HospitalInspections.org

Based on record review and interview, the hospital did not have a governing body that was responsible for the conduct of the hospital. The hospital did not promote each patient's rights (A115); did not develop, implement, and maintain an effective ongoing hospital-wide, data driven quality assessment performance improvement (QAPI) program, and did not involve all hospital departments and services, including services furnished under contract or arrangement in QAPI (A263); did not ensure that the hospital had an organized nursing service that provided 24-hour nursing services that was furnished and supervised by a registered nurse (A385); did not provide radiological services to meet the needs of each patient (A528); and did not ensure that the emergency needs of each patient were met (A1100). The cumulative effect of these systemic practices resulted in the failure of the hospital to comply with the statutorily mandated regulations under Governing Body.

Based on record review and interview, the hospital failed to follow the hospital's grievance policy and procedures and established timeframes for review and response to patient grievances (A122); did not ensure that the patient had the right to to receive care in a safe setting (A144); and failed to ensure that newly hired staff had background checks completed prior to being placed in positions that allowed unsupervised access to patients (A145). The cumulative effect of these systemic practices resulted in the failure of the hospital to comply with statutorily mandated regulations under Patient Rights.

Based on interview and record review, facility staff failed to follow the hospital's grievance policy and procedures' established timeframe for review and response to patient grievances for 4 of 5 grievances reviewed. This failure compromised patients' right to a timely response to concerns.

Findings include:

The hospital's policy entitled "Patient Comments, Concerns, Compliments, Complaints and Grievances Policy" with an effective date of 07/2017 indicated the following:

" ...B. Reporting a Comment, Concern, or Complaint ...3. The Patient Advocate will attempt to resolve the patient's (or patient's representative's) comment, concern, or complaint to their satisfaction and before the patient leaves the facility ...C. Reporting Grievances ...2. The Patient Advocate or staff present will input the grievance into the event reporting system and forward the patient grievance to the department supervisor. 3. The timeframe for responding to the patient's (or patient representative's) grievance is seven (7) business days from the day the grievance was received. If additional time is needed, the patient, or patient's representative, will be notified in writing. A. Within two (2) business days after receipt of the grievance, the Patient Advocate will send a letter acknowledgement to the patient or patient's representative indicating that the complaint has been received and forwarded to the department supervisor for further investigation. The letter will provide the recipient with the name of the Point of Contact and contact information for that individual. 4. The department supervisor will conduct an investigation of the grievance in the event reporting system and provide a response to the Patient Advocate within five (5) business days. If the Patient Advocate has not received documentation and/or communication about the follow-up and plan for resolution within five (5) business days, the Patient Advocate will send a request for action to the next person in the chain of command for the involved department. 5. When the review or investigation is completed, a written notice of resolution will be sent to the patient ...9. A grievance is considered resolved if the patient is satisfied with the actions taken or no response is received from the patient within ten (10) business days from the date indicated on the notice of resolution."

1. Patient 2, Grievance #2633:

On 12/11/19, the hospital received a letter dated 12/10/19 from Patient 2 regarding three separate incidents that occurred on 11/22/19, 12/4/19, and 12/9/19; in which, the patient had complaints about the services provided. The first letter sent to Patient 2 was dated 12/12/19, which acknowledged her complaint.

On 12/26/19 (11 business days after the grievances were reported) a second letter was sent to Patient 2. In this letter, Patient 2 was notified that the grievance was still being investigated and that "" ...I [Patient Advocate] will provide a follow-up with a written response within 28 business days."

On 3/13/20, the grievance was still in an "in progress" status, which was 56 days since the date of the second letter. No additional communication was provided to the patient.

2. Patient 3, Grievance #2905:

On 1/27/20, the hospital received a grievance from Patient 3 regarding an incident that occurred on 12/26/19. The first letter sent to Patient 3 was dated 1/27/20.

On 2/11/20 (11 business days after the incident was reported) a second letter was sent to Patient 3. In this letter, Patient 3 was notified that the grievance was still being investigated and that " ...I [Patient Advocate] will provide a follow-up with a written response within 28 business days."

On 3/13/20, the grievance was still in an "in progress" status, which was 23 days since the date of the second letter.

(Cross Reference-see A1112.)

3. Patient 1, Grievance #2928:

On 1/24/20, Patient 1 reported an incident that occurred on 1/23/20. The first letter sent to Patient 1 was dated 1/30/20, which acknowledged the grievance.

On 2/11/20 (12 business days after the incident was reported), a second letter was sent to Patient 1. In this letter, Patient 1 was notified that the grievance was still being investigated and that " ...I [Patient Advocate] will provide a follow-up with a written response within 28 business days."

On 3/13/20, the grievance was still in an "in progress" status, which was 23 days since the date of the second letter.

4. Patient 4, Grievance #2912:

On 1/28/20, the hospital received a grievance from Patient 4's representatives regarding an incident that occurred on 1/28/20. The first letter sent to Patient 4's representatives was dated 1/28/20 acknowledging the receipt of the complaint.

On 2/10/20 (8 business days after the complaint was received) a second letter was sent to Patient 4's representatives. In this letter, Patient 4's representatives were notified that the grievance was still being investigated and that " ...I [Patient Advocate] will provide a follow-up with a written response within 28 business days."

The second letter was returned to the hospital, "Not deliverable as addressed."

On 3/13/20 at approximately 9:30 a.m., an interview was conducted with Employee 2. Employee 2 was asked about the timeframe for the grievance process. Employee 2 stated that the facility had 2 days to acknowledge the grievance and then 7 days to address the grievance. Employee 2 further stated that it was business days. Employee 2 was asked about the 28 days that was referred to in the second letter. Employee 2 stated that the hospital's policy did not indicate anything about 28 days. The policy does speak to the need for additional time but it does not specify 28 days. She explained that the 28 days was from a previous policy and the patient advocates were still using the 28-day process.

Admin5 was interviewed on 3/13/20 at approximately 1:30 p.m. Admin5 was asked about the grievance process and the timeframe requirements. Admin5 stated that she was aware that staff were using the routine timeframe of 28 days when additional time was needed to complete the investigation. Admin5 acknowledged this was not part of the hospital's policy and that there were plans to adjust the policy.

Based on record review and interview, the hospital did not ensure that the patient had the right to to receive care in a safe setting.

Finding includes:

Review of the medical record revealed that Patient 26 presented to the ED on 12/26/19 at 12:32 p.m. with several complaints including weakness and abdominal pain after every meal. Accordingly, the patient was triaged an hour later at 1:32 p.m. and assigned an ESI (estimated severity index) level of 3-urgent.

According to triage notes, Patient 26 also had a "chief complaint" of "not feeling good," and that her health "had gone down since (February) 2019 when she had a stroke." An "observational assessment" during triaged further indicated that the "(Patient) appears lethargic." According to the hospital's ESI Algorithm, lethargy indicated a priority level of "2."

During an interview on 3/10/20, a licensed staff (LSI) stated that Patient 26 was found unconscious in the waiting room in her wheelchair. The resident who was accompanied by a family member had been in the waiting room for about 4 hours after she presented to the ED.

Further review of the medical record revealed that Patient 26 was then brought inside the main ED at 4:24 p.m. (on 12/26/19). There was no mention of the patient's condition at this time except that she was unable to stand on her own and "grouted (sic)" when she was put in bed. At 4:26 p.m., The patient was attached to a monitor but no pulse was present, according to a nurse's progress note. Cardiopulmonary resuscitation (CPR) was initiated and then terminated. Death was called by the physician at 4:38 p.m. The cause of death, according to a physician's progress note, was "unclear."

Review of the medical record revealed the lack of indication that Patient 26 was monitored and/or visually checked by any ED staff member while she was in the waiting room for about 3 hours after triage. There was no documentation available of any assessment of the patient's immediate needs or condition until 4:26 p.m. (on 12/26/19) when the patient "Arrived to room 5" (inside the ED) and was subsequently attended to by a physician and cardiopulmonary resuscitation was initiated. (Cross-refer to A1100.)

