag with disposable containers was observed underneath the steam table. The opening of the bag was on the floor.

At 1:39 PM, a buildup of peeling, dried-on, burnt food spill was observed in the bottom oven next to the two compartment sink.

At 1:41 PM, a blue rag was observed on the floor in the pots and pans area of the kitchen, which posed a trip hazard.

At 1:48 PM, a white towel (rag) was observed on the pipe in between the wall and the salad bin. In the same area, (salad preparation) there was a stainless steel cart that had old buildup of black grimy residue, with dried food debris on both shelves of the cart.

At 1:50 PM, the white colored salad bin had visible dark colored stained, grimy buildup of dirt on the lid, exterior and inside of the bin, which contained several heads of lettuce for use.

At 1:52 PM, there was oily residue on the floor and wheels of the double oven. The floor next to the oven and under the spice cart was visibly soiled, grimy, with dried food debris.

At 2:15 PM, the emergency supplies plastic container stored on a shelf underneath the table in the tray assembly was visibly soiled with a light brown dried-on spill. The finish, brown colored, on the shelf was worn exposing a metallic color. The lack of a smooth surface had the potential to prevent proper cleaning and sanitizing of surfaces.

At 2:17 PM, the floor next to the ice machine was observed to have food debris and buildup of dirt.

At 2:30 PM, the food delivery cart was observed to have a dark brown dried-on spill on the lower shelf and exterior. The Food Service Manager (FSM) stated it was coffee from the morning meal.

On 5/23/16, at 1:55 PM, during an interview with Food Service Assistant (FSA) 1, who was present in the salad area when the observations were made, he stated the salad bin and lid had been cleaned the week before and the "dirt just did not come off." The FSA 1 demonstrated how he cleaned the bin with a soft sponge. Above the sink in the salad preparation, a container of a cleaner (chlorine based abrasive powder cleaner) was observed. The FSA 1 stated he "did not know he could use it" [the chlorine based powdered cleaner] to remove the stains.

During an interview with the FSM, who was present during the tour, on 5/23/16, at 2 PM, she stated the staff followed a cleaning schedule and that some of the items were cleaned according to schedule. She further stated she previously had a position assigned to the cleaning of the equipment and general cleaning of the kitchen but when she was short staffed some of those duties were not maintained.

The hospital policy and procedure titled "Sanitation," dated 2015, indicated "...the maintenance department will assist the dietary...in doing janitorial duties which dietary employees cannot do." During an interview with the Manager of Environmental Services (MEVS), on 5/25/16, at 9 AM, he stated cleaning dietary was not part of the maintenance department responsibilities.

The hospital policy titled "General Appearance of the Dietary Department," dated 2015, indicated "Sweep the floor pushing all debris forward...Mop under and around equipment, along the walls and in corners. Wipe all splash and soil marks from baseboards and walls. Wipe up all spills as they occur."



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2. During an observation and interview with Radiology Technician (RADT) 1, on 5/23/16, at 12:10 PM, in Radiology Room One, the floor was noted to have several spots with build up dust, paper clips, rubber bands, plastic bottle caps, and tubing connectors. RADT 1 stated the floor was dirty and Housekeeping was supposed to clean it. An equipment shelf, in Radiology Room One, located next to a wall was covered with thick dust and one dead bug. On the shelf was an open suction tubing (flexible plastic tubing used to suction a patient). The tip of the tubing used for patient care was laying in the dust approximately 2 inches from the dead bug RADT 1 stated the radiology staff had cleaned the equipment and the suction tubing should have been discarded.

During a concurrent observation and interview with RADT 1, on 5/23/16, at 12:35 PM, in Radiology Room One, the wall above the countertop work space had peeling paint approximately 12 inches in height and 18 inches in width. RADT 1 stated the paint was damaged when paper flyers were removed. A plastic canister holder approximately 4 inches in height and 6 inches in width, screwed into the wall in Radiology Room One, was covered with dust. RADT 1 stated the room was used for procedures including Myelograms (a procedure that combines the use of a form of X-rays and injections of contrast [dye] to evaluate the spinal cord, nerve roots, and spinal lining). RADT 1 stated housekeeping was supposed to clean the walls.

During an interview with the Manager of Environmental Services (MEVS), on 5/25/16, at 12:10 PM, he stated on the PM shift (between 3 PM and 11 PM) one housekeeper was assigned to work in both Radiology and the Emergency Department to clean the floors, walls, empty trash daily, and perform high dusting weekly. The MEVS stated he made daily rounds "in am, about noon, and again at 4 PM" to ensure the assigned work had been completed. The MEVS was unable to provide documentation of any environmental rounds made during the past 90 days.

During a concurrent observation and interview with the Radiology Supervisor (RADSUP), on 5/23/16, at 12:40 PM, in the radiology supply storage/breakroom area, one ceiling tile had a crack across the width of the tile, approximately 24 inches long and the crack gap measured approximately 1/8 inch. Two ceiling tiles were stained and two other tiles were missing pieces. One ceiling tile, approximately 24 inches wide and 48 inches in length, which contained a fire alarm, was cracked and sagging from the ceiling. The ceiling tile was stained with a brown substance over approximately half of the tile. The RADSUP stated the ceiling tiles had been that way for a while but remained dry.

3. During a concurrent observation and interview with the MEVS, on 5/25/16, at 11:45 AM, in the clean linen room, two staff members were folding clean linen. One staff member was removing clean linen from a dryer. Three of three staff members had hair extending out of the disposable caps they were wearing. Laundry Aide (LA) 1 stated they had been trained to wear hair caps correctly and all hair should be covered. The MEVS stated the staff had been trained on proper hair covering.

During a concurrent observation and interview with the MEVS and Director of Maintenance (DOM), on 5/25/16, at 12:10 PM, in the clean linen storage room, three of three sampled linen carts, filled with clean linen ready for delivery to patient care areas, had a layer of thick black dust on the the bottom shelves. The three carts also had torn covers. The MEVS stated the carts needed to be cleaned and the covers were torn. Two carts loaded with clean patient linen were moved away from the wall. The floor under the carts was dusty. One dead brown bug approximately 1 1/2 inches in length was found under one cart. The MEVS stated the bug should not be there and the room was cleaned everyday. Portions of the ceiling in the clean linen storage room were covered with a spray on coating that appeared damaged, gray, brown, and black in color, and was missing pieces. There were multiple areas of dusty black discoloration in the coating. Two air vents were covered with pieces of cardboard and secured with tape around all four sides of each vent. The DOM stated the ceiling was covered with Monokote (fireproofing material sprayed on to prevent or delay the failure of steal and concrete structures during a fire) and the wall vents were covered with cardboard because the Laundry staff communicated they were cold when working in the room. The DOM stated there was no way to clean the ceiling coating. The DOM also stated "the ceiling has been this way for 20 years and no one had a problem with it until now."

