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Based on observation, interview, and record review, the hospital failed to ensure documents belonging to an unknown number of patients were protected. This failure had the potential to result in a breach of patients protected health information (PHI).

Findings:

During an observation and concurrent interview with the Risk Manager (RM), on 11/6/15, at 2:20 PM, an unknown number of intravenous piggyback (IVPB - a method of infusion used for intravenous medication administration) dated 1/2015, with information labels that included patient name, medical record number, date of birth, name of the medication and date medication provided, were found in the bio-hazardous waste storage. The RM stated, "The labels should be removed before disposal."

The patient information was able to be accessed by anyone entering the bio-hazard storage unit. This group of people would include maintenance staff, bio-hazard waste transport company personnel, or other non-patient care staff.

The Health and Humans Services, Office of Civil Rights document titled "THE HIPAA PRIVACY AND SECURITY RULES ", dated 1996, indicated "Covered entities must implement reasonable safeguards to limit incidental, and avoid prohibited, uses and disclosures of PHI, including in connection with the disposal of such information. Failing to implement reasonable safeguards to protect PHI in connection with disposal could result in impermissible disclosures of PHI. Covered entities are not permitted to simply abandon PHI or dispose of it in dumpsters or other containers that are accessible by unauthorized persons. A covered entity may not dispose of PHI in paper records, labeled prescription bottles.. in dumpsters, recycling bins, garbage cans, or other trash receptacles accessible by unauthorized persons."

Based on observation and interview, the hospital failed to ensure the pediatric care area was configured to provide a safe setting for pediatric patients. This had the potential to cause injuries to its pediatric patients that could be prevented.

Findings:

During a concurrent observation and interview with the facility Risk Manger (RM), the Infection Control Nurse, and the Director of Pharmacy, on 11/2/15, at 1:29 PM, the pediatric inpatients area was observed. This enclosed area had one door for entrance and exit. There was one large open area, approximately 10 by 20 feet. Around the open area was three patient rooms, a shower, and one patient bathroom. The large open area, according to the RM, was called the "Playroom." It was noted a supply cabinet, a nurses' desk, a chart rack, a rolling cart, two small refrigerators, a hand washing fixture, a portable blood pressure machine, two small oxygen cylinders, a trash can, a linen cart, and a pediatric crash cart. The RM also stated this large area, in addition to being used as a playroom, also was used as a medication room. The RM stated, "The shower is used by family members staying with pediatric patients."

The supply cabinet, approximately six feet tall, was observed to be unlocked. Inside the cabinet were: heel warmers (a device used to warm baby's heels), vacutainers (an item used to collect a blood sample tube), unwrapped and undated 4 x 4 sponges (a type of gauze bandage) and 2 x 2 sponges, head covers (a cap to cover hair), blood pressure cuffs, sterile gloves, syringes, intravenous catheters (used to obtain intravenous access for fluids, antibiotics, etc.). There was a tub in the cabinet contained gloves, open cotton balls, fluffs (a type of gauze dressing), alcohol pads, and unwrapped and undated gauze bandages. The RM agreed all items in the supply cabinet were accessible to children playing in this large open area.

During an interview with the RM and the Registered Nurse Manager (RNM), on 11/2/15, at 1:29 PM, the RNM of the pediatric area stated: "These items should not be stored like this. We will have the lock repaired for the medication cabinet."



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36543

Based on interview and record review, the hospital failed to ensure patient health care plans were developed for two of 18 sampled patients (1 and 3) which had the potential to result in unmet care needs.

Findings:

During a review of the clinical record and concurrent interview with Registered Nurse (RN) 2 for Patient 1 on 11/3/15, at 3 PM, there was no care plan for Patient 1's gastrostomy tube (G-Tube - a tube inserted through the abdomen that delivers nutrition directly to the stomach) found in his record. RN 2 stated, "We do not have the capability to add care plans so I used a nutrition care plan." The care plan did not indicate whether the patient could eat or drink, how they should be positioned, how and with what the tube should be flushed or how to care for the incision site.

During a concurrent interview with Licensed Vocational Nurse (LVN) 1 and review of the clinical record for Patient 3, on 11/3/15, at 3 PM, there was no care plan for Patient 3's gastrostomy tube was found.

During further review of the hospital's computer system, there was no generic care plan for G-tube care found in the hospital's care plan library (a computerized system of patient care plans).

During an interview with the Risk Manager, on 11/2/15, at 11:30 AM, she stated "Floor nurses do not have the ability to create care plans. Care plans must be developed by administration."

