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Based on the nature of standard level deficiencies referenced to the Condition, it was determined the Condition of Participation §482.42, INFECTION CONTROL, was out of compliance.

A-0749 - Standard: The infection control officer or officers must develop a system for identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel. The facility failed to maintain appropriate infection control processes and follow infection control standards in multiple areas throughout the hospital; in the areas of hand hygiene, glove changing practice, integrity of patient care supplies, and safe medication preparation. These failures created the potential for transmission of health care acquired infections to patients receiving care in the facility.

Based on observations and interviews, the facility failed to maintain appropriate infection control processes and follow infection control standards in multiple areas throughout the hospital, in the areas of hand hygiene, glove changing practice, integrity of patient care supplies, and safe medication preparation.

These failures created the potential for transmission of health care acquired infections to patients receiving care in the facility.

FINDINGS

POLICY

According to the policy, Hand Hygiene, promoting hand hygiene is the most important procedure in preventing the transmission of harmful organisms from person to person in the health care setting. The policy further states that hand hygiene should be performed before and after each patient contact and between different types of care on the same patient. Other specific indications for hand washing include: before and after performing invasive procedures, after contact with anything that is highly likely to be contaminated, before donning and after removal of personal protective equipment, and after touching objects that the patient or patient's secretions have touched (bed rails or tray tables), before handling "clean" items, and after using the computer.

According to the policy, Precautions: Standard and Transmission-Based Isolation, staff should put clean gloves on clean hands, prior to contact with mucous membranes and non-intact skin and to remove gloves promptly and perform hand hygiene.


REFERENCE

According to the Association of perioperative Registered Nurses (AORN), Guidelines for Perioperative Practice, 2017:

Recommendation III.e.2. (page 39), Sinks designated for hand hygiene should only be used for hand hygiene. Performing activities other than hand washing or surgical hand antisepsis could contaminate the sink, faucet, or hands of personnel subsequently using the sink.

According to Covidien Mallinckrodt Tracheal Tubes Airway Product Catalogue, all tubes are delivered sterile packed, for single use only.

1. The facility failed to ensure patient care staff performed hand hygiene and glove changes according to established infection control guidelines.

a) Observations in hand hygiene were conducted on 05/30/17, 05/31/17 and 06/01/17. There were multiple breaches throughout the Peri-Operative area. As example:

i) On 05/30/17 at 10:15 a.m., a tour of the Core Room where sterile supplies were kept was conducted with Operating Room (OR) Manager #1. Surgeon #2 and Physician Assistant (PA) #3 were observed outside OR #2 in the Core Room wearing visibly blood-soiled gloves. Surgeon #2 was observed holding a cart with his/her right gloved hand while holding up his/her left blood-soiled gloved in the air. Sterile trays were stored on the cart. According to OR Technician #4, the trays were prepared for surgeries scheduled later the same day and the following day. Although, PA #3 did not touch the supplies, s/he remained in the Core Supply Room with blood-soiled gloves in conversation with several other staff, then re-entered OR #2.

In an interview, conducted on 06/01/17 at 3:14 p.m. with Manager #1 and the Director of Peri-Operative Services (Director #5), Manager #1 stated staff should not be wearing blood-soiled gloves in the Core Room where clean supplies were kept. S/he stated staff should not be going into a clean area with contaminated gloves and should not touch anything. Manager #1 stated staff should remove gloves in the OR before leaving the room.

ii) On 05/31/17, a surgical case tracer was conducted for Patient #6. At 9:17 a.m., the Pre-Op RN #8 exited the patient's room without performing hand hygiene. S/he then handled supplies in the intravenous (IV) cart and removed IV fluids from the locked warmer located in an open area of the department. RN #8 proceeded to the Automated Dispensing Cabinet (ADC) located in the nursing station, again touching the computer and cabinet doors, and removed 2 medication vials. Still without performing hand hygiene, s/he then returned to the IV preparation area, and spiked the IV fluids and primed the tubing.

At 09:45 a.m., Anesthesiologist #9 entered the patient's room, placed his/her stethoscope on the patient, assessed the patient, then exited the room without performing hand hygiene.

