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640 ULUKAHIKI ST

KAILUA, HI 96734

PATIENT RIGHTS: EXERCISE OF RIGHTS

Tag No.: A0129

The patient has the right to have reasonable expectations of care and services. Based on Record Review (RR), observations and interviews the facility failed to meet one patient's expectations of personal and diagnostic needs that would be reasonable to expect. In response to the COVID-19 pandemic, the facility activated their Incident Command System, set up screening, managed corridors and a tent outside the Emergency Department (ED). On arrival patients were screened and those who met criteria were triaged to the tent. Labor pool staff were oriented to work in the screening station and the tent. The facility failed to anticipate that patients would need to have access to a bathroom in their planning. As a result, a patient left the premises and went home to use the bathroom when she was not allowed access to the facility. The facility also did not have a process in place to monitor the physician ordered the COVID-19 test or track the status of results. As a result of this deficiency, when the physician mistakenly forgot to order the test, it was not identified in a timely manner and the test could no longer be run.

Findings Include:

1. On 04/03/20, the Office of Healthcare Assurance (OHCA) received a telephone call from a Family Member (F) whose daughter was a patient (P1) in the tent outside the ER (ED) on 03/19/20. The F said P1 is 12 years old and had been sick for a few days. "When P1's temperature went up to 103.9 degrees, I took her to the Hospital. We were in the tent adjacent to the ED. They weren't busy and I think we were the only ones seen in the tent the whole two hours we were there. My daughter wanted to use the bathroom and we were told said she couldn't go inside to use the restroom. I had to drive her home to go to the bathroom and return." F went on to say P1 had a nasal and throat swab and was tested for influenza A and B, Strep, and RSV. She was told if those test results were negative, they would do the COVID-19 test. "I got discharge instructions that said someone will call me in about five to seven days. They dropped the ball." F went to say she said it was extremely "stressful waiting for results because her husband had an underlying health condition and we all had to quarantine for 14 days. On the sixth day I started to call for results. I called several times and each time they told me the results weren't back. I kept telling them my discharge papers listed she had the influenza, Strep and RSV test. COVID wasn't listed. On day 14, I spoke with RN1 in the call center who informed me the sample wasn't sent in. I called and spoke to the Risk Coordinator (RC) who apologized and said she was very sorry; we dropped the ball." F said she went to the ER and spoke with the ER Manager (RN3) who said she looked at the chart and the only tests ordered by the physician (MD) was Strep, Group A and Group B influenza and a culture for upper respiratory." F wanted to know what really happened as she felt she was getting different stories from people when she called. F said "I want to know the truth. Was it ordered, or was it not sent in? Did they lose it? Why couldn't they figure this out earlier when I kept calling for results from day four, and had told me they weren't back yet?"

2. RR of the Emergency Department Reports revealed the following:

P1 presented to the ER on 03/19/20 at "16:52". P1 was seen and treated by MD1. P1's temperature was 102.3 Degrees Fahrenheit and Pulse rate was 138.

MD1's documentation included: "12-year-old female presents to emergency department with 2-3 days of a sore throat, cough and fever. Patient started with a sore throat, followed by the cough and fever that started yesterday ...F states that they did host friends at their home from Okinawa, however they had no symptoms. Influenza and Strep done, although I believe rapid Strep will be negative, patient has no exudate. If influenza and Strep negative, COVID will be done. Influenza and Strep negative. Patient discharged with quarantine precautions."

The medical record included the following orders: a. "Infection Control Preventionist Consult on 03/19/2020 at 17:34." Order comment was " P1 has traveled outside the U.S. to Japan in the past 90 days and is not experiencing symptoms of Fever." b. Culture Respiratory Upper (throat culture) c. Influenza AB + RSV (Respiratory Syncytial Virus) Antigen PCR (Influenza A+B+RSV ...) d. Strep (Streptococcus) Grp (Group) A Screen (Rapid)

Lab results : Influenza A ... "Not detected" Influenza B ... " Not detected" Respiratory Syncytial Virus ... "Not detected" Streptococcus Grp ... "Negative" Throat Culture ... "Normal Flora of the upper respiratory"

RR Clinical note entry by RN1 on 04/02/20 at 01:40 PM: " PT CHART WAS ACCESSED FOR REVIEW FOR COVID SWAB, NO SWAB ORDERED ON PT PER RN1 PHONE CALL FOR CONFIRMATION."