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

1. Monitor temperatures for intravenous (IV) solutions stored in the hospital warehouse. This had the potential for all patients to receive IV solutions that may have reduced stability, strength, and purity. (refer to A 491, Item 1)

2. Provide pharmaceutical oversight of the storage of IV solutions in the hospital's warehouse. This had the potential to administer deteriorated IV solutions to its patients. (refer to A 491, Item 2)

3. Ensure IV solutions and IV medications were properly labeled per the hospital policy and procedure. This failure had the potential to cause patients to receive the wrong medication, out dated medications, and receive medications that were incomparable and compromised. (refer to A 505)

The cumulative effects of these systematic problems resulted in the failure of the pharmacy services at the hospital to ensure safe practice of medication administration to all patients.

The hospital policy and procedure titled "IV labeling" dated 4/23/14, indicated, "1. All Intravenous (IV) admixture (a product of combining two or more substances) labels will contain the following details: a. Name, location and ID number of patient b. Medication, dosage with frequency, C. diluent (diluting agent) and volume d. Infusion time and/or rate e. special instructions, f. Initials of technician making product an/d pharmacist validating, g. Barcode for product. 2. Stickers are affixed to the IV admixture: a. Beyond use date and time b. warning or caution stickers."

Based on observation, interview, and record review, the hospital failed to provide pharmacy services that provided a safe medication use process. The hospital Pharmacy Services failed to:

1. Store intravenous (IV) solutions in temperatures recommended by the manufacturer's direction when the temperature in the warehouse exceeded the acceptable temperature range. This had the potential to administer deteriorated IV solutions to its patients.

2. Provide pharmaceutical oversight of medications and IV solutions storage area. This had the potential to cause patients to receive deteriorated medications and IV solutions.

Findings:

1. On 11/3/15, at 9:30 AM, accompanied by the Materials Manager (MM), the hospital's warehouse/receiving department was toured. The warehouse, supported by several columns, was about the size of two two-car garage with a 12-foot double door open to a loading/unloading area. It was noted there was a thermometer on the center column of the warehouse. It recorded a temperature of 73 degrees Fahrenheit. The hospital MM was questioned how was the temperature of the warehouse monitored, the MM replied, "I do not know if I have products that need to be kept at a prescribed temperature." Concurrently, a one-liter bag of Normal Saline IV solution stored in the area had a label that read, "Keep at temperatures between 64 and 72 degrees Fahrenheit." the MM stated "I was not aware that IV solution's were to be maintained at a certain temperature."

2. During an observation and concurrent interview with the hospital MM, on 11/3/15, at 9:30 AM, in the hospital warehouse/receiving department, two plastic containers (drums) were observed on the concrete floor and stored in front of a multi-leveled metal shelf where boxes of IV solutions were placed. Both drums were full and each had a label "Corrosive" on the outside. On top of one of the drums was an already opened cardboard box containing IV solutions. The MM stated: "They [the drums marked Corrosive] are to be returned but I am not aware of their intended use at the hospital. I don't understand what the problem is. We've had surveys for the last twenty-six years and nobody has ever said anything was wrong here."

During further observation of the warehouse, it was noted more than 20 boxes of various IV solutions (six one-liter size bags of IV solutions per box) were stored in cardboard boxes on the cement floor or on metal shelving throughout the warehouse. Some boxes had been opened with IV bags removed. The metal shelving where the IV solutions were placed on had areas of greasy, gray matter on it. Some pieces of metal with had bugs and spider webs over them. Some metal shelves had orange discoloration on them. Some shelves had dried and stained cardboards glue to it. A couple of employees' personal jackets were observed hanging from the shelves. It was also noted, close to the 12-foot double door, was a table with six boxes of Lidocaine Jelly (a medication used to numb the skin) covered with a layer of dust, there were also packages of IV tubings, IV catheters, disinfectant wipes, and IV start kits observed on the table. The MM stated these medications and supplies were provided by the hospital pharmacy to use in the hospital nursing units' crash carts (a cart containing medical supplies, equipment and medications for use in an emergency). All items were covered with a layer of dust.



34401

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

1. Outdated intravenous intravenous (IV) solutions; and,

2. One IV medication for one of 18 sampled patients (10) were not available for patient use.

This failure had the potential to administer compromised medications to its patients.

Findings:

1. A cart with six boxes of IV fluids (some partial boxes) all had an expiration date of 2/2015 stamped in black ink. The Material Management Director (MM) stated "They (IV Fluids) were to be disposed of." The MM did not comment when asked why they had not been disposed of for nine months.

