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Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.42 Infection Prevention and Control and Antibiotic Stewardship Programs was out of compliance.

A-0750 The infection prevention and control program includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and addresses any infection control issues identified by public health authorities. Based on observations, interviews, and document review the facility failed to maintain a clean and sanitary environment to avoid sources of infection. Specifically, the facility failed to follow policy and national guidelines for contact isolation patients to wear personal protective equipment when in shared spaces.

Based on observations, interviews, and document review the facility failed to maintain a clean and sanitary environment to avoid sources of infection. Specifically, the facility failed to follow policy and national guidelines for patients who required contact isolation (isolation used to decrease the transmission of microorganisms that spread by direct or indirect contact with an infected individual or that person's environment) to wear personal protective equipment (PPE) when in shared spaces in one of one observation of a patient and visitors leaving an isolation room (Patient #2).

Findings include:

Facility policies:

The Transmission Based Precautions policy read, these recommendations are designed to prevent the transmission of infectious agents among patients and healthcare personnel in all settings where healthcare is delivered. Contact precautions are intended to prevent the transmission of infectious agents, including epidemiologically important microorganisms (infectious microorganisms that were easily transmissible, caused outbreaks, had a possibility of a severe outcome, and/or were difficult to treat), which are spread by direct or indirect contact with the patient or the patient's environment. Donning PPE upon room entry and discarding before exiting the patient's room is done to contain pathogens (microorganisms that cause disease), especially those that have been implicated in transmission through environmental contamination.

Transportation of patients in isolation precautions: For ambulation (walking), the patient performs hand hygiene and dons a clean hospital gown.

The Donning and Removal of Personal Protective Equipment policy read, the use of PPE is wearing items such as gowns, gloves, masks, and goggles to prevent contamination of clothing or skin with potentially infectious blood or body fluids. PPE should be used when there is a risk of this contamination. PPE is always to be used with a patient in contact precautions.

The Hand Hygiene (cleaning the hands to reduce the number of infectious organisms) policy read, hand hygiene is to be performed after touching a patient's surroundings.

References:

The Infection Prevention and Control Plan read, the goal of the facility is to establish a comprehensive infection prevention and control program to ensure the organization has a functioning, coordinated process in place to minimize the risks of healthcare-associated infections in patients and healthcare workers and to optimize the use of resources through a strong preventative program. The infection control function includes any and all activities, at both the direct patient care level and the patient care support level, aimed at reducing the risk of nosocomial (healthcare-acquired) infections in patients.

The Centers for Disease Control and Infection Prevention (CDC) 2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings update July 2023 provided by the facility read, limit transport of patients requiring transmission-based precautions to essential purposes, such as diagnostic and therapeutic procedures that cannot be performed in the patient's room. When transport is necessary, use appropriate barriers on the patient (mask, gown, wrapping in sheets or the use of impervious dressings to cover the affected areas when infectious skin lesions or drainage are present) consistent with the route and risk of transmission.

Family members or visitors who are providing care or having very close patient contact (feeding, holding) may have contact with other patients and could contribute to transmission if barrier precautions are not used correctly.

Donning PPE upon room entry and discarding before exiting the patient room is done to contain pathogens, especially those that have been implicated in transmission through environmental contamination, including vancomycin-resistant enterococcus (VRE, an infectious microorganism resistant to antibiotics).

1. The facility failed to follow policy and national guidelines to avoid sources of infectious microorganisms when patients with orders for contact isolation and their visitors were in shared spaces without wearing PPE or performing hand hygiene.

a. Observations

i. On 10/3/24 at 11:42 a.m., observations were conducted on the facility's third floor. The observations revealed a door to a private patient room with a posted contact isolation sign that read, "glove and gown precaution: Everyone must wash hands or use an alcohol-based hand rub when entering or leaving the patient's room." Observations further revealed Patient #2, his wife, and his granddaughter exiting the room. Patient #2 wore personal clothes and did not have on a clean hospital gown. Patient #2's wife and granddaughter had not put on PPE while in his room. Patient #2, his wife, and his granddaughter did not perform hand hygiene when exiting the room. Patient #2 did not put on PPE upon leaving the contact isolation room. Patient #2 and his family walked past other patients working with physical therapy in the hallway, used the elevators, and spent time in a waiting room near the entrance to the facility.

