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1190 WAIANUENUE AVENUE

HILO, HI 96720

COMPLIANCE WITH 489.24

Tag No.: A2400

Based on interviews, record review and document review, the hospital which operates a dedicated emergency department failed to comply with the all of the special responsibilities of Medicare hospitals in emergency cases.

Findings include:

1) A-2406 Medical Screening Exam
The Board did not approve policy number (#)7451780 titled "Emergency Medical Treatment and Labor Act (EMTALA)" that identified the qualified medical personnel (QMP) to conduct Medical Screening Examinations (MSE). In addition, the Emergency Department (ED) has a Physician Assistant (PA) who conducts MSE's, but was not identified in the policy as a QMP

2) A-2408 Delay in Examination or Treatment
The hospital failed to follow a reasonable registration process for four obstetrical (pregnant) patients of a sample size of 10 who presented to the Emergency Department (ED) for evaluation. When the patients arrived to the ED, the ED staff consulted Labor and Delivery (L&D) staff, and the decision was made for the patients to go to L&D for the MSE. Prior to going to L&D for the MSE, they were taken or directed to registration where a full registration including review of demographics and insurance was completed. This process delayed the MSE.

3) A-2411 Recipient Hospital Responsibilities
The hospital failed to demonstrate or provide evidence why they were unable to accept a transfer and provide the specialized care of inpatient hemodialysis (HD) to one individual of a sample size of five who needed inpatient HD which was not available at their facility.

MEDICAL SCREENING EXAM

Tag No.: A2406

Based on review of policies/documents and interviews, the Board did not approve policy number (#)7451780 titled "Emergency Medical Treatment and Labor Act (EMTALA)" that identified the qualified medical personnel (QMP) to conduct Medical Screening Examinations (MSE). In addition, the Emergency Department (ED) had a Physician Assistant (PA) who conducts MSE's, but was not identified in the policy as a QMP.

Findings include:

1) Hilo Medical Center (HMC) is a part of the Hawaii Health Systems Corporation (HHSC) which consists of five regions, East Hawaii, West Hawaii, Kauai, Oahu and Maui. Each regional health system has their own Board of Directors in addition to the existing corporate board.

2) On 05/25/2022 reviewed the "East Hawaii Region Hawaii Services Corporation Unified Medical Staff Bylaws" approved 11/17/2020. The preamble included "Hilo Medical Center, Hale Ho'ola Hamakua (HHH-Critical Access Hospital) and Ka'u Hospital (Critical Access Hospital) with their affiliated clinical facilities and outpatient clinics comprise the East Hawaii Region of HHSC under the governance of the Board of Directors of the East Hawaii Region of Hawaii Health Systems Corporation. ...These Bylaws, as well as the Policies and Procedures for each facility, provide the professional and legal structure for Medical Staff Operations..."
" Article 16: Adoption and Amendment of Policy and Procedures or Organizational Protocols and Additional Issues. ...The Unified Medical Staff shall have the authority to create and amend any policies, procedures, and protocols that are needed to conduct Medical Staff governance and to ensure safe, high-quality medical care. ..."

3). On 05/25/2022 and 05/27/2022 reviewed the following policies:
Hawaii Health Systems Corporation policy #PAT 0003A, titled "Emergency Medical Treatment and Labor Act (EMTALA)" approved at the Board meeting 05/26/2022. The policy included the following: "Qualified Medical Personnel (QMP) means, the individuals determined qualified to conduct an MSE by Hospital bylaws or rules and regulations, and approved by the Hospital's governing board."

Hilo Medical Center policy #7451780, titled "Emergency Medical Treatment and Labor Act (EMTALA)" last approved by the Executive Management Team (EMT) 01/2020. The EMT consists of the Compliance Officer, Chief Executive Officer, Chief Financial Officer, Chief Nurse Executive, Human Resources Director, Hospital Systems Services Director, Chief Medical Officer, Long Term Care Administrator and/or Critical Access Hospital Administrators and Ad Hoc members as needed. The policy included "Medical Screening Examination--Practioner's authorized to perform or complete the medical screening examination include:
1. Appropriately privileged physicians.
2. Labor and Delivery Department registered nurses qualified by experience and demonstrating competency in the area, may collect assessment data to report to the physician in person or over the telephone. 1. The collaboration and discussion of this data will determine the presence of active labor and /or an emergency medical condition. 2. If neither is found to exist, the patient may be discharged with the physician's order."