At 9:55 a.m., the OR RN (RN #10) removed 1 vial of Versed from the ADC located at the nursing station. S/he then touched the cabinet above to remove supplies, drew the IV medication into a syringe without performing hand hygiene, and returned to the patient room and performed hand hygiene.

RN #10 placed the medication syringe into his/her scrub shirt pocket. S/he then touched the patient's gown and adjusted the patient's Sequential Compression Device (SCDs). RN #10 removed his/her phone from the back pants pocket of his/her scrubs. At 10:00 a.m., s/he then removed the syringe from his /her scrub pocket, administered a partial dose through the patient's IV access and then returned the syringe to his/her pocket. RN #10 transferred the patient out of the room to the OR. No hand hygiene was done prior to medication administration or when the RN left the patient's room.

At 10:03 a.m., Anesthesiologist #9 was in the OR. S/he placed the oxygen tubing on Patient #6. S/he helped reposition the patient for the invasive spinal anesthesia procedure. Anesthesiologist #9 removed a marker from his/her scrub pocket and marked the patient's back using gloved hands. Anesthesiologist #9 then touched several items including a cart and a warm blanket. Chloraprep (an antiseptic skin preparation) was applied twice to the patient's back with Anesthesiologist #9's contaminated gloved hands. Anesthesiologist #9 then touched his/her glasses, removed the gloves and immediately donned sterile gloves. No hand hygiene was performed by Anesthesiologist #9 before the sterile gloves were donned. Anesthesiologist #9 placed the sterile drapes and inserted the needle into the patient's back.

After the procedure was complete, Anesthesiologist #9 used the same gloves to perform several other tasks, including connecting an IV syringe of Propofol to an IV port, followed by opening the drawer of the medication cart, repositioning the patient, and placing an oxygen mask on the patient. Anesthesiologist #9 then removed his/her sterile gloves and donned new gloves. No hand hygiene was done.

During the room turnover, OR Technician #11, who was cleaning the OR, handled the patient's specimen, pressed the specimen inside the container and closed the lid. OR Technician #11 removed one glove, performed no hand hygiene and placed his hand in his pocket to remove his/her phone, donned a new glove, again with no hand hygiene, and continued to strip the room.

Additional hand hygiene breaches were observed during the surgery by the circulating Registered Nurses and the OR Technicians. As example, at 10:26 a.m., OR RN #10 performed antisepsis prep on the patient's right hip. After s/he discarded the gloves used, RN #10 retrieved a specimen container from the clean patient supplies cabinet without performing hand hygiene after glove removal.

b) On 05/31/17 at 2:15 p.m., an interview was conducted with Anesthesiologist # 9. After review of the observation of Patient #6's invasive spinal procedure, Anesthesiologist #9 stated s/he considered his/her hands clean after repositioning the patient and everything s/he touched was considered the patient's own "stuff." S/he reported there was no reason to perform hand hygiene after changing gloves used to reposition the patient and prior to donning sterile gloves for the procedure. This was in contrast to policy.

c) During an interview on 06/01/17 at 9:47 a.m., RN #8 described the hand hygiene training s/he had received and stated hand hygiene was expected every time staff entered a patient's room, after IV placement, and if touching the patient's bare skin. S/he stated hand hygiene should be done for disinfection, including after using the restroom and after using computers. RN #8 stated hand hygiene and glove usage was important because it kept patients and staff safe and stopped the chain of infection. RN #8 stated s/he was always cognizant of touching dirty areas prior to performing a clean task.

The specific hand hygiene observations made on 05/31/17 were discussed with RN #8, who stated perhaps the errors were because the survey team was present, the hand gel was not there or perhaps s/he just forgot.

d) An interview was conducted on 06/01/17 at 12:00 p.m., with the Infection Prevention RN (IPRN #7) and the Infection Prevention Coordinator (IPC #6). IPC #6 stated staff were expected to follow the established hand hygiene and glove changing procedures. Changing gloves and performing hand hygiene before and after gloving was required every time. IPC #6 explained the risk of not following facility hand hygiene guidelines was the possibility of patients acquiring a Hospital Associated Infection (HAI) or a Surgical Site Infection (SSI). S/he stated HAIs and SSIs could occur by spreading infection to equipment, inanimate objects and indirectly to other patients.