The hospital document titled "Environment of Care Rounds", dated 9/29/15, indicated under the Finding column, "It was noticed during a site visit to the hospital laundry that the ceiling of the area did not meet the specified architectural requirements, and was caked with the dust of laundry services. It is required that this area have a particular type of ceiling as well as the overarching requirement to have a safe and hygienic environment." Under the Outcome column the document indicated, "This has been referred to maintenance for review and costing."

4. During an observation and interview with the Risk Manager (RM), MEVS and Manager of Quality and Education (MQE), on 5/24/16, at 3:30 PM, in the closed surgery/recovery area on second floor, the RM stated the 3818 square foot area had been used for general hospital storage for two years. The entire area was warm and had an offensive odor. The closed surgery/recovery area contained patient beds, intravenous fluid pumps (an external pump that delivers fluids into a patient's body in a controlled manner) in various states of repair, stretchers, and pediatric cribs. The storage area had multiple sterile (free of all bacteria and living germs) and unsterile supplies mixed together, some in corrugated cardboard shipping boxes, 39 Intra Ocular Lens implants with expiration dates from 2009 to 2010. One plastic box containing sterile infant suction catheters with two dusty video machines were stacked on top of the sterile packages. One dusty corrugated cardboard box contained packages of sterile adult suction catheters stored next to a cart with dusty cables and dusty plastic bags. Three dusty wooden pallets located at the entry doorway were stacked with 19 opened and unopened corrugated cardboard shipping containers. Supplies in the opened containers were dusty. Additionally there were two boxes of holiday decorations, computers, 11 gallons of Formalin (a toxic combustible liquid requiring temperature control, that has a significant danger to human health, and is used to preserve human or animal tissue), two unsecured plastic bags of syringes, one 32-ounce bottle of eye wash fluid expired 4/2015, and one hopper (a built in container resembling a toilet used to flush some types of liquid waste). The hopper fluid was odorous and yellow. The bottom of the container was covered with green and black granules. The MQE stated she did not know what was in the hopper. The MEVS stated the hospital never asked housekeeping to clean the closed surgery/recovery area. Four of four wall mounted fire extinguishers were blocked by equipment and not accessible by hospital staff in case of fire. Cases of food items including sodas, bottled tea, fruit drinks, bottled coffee, energy drinks, chips, and cookies for restocking the vending machines were found on the floor of one room. Three cases of chips were stacked on top of each other resulting in crushing the chips in the lower boxes. The MQE stated some of the sterile and unsterile patient care supplies were overstocked and could not be stored in the departments due to lack of space. Infant isolettes (incubators to stabilize the temperature and vital signs of a newborn baby), covered with plastic were located next to two corrugated cardboard shipping containers. Dusty patient care furniture, transport carts, and biomedical equipment were located next to the isolettes. One corrugated shipping container held used stuffed animals, and two dusty plastic bags. The MQE stated hospital staff had access to this area and could potentially remove expired patient care supplies for patient care.

Based on observation, interview, and record review, the hospital failed to provide patient care services in a safe and sanitary manner as evidenced by the hospital's failure to:

1. Ensure a hospital physician did not order hydromorphone (opioid pain medication) at doses not in accordance with professional standards of practice for opioid naïve patients (patients who are not receiving opioid medications on a regular basis). (Refer to C-0276)

2. Ensure a pass thru window (a window where cleaned instruments are passed through to the sterilizing room for sterilization), located between the decontamination room (an area where dirty instruments are cleaned) and the sterile processing area (an area where surgical instruments/reusable items are sterilized), was closed while not in use. (Refer to C-0278, No: 1)

3. Have a method for determining the humidity level in their decontamination room. (Refer to C-0278, No: 1)

4. Follow nationally accepted standards in the processing and sterilization of surgical equipment and devices. (Refer to C-0278, NO: 2)

5. Ensure sterile and unsterile patient care supplies, non-functioning equipment, chemicals, trash, and food items were not stored together in the closed surgery/recovery area. (Refer to C-0278, No: 3)

6. Properly clean and disinfect a vaginal transducer (a probe used in the vagina to visualize organs within the pelvic cavity) in accordance to the manufacturer's guidelines in the imaging department. (Refer to C-0278, No: 4)

7. Implement its policy and nationally recommended infection control guidelines to have all healthcare workers vaccinated. (Refer to C-0278, No: 5)

8. Train hospital staff in the proper use of disinfectants and disposal of expired cleaning supplies. (Refer to C-0278, No: 6)

9. Ensure outdated medical supplies were not available for patient use. (Refer to C-0278, No: 7)

10. Follow policy and procedures in maintaining contact isolation precautions in the Medical-Surgical area. (Refer to C-0278, No: 8)

11. Replace cracked and stained ceiling tiles in the Radiology Department. (Refer to C-0278, No: 9)

12. Secure one anesthesia cart contained medications and patient care supplies to prevent unauthorized access. (Refer to C-0278, No: 10)

13. Train dietary staff to accurately test the chemical concentration of the sanitizing solution used to sanitize non-food contact surfaces. (Refer to C-0278, No: 11)

14. Offer substitutes of equal nutritive value to one of 20 patients (19). (Refer to C-0279)

The cumulative effective of these systemic failures resulted in the hospital's inability to ensure a safe and sanitary environment. This had the potential to place all patients, staff, and visitors at risk for infectious diseases.

Based on observation, interview, and record review, the hospital failed to ensure policies and procedures were developed for the medical management of patients who have physician ordered fluid restrictions. There was no formal distribution of fluids between the nursing department and the nutrition services departments. This failure had the potential to result in fluid overload for one of 20 sampled patients (18) due to the improper amount of fluid provided to the patient who had diagnoses in which fluid management was important to the treatment.

Findings:

During a review of the clinical record for Patient 18, it was noted the patient was admitted to the hospital on 5/23/16, with diagnoses including shortness of breath, severe pulmonary hypertension (a condition in which the pressure inside the pulmonary artery [blood vessel that takes blood to the heart] is abnormally high), 2+ non-pitting edema (excess fluid in tissues in which the indentation made by pressure on the affected area does not leave a depression [dent] in the tissue) of the extremities and chronic obstructive pulmonary disease (COPD - a disease that makes it difficult to breathe that worsens over time).

During a review of the physician's orders, on 5/23/16, Physician (PHY) 6 ordered a 2 gram sodium diet (a diet which restricts the amount of sodium to 2 grams daily) and on 5/25/16, PHY 6 ordered a 1200 cc (cubic centimeters) fluid restriction per day.

During a concurrent interview and record review with the Clinical Dietitian (CD), on 5/24/16, at 1:30 PM, she stated the nurses informed her Patient 18 was placed on a fluid restriction and the Lasix (a diuretic medication, 'water pill') medication was held because Patient 18's blood pressure became too low and the patient's edema did not improve.