Based on interview and record review, the hospital failed to ensure newly hired staff had background checks completed prior to being placed in positions that allowed unsupervised access to patients for 2 of 8 personnel files reviewed for background checks. The hospital also allowed a contracted staff member to complete background checks on other contracted staff, which was not within that person's scope of work. These failures placed all patients at risk for potential harm when receiving care from a staff person who may have had inappropriate conduct in the past.

Findings include:

Hospital policies direct the following:

Policy "Hiring, Orientation, and Probation" with a revised date of 11/1/18, Section I indicated, " ...HR [human resources] shall conduct reference checks, pre-employment drug testing, background or criminal history investigations, and any other investigations as appropriate for the position as determined by HR, the hiring supervisor, and the Division Chief."

Policy "Minimum Standards of Character & Suitability for Employment" with a revised date of 11/1/18, under the "Policy" Section indicated "FDIHB's [Fort Defiance Indian Hospital Board] policy is to select and employ only those individuals whose performance, conduct, character and suitability will promote the efficiency and overall strategic success to FDIHB ...FDIHB conducts background investigations before a final selection or employment commitment is made ...B. 1. The minimum standards of character shall be considered met only after the individual has been the subject of a satisfactory background investigation. The background investigation shall include a review of the following factors in addition to minimum standards of character ...b. A criminal history background check, which includes a fingerprint check through the Criminal Justice Information Services Division of the Federal Bureau of investigation (FBI) ...and inquiries to state and tribal law enforcement agencies for the previous five years of residence listed on the individual's application ...4. FDIHB will conduct background investigations every five (5) years."

Policy "Non Employee Nursing Contract" with a last revised date of 03/2019, defined the following, "Temporary nurse: Nurses employed by FDIHB, Inc., who is not in a permanent position. Agency nurse: Nurse employed by FDIHB, Inc., through a staffing agency. Personal Service Contract: Nurse employed by FDIHB, Inc., through a personal service contract." The policy further directed under section "D. The process for hiring a nurse on a Personal Service Agreement (PSA) is as follows ...2. The office of the Chief Nursing Officer sends the PSA nurse the Background Check form ...for completion. 4. The Office of the Chief Nursing Officer sends the Background Check form to the company. The PSA nurse cannot start until the Background Check is complete ..."

Background checks for a random list of employees was requested from the hospital (Employee [E] 1, E2, E3, E4, E5, E6, E7, and E8) on 3/11/20.

On 3/12/20 at approximately 11:30 a.m., an interview with Admin6 was conducted regarding Human Resources [HR] process for obtaining background checks on new employees. Admin6 indicated that HR only processed permanent employees' background checks. Admin6 further explained that currently there were two different types of background checks completed on permanent employees. The first background check was an inquiry to the state law enforcement, which came back relatively quick. The second background check was actually a character check, which was a more in-depth background check. Admin6 stated that the second background check could take up to 6 months to complete. After the first background check, if the person was cleared, the new staff person could begin work. Admin6 stated "we need workers so we cannot wait for 6 months; so we get the 'first Defense' check while waiting for the more in-depth 'character' check."

This process was reviewed for E1, E2, E3, and E4, who were permanent employees.

This surveyor was told that E8 would be the person to speak with for the contract nurses. An interview was conducted with E8 on 3/13/20 at approximately 8:10 a.m. E8 stated that she arranged for the background checks for contracted employees. E8 was asked about the type of background checks that were completed, E8 indicated it was a routine background check that looked at all state's law enforcement records for the previous 7 years. E8 was asked if any other background checks were completed on contracted staff; E8 indicated that no other background/s were completed on contracted staff.

This process was reviewed for E5 and E6 who were contract employees.

E8 was asked about her and E7's background checks; E8 stated that this surveyor would have to speak with one of the Chief Nursing Officers about background checks for the PSAs.

Admin3 was interviewed on 3/13/20 at approximately 10:00 a.m. regarding the background checks for the PSAs. Admin3 stated that the Chief Nursing Officer was responsible for the PSAs background checks. However, E8 started in September and no background check was completed. There was no background check provided for E7 either who was also a PSA.

A copy of E8's job description was requested. On 3/13/20 at approximately 12:30 p.m., Med1 informed this surveyor that E8 had no job description because E8 was a PSA so there was only a contract. Med1 further stated that E8 should not have been doing the background check process because E8 herself was a contract employee.

An agenda from the 11/19/19 Nurse Executive Team (NET) meeting indicated one of the discussion items was "Contractors: Background/Time Cards/Exit Forms/Expectations." E8 was one of the presenters to lead this discussion.

Review of E8 and E7's contracts with the FDIHB's indicated the following:

*E8's contract date October 1, 2018 and the agreement shall end when either party terminates the agreement. Scope of Work was to "assist the CNO with Nurse Executive Duties at the Nahata'Dziil Health Clinic (offsite outpatient clinic approximately 40 miles from the hospital). These duties include training staff on direct rooming and triage, working with staff on various projects that have been assigned, running day to day operations and fielding questions from front line staff in the absence of the CNO, assist with resolving action cues. Section 10, Indian Child Protection and Family Violence Prevention Act of the contract indicated, "...All background investigations will be performed in accordance with the FDIHB Human Resources Policies and Procedures, and such employee or contractor agrees to provide and, if applicable, to cause Contractor's employee to provide, any information necessary for such investigation."

*E7's contract date July 18, 2017 and the agreement shall end when either party terminates the agreement. Scope of Work was to provide "Registered Nurse Services within various clinics located in Primary Care Clinic, Pediatric Clinic, Emergency Department, Woman's Health Clinic, and Surgery Clinic. Section 10, Indian Child Protection and Family Violence Prevention Act of the contract indicated, "...All background investigations will be performed in accordance with the FDIHB Human Resources Policies and Procedures, and such employee or contractor agrees to provide and, if applicable, to cause Contractor's employee to provide, any information necessary for such investigation."

Based on record review and interview, the hospital did not develop, implement, and maintain an effective ongoing hospital-wide, data driven quality assessment performance improvement (QAPI) program; and did not involve all hospital departments and services, services furnished under contract or arrangement; and did not measure, analyze, and track quality indicators and other aspects of performance that assess the processes of care, hospital service, and operations (A273). The cumulative effects of these systemic practices resulted in the failure of the hospital to comply with statutorily mandated regulations under Quality Assessment and Performance Improvement.

Based on record review and interview, the hospital did not measure, analyze, and track quality indicators and other aspects of performance that assessed the processes of care, hospital service, and operations.

Findings include:

1. The radiology department did not participate in a hospital-wide quality assessment and performance improvement (QAPI) program.

Request for documents evidencing QAPI revealed the lack of indication that the radiology department was engaged. During an interview on 3/10/20, AdminStaff2, who had management responsibility for the radiology service, stated that the teleradiology group (Contract A) periodically provided data to her which included turn-around times for the reading and interpretation of diagnostic studies transmitted to Contract A by the hospital.

Review of the documents provided by AdminStaff2 revealed pages of raw data which, accordingly, noted when a diagnostic study was completed by hospital radiology techs and then read by a radiologist from Contract A. When asked whether the data was being reviewed, analyzed, and tracked, AdminStaff2 was unable to respond and recommended that the surveyor should call Contract A for any data or other information the surveyor wanted to review. In the same interview, AdminStaff2 did not provide any document to indicate that analysis of the data was being conducted and monitored; and did not share key indicators or performance improvement projects undertaken by the radiology department.

Review of written communications revealed hospital staff concerns with radiology services provided by Contract A including the lack of availability and the long turn-around times of interpretations of diagnostic studies.

