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Based on document review, observation and interview, it was determined that the Hospital failed to ensure an effective Infection Control Program, with adherence to infection control practices and surveilance, was in place. As a result, it was determined that the Condition of Participation, 42 CFR 482.42, Infection Control was not in compliance.

Findings include:

1. The Hospital failed to employ methods for preventing and transmitting infections within the Hospital, by not ensuring the proper placement of patients with suspected COVID-19 infection. A-749 A

2. The Hospital failed to ensure that the Infection Control Committee met formally on a quarterly basis, as per the Infection Control Plan. A-749 B

A. Based on document review and interview, it was determined that for 2 of 10 patients (Pt. #1 and Pt. #2) reviewed for infections, the Hospital failed to employ methods for preventing and transmitting infections within the Hospital, by not ensuring the proper placement of patients with suspected COVID-19 infection.

Findings include:

1. On 11/9/2020, the Hospital's policy titled, "Infection Control policy (reviewed/revised by the Hospital February 2020) was reviewed. The policy required, "Droplet Precautions (in addition to standard precautions) are used to reduce the risk of microorganisms transmitted by droplets generated by the patient coughing, sneezing, talking or during the performance of procedures such as suctioning ...a. Patient placement should be in a private room. Door may remain open." An attachment to the Hospital's Infection Control policy entitled, "Memo: Update to the Interim Recommendations for Care of Persons with Suspected or Confirmed COVID-19" (undated), required, "Patients admitted from symptoms suspected, or confirmed COVID-19 should be placed in a single room with door closed.

2. On 11/9/2020, Pt. #1's clinical record was reviewed. Pt. #1 presented to the Hospital's Emergency Department (ED) on 9/25/2020 at 10:18 AM, with the complaints of cough, shortness of breath and emesis (vomitting).
-On 9/25/2020 at 2:31 PM, while still in the ED, an order was placed for Pt. #1 to have contact and droplet precautions with a diagnosis of Acute Respiratory Disease due to COVID-19 virus.
-The COVID-19 test performed on 9/25/2020 at 11:13 AM was resulted, as negative, on 9/26/2020 at 3:09 PM.
-The Infectious Disease consult dated 9/25/2020 at 2:51 PM, included, "Assessment: 1. r/o [rule out] SARS Coronavirus-2 infection, r/o aspiration pneumonia [inflammation of the lungs] related to vomiting, r/o other viral, bacterial gastroenteritis. Plan: await results of SARS Coronavirus-2 PCR [COVID-19]."
-The Pulmonary consult dated 9/25/2020 at 3:23 PM, included, "Assessment & Recommendations: Pneumonia, rule out COVID infection ..."
-The History and Physical dated 9/26/2020 at 2:13 PM, included, "Assessment/Plan: Principal problem - bilateral pneumonia ...await sarscov-2 PCR [COVID-19 test]."
-The COVID-19 test performed on 9/29/2020 at 12:32 PM was resulted, as positive, on 9/30/2020 at 4:07 PM.
-The discharge summary dated 10/5/2020 at 6:35 PM, included, "...Though initial COVID-19 was negative, which turned +ve [positive] in 4 days, we continued his therapies as a positive for COVID-19 pt. [Pt. #1]."
-The room activity event record, included documentation that Pt. #1 was admitted to 315-1 on 9/25/2020 at 6:20 PM- 9/26/2020 6:42 PM.

3. On 11/9/2020, Pt. #2 clinical record was reviewed. Pt. #2 was admitted on 9/17/2020 with a diagnosis of shortness of breath and COVID-19.
-The ED [Emergency Department] provider note dated 9/17/2020 at 3:06 PM, "He was tested this past Thursday by his primary care physician for COVID-19, which came back positive. Associated with mild fever and occasional nonproductive cough."
-The COVID-19 test results dated 9/18/2020, was positive.
-The discharge summary dated 10/7/2020, included, "Admitting diagnosis: shortness of breath, COVID-19 virus detected."
-The room activity event record, included documentation that Pt. #2 was admitted to room 315-2 on 9/20/20 - 10/02/2020.

4. The Hospital census showed that Pt. #1 (r/o COVID) and Pt. #2 (confirmed COVID) shared room 315 on 9/25/2020 - 9/26/2020.

5. On 11/9/2020, the Risk Event report, dated 10/1/2020, was reviewed. The report included, "Type: Infection Control, failure to institute proper isolation ...Patient [Pt. #1] was admitted on 9/25 as being suspected COVID positive and admitted to a room with a known positive patient [Pt. #2]. Day later lab was negative. Patient [Pt. #1] was moved to 321-1 on 9/26/2020. Second test, 9/30/2020 COVID test is positive [for Pt. #1]. ID [Infectious Disease] always felt patient was positive. Patient [Pt. #1] feels we gave him COVID since he was in a room with a known positive patient [Pt. #2] and his [Pt. #1] first test was COVID negative."

6.The CDC (Center for Disease Control) guidelines for COVID-19 were reviewed on 11/10/2020 and included, "Patient Placement: ... Only patients with the same respiratory pathogen may be housed in the same room."

7. On 11/9/2020 at approximately 11:25 AM, an interview was conducted with the Vice President of Regulatory and Compliance (E #1). E #1 stated that when Pt. #1 was admitted on 9/25/2020, Pt. #1 was presumed to be positive for COVID-19. E #1 stated that Pt. #1 was placed in a room with a COVID-19 positive patient [Pt. #2] on 9/25/2020 and was moved to a private room in less than 24 hours after being admitted.