4) On 05/26/2022 at 10:00 AM, during an interview with the Quality Director (QD), discussed the approval process for individuals identified to conduct MSE's and the HMC EMTALA policy. She said the EMTALA policy is a compliance policy and the Compliance Officer was responsible to bring the policy to the EMT for approval. The QD confirmed the policy was not approved by the Board. She went on to say the Board felt many of the policies they had been approving may not need to have "board approval." The QD said the decision was made several years ago only the policies the Joint Commission standards required Board approval would go to the Board. The QD said the number of policies requiring Board approval had been reduced to five.

5) The QD provided emails and documents that included references of the Board approving policies. The 12/12/2018 East Hawaii Regional (EHR) Board of Directors Meeting minutes included: "Chair...commented on the amount of policies filtered through Committees to the Board and the correlation to Joint Commission requirements and standards. Staff is currently looking into what policies call for EHR approval."

6) Hilo Medical Center Quality Management policy #6933262 applicable to HHSC East Hawaii Regional Document titled "Policy & Procedures and Scopes of Services approved by Quality Management, Hilo Medical Director, and Risk Manager (RM) September and October 2019 included the attachment "Hilo Medical Center and Clinics" Policy Approval Workflow's" developed by the RM, dated 09/12/2019. This document included the following:
"B. Other individuals as deemed appropriate will be included in the approval process (i.e. committees or interdisciplinary policies."
"C. Leaders approve policies: The approval process should, at the least, include an owner/content expert (i.e. the Joint Commission chapter owner) and the area(s) or department(s) manager, supervisor or executive member...)
"E. The EHR Board will review/approve policies which relate to: 1. Medical Staff policies, 2. Medical Staff By-laws, and 3. Conflict of Interest."
"G. The Executive Management Team (EMT) will review/approve...3. Risk Management policies."

7) On 05/26/2022 at 09:20 AM during an interview with the Medical Staff Services Coordinator (MSC), she validated the Medical Staff did not have rules and regulations, "just policies." She went on to say she searched and did not find any other policy referencing medical screening exams. The MSC said she searched the OB-GYN minutes back to 2011 and did not find any reference to medical screening exams. The MSC said she does not usually see "compliance policies," but if a policy has anything to do with the medical staff it should be routed through the appropriate clinical division committees, which then go to the Medical Executive Committee and the Board for approval.

At the time of the interview with the MSC, the credentialing file for the ED PA was reviewed. There was no specific reference to MSE in the credentialing file. The MSC was unable to locate any document, or policy that identified the PA as a QMP to conduct MSE's.

DELAY IN EXAMINATION OR TREATMENT

Tag No.: A2408

Based on record review (RR) and interviews, the Hospital failed to follow a reasonable registration process for four obstetrical (pregnant) patients (P)2, P3, P4, and P5 of a sample size of 10 who presented to the Emergency Department (ED) for evaluation. When the patients arrived to the ED, the ED staff consulted Labor and Delivery (L&D) staff, who made the decision if the patient would go to L&D for the Medical Screening Exam (MSE) or be seen in the ED by the ED physician. The patients were taken to registration where a full registration including review of demographics and insurance was completed prior to going to L&D. This process delayed the MSE.

Findings include:

1) On 05/26/2022, reviewed the facility policy #7451780, titled "Emergency Medical Treatment and Labor Act (EMTALA)" last approved by the Executive Management Team (EMT) 01/2020. The policy included the following:
Definitions:
"Medical Screening Examination. 1. A medical screening examination is the process required to reach with reasonable clinical confidence, the point at which it can be determined whether a medical emergency does or does not exist. Depending on the patient's presenting symptoms the medical screening examination varies from only a brief history and physical examination, to a complex process that also involves ancillary studies."
Triage: "1. a. ...The Emergency Department Triage at Hilo Medical Center does not constitute a medical screening examination."