During a subsequent interview and review of the clinical record for Patient 18, with the CD on 5/24/16, at 1:35 PM, she stated the current diet order for Patient 18 was a 2 gram sodium diet without any fluid restriction. The clinical record did not show the fluid restriction which was previously described by the CD. The CD stated there should be a distribution of fluid between nutrition services and the nursing services to ensure the patient receives the correct amount of fluid as ordered by PHY 6.

During an interview with Registered Nurse (RN) 6 and RN 7, on 5/24/16 at 1:45 PM, who were responsible for the care of Patient 18, RN 6 and RN 7 confirmed Patient 18 was on an 800 cc fluid restriction and PHY 6's order was communicated that morning at approximately 8 AM by PHY 6 during patient rounds. RN 6 explained a pitcher is filled with the amount of fluid the patient is allowed for the day and the nursing staff use the water from the pitcher to provide the fluids for the patient to ensure the amount of fluids ordered by the physician is not exceeded.

During a concurrent observation and interview with RN 6 and RN 7, on 5/24/16, at 2 PM, RN 6 and RN 7 showed a pitcher filled with water on the tray table in Patient 18's room. RN 6 stated Patient 18 was started with 600 cc of fluid and now there was 400 cc of fluid left, indicating Patient 18 consumed 200 cc of fluid since the pitcher was placed in the room.

During a review of the clinical record for Patient 18, the care plans for Patient 18 were reviewed. A care plan problem dated 5/24/16, "Plan of Care Fluid Volume Excess" was noted. The interventions included, "monitor intake and output", but did not indicate the exact amount of fluid being monitored.

During an interview with RN 6 on 5/25/16 at 2 PM, she stated she was unaware of how much fluid was allotted to the nursing department and how much fluid was allotted to the nutrition department. RN 6 stated she was unaware nutrition services was included as part of Patient 18's fluid restrictive diet.

During an interview the Food Service Manager (FSM) on 5/25/16 at 2:30 PM, regarding the hospital policy on fluid restriction, the FSM stated the nutrition department did not have such policy.

During an interview with the Administrator of Patient Care Services on 5/25/16 at 3:10 PM, she stated there was no nursing policy on fluid restriction.

According to the University of California, San Francisco Standard Therapeutic Diet Definitions website, it defines "Fluid Restriction [as] Fluids on the meal trays are limited to the amount ordered by the provider [physician]. The fluid content of solid foods is not included in the estimation of total fluid intake... Nutrition and Food Services will generally provide half of the fluid restriction volume on meal trays and snacks. The other half is reserved for nursing care."

Based on interviews and record reviews, the hospital failed to:
1. Ensure a physician ordered hydromorphone (opioid pain medication) at doses in accordance to professional standards of practice for opioid naïve patients (patients who are not receiving opioid medications on a daily basis) when two opioid naïve patients of twenty sampled patients (4 and 17) were ordered hydromorphone 2 mg (milligram) intravenous (IV- within the vein) every 4-6 hours as needed for pain. The manufacturer recommends a starting dose of 0.2 to 1 mg.

2. The hospital pharmacy staff did not date multi-dose vials after first use in accordance to hospital policy. The hospital policy indicated multi-dose vials are to be labeled with a discard date equal to 28 days after first use.

3. The hospital pharmacy staff dated a single dose vial of Sodium Chloride 23.4% with a beyond use date and the vial was available for re-use for the preparation of intravenous (IV) medications.

4. The hospital pharmacy and operating room staff had injectable medications, available for use, that exceeded the beyond use date (BUD).

These failures had the potential to cause unwanted medication outcome and the availability of deterioriated medications for patient use.

Findings:

1. A) A review on 5/25/16 of Lexicomp online, a nationally recognized medication information resource, indicated for IV hydromorphone, the starting dose for opioid naïve patients should be 0.2 to 1 mg every 2 to 3 hours as needed.

A review on 5/25/16 of the manufacturer's package insert indicated the recommended starting dose for IV hydromorphone is 0.2 to 1 mg every 2 to 3 hours as needed.

Patient 4's clinical record was reviewed on 5/25/16. Patient 4 had not been using opioid on routine basis. Patient 4 would be considered an "opioid naïve patient" and the starting dose for him would have been 0.2 to 1 mg every two to three hours instead of 2 mg every four to six hours.

During an interview with Patient 4, on 5/25/16, at 9 AM, Patient 4 looked groggy and said she was nauseated and the hydromorphone made her sick. She said the hydromorphone was too strong and she did not want as much hydromorphone as she had received. She asked for a lower dose or a different pain medication.

During an interview with Registered Nurse (RN) 5, on 5/25/16, at 10:58 AM, RN 5 stated she was Patient 4's nurse and said she was uncomfortable giving such a high dose of hydromorphone. RN 5 also stated the 2 mg dose was standard for Physician (PHY) 1 and it was always too much for all her patients.

During an interview with the Manager Med-Surg/ICU (MMS), on 5/25/16, at 11 AM, the MMS stated that she had called PHY 1 regarding the high dose orders of hydromorphone. She also stated that PHY 1 said "Just deal with it!" She acknowledged the high dosing was inappropriate and that she should have escalated the issue with upper management.

B). Patient 17's clinical record was reviewed on 5/25/16. Patient 17 was prescribed to have hydromorphone 2 mg every 4 hours as needed for pain. The clinical record also indicated Patient 17, prior to starting the hydromorphone, was not on any routine opioids. Patient 17 was opioid naive.

During an interview with both Patient 17 and RN 5, on 5/25/16, at 10:58 AM, RN 5 stated after the administration of hydromorphone to Patient 17, he no longer wanted the hydromorphone anymore because the dose was too high and made him sick.

1. A review on 5/23/16 of the hospital policy titled "Infection Control: Multiple-Dose Sterile Medications", dated 3/22/12, indicated "Use the following guidelines if the intent is to re-use a multiple dose vial ... The healthcare professional first puncturing the vial must place the beyond-use date on the vial ...Multiple-dose vials may be used for up to 28 days after the initial entry when stored as required in the package labeling, unless the manufacturer recommends a shorter time ..."

During an observation on 5/23/16, at 4:30 PM, in the pharmacy intravenous (IV) preparation area, there was a tray of partially used injectable medications. There were two vials of injectable medications (Tobramycin-antibiotic and Insulin-treatment for diabetes) that were not dated and partially used. There was no beyond-use date on the vials of Tobramycin and Insulin.

During an interview with the Director of Pharmacy (DOP), on 5/23/16, at 4:45 PM, the DOP stated the medications on the tray were going to be reused, referring to the un-dated Tobramycin and Insulin, to prepare IV medications. He said his staff must have forgotten to date the vials with the beyond use date.