The observations were in contrast to the Donning and Removal of Personal Protective Equipment policy which instructed to use PPE when there was a risk of contamination. The policy further instructed PPE to always be used with a patient in contact precautions.

The observations were also in contrast to the facility's Infection Prevention and Control Plan, which instructed to minimize the risks of healthcare-associated infections in patients through a strong preventative infection control program. The plan further read that the infection control function included any and all activities aimed at reducing the risk of nosocomial infections in patients.

The observation of Patient #2's wife and granddaughter in the contact isolation room without PPE was in contrast to the Transmission Based Precautions policy, which instructed to don PPE upon room entry and discard PPE before exiting the patient's room to contain pathogens. The policy also instructed patients to perform hand hygiene and don a new gown when ambulating (walking).

The observation of Patient #2, his wife, and his granddaughter not performing hand hygiene upon leaving the contact isolation room was in contrast to the Hand Hygiene policy which instructed to perform hand hygiene after touching a patient's surroundings.

Furthermore, the observations of Patient #2 not wearing PPE when leaving his contact isolation room were in contrast to the CDC's Guideline for Isolation Precautions which instructed to use appropriate barriers on the patient consistent with the route and risk of transmission.

b. Interviews

i. On 10/3/23 at 12:55 p.m., an interview was conducted with Patient #2's wife. She stated she had asked staff if she needed to wear PPE because she was immunocompromised (had a weakened immune system). Patient #2's wife said staff told her PPE was not necessary for patients or visitors. She further said Patient #2 had been at the facility since May of 2023. Patient #2's wife stated staff had never asked her to wear a gown in his room or to perform hand hygiene. She also stated staff had never asked Patient #2 to wear a gown when he was outside of his room in hallways, the cafeteria, or the physical therapy (PT) gym.

ii. On 10/3/23 at 12:55 p.m., an interview was conducted with Patient #2's granddaughter. She said she became concerned about not wearing PPE in Patient #2's room, as she had a young child at home with health concerns. Patient #2's granddaughter stated she had not been asked to wear PPE when she visited him. She also stated Patient #2 had never been asked to put on PPE when he came out of his room, even when working with PT at the gym.

The interviews with Patient #2's wife and granddaughter were in contrast to the CDC's Guideline for Isolation Precautions which read, family members or visitors who provided care or had very close patient contact may have contact with other patients and could have contributed to infection transmission if barrier precautions were not used correctly.

iii. On 10/3/23 at 1:27 p.m., an interview was conducted with Patient #4, a patient in contact isolation for a multi-drug resistant organism (a microorganism that will not respond to many common antibiotics). Patient #4 said the staff allowed him to access the outdoors and to walk in the hallways. He stated staff had never asked him to wear a gown or gloves upon leaving his contact isolation room.

The interview with Patient #4 was in contrast to the Transmission Based Precautions policy, which instructed patients in isolation precautions to perform hand hygiene and don a clean hospital gown when they left the room.

iv. On 10/3/23 at 10:57 a.m., an interview was conducted with registered nurse (RN) #1. RN #1 stated patients in contact isolation who left their rooms should have been in an isolation gown and gloves. RN #1 explained the use of the gown and gloves by contact isolation patients outside of their private rooms lowered the risk of infection for other patients, employees, and visitors.

v. On 10/3/23 at 11:19 a.m., an interview was conducted with RN #2. RN #2 explained all contact isolation patients wore a gown when leaving their private rooms. She further explained the PPE prevented the patient from transferring microorganisms to anyone else at the facility. RN #2 said patients wearing PPE warned staff, patients, and visitors to avoid physical contact with the patient. She stated isolation patients wearing PPE in shared spaces prompted staff to provide extra environmental cleaning.

