HospitalInspections.org

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Based on interviews, and review of documents and records, it was determined that the governing body of the critical access hospital (CAH) failed to ensure that the CAH and its staff were in compliance with all applicable Federal and State laws and regulations and rules that apply to the CAH and to its staff.

Findings include:

CFR 485.627, Condition of Participation: Organizational Structure.

Refer to C-962: Failed to ensure the development and rapid implementation of a process to recruit and/or retain physicians for the safe operation of the hospital. This failed practice created a severe physician shortage at the facility which created a risk for poor patient outcomes and increased mortality.

Refer to C-966: Failed to ensure the appointment of a medical director and failed to ensure the State agency was notified of the former medical director resigning. This failed practice denied patients an advocate in their clinical care and necessary communication to front line staff about quality improvement, medical leadership, clinical standards, and strategic vision.

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Based record review, interview, and policy review the facility failed to ensure accurate data collection for the quality program and failed to ensure a root cause analysis (RCA) accurately reflected historical data. This failed practice placed the facility at risk for not having relevant goals and targets for improvements in safety for all patients. Findings:

Root Cause Analysis

Review of a list of RCAs completed by the facility within the last 6 months revealed: 10 events had been reviewed.

2 cases for Patient #1 on the same event that happened 6/24/20.

#3 "Patient Fell in Inpatient room-BBAHC non-slip footwear not used
#4 "Patient Fell in Inpatient room-Bed alarm not used

Review of the RCA, completed by the Quality Manager (QM), undated revealed "Root Cause Analysis Form" "dated 7/1/20, revealed "The event (what happened, any harm proximate cause) Patient Fell in Inpatient room Patient got up to use the bathroom without assistance or cane located at bedside. Not wearing non-slip socks. Climbed over the rails at 0430, no bed alarm. Found on floor. Resulted in hip fracture.

Background Factors [and] Summary" Patient had a high fall score, 60 [above 45 is high risk]. Patient refused to wear non-slip socks since [he/she] said they were not comfortable. Known unsteady gait, walking assistive device, elderly, no sitter, and no bed alarm due to no bed alarm on the unit."

"Recommendation to prevent this event or event type in the future ...Non-compliant patients are at greater risk for injury. Interventions must be followed 100% of the time. Obtain better anti slip socks patients will want to wear ..."

Patient #2

2 cases for Patient #2 for the same event that happened 6/24/20.

#5 "Patient fell after climbing over bedrails in ER [emergency room]-lack of contingency plan for staffing."
#6 "Patient fell after climbing over bedrails in ER-bed alarm not used."

Review of the RCA, completed by the Quality Manager (QM), undated, revealed "Root Cause Analysis Form" "The Event ...patient fell after climbing over bedrails in the ER [emergency room] Patient was very intoxicated and non-complaint."

"Background Factors [and] Summary" Patient had a high fall score, 60 [above 45 is high risk]. Patient refused to wear non-slip socks since [he/she] said they were not comfortable. Known unsteady gait, walking assistive device, elderly, no sitter, and no bed alarm on due to no bed alarm on the unit."

"Recommendation to prevent this event or event type in the future ...A bed alarm may have helped detect the patient climbing out of bed. Extra staff would have likely helped prevent the fall. A contingency plan to call more staff should be developed and trained."

Further review of the above RCA revealed the "Background Factors [and] Summary" for Patient #1 and been cut and pasted into the RCA for Patient #2.

During an interview on 9/24/20 at 1:05 pm, when asked about the error, the Quality Manager (QM) stated the information was wrong. He then removed the information in the computer.



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Based on record review, interview, and policy review the facility failed to ensure delays in diagnostic testing and results were evaluated, process improvements were developed, implemented and re-evaluated. This failed practice caused a delay in services for 4 patients reviewed (#s 4; 5; 10 and 11) and created a risk for delay in treatment. Findings:

Delay in emergency diagnostic results.

Patient #5

Record review on 9/23/20 revealed Patient #5 was transported to the hospital on 9/9/20, during the transport the Patient lost consciousness and had a seizure. The Patient's diagnoses included 23 week pregnancy, gestational diabetes, and preeclampsia (a disorder in pregnancy that can increase the risk of poor outcomes for mother and baby).

Review of the laboratory results revealed the Patient had blood collected for labs at 5:25 pm, The Patient had a low magnesium (mineral) and lactic acid levels. The physician orders for the complete blood count (check red and white blood cells), comprehensive metabolic panel (check chemical imbalance), PT/INR (check for clotting), reactive protein and sedimentation rate (checks for inflammation), were never completed.

