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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, document review, and interviews, the facility failed to ensure infection risks had been identified and mitigated before facility renovations were implemented for an area used to treat patients with high risks of infection.

Based on observation, document review, and interviews, the facility failed to ensure infection risks had been identified and mitigated before facility renovations were implemented for an area used to treat patients with high risks of infection.

Findings include:

Facility policies:

The Infection Prevention During Construction and Renovation policy read, the purpose is to prevent transmission of infectious agents to vulnerable patient populations related to construction and renovation activities. During the planning phase, an Infection Control Risk Assessment (ICRA) will be completed. When planning renovation work; Infection Prevention (IP), Safety and Facilities will conduct a proactive risk assessment using risk criteria to identify hazards that could potentially compromise patient care in occupied areas of the hospital.

The Infection Prevention and Control Plan FY23 read, the goals and objectives for the Infection Prevention and Control (IPCC) program are to identify and minimize or eliminate the risk of acquiring or transmitting infections that pose the most threat to any person within our facilities. This is accomplished through: Surveillance, prevention and control strategies, education, ongoing risk assessment, participation in Patient Safety and Process/Quality Improvement projects, and review, evaluation, and revision of the surveillance plan at least annually.

References:

The Code of Colorado Regulations 6 CCR 1011-1 Chapter 2, Part 1, 1.52 read in part, "Renovation" means the changing of the functional operation of the space.

According to the Centers for Disease Control and Prevention (CDC) (2023) Preventing Infections in Cancer Patients, Neutropenia and Risk for Infection, retrieved from https://www.cdc.gov/cancer/preventinfections/neutropenia.htm, neutropenia is a decrease in the number of white blood cells (WBCs). These cells are the body's main defense against infection. Neutropenia is common after receiving chemotherapy and increases your risk for infections.

According to the CDC (2023) Preventing Infections in Cancer Patients, Information for Health Care Providers on Infections During Chemotherapy, retrieved from https://www.cdc.gov/cancer/preventinfections/providers.htm, neutropenia is recognized as the most serious hematologic (relating to blood) toxicity during cancer treatment with chemotherapy. Patients receiving chemotherapy are at risk for developing infections that may lead to hospitalization, disruptions in chemotherapy schedules, and even death.

1. The facility failed to ensure infection prevention measures were implemented for immunocompromised (impaired immune system) patients before facility renovations were implemented for an infusion center where cancer patients received medications to treat neutropenia.

A. Observations

i. On 8/2/23 at 2:21 p.m., observation of the emergency department (ED) annex area revealed an ED patient was transported by wheelchair into ED exam room H. The entrance to the infusion center was at the end of the ED corridor passed exam room H.

ii. On 8/7/23 at 9:50 a.m., observation of the ED corridor revealed a patient was escorted by a staff member to the infusion center. In order to get to the infusion center, the patient and escort had to walk through the ED entrance and corridor.

iii. On 8/7/23 at 9:16 a.m., observation of the ED entrance revealed a table to the left of the security desk. A box of masks and boxes of gloves were observed on the table, however, there was no signage or guidance posted providing instruction on use for patients.

B. Document Review

i. Email correspondence from the director of quality and patient safety (Director) #1 from 7/8/22 at 4:18 p.m. was reviewed and revealed the infusion center opened on 7/1/22.

ii. Medical record reviews revealed immunocompromised patients were treated in the infusion center. Examples included:

a. Patient #1 presented to the infusion center on 7/3/23 to have blood drawn for laboratory tests. Patient #1's visit diagnoses included malignant neoplasm (cancerous tumor) of the ovary and chemotherapy-induced neutropenia.

b. Patient #4 presented to the infusion center on 10/22/22 and 10/23/22 for Zarxio (a medicine used to treat neutropenia) injections. Patient #4's visit diagnosis was chemotherapy-induced neutropenia.

c. Patient #8 presented to the infusion center on 7/2/23, 7/14/23, and 7/28/23 for Granix (a medicine used to treat neutropenia) injections. Patient #8's visit diagnoses included malignant neoplasm of the ovary and chemotherapy-induced neutropenia.

iii. Upon request, the facility was unable to provide evidence an infection control risk assessment had been completed before renovation was implemented for the infusion center.

This was in contrast to the Infection Prevention During Construction and Renovation policy which read, an ICRA would be completed when renovation was planned. IP would conduct a proactive risk assessment which used risk criteria to identify hazards which could potentially compromise patient care in occupied areas of the hospital.

C. Interviews

i. On 8/7/23 at 12:10 p.m., an interview was conducted with infusion center registered nurse (RN) #3. RN #3 stated if a patient did not have lab work in the system, staff would not know if the patient was neutropenic. RN #3 also stated staff depended on patients' knowledge of their diagnoses to know if they were neutropenic. Additionally, RN #3 stated if neutropenic patients did not wear a mask, the patients were at risk for infectious exposure. Furthermore, RN #3 stated anyone could be a potential vector (carrier for an infectious agent) for infections, especially for someone who was neutropenic, and staff could not always tell if a patient was contagious.

ii. On 8/3/23 at 11:40 a.m., an interview was conducted with infusion manager (Manager) #2. Manager #2 stated the infusion center had moved to the ED annex area on 7/5/22. Manager #2 also stated infusion center patients did not have their own entrance or waiting area. Manager #2 stated infusion patients were expected to wear a mask and wash their hands. Manager #2 stated the ED Annex was only used for ED patients 50 percent of the time and no infectious patients requiring isolation or contagious patients were placed there. Manager #2 further stated critical patients were never placed in the Annex.

Upon request, the facility was unable to provide evidence to verify contagious ED patients were never roomed in the ED Annex area.

iii. On 8/7/23 at 2:27 p.m., an interview was conducted with infection preventionist (IP) #4. IP #4 stated neutropenic patients were not tracked at the facility. IP #4 also stated people were capable of being infectious unknowingly. IP #4 explained that risk assessments were completed to assess for risks related to patient safety, infection prevention, and to ensure all things were safe. However, IP #4 stated she was unable to provide a risk assessment related to the facility's renovation of the infusion center.

This was in contrast to the Infection Prevention and Control Plan FY23 which read, the goals and objectives of the Infection Prevention and Control (IPCC) program were to identify and minimize or eliminate the risk of acquired or transmitted infections that posed the most threat to any person within the facility. This was accomplished through (in part), ongoing risk assessment.

This was also in contrast with the Infection Prevention During Construction and Renovation policy which instructed to complete an ICRA during the planning phase of construction and renovation activities.