2. During a concurrent observation and interview with Registered Nurse 1 and the Director of Pharmacy on 11/3/15, at 10:35 AM, on the Medical Surgical unit, Patient 10 had IV fluid infusing continuously into an IV site into his right arm. A second bag of fluid, covered with a black plastic bag, was hanging with the end of the tubing piggybacked into a side port of the main IV line. The second bag was a 250 milliliters of IV fluids contained Amphotericin B (a medication used to treat fungal infection and needed to be kept from lights). It was noted there was approximately 100 milliliters of fluids left in it. On the bag, there was a label read, "DO NOT USE BEYOND 1530 (3:30 PM) 110115 (11/01/15)." The IV solution contained Amphotericin B was not to be used after 3:30 PM the day before the observation. RN 1 was asked why the Amphotericin B was still hanging, RN 1 stated she was not sure.

36543

Based on observation, interview, and record review, the hospital failed to have an Eyewash Station available and accessible to staff in the Central Supply Processing Room. This failure had the potential to cause injury during an accident involving chemicals or hazardous materials.

Findings:

During an observation of the Central Supply Processing Room, on 11/3/15, at 11:03 AM, there was no eye wash station noted in the dirty processing area. The Risk Manager and Operating Room Supervisor pointed out a wall mounted manual flush eye station in the clean room next door. To reach the eye wash station, it was necessary to go through two doors, one of which was locked. There was a tower in the pathway which created an obstruction to access to the eye station.

The Association for PeriOperative Registered Nurses (AORN) Recommended Practices for a Safe Environment of Care IX.i indicates, "Eyewash stations must be provided where chemicals that are hazardous to the eyes are located." IX.i.3 "Eyewash stations should be immediately available if the chemical is caustic or is a strong acid. While there is no standard that prohibits the small supplemental personal wash bottles, they cannot meet the flow rate requirements for a 15 minute flush, and therefore are not a substitute for a plumbed eye wash station."

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Based on observation and interview, the hospital failed to provide proper ventilation in an area where toxic chemicals were used. This failure had the potential to cause respiratory difficulties and eye discomfort to any individual entering the area.

Findings:

During a concurrent interview and observation of the Central Processing Cleaning Room, on 11/2/15, at 12:53 PM, a strong acidic odor was noted. No exhaust fan was observed. During an interview with the Gastrointestinal Technician (GIT), on 11/2/15, at 12:53 PM, he stated "Peracetic Acid (a mixture of acid and hydrogen peroxide) is used for high level disinfection of the endoscopes [an instrument used to examine the interior of a hollow organ or cavity of the body]."

The Steris (an infection prevention, decontamination, and surgical and critical care company) website indicates Peracetic acid is used in the Steris endoscope processors for the liquid chemical sterilization of endoscopes.

The safety data sheet for Peracetic acid indicates it is a "colorless liquid with a characteristic odor. It can be absorbed into the body by inhalation, through the skin and by ingestion. Peracetic acid may cause respiratory problems such as a burning sensation, cough, labored breathing, shortness of breath and/or a sore throat upon inhalation. Peracetic Acid may also cause eye redness and pain."

During an interview with the GIT, on 11/2/15, at 12:53 PM, he stated, "At times there was a strong odor. There is not an exhaust fan [in the Central Processing Cleaning room]."

The Association for PeriOperative Registered Nurses (AORN) Recommended Practices for Cleaning and Processing Flexible Endoscopes and Endoscope Accessories Recommendations, indicated "Recommendation XI.a. Adequate ventilation is required to protect personnel from the high-level disinfecting fumes."

Based on observation, interview, and record review, the hospital failed to provide an environment to avoid sources and transmission of infections as evidenced by the hospital's failure to have effective systems in place to ensure:

1. Surgical hinged instruments were sterilized in the open position in accordance with nationally accepted infection control standards. ( refer to A 749)

2. Patient care supplies, Intravenous (IV) fluids and equipment were stored in a sanitary and safe manner in patient care areas and central supply. (refer to A 749)

3. The pediatric area was a safe and sanitary area for pediatric patients. (refer to A 749)

4. Dialysis (a process for removing waste and excess water from the blood) machines were cleaned per hospital's policy and procedures. (refer to A 749)

5. Endoscopes (an instrument used to examine the interior of a hollow organ or cavity of the body) used in procedures were appropriately cleaned and stored. (refer to A 749)

6. Infection Control policy and procedures were followed when ceiling tiles were removed in the Medical-Surgical areas. (refer to A 749)

7. Mattresses used for patients were intact and able to be properly disinfected after each patient use. (refer to A 749)

8. Isolation carts were properly stocked. (refer to A 749)

9. Bio hazard waste receptacles were cleaned and covered. (refer to A 749)

10. Intravenous bags, tubing and sites were labeled per hospital policy and procedure. (refer to A 749)

The cumulative effects of these systemic failures resulted in the hospital's inability to ensure a sanitary environment placing patients, staff, and visitors at risk of being exposed to hospital associated infectious and communicable diseases.