Patient #4

Record review on 9/23/20 revealed Patient #4 presented to the emergency department on 9/17/20 with chest pain.
Review of the laboratory results revealed the provider ordered a Troponin level (to check for cardiac damage) at 1:17 pm. The Physician was notified of the abnormal elevated results at 2:40 pm, almost 1 ½ hours after the test was ordered.

During an interview on 9/23/20 at 8:30 am, Physician #2 stated there was a severe delay in emergency labs being run. The Physician stated she/he had to wait almost an 1 and ½ hour for a cardiac lab for a patient that had presented with chest pain (Patient #4) and the sedimentation rate needed for a pregnant patient that was having preeclampsia symptoms was never performed (Patient #5).

During an interview on 9/23/20 at 9:30 am the Clinical Services Manager was asked for a guide on laboratory testing and how long it took to run each test.

Review of the "Laboratory Test Turn Around Times", dated 5/15/19, revealed "All Emergency Room tests with the exception of the Send Out tests and cultures are to be completed within 60 minutes, to make sure this is being done; we do a Performance Improvement each month."

During an interview on 9/24/20 at 9:10 am, when asked about the delay in lab results, the Acting Lab Manager (ALM) stated the patient lab program interfaces with the EMR for the result entry into the chart. When asked if lab results had been late, she stated it does happen. The ALM stated nursing and medical staff completes the incident reports on late and/or missing labs.

Review of incident reports, completed by nursing staff after both events, did not identify a cause for the delay in emergency labs or identify remedial actions to prevent further processing delays.

Laboratory

CT/NG (chlamydia trachomatis and gonorrhea) testing

Review of the "Monthly Report-Roll up of BBAHC Division Reports", dated 9/11/20, revealed "Laboratory ...Pathologist site visits moved to teleconferences. Quality control and successful monitoring and validation for blood bank, chemistry, and hematology performed ...Med technologist on afternoon shift is performing quality control and equipment validation for the new Cepheid [diagnostic analyzer] equipment which will allow BBAHC to do CT/NG (chlamydia trachomatis and gonorrhea) in house."

During an interview on 9/26/20 at 10:30 am the Infection Control Nurse (ICN) stated she was responsible for immunizations of patients and staff as well as Infection Prevention. The ICN stated the tests for gonorrhea and syphilis are sent to the State lab, it takes up to a week to get the results. The ICN stated the region had experienced an outbreak, she requested additional screening to be initiated during patient visits. The ICN stated the request had been denied. The ICN stated the laboratory had a diagnostic machine (the Cepheid) that could run faster test results (within an hour), but the facility had been waiting to get it certified for 2 years (since 2018).

Further review of the lab "Monthly Report-Roll up of the CBBHC Division Reports" identified no date when the Cheeped would be available and faster STD screening could be implemented.

During an interview on 9/25/20 at 9:00 am, Physician #3 stated patients had tested for sexually transmitted diseases (STD). The specimens were sent to the lab who sent them to the send out lab for processing. Normally the results should be back in less than 7 days. The patients' results were not back in 12 or 14 days. When the Physician called the lab for the results the lab did not have the results back yet from the "send out" lab. When the results did arrive (over 14 days since the specimen was obtained) the Physician stated the results were positive. The patient had left the state and could not be located to notify of positive results. This left the patient untreated for the STD's and at risk of potentially spreading the disease to others.

Review of the "Bristol Bay Area Health Corp" (state laboratory report), approval date 11/23/20 at 11:59 pm, revealed:

Patient #10 had detected gonorrhea from a test conducted 9/17/20, more than 7 days ago.

Patient #11 had detected gonorrhea from a test conducted 9/18/20, more than 6 days ago.

Review of the "Anatomic Stewardship Program Committee" minutes, dated 8/13/20, revealed under "Topic" "New Business" "Discussion/ Information ...TB and syphilis increase in Bristol Bay, the "Action Required" was "Physician to notify public health for each case. Public health prophylactic treatment and possible communication with the public needed?"

According to the "State of Alaska Epidemiology Bulletin", released 9/30/20, at http://dhss.alaska.gov/dph/Epi "Gonorrhea Outbreak Update - Alaska, 2019 and Recommendations for Care ...Alaska has been experiencing a gonorrhea (GC) outbreak since October 2017 and our 2018 GC rate was the second highest in the nation. 1, 2 from 2009 to 2018, the national rate of reported GC cases increased by 82.6% and the state rate nearly doubled."

Recommendations

1. Routinely elicit a thorough sexual history on all sexually-active patients that includes questions about genital, oral, and anal sexual activity...

