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Based on observation, review of facility policy and procedure, review of manufacturers instructions for use (MIFU), and staff interview, it was determined that the facility failed to ensure that: 1) hand hygiene procedures are performed to minimize the spread of infection in two of two areas toured (A0749); 2) reusable patient care equipment is disinfected in accordance with the MIFU in one of three observations and facility policy in three of three observations (A0749); and 3) clean supply storage areas are kept free of potential contamination in one of one observations (A0749).

Cross Reference:
482.42(a)(2) Infection Prevention and Control and Antibiotic Stewardship Programs: Infection prevention and control program organization and policies

Based on observation, review of facility policy and procedure, review of manufacturer's instructions for use (MIFU), and staff interview, it was determined that the facility failed to ensure that: 1) hand hygiene procedures are performed to minimize the spread of infection in two of two areas toured; 2) reusable patient care equipment is disinfected in accordance with the MIFU one of three observations and facility policy in three of three observations; and 3) clean supply storage areas are kept free of potential contamination in one of one observations.

Findings include:

1. Facility policy titled, "Hand Hygiene," effective date 02/24/2023, stated, "... Indications for Hand Hygiene for all healthcare workers (HCW): HCWs will use an alcohol-based hand rub or wash with soap and water for the following clinical indications: Before and after patient contact. ... When moving from a dirty body site to a clean body site during patient care. ... After touching a patient or the patient's immediate environment. After contact with blood, body fluids, or contaminated surfaces. Immediately after glove removal. ... Procedure for performing hand hygiene: ... Soap and water: wet hands, apply soap, and lather for 15 seconds, then rinse. Alcohol-based hand rub or hand gel (ABHR: [sic] Dispense product, completely cover the entire hand, fingers, up to wrists, and rub until dried. ... A. Hand washing: ... 3. Rub hands together vigorously for at least 15 seconds covering all surfaces of hands and fingers ... F. Gloves: The HCW will follow these glove guidelines: a. Perform hand hygiene immediately before applying gloves and after removal. b. Use gloves whenever contact with blood, body fluid or other potentially infectious matter is present ... as a part of transmission-based precautions, ... c. Change gloves when moving from a dirty to a clean or sterile activity involving patient care. d. Remove gloves after completing care for the patient or finishing the work activity requiring gloves. ..."

On 8/19/24 at 10:44 AM, during a tour of the Neonatal Intensive Care Unit (NICU), in the presence of Staff (S) 8, the Manager of Infection Control, an observation of the cleaning and disinfection of a Giraffe Incubator by S10, a Sec/Tech (Secretary/Technician) was conducted in Room 14.

At 11:27 AM, S10, with gloved hands, cleaned the humidifier reservoir portion of the incubator with Cavi Wipes XL disinfection wipes and placed it on a countertop located in the room. S10 then removed his/her gloves, performed hand hygiene with soap and water for six seconds at a sink located in the room, dried his/her hands with a paper towel, reapplied new gloves and then continued to clean and disinfect the incubator.

At 11:32 AM, S10, with gloved hands, placed two empty containers of Cavi Wipes XL disinfection wipes into a waste receptacle located next to the sink in the room. S10 then removed his/her gloves, performed hand hygiene at the sink with soap and water for eight seconds, dried his/her hands with a paper towel, then reapplied new gloves.

At 11:38 AM, S10 cleaned the clear plate and the mattress portions of the incubator and placed them onto the countertop next to the sink. S10 then removed his/her gloves, performed hand hygiene at the sink with soap and water for six seconds, reapplied new gloves, and then placed the clear plate and mattress back into the incubator.

At 11:44 AM, upon completion of the cleaning and disinfection of the incubator, S10 removed his/her gown and gloves, performed hand hygiene at the sink for seven seconds, dried his/her hands with a paper towel, and then replaced the humidifier reservoir back onto the incubator.

At 11:58 AM. the above findings were confirmed with S8.