In March 2020, for example, an announcement was made to emergency department (ED) staff that there will be no radiology readings after 5:00 p.m. by Contract A radiologists. Accordingly, Med3 will cover from 8:00 a.m. to 5:00 p.m. each day and that after these hours, readings will not resume until the following morning, unless there was a critical patient at which time Med3 will then be called to read the scan. During confidential interviews on 3/10/20 and 3/11/20, licensed nursing staff members stated that Med3 worked "very long hours," and "easily puts in about 60 - 90 hours" at the hospital which "wasn't safe."

In February 2020, another announcement was made outlining contingency procedures to hospital providers because of the lack of radiology coverage for "the upcoming 64 hours" by Contract A staff. The lack of coverage was described by a hospital provider as "a disaster" which essentially made the ED "a clinic."

In January 2020, ED staff were informed that there would be "ongoing holes in coverage" for "(at least) the next week" as there would not be any Contract A availability between 2:00 a.m. and 8:00 a.m.

Review of the data provided by AdminStaff2 (noted above) on 3/10/20 revealed many instances when the turn-around time of diagnostic studies interpreted or read exceeded the timeframe, including but not limited to, March 2020:

On 3/09/20, a chest x-ray (2 views) was not read until after 4 hours.

On 3/06/20, an ultrasound examination was not read until after 10 hours.

On 3/06/20, an MRI of a lower extremity was not interpreted until about 7 hours; and another MRI of a joint of the lower extremity (without dye) was not read until after 13 hours later.

Another MRI of the lumbar spine (without dye) was not read until after 12 hours on 3/06/20; and another MRI of the lumbar spine was also not read until after 7 hours later.

On 3/06/20, an x-ray examination of the foot was not read until over 6 hours later.

On 3/06/20, the following took over 7 hours to be read: an OB ultrasound of a 15-week single fetus; an echo examination of the abdomen; an x-ray examination of a wrist; and a CT scan of the lower extremity (without dye).

Still on 3/06/20, an x-ray examination of the neck/spine took about 7 hours to be read. On 3/06/20, an extremity study took about 9 hours before it was read; an echo examination of the abdomen took about 9 hours to read; and an x-ray of the foot took over 8 hours before it was read.

On 3/06/20, a CT scan of the abdomen took about 19 hours before it was read; and another CT scan of the thorax (with dye) took over 9 hours before it was read.

An MRI of a joint of the lower extremity was not read until after 14 hours later; and an MRI examination of the abdomen was not read until after 12 hours later, on 3/06/20.

On 3/06/20, a CT scan of the bone for density took about 17 hours to be read; and a fluoroscopy examination took 22 hours before it was read.

Another MRI of the brain stem (without dye) was not read until after 20 hours on 3/06/20.

On 3/05/20, several x-ray examinations including neck /spine; shoulder; L-S spine, took about 7 hours to be read.

On 3/05/20, two ultrasound examinations of the abdomen were not read until after 10 hours later; and two CT scans (abdomen, thorax) were not read until after 9 hours.

On 3/05/20, another ultrasound examination of the head and neck was read after 10 hours; and a fluoroscopy exam was read only after 8 hours.

Exhibit A of the agreement revealed that Contract A "will provide professional interpretation of Diagnostic Studies on a full time 24/7 basis as needed, 365 days per year." The document also noted that for diagnostic studies not designated as "STAT," Contract A will transmit electronic reports to the hospital "within 4 hours of receipt and validation of the study." For studies designated for STAT interpretation, Contract A will transmit electronic reports to the hospital "within thirty minutes of receipt and validation of the study."

In light of concerns from hospital providers and licensed staff, as well as data that AdminStaff2 possessed, there was no indication that information was being analyzed, tracked, and evaluated to determine whether Contract A was adhering to the terms of the service agreement, and was providing services to hospital patients that met quality and safety expectations so that appropriate remedial actions could have been undertaken.

In the same interview, AdminStaff2 stated that the hospital was working towards getting another agreement with another teleradiology group (Contract B) since the services provided by Contract A started to deteriorate in August 2019.

Review of the position description of the radiology manager included establishing and maintaining an effective quality control, quality improvement, preventive maintenance, and a safety program.

In a separate interview on 3/11/20, a quality committee staff interview (AdminStaff1) verified that the radiology department was not submitting data as part of the hospital-wide QAPI program. The committee was also unaware about key indicators and high-risk, high-volume, problem prone areas the department was focused on.

2. During an interview on 3/13/20, LS1 stated that she was not aware about QAPI program activities the emergency department (ED) was working on and where these, if documented, were being maintained.

LS1 who recently assumed management responsibility of the ED mid-February 2020, added that at some point from 2018 - 2019, the ED was engaged in monitoring laboratory mislabeling and drug discrepancies as part of QAPI. LS1 added, however, that documentation of the process, including data collection, review, analysis, monitoring conducted; and/or whether any data had been shared outside of the ED, was not available.

In the same interview, LS1 stated that the department was tracking the number of ED visits ranked by diagnoses every month. Review of the data from August 2019 to February 2020 revealed that while the number of patients leaving the ED prior to being seen by a health care provider was also being captured, no other documentation was provided including the goals and objectives of data collection; analysis, whether the focus area was high-risk, high-volume, problem prone; and how performance improvement could be achieved. The data, according to LS1, was being collected by a member of the ED medical staff but LS1 did not know if it was being shared with the QAPI committee.

In a separate interview, AdminStaff1 stated that the ED had not been submitting data to the quality committee, a requirement of the hospital-wide QAPI program.

(Cross-refer to A529.)

Based on interview and record review, the hospital did not make recommendations to the governing body on the appointments of candidates in accordance with the medical staff by-laws, rules, and regulations.

Finding includes:

Review of the medical staff by-laws, rules, and regulations for clinical privileges revealed that "in the case of initial privileging, the Medical Executive Committee shall have an applicant's request for privileges reviewed by his or her former supervisor, chairperson of his or her training program, chief of his or her clinical department for their recommendation regarding the applicant's skills to perform the requested privileges."

Review of credential files for Providers A, B, and C who were members of a teleradiology group (Contract A) providing radiological services under an agreement to hospital patients revealed that initial requests for privileges were reviewed and recommended (for approval) by a staff radiologist (Med3) who was neither supervisor nor chief of the hospital radiology department; and/or by Med2 who was the chief of the medical staff but did not have background training and experience in radiology services, and was neither chief of the department (of Radiology) nor chairperson of the training program.

Provider A's credentialing file, for example, revealed that his request for initial privileges as a consulting staff member was reviewed and recommendation for approval was made on 9/10/18 by Med3.

Provider B's request for initial privileges as a consulting staff member were reviewed and recommendations for approval dated 9/06/18 were made by Med2 and Med3.

Provider C's credential file noted that review of her request for initial privileges and recommendation for approval of the request was granted by Med2 on 6/28/18.

During an interview on 3/10/20, Med3 stated that he was a staff radiologist and did not assume any supervisory responsibilities within the department.

Review of the position description revealed that while the duties and responsibilities of the staff radiologist included assisting the radiology department to interpret medical images such as magnetic resonance imaging, x-rays, CT scans, and ultra sounds, the radiologist, however, was also to assume the responsibility of evaluating the performance of temporary radiologists and recommending to the medical executive committee appropriate continued privileges, contrary to the by-laws, rules, and regulations of the medical staff.

In a separate interview on 3/12/20, a medical administrative staff member (Med1) verified that the hospital did not have a chief of radiology in "a while," and that radiology services were being provided to hospital patients by a teleradiology physicians' group under an agreement. Med1 added that he was aware of the problems and concerns regarding Contract A.

Based on interview and record review, the hospital failed to have nursing services under the direction of one registered nurse, which does not meet the regulations for Nursing services and had the potential of being confusing for department nurse executives (A386). Also, the hospital failed to have a process for policy development, revision, and updates that addressed how the policy process would flow when there were positions that were held by interim staff (A386). The cumulative effects of these failures placed patients at potential risk due to the inability of nursing services to operate effectively.

Based on interview, the hospital failed to have a nursing service that was under the direction of one registered nurse when the facility had two registered nurses acting as interim chief nursing officer. This had the potential of causing confusion and a lack of continuity of care in the hospital's nursing services.