After review of the observation conducted in the Core Room on 05/30/17, both stated the practice was not okay. IPRN #7 stated s/he would be concerned with cross-contamination of patient care supplies.

IPRN #7 and IPC #6 stated the operating room followed the Association of Perioperative Registered Nurses (AORN) national guidelines, as did the Peri-Operative area. The remainder of the facility followed Center for Disease Control (CDC) guidelines.

2. The facility staff failed to follow safe medication injection practices in 1 of 2 observations. Nursing staff did not disinfect the rubber septum on IV medication vials prior to piercing the septum.

a) On 05/31/17 at 9:20 a.m., an IV medication administration observation was conducted in the Pre-Op area for Patient #6. RN #8 removed the plastic cap from a Lidocaine medication vial and proceeded to pierce the top of the vial with a needle and a syringe. RN #8 did not disinfect the top of the vial. The medication was then administered subcutaneously to the patient. At 9:30 a.m., RN #8 repeated the process, removing the plastic cap from a Decadron medication vial and piercing the top of the vial with a needle and syringe. RN #8 did not disinfect the top of the vial. The medication was administered to patient #6 through the IV tubing port.

b) During an interview on 06/01/17 at 9:47 a.m., RN #8 stated s/he was unaware the septum of single use vials must be disinfected. S/he stated s/he was taught in nursing school the area under the cap was sterile and thus s/he did not need to disinfect the septum before piercing. RN #8 stated s/he had not had any education or training at the facility regarding this practice requirement.

c) On 06/01/17 at 12:00 p.m., an interview was conducted with IPRN #7 and IPC #6. IPRN #7 and IPC #6 stated disinfection of the medication vial septum was necessary. IPRN #7 stated there was no guarantee the top was sterile. IPC #6 stated it was possible staff could have unintentionally contaminated the vial when opened, which would have led to a risk of cross-contamination.

3. The facility failed to ensure areas used for surgical handwashing were not contaminated.

a) On 05/30/17 at 9:50 a.m., 2 one-liter bags of IV fluids were observed draining inside a scrub sink located in the OR corridor between ORs #3 and #4. Manager #1 stated the bags probably came from the adjacent OR which had just been cleaned.

b) On 05/31/17 at 1:35 p.m., an OR staff was observed leaving OR #5 with gloves on and carrying a 500ml bag of IV fluids. The bag was then drained into the adjacent scrub sink, located in the OR corridor. This was in contrast to AORN guidelines.

c) On 06/01/17 at 1:19 p.m., an interview with IPRN #7 and IPC #6 was continued. IPRN #7 stated saline bags should not be drained in the scrub skin due to the risk of cross-contamination. S/he further stated the bags should be discarded in the OR.

4. The facility did not ensure patient care supplies stored in anesthesia carts in the Operating Rooms (ORs) were handled in a way to prevent cross-contamination among patients.

a) On 05/31/17 at 11:30 a.m., immediately after the surgical case tracer was completed for Patient #6, an inspection of the anesthesia cart located in the same OR was conducted. In the top drawer of the cart, two opened packages were found each containing a Mallinckrodt Hi-Lo Oral/Nasal Tracheal Tube Cuffed (ET tube). Both were stored next to unopened, packaged, clean ET tubes. The opened ET tubes were the same ones which were observed on top of the cart during Patient #6's procedure.

b) An interview was conducted on 05/31/17 at 2:15 p.m. with Anesthesiologist #9 who stated s/he always left ET tubes opened during patients' procedures in case of an emergency. S/he stated s/he placed the opened packages in the drawer and discarded the opened packaged ET tubes at the end of the day.

c) In the interview with the Infection Control leaders on 06/01/17 at 12:00 p.m., IPRN #7 and IPC #6 stated they would expect the ET tubes to be kept clean and individually packaged, and the packaging must be closed. They were unsure whether the tubes had to be kept sterile before use.

d) The Director of Perioperative Services (Director #5) was interviewed on 06/01/17 at 3:14 p.m. S/he stated the ET tubes should be discarded or used if they were opened.