On 8/19/24 at 11:26 AM, during an observation in the NICU, S12, a Physician Assistant, entered Bay 4 and donned (put on) gloves without first performing hand hygiene. S12 cleaned the earpieces of the stethoscope at the bedside. Without removing his/her gloves and performing hand hygiene after cleaning the stethoscope, S12 proceeded to assess the patient. After performing an assessment, S12 removed his/her gloves and wrote on papers brought into the bay from the nurse's station. S12 did not perform hand hygiene after removing his/her gloves and prior to writing on the papers.

At 11:32 AM, while in Bay 3 assessing the patient, S12's cellphone began to ring. S12 removed one PPE (personal protective equipment) glove and without removing the other glove or performing hand hygiene, S12 answered the cell phone.

At 11:51 AM, S33, a NICU RN (Registered Nurse), took the workstation on wheels (WOW) that was in Bay 4 and brought it into Bay 7. S33 did not clean any of the WOW surfaces after removing it from Bay 4 and before entering Bay 7. S33 removed PPE gloves from a box and placed them on the WOW countertop prior to donning the gloves. S33 donned the gloves, and then removed them to go to another area to briefly check another patient. Upon returning, S33 applied hand sanitizer and without allowing it to dry, touched the controls on the pump at Bay 8 used to deliver the patient's nasogastric (NG) tube feeding. S33 performed hand hygiene and then donned gloves and began typing on the keyboard of the WOW in Bay 7. S33 took the scanner from the WOW into the isolette to scan the neonate's identification bracelet. S33 did not remove his/her gloves and perform hand hygiene after touching the WOW and before contact with the patient and items within the immediate vicinity of the patient.

On 8/19/24 at 1:47 PM, an observation of the cleaning and disinfection of OR (Operating Room) 1, in the Labor and Delivery OR Suite, was conducted in the presence of S6, the Labor and Delivery Nurse Manager, S8 and S29, Assistant Manager of Infection Prevention. S8 stated that a tubal ligation procedure was conducted in the room prior to the observation.

At 1:49 PM, S21, a Scrub Nurse, with gloved hands, removed, inspected, and then the wiped instruments with a white colored gauze, that were used in the OR procedure, one by one, from a basin that had light, red-colored water, and then placed the instruments into a metal mesh-like basket that was sitting on a metal table covered with a blue drape. At 2:05 PM, after removing, inspecting, and wiping all of the instruments, S21, did not remove his/her gloves, did not perform hand hygiene, and then picked up a bottle of Ecolab OptiPro Gel Instrument Pre-Cleaner solution that was sitting on top of a laminated paper that contained facility information, from a countertop in the OR, and then sprayed the instruments with the solution.

At 2:10 PM, S21 then removed his/her gloves, gown, and face shield, and placed them into a waste receptacle in the OR. S21 did not perform hand hygiene and then without wearing PPE gloves, picked up the metal basket that contained the soiled instruments and proceeded to touch the metal door handle and exit the OR. At 2:11 PM, S21 re-entered the OR and then with ungloved hands, rolled up the blue drape that the metal mesh-like basket that contained the soiled instruments was sitting on, from the OR table and then placed it into a waste receptacle. S21 did not perform hand hygiene and then applied new gloves.

On 8/19/24 at 3:08 PM, the above findings were confirmed with S8.

2. Facility policy titled, "Cleaning, Disinfecting and Storage of Non-Critical, Reusable Patient Care Equipment," effective date 9/12/2022, stated, "... Procedure: 1. Medical equipment should be cleaned and disinfected in accordance with the manufacturer's instructions (IFU). ... 9. All equipment must be cleaned/disinfected before and after use on patients. ... 12. All equipment that travels from patient-to-patient should be cleaned/disinfected at the point of use. 13. If equipment cannot be cleaned/disinfected immediately it should be moved to the soiled utility room until it can be cleaned /disinfected. ... 23. Team members using the workstations on wheels (WOW) are responsible for intermittent cleaning of the devices, including but are not limited to computer keyboards, mice, and bar code scanners. Cleaning should be done: ... c. Prior to entry and upon exiting the patient room ... Steps in Cleaning: 1. Follow the manufacturer's instructions for cleaning, disinfecting, and maintaining medical equipment. ... 4. ... d. Avoid cross contamination, ... APPENDIX I ... ITEMS ... Workstation on Wheels (WOWs) ... WHEN TO CLEAN ... After each patient use ...WHO CLEANS ...User ..."