Findings include:

During an interview with administrative staff members (Admin3 and Admin4) on 3/12/20 at approximately 8:30 a.m., a.m., the role/s of the interim Chief Nursing Officer (CNO) were discussed. Admin3 and Admin4 indicated that they were sharing the role of interim CNO. They both started in April 2019 and function as CNO every other month. Admin3 and Admin4 were asked if there was a policy that illustrated the division of the position. Admin3 and Admin4 stated there was not a policy because it was a temporary situation.

1. Nurse Executive Team (NET)

a. On 3/12/20 at approximately 11:15 a.m., Admin4 presented copies of the NET meeting agendas and copies of the calendars for CNO coverage. Admin4 stated she could not remember for sure if copies of the calendar were passed out during the February 2020 NET meeting. Admin4 stated she does remember that the calendar was discussed.

Agendas for the NET meetings were reviewed for the previous five months. The agendas indicated that Admin4 was the facilitator of all five meetings.

*The February 18, 2020 NET agenda indicated there was a calendar for CNO coverage for March.

*The December 17, 2019 NET agenda indicated that Admin3 was covering January and Admin4 would be "out of the office" in January.

On 3/12/20 at approximately 3:40 p.m., Med1 was interviewed. During the interview Med1 stated that he realized having two CNOs was not the best approach and that he was pushing to get a permanent CNO hired.


b. On 3/12/20 at approximately 10:15 a.m., a licensed staff member (LS1) stated that she was placed in an interim position of Nurse Executive for the Emergency Department (ED) in February 2020. LS1 was asked if she was aware of a calendar that indicated who was acting CNO. LS1 stated she was not aware that there was a calendar that reflected who was acting CNO. LS1 was also asked about staffing issues in the ED. LS1 stated that she was aware that there was going to be staffing issues in the ED being around November 2019, which was due to staff contracts expiring so there was going to be a foreseeable shortage in the ED. LS1 was asked if a staffing plan had been requested from the CNOs; LS1 indicated that she was not aware that staffing plans had been requested. LS1 stated the only thing she was aware of was the addition of nursing staff having the ability to be scheduled for on-call, which was new for the ED.

LS1 stated that since being placed in the interim position she had not been invited to the NET meetings. Review of the agenda and sign-in sheet for the February 2020 NET meeting confirmed that LS1 was not on the "Invitee/Team Member" list. The February 2020 NET agenda indicated that staffing plans were discussed.


2. Policy Process
The hospital policy entitled "Policy on Policy" with a revision date of 1/27/17 indicated the following:

" ...Purpose: To establish standardized system for the implementation of policies of the Fort Defiance Indian Hospital Board, Inc ...C. Policy Review and Approval New policies and policy revisions in all policy categories will be reviewed by the Policy Committee to insure compliance with CMS standards before forwarding to the appropriate Chief or Subcommittee. The Policy Committee will also ensure specific policies will con conflict or be redundant with other existing policies ...1. d ...The Subcommittees will review and revise specific policies, then recommend the policies to the Board in a resolution format for consideration for final approval. 2. Operational Policies - Presented to Policy Committee for review and presented to the Chief Executive Officer for final approval. 3. Division Policies - Reviewed by involved Department Directors and presented to the Chief Executive Officer for final approval. 4. Department Policies - Reviewed by Department Director and presented to Division Chief for review and final approval."


During an interview with LS1 on 3/13/20 at approximately 9:00 a.m., LS1 explained that even before she was placed in the interim nurse executive position, the ED's nursing executive had been trying to get policies approved; however, the policies seemed to be stuck in the process. LS1 stated it was very frustrating.


During an interview on 3/13/20 at approximately 10:30 a.m., AdminStaff1 was asked about the hospital's procedure for reviewing and developing policies. AdminStaff1 stated the process for developing, editing, and approving policies fell under the Quality Department, in that, the hospital had a software program (PolicyStat) that helped manage the policy process. AdminStaff1 explained that she managed the software program. During the interview, AdminStaff1 revealed that a person in an interim position would not have "rights" to be an approver in the system. AdminStaff1 further explained that if a position was held by an interim person, for example, the current CNO position (held by two interim nurses) and the ED had an interim Executive Nurse; none of the policies that were in the system for approval for the division of nursing or the ED department could be changed and/or approved because of the interim status of the leadership. AdminStaff1 was specifically asked about the CNO position that was currently held by two interim CNOs; AdminStaff1 stated that it was a problem because the policy process for the division of nursing stopped. AdminStaff1 said she went to Med1 and Med1 gave AdminStaff1 permission to make Admin4 an approver in the system. AdminStaff1 was unable to remember the exact date of this action. AdminStaff1 was asked about the numerous interim positions within the hospital; AdminStaff1 indicated that there were quite a few interim positions and that these departments' policy development, review, etc. were on hold until the positions were filled with permanent employees, which included the ED.

Based on record review and interview, the hospital did not maintain and made available, radiology services according to the needs of its patients (A529); and did not ensure that a qualified full-time, part-time or consulting radiologist supervised the radiologic services (A546). The cumulative effects of these systemic practices resulted in the hospital's failure to comply with statutorily mandated regulations under Radiologic Services.

Based on record review and interview, the hospital did not maintain or made available, radiology services according to the needs of its patients.

Findings include:

Review of documents revealed that radiology services were provided to hospital patients by Contract A under an agreement. Accordingly, Contract A was the "exclusive remote provider of interpretive services for Diagnostic Studies," and that Contract A "desires to be "the exclusive provider of such services all under the terms and conditions" of the agreement.

Exhibit A of the agreement revealed that Contract A "will provide professional interpretation of Diagnostic Studies on a full time 24/7 basis as needed, 365 days per year." The document also noted that for diagnostic studies not designated as "STAT," Contract A will transmit electronic reports to the hospital "within 4 hours of receipt and validation of the study." For studies designated for STAT interpretation, Contract A will transmit electronic reports to the hospital "within thirty minutes of receipt and validation of the study."

1. Review of confidential written communications revealed hospital staff concerns with the services provided by Contract A including the lack of availability and long turn-around times of interpretations of diagnostic studies.

a. In March 2020, for example, an announcement was made to emergency department (ED) staff that there will be no radiology reads after 5:00 p.m. by Contract A radiologists. Accordingly, a hospital staff radiologist (Med3) will cover from 8:00 a.m. to 5:00 p.m. each day and that after, readings will not resume until the following morning, unless there was a critical patient at which time Med3 will then be called to read the scan. During confidential interviews on 3/10/20 and 3/11/20, licensed nursing staff members stated that Med3 worked "very long hours," and "easily puts in about 60 - 90 hours" at the hospital which "wasn't safe."

b. In February 2020, another announcement was made to hospital providers outlining contingency procedures because of the lack of radiology coverage for "the upcoming 64 hours," a situation described as "a disaster" which essentially rendered the ED "a clinic."

c. In January 2020, ED staff were informed that there would be "ongoing holes in coverage" for "(at least) the next week" as there would not be any Contract A availability between 2:00 a.m. and 8:00 a.m.

d. In June 2019, review of a confidential written communication between a licensed nursing staff member and AdminStaff2 about concerns with diagnostic studies not being read timely indicated that Patient 19 had a thoracic scan at 3:59 p.m. and was discharged home at 10:32 p.m. Accordingly, Patient 19 waited 7 hours and wanted to go home. The scan was not read until 10:53 p.m.

e. In the same communication, Patient 20 had a chest x-ray examination at 6:55 p.m. and was discharged at 7:57 p.m. The x-ray results were not received until 10:46 p.m. The physician had to call the patient to come back in and had to leave a message because the patient was not available. Accordingly, Patient 20 needed blood work and a reevaluation. AdminStaff2 was asked to follow-up on the incident with Contract A so that future delays can be prevented.

f. Patient 17 was admitted to the ED on 12/21/19 after a fall resulting in a laceration on his left knee. The depth of the laceration and its location resulted in an order by the physician for a CT scan of the knee at about 4:43 p.m. The scan result was not available when a follow-up telephone call with a Contract A radiologist was made at about 7:54 p.m. In the meantime, the patient who needed medications eloped prompting another nurse to reach him later by phone to pick up his medications.

g. Patient 21 presented to the ED on 4/28/19 via ambulance with complaints of chest pains with periods of shortness of breath. A nurse's note dated 4/28/19 described the pain as being mid-chest which was increasing through the day.