RR revealed MD1 entered an addendum on 04/02/20 at 08:36 PM: "This provider was contacted in regard to COVID testing after negative Strep and influenza on 04/02/20. This provider simply forgot to order COVID testing. RN's addressed this in the ED. I attempted to have the influenza swab sent, but at this point the specimens weren't frozen, therefore this couldn't be sent. I contacted the patient's PCP (Primary Care Physician) and explained the situation and suggested reswab in the ED or give the patient an outpatient order for drive through testing."

RR Discharge instructions provided to P1 by RN2 at 07:20 PM on 03/19/20 included the following: "You had the following tests performed during your ED visit today:" " ...Culture Respiratory Upper" " ...Strep Grp A Screen (Rapid)" " ...Influenza AB + RSV Antigen PCR"

3. On 04/22/20 at 11:38 AM during a phone interview with RN2, she said she had recently been given the responsibility of coordinating the operations of the tent. RN2 said, " I think that day (03/19/20) was my first day in the tent. MD1 came out, assessed the patient and swabs were taken for tests. We gave them (F and P1) the option to wait in the tent or in the car for the results. They chose to wait in the car. RN2 stated, " When the lab results came back, I got all the paperwork and discharged them ... The F became very upset when I told them the other tests was negative and P1 didn't have the flu. She assumed it meant P1 had COVID. I spent a lot of time reviewing discharge instructions and calming her down. I went inside to the ER and had the Charge Nurse print some additional educational material for her." Inquired if MD1 saw P1 before discharge and RN2 said he did not. RR revealed discharge Instructions were provided to P1's F by RN2. The discharge instructions included a section that stated, " You had the following tests performed during you ED visit today: Culture Respiratory Upper ...Strep Grp A Screen (Rapid) ...Influenza AD + RSV Antigen PCR." The COVID test was not listed as being performed.

4. On 04/16/20 at 12:15 PM during an interview with RN1, she said the facility established two phone lines for COVID. One was for internal questions from the staff and other was for patients who are calling for results of the COVID test. RN1 said, "When they call for results, there is a message that instructs them to leave details and I will call them back. I had a message from P1's F about COVID results. I looked into the ED chart and saw no result available. I called the F and told her I needed some time to investigate. I contacted the ED to review the chart with me and they said there was no order for it. I called the F back and told her the test had not been ordered. She was advised if symptoms persist, to get a test now. She said it was a horrible experience and didn't want to put P1 through that again. She also mentioned her husband got sick . She wanted to know why this happened, and who was responsible. She had already contacted the Quality Director (QD). I called Risk Management Coordinator to inform her. As soon as I talked to the ED, I filled out the Radar report (incident report). I told the F I could escalate the concern if she wanted. I felt it should go up a level. I then discussed it with a supervisor."

5. On 04/17/20 at 05:00 PM during a phone interview with the ER Manager (RN3), she said she was aware of the incident and spoke in person with the F because she had presented to the ER and requested to speak with someone about her concerns. "I had already looked at the chart and MD1 did not order the COVID test. The F was very anxious. She said she kept calling to the ER every day and was told the results weren't back. The way the computer system was, you couldn't see the results in First Net (ER electronic medical record). They weren't crossing over. I went to the lab and reviewed this with them. We had just started using the tent and putting processes in place. The F was very anxious. I reviewed everything with her and told her I couldn't really explain why the test wasn't ordered but would work to improve our processes. At the time, due to minimal COVID-19 test kits and the criteria was very strict, the MD had to make the decision after the other results came back and put in another order for the COVID." RN3 went on to say that F told her "P1 had to use the bathroom and was told they couldn't come in, so she took P1 home and then came back." RN4 said it was shift change and as soon as she finished talking with the F, so she reviewed with both shifts at the huddle that patients can use the lobby restroom if they have mask on. RN3 said this was communicated to all staff through daily huddles.

