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Based on observation, interview and record review, the facility failed to have an emergency preparedness plan for backup medical record documentation in the event of electronic health record (E.H.R., digital version of a patient medical record including information on demographics, progress notes, problem lists, orders, medications, vital signs, past medical history & treatment, laboratory data and radiology reports) system failure during an emergency or disaster. This failure had the potential to result in the facility's inability to preserve documentation of patient treatment in a legal health record, in lack of a means of communication of patient care history among care providers, and in a lack of access to critical medical information for patients or future care providers in downtime (when production is stopped) of the electronic health record system.

Findings:

During an observation of the Emergency Department (ED) with concurrent interview with the Director of Emergency Services (DES) on 8/2/21, at 2:20 p.m., the location of the hospital's emergency preparedness policy and procedure was requested and what the ED staff would do when the E.H.R. system failed or was not functioning due to an electrical power outage. DES stated that planned E.H.R. outages were scheduled every third Thursday evening from 11 pm to 4 am. DES had never participated in a planned monthly E.H.R. downtime exercise with the evening ED staff. When asked how documentation of patient care would be implemented if the E.H.R. system was in downtime, DES located a large downtime cart (photo ED-1). The downtime cart contained approximately 20 medical record forms which would be used by ED staff.

During a review of the backup paper medical record forms to be used by ED staff provided by DES on 8/2/21, included were forms that were titled:
· Patient Status Request Form (version '01-2001')
· Downtime Form - Continuous Observation ( 2 pages)
· Nurse Note (2 pages)
· Additional Nurse's Notes - ER (revised '12/07')
· ER Medication Administration Record
· Triage/Rapid Medical Evaluation - ER (2 pages)
· Trauma Flow sheet (4 pages)
· Physician's Orders - ER ('revised date 03/11')
· Physician's Immobilization Order ('1/02')
· Physical restraint Physician Order Form ('5/08')
· Laboratory Downtime Order Form ('7-2016')
· Radiology Request ('12/97')
· Ultrasound-CT-Specials ('rev 2020')
· Code Blue Flow Sheet ('version 7/13')
· Environmental Behavioral Suicide Risk Safety Form (2 pages, 'Revised Date 8/10')
· MRSA Nasal Screening ('3/09')
· Emergency Department Aftercare Sheet (version '1/19/04')
· ER Charge Sheet (2 pages)
The ED medical record forms had revision dates dating back to 1997, and mostly around 2011 and prior to the time that the hospital E.H.R. system was adopted in 2012. None of the formats of the medical records matched what ED medical and nursing staff completed as medical records in their daily functions to document patient treatment in the E.H.R.

During an interview on 8/3/21, at 9:08 a.m, the Supervisor of Health Information (SHI) stated that the Health Information Management (HIM) department was staffed to handle medical records on Monday - Friday, 7:30 am to 5:00 pm. SHI confirmed that the E.H.R. system in use since 2012 was supported by HIM and in an emergency or disaster when the system was not operating, the department would support the handling and scanning of paper medical record forms. SHI stated that no disaster downtime drill had been conducted in the HIM department in the past two years. SHI and the Medical Record Technician II (MRT2) stated that there was no backup downtime E.H.R. computer located in the HIM Department. When asked to locate a facility Emergency Operations Policy and Procedure manual, SHI and MRT2 stated there was none to their awareness and that downtime backup procedures for the EHR system were conducted by the Information Technology (IT) department.

During an interview on 8/3/21, at 2:56 p.m., the Director of Information Technology (DIT) was asked about the IT Maintenance Downtime log (a tracking of when the information systems are not in production or working), a report for 2019 - 2020 reflecting 20 monthly "Routine Server updates & maintenance" events between 11 pm and 6 am on the third Thursday of a month. DIT shared the most recent announcement for the Monthly Scheduled IT Maintenance (an email notifying hospital staff of information system downtime) in 7/2021 that described the systems affected included the E.H.R. and email communication which would be down and "departments must be prepared on downtime procedures during the entire time". When asked why the planned downtime was always on the late evening staff shift after 11 pm. DIT stated that it was the time of the least activity in the hospital. When DIT was asked if hospital staff of the more active dayshift should be prepared for downtime procedures, it was stated that this had been suggested to leadership. DIT was asked where backup E.H.R. computer terminals (equipment to be used by staff where patient data should be stored at least every 24 hours) were located in the hospital and DIT identified that there was only one backup E.H.R. computer located on the second floor patient care area of the Medical/Surgical unit. DIT also discussed the IT Downtime log entry for 6/19/20 listed as "DCI Failover" when the information systems were down for 48 hours.