Policy statements:
"E. Co-payments, Financial Screening, and Treatment Authorizations--No inquiries regarding financial status shall delay the completion of a medical screening examination. ..."
"F. Triage of Ambulatory Patients--...2. Patients requesting obstetrical care, who are greater than 20 weeks gestation, shall be escorted to the Labor and Delivery Department."
"G. Medical Screening Examination -- Practitioners authorized to perform or complete the medical screening examination include:
1. Appropriately privileged physicians.
2. Labor and Delivery Department registered nurses qualified by experience and demonstrating competency in the area, may collect assessment data to report to the physician in person or over the telephone. 1. The collaboration and discussion of this data will determine the presence of active labor and /or an emergency medical condition. 2. If neither is found to exist, the patient may be discharged with the physician's order."

2) On 05/26/2022 10:45 AM, during an interview with the ED Triage Aide (TA)1, he explained the process when someone presents to the ED requesting to be seen. TA1 said the security officer outside the entrance screens everyone for contraband and directs them to the window in the lobby where triage is located. He went on to say triage is staffed with an Aide and a Registered Nurse (RN). The patient is greeted and asked what brought them to the ED. TA1 said they give a one page form to the patient to complete with some basic information (name, chief complaint [referred to as "quick reg"]), just to get an ED account in the system. When the RN is available, the patient will be triaged to determine the priority to be seen by the physician. A "full registration" including review of demographics and insurance is done later in the ED and does not delay the MSE.

Surveyor inquired what the process was when a
pregnant patient presents and requests to be seen. The TA1 said it depends on the symptoms, and went on to say he just had a pregnant patient (P2) with abdominal pain and accidentally registered her as an ED patient before he called L&D who directed him to send P2 to L&D. TA1 said one of the ED staff took P2 to registration in a wheelchair and then up to L&D. TA1 said the policy was if the patients are over 20 weeks pregnant, they contact L&D who determines if the patient should be seen in L&D or the ED. He said sometimes the patient will be seen in the ED and "medically cleared" by the ED physician and then sent to L&D for evaluation. TA1 said if the patient is in a lot of pain or appears to be having contractions, they take them straight upstairs [L&D] and don't stop at registration.

3) RR of P2's visit on 05/26/2022 revealed the following documented times from the Account Activity Report and Medical Record:
10:31 AM: Arrival to ED
10:45 AM: Full registration completed, including demographics and insurance.
10:52 AM: OB RN Outpatient Assessment
10:54 AM: Vial signs
11:35 AM Discharged from L&D
11:39 AM: Returned to ED after L&D determined P2 was not in active labor.
11:43 AM: ED Triaged as Priority level 3-Urgent. Chief complaint abdominal pain.
01:20 AM: Seen by ED provider.
06:18 PM: Discharged home
P2's MSE in L&D was delayed by stopping to do the full registration on the way to L&D.

The ED Provider (MD)2 note included: "20 yr G2 (Gravida-Total number of confirmed pregnancies regardless of outcome) P1 (Para-Number of births after 20 weeks gestation) approx 34 weeks, presenting upper abdominal pain. Worse on right. Constant, worse after eating...previously diagnosed with gallstones...She report occasional cramps, but has not had regular contractions. ..." P2's exam included laboratory tests, an abdominal ultrasound, and a Magnetic Resonance Imaging (MRI) of the abdomen. The MRI revealed a questionable gallstone in the distal duct. The case was discussed with the Gastrointestinal MD on call and P2 was discharged with a new prescription.

4) P3's RR revealed she was a 35 yr old who was pregnant with expected date of delivery 08/02/2022. She presented to the ED on 04/11/2022 with complaint of bleeding after intercourse. The OB assessment revealed she had problems with previous pregnancies and documented obstetrical history of Gravida 5 Para 2 AB (abortion) 2. P3 was taken to registration and then to L&D for the MSE. The timeline of her visit was as follows:
11:49 PM 04/11/2022: Arrival to ED
00:02 AM 04/12/2022: Full registration with demographics and insurance
00:30 AM 04/12/2022: OB RN Outpatient Assessment completed.
02:30 AM 04/12/2022: Discharged home.
P3's L&D MSE was delayed because she was taken to complete a full registration before going to L&D.