On 8/19/24 at 10:43 AM, during a tour of the NICU, S9, Assistant Nurse Manager of the NICU, explained that patient Room 14 is used to clean and disinfect the isolettes when it is not occupied by a patient, due to limited space in the NICU for the cleaning and disinfection of the isolettes. At 10:44 AM, in the presence of S8, an observation of the cleaning and disinfection of a Giraffe Incubator, by S10, was conducted in Room 14. S10 explained that the soiled incubator was placed into the room on 8/19/24 at 6:00 AM and that Room 14 was a clean room when the soiled incubator was placed in it. S8 confirmed that Room 14 was last cleaned on 8/16/24. S10 stated he/she disassembles the incubator, then individually cleans, and disinfects each piece with CaviWipes XL disinfectant wipes and then reassembles it.

At 10:45 AM, without first cleaning and disinfecting the countertop, S10 placed a blanket down on the countertop, then removed two porthole seals from the side portion of the incubator, cleaned and disinfected them with CaviWipes and then placed them on top of the blanket. S10 stated the blanket was clean. At 10:52 AM, S10 opened a drawer located under the side door of the incubator and removed a white plastic insert, wiped it with the CaviWipes and then placed it directly onto the countertop next to the blanket that had the clean porthole seals on it.

At 10:57 AM, S10, without disassembling the door from the incubator first, opened the side door of the incubator, rotated the outer wall of the door downward and then proceeded to wipe the outer wall of the door and then the inner wall of the door with CaviWipes. Review of the Giraffe Incubator Operator's Manual stated, "... Maintaining the Incubator Disassembling the incubator for a complete cleaning ... 5. Remove the side doors by pushing in on either of the spring loaded buttons located at the bottom corners of the door (C) and lifting the door out of its hinges (D). ..."

At 11:00 AM, S10, without first cleaning and disinfecting the countertop, removed the mattress from the incubator, cleaned, and disinfected it then placed it on another countertop in the room, that was adjacent to a sink. S10 then removed the "Clear Plate" portion of the incubator, wiped it with CaviWipes, then leaned it up against the mattress on the countertop. S10 then removed the rotating bed portion of the incubator, wiped it down and placed it directly onto the countertop in front of the clear plate and mattress. S10 then proceeded to one by one, remove, clean and disinfect the x-ray tray, the translation deck, the tilt platform, and the pan and placed them on top of the rotating bed.

At 11:15 AM, S10 proceeded to clean and disinfect the back area of the incubator that had an electrical cord on the lower portion of it. S10 cleaned the back portion, then unraveled the cord that was attached to the back of the incubator. While holding the cord, S10 removed several CaviWipes from a container while touching the uncleaned cord to back area of the incubator that was just disinfected and then wiped the cord with the CaviWipes. S10 did not reclean the area that the uncleaned cord had touched.

At 11:27 AM, S10 washed his/her hands with soap and water in the sink in Room 14 that was directly adjacent to the cleaned equipment (mattress, clear plate, rotating bed, the x-ray tray, the translation deck, the tilt platform, and pan) on the countertop. At 11:30 AM, S10, without first cleaning and disinfecting the countertop and the humidifier reservoir, removed the humidifier reservoir from the incubator and placed it on the countertop directly next to the cleaned porthole seals. At 11:32 AM, S10 then picked up the humidifier reservoir from the countertop, cleaned and disinfected the outside portion of it with CaviWipes and then, without cleaning and disinfecting the countertop first, placed the humidifier reservoir back onto the countertop.

When questioned by the surveyor regarding the cleaning of the interior portion of the humidifier reservoir, S10 stated that if the reservoir had been used by the last patient, then he/she would just rinse it out in the sink with tap water and let it dry. S10 did not clean the interior portion of the reservoir during the observation. Review of the Giraffe Incubator Operator's Manual stated, "... Maintaining the Incubator Cleaning and disinfecting individual components ... Disassemble the humidifier reservoir. Clean the interior with a mild detergent-disinfectant solution. Rinse and thoroughly dry the parts before reassembly. ..."