The interviews with RN #1 and RN #2 were in contrast to the observation of Patient #2 leaving his room without PPE.

vi. 10/3/23 at 11:48 a.m., an interview was conducted with occupational therapist (OT) #3. OT #3 explained facility procedure allowed patients with carbapenem-resistant enterobacterales (CRE, a microorganism that required contact isolation because it was resistant to common antibiotics) to leave their rooms, but only to go outside on the facility's grounds. OT #3 said patients in other types of contact precautions were allowed in the gym if they wore a gown. OT #3 said staff allowed patients in contact isolation to use the gym while other facility patients were also in the gym. OT #3 also said she had never seen a contact isolation patient in the PT gym without PPE.

The interview with OT #3 was in contrast to the interviews with Patient #2's wife and granddaughter, who stated staff allowed him to use the PT gym without PPE.

vii. On 10/5/23 at 11:34 a.m. an interview was conducted with RN #4. RN #4 explained the facility had recently discharged Patient #5, who had been infected with CRE. RN #4 said Patient #5 frequently resisted when staff asked him to wear PPE. She further said Patient #5 would occasionally leave his isolation room and interact with other patients without wearing PPE. RN #4 explained staff could not know what patients in contact isolation without PPE touched while in shared spaces, and that infectious diseases such as CRE could have spread through environmental surfaces.

viii. On 10/04/23 at 8:47 a.m., an interview was conducted with assistant director of nursing (ADON) #5. ADON #5 stated she had been the facility's infection preventionist until two months before, as the role transitioned to another person who was still receiving training. ADON #5 said facility policies instructed visitors to wear PPE while in a contact isolation room. ADON #5 further said visitors should have removed PPE when leaving the room. She explained patients in contact isolation should have put on a clean hospital gown and placed PPE on top. ADON #5 said staff, patients, and visitors should have performed hand hygiene every time they entered or left a contact isolation room.

ADON #5 explained CRE was a carbapenem-resistant (a powerful antibiotic that worked against a wide array of infectious microorganisms that became ineffective) "superbug" that was highly infectious and difficult to treat. ADON #5 explained every patient infected with CRE required treatment from a physician who specialized in infectious diseases. ADON #5 further explained the state health department tracked every case of CRE to ensure it did not spread to other patients in the facility. ADON #5 said CRE required contact isolation for protection of staff, the patient, and visitors.

ADON #5 stated contact isolation patients and their visitors should have used PPE and performed hand hygiene every time they entered or left an isolation room. ADON #5 explained this protected other patients from infectious microorganisms. She said contact isolation patients not wearing PPE and using the PT gym or traveling the hallways alongside immunocompromised patients could have transmitted infections. ADON #5 said contact isolation signs and contact isolation policies applied to staff, patients, and visitors.

The interview with ADON #5 was in contrast to the observation of Patient #2, his wife, and his granddaughter leaving his contact isolation room without using PPE or performing hand hygiene.

ix. On 10/3/23 at 10:38 a.m., an interview was conducted with director of nursing (Director) #6. Director #6 stated the facility followed CDC guidelines for infection control. He explained the public health department followed patients with CRE infections to ensure CRE did not pass to other patients. Director #6 said he personally worked with Patient #5, who was infected with CRE, to wear PPE when the patient left his private room.

x. On 10/3/23 at 4:47 p.m., an interview was conducted with chief medical officer (CMO) #7. CMO #7 explained patients in contact isolation needed to be in a clean gown, especially when they worked with therapy in the gym or were cognitively intact (able to think logically and clearly) and therefore could go outside of their isolation rooms. CMO #7 stated PPE protected the public, and that lack of PPE in public spaces led to accidental transmission, such as on a surface or by direct contact with the isolated patient.

CMO #7 said with highly resistant bacteria, such as CRE, the facility took steps to prevent the spread of infection. CMO #7 said failing to enforce PPE usage could have spread an infection to an immunocompromised patient. CMO #7 explained patients with diabetes mellitus (the body's ability to produce or react to blood sugar was impaired, leading to high levels of sugar in the blood and urine), the elderly, or anyone else whose immune system didn't work well had a high risk of contracting an infection. CMO #7 further explained an immunocompromised patient who became infected with an microorganism such as CRE would develop such a high amount of bacteria that they became a threat to the public because the bacteria could easily spread by overcoming a normal immune system.