5) P4 was a 23 yr old female who presented to the ED on 05/09/2022 with chief complaint documented as "pregnancy related problems." The timeline of her visit was as follows:
08:01 PM: Arrival to ED
08:47 PM: Triage by ED RN.
08:51 PM: Full Registration with demographics and insurance
09:15 PM: OB RN Outpatient Assessment completed
09:45 PM: Physician notified
09:55 PM: OB RN documented vaginal exam
09:55 PM: Physician notified
Discharged home.
P4's MSE was delayed because she was taken to complete a full registration before going to L&D.

6) P5 was a 35 yr old female who presented to the ED on 04/17/2022 with chief complaint of "abdominal pain." She was Gravida 4 Para 3 with expected date of delivery 05/18/2022. The timeline of her visit was as follows:
09:13 PM: 04/17/2022: Arrival to ED
09:32 PM: Full Registration with demographics and insurance.
09:55 PM: OB RN Outpatient Assessment completed
10:26 PM 05/17/2022 and 00:40 PM 05/18/2022: The OB RN documented vaginal exams
10:12 PM: and 10:48 PM on 05/17/2022, and 00:45 AM on 05/18/2022: The OB RN documented the MD ordered two liters of Intravenous (IV) fluids.
01:03 AM 04/18/2022: discharged home.
P5's MSE was delayed because she was taken to complete a full registration before going to L&D.

7) On 05/26/2022 at 02:15 PM, during an interview with ED Registered Nurse (RN)1, she said the triage is staffed with one Aide and an RN. She said if an OB patient comes to the ED and is 20 weeks or more gestation and has abdominal cramping or bleeding, we call L&D. If they request the patient to be seen upstairs [in L&D] for an exam, the ED staff will take them to the registration area where they make them an account. Someone presenting with other medical complaints will probably be seen in the ED. If they appear to be in active labor they go straight to L&D.

8) On 05/26/2022 at approximately 1:30 PM, during an interview with the ED Nursing Director (EDD) and ED Nursing Manager (EDM), reviewed the process for the OB patient presenting to the ED. They said the process was not in a policy, but there was a flow diagram. A flow chart for pregnant patients presenting to the ED was provided. The flow chart was specific to screening during the pandemic, but the EDM said the process was the same for all OB patients. The EMD and EDD confirmed the patient goes to registration prior to L&D unless they appear to be in active labor, and if they have other medical complaints they would be seen in the ED.

9) On 05/31/2022 at 09:15 AM, during a phone interview with Outpatient Access Representative (OAR-Registration)1, she said they are in the process of renovating the registration area, and currently function out of two separate areas. The ED Registrar is located in the switchboard room, and responds to the ED to register patients, and the OAR is located at a window in Radiology. She said her role was to register all the outpatients that includes but not limited to procedures, Physical, Occupational and Speech therapy, Respiratory therapy, L&D checkups and NST's (Fetal non stress test for contractions). OAR1 went on to say if an OB patient walks into the ED entrance, they determine if the patient will go to ED, straight up to L&D, or brought to registration. She said when they register someone, "We run through the account, verify demographics, ask legal name, social security number, address, go over insurance and have them sign all the papers."

RECIPIENT HOSPITAL RESPONSIBILITIES

Tag No.: A2411

Based on document review and interviews, the Hospital failed to demonstrate or provide evidence why they were unable to accept a transfer and provide the specialized care of inpatient hemodialysis to one individual of a sample size of five who needed inpatient hemodialysis not available at the other hospitals.

Findings include:

1) On 05/26/2022 at 10:00 AM, during an interview with the Director of Quality (DQ), she said Hilo Medical Center (HMC) was the only hospital located on the Island of Hawaii that has capability for inpatient hemodialysis. She said the maximum number of hemodialysis inpatient was determined by the contracted vendor that provides the service based on their staffing and ability to provide the service. The RM went on to say due to the demand, they worked with the vendor and increased the number of hemodialysis from 16 to 18 on April 28, 2022.

