HospitalInspections.org

Based on observation, interview, record review, and policy review, the provider failed to:
*Ensure medications stored in one of one pharmacy and in one of one medication room had been accessible to only those authorized to have access.
*Maintain a system of accountability for narcotic medications brought for patient use from their home.
Findings include:

1. Observation and interview on 1/6/16 at 11:30 a.m. with the pharmacy director revealed:
*The pharmacy and the medication room doors were locked with a keyless push-button number code.
*When the door locks required a new code the maintenance supervisor was responsible for changing those codes.
*The pharmacy director had agreed the maintenance supervisor was not authorized to have access to the medications.

Interview on 1/6/16 at 12:15 p.m. with the director of nursing (DON) revealed:*She agreed the maintenance supervisor was not authorized to have access to the pharmacy or medication room.
*She or the pharmacy director would have to change the door code when it was needed.

Review of the provider's December 2015 Medication Security in Facility policy revealed, "Precautions have been made to insure that the medications located in the facility are secure and unavailable to unauthorized personal, or employees."

2. Observation and interview on 1/6/16 at 11:45 a.m. with the pharmacy director in the medication room revealed:
*A Pyxis (computerized medication system) was used for dispensing medications used for patients.
*A large locked unmarked cabinet on the wall of the medication room.
*A set of keys hung on a shelf below the cabinet.
*The pharmacy director revealed:
-That locked cabinet was previously used to store narcotic medications requiring a double-lock system prior to using the Pyxis system.
-It was no longer used for narcotic storage, because the Pyxis system kept the narcotics double-locked.
*When the pharmacy director used the keys located on the shelf to open the cabinet at that time there were four boxes of fentanyl (narcotic pain medication) for patient 31.

Further interview at that time with the pharmacy director revealed:
*Patient 31 was a hospice patient and had wanted to use his medication he brought from home.*He had thought the patient had passed away over the weekend.
*His expectation was the charge nurse would have stored the medication in the locked cabinet and notified him of those medications.
*He would have destroyed them when he returned to work if he had been notified.

Further investigation of the above medication revealed:*The forms accompanying the medication had been dated for October 2015.
*Review of the electronic medical record revealed patient 31 had not been hospitalized since October 2015.
*The pharmacy director had not known how long the fentanyl medication had been stored in the medication room.
*He was not sure what the policy was on medications brought from home.
*That medication had not been dispensed by the provider's pharmacy.

Interview on 1/6/16 at 12:15 p.m. with the DON revealed she:
*Had not been aware of narcotics being stored in the cabinet.
*Was not sure what the policy was for using or destroying medications that had been brought from home.
*Was not sure if she would expect medications brought from home to have been counted routinely to maintain accountability of the narcotics.
*Agreed there should have been a system for accountability of those medications.

Review of the provider's December 2015 Medication Storage in Facility policy revealed:
*"The Pyxis machine houses all the medications, including controlled substances [narcotics]."*The policy had not included a procedure for safe storage of medications brought in from home.

Review of the provider's December 2015 Medication Administration policy revealed:
*Only medications dispensed by the hospital pharmacy would have been administered to patients.
*The only exception would have been unobtainable medications not supplied by the pharmacy.

A. Based on observation, interview, record review, and procedure review, the provide failed to ensure sanitary conditions were maintained:
*During the administration of fluids for one of one sampled patient (17) who required fluid hydration through a gastronomy tube (g-tube) (tube inserted into the stomach for nutrition and hydration) by one of one registered nurse (RN) B.
*During two of two dressing changes for one of one sampled patient (19) who had stage IV pressure ulcers (wounds from constant pressure to an area of the body) to both buttocks (bottom) by one of one RN (A).
Findings include:

1. Review of patient 17's medical record revealed:
*An admission date of 1/4/16.
*Diagnoses of respiratory distress (difficulty breathing), dehydration, pneumonia, and a swallowing dysfunction requiring the use of a g-tube for nutrition and hydration.
*She had a history of respiratory syncytial virus (RSV) (highly contagious respiratory infection).
*She had been placed in isolation for droplet precautions.