2. A review on 5/23/16 of the Centers of Disease Control and Prevention website (http://www.cdc.gov/injectionsafety/providers/provider_faqs_singlevials.html), a nationally recognized infection control resource, indicated "A single-dose or single-use vial is a vial of liquid medication intended for parenteral administration (injection or infusion) that is meant for use in a single patient for a single case/procedure/injection. Single-dose or single-use vials are labeled as such by the manufacturer and typically lack an antimicrobial preservative..."

A review on 5/23/16 of the manufactures' insert for Sodium Chloride 23.4% indicated "These vials are Single Dose Vials ..."

During an observation on 5/23/16, at 4:45 PM, in the pharmacy intravenous (IV) preparation area there was a tray of partially used injectable medications. There was a single dose vial of Sodium Chloride 23.4% that was dated with a beyond use date and was partially used.

During an interview with the DOP, on 5/23/16, at 4:45 PM, the DOP stated the Sodium Chloride 23.4% should not be re-used because the vial label indicated "single dose vial". He stated he did not know why it was available for reuse.

3. An observation on 5/23/16, at 4:30 PM, in the pharmacy intravenous (IV) preparation area, revealed a tray of partially used injectable medications (Gentamicin-antibiotic and Heparin- treatment for blood clots). The BUD for the Gentamicin was 4/20/16, and Heparin was 4/07/16. The BUD was exceeded for more than 30 days for both medications.

An observation on 5/24/16, at 3:02 PM, in the OR refrigerator, revealed a vial of Tuberculosis Skin Test (PPD) with a BUD of 3/16/16. The BUD for the PPD exceeded more than 60 days.

Based on observation, interview, and record review, the hospital failed to provide a functional and sanitary environment when infection control practices were not implemented in accordance with hospital policy and nationally recognized standards. The hospital also failed to ensure they had an effective, active and a systematic infection control surveillance program in place for identifying, investigating and controlling infections as evidenced by the hospital's failure to:

1. a. Ensure a pass thru window (a window where cleaned instruments are passed through to the sterilizing room for sterilization), located between the decontamination room (an area where dirty instruments are cleaned) and sterile processing area (an area where surgical instruments/reusable items are sterilized), was closed while not in use and according to nationally recognized infection control standards.

1 b. Failed to have a method for determining the humidity level in their decontamination room.

2. Ensure the processing and sterilization of surgical equipment and devices followed nationally accepted standards when there was presence of spotting and staining on two of two processed surgical trays (previously cleaned, disinfected and sterilized surgical instruments).

3. Provide and maintain a safe and sanitary environment to avoid sources and transmission of infections, when the closed surgery/recovery room area was not used to store sterile and unsterile patient care supplies, non-working patient equipment, chemicals, trash, and food items.

4. Ensure the hospital had a system in place to ensure a vaginal transducer (a probe used in the vagina to visualize organs within the pelvic cavity) was properly disinfected between use in the imaging departments.

5. Ensure all healthcare workers were vaccinated according to policy, and nationally recommended infection control guidelines.

6. Ensure hospital staff were trained and competent in the use of disinfectants used in the hospital, that resource information was available and that expired cleaning products were not used.

7. Ensure outdated medical supplies were not available for patient use.

8. Ensure staff followed policy and procedures in maintaining contact isolation precautions in the Medical Surgical area.

9. Ensure ceiling tiles removed in the Radiology department were monitored by the Infection Control Preventionist.

10. Secure one anesthesia cart that contained medications and patient care supplies.

11. Ensure dietary staff were properly trained to accurately test the chemical concentration of the sanitizing solution used to sanitize non-food contact surfaces.

These failures had the potential to transmit communicable diseases throughout the hospital, which could impact the health and welfare of all patients, visitors and staff.

Findings:

1. During an observation tour on 5/23/16, at 12:30 PM, in the hospital's decontamination room (an area where dirty instruments are cleaned) and sterile processing room (an area where surgical instruments/reusable items are sterilized), with the Infection Control Preventionist (ICP), the Operating Room Manager (ORM) and the Sterile Processing Technician (SPT), the adjoining rooms had a door which connected both rooms and also had an opened pass thru window (a window used to pass items from the decontamination room to the sterile processing room). While standing in the sterile processing room and looking through the opened pass through window into the decontamination room, a hospital employee was observed cleaning dirty instruments.

During a concurrent interview with the SPT and the ICP , on 5/23/16, at 12:30 PM, the SPT stated the pass thru window was not supposed to be left open. The ICP stated the hospital followed the AORN (Association of Perioperative Nurses), AAMI (Association for the Advancement of Medical Instrumentation - an organization for advancing the development, and safe and effective use of medical technology Association), and Centers for Disease Control (CDC), among others, as their nationally recognized infection control standards. According to nationally recognized standards, such as AAMI, "doors and pass through windows separating the decontamination room from the adjoining disinfection/sterilization area should remain closed".

During an interview with the ORM and the SPT, on 5/23/16, at 1:20 PM, they stated that they did not monitor the humidity level in the decontamination room and did not have a method for monitoring humidity level. The SPT stated they did not have a humidity control and did not have a policy which addressed climate in the decontamination room.

According to AAMI, Sterility Update 2010, relative humidity should be maintained between 30% and 60% in all work areas.

2. On 5/23/16 at 1:50 PM, during an inspection of the hospital's sterile processing area, an observation was made of two of two processed surgical trays (previously cleaned, disinfected and sterilized surgical instruments). In the presence of the ICP, the ORM and the SPT, they were asked to provide a tray which contained sterilized instruments and to open the trays to visualize the instruments. The tray was wrapped and sealed, which indicated they had been processed. Once opened, the major tray contained three surgical instruments with brownish discoloration (around the hinges) and the C-section tray (a surgical tray used for cesarean deliveries) contained one surgical instrument with brown stains. All of the surgical instruments (approximately 30 to 40) in both trays contained white spotting.

During a concurrent interview with the SPT, ORM and the ICP, on 5/23/16, at 1:50 PM, the SPT stated that the brown stains were "possibly rust but not sure." The ORM and the SPT stated that the white spots were probably "hard water deposits". The ORM and the SPT, stated the hospital's water was hard and they did not use filtered or reverse osmosis (a water purification technology) water systems.

The ICP stated the hospital adopted the AORN, AAMI, and CDC, among others, for the their infection control standards.