4. Promptly treat GC patients and their sex partner(s) with ceftriaxone 250 mg IM [intramuscular] PLUS azithromycin 1 g PO [by mouth], each in a single dose on the same day."

Review of the Notes from the "Flu, STD, Infectious Disease Update Meetings", dated August and September 2020 by the QM, revealed the response to extra questions on sexual history was "No" for nursing and the clinics.

There was no information as to why the facility did not follow the recommendations from the State of Alaska Department of Epidemiology. .

During an interview with the Acting Laboratory Manager and the Systems Manager on 9/26/20 at 9:00 am, when asked about the ability of the Cepheid to run the STD tests, both staff stated they had just sent the information to the Laboratory Director for sign off, today. Both had confirmed the facility had the diagnostic machine for over 2 years (since 2018), and had not yet been certified for diagnostic testing of STDs. As a result patients were not treated promptly after positive test results.



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Based on interviews and record review the facility failed to ensure the development and rapid implementation of a process to recruit and/or retain physicians for the safe operation of the hospital. This failed practice created a severe physician shortage at the facility which created a risk for poor patient outcomes and increased mortality. Findings:

During the survey on 9/22-25/2020, the facility did not have a physician functioning as a clinical director.

Review of the "Executive Committee Meeting Minutes" dated 8/17/20, revealed the former Clinical Director provided a written report that included information about "...staffing, recruitment, medical staff leadership concerns, village services, medical trends, and response to COVID-19...noted that tuberculosis is currently a big public health issue...and that syphilis is on the rise in Bristol Bay and the State of Alaska."

During an interview on 9/23/20 at 8:15 am, Physician #2 stated, he/she had spoken to the Chief Operations Officer (COO) and the Human Resources Manager (HRM) about a formal feedback process for TDY (Temporary Duty) staff but the Medical staff did not get any feedback. The (Medical Staff) did not want some of the TDY providers to return to the facility to work.

During an interview on 9/22/20 at 8:30 am, Physician #3 stated he/she talked to facility Administration about the need of long term permanent providers vs. TDY (temporary duty assignment) providers. He/she further stated during this conversation the HRM was informed physicians needed to have emergency medicine, inpatient and outpatient, and maternity skills to be able to work in the facility.

During an interview on 9/23/20 at 8:30 am, Physicians #'S 1; 2; 3; and 4 stated the Chief Compliance Officer notified them the HRM had 11 provider recruits. The physicians stated the facility had hired midlevel providers (nurse practitioners) and had recently offered a position to 2 physician providers and 1 physician accepted. All of the Physicians in the meeting shared they would be gone in December as 2 were moving, one was going on leave, and 1 was part time. A 5th Physician was out on medical leave and they were unsure when he/she would return.

During an interview on 9/24/20 at 4:00 pm, the HRM stated the facility recently signed up with several agencies for physician recruitment. The HRM stated there was a shared folder between medical staff and Human Resources (HR) that has a live spread sheet which outlined the steps met for physician recruitment. He further stated he was working with the Medical Staff Department Manager to get information on who was a good fit with the medical staff.

During an interview on 9/25/20 at 9:15 am, Physician #3 stated late 9/24/20 the HRM sent an email with a list of available physician recruits. The Physician stated none of the providers met the criteria for a Critical Access Hospital. The Physician stated 1 provider was an orthopedic surgeon, 1 wanted to work acute care only, and another did not have emergency medicine experience. All of the providers were rejected as they did not meet the patient needs of the facility that the medical staff specified to the HRM.



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Based on interview and meeting minute review, the facility failed to ensure the appointment of a medical director and failed to ensure the State agency was notified of the former medical director resigning. This failed practice denied patients an advocate in their clinical care and necessary communication to front line staff about quality improvement, medical leadership, clinical standards, and strategic vision. Findings:

During an interview on 9/22/20 at 8:15 am, the Chief Compliance Officer (CCO) stated the facility did not have a Clinical Director [Medical Director].

Review of the "Executive Committee Meeting Minutes" dated 8/17/20, revealed the former Clinical Director provided a written report that included information about "...staffing, recruitment, medical staff leadership concerns, village services, medical trends, and response to COVID-19...noted that tuberculosis is currently a big public health issue...and that syphilis is on the rise in Bristol Bay and the State of Alaska."

During an interview, on 9/25/20 at 8:15 am, Physician #3 stated the facility did not have a Medical Director. The Physician stated the Medical Director had stepped down on 8/19/20.

Confirmation with the State Agency Manager on 9/25/20 revealed the State never received notification the facility no longer had a Medical Director.