Due to the hospital's failure to implement an effective Infection Control Program and an effective Pharmaceutical Service, the Chief Nursing Officer (CNO), Risk Manager (RM), President, Infection Control Nurse (ICN) were verbally notified of an Immediate Jeopardy (IJ) situation on 11/03/15 at 10:30 AM. The hospital was informed of the findings in infection control services including surgical hinged instruments found in the closed position, the unsanitary conditions of the hospital central supply and receiving area, and the unsanitary conditions of the patient care areas.

The Immediate Jeopardy was removed on 11/10/15, at 4:15 PM in the presence of the CNO, President, RM and the ICN. No further instruments were found in the closed position. The Pediatric area was closed for patient use. The hospital Materials Management Department area including the central supply area and the medical surgical floors were observed to confirm the unsanitary conditions were removed. An acceptable plan of correction was accepted.



29618

Based on observation, interview, and record review, the hospital failed to provide a safe and clean environment for all patients. The hospital failed to ensure:

1. Surgical hinged instruments were sterilized in the open position in accordance with nationally accepted infection control standards.

2. Patient care supplies, intravenous (IV) fluids (fluids and given through a patient's vein) and equipment were stored in a sanitary and safe manner in patient care areas and the central supply area.

3. The pediatric area was safe and sanitary for pediatric patients.

4. The dialysis (a process for removing waste and excess water from the blood) machines were cleaned per hospital policy and procedures.

5. Endoscopes (an instrument used to examine the interior a hollow organ or cavity of the body) used in procedures were appropriately cleaned and stored.

6. Infection control policy and procedures were followed when ceiling tiles were removed in the Medical-Surgical areas.

7. Mattresses used for patients were intact and able to be disinfected after each patient use.

8. Isolation carts (a cart stocked with equipment and supplies used by staff and visitors to prevent the spread of infection) were properly stocked.

9. Ensure bio-hazard (used patient care supplies that has the potential to spread infection), linen carts, patient care equipment and supplies were maintained in a sanitary and safe manner in the hospital maintenance area.

10. Intravenous fluid bags, tubing and sites were labeled per hospital policy and procedure. (refer to A 749)

These failures placed all hospital patients, staff and visitors at risk for contracting hospital associated infectious diseases.

Due to the hospital's failure to implement an effective Infection Control Program and an effective Pharmaceutical Service, the Chief Nursing Officer (CNO), Risk Manager (RM), President, Infection Control Nurse (ICN) were verbally notified of an Immediate Jeopardy (IJ) situation on 11/03/15 at 10:30 AM. The hospital was informed of the findings in infection control and pharmacy services including surgical hinged instruments found in the closed position, the unsanitary conditions of the hospital central supply area, and the unsanitary conditions of the patient care areas.

Findings:

1. During an observation of the hospital Intensive Care area and concurrent interview with the ICN, on 11/2/15, at 10:30 AM, a surgical pack labeled, "chest 8/11/14", was found on a shelf in a cabinet. The pack, wrapped in blue cloth, was opened by the ICN. The pack contained various instruments including eight scissors and clamps that had been sterilized in the closed position. The ICN stated, "We will remove that tray from service to be reprocessed. I thought we got them all (removed them from use)."

2. During an observation of the hospital Intensive Care area and concurrent interview with the ICN 11/2/15 at 10:30 AM, on the lower shelf of a cabinet, the following was found: a box of intravenous needles next to a package of "Mr. Clean" cleaning liquid, a box of hemoccult (blood in the stool laboratory test) testing slides with a liquid testing agent on top of the box, individual paper packaged dressings and four packaged syringes. The lower cabinet had five patient ambu-bags (used to breathe for patients in emergency cases of respiratory arrest) stored with five packages of patient dressings, multiple used blood pressure cuffs and various other patient care supplies. The wood cabinet shelves had peeling paint and a layer of gray matter.

