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Based on medical record review, policy review, observations, and staff interviews, the Critical Access Hospital's (CAH's) administrative staff failed to ensure attending physicians produced and maintained appropriate clinical records for all patients as follows per hospital policy and Medical Staff Bylaws:

1. Attending physicians failed to maintain complete and accurate clinical records per hospital policy and Bylaws, including documentation of pertinent past medical history and medical screening examinations. (see C-1104);

2. Hospital staff failed to produce evidence of properly executed informed consents per hospital policy, including documentation of the time of patient consent and name/signature of the person who explained the procedure(s) to the respective patient or guardian. (see C-1110); and

3. Hospital staff failed to implement appropriate protective measures to maintain the confidentiality of clinical records, including preventing access to clinical records by unauthorized individuals. (see C-1120).

The cumulative effect of these systemic failures and deficient practices resulted in an inability of the CAH's administrative staff to ensure the quality, reliability, and confidentiality of services provided to patients met acceptable standards of practice, resulting in an increased risk of adverse health and privacy outcomes for patients.

Based on medical record review, policy review, and staff interviews, the CAH's administrative staff failed to ensure all attending physicians produced complete and accurate clinical documentation per hospital policy and Medical Staff Bylaws for 4 of 21 patients sampled (Patients #3, #12 #14 and #29).

Failure to produce and maintain a complete and accurate set of clinical records could result in missed diagnoses of emergency medical conditions (EMCs) and reduced quality of care, each of which increase patients' risk of suffering adverse outcomes, which could include a deterioration in health, disability, or death. A complete set of clinical records comprises all orders, test results, evaluations, treatments, interventions, care provided, and the patient's response to treatments, interventions, and care.

Findings include:

1. Review of the CAH's 2/28/22 Medical Staff Bylaws revealed the following: "Article VI: Medical Staff Membership . . . Responsibilities of Membership . . .Timely complete and sign medical records for all Hospital patients to whom the member provides care in accordance with all Hospital and Medical Staff policies."

2. Further review of the CAH's 2/28/22 Medical Staff Bylaws revealed the following: "Article XIII: Committees of the Medical Staff . . . Other Committee Functions . . . The Executive Committee shall be responsible for carrying out, on a regular basis and according to established schedules, Medical Staff functions relating to medical records . . . In the event that any of the functions enumerated below are delegated to subcommittees, the President of the Medical Staff shall appoint a chair of such subcommittee from among the members of the Medical Staff. The specific functions to be carried out include, in addition to other functions designated from time to time, the following: a. Medical Records. Examine medical records and be responsible for their maintenance with the required standards. Currently maintained records will be reviewed to assure that they properly describe the condition and progress of the patient, therapy provided and outcomes, and that they meet the criteria of medical comprehension of the case in the event of transfer of physician responsibility for patient care."

3. Further review of the CAH's 2/9/22 Medical Staff Rules and Regulations revealed the following: "...Medical Records...Attending Physician Duties...The attending physician (and when applicable, other attending practitioners) shall be held responsible for the preparation of a complete medical record for each patient. This record shall include . . . complaint, personal history . . . history of present illness, physical examination . . . provisional diagnosis on admission . . . progress notes, final diagnosis, condition on discharge . . ."

4. Review of the CAH's 2/9/22 Medical Staff Rules and Regulations revealed the following: "... Progress Notes. Pertinent progress notes shall be completed at the time of observation, sufficient to permit continuity of care. Wherever possible, the patient's clinical problems shall be identified in the progress notes and correlated with specific orders as well as the results of tests and treatment."

5. Further review of the CAH's 2/9/22 Medical Staff Rules & Regulations revealed the following: "An appropriate medical record shall be kept for every person presented for treatment in the emergency room. Such record should include identification of person; information concerning time and means of arrival; pertinent details of injury or illness for which treatment sought including history and physical, emergency care provided prior to arrival, and vital signs; description of examination, treatment, and advice rendered, including diagnostic and therapeutic orders and clinical observations; whether a physician was called and, if so, matters communicated to and from the physician; reports of treatment, test and results; diagnosis; and conclusion of treatment. Should the person leave the hospital, the record should also include a description of the person's condition at that time, the person's reason for leaving, destination, instructions given to patient and/or family, and whether the departure was against the advice of clinical staff."

6. Review of the policy "Access and Maintenance of the Electronic Health Record" revealed the following: "(the hospital) will create a complete electronic health record (EHR) for each patient."