According to AORN recommendations, "The final rinse should be performed with treated (e.g., distilled, reverse osmosis, filtered) water of a quality that will not stain or cause damage to instruments or contribute to recontamination of the instrument. Untreated water can contain contaminants, including endotoxins, which can be deposited on instruments during the final rinse. Rinsing with treated water can prevent deposits of impurities or contaminants on instruments. Endotoxins are heat stable and may not be destroyed by subsequent steam sterilization. Tissue contaminated with endotoxins can cause severe inflammation. Treated water can prevent spotting, stains, deposits, and corrosion on the surfaces of instruments". Guidelines for Perioperative Practice. Denver, CO: AORN, Inc. ANSI/AAMI ST79: Comprehensive Guide to Steam Sterilization and Sterility Assurance In Health Care Facilities.

3. During a concurrent observation and interview, with the Manager of Quality and Education (MQE), Risk Manager (RM), and the Director of Maintenance (DOM), on 5/24/16, at 3:30 PM, in the closed surgery/recovery area, there were five corrugated cardboard boxes and two bins containing a mixture of sterile and unsterile surgery supplies. Two of the corrugated cardboard boxes were stacked on top of each other, crushing the supplies in the lower box. The MQE stated "some of the sterile packages look dusty." The DOM stated there was no temperature or humidity monitoring being done in the area.

During a concurrent observation and interview with the Director of Obstetrics (DOB), the RM, and the MQE, on 5/24/16, at 3:20 PM, the patient care supply cart had a mix of sterile items, unsterile items, and liquids stored together in the same bins. The bins were over filled, which resulted in some sterile packages being crushed. One bottle of sterile irrigation solution and seven packages of sterile dressings were on the dusty floor behind the cart. The DOB stated the supplies would be removed.

During a concurrent inspection and interview with the ICP, the DOM and the Biomedical Technician (BMT), on 5/25/16, at 8:25 AM, in the hospital's permanently closed surgery/recovery room area, the ICP and DOM stated the area had been closed for approximately 10 years (staff were unsure if the hospital received authorization to use the space after it had been permanently closed). In the area to the left of the entrance door were various items such as intravenous pumps (IV pumps infuses fluids, medication or nutrients into a patient's circulatory system), boxes of gloves, blood pressure cuffs, various cables, telephones and multiple other items. It was unclear whether the observed items were clean or dirty. The floors of the area contained multiple black stains, grayish fuzzy matter, a crinkled trash bag and other crinkled papers on the floor.

During an interview with the BMT, on 5/25/16, at 8:26 AM, when asked to identify which items were clean and which items were dirty, he stated there were various items that were nonfunctional and in the process of getting repaired and also stated that some of the IV pumps (which he pointed to), were ready for patient use. The items he pointed to were on a shelf that indicated they were not ready for patient use. The BMT stated, "Then they're not ready for patient use, I guess." The BMT was also asked when housekeeping provided environmental cleaning and if he kept a log of the cleaning schedule. He stated, as he flailed his arms, "Everything is filthy dirty, nobody cleans, and dust falls on it daily and all day." The DOM instructed the BMT to lower his voice and to maintain control. The BMT stated that he was employed by the hospital two days earlier.

During an observation on 5/25/16, at 8:25 AM, in multiple rooms of the same area, the following items were being stored by the:

· Surgery C, the hospital was storing multiple food items such as chips, granola bars, candy, sodas, and cups.
· Surgery B, contained three hospital beds, three gurneys, one geriatric chair, 15 boxes of sequential compression systems (Elastic stockings and sequential compression devices used for patients who are on bed rest or immobile because of an illness, injury, or surgery are at risk for developing blood clots). There was grayish fuzzy matter on the floor and on shelving.
· Surgery D, contained multiple "Sterile Specimen Traps" (used to collect specimen samples), multiple "Micro-Volume Suction Bottles" (sterile containers used to collect specimen samples), and adjacent to the items, were 10 bottles (1 gallon each) of "Protocol Formalin" (a liquid chemical which could be considered hazardous), and endotracheal tubes (labeled sterile [small usually plastic tube inserted into the trachea through the mouth or nose to maintain an unobstructed passageway especially to deliver oxygen or anesthesia to the lungs, also called a breathing tube]).
· Other items found in the area were sterile labor and delivery packets which contained syringes, sterile drapes, sterile sponges, boxes of needles, syringes, basinets, and cases of intravenous fluids.

During an interview with the ICP, on 5/25/16, at 9 AM, she stated she was unsure how long the items had been stored in the space. She stated she identified the concern and emailed various department managers requesting they remove the items in July of 2015. The ICP stated she had not followed up since that email, after identifying that the area was being used as a storage space. The ICP was aware of some of the sterile items which were stored and was not sure if the surgical/recovery room space was climate controlled. She stated she was aware that the sterile items should be stored in environmentally controlled conditions and she did not have an answer as to why the items were still stored in that space.

During a concurrent interview with the DOM, on 5/25/16, at 9 AM, he stated the area did not have humidity or temperature controls. The hospital staff was unable to produce a copy of the policy addressing storage of sterile items.

According to CDC guidelines, sterile supplies should be stored in a manner which prevents contamination, there should be a clear separation of sterile items and dirty items, and there must be separate clean/dirty rooms or the designated utility room must flow from clean to dirty.

According to AORN, Inc; 2013:513-540 Recommended practices for sterilization. In: Perioperative Standards and Recommended Practices. "Sterile items should be stored under environmentally controlled conditions, which mean a temperature of approximately 75°F (24°C), a maximum relative humidity of 70%..."

4. On 5/24/16, at 1 PM, a tour of the hospital's women clinic was conducted with the ICP, to observe the hospital's high level disinfection (HLD) process (complete elimination of all microorganisms in or on an instrument, except for small numbers of bacterial spores) of vaginal transducers (a probe used in the vagina to visualize organs within the pelvic cavity).

An observation and concurrent interview with Ultrasound Technician (UST) 1, on 5/24/16, at 1 PM, indicated UST 1 demonstrated the hospital's HLD process. The UST 1 performed the following:

· Applied gloves and face shield.
· Explained they used a disinfectant called Revital-Ox Resert XL HLD, which required an eight minute soak time and a 21 day reuse time.
· The HLD solution bottle did not contain an open date label to indicate when the container was originally opened.
· UST 1 stated she performed a daily test on the solution and the chemical strips.
· She stated that after she removed the probe cover {a plastic sleeve cover), she quickly ran it under running water in a sink (the sink was located in a locked room designated for the HLD process). UST 1 stated they did not have a rinse time and that she "quickly runs it under the sink and immediately puts it into the soaking container."
· After soaking the probe for eights minutes in the solution, which is contained in a white plastic container, she rinsed the probe again under running water for "couple of seconds."
· UST I wrapped the probe in a towel, which she stated remained in the towel until it was reused.
· The UST 1 stated that their process followed the HLDs manufacturer's guidelines.

UST 1 stated that they did not monitor the HLD temperature and she used a clock located in another room to determine the soaking time of the probe (no clock or thermometer were seen at the HLD soaking station).