2) On 05/27/2022, reviewed the policy number HMC-ADM-02986 titled "Patient Transfer Line: (808) 657-9559" last revised 05/202. The policy included the following:
"Background: Hilo Medical Center (HMC) is the largest acute care hospital in East Hawaii, and a safety net hospital for Hawaii Island. HMC accepts patients from other health care facilities through the Emergency Department (ED) or other established admission processes.
Health Care facilities and or their health care providers requesting to transfer their patient to HMC for admission will call the PATIENT TRANSFER LINE number. This will allow HMC to determine whether it can provide the level of care needed.
The patients level of care, availability of accepting Health Care Provider (HCP), required specialty, and bed availability are requirements that will determine transfer acceptance. If we are unable to meet those requirements, HMC will not accept the transfer. The reviewing/accepting HMC HCP will call the requesting HCP, review patient
situation and determine if patient will be accepted."
General Procedure: "E. House Supervisors will complete the (X):drive: Patient Services Depart. Transfer log for every request whether admitted or denied and will include he reason for refusal to accept the patient."

3) On 05/27/2022 at 08:15 AM during an interview with House Supervisor (HS)1, she said the HS carried the transfer line phone and all requests for a bed and transfer to HMC go through the HS. She said they get calls from throughout the state depending on the availability of services. A lot of requests for specialty services are for hemodialysis, psychiatric beds and cardiac services. HS1 went on to say the requests are for services other hospital so not have and from other islands if their beds are full. She said at the time of the request, they consider if they have capacity and "can run a real time report to target specific modalities." She said they complete the transfer log. HS1 said HMC is the only hospital on the "Big Island (Hawaii)" with inpatient dialysis so it makes it very difficult. She said due to the geographic location, all patients transferred from Kona Community Hospital (KCH) and North Hawaii Community Hospital (NHCH) come by air and travel time would be about the same to Oahu.

4) On 05/27/2022 reviewed the HS excel sheet "Transfer Log," for 11/01/2021 through 05/21/2022. The log included, but not limited to a designated area to document Date of and time of referral, Patient Name, Transferring from, Referring MD, Level of care, Diagnoses/Reason for transfer, Hospitalist Review, Accept/Decline and Comments. Although there was a designated column for the time of request, it was not consistently documented.

5) The HS completes a report to summarize the activity during the shift. The report included but not limited to all available beds, including hemodialysis, number of COVID positive patients, pending admits, staffing issues, a census screen shot (Number of Occupied and available beds for each service), overflow census for post anesthesia and obstetrics, ED Holds, and transfer line activity.
The designated are for the transfer line included "Please document all TRANSFER requests in the Transfer log. All requests need to be documented as accepted or declined. See below regarding process from Dr.(MD-Chief Medical Officer)1."
"All transfers will be accepted to HMC from Kau and HHH always.
All transfers will be accepted from KCH (Kona Community Hospital) and NHCH (North Hawaii Community Hospital unless ALL three criteria are met:
1. Al beds are full
2. There are 4 or more holds in the ED
3. There is NO staff to open PACU (post anesthesia care unit) overflow
If all three criteria are met then each case needs to be considered by the House Sup after a real time bed status review. If after review, there is not bed and no staff to care for the patient, the transfer should be declined. This would entail real time phone discussion between the accepting physician and the on-duty House Sup."

6) On 02/01/2022 HS2 documented on the transfer log NHCH requested a Medical Dialysis bed for P 1 that was declined. The comment on the transfer log was "No available beds." There was no time documented when the facility called.

Review HS's shift report on 02/01/2022, 06:45 AM-07:15 PM included, but not limited to the following information regarding status and capability:
16 COV+ (positive COVID patients)
Available beds: ICU-2, PCU-4, MED-1 (there was no time documented when the availability was taken).
HD beds available -10
Tele (telemetry monitoring) box-0 (6 tele broken)
The census screen shot of available beds: ICU-0, PCU-6, Med-4. (no time documented)
No ER holds (admitted patients waiting for beds).
Transfer line: "See transfer log"
There were no comment notes.

7) The DQ ran a report and validated there were hemodialysis beds available on 02/01/2022. She also ran a report titled "potential ER Holds 05/27/2022 which listed the patients located in the ED with the time they had an admission order written. On 2/01/2022 there were a total of 19 patients who had admission orders written over that 24 hour period of time.

8 ) Having an empty bed does not translate to having capability or capacity and needs to be based on the unique circumstances at the time of the transfer request. Based on the documents the facility did not provide evidence they did not have the capacity or demonstrate why they were unable to provide care to the patients in need of the specialized services of hemodialysis.