7. Review of the policy "Clinical Pertinence Review" revealed the following: "The medical record contains . . . the record and findings of the patient's assessment; a statement of the conclusions or impressions drawn from the medical history and physical examination; the diagnosis or diagnostic impression . . . The history and physical includes chief complaints, details of present illness, relevant past/social/family history, body system inventory, physical exam, conclusions/impressions, (and) plan of treatment . . . Assessments for Emergency Room patients shall include final disposition, patient's condition and instructions for follow up care."

8. Review of the policy "Emergency Medical Treatment and Active Labor Act (EMTALA) "revealed that appropriate documentation of an MSE should include the following: "ongoing vital signs including temperature, pulse, respiration, and blood pressure; pain scale and supporting details; documentation of allergies and/or medical conditions; description of injury or illness; and diagnostic testing (laboratory and radiology). Additionally, appropriate ED record documentation should include the following: "history, physical exam; assessment of whether the individual had an emergency medical condition; actions taken to determine condition and interventions provided; results of any diagnostic testing and narrative describing QMP or Physician findings, conclusions and plan of care; discharge/transfer vitals . . . "

9. Review of Patient #3's medical record revealed:

a. The face sheet, dated 2/9/24, for Patient #3's medical record identified Staff F ED Physician as the attending physician of the patient.

b. Documentation in the medical record revealed Staff B ED RN documented Patient #3 presented to the ED on 2/9/24 at 3:45 AM with complaints of intermittent back pain at approximately 28-weeks of pregnancy. Further review of the documentation revealed Staff B informed Staff F ED Physician of the patient's symptoms, and Staff F determined the reported symptoms indicated possible contractions. Staff F ED Physician instructed Staff B to recommend Patient #3 contact their Obstetric (OB) provider via phone and travel to their OB provider in another town approximately 38 miles away.

c. The medical record did not contain evidence Staff F ED Physician (Attending Physician) signed the medical record, completed a progress note, documented their findings related to an MSE, or documented any treatment orders-including orders for discharge.

10. During an interview on 3/4/24 at 1:00 PM, Staff F ED Physician confirmed their presence in the ED upon Patient #3's arrival and confirmed that they did not document their findings related to the patient's presenting complaints or symptoms, did not provide any orders for testing or treatment, including orders for discharge, and did not document their medical decision-making in the patient's medical record.

11. Review of Patient #12's medical record revealed:

a. The face sheet, dated 8/31/23, for Patient #12's medical record identified Staff DD ED Provider/Physician Assistant as the attending physician of the patient.

b. Documentation in the medical record revealed Staff C ED Critical Care Paramedic (CCP) documented Patient #12 presented to the ED on 8/31/23 at 3:47 PM with complaints of vaginal bleeding of unknown etiology and a PMH significant for recent pregnancy and preexisting kidney stone, status post placement and removal of a nephrostomy tube and subsequent placement of a ureteral stent. Further review of the documentation revealed Staff C informed Staff DD ED Provider/Physician Assistant of the patient's symptoms, and Staff DD determined the patient did not have an EMC.

c. The medical record did not contain evidence Staff DD ED Provider/Physician Assistant (Attending Physician) signed the medical record, completed a progress note, provided support for a diagnosis, documented their findings related to an MSE, or documented any treatment orders including orders for discharge.

12. Review of Patient #14's medical record revealed:

a. The face sheet, dated 8/26/23, for Patient #14's medical record identified Staff D ED Physician as the attending physician of the patient.

b. Documentation in the medical record revealed Staff J ED CCP documented Patient #14 presented to the ED on 8/26/23 at 11:12 PM with complaints of nausea and cramping at 4-6 weeks of pregnancy with a PMH significant for 3 previous miscarriages. Staff J ED CCP alerted Staff D ED Physician of the patient's vital signs and signs and symptoms associated with the patient's chief complaint. Per the documentation, the patient requested fetal monitoring services, to which Staff D ED Physician informed the patient the CAH lacked such capabilities. Further review of the documentation revealed Staff D ED Physician determined the patient did not have an EMC.

c. The medical record did not contain evidence Staff D ED Physician (Attending Physician) signed the medical record, completed a progress note, provided support for a diagnosis, documented their findings related to an MSE, or documented any treatment orders-including orders for discharge. Additionally, Staff D ED Physician failed to accurately document the patient's final disposition as having left against medical advice (AMA).

13. During an interview on 5/14/24 at 4:15 PM, Staff D ED Physician (Attending Physician) confirmed their presence in the ED upon Patient #14's arrival and confirmed that they did not document their findings related to the patient's presenting complaints or symptoms, did not provide any orders for testing or treatment-including orders for discharge, and did not document their medical decision-making in the patient's medical record.