On 5/24/16 at 1:20 PM a concurrent observation and interview with UST 2, of one of the two hospital Imaging Departments, where HLD was performed on vaginal probes. UST 2 performed and explained the following HLD process near a sink in a patient examination room (no patient present):

· Removed the used plastic probe cover sheet, wiped the probe with a "Sani-Cloth HB" wipe (a wipe that is used to clean, disinfect and deodorize, when used according to manufacture guidelines". The Sani-Cloth stipulated the contact time was 10 minutes (the length of time the surface wiped must remain visibly wet in order for the cloth to be effective).
· Soaked the probe in the HLD solution for eight minutes and stated she checked the time by using her cell phone or a co-workers cell phone (no thermometer or clock was seen near the soaking station).
· The HLD solution bottle did not contain an open date label to indicate when the container was originally opened.
· After removing the probe from the HLD solution, she rinsed the probe in the sink (no rinse time needed according to UST 2) and placed it between a towel to allow to dry. She stated the probe remained in the towel until it was reused.

UST 2 stated she did not have to adhere to the 10 minute wet time as instructed by the Sani-Cloth guidelines because "The probe goes through the HLD process". She also stated their process did not indicate to rinse the probe for any particular length of time. A copy of the HLD's manufacture's guidelines was provided.

On 5/24/16 at 2:30 PM, a review of the hospital policy titled, "Use of Disinfectant in Ultrasound," effective date 1/2013, was conducted. The policy indicated probes were to be soaked for eight minutes and "after a 8 minute soak, probe is rinsed twice with water..." The policy did not mention to soak the probe for 8 minutes at 68 degrees Fahrenheit and did not mention to rinse for any length of time after the soaking time was performed.

On 5/24/16 at 2:45 PM, a review of the HLD solution' manufacturer guidelines was conducted. The following steps were stipulated:

· "Cleaning/Decontamination ...Following thorough cleaning and rinsing, rough dry all instrumentation prior to immersion in Revital-Ox Resert XL HLD solution ..."
· "Record the date the original container was opened on the Revital-Ox Resert XL HLD container label or in a log book ..."
· "HIGH LEVEL DISINFECTION: Place pre-cleaned, rinsed and dried instruments in solutions of undiluted Revital-Ox Resert SL HLD ...Once the instrument has been immersed and all surfaces in contact with the disinfect and solution, soak the instrument for 8 minutes at 20 degree Celsius (68 degrees Fahrenheit). Monitor the time the instrument is in contact with the solution using a timer ..."
· "Set a timer for eight minutes and allow the device to be immersed in the solution for the entire eight minute period of time."
· "Upon completion of eight minutes immersion, remove the instrument from the secondary container. Follow the instrument manufacturer's instructions for draining the lumens prior to rinsing. Follow the rinsing instructions below."
· "RINSING INSTRUCTIONS: Following removal from Revital-Ox SL HLD solution, thoroughly rinse the medial device by immersing it completely in water. Use sterile water or potable water as required by facility policies. Refer to sections" STERILE WATER RINSE" and "POTABLE WATER RINSE" for further recommendations ..."
· "STERILE WATER RINSE: The following instruments or medical devices should be rinsed with sterile water, using aseptic techniques when rinsing and handling: Devices intended for use in known immunocompromised patients based on institutional procedures (e.g. high risk population served) ..."
· "POTABLE WATER RINSE: For all other devices, a sterile water rinse is recommended when practical. Otherwise, potable tap water rinse is acceptable. When using potable water for rinsing, the user should be aware of the increased risk of decontaminating the medical device with microorganisms which may be present in potable water supplies ..."
· "DRYING: A device that is not completely dried provides an ideal situation for rapid colonization of bacteria. As these waterborne bacteria are highly resistant to drying, rapid drying will avoid possible colonization but may not result in a device free from these bacteria. A final rinse using a 70% isopropyl alcohol solution may be used to speed the drying process ..."

On 5/24/16 at approximately 3 PM, during an interview with UST 1, she stated they, at times, performed vaginal examinations every hour with 30 minutes in-between cases and their process was the same whether or not the patient was immunocompromised (a weak immune system that protects your body from diseases and infections). UST 1 stated according to the hospital process, they did not need to obtain a temperature of the HLD solution and there was no rinsing time.

During a concurrent interview with the ICP, on 5/24/16, at 3 PM, she stated she did not know who their high risk population was. In addition, she stated she did not monitor the departments who provide HLD, to ensure they were performing the process according to manufacturer guidelines.

5. On 5/25/16 at 3 PM, employee health files were reviewed with Administrator of Support Services (ADMIN) 1. Three of three files did not have complete vaccination record. The following employee health files did not contain evidence of complete vaccination records:

The ICP's file did not have evidence of Measles, Mumps and Rubella (MMR - a viral infection of the respiratory system characterized by a rash; Mumps - an acute viral infection characterized by inflammation of the parotid gland; Rubella - a contagious viral infection that is characterized by a rash) or Varicella (chickenpox).

A SPT file did not have evidence of MMR or Varicella.

UST 1's file did not have evidence of Varicella.

During an interview with ADMIN 1, on 5/25/16, at 3 PM, she stated she was unable to find evidence of the completed vaccination records and the employee health nurse was not available for interview.

During an interview with the ICP, on 5/25/16, at 4 PM, when asked if she provided oversight of the employee health files to ensure staff was up to date on their vaccinations she stated she did not provide oversight of vaccinations, she only reviewed employee health exposures. During an earlier interview on 5/23/16, at 12:30 PM, the ICP stated the hospital adopted the CDC as one of the hospital's nationally recognized infection control standards, among others.

On 5/25/16, at 4:30 PM, a review was conducted of a hospital policy titled, "Authority for Institution of Infection Surveillance, Prevention or Control Measures (PIB)," revised on 2/25/14. The policy indicated, "The Chairman of the Infection Control Committee authorizes/orders treatment of employees, medical staff, students, and volunteers for immunizations as recommended for healthcare workers by the CDC/ACIP (see attachment). The orders are given on an annual basis and filed in the Pharmacy/Infection/Blood Committee (PIBC) minutes. The orders authorize the Infection Preventionist/Employee Health Nurse or his/her designee(s) to implement the same ..."

Further review was conducted of the attachment to the policy titled, "Healthcare Personnel (HCP) Vaccination Recommendations" which indicated "all healthcare workers (HCP) be immune to varicella and evidence of immunity included documentation of 2 doses of varicella vaccine given at least 28 days apart, history of varicella or herpes zoster based on physician diagnosis ..." The attachment also indicated healthcare personnel should be immune to MMR and documented evidence of immunity was to be provided.

The CDC further recommended staff that work directly with patients or handle material that could spread infection, should get appropriate vaccines to reduce the chance they will get or spread vaccine-preventable diseases. The State of California immunization law for healthcare workers also requires MMR and Varicella, among others.



