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Based on interviews, medical record reviews, policy review, observations, and review of Centers for Disease Control and Prevention (CDC) guidance, the facility failed to implement hospital-wide infection surveillance, prevention, and control policies and procedures that adhere to nationally recognized guidelines for Carbapenemase Producing Carbapenem-Resistant Enterobacteriaceae (CP-CRE) patients. The cumulative effects of these systemic practices resulted in the facility's inability to ensure patients received care in accordance with nationally recognized infection prevention and control guidelines to limit the spread of infectious diseases (SARS-CoV-2). This had the potential to affect the facility's 1070 patients.


Refer to citation at A0772.

Based on interviews, medical record reviews, policy review, observations and review of Centers for Disease Control and Prevention (CDC) guidance, the facility failed to implement hospital-wide infection surveillance, prevention, and control policies and procedures that adhere to nationally recognized guidelines for Carbapenemase Producing Carbapenem-Resistant Enterobacteriaceae (CP-CRE) patients for seven (Patient #1, #2, #3, #5, #13, #14 and #15) of 15 medical records reviewed. This had the potential to affect all the facility's 1070 patients.

Findings include:

1. Review of the CDC guidance at https://www.cdc.gov/hai/organisms/cre/cre-facilities.htm (reviewed 11/04/19) titled "Healthcare Facilities: Information about CRE" revealed: Carbapenem-Resistant Enterobacterales (CRE) are a serious threat to public health. Infections with CRE are difficult to treat and have been associated with mortality rates of up to 50% for hospitalized patients. Bullet points under the heading "Healthcare Facilities Should" included:
- Ensure precautions are implemented for CRE colonized or infected patients. These include:
- Whenever possible, place patients currently or previously colonized or infected with CRE in a private room with a bathroom and dedicate noncritical equipment (e.g., stethoscope, blood pressure cuff) to CRE patients.
- Have and enforce a policy for using gown and gloves when caring for patients with CRE.

2. The CDC guidance at https://www.cdc.gov/hai/organisms/cre/cre-clinicians.html (reviewed 11/13/19) titled "Clinicians: Information about CRE," under the heading When Can Contact Precautions Be Discontinued for Patients Colonized or Infected with CRE? revealed there is currently not enough information for CDC to make a general recommendation on when isolation can be discontinued for patients colonized or infected with CRE. CRE colonization can be prolonged (> 6 months). If considering discontinuing Contact Precautions based on the results of surveillance cultures, it is appropriate to wait for at least three to six months since last positive culture or screen. The decision to discontinue Contact Precautions for an individual with a history of colonization or infection with CRE should be made in consultation with public health. In general, failure to identify CRE from at least two sets of screening cultures are the minimum criteria that should be met before an episode of colonization is considered resolved. Additionally, retesting of the site(s) that were positive initially from clinical cultures is usually indicated, particularly non-sterile sites such as a wound or urine.

3. The CDC's guidance titled "Facility Guidance for Control of Carbapenem-Resistant Enterobacteriaceae (CRE) November 2015 Update CRE Toolkit" heading Facility-Level Prevention Strategies revealed interventions recommended to prevent CRE transmission in healthcare settings. The listed interventions might be applied differently by facilities based on the underlying epidemiology of CRE in the region including the regional prevalence, the underlying CRE resistance mechanisms found in the area, and the type of healthcare facility involved. In general, standard interventions designed to prevent the transmission of multidrug-resistant organisms (MDROs) (e.g., hand hygiene, Contact Precautions) should be implemented for most CRE (CP-CRE and non-CP-CRE). However, facilities might choose to apply a wider range of interventions for CRE they judge to be epidemiologically important, including all CP-CRE.

Bullet point 2. Contact Precautions noted the use of Contact Precautions by healthcare setting type based on the type of care provided. The third section outlines general guidance for any facility using Contact Precautions.

Bullet point 2a. Acute Care Hospitals and High- Acuity Post-Acute Care Settings
Acute care hospitals, long-term acute care hospitals, and ventilator units of skilled nursing facilities should generally place patients who are colonized or infected with CRE on Contact Precautions. Some facilities might choose to not place some non-CP-CRE that remain susceptible to other antimicrobials on Contact Precautions. All patients with CP-CRE should be placed on Contact Precautions.

Bullet point 9. Patient and Staff Cohorting noted when available, patients colonized or infected with any CP-CRE or any non- CP-CRE judged to be epidemiologically important should be housed in single patient rooms. In addition, consideration should be given to cohorting patients with CRE in specific areas (e.g., units or wards), even if in single patient rooms, and to using dedicated staff (i.e., without responsibility for care of non-CRE patients) to care for them. At a minimum, dedicated staff should include the providers that provide the bulk of the patient's care (e.g., nurses, nursing assistants) but could be expanded to include other staff (e.g., respiratory therapists) particularly if there are a larger number of CRE patients or during an outbreak. The specific staff that are dedicated may vary depending on the healthcare setting. If there are an insufficient number of single rooms, preference should be given to patients at highest risk for transmission such as patients with incontinence, medical devices, or wounds with uncontrolled drainage.