14. Review of Patient #29's medical record revealed:

a. The face sheet, dated 12/7/23, for Patient #29's medical record identified Staff D ED Physician as the attending physician of the patient.

b. Documentation in the medical record revealed Staff BB ED RN documented Patient #29 (3-year-old child) presented to the ED on 12/7/23 at 9:05 PM with symptoms characterized as a coughing fit, excessive crying, and a period of unresponsiveness. Further review of the documentation revealed Staff BB ED RN informed Staff D ED Physician of the patient's symptoms. Staff D ED Physician determined the patient did not have an EMC and recommended the patient follow-up with their Primary Care Provider (PCP).

c. The medical record did not contain evidence that Staff D ED Physician (Attending Physician) signed the medical record, completed a progress note, provided support for a diagnosis, documented their findings related to an MSE, or documented any treatment orders-including orders for discharge.

15. During an interview, on 3/5/24 at 10:30 AM, Staff N Director of Emergency & Inpatient Services reported that the minimum expectations for documentation on ED patients include vital signs, chief complaint, signs and symptoms, consultation between the CCP or RN and provider, medical recommendations(s) of the provider, and final disposition. Staff N acknowledged that the CAH's attending providers failed to meet these expectations for all patients who presented to the ED for medical care.

16. During an interview, on 5/22/24 at 7:00 AM, Staff O ED Medical Director confirmed their presence on and oversight of the Executive Committee responsible for ensuring attending physicians met their obligations to ensure every patient (including ED patients) have a complete medical record that meets the required standards set forth by the Board of Directors, applicable standards of practice, and state and federal regulations. Staff O acknowledged prevalent and ongoing difficulties related to attending providers failing to maintain complete and accurate clinical records for all patients, for which the CAH has implemented disciplinary measures as part of previous corrective actions to attenuate the occurrence of incomplete clinical documentation, including the imposition of monetary fines.

The cumulative effect of these deficient practices resulted in a systematic failure to maintain complete and accurate clinical records, which in turn poses a potential risk of a serious adverse outcome for patients whom the CAH's administrative staff failed to ensure attending providers appropriately documented pertinent findings related to the respective patients' PMH and/or MSE. Proper documentation of patients' PMH and MSE informs the continuing treatment and care of patients; therefore, the absence of proper documentation poses a potential risk of administering contraindicated (inappropriate or ill-advised) medications or procedures, which could result in serious adverse outcomes up to and including death.

Based on medical record review, policy review, and staff interview, the CAH's administrative staff failed to ensure attending providers maintained clinical records that include evidence of a properly executed informed consent form (ICF) for 14 of 20 sampled patients (#12, #14, #21, #23, #25, #26, #28, #29, #30, #31, #32, #33, #34 and #35) who presented to the ED for emergency medical services.

Failure to document each necessary component of an ICF could prevent verification that CAH staff properly obtained informed consent prior to initiating patient treatment.

Findings include:

1. Review of the policy "General Consents" revealed "A patient's medical record must contain evidence of the patient's or his/her legal representative's general consent for treatment during each inpatient or outpatient encounter." The policy did not stipulate the following requisite components of a properly executed informed consent: time of patient consent, name of procedure(s), name of practitioner(s) performing the procedure(s), statement that the patient or guardian received an explanation of the procedure, signature of professional person witnessing the consent, and name/signature of person who explained the procedure to the patient or guardian.

2. Review of the CAH's 2/28/22 Medical Staff Bylaws revealed the following: "Article VI: Medical Staff Membership . . . Responsibilities of Membership . . .Timely complete and sign medical records for all Hospital patients to whom the member provides care in accordance with all Hospital and Medical Staff policies. "

3. Further review of the CAH's 2/28/22 Medical Staff Bylaws revealed the following: "Article XIII: Committees of the Medical Staff . . . Other Committee Functions . . . The Executive Committee shall be responsible for carrying out, on a regular basis and according to established schedules, Medical Staff functions relating to medical records . . . In the event that any of the functions enumerated below are delegated to subcommittees, the President of the Medical Staff shall appoint a chair of such subcommittee from among the members of the Medical Staff. The specific functions to be carried out include, in addition to other functions designated from time to time, the following: a. Medical Records. Examine medical records and be responsible for their maintenance with the required standards. Currently maintained records will be reviewed to assure that they properly describe the condition and progress of the patient, therapy provided and outcomes, and that they meet the criteria of medical comprehension of the case in the event of transfer of physician responsibility for patient care. "

4. Further review of the CAH's 2/9/22 Medical Staff Rules and Regulations revealed the following: "...Medical Records...Attending Physician Duties...The attending physician (and when applicable, other attending practitioners) shall be held responsible for the preparation of a complete medical record for each patient. This record shall include . . . complaint, personal history . . . history of present illness, physical examination . . . provisional diagnosis on admission . . . progress notes, final diagnosis, condition on discharge . . ."