During an observation and concurrent interview with the hospital RM, the ICN and the Director of Pharmacy (DP), on 11/2/15 at 10:30 AM, the Medical Surgical area was observed. The room the ICN indicated was a clean room contained the following items: two wheelchairs, a patient bed, and various used mechanical medical equipment. The ICN stated, "If these items were clean they would have a green tag that indicated ready for use." No green tags were observed. The dirty wheelchair leaned upon boxes of clean respiratory patient equipment. On the shelf was a large box overflowing with used oxygen sensors. Each oxygen sensor had old, used patient tape at the end of the sensor and was located next to an open box of sterile gloves and isolation masks. On the top shelf was a large box of syringes next to open containers of germicidal wipes. The second shelf had various respiratory masks and tubes next to a container of bleach wipes. On top of a wheelchair were three green pressure stockings. The ICN stated, "I'm not sure if these have been used."

During an observation on 11/2/15, at 10 AM, in the Medical Surgical Medication room, a storage cupboard had a shelf with patient soap next to an open box of tracheostomy tubes (tubes that are surgically inserted in the neck to open the airway) and a container of germicidal wipes. The shelf had a cardboard box which contained two opened bottles of hydrogen peroxide (no open date indicated), sterile intravenous line tubing, used blood pressure cuffs, patient combs and lotion. The ICN stated, "These things should not be stored together." A third cardboard box of items included patient suction catheters, one half bottle of drinking water, blood pressure cuffs, patient wound dressings, two packages of potassium (electrolyte supplement used for patients with low potassium levels) from the pharmacy and various sizes patient care syringes. The RM stated, "We will clean this up." The Medical Surgical hallway had a double door closet with a non-functional lock. Inside the closet were two full uncovered trash cans with five plastic trash bags piled on top. The bags contained used isolation gowns, multiple patient care supplies and other trash from patient rooms and care areas. The RM stated, "we will get this locked and the trash cleaned up."

According to APIC (Association for Professionals in Infection Control), "Waste should be collected from all areas at least daily. If large volumes of waste are generated, more frequent pickups must be scheduled. Filled waste containers must be emptied or replaced before they overflow. Each container should be lined to minimize contamination. In most areas, liners are plastic bags. Lining the container with several layers of bags is optional and helps to reduce contamination of the container if liquids spill. The inside and outside of the receptacles and their covers should be routinely cleaned and disinfected. In patient care areas and departments handling high volumes of blood and body fluids, this should occur at least daily. There are separate containers for biohazardous and non-biohazardous waste. Local regulatory agencies may require that biohazardous containers not in continual use (i.e., those in a procedure room or soiled utility room) be kept covered."