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6. a. During an observation and interview with Radiology Technician (RADT) 1, on 5/23/16, at 12:05 PM, in the radiology department, a plastic container labeled "Disinfectant Cleaner Solution Station 700" (a solution used to kill harmful germs and bacteria) was on a counter with no manufacturer's instructions for use. RADT 1 stated the disinfectant was used to clean the room, table, and countertops, but he did not know how long the disinfectant should be left wet on the surfaces. RADT 1 was unable to find manufacturer's directions for use on the plastic container.

During an interview with the Manager of Environmental Services (MEVS), on 5/25/16, at 12:15 PM, the MEVS stated the "Disinfectant Cleaner Solution Station 700" was provided to hospital departments by Housekeeping. The MEVS also stated the contact time for the disinfectant was ten minutes, but he could not find manufacturer directions. The MEVS stated housekeeping staff uses the disinfectant for floors and walls in all departments.

The hospital policy and procedure titled "Selection of Disinfectants" dated 9/4/15 indicated "Disinfectants...for hospital use shall be appropriate...for surface cleaning when used as directed by the manufacturer."

6 b. During an observation and concurrent interview with RADT 1, on 5/23/16, at 12:20 PM, in Radiology Room 1, one container of Clorox Healthcare Germicidal Wipes (disposable wipes saturated with solution used to clean equipment and patient care and work surfaces), inside a holder mounted on the wall. The container had an expiration date of "14 JAN16". RADT 1 stated the wipes would be removed.

7. a. During an observation and concurrent interview with the MQE, on 5/24/16, at 3:30 PM, in the closed surgery/recovery room area, the MQE stated the area was being used as a hospital storage area and accessible by hospital staff. A dusty plastic bag with 39 boxes of intra ocular lenses (used in eye surgery to replace a patient's own lens) was observed on a desktop. The lenses all had expiration dates between 2009 and 2010. The MQE stated "these need to be thrown out."

7 b. During an observation and concurrent interview with RADT 1, on 5/23/16, at 12:20 PM, in Radiology Room 1, one container of Clorox Healthcare Germicidal Wipes, used for cleaning equipment and surfaces, had an expiration date of "14 JAN16". RADT 1 agreed the wipes were expired.

8. During an observation and concurrent interview with Manager of the Medical Surgical Unit (MMS), on 5/25/16, at 2:30 PM, outside of a patient room with a sign indicated the patient was in "Contact Isolation." There was a red and a yellow biohazard bin in the hallway. Registered Nurse (RN) 5 was observed exiting the room with a portable computer and with her yellow isolation gown and gloves on. She disposed of the yellow gown and gloves in the red bio hazard bin and donned a pair of new gloves without performing hand hygiene nor did she clean the computer with disinfectant wipes. The MMS stated, "It's always been like this."

The hospital policy and procedure titled, "Guidelines for Isolation Precautions" dated 5/24/16 indicated "Isolation gowns should be removed in the patient's room. Gloves should never take the place of handwashing. Gloves should not be worn outside the patient room."

9. During a concurrent observation and interview with RADT 1, on 5/23/16, at 12:20 PM, in Radiology Room 1, two ceiling tiles approximately 24 inches by 48 inches in size were missing. RADT 1 stated water had been dripping from the ceiling and the tiles had been removed for five to seven days. An Infection Control Construction Permit, usually issued by the ICP, was not found posted at the work site.

The hospital document titled "ICRA Process" (ICRA - Infection Control Risk Assessment - a tool used to identify precautions to be taken with any type of construction), undated, indicated the removal of more than one ceiling tile constituted a Type C construction project activity that cannot be completed in a single work shift. The Radiology Department was identified as a "Medium Patient Risk Group" which corresponded to a "Type C, Medium Risk Group Class III". The ICRA process indicated the required infection control precautions for a Class III level construction project required the following:

"During the construction project, 1. Remove or isolate HVAC [Heating, Ventilation, Air Conditioning] system in area where work is being done to prevent contamination of the duct system. 2...seal area from non work area. 3...maintain negative air pressure within the work site... 4. Contain construction waste...", and "5. Cover transport receptacles..." The ICRA process indicated it was a "guideline to planning maintenance, renovation or construction work ahead of time in order to identify and mitigate any potential health risks to our patients and our staff." The ICRA further indicated "Fill out the worksheet [documents attached to the ICRA Process] to identify the risk...follow the precautions listed, and submit a copy of the ICRA to IP (Infection Prevention) for prior to the start of the work. The tool is designed to help you identify the infection control risks and put in place the proper precautions to protect yourselves and our patient population... If you(r) ICRA is a ...Class III, submit it to the Infection Prevention Office. IP will review the submission...and issue a Construction Permit to you to post at the site of the construction..." The permit "...summarizes the agreement...and what precautions will be carried out for the duration of the effort, be it 1 day, one month or longer."

During an interview with the ICP, on 5/24/16, at 12 PM, she stated "We use the ICRA for major construction only."

10. During a concurrent observation and interview with the DOB, on 5/24/16, at 2 PM, in the Obstetrics department, an anesthesia cart was observed in a hallway unlocked. The top drawer of the cart contained patient medications including, but not limited to: Propofol (a medication that causes lack of memory, and maintains sedation during surgery), Narcan (a medication that reverses or prevents the effects of narcotics), and Noropin (medication that numbs the skin). The cart also contained some sterile procedure trays, syringes with needles, and unsterile patient care supplies. The DOB stated the maintenance would be notified to fix the lock and the Pharmacy would be notified to relock the cart.



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11. During a concurrent observation and interview on 5/25/16, at 11:05 AM, in the kitchen, two dietary employees, Food Service Assistant (FSA 2) and FSA 3, were asked to test the chemical concentration of the quaternary ammonia (a cleaning chemical) in the sanitizing bucket. FSA 2 immersed the test strip for 3 seconds and read out loud "400" ppm (parts per million). FSA 3 immersed the test strip for 3 seconds and read out loud "looks like 200". FSA 3 was asked to retest as she was not observed to be wearing her reading glasses. FSA 3 retested the sanitizing bucket with glasses on immersing the strip for 3 seconds and read out loud "between 200 to 400 (ppm)". According to the instructions on the test strip, the strip required to be immersed for 10 seconds before reading against the color chart on the test strip container.

During an interview with the Food Service Manager (FSM), who was present during the observation, on 5/25/16, at 11:15 AM, she was asked what training the dietary services employees received on the testing of the sanitizing bucket. The FSM stated she was unsure what training was provided by the previous manager. A review of the training logs for the previous two years did not include any training on testing the sanitizer.

Based on observation, staff interviews, and review of hospital menu, the hospital failed to ensure that the nutritional needs of all patients were met when it failed to offer substitutes to one of 20 patients (19) that was of equal nutritive value. This failure had the potential to have unmet nutritional needs.