During an interview, on 9/25/20 at 11:30 am, the CCO and the Human Resource Manager (HRM) stated they would draft a letter of notification to the State Agency. The CCO stated the facility did not know they needed to notify the State Agency of a change in a Medical Director.

Review of a policy draft, Notification of Change in Clinical Director [CD]", dated 9/18/20, revealed "Send a letter stating the effective date of the change and the name of the new CD to: State of Alaska Department of Health and Social Services..."

The Medical Staff Development Manager was out of the office and unavailable for interview during the survey.

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Based on document review and interviews the facility failed to ensure a process identified all medication errors and failed to ensure staff initiated incident reports for actual and potential medication errors. This failed practice denied the facility accurate information needed for sustainable quality improvement in the pharmacy and placed patients at risk for medication errors from systemic failures. Findings:

Medication Error Reports

During the Pharmacy and Therapeutics meeting on 9/24/20 from 9:00 am until 11:00 am, the Deputy Director of Pharmacy (DDP) reviewed medication errors for the month of August 2020.

The DDP identified concerns regarding expired medications in the village clinics, administration/dosing errors, medications unavailable, and vaccine storage issues.

Review on 9/24/20 of the "Total Med Error(s) by Location", August 2020, presented at the meeting, revealed 2 medication errors in outpatient and 5 in the village clinics.

The total number of doses of medications administered for the inpatient, outpatient, and village (clinics) was not listed. There were no medication errors listed for the inpatient or emergency department for the month of August.

Review of the scan rates (bar codes on a patient's bracelet and the medications) for inpatient and emergency department medications administered, presented at the meeting, revealed patients' bracelets were scanned 85% of the time and the medication was scanned 76% of the time.

During an interview on 9/24/20 at 10:30 am, when asked if not scanning a medication is considered a medication error, the DDP stated yes, it was. The DDP stated a RME [Medication Error Risk Management Event Report] should be completed. When asked why there were no inpatient or emergency department medication errors when the scan rate is not at 100%, the DDP stated it was not always an error, but it could be an error or not an error, because it's on a case by case basis and depended on why the bar code didn't scan and if the code on the medication didn't work.

During the meeting on 9/23/20 at 10:05 am the Pharmacy Manager (PM) stated the Pyxis (automated medication dispensing system) report should match the patient profile. The PM stated there were pages of discrepancy reports daily.

Review of the August 2020 Pyxis discrepancy report binders, on 9/24/20, for the 3 in-house Pyxis cabinets (inpatient, outpatient, and emergency department) revealed multiple events of medication counts being off and medications being pulled without a patient profile.

There were no RMEs that reflected the errors related to the discrepancy reports.

Recalled Medication

During an interview on 9/23/20 at 8:15 am, Physician #2 stated, there was a recall on a liquid antibiotic Cephalexin, which is widely used in the facility and outlying villages. The pharmacy had the replacement medication which was to go to the village clinics. The Physician stated he/she was unable to order the medication for the patient. The Physician stated the Pharmacy was not going to send out the medication for patient use until the village clinics sent back the recalled medication.

During an interview on 9/24/20 at 10:10 am, Physician #5 requested the PD send out the new supply of the Cephalexin to all villages by 9/25/20.

There was no RME that reflected the inability of the Physician to order the necessary medication for his/her patient.
Delivery Storage Concerns

During the 9/24/20 meeting the DDP and the PM identified issues with the delivery and storage of medication/ vaccinations in the village clinics. The DDP stated they planned to have a weekly meeting with the CHAPs (community health aid practitioners) and the pharmacy was trying the get the clinics to send back expired medication and immunizations prior to restocking. The PM stated they planned to send someone out to the villages to check medication storage. In addition, the PM stated some of the clinics did not have staff.

During an interview on 9/24/20 at 10:30 am, the Infection Control Nurse (ICN) stated the facility used to have an Immunization Coordinator. The ICN stated the Coordinator would travel to the villages and help the CHAPS with storage and managing immunization administration. The ICN stated the job was combined the ICN job and she had recently been out to help administer flu vaccinations. The ICN stated she had been very busy since the pandemic began in March 2020.

Review of the facility policy, "Patient Safety Program", dated 1/24/20, revealed "Patient safety occurrence information from aggregated data reports and individual Risk Management Event (RME) reports will be reviewed by the Patient Safety Committee to prioritize organizational patient safety activity efforts ...a. No Harm Errors ...b. Mild/Moderate Adverse Outcome Errors ...c. Any Medication Errors ..." "vii. Near Miss"

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