In the ED, an EKG performed at 1:15 p.m. showed signs of cardiac pathology and concerns about NSTEMI (non-ST-elevation myocardial infarction). A repeat EKG at about 2:00 p.m. showed increasing concerns. A Troponin test result that was positive confirmed the NSTEMI.

A chest x-ray was ordered at 1:20 p.m. and was acknowledged by a radiology tech at 1:21 p.m. According to Med4, the chest x-ray was a typical part of the chest pain evaluation to identify other pathology that is not primarily cardiac as the underlying cause of the symptoms. In Patient 21's case, while the chest x-ray was ordered and performed quickly, a formal radiology reading was not made until after 80 minutes delaying initiation of anticoagulation therapy for the NSTEMI.

h. Patient 18 was admitted to the ED on 6/18/19 at 9:48 p.m. with several complaints including abdominal pain, emesis, and loose stools. The patient was triaged as a level 3-urgent.

Review of the medical record revealed that a CT scan of the abdomen was ordered at 10:42 p.m. and was performed by a scan tech at 11:30 p.m. (on 6/18/19). Scan images were sent to a Contract A radiologist at 11:33 p.m.

Further record review revealed a physician note at 4:57 a.m. on 6/19/19 that "At this point I have called (Contract A) radiology no less than seven times requesting a critical CT angio abdominal/pelvic CT scan report. At this time the CT was performed over six hours ago. I have still not received a report." (All in CAP letters.)

It was not until 5:37 a.m. (on 6/19/19) when the result of the CT scan was conveyed to Med5 via telephone significantly delaying evaluation of the patient and subsequent hospital admission.

i. Patient 23 was admitted to the ED on 6/15/19 with several complaints including dizziness and weakness and was triaged a level 3-urgent. According to admission notes, Patient 23 had a fall landing on his right shoulder. The same notes indicated that the patient had a history of a stroke in February/March 2018.

A "stat" physician's order was made on 6/15/19 at 9:13 a.m. for a CT scan and angiogram of the neck. The diagnostic study was not read until 3:04 p.m. (on 6/15/19).

Review of a confidential written communication during the incident revealed that Contract A was understaffed amidst a backlog of CT scan studies that needed to be read.

2. During an interview on 3/10/20, AdminStaff2 stated that Contract A periodically provided her data which included turn-around times from when a diagnostic study was performed by hospital radiology techs to when the study was read or interpreted by Contract A radiologists. Review of the data revealed many instances when the turn-around time of diagnostic studies interpreted or read exceeded the timeframes:

On 3/09/20, a chest x-ray (2 views) was not read until after 4 hours later.

On 3/06/20, an ultrasound examination was not read until after 10 hours.

On 3/06/20, an MRI of a lower extremity was not interpreted until about 7 hours; and another MRI of a joint of the lower extremity (without dye) was not read until after 13 hours.

Another MRI of the lumbar spine (without dye) was not read until after 12 hours on 3/06/20; and another MRI of the lumbar spine was also not read until after 7 hours later.

On 3/06/20, an x-ray examination of the foot was not read until over 6 hours after.

On 3/06/20, the following took over 7 hours to be interpreted: an OB ultrasound of a 15-week single fetus; an echo examination of the abdomen; an x-ray examination of a wrist; and a CT scan of the lower extremity (without dye).

Still on 3/06/20, an x-ray examination of the neck/spine took about 7 hours to be read. On 3/06/20, an extremity study took about 9 hours before it was read; an echo examination of the abdomen took about 9 hours to read; and an x-ray of the foot took over 8 hours before it was read.

On 3/06/20, a CT scan of the abdomen took about 19 hours before it was read; and another CT scan of the thorax (with dye) took over 9 hours before it was read.

An MRI of a joint of the lower extremity was not read until after 14 hours later; and an MRI examination of the abdomen was not read until after 12 hours later on 3/06/20.

On 3/06/20, a CT scan of the bone for density took about 17 hours to be read; and a fluoroscopy examination took 22 hours before it was read.

Another MRI of the brain stem (without dye) was not read until after 20 hours on 3/06/20.

On 3/05/20, several x-ray examinations including neck /spine; shoulder; L-S spine, took about 7 hours to be read.

On 3/05/20, two ultrasound examinations of the abdomen were not read until after 10 hours later; and two CT scans (abdomen, thorax) were not read until after 9 hours.

On 3/05/20, another ultrasound examination of the head and neck was read after 10 hours; and a fluoroscopy exam was read only after 8 hours.

Three x-ray examinations of the foot were not interpreted until 9:43 a.m. on 2/4/20 after the studies were by completed by hospital radiology techs at 10:09 p.m. on 1/29/20.

Another foot x-ray examination was not read until 2/03/20 at 9:51 p.m. after the diagnostic study was completed by a hospital radiology staff at 11:16 a.m. on 1/31/20.

On 1/31/20, an x-ray examination of the leg of an infant was not read until 2/04/20, after about 4 days.

Review of a confidential written communication in June 2019, from a licensed staff member (LS12) about why radiology readings were taking a long time, AdminStaff2 responded that "it's an ongoing issue for several months now," and that (members of the medical staff) and administrative staff addressed this with them (Contract A) but it is still happening." AdminStaff2 added, "We get nowhere when we call them."

While the job description of the radiology manager included maintaining liaison with hospital departments and offsite interpreting radiologist (teleradiology) to ensure smooth and cooperative functioning of the patient care team, there was no indication that services provided by Contract A radiologist had been evaluated and addressed to ensure that it met the patients' needs and hospital expectations.

3. Further review of medical records indicated concerns regarding the quality of interpretations of diagnostic studies by Contract A radiologists:

a. Patient 16 was admitted to the emergency department (ED) on 11/27/18 for evaluation and treatment for post-operative abdominal pain. Review of the medical record revealed that a CT scan of the abdomen was conducted earlier on 11/22/18 but did not report a "subscapular hematoma" that was present. The hematoma progressed to an infected hematoma.

On 11/27/18, another CT scan was conducted and a discussion with a radiologist who read the study on 11/27/18 stated that the hematoma was present on 11/22/18 but was not read.

b. Patient 24 presented to the ED on 3/25/19 at about 12:27 a.m. with a family member following a fall from a wheelchair resulting in loss of consciousness. The patient was assigned a triage level of 3-urgent.

Review of the electronic medical record revealed that CT scans of the head and spine were obtained and were "(without) acute findings," according to a provider's progress note on 3/25/19 at 12:37 a.m.

On 3/25/19 at 8:19 p.m. however, another physician's progress note revealed that the CT scan result showed "a small cerebral hematoma and subarachnoid hemorrhage." A subsequent discussion with neurology and neurosurgery staff from another hospital recommended repeating the CT scan in 12 hours. The patient was thereafter diagnosed with a subarachnoid bleed and subdural hemorrhage and was admitted.

At 10:28 p.m. on 3/25/19, another physician's note indicated that Patient 24 had a "very small amount of subarachnoid bleed within a prominent Left sylvian fissure," with "addition of a tiny amount of subdural bleed seen along the Left frontal lobe convexity," which was not read initially on the CT scan. The patient had an intracranial bleed, a small subarachnoid hemorrhage, and a small subdural hematoma left of the frontal lobe, according to the same progress note.