8. On 11/10/2020 at 8:58 AM, an interview was conducted with the Director of Infection Control/Employee Health Nurse (E #3). E #3 stated that Person Under Investigation (PUI) for COVID-19 are placed in a single room, until there is a confirmed lab test for COVID-19. E #3 stated Pt. #1 was presumed positive, but should have been placed in a single room until the test results for COVID were confirmed.


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B. Based on document review and interview, it was determined that the Hospital failed to ensure the Infection Control Committee has provided surveillance to prevent and control infections, with the committee not meeting formally on a quarterly basis, as per the Infection Control Plan. This could potentially affect all hospitalized patients.

Findings include:

1. The Hospital's, "Infection Control Plan (1/2020)" was reviewed on 11/9/2020 and required, "The Infection Control Committee is a multi-disciplinary group. ... The Infection Control Committee meets quarterly. Findings of the Committee and recommendations are reported to the Medical Staff."

2. The Quarterly Infection Control Meeting Minutes for 2019 and 2020 were reviewed on 11/9/2020. The last meeting minutes were from August 2019. There were no meeting minutes from November 2019 - 11/9/2020.

3. During an interview on 11/10/2020 at 8:50 AM, the Director of Infection Control (E#3) stated, "There were meetings in November 2019 and February 2020, but I did not record the minutes. I have met weekly, informally with Quality and the Infection Control Physician and have some hand written notes. Most of this year has been spent on COVID requirements." E#3 stated that the information was not forwarded to the Medical Staff. No Documentation of the Infection Control meetings was provided by survey exit date, 11/10/2020.


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C. Based on document review, observation, and interview, it was determined that for 2 of 2 staff (E#4 and MD#1) observed exiting isolation rooms on the 3 North/South Stepdown Unit, the Hospital failed to ensure that personal protective equipment (PPE) was removed upon exiting an isolation room and hand hygiene performed, in order to prevent cross contamination, as part of the infection prevention and control program, potentially affecting the 32 patients on census 11/9/2020.

Findings include:

1. The Hospital's policy titled, "Transmission Based Precautions" (revised February 2020), was reviewed on 11/9/2020 and required, "...Contact Precautions:... Wear gloves upon reentering the room... Remove gloves before leaving the patient's room and perform hand hygiene... Wear a clean non-sterile impervious gown when having direct patient contact or contact with patient's environment and equipment. Remove gown before leaving patient's room and perform hand hygiene..."

2. An observational tour of 3 North/South Stepdown Unit was conducted on 11/9/2020, between approximately 9:50 AM and 11:30 AM.

- At approximately 10:06 AM, a Certified Nursing Assistant/CNA (E#4) was observed exiting Pt. #6's contact and droplet isolation room with a gown on. Pt. #6 was on contact and droplet isolation precautions to rule out COVID-19 infection (results not yet confirmed). E#4 then pushed a clean linen cart over to Pt. #7's room and retrieved clean linens from the cart to bring into Pt. #7's room. E#4 wore the same gown into Pt. #7's room. Pt. #7 was on contact and droplet precautions to rule out COVID-19 infection. At approximately 10:09 AM, E#4 came out of Pt. #7's room to retrieve more linens from the cart while still wearing the isolation gown and gloves.

- At approximately 10:18 AM, a Physician (MD#1) exited Pt. #7's isolation room with gloves on and then went to grab papers at the nurse's station without removing the gloves and performing hand hygiene. MD#1 then went to another patient's room with the same pair of gloves on."

3. An interview was conducted with the CNA (E#4) on 11/9/2020, at approximately 10:40 AM. E#4 stated that isolation gowns are to be removed and left inside the patient's room. E#4 stated, "We should not come out with a dirty gown." E#4 stated that the clean linen cart was for all of her assigned patients, which included confirmed and suspected COVID-19 patients, as well as patients not on any isolation precautions.

4. An interview was conducted with the Director of Infection Control and Employee Health (E#3) on 11/9/2020 at approximately 11:55 AM. E#3 stated that gowns should only be reused for the same patient. E#3 stated that staff are expected to remove the PPE, including gown and gloves, prior to exiting the patient's room, and then perform hand hygiene.


D. Based on document review, observation, and interview, it was determined that for 1 of 5 patients (Pt. #8) reviewed for COVID-19 isolation precautions on the 3 North/South Stepdown Unit, the Hospital failed to ensure that a contact isolation sign was posted to prevent cross contamination, as part of the infection prevention and control program, potentially affecting the health of the 32 patients on the unit.

Findings include:

1. The Hospital's policy titled, "Transmission Based Precautions" (revised February 2020), was reviewed on 11/9/2020 and required, "...Initiating Transmission Based Precautions: ... Place appropriate signage for transmission based precautions at door... Use standard, contact, droplet precautions, and eye protection when caring for patients who are confirmed or suspected to have COVID-19..."

2. An observational tour of 3 North/South Stepdown Unit was conducted on 11/9/2020 between approximately 9:50 AM and 11:30 AM. There were 15 patients on census on contact and droplet isolation precautions due to confirmed or suspected COVID-19 infection, including Pt. #8. The door of Pt. #8's room lacked a sign for contact precautions.

3. The clinical record of Pt. #8 was reviewed on 11/9/2020 at 11:06 AM. Pt. #8 was admitted on 11/8/2020 with diagnoses of hemoptysis (coughing up blood) and anemia (low red blood cell count). A physician's order for contact and droplet precautions was placed on 11/8/2020 at 10:16 AM for suspected COVID-19.

4. An interview was conducted with the Chief Nursing Officer (E#2) on 11/9/2020, at approximately 11:25 AM. E#2 stated that Pt. #8 should have a contact isolation sign posted on the door.