During an observation and concurrent interview with the Materials Management Director (MM), ICN, RM and DP, on 11/3/15, at 9:30 AM, of the hospital supply building, the large front door was open and supplies were being moved in and out of building. No air curtain was in place to prevent flying insects, dirt and dust from entering the storage facility. Multiple cardboard boxes were on the cement floor. Four large dirty ice chests were on a cart in front of shelving units with sterile patient care supplies, the MM stated "these (the ice chests) are used for community events." There were two plastic drums placed on the concrete floor, in front of the intravenous (IV) fluid storage shelves. The drums were clearly marked "Corrosive." One drum had an opened split cardboard box with IV fluids placed on top of it it. The MM stated "They (the containers marked Corrosive) are to be returned." She was not aware of their intended use at the hospital. The thermometer on a wall facing the back of the warehouse recorded a temperature of 73 degrees Fahrenheit. The MM concurred with the temperature reading. She was unable to provide a temperature log for the warehouse and stated she did not know if she had products that needed to be kept at a prescribed temperature. A one liter bag of Normal Saline Intravenous (IV) solution which was stored on a shelf indicated, "Keep at temperatures between 64 and 72 degrees Fahrenheit." The MM stated she was not aware that IV solutions were to be maintained at a certain temperature. A metal shelving unit with multiple bins and a table with three trays holding patient care supplies from crash carts with opened plastic wrap was located by the front door. The MM stated "the trays are returned to the warehouse after use to be restocked for the crash carts." On the table were mixed unpackaged and packaged items including: a bone aspirator, a gastric pump (used for suctioning (removal) of gastric (stomach) contents), electrocardiogram (heart electrical tracing [ECG]) paper, syringes, assorted fluids, tubing, alcohol wipes, tracheostomy tube and gloves. The MM stated "These items had been removed from previous trays and were to be restocked or used to restock crash cart trays." She stated "We are limited on space and that's why this table is so disorganized." The Material Management Assistant stated, "I don't see the problem here, everything is in packages." The bins containing items to be stocked in the crash cart were dusty and bug infested. One of the bins on the shelving unit contained eight tubes of Lidocaine jelly (medication to numb the skin). The MM stated "They are in individual packaging." A dirty extension cord was found draped across an open box of tongue depressors. On Shelf R-1, a cardboard box was found with two stacks of unwrapped and undated 4 x 4s (gauze bandage material). The MM stated "They (4 x 4s) had been returned from the floor and were to be disposed of." The MM did not answer when asked why they had been placed on the shelf rather than in the trash can. On Shelf R-3 batteries were found next to bandages. On Shelf R-5, an open package of paper calculi filters (used to collect sediment and kidney stones) and an open package of loose disposable plastic forceps clamps (handheld, hinged instrument used for grasping and holding objects. Forceps are used when fingers are too large to grasp small objects or when many objects need to be held at one time while the hands are used to perform a task) were observed. On another shelf an open cardboard carton with plastic bags, closed by a drawstring, which indicated "new mothers." The MM stated "they came that way from the manufacturer and the drawstring was closed so they were clean. What can I do?" A dusty open cardboard box with unwrapped disposable pediatric patient paper gowns (used for children) and a dusty gray box with 20 infant airways in opened packages was found on the same shelf. On Shelf R-7, there was a broken dirty light cover with insect webbing and bug remains stored next to cardboard boxes of sterile patient care supplies. On shelf R-12, there was an open cardboard box with unwrapped water pitchers for patient use. Various personal items were found in the patient care storage area including employee jackets, and a dusty radio. Chemical cleaning items were stored next to patient care items. Several old, dusty chairs were stored in front of shelving with bottled water for patient use. Three large pieces (8 inches by 6 inches) of metal shelving parts were found lying on wooden shelves. Each of these pieces of shelving parts had multiple dried bugs and insect webbing on them. A cart with six boxes of IV fluids (some partial boxes) all had an expiration date of 2/2015 stamped in black ink. The MM stated "They (IV Fluids) were to be disposed of." The MM did not comment when asked why they had not been disposed of since it is now November. Next to this cart was a dusty recycle can. Patient care items were on the shelf next to the dusty recycle can. Throughout the area were numerous IV poles with oxygen tanks attached with no indication if they were ready to be used by patients. A used torn, insulated bag was found on a cart holding boxes of patient drinking cups and IV fluids. The MM stated, this bag was used for "transporting lab specimens (blood, urine and stool) out of town." A crushed empty soda can found the on shelf next to IV fluids. The MM stated it should not be there. The air return vent at the back wall of the building had gray matter and large dust particles attached to it. A gray cart with brown stains was found near the vent and water. The MM stated, "This is used to transport our supplies." The DP, RM and ICN all stated "We have never been in here before." The DP stated, "I didn't know how dirty it was in here."

The hospital policy and procedure titled "Materials Management Safety" dated 4/29/14, indicated, "All equipment and supplies must be properly stored."

During a review of personnel records with Human Resources Representative (HR) on 11/03/2015 at 2 PM, HR was unable to find documentation of Material Management training or competency for the MM.

During a review of personnel records with HR on 11/03/2015 at 2 PM, HR was unable to find documentation of Infection Control training or competency for the ICN.

3. During an observation and concurrent interview with the hospital RM, the ICN and the DP on 11/2/15, at 1:30 PM, the pediatric unit was observed. One room functioned as the pediatric medication room, the children's play room, and the nursing station. On one side of the room was a bathroom and a shower with a glass door. The RM stated the shower was used by family members staying with pediatric patients.

The supply cabinet across from the children's play area was unlocked. Inside the cabinet was a smaller cabinet used for medications with a broken lock. Inside the cabinet, multiple items were found stored together such as: heel warmers, vacutainers (type of needle to draw blood), unpackaged and undated 4 x 4s and 2 x 2s (patient care dressings used to cover and clean wounds and IV sites), head covers, blood pressure cuffs, sterile gloves (some in partially opened packages), syringes, intravenous catheters (used to obtain intravenous access for fluids, antibiotics, etc.). One tub contained gloves, open cotton balls, fluffs, alcohol pads, and opened, unpackaged gauze bandages. All items would be accessible to children playing a few feet away. The crash cart and two additional oxygen cylinders were kept next to the play area. During an interview with the RM and the Registered Nurse Manager (RNM), on 11/2/15, at 1:30 PM, the RNM stated, "This area serves as the play area and medication area as well as the nurse's area. But these items should not be stored like this. We will have the lock repaired for the medication cabinet."