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4. A request for unusual events for radiology were requested from the hospital. The following reflects the review of the radiology events:

a. Patient 5 had a limited abdominal ultrasound on 12/13/19 for elevated LFTs (liver function tests-blood test). The ultrasound was read by the hospital's contracted teleradiology group. The findings indicated the following:

"The liver appears normal ...Gallbladder is not well seen and appears to be completely filled with stones and sludge as seen on the prior study ...There is no gallbladder wall thickening. If there is need to assess further regarding cholecystitis, HIDA (an imaging test used to diagnose problems with the liver, gallbladder, and bile ducts. A radioactive liquid is injected into a vein and then x-ray or ultrasound is taken) ..."

On 1/17/20, Patient 5 was seen in the surgery clinic. The history of present illness (HPI) indicated the patient was referred because of "symptomatic gallstones ...has had a problem for 2-3 years with almost daily right upper quadrant sharp pain which radiates to her back and occasionally the shoulder and occasionally associated with nausea. Pain comes on almost immediately after she eats and lasts up to 2 hours. An ultrasound performed recently of the gallbladder showed multiple gallstones with sludge but no distention of the gallbladder ...The patient apparently has not had acute cholecystitis (inflammation of the gallbladder) and has never visited the emergency room ...Plan: Laparoscopic cholecystectomy with cholangiogram (a procedure where a small tube is placed into the duct, which drains bile from the gallbladder before the gallbladder is removed)."

Patient 5's surgery was on 2/05/20. The pre-operative diagnosis was for a symptomatic bladder disease. The post-op diagnosis indicated "absent gallbladder multiple mental [sp] adhesions in the right upper quadrant." The report indicated under the procedure, "exploratory laparoscopy with lysis (breaking down) of right upper quadrant adhesions and confirmation of absent gallbladder."

A surgery/procedure event dated 3/11/20 indicated the following:

*Specific Event Type-Complications of surgery/procedure
*Severity Level (Reported)-Harm, Temporary, Hospitalization Needed
*Brief Factual Description-Client arrived for Laparoscopic cholecystectomy with intraoperative cholangiogram. Performing the procedure surgeon realized there was no gallbladder.

b. Patient 6's Diagnostic Imagining Event (#2264) dated 3/11/20 revealed the following that occurred on 10/20/19:

*Specific Event Type - Delay in care
*Type of person affected-Outpatient
*Severity Level-Harm-temporary, Intervention needed
*Brief Factual Description: Patient arrived at 8:49 p.m., Ultrasound ordered at 9:33 p.m. Called the facility's teleradiology group (Contract A) at 11:23 p.m. and spoke with teleradiology employee who said the ticket would be escalated (2 hours since ordered). Called back at 12:07 a.m. and said the scan had just been assigned to a radiologist. The official read was not received until after 12:45 a.m. The over two hours wait for an official read could have caused potential harm if the decision to transfer the patient had been made.

On 11/15/19, AdminStaff2 signed off on the event report. AdminStaff2's corrective action was to "Refer to Chief of Quality or CEO (Chief Executive Officer) for further action on the [teleradiology group]."

c. Patient 7 had a Diagnostic Imagining Event (#2493) on 3/11/20 which revealed the following that occurred on 11/22/19:

*Specific Event Type-Resulted in delay impacting patient care
*Type of Person Affected-inpatient
*Severity Level-Unsafe Condition
*Brief Factual Description: Patient had CT scan at 12:45 p.m. to rule out osteomyelitis (inflammation of bone due to infection) to spine. Nurse Practitioner (NP) noted no results of CT scan for approximately 1.5 hours into assessment and called the teleradiology group. NP followed up with the teleradiology group approximately 2 hours after imaging who stated image was in the queue for reading. At 4:20 p.m., (3.5 hours since CT scan was taken) nurse noted no reading and notified the NP and charge nurse. At 4:40 p.m., the teleradiology group was called by the charge nurse and was informed they were reading the scan at this time. At 5:00 p.m. there was still no official read. At 5:04 p.m., the charge nurse called again. The nurse was told that it was being placed in the computer at this time. At 5:17 p.m., (4.5 hours after the CT scan was taken) the read was completed.

On 1/27/20, AdminStaff2 signed off on the event report with the following comment, "Please refer this to administration. They are aware of the teleradiology group's lack and/or delay of reading. Nothing we can do about it from our end here in Radiology. The staff in ER has been made aware of the process that [physician's name] put in place for all STAT reads. Maybe you can defer this to him as well to remind his staff of the process that he implemented regarding urgent/STAT reads."

d. Patient 8 had a Diagnostic Imaging Event (#2190) dated 3/11/20 that revealed the following incident on 10/5/19:

*Specific Event Type-Delay in care
*Type of Person Affected-Outpatient
*Severity Level-Near Miss-No Harm Didn't Reach Patient Caught by Chance
Brief Factual Description: Patient presented to the Emergency Department (ED) at 7:33 p.m. and was seen by a provider who ordered imaging at 8:21 p.m. The provider called the teleradiology group (Contract A) at around 9:00 p.m. and was told "we had a lot of traumas that had to be read first and we will get to it." At 10:05 p.m., (approximately 2.5 hours later) the provider still had not received the reading. Called back and was told a physician had just entered the images one minute prior to the call. The teleradiology group's employee stated that another provider had "entered the document, but got out. Not sure why he didn't read the images." The ED provider told the employee that he would call back in 15 minutes. Within the 15 minutes, the images had been read and finalized.

On 11/15/19, AdminStaff2 signed off on the event report and indicated "Refer to Chief of Quality or CEO for further action on [Teleradiology Group]."

e. Patient 9 had a Diagnostic Imaging Event (#2335) dated 3/11/20 which noted the following incident that occurred on 11/2/19:

*Specific Event Type-Delay in Care
*Type of Person Affected-Outpatient
*Severity Level-Harm-Temporary, Intervention Needed
*Brief Factual Description: Patient seen by MD and a CT Scan of the abdominal/pelvic area was ordered to rule out "acute abdomen." The teleradiology group (Contract A) was called once by ED physician and three times by the ED charge nurse. The scan was completed at 7:43 p.m. At 10:00 p.m., (just over 2 hours), the teleradiology group's employee stated she would escalate the ticket and have a radiologist "get right on it." The CT scan was not read until after 10:45 p.m. The 3-hour wait for an official read caused a delay in care for a patient who potentially could have had an "acute abdomen."

On 11/12/19, AdminStaff2 signed off on the event report: "No comment except that this is not new and will continue to occur if administration does not properly address this with the teleradiology company." No additional interventions implemented.

f. Patient 10 had a Diagnostic Imaging Event (#2182) on 3/11/20 which detailed the following incident on 10/3/19:

*Specific Event Type-Delay in Care
*Type of Person Affected: Outpatient
*Severity Level-No Harm "Reached Patient Monitored Required"
*Brief Factual Description: The patient presented to ED with chest pain and indigestion times 5 days. Patient 10 was triaged at 1:09 p.m. and assessed by a primary nurse at 2:25 p.m. Patient was thereafter seen by a physician at 3:26 p.m. and a CT scan was ordered at 5:45 p.m. for left chest pain, radiating to back-ultrasound abnormal with bile duct, rule out tumor. At 9:28 p.m., there was still no CT report. The teleradiology group was called and a group employee stated that the image was being read and they would call with the report. At 9:52 p.m., an ED staff person called and received the completed report.

On 11/15/19, AdminStaff2 signed off on the event report with this comment: "Refer to Chief of Quality or CEO for further action ..." to the teleradiology Group.

g. Patient 11 had a Diagnostic Imaging Event (#2746) dated 3/11/2020 which revealed the following event that occurred on 12/31/2019:

*Specific Event Type-Not reading imaging today per [Radiology Consulting Group]
*Type of Person Affected-Inpatient
*Severity Level-Unsafe Condition
*Brief Factual Description: The patient was admitted to the Intensive Care Unit (ICU) for transient ischemic attack (TIA-temporary blood clots). An MRI (Magnetic Resonance Imagine-uses a large magnet, radio waves and a computer to create a detailed image) to further evaluate for a possible stroke. Originally spoke with the hospital's radiology department and was told that the hospital radiologist was not working. Called the hospital's teleradiology group and was notified that they were "not reading any imaging from Fort Defiance." Patient 11's physician was notified, since the official read of the MRI was needed before the patient could be discharged, the patient remained hospitalized.