At 11:32 AM, S10 washed his/her hands with soap and water in the sink in Room 14 that was directly adjacent to the cleaned equipment (mattress, clear plate, rotating bed, the x-ray tray, the translation deck, the tilt platform, pan) on the countertop.

At 11:35 AM, S10, without first re-cleaning and disinfecting the port hole seals, reassembled them onto the door of the incubator. At 11:36 AM, S10, without first re-cleaning and disinfecting the rotating bed, the x-ray tray, the translation deck, the tilt platform, and the pan portions, re-assembled them back into the incubator. At 11:38 AM, S10 re-cleaned and disinfected the clear plate and the mattress that were on the countertop next to the sink, and then without cleaning and disinfecting the countertop first, placed them back onto the same countertop. At 11:41 AM, S10, without first re-cleaning and disinfecting the clear plate, the mattress, and the humidifier reservoir, re-assembled them back into the incubator.

The above findings were confirmed with S8 at 11:58 AM.

On 8/19/24 at 11:26 AM, during observation in the NICU, S12 entered Bay 4 and proceeded to assess the patient and write on papers that he/she had brought into the bay and placed on the counter of the WOW. After completing the assessment of the patient in Bay 4, S12 took the same papers and placed them on a table/stand located beneath the patient's heart monitor in Bay 3. S12 did not disinfect the tabletop of the WOW after removing his/her papers. At 11:32 AM, while in Bay 3, S12's cellphone began to ring. After speaking on the phone, S12 placed his/her pen in his/her scrubs pocket, placed the papers he/she was documenting on back at the nurse's station and exited the unit. S12 did not disinfect the table/stand beneath the heart monitor where the papers from the nurse's station and the tabletop of the WOW in Bay 4 had been placed.

At 11:51 AM, S33, a NICU RN, took the WOW that was in Bay 4 and brought it into Bay 7. S33 did not clean any of the WOW surfaces after removing it from Bay 4 and before entering Bay 7. Shortly after, S33 performed hand hygiene, donned gloves, and began typing on the keyboard of the WOW in Bay 7. S33 then took the scanner from the WOW into the isolette of the patient in Bay 7 to scan the neonates identification bracelet. S33 returned the scanner to the WOW without any cleaning or disinfection. During an interview at 12:15 PM, S33 was asked about the frequency of cleaning of the WOW and the scanner. S33 stated that both are cleaned at the beginning and end of each shift. When asked if the scanner should be cleaned after being brought into the isolette and between patient use, S33 stated that he/she "can't tell you for sure" if they are cleaned in between patients but confirmed that he/she did not clean the scanner or WOW.

Facility policy titled, "Surgical Areas Cleaning," last reviewed 9/1/2022, stated, "Purpose: The Surgical and Operating Room (O.R.) are the most critical areas of the hospital. Extreme care must be taken to ensure the following schedule is carried out rigorously and in accordance with departmental procedures and AORN standards to include OR areas, ... Procedure: ... Surface cleaning is completed using a damp wipe method. ... Daily Routine Cleaning Between Case Cleaning (AORN ENV Cleaning Recommendation 11) 1. Remove soiled waste and linen ... 3. Wash O.R. table, ... and furniture with germicidal solution. ..."

On 8/19/24 at 1:47 PM, an observation of the cleaning and disinfection of OR 1, in the Labor and Delivery OR Suite, was conducted in the presence of S6, S8, and S29.

At 1:49 PM, S21, a Scrub Nurse, with gloved hands, removed and wiped instruments that were used in a OR procedure, that were soaking in a basin filled with light, red-colored water, located next to a metal table covered in a blue drape, and then placed the instruments in a metal basket that was sitting on the blue drape. At 2:05 PM, S21, wearing the same gloves, picked up a bottle of Ecolab OptiPro Gel Instrument Pre-Cleaner solution that was sitting on top of a laminated paper that contained facility information, from a countertop in the OR. S21 sprayed the instruments in the metal basket with the solution and then placed the bottle on the blue drape next to the metal basket that contained the soiled instruments. S21 then removed the bottle from the blue drape and placed it back on top of the laminated paper on the countertop.