Observation on 1/5/16 at 1:30 p.m. of RN B with patient 17 revealed:
*She had retrieved supplies to administer 30 milliliters (ml) of pedialyte (to help replenish fluids in the body) through the patient's g-tube.
*There had been a cart outside of the patient's room. That cart contained isolation supplies for the staff to wear when taking care of the patient.
*She had put on a mask, gown, and gloves before entering the patient's room.
*With those clean gloves she:
-Knocked on the patient's door, grabbed the door handle, and opened the door.
-Pulled a bed table over to the patient's crib.
-Retrieved several supplies needed to administer the pedialyte through the g-tube.
-Turned on the faucet handles and filled a container with water.
-Turned off the faucet handles and placed the container of water on the bedside table.
-Pulled a knob attached to the crib to lower the rail.
-Uncovered the patient to expose the g-tube.
-Opened the g-tube cap, attached extra tubing, and administered the pedialyte.
-Removed the extra tubing and closed the cap attached to the g-tube.
*After RN B had administered the pedialyte and provided personal care she:
-Removed her soiled gloves, gown, and mask.
-Left the room and sanitized (cleaned) her hands.
*She had not been observed changing her gloves or sanitizing her hands until she had completed the tasks observed above.

Interview on 1/5/16 at 1:45 p.m. with RN B regarding the above observation revealed:
*She confirmed that had been her usual process to administer pedialyte through the patient's g-tube.
*She confirmed the above process had not been done in a sanitary manner.
*She should have changed her gloves and washed her hands prior to administering the pedialyte through the patient's g-tube.
*She confirmed the above process had created the risk of cross-contamination (spread of bacteria from one person to another) and the potential of infection for the patient.

2. Review of patient 19's medical record revealed:
*An admission date of 12/21/15.
*Diagnoses:
-Recent colostomy (surgical opening into stomach for digested foods to pass into a collection bag).
-G-tube for malnutrition and hydration.
-Past spinal cord injury that had created the inability to move his legs and feet without assistance and thought.
-Two stage IV pressure ulcers on both of his buttocks.

Observation on 1/5/16 at 2:00 p.m. of RN A with patient 19 during two dressing changes revealed:
*He was resting in bed and was covered with a hospital gown.
*She retrieved a container with supplies for the dressing changes.
*She washed her hands and put on a clean pair of gloves.
*With those clean gloves she:
-Pulled back his hospital gown to reveal his left buttock. There had been no dressing covering the wound.
-Repositioned the sheet he had been laying on. The sheet had been covered with a red/brown colored drainage from the wound.
*With those soiled gloves she:
-Retrieved a large disposable cloth from his bathroom.
-Assisted him to turn further on his side and placed the cloth underneath the wound.
-Retrieved several packages, tape, bottle of Dankins solution (wound cleaner), scissors, and idoform packing strips (special gauze dressing) from the container.
-Opened the Dankins solution bottle and filled a syringe with it.
-Opened two packages of gauze.
-Cleansed the wound with the syringe filled with the Dankins solution. She used one gauze to catch the extra solution and dry the wound.
-Covered the wound with the idoform strips and the second piece of gauze.
*She had asked the patient to turn onto his other side to expose the wound on his right buttock. There had been no dressing covering the wound. The sheet had red/brown drainage on it from the open wound.
*She removed her gloves after completing the cleansing and dressing change to his left buttock. Without washing or sanitizing her hands she put on a clean pair of gloves.
*With those clean gloves she:
-Placed the disposable cloth used to clean and dress the wound on his left buttock. She had stated "I just re-use this, it is still clean on this one corner. It's dry there."
-Repeated the same above process for cleaning and dressing the wound to his right buttock.
*She removed her gloves after completing the cleansing and dressing change to his right buttock and sanitized her hands.
*She had not been observed sanitizing her hands between the two dressing changes and prior to putting on clean gloves.
*She had not been observed changing her gloves after cleansing the wounds and applying the clean dressings.

Interview on 1/5/16 at 2:30 p.m. with RN A regarding the observation above revealed:
*She confirmed that had been her usual process for completing his dressing changes.
*She confirmed the above process had not been done in a sanitary manner.
*She stated "I should have washed my hands more."
*She confirmed the above process had created the risk of cross-contamination (spread of bacteria from one person to another) and the potential of infection for the patient.

Interview on 1/6/16 at 1:50 p.m. with the director of nursing (DON) revealed:
*She had been the infection control nurse for the facility.
*She confirmed:
-The above techniques had not been done in a sanitary manner.
-The techniques had created the potential for cross-contamination and the potential for the patients to acquire an infection.
*She had been responsible for any infection control training and competency testing.
*She would have done infection control competency testing and training once a year in October.
*She had not observed:
-The staff administering fluids through a g-tube.
-The staff performing dressing changes.