Heading titled "Summary of Prevention Strategies for Acute and Long-Term Care Facilities" indicates for Acute Care:
- Place CRE colonized or infected patients on Contact Precautions (CP)
- Empiric CP might be used for patients transferred from high-risk settings

4. Review of the facility policy titled "Contact Precautions," (Version 4, Effective 12/12/18), indicated Contact Precautions will be applied to any patient with a confirmed or suspected infection of an epidemiologically important pathogen that can be transferred from one person to another via direct or indirect contact.
Isolation Order:
- Place an order for Contact Precautions in the medical record
- A physician, licensed independent practitioner (LIP), registered nurse, or infection preventionist may place the order
Patient Placement:
- Place patient in private room.
- Locations without private rooms - draw privacy curtains and place adequate signage to ensure all personnel are aware of Contact Precautions
- May cohort patients only after consulting with Infection Prevention Signage
- Place Contact Precautions sign on patient's door or bed space
Gowns:
- Wear an impervious cover gown with sleeves upon entering room
- Dispose of gown after each use

5. Review of a list of active patients with CRE on 06/01/21, Staff G identified Patients #1, #2, #3, #5 and #6 as CP-CRE positive.

Interview with Staff J revealed infectious disease service was consulted for Patient #5 who had a new diagnosis of CRE which was found in the patient's urine. Staff J verbalized that as of 05/18/21 the facility no longer isolated or placed positive CRE patients in precautions. This was to preserve Personal Protective Equipment (PPE) during the COVID-19 pandemic. The CRE patient was placed in standard precautions only based on the advice of infectious disease guidance.

6. Review of the medical record for Patient #1 revealed the patient had a previous admission from 12/23/20 until 05/12/21. The medical record revealed the patient was diagnosed from the tracheal aspirate sample on 12/29/20 with Klebsiella pneumonia, (CP-CRE, also referred to as Klebsiella pneumonia carbapenemase (KPC)). Patient #1 incurred a re-admission to the facility on 05/14/21 for increased white blood cell count and urinary infection. The facility identified Patient #1 as CP-CRE positive during survey entrance activities on 06/01/21. Observations of Patient #1 on 06/01/21 at 9:41 AM revealed the patient was in a surgical intensive care unit (SICU). The patient was observed in a private cubicle equipped with privacy curtains and a sliding glass room partition which was currently in the open position. There was no observed signage that indicated the patient was in Contact Precautions for CRE. Review of the medical record revealed there was no documentation to indicate the patient was in Contact Precautions until 06/02/21 when brought to the attention of the facility by the survey team.

7. Review of the medical record for Patient #2 revealed the patient was admitted on 05/20/21. Diagnoses included liver cirrhosis and history of a liver organ transplant. The medical record revealed a tracheal aspirate sample dated 12/29/20 diagnosed Patient #2 with KPC/CP-CRE in the blood stream . A repeat sputum (respiratory secretion) sample sent to the laboratory for testing on 05/29/21 again grew KPC with recommendations for an infectious disease consult. The facility identified Patient #2 CP-CRE positive on 06/01/21 during survey entrance activities. Patient #2 was observed on 06/01/21 at 9:44 AM in a private room without a Contact Precautions sign on the door. There was no medical record documentation to indicate the patient was in Contact Precautions until 06/02/21 when brought to the attention of the facility by the survey team.

8. Patient #3 was admitted on 05/11/21. Diagnoses included liver cirrhosis and respiratory distress. The medical record revealed the patient was diagnosed with CP-CRE from tracheal aspirate on 05/11/21. The facility identified Patient #3 as CP-CRE positive on 06/01/21 during survey entrance activities. Tour conducted on 06/01/21 at 10:11 AM revealed there was no Contact Precautions signage observed on the patient's door at the time of tour. There was no medical record documentation to indicate the patient was in Contact Precautions until 06/02/21 when brought to the attention of the facility by the survey team.

9. Patient #5 was admitted on 05/06/21. Diagnoses included history of acute myeloid leukemia and admission for a bone marrow transplant. The medical record revealed the patient was diagnosed with CP-CRE from blood cultures obtained from the central venous catheter on 05/19/21 which grew KPC The laboratory results revealed the culture results were reported to the nurse who cared for Patient #5 on 05/19/21. An Infection Prevention note, dated 05/24/21, documented isolation for CRE has temporarily been suspended as part of COVID surge planning per the COVID Recovery Taskforce (CORT) meeting of 12/14/20. Contact Precautions have been discontinued. Please continue with Standard Precautions and Universal Pandemic Precautions in the care of this patient. The facility identified Patient #5 as CP-CRE positive on 06/01/21 during survey entrance activities. Tour conducted on 06/01/21 at 10:33 AM revealed there was no Contact Precautions signage observed on the patient's door at the time of tour. There was no medical record documentation to indicate the patient was in Contact Precautions until 06/02/21 when brought to the attention of the facility by the survey team.