Finding:

1. During an interview and review of the dinner menu with Food Service Assistant (FSA) 3, on 5/23/16, at 1:34 PM, the main entrée included a 3-ounce (oz) Fiesta Pork Chop. The alternate entrée was Cheese Quiche. Patient 19 had selected the Cheese Quiche. FSA 3 stated the menu was misread and prepared cheese quesadilla instead of the quiche. Patient 19 was given another substitute item.

During an observation on 5/23/16, at 1:40 PM, the substitute item Patient 19 selected was an egg hash brown casserole. The portion size offered to the patient two ounces (4 x 6 "). The portion size served as the substitute was not adjusted to match the 3-oz protein portion in the cheese quiche. The decrease in protein content of the meal could be of significance if the patient had a disease or diagnosis such as malnutrition in which adequate protein is beneficial to treatment.

Based on observation, interview, and record review, the hospital failed to ensure the clinical record for one of 20 sampled patient (18) accurately reflect the care that was being provided when the physician failed to document an order for fluid restriction that was already initiated by the nursing staff as a result of the information communicated by the physician during patient rounds. The lack of documentation had the potential to result in medical errors which compromise the health of the patient.

Finding:

During a review of the clinical record for Patient 18, it was noted the patient was admitted to the hospital on 5/23/16, with diagnoses including shortness of breath, severe pulmonary hypertension (a condition in which the pressure inside the pulmonary artery [blood vessel that takes blood to the heart] is abnormally high), 2+ non-pitting edema (excess fluid in tissues in which the indentation made by pressure on the affected area does not leave a depression [dent] in the tissue) of the extremities and chronic obstructive pulmonary disease (COPD - a disease that makes it difficult to breathe that worsens over time).

During a review of the physician's (PHY 6) orders dated 5/23/16, PHY 6 ordered Lasix (water pill) among other medications to be given intravenously (through the vein). Lasix is a medication used to treat fluid build-up due to heart failure. It is also used to treat high blood pressure. PHY 6 also ordered a 2-gram sodium diet (reduced salt diet).

During a concurrent interview and record review with the Clinical Dietitian, (CD), on 5/24/16, at 1:30 PM, she stated the nurses informed her Patient 18 was placed on a fluid restriction and the Lasix medication was held because Patient 18's blood pressure became too low and the patient's edema did not improve. After the CD reviewed the clinical record, she did not find an order in Patient 18's chart to place the patient on fluids restriction. During an interview with two Registered Nurses (RN 6 and RN 7), on 5/24/16, at 1:45 PM, who were responsible for the care of Patient 18, both RN 6 and RN 7 stated Patient 18 was on 800 cc (same as millimeters or ml) fluid restriction as communicated by PHY 6 during patient rounds. RN 6 stated a water pitcher filled with the amount of fluids the patient was allowed for the day at bedside daily. This ensured the amount of fluids ordered by the physician was not exceeded.

During a concurrent observation and interview with RN 6 and RN 7, on 5/24/16, at 2 PM, RN 6 and RN 7 showed a water pitcher on the tray table in Patient 18's room. RN 6 stated Patient 18 was started with 600 cc of fluid and now there was 400 cc of fluid left. RN 6 acknowledged there was no written order by PHY 6 for Patient 18's fluid restriction which was being implemented by the nurses. RN 6 stated she thought PHY 6 had written the order after the patient rounds. At 2:40 PM, RN 7 stated PHY 6 was notified and wrote an order for 1200 ml fluids restriction instead of 800 ml.

During an interview with PHY 6, on 5/25/16, at 3 PM, she stated she conducted patient rounds with the nurses at 8 AM, to discuss goals of the day for each patient. PHY 6 indicated she just "forgot" to write the order for Patient 18's fluid restriction.

Based on observation, interview, and record review, the hospital failed to maintain an effective Quality Assessment Program Improvement (QAPI) when they failed to address concerns regarding the use of the closed surgical unit as a storage area for multiple hospital departments. This failure had the potential for the un-kept closed surgery/recovery area to become a breeding ground for insects and rodents.

Findings:

During an interview with the Administrator Patient Care Services (ADMIN 2), on 5/25/16, at 2 PM, she stated she was aware of the condition of the closed surgery storage area, "it had become a storage area two years ago. We have a usage map and [DOM (Director of Maintenance)] would have gotten a permit for the storage."

The hospital document titled "Old Storage Area" dated 7/07/15 was reviewed with the facility Infection Preventionist (IP). The IP stated the letter was sent to all department heads via e-mail, including the facility Administrator, the letter indicated: "an Infection Prevention Care Round (conducted on 7/6/15), focused our attention on the old surgery storage area. It appears many people are using that area for storage and we are noting our concerns. We found large amounts of bottled water next to imaging supplies next to soiled linens and commodes (portable toilets). We also found a used inhalation saline bag with a patient sticker dated Feb 2015...I'd like to suggest to everyone that, we survey the area for the purpose of disposing equipment that is no longer needed, cleaning up the area and controlling access."

During an observation and interview on 5/24/16, at 3:30 PM, in the closed surgery/recovery unit on second floor, the Risk Manager stated the 3818 square foot area has been used for general hospital storage for two years. The entire area was warm and had an odor. The Director of Maintenance stated temperature and humidity had not been monitored. The closed surgery/recovery area contained the following items: patient beds, intravenous fluid pumps (an external pump that delivers fluids into a patient's body in a controlled manner) in various states of disrepair, stretchers, and pediatric cribs. Multiple sterile (free of all bacteria and living germs) and unsterile supplies were mixed and placed together, some in corrugated cardboard shipping boxes. Thirty nine Intra Ocular Lens implants (replacement for a patient's lens) with expiration dates from 2009-2010 were found in a dusty plastic bag. There were three wooden pallets at the entry doorway stacked with multiple corrugated cardboard shipping containers. Two boxes of holiday decorations, used computers, 11 gallons of Formalin (a toxic combustible liquid requiring temperature control, that has a significant danger to human health, and used to preserve human or animal tissue), two unsecured plastic bags of syringes, one 32-ounce bottle of eye wash fluid expired 4/2015, and one hopper (a built in container resembling a toilet used to flush some types of liquid waste). The hopper had yellow liquids in it and smelled similar to urine. Cases of food items including sodas, bottled tea, fruit drinks, bottled coffee, energy drinks, chips, and cookies for restocking the vending machines were on the floor and on shelves.

The Manager of Quality and Education stated some of the supplies were overstocked and could not be stored in the patient care departments due to lack of space.

The hospital policy and procedure titled "Performance Improvement" dated 1/13/16, indicated "The purpose of the Performance Improvement Program is to ensure that patients are provided safe and appropriate quality care in an environment of minimal risk."