On 1/27/20, AdminStaff2 signed off on the event report and the following was noted: "This was already communicated to medical staff that [teleradiology group] was not reading that day and that there would be a delay in reads until [name of radiologist] came in at 3 PM that day. You can defer this to Administration to address because they are aware of [the teleradiology group] lack/delay of reads for imaging. Nothing we can do on our end here to remedy this situation."

h. Patient 12 had a Diagnostic Imaging Event (#2263) dated 3/11/20 which revealed the following that occurred on 10/20/2019:

*Specific Event Type-Delay in Care
*Type of Person Affected-Outpatient
*Severity Level-Harm, Temporary Intervention Needed
*Brief Factual Description: Trauma patient transferred for higher level of care. The patient's CT scans of the cervical spine, thoracic spine, lumbar spine, abdomen/pelvis ordered prior to discharge. The official read was not available at the time of transfer. The ED Charge Nurse called at 7:45 p.m., 8:00 p.m., and 9:15 p.m. for the official read and was told all three times that the requests were escalated and sent to a radiologist. The official reads for all three scans were not received until after 9:15 p.m. "The over three hour wait time in the reads could have been life-threatening had the patient remained here before being transferred out to a higher level of care."

A follow-up action note indicated, " ...According to [provider's name] note on 10/19/19 in the John Doe Chart it reads he waited over one hour and 40 minutes for the results. [Provider's name] stated 'On my reading of the CT of the Thorax there is no pneumothorax noted.'"

On 11/15/19, AdminStaff2 signed off on the event report and noted "Refer to Chief of Quality or CEO to take action with [the teleradiology group]."

Another Diagnostic Imaging Event (#2262) dated 3/11/2020 for the same incident involving Patient 12 occurred on 10/20/19. According to the note during this event report, the patient "waited 4-5 hours in the ED for CT ...results."

i. Patient 14 had a Diagnostic Imaging Event (#2727) dated 3/11/20 that revealed the following incident on 12/30/19:

*Specific Event Type-Teleradiology group not reading images today
*Type of Person Affected-Inpatient
*Severity Level-unsafe conditions
*Brief Factual Description: Call placed to the teleradiology group regarding an ETA (estimated time of arrival) for an x-ray read of the patient's knee. Per the teleradiology, "not reading anything from fort Defiance today." The physician was told. It was noted that the patient's discharge was dependent on the x-ray read.
On 12/31/19, the event was signed off by an unknown staff person who documented, "This is a serious potential for delay of care and causing patient harm. This particular RL6 (incident report) caused a delay in patient's discharge. If something negative had been on the imaging and not read the consequences could be much worse. This has been and [sp] ongoing and frequent problem and I have instructed MSU/ICU staff to make out an RL6 each time we cannot get imaging read in a timely manner. That way we can track just how frequent and serious the problem is. I would suggest that we obtain second radiologist to read our own x-rays when the other radiologist is not available. That way we would always have someone that has a vested interest in our facility, our patients, and the staff."

j. Patient 13, Patient 15, and Patient 33 were noted in a Diagnostic Imaging Event (#2306) on 3/11/20 involving the following that occurred on 10/29/19:

*Specific Event Type-Process Issue
*Type of Person Affected-Outpatient
*Severity Level-Near Miss-No harm didn't reach Patient because of active recovery by caregivers
*Brief Factual Description: On 10/28/19, there was a significant delay in getting CT films read by the teleradiology group (Contract A). The wait was one hour for one patient (Patient 13), 2.5 hours for another patient (Patient 15), and 2.75 hours for Patient 33. The teleradiology group was contacted by an ED physician who was informed the teleradiology group was "trying to find" a radiologist to read the films. Another ED staff person contacted the teleradiology group 30 minutes later to ensure that Fort Defiance patients were moved to priority. The staff person was told that a teleradiology group supervisor was contacted to get more radiologist to read because 5 were listed as priority. The ED physician called the teleradiology group again at 8:40 p.m. and spoke with the supervisor. The teleradiology supervisor stated that she was still trying to find a radiologist to read the films. At 9:52 p.m., the teleradiology group called to inform ED staff that the films were being read.

On 11/12/19, AdminStaff2 signed off on the event report documenting "No comment except to say that this will continue to occur if administration does not address this with the teleradiology company."

k. Patient 31 had a Diagnostic Imaging Event (#2265) dated 3/11/20 which noted the following incident that occurred on 10/20/19:

*Specific Event Type-Delay in Care
*Type of Person Affected-Outpatient
*Severity Level-Harm, temporary, intervention needed
*Brief Factual Description: Patient arrived at 8:45 p.m. A CT scan of the abdomen/pelvis was ordered at 10:18 p.m. The teleradiology group was called at 12:05 a.m. because an official read had not been received. The teleradiology group employee stated that the read had been escalated and would be read shortly. The official read was not received until after 12:40 a.m. The delay in patient care was over two hours.

On 11/15/19, AdminStaff2 signed off on the event report and documented "Refer to Chief of Quality or CEO for further action" on the teleradiology group.

l. Patient 32 was noted in a Diagnostic Imaging Event (#2193) on 3/11/20 following an incident that occurred on 10/07/19:

*Specific Event Type-Delay in Care
*Type of Person Affected-Outpatient
*Severity Level-Harm temporary, intervention needed
*Brief Factual Description: The patient was seen by a provider in the ED. An x-ray was ordered at 7:29 p.m. At 8:50 p.m., the patient was transferred to the observation unit. Documentation indicated "Had the X-ray been read in a timely manner, the patient would have been admitted directly to MSU [medical/surgical unit] instead of going from ER, to OBS [observation unit], to MSU."

On 11/15/2019, AdminStaff2 signed off on the event report and documented "Refer to Chief of Quality or CEO for further action" on the teleradiology group.

Based on record review and interview, the hospital did not ensure that a qualified full-time, part-time or consulting radiologist must supervise the radiology services.

Finding includes:

During an interview on 3/10/20, Med3 stated that he was a staff radiologist and did not assume any supervisory responsibilities within the radiology department.

In the same interview, Med3 stated that the department, however, had a radiology manager who was responsible for the administrative and technical direction of the medical imaging services.

In a separate interview on 3/10/20, AdminStaff2 stated that she was responsible for the day-to-day operations of the radiology department but that she did not supervised the radiologist. AdminStaff2 added that she reported to the director of ancillary services who was not a radiologist, and was not the same individual that the staff radiologist reported to. According to AdminStaff2, she also maintained liaison with the teleradiology group (Contract A) and was aware of the complaints and concerns by hospital staff about the services provided by the group.

In light of this, however, responsibility for oversight and supervision of the radiology service, including those provided by Contract A, were not clearly delineated resulting in on-going problems and concerns by hospital staff members; as well as concerns about the long work hours by the staff radiologist described as "unsafe" to fill gaps when Contract A radiologists were unavailable.

During an interview on 3/12/20, a medical administrative staff (Med1) verified that the hospital did not have a chief of radiology in "a while," and that radiology services were being provided to hospital patients by a teleradiology physicians' group (Contract A) under an agreement. The staff radiologist, according to Med1, reported to the chief of the medical staff who did not have background training or experience in radiology.

When a request was made for a copy of the chief of radiology department's job description, none was provided.

Based on record review and interview, the hospital did not meet the patient's emergency needs.