During an observation of the care unit on the second floor with concurrent interview on 8/3/21, at 3:30 p.m, with medical/surgical unit Director of Medical and Surgical Service (DMSS), the downtime procedure policy and procedure was requested along with all downtime medical record forms, located in a binder on the file shelf behind the Medical/Surgical nursing counter. When a downtime of the E.H.R. occurred, all backup medical record forms would need to be immediately available for each and every patient and DMSS agreed that it would take some time to create a medical record packet for each patient and each day of the patient stay. DMSS stated that there were 56 patient beds in the unit with an average census count of 30 patients on most days.

In a review of the contents of the binder, the Emergency Operation Plan was not located and multiple unindexed medical record forms were included. DMSS was requested to provide a full packet of all medical record forms to be used for each patient in the hospital at the time of a failure of the E.H.R. system and more than 25 medical record forms including:
· Med/Surg 24 hr (4 pages of daily flow sheet, 'rev 4/08' and on pg 3 '9/07')
· Patient Status Request Form, 2 part copy ( 01/2001)
· Progress Record ('Revised Feb 2011)
· Physician's Orders, 2 part copy ('3/13')
· Nurse Notes
· Medication Administration Record
· Diabetic Flow Sheet ('7/99')
· Insulin Basal, Nutritional and Correctional Orders
· Clinical Lab Manual Report Form, 2 versions (last 'Revised January 17th, 2012)
· Monitoring Daily Weight
· Nursing Vaccine Assessment Form ('Rev 7/09')
· Patient Charge Form
· Warfarin (Coumadin) Flowsheet (pre-printed orders '7-09')
· US (ultrasound), CT(computed tomography), Specials Request (photocopy of 3 part form,'3/98')
· Radiology Request, 3 part copy ( '12/97')
· Laboratory Down-Time Order Form ('11-2013')
· Time Out ('6/06')
· Home Medication Reconciliation List ('rev 12/11')
· Downtime Form- Suicide Risk Assessment, 3 pages
· MRSA Nasal Screening ('3/09')
· Venous Thromboembolism Risk Assessment and Prophylaxis Orders ('Revised 4/11')
· Arrhythmia Monitoring Protocol ('Revised Date: 06/07')
· Downtime Form - Continuous Observation 2 pages
· Environmental Behavioral Suicide Risk Safety Form-Attachment #1 ('Revised date 6/10')
· Patient Suicide Risk Assessment-Attachment #2 ('Revised date 8/10')
The Medical/Surgical medical record forms had revision dates dating as far back to 1999, and most were prior to the time that the hospital E.H.R. system was adopted in 2012. None of the formats of the medical records matched what ED medical and nursing staff completed as medical records in their daily functions to document patient treatment in the E.H.R.

During an observation and interview on 8/4/21, at 2:01 p.m, DIT and Applications Supervisor (AS) confirmed that there was only one back-up E.H.R. computer terminal in the hospital, located on the second floor Medical/Surgical unit, in a room behind the nursing station. In observing this computer terminal, a sign was affixed stating: "Please do not touch or turn off Down time computer only" (photo MS 1). AS was requested to start the computer to access the E.H.R. back up and it was discovered that the mouse (hand-controlled device for computer interaction) did not work and the printer dedicated to the downtime computer was off and linking to create a medical record took over 20 minutes to work. The only medical record documents that could be produced from the backup E.H.R. system were the Medication Summary report (MCH Backup MAR) and the eMAR (electronic Medication Administration Record) Report (eMAR Ad Rept). The supporting medical record documents for current patients such as emergency room reports, history and physicals, consultation reports, operation report, physician orders, nursing notes, vital sign flow sheets, laboratory reports, radiology reports could not and would not be generated, making medical information for patient care not accessible for the duration of any downtime of the E.H.R. system, such as the monthly planned 6 hour outage drills or unplanned disasters of a power outage or natural disasters such as fire or earthquake which might involve patient evacuation or transfer from the facility.

During an observation and concurrent interview on 8/3/21 at 1:57 pm with Director of Diagnostics Services (DDS) and Chief Technologist Clinical Laboratory (LCT), the Laboratory Downtime Procedure was requested and discussed. LCT provided a copy of the policy and procedure dated 5/2019, titled Laboratory Downtime Procedures.
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During an observation and concurrent interview with the DIT on 8/4/21, at 3:00 p.m, the only back up computer terminal for the laboratory system in the Clinical Laboratory department was in the back room. DIT stated the computer terminal had been recently relocated from another room and it was discovered that the backup terminal had been disconnected for two years since 2019 and recently made operational. The only report that could be generated on this terminal was for Blood Transfusions to indicate blood type, and no other critical clinical laboratory reports including microbiology (culture reports of infectious diseases), hematology (blood cell studies) blood chemistry (tests of blood content), urinalysis, and therapeutic drug testing (study of medication levels).