4. During an observation in the Intensive Care Area on 11/4/2015 2 PM, Dialysis Nurse (DRN) was assessing Patient 4 as she was being dialyzed. When asked how she cleaned the exterior surface of the dialysis machine, the DRN stated she used Clorox (bleach) out of the original bottle, pours it on a washcloth with a few drops of water and wipes down the machine after each use.

The hospital policy and procedure titled, "Dialysis" dated 6/24/14, indicated "Bleach solution for cleaning and disinfecting are prepared daily using bleach and water in a 1:150 bleach to water ratio." A conflicting policy provided titled, "Disinfection Dialysis Equipment/Surfaces" undated, indicated, "All dialysis machines will be disinfected by wiping thoroughly with a 10% (1/100 parts bleach to water) chlorine bleach solution"

5. During an observation on 11/2/15, at 12:50 PM, in the Central Processing Unit, the endoscopes were noted to be hanging in a non-vented cabinet. Three endoscope tips were touching the bottom of the cabinet.

During an interview with the Gasto-Intestinal Technician (GIT), on 11/2/15, at 12:50, he explained the cleaning process. The GIT stated "the scopes are flushed with alcohol to dry them and then they are hung in the cabinet." The GIT stated he did not use air or carbon dioxide to dry channels.

The Association for PeriOperative Registered Nurses (AORN) Recommended Practices for Cleaning and Processing Flexible Endoscopes and Endoscope indicated "VII.a. After rinsing with 70% to 90% ethyl or isopropyl alcohol, the channels should be dried using low pressure forced air... Using forced air assists with the removal of moisture remaining in the channels. Dry air channels do not support microbial growth." Recommendation IX "Flexible endoscopes should be stored in a manner that protects the device from damage and minimizes contamination." "IX.a. Flexible endoscopes should be stored in a closed cabinet with venting that allows air circulation around the flexible endoscopes... adequate height to allow flexible endoscopes to hang without touching the bottom of the cabinet..."

6. During an observation and concurrent interview with the MM on 11/4/15, at 1:30 PM, on the Medical Surgical hallway, outside of patient rooms, four ceiling tiles were found removed from the hallway ceiling. The opening was covered by a lightweight plastic sheeting. The MM stated an ICRA (infection control risk assessment) had been done for the work. A review of the ICRA presented to the survey team at 3 PM, indicated the work was to be started on 11/13/2015 and ended on 11/13/15. The work was classified as a "RISK LEVEL 1 low", which indicated work was being done in an office or non-patient care area. The ICN had not filled out her portion of the ICRA and was unavailable for interview.

7. During an observation and concurrent interview with the RM on 11/4/15, at 1:30 PM, in the Medical Surgical Area, a patient room was in the process of being cleaned after a patient had been discharged. The black mattress had two worn areas of approximately 10 inches by 10 inches through which you could visualize the white mattress contents. The RM stated the mattress would be removed from service.

8. During an observation and concurrent interview on 11/2/15 at 10:50 AM, with the ICN and the RM, the isolation cart outside of a room in the Medical Surgical Unit (Med-Surg) was found to be empty. Patient 6 was on contact isolation requiring gowns, gloves and a mask. The RM stated, "The cart should be stocked."

During an observation on 11/2/15, at 11:15 AM, with the RM, the isolation cart outside Patient 8's door in the Intensive Care Unit (ICU) was observed. The cart contained one gown, masks and a box of gloves on top of cart. No isolation sign was posted and no disposable stethoscope was found.

During an observation and concurrent interview with the RM, on 11/5/15, at 2:50 PM, the isolation cart outside Patient 9's room was stocked with gowns, gloves, and masks. The RM stated she was "unaware that the policy and procedure indicated disposable stethoscopes were to be in the isolation cart."

The hospital policy and procedure titled "Transmission Based Isolation (Airborne, Droplet, Contact, Enteric)" dated 4/22/15, indicated "Isolation carts must contain the following items: Non-sterile gloves, non-sterile gowns, surgical mask, alcohol hand rub, disposable stethoscopes, disinfectant wipes, bleach wipes for C-diff (a bacteria that can cause diarrhea and infection) in patients, Isolation signs."