Review of the provider's August 2014 Percutaneous Tube Feeding Procedure revealed no procedure in place for the staff to follow for administering fluids through a g-tube.

Review of the provider's 2009 Lippincott's Nursing Procedures manual revealed:
*The provider had followed the above manual's guidelines for dressing changes.
*After cleansing the wound "Remove and discard your soiled gloves, and put on a fresh pair."
*The staff were to have washed their hands upon completion of a dressing change.



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B. Based on observation, interview, and policy review, the provider failed to ensure two of two endoscopes (lighted tubes to view inside specific area of the body) were stored in a vented area. Findings include:

1. Observation on 1/6/16 at 8:40 a.m. of surgical technician (tech) C storing an endoscope after cleaning it revealed:*She hung the wet endoscope in a closet in the endoscopy/procedure room.
*The closet stored two endoscopes and had two doors.
*No ventilation system was seen inside the closet or in the doors.

Interview at that time with surgical tech C and the surgery manager revealed:
*That was the only storage area for the endoscopes.
*They agreed there was no system for ventilation in the closet.
*They were not aware the closet required ventilation for endoscope storage.

Review of the provider's March 2015 Cleaning and Disinfection of Endoscopy Scopes policy revealed the endoscope was to have been stored in a dry environment.

Review of Association of PeriOperative Registered Nurses (AORN) 2014 guidelines for Cleaning and Processing Endoscopes policy, p. 534, revealed:
*"Flexible endoscopes should be stored in a manner that protect the device from damage and minimizes microbial contamination.
IX.a. Flexible endoscopes should be stored in a closed cabinet with:
-venting that allows air circulation around the flexible endoscopes;
-internal surfaces composed of cleanable material;
-sufficient space for storage of multiple endoscopes without touching."



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C. Based on interview, policy review, and review of manufacturer's instructions for use, the provider failed to follow manufacturer's instructions for use for MetriCide (a high-level disinfectant used to disinfect endoscopes). Findings include:

1. Interview on 1/5/16 at 11:15 a.m. with surgical technician C and the operating room (OR) manager revealed:
*The endoscopes were being manually cleaned since the automatic reprocessor had quit working.
*The endoscopes were being soaked in Metricide for twenty minutes to obtain a high-level disinfection.
*They were following the Society of Gastroenterology Nurses and Associates (SGNA) guideline for use of high-level disinfectants and sterilants for reprocessing flexible gastrointestinal endoscopes as their policy.

Review of the provider's policy which was from the SGNA guideline for use of high-level disinfectants and sterilants for reprocessing flexible gastrointestinal endoscopes revealed:
"Soak time exception:
SGNA, in collaboration with the American Society for Gastrointestinal Endoscopy (ASGE), the American Gastroenterology (ACG), and the Association for Professionals in Infection Control and Epidemiology (APIC) adopted the Multi-society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes. This guideline, based on scientific data, supports the position that after meticulous manual cleaning, high-level disinfection is achievable with a 20-minute exposure at 20 C (room temperature) in a 2% glutaraldehyde solution which does not contain surfactant and which tests above its minimum effective concentration (Nelson et al. 2003). These conditions may not be extended to other glutaraldehyde solutions. This recommendation differs from the label claims on 2% glutaraldehyde stating a 45-minute exposure at 25 C for HLD (high-level disinfection) because the current federal labeling regulation assumes no cleaning of the medical device prior to chemical exposure."

Review of the MetriCide instructions for use revealed:
*"MetriCide Activated Dialdehyde Solution is a liquid chemical sterilant and high-level disinfectant, when used according to the Directions for use."
*"High-Level Disinfectant: MetriCide solution is a high-level disinfectant when used or reused, according to Directions for Use, at full strength for a maximum of 14 days at 25 C with an immersion time of at least 45 minutes."
*"The user MUST adhere to the Directions for Use, because any modification will affect the safety and effectiveness of the germicide."

Interview on 1/7/16 at 3:35 p.m. with METREX technical support who manufactures Metricide revealed:
*They were aware of the guidance provided by SGNA.
*At the time Metricide was labeled they could not assume the scopes had been cleaned prior to high-level disinfection. To ensure all scopes would be high-level disinfected they chose the forty-five minute immersion time.
*They would not recommend altering the immersion time.