Based on observation, interview and record review the facility failed to establish a method of sharing information and documentation in medical records for inpatients to maintain continuity of care in a disaster or emergency. This failure had the potential to result in lack of access to medical records during downtime of the E.H.R. system, with no means to relay past medical history and treatment when patients were transferred or evacuated, and no means for patients to have access to request critical medical information regarding care and treatment in a disaster or emergency. The facility Emergency Operations Plan failed to outline the process to provide accurate and timely information about the general condition, location and status of patients during an emergency situation such as a major power outage, regional fire, earthquake or other threatening disaster.

Findings:

During an observation and concurrent interview on 8/2/21 at 2;20 p.m, in the Emergency Department (ED), the Director of Emergency Services (DES) was requested to provide the Emergency Operations Plan. DES stated that there was a scheduled monthly IT maintenance downtime (when a computer system is out of action or unavailable for use) with a drill to shut down the electronic health record (EHR) system every third Thursday of the month in the evening hours of 11 pm to 4 am. DES did not recall participating in a Disaster Preparation drill in the previous calendar year, nor participation in a planned monthly outage of the E.H.R. DES retrieved the Downtime Cart which contained more than 20 medical record forms that could be used for a ED patient.

During a review of one of the medical record forms titled Patient Status Request Form (PSRF) with a revision date of "01-2001", the PSRF had spaces to indicate transfer, discharge, or expiration of a patient. The PSRF was a 2 part form marked for the original to go to the cashier and a yellow copy to go to the PBX (a private branch exchange which is a telephone system within the facility). The PSRF had spaces to indicate discharge of a patient to home, long term care, acute hospital or other locations yet no specific designation or address to provide which would be critical for tracking of patient location in an emergency involving evacuation of patients.

During an interview on 8/3/21 at 2:56 pm, with the Director of Information Technology (DIT), a copy of the Emergency Operations Plan dated 1/2017 was discussed. The plan was missing appendix H for Power Outage and appendix J for Information Systems Failure and provided no procedure on the sharing of information and medical records for continuing care of patient that were transferred or evacuated in an emergency. DIT was asked about the location of backup computer terminals for the E.H.R. information system, and stated that there was none in the ED, the ICU (Intensive Care Unit), the OB (Obstetric for delivery of infants) unit, and only one for the facility in the Medical/Surgical unit. According to DIT, this one backup computer could only produce copies of the electronic Medical Administration Record (eMAR) within the 24 hours of a EHR system outage.

During an interview on 8/3/21 at 9:08 am, the Supervisor of Health Information (SHI) was asked about the operation of the Health Information Management (HIM, medical records) department. SHI stated the HIM department was staffed on Monday - Friday, 7:30 am to 5:00 pm. SHI stated the E.H.R. system in use at the facility since 2012 was supported by the HIM department to scan paper (hardcopy) medical record documents, such as the backup forms needed in a emergency or disaster. SHI stated that there was no backup computer terminal for the E.H.R. located in the HIM department and that no disaster drills had been conducted in the past two years involving the HIM department. SHI stated that downtime and backup processes to support the E.H.R. during downtime were handled by the IT department. Copies of downtime procedures used in the HIM department were requested.

During a review of the HIM department's policy and procedure titled, Downtime Procedure-Release of Information (DP HIM) dated 1/28/08 and revised 4/8/10, and last reviewed 12/27/2018, the purpose was stated as "To ensure alternative methods of release of information ... in the event of power outages, hardware and/or software malfunction". In the DP HIM, for procedure section III ( E) and (F) indicated "analyze medical record" and "copy records" yet without access to a downtime computer during a prolonged outage of the E.H.R., there would be no means to provide medical record information for a request related to a specific patient. There was no plan or procedure to address release of the backup medical record forms by the HIM department during a downtime of the E.H.R. system. The DP HIM did not support providing access to an accurate medical record that included complete documentation of all diagnoses, orders, test results, evaluations, care plans, consents, treatments, interventions care provided and the patient's response to those treatments, interventions and care. The DP HIM did not outline a system for private and secure medical record information that could not be lost, destroyed, altered or reproduced in an unauthorized manner, which ensured the integrity, security, and protection of the medical records of the facility in accordance with federal and state regulations.

During an observation and concurrent interview on 8/4/21 at 2:30 pm with DIT and Applications Supervisor (AS), a demonstration of use of the only backup computer terminal in the facility was conducted. Located on the second floor medical/surgical unit, the computer was not linked to a working mouse (hand-controlled device for computer interacting) and was not linked to a printer, requiring more than 20 minutes to produce a medical record. for a patient. The only medical record document that could be produced was a medical administration report (eMAR Ad Rept) and MAR summary report. There were no medical records that could be printed as a special disaster medical record to accompany a patient when evacuated. Medical documentation for inpatient care should include progress notes, orders, nursing noted, patient identification information, next of kin contact information, as well as records which reflect the hospital stay and results of care, treatment, and service as required in emergency preparedness communication.