Finding includes:

Review of the medical record revealed that Patient 26 presented to the ED on 12/26/19 at 12:32 p.m. with several complaints including weakness and abdominal pain after every meal. According to triage notes, the patient was assigned an ESI (estimated severity index) level of 3-urgent at 1:33 p.m. The hospital's Emergency Severity Index Algorithm (last reviewed on 08/2011) was based on the patient's vital signs and the number of different resources needed. Patient 26's vital signs were noted to be 36.6 (temperature), 81 (pulse rate), 18 (respiration), and a blood pressure of 138/77.

Further record review revealed that Patient 26 had a "chief complaint" of "not feeling good," and that her health "had gone down since (February) 2019 when she had a stroke," according to triage notes, An "observational assessment" indicated that the "(Patient) appears lethargic" which, according to the ESI Algorithm, warranted a higher priority level of "2" instead of "3."

During an interview on 3/10/20, a licensed staff (LS1) explained that after registration, a patient is triaged by a registered nurse, and based on the priority level assigned (1 - 5, with 1 being the highest, most acute), the patient is either taken inside the main ED or instructed to wait in a room outside the ED until his/her name is called.

In the same interview, LS1 added that Patient 26 who was accompanied by a family member was in the waiting room outside the ED when she was found unresponsive in her wheelchair almost 4 hours after presenting to the ED.

Review of the medical record revealed that Patient 26 was brought to the main ED at 4:24 p.m. and was assessed by a physician at 4:26 p.m. at which time the resident was attached to a monitor and cardiopulmonary resuscitation (CPR) was initiated. Accordingly, the patient was described as asystolic. At 4:34 p.m. the patient remained asystolic and CPR was resumed and an endotracheal tube (for breathing) was inserted at 4:36 p.m. At 4:38 p.m., the patient remained pulseless; CPR was stopped, and the physician called time of death. The cause of death leading to cardiac arrest, according to a physician's note, was unclear.

Further review of the medical record revealed the lack of indication that patients in the waiting room were being monitored by ED staff especially for those with long wait times. Patient 26, for example, had no documentation about any visual checks conducted to determine her condition, level of comfort, or other needs.

In addition, there was no documentation that the ED had delineated how monitoring of patients in the waiting room was to be performed including intervals for when monitoring or visual checks were scheduled.

During an interview on 3/12/20, Admin4 stated that the ED was usually busy during and after the holidays and that after the incident, staffing patterns were reviewed. It was not clear however, if the review resulted in any discussion or hiring of additional nurse especially since ED visits in January and February 2020 continued to peak.

Review of the hospital's investigation following the incident revealed that understaffing in the ED could have been a contributing factor in the demise of Patient 26. (Cross-refer to A1112.)

Based on record review and interview, the hospital did not ensure that there was adequate medical and nursing personnel qualified in emergency care to meet emergency procedures and needs anticipated by the hospital.

Findings include:

1. Following the incident involving Patient 26 on 12/26/19, an interview with Admin3 and Admin4 was conducted on 3/12/20. Admin4 stated that the ED was usually busy after the holidays and that after the incident, nursing staffing patterns were reviewed. Staffing shortage, according to Admin4 was exacerbated by leave requests for the holidays by ED nursing staff as well as traveling nurses working at the hospital on 13-week contracts. In the same interview, Admin3 added that because ED admissions were unpredictable, the hospital sends out notices to available licensed staff who wish to work additional days or hours, and half-shifts if needed, as a measure to augment already scheduled staff.

While this might be in place, there was no indication, however, that the acceptance rate was being tracked. In a separate interview on 3/12/20, LS1 stated that she frequently monitored staffing in the ED. On 12/16/19, for example, LS1 sent an email asking ED nursing staff if they were available to work extra shifts or hours on 12/26/19. Similar emails were also sent on 12/17/19 and 12/19/19 for additional nurses from 12/25/19 through 12/29/19 for all shifts. In the same interview, LS1 stated that the solicitation was not always successful because of the holidays and because nurses were "just tired."

In light of this and the incident involving Patient 26, there was no indication that hiring and staff retention practices were reviewed to address understaffing in the ED, including the use of traveling nurses. A review of the incident revealed that nursing understaffing was a contributing factor to Patient 26's demise.

Review of ED visits from August 2019 through February 2020 was reviewed. In August 2019, for example, the ED saw a total of 2547 patients for an average of 82 patients per day. In October 2019, the ED saw 2949 patients for the month for an average of 95 per day.

In December 2019, the ED recorded 3263 patients seen for an average of 105 per day. In January 2020, the ED saw 3723 patients, averaging about 120 each day.

The hospital did not always ensure that licensed nurse staffing was available during peak seasons when ED visits are highest. Following the incident on 12/26/19, an action item developed was to increase permanent registered nurse staffing in the ED. While a discussion and strategic planning was conducted from 1/15/20 to 1/17/20, no new updates were available and the status of the action item remained "Open" when the action plan was reviewed on 3/12/20.

Following the same incident, a recommendation was made to add additional physicians to increase coverage to maximize treatment space; allow the hospital to see more patients; increase efficiency by providing a physician on shift for direct consultation; allowing another clinician to see more patients, and minimize independent practice for clinicians not specifically trained in emergency medicine. Review of hospital documents however revealed the lack of indication that this was followed-through during the survey on 3/12/20.



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2. Patient 3 presented to the emergency department (ED) on 12/26/19 at 9:45 a.m. According to the electronic health record the patient was triaged at 10:42 a.m. as an Emergency Severity Index 3 (ESI-a five-level emergency room triage system that is based on clinically relevant classification of patients into five groups from 1 (most urgent) to 5 (least urgent)). Patient 3 symptoms included left lower quadrant pain with a pain level identified as a 6 out of 10 severity.

The history of present illness (HPI) indicated, "...w [with] GERD [gastroesophageal reflux disease] comes in w [with] left sided abdominal pain, no nausea, vomiting, diarrhea. This has been going on for about a week and a half ago after he drank with a gradual onset of dull achy pain. Has also had intermittent reflux symptoms with epigastric burning sensation that goes to the chest. Currently no chest pain/shortness of breath ..."

The next note was at 14:40 (2:40 p.m., 4 hours since triage) when a chest x-ray was ordered STAT (immediately); a CT (computed Tomography) scan of the abdomen and pelvic with contrast was ordered STAT 14:41 (2:41 p.m.) was ordered by the initial ED physician.

At 1730 (5:30 p.m.--7 hours since triage, 3 hours since x-ray and CT ordered) a second ED physician documented "In brief this is a 50 year old male here with abdominal pain seen by Dr [name]. I was asked to follow up on CT imagining. Initial labs, EKG and trop were unremarkable. At 1730 (5:30 p.m) pt [patient] reported he wanted to leave. He reported his ride was going to leave and that he 'felt fine' it was explained that we would not be able to contact him regarding the CT imaging and that we recommended staying because we do not know what is causing his pain. He reported he understood and will return if his pain changes.

It was unclear in Patient 3's health record when the chest x-ray and the CT scan were available for the ED physician. However, the x-ray and scan were not available at 5:30 p.m when the patient stated to ED staff that he was leaving, which was 3 hours since the x-ray and scan had been ordered.

On 3/10/20 at 2:45 p.m., an interview was conducted with Med3. Med3 was asked about the time frame for a STAT x-ray and/or scan. Med3 indicated a STAT read should be available in 1 hour after the x-ray/scan was taken.

On 1/27/20, the hospital received a grievance from Patient 3. The complaint indicated that the patient "came into the hospital for my chief complaint; abdominal & chest pain ...I waited for 7 long hours ...Their excuse was 'there's a whole bunch of sick people coming in.' I was x-rayed, CAT scan, EKG, vitals checked & blood work ...I got tired of waiting so I voluntary [sp] left ...Patients shouldn't wait 7 hours w/ [with] chest pain or abd [abdomen] pain."

3. The hospital did not ensure that radiological services were provided to meet the needs of patients presenting to the emergency department. This failure resulted in long wait times to interpret diagnostic studies and consequently, to the delay in providing care and services to patients.

(Cross-refer to A112 and A529.)