Interview with the nurse who provided care for Patient #5 on 06/01/21 at 10:23 AM confirmed the lack of Contact Precaution signage and verbalized the facility had suspended CP-CRE contact precautions as part of the COVID surge program and the facility utilized Standard Precautions for management of CP-CRE patients.

10. Patient #15 was admitted to the facility on 04/29/21 and discharged on 05/27/21. The facility was notified of the patient testing positive for CP-CRE on 05/24/21 at 9:40 AM. The final urine culture result from 05/24/21 at 9:40 AM revealed Klebsiella pneumoniae, KPC carbapenemase enzyme detected. The isolate is considered resistant to all carbapenems and beta-lactams with possible rare exceptions. Infectious Disease consult recommended.
Patient was placed in Contact Precautions.

Contact precautions were ordered on 05/22/21 at 12:08 PM.

A note by Staff K on 05/23/21 at 5:00 PM documented nursing notified of CRE and need for Contact isolation.

A note from Staff L on 05/23/21 at 5:03 PM documented: 5:00 PM received call from micro lab regarding blood culture from 05/20/21 at 4:45 PM was positive for Klebsiella pneumoniae resistant to carbapenems. Micro lab recommending Contact Isolation.

An Allied Health - All Nursing Note from 05/24/21 at 10:03 AM documented isolation for CRE has temporarily been suspended as part of COVID surge planning per the COVID Recovery Taskforce (CORT) meeting of 12/14/20. Contact Precautions have been discontinued. Please continue with Standard Precautions and Universal Pandemic Precautions in the care of this patient.

Contact precautions were discontinued on 05/24/21 at 10:03 AM.

The findings were confirmed by Staff M on 06/03/21 at 11:05 AM.

11. Patient #13 was admitted to the facility on 04/09/21 and discharged on 05/20/21. On 04/21/21, a urine culture resulted with Klebsiella pneumoniae. The report documented: This organism is carbapenem resistant (meropenem or ertapenem MIC is in resistant range). KPC carbapenemase enzyme detected. The isolate is considered resistant to all carbapenems and beta-lactams with possible rare exceptions. Infectious Disease consult recommended.
This Klebsiella is CP-CRE.

The medical record did not contain orders for contact precautions.

The findings were confirmed by Staff M on 06/03/21 at 11:02 AM.

12. Patient #14 was admitted to the facility on 02/24/21 and discharged on 05/24/21. A lab result dated 03/26//21 at 12:07 AM documented Patient #14's respiratory culture and stain returned with KPC carbapenemase enzyme detected. The isolate is considered resistant to all carbapenems and beta-lactams with possible rare exceptions. Infectious Disease consult recommended. This Enterobacteriaceae is carbapenemase producing CRE (CP-CRE: positive for carbapenemase resistance gene or phenotypic test).

A lab result from 03/28/21 at 9:49 AM noted the patient's wound culture results revealed the organism is carbapenem resistant (meropenem or ertapenem MIC is in resistant range). This Enterobacteriaceae is carbapenemase producing CRE (CP-CRE: positive for carbapenemase resistance gene or phenotypic test). KPC carbapenemase enzyme detected. The isolate is considered resistant to all carbapenems and beta-lactams with possible rare exceptions. Infectious Disease consult recommended.

A lab result dated 04/16/21 at 7:10 PM documented Patient #14's respiratory culture and stain returned with KPC carbapenemase enzyme detected. The isolate is considered resistant to all carbapenems and beta-lactams with possible rare exceptions. Infectious Disease consult recommended. This Enterobacteriaceae is carbapenemase producing CRE (CP-CRE: positive for carbapenemase resistance gene or phenotypic test).

Contact and Droplet Precautions were ordered from 04/13/21 through 04/17/21.

The medical record did not contain additional Contact Precaution orders.

The findings were confirmed by Staff M on 06/03/21 at 12:16 PM.

13. Staff O was interviewed on 06/01/21 at 10:33 AM . Staff O reported the facility is not isolating patients for CP or CP-CRE. Staff O reported the facility is using Standard Precautions for the CP-CRE and CRE patients.

14. Staff N was interviewed on 06/01/21 at 10:35 AM. Staff N reported the facility's COVID taskforce met and made the decision to temporarily pause isolation for CP-CRE patients. Per Staff N, the facility made this decision in order to prioritize private rooms to COVID patients. The facility determined it needed more isolation rooms for COVID patients than it had available. The decision to stop isolation of CP-CRE patients was made during a meeting where the Medical Director of Infection was present. The facility started pausing CRE isolation on 12/14/20. Staff N stated the facility did not work with local health departments or Emergency Management Agency (EMA) on the decision to pause isolating CRE patients.

15. On 06/02/21 at 11:34 AM, Non-staff R was interviewed. Non-staff R reported CP-CRE is not considered endemic and still requires contact precautions.

This deficiency substantiates Substantial Allegation OH00122044