6. On 04/22/20 at 11:45 during a phone interview with the Charge Nurse (RN4) the day of the incident, inquired what the policy was if a patient screened and triaged to be treated in the tent needed to use a restroom. RN4 said, " We should make sure they have a mask on and call housekeeping to clean the bathroom right after they leave." RN4 went on to say she had no direct contact with F or P1 but recalled that "someone asked or brought it up and I told them we don't have restrictions. I don't recall who it was. I wasn't aware that anyone was not allowed in at that time. By the time the information got out to the staff, P1 had already left."

7. On 4/22/20 received a faxed document from the QD of an interview she conducted with Staff (S)1. The document revealed the following: "Conversation QD had with S1 April 22, 2020 approximately 8AM. S1 was assigned to the ED entrance as a screener on Thursday, March 19, 2020 from 11AM to 1900. I asked her about the evening P1 came in. Patient's F drove up, dropped P1 off and parked the car. The patient's temperature was taken, and she was seated in the area to the right of the ED entrance (blue chairs). The patient asked to use the restroom. S1 wasn't sure what the process was, so she asked the registrar in the ED lobby. The registrar then asked one of the ED nurses (could not remember who), who was unsure if they could allow P1 in to use the restroom. They decided to decrease the risk of cross contamination and have her wait. S1 went to speak with the P1 and the F, who was then present. S1 explained that they couldn't use the restroom inside the lobby to which the F responded it was okay and volunteered to take the patient home to use the restroom as they lived very close and would come back."

There was sufficient evident the deficiencies and facility practice that contributed to the complaint had been corrected before this survey was conducted and meets the criteria for past noncompliance. The facility was found to be in substantial compliance with 42 CFR Part 482 conditions of participation.

Findings of process improvements and interventions include:

1. Nursing/Tent Operations: An RN that had ER experience was appointed Tent Coordinator to ensure continuous process improvements were communicated and implemented. A form "Patient Checklist" was updated to include information that required follow-up by the ER Charge Nurse and Physician. It was communication to all tent staff it is their responsibility to review all care prior to discharge to ensure tests are ordered. Additional discharge instructions were implemented and staff are directing patients/families to the right resource for COVID test results.

2. Laboratory and Result tracking : The lab changed where the COVID-19 tests were sent as resources became available to improve timeliness of results. COVID lab test timeline provided by facility laboratory: Tests before 03/09/20 were sent to the State Department of Health. Persons Under Investigation (PUI) had an expected 24-hour turnaround time. All others were sent to the Center of Disease Control (CDC) with expected turnaround time of seven days. 03/09/20 Diagnostic Lab Services (DLS) on Oahu went live with limited testing for PUI. The remainder of tests were sent to ARUP laboratories with an expected turnaround time of four-six days. This time frame was not met. 03/16/20 - 03/26/20 Samples sent to Quest labs which had turnaround of 10-14 days if not a PUI. 03/27/20 DLS increased testing capacity. 04/10/20 Facility implemented in house testing.
At the time of the survey, the facility was testing on site with a turnaround time of approximately six hours. The lab initially used a manual system to track patients that had COVID tests and have implemented a computer-generated report. The lab changed the specimen storage process and now store them in the freezer for longer stability. This process was validated 04/20/20.

3. Communication of results: The facility implemented a designated COVID-19 telephone line implemented on 03/26/20 . A RN was assigned to monitor the calls and check on results. If patient/families called the operator or other departments inquiring about COVID-19 results, they were transferred to this line and received a message to leave information. The RN investigated and called patients back with result status. On 04/20/20, with inhouse testing, the ER Nurses began calling the patient/family back with results which is the same process they had in place for several other test results. These calls are logged and monitored.

4. Physician Interventions: On 04/20/20 at 01:00 PM during a phone interview with the Medical Director, she discussed corrective action and communications. The ER physicians meet virtually every two weeks. The Medical Director provided emails sent to the ER physicians. In addition, review was conducted of communications sent to the Medical Staff by the Medical Staff Office.

5. The day of the incident, the ER Manager met with both shifts to clarify patients can access the restroom in the lobby if they have a mask on. Housekeeping should be notified after to clean the restroom. This information was passed on at the huddles that were held every day. During interviews on 04/13/20 with RN5 at 11:30 AM and with RN6 at 11:39 AM, they verbalized the correct process.