At 2:12 PM, S22, an Environmental Aide, entered OR 1. At 2:24 PM, S22 cleaned and disinfected a green colored "Metadyne" mat that was located on the top and middle portion of the OR bed with Oxycide Daily Disinfectant Cleaner Wipes. At 2:26 PM, S22 then placed an uncleaned black arm board on top of the clean Metadyne mat and then proceeded to pick it up off the mat, clean and disinfect it, then placed it back on top of the Metadyne mat. S22 did not reclean the Metadyne mat prior to placing the clean arm board on it.

At 2:29 PM, S22 was observed to clean and disinfect the countertop area that had the Ecolab OptiPro Gel Instrument Pre-Cleaner solution sitting on top of the laminated paper. S22 did not clean the bottle that S21 had touched or the laminated paper that the solution was sitting on.

At 2:36 PM, S22 wiped both sides and the front portion of an opened red container labeled "Sharps." S22 did not wipe the tan colored top portion of the container.

At 2:40 PM, S22 removed an uncleaned mattress from the infant "Panda Warmer" located in OR 1 and placed it on top of the following unopened/unused supplies (one 8 french (fr) suction catheter mini tray, one 10 fr suction catheter mini tray, one 14 fr suction mini tray, two pulse oximetry sensors, one box that contained a stethoscope, one paper measuring tape) that were sitting on top of a black plastic container that contained supplies on a shelf next to the warmer. S22 then proceeded to clean and disinfect the infant warmer. At 2:43 PM, S22 then placed the uncleaned mattress onto the clean bed of the warmer, then picked up the mattress, cleaned and disinfected it, and then placed it back on to the bed portion of the warmer. S22 did not reclean the bed portion of the warmer prior to placing the clean mattress on it.

At 2:45, S22 stated "the cleaning is done and now I just have to clean the floors." At 2:46 PM, a portable metal crib that had a mattress covered with a pillowcase in it was observed next to the infant Panda warmer. Upon interview at the time of discovery, S6 was questioned about whether the pillowcase should have been removed from the mattress and the if the portable crib should have been cleaned and disinfected. S6 stated "yes the pillowcase should be changed out and the crib should be cleaned as well." Upon discovery, S6 ensured the crib would be cleaned. S6 was then interviewed regarding the unopened/unused supplies that were placed on the shelf next to the infant warmer. S6 stated that the supplies are typically kept in the drawer located in the infant warmer but that sometimes the staff will remove them per the neonatologist's preference and that the black plastic container on the shelf is called a "resuscitation box" and is used for immediate intubation. S6 stated that the unused supplies should have been discarded and that the resuscitation box should have been cleaned and disinfected. Upon discovery, S6 ensured the supplies would be discarded and the resuscitation box would be cleaned.

The above findings were confirmed with S8 at 3:08 PM.

3. Facility policy titled, "Cleaning, Disinfecting and Storage of Non-Critical, Reusable Patient Care Equipment," effective date 9/12/2022, stated, "... Utility Areas and Storage of Medical Equipment: ... 4. Clean supplies should be stored: a. At least 8 inches off the floor ... c. Outside of external shipping boxes ..."

On 8/19/24 at 11:07 AM, during an observation in the NICU, S32, a staff member from Materials Management, was observed dragging cardboard boxes of Enfamil Infant formula along the floor and through the door into the Breastmilk Storage Room. Upon entering the Breastmilk Storage Room, S32 had stacked the two cardboard boxes of Enfamil on top of the garbage can lid. S32 then took each box and placed it on the counter while he/she unloaded the individual formula packages into cabinets. The counter contained clean, unused infant feeding supplies such as feeding tubes in various sizes. S32 did not clean the countertop after placing the cardboard boxes that had been on the floor and the lid of the garbage can upon it. This observation was confirmed with S9 who stated that it was not the usual process to bring boxes into the storage room in this way.



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