9. During an observation and concurrent interview with the Facility Manager (FM) on 11/5/15, at 2:10 PM, the area outside of the hospital maintenance and biohazard area contained one uncovered box of Hepa filters (filters used to remove airborne particles from the air), one uncovered box of carbon filters (filters used to remove odors from the air), three IV poles with pumps, one of which had an oxygen cylinder in the stand. The FM stated "These are broken and need to be repaired." Multiple trash containers, boxes and carts were observed. Outside the biohazard waste storage unit was a rusted bedside commode and a used mattress with holes. The FM stated, "These things should not be stored here." The area between the biohazard waste storage and the hospital contained: dirty gloves, a medication bottle and a dirty linen transportation cart that contained 12 dirty patient use gloves, food particles, dog kibble food, plastic wrap and used plastic utensils. A biohazard waste transport cart contained nine dirty patient-use gloves. The biohazard waste storage unit contained nine white pharmaceutical containers. The FM stated biohazard waste receptacles must have lids and be sealed in order for the company to pick them up for disposal. Three out of nine containers did not have blue lids and contained mixed items: gloves, used intravenous bags with tubing and patient names, phenytoin (a medication for seizures) packaging, carbamazepine phenytoin (a medication for seizures) packaging and a tube of Vitamin A and vitamin D ointment with a patient name on it. Seven out of the nine containers were not dated or sealed. The FM stated, "We will get this area cleaned up."

The Association for Professionals in Infection Control (APIC) APIC, dated 2015, indicated "Waste is collected from all areas at least daily. If large volumes of waste are generated, more frequent pickups must be scheduled. Filled waste containers must be emptied or replaced before they overflow. Each container should be lined to minimize contamination. In most areas, liners are plastic bags. Lining the container with several layers of bags is optional and helps to reduce contamination of the container if liquids spill. The inside and outside of the receptacles and their covers should be routinely cleaned and disinfected. In patient care areas and departments handling high volumes of blood and body fluids, this should occur at least daily.

10. During a concurrent observation and interview, 11/2/15 at 10 AM, in the Medical Surgical area, with Registered Nurse (RN) 1, Patient 1 had intravenous (IV) fluid infusing into an IV site. A second smaller bag was hanging and had the end of the tubing plugged into a port on the same line. The IV bags and IV site were not labeled with the patient's name, date and time started, or the nurse that started the solution. RN 1 stated, she did not know when the IV site or medications were started and she could look in the computer. Patient 1 had a blood pressure cuff on a rolling pole with a basket in his room. In the basket were two used oxygen sensors with a dressing attached at the end, a pill crusher for general patient use was on top of the computer stand as well as three syringes filled with Normal Saline. A half full water pitcher was at the bedside and an uncovered, undated Styrofoam cup labeled "flush". RN 1 stated the patient was NPO (nothing to eat or drink per mouth) and she would remove the water pitcher and dirty care items.

During an observation on 11/02/15, at 10 AM, Patient 2 had three unlabeled IV bags and an unlabeled IV site. The IV bag tubing was not capped off but rather plugged into a side port of the same tubing.

During an observation on 11/02/15, at 10 AM, Patient 3 had two unlabeled IV bags, three unlabeled tubings and an unlabeled IV site. RN 2 stated all IV's, tubing and sites should be labeled.

The 2013 CDC (Center for Disease Control) guidelines indicate, "The practice of plugging an end of an IV tubing into the same tubing is not recommended. The tubing end should be capped after disinfecting the port."

The hospital policy and procedure titled "IV labeling" dated 4/23/14 indicated 1. All Intravenous (IV) admixture (a product of combining two or more substances) labels will contain the following details: a. Name, location and ID number of patient b. Medication, dosage with frequency, C. diluent (diluting agent) and volume d. Infusion time and/or rate e. special instructions, f. Initials of technician making product and pharmacist validating product, g. Barcode for product. 2. Stickers are affixed to the IV admixture: a. Beyond use date and time b. warning or caution stickers.

The hospital policy and procedure titled "IV therapy, IV Tubing Change" dated 8/2015, indicated Policy 6. "Regard IV systems as closed systems and maintain as such. "IV Site Care: 3. "The dressing is to be dated, time indicated and initials." 4. "All IV sites are to be changed every 96 hours or earlier if the site indicates a need for change."and IV Tubing Changes 2. "The IV tubing must be labeled with the date, time, and initials of person changing the tubing." 4. All IV Tubing will be labeled with the appropriate colored sticker for the day the tubing is changed.



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