5. During an interview on 5/20/24 at 1:19 PM, Staff M (Director of Compliance & Quality) reported that the CAH's staff did not document the time of patient consent when using a paper Consent for Treatment form in lieu of the electronic equivalent.

6. Review of 20 patient medical records revealed the following:

a. Review of the medical record for Patient #12 revealed:

1) The face sheet, dated 8/31/23, for Patient #12's medical record identified Staff DD ED Provider/Physician Assistant (PA) as the attending physician of the patient.

2) On 8/31/23, the CAH's administrative staff failed to ensure Staff DD ED Provider/PA (Attending Physician) documented the time of patient consent and the name/signature of the person who explained the procedure(s) to the patient or guardian.

b. Review of the medical record for Patient #14 revealed:

1) The face sheet, dated 8/26/23, for Patient #14's medical record identified Staff D ED Physician as the attending physician of the patient.

2) On 8/26/23, the CAH's administrative staff failed to ensure Staff D ED Physician (Attending Physician) documented the time of patient consent and the name/signature of the person who explained the procedure(s) to the patient or guardian.

c. Review of the medical record for Patient #21 revealed:

1) The face sheet, dated 5/14/24, for Patient #21's medical record identified Staff EE ARNP as the attending physician of the patient.

2) On 5/14/24, the CAH's administrative staff failed to ensure Staff EE ARNP (Attending Physician) documented the time of patient consent and the name/signature of the person who explained the procedure(s) to the patient or guardian.

d. Review of the medical record for Patient #23 revealed:

1) The face sheet, dated 5/13/24, for Patient #23's medical record identified Staff DD ED Provider/PA as the attending physician of the patient.

2) On 5/13/24, the CAH's administrative staff failed to ensure Staff DD ED Provider/PA (Attending Physician Assistant) documented the time of patient consent and the name/signature of the person who explained the procedure(s) to the patient or guardian.

e. Review of the medical record for Patient #25 revealed:

1) The face sheet, dated 5/12/24, for Patient #25's medical record identified Staff FF ED Physician as the attending physician of the patient.

2) On 5/12/24, the CAH's administrative staff failed to ensure Staff FF ED Physician (Attending Physician) documented the time of patient consent and the name/signature of the person who explained the procedure(s) to the patient or guardian.

f. Review of the medical record for Patient #26 revealed:

1) The face sheet, dated 5/13/24, for Patient #26's medical record identified Staff FF ED Physician as the attending physician of the patient.

2) On 5/13/24, the CAH's administrative staff failed to ensure Staff FF (Attending Physician) documented the time of patient consent and the name/signature of the person who explained the procedure(s) to the patient or guardian.

g. Review of the medical record for Patient #28 revealed:

1) The face sheet, dated 12/4/23, for Patient #28's medical record identified Staff GG ED Physician as the attending physician of the patient.

2) On 12/4/23, the CAH's administrative staff failed to ensure Staff GG ED Physician (Attending Physician) documented the time of patient consent and the name/signature of the person who explained the procedure(s) to the patient or guardian.

h. Review of the medical record for Patient #29 revealed:

1) The face sheet, dated 12/7/23, for Patient #29's medical record identified Staff D ED Physician as the attending physician of the patient.

2) On 12/7/23, the CAH's administrative staff failed to ensure Staff D ED Physician (Attending Physician) documented the time of patient consent and the name/signature of the person who explained the procedure(s) to the patient or guardian.

i. Review of the medical record for Patient #30 revealed:

1) The face sheet, dated 12/23/23, for Patient #30's medical record identified Staff O ED Physician as the attending physician of the patient.

2) On 12/23/23, the CAH's administrative staff failed to ensure Staff O ED Physician (Attending Physician) documented the time of patient consent and the name/signature of the person who explained the procedure(s) to the patient or guardian.

j. Review of the medical record for Patient #31 revealed:

1) The face sheet, dated 1/15/24, for Patient #31's medical record identified Staff DD ED Provider/PA as the attending physician of the patient.

2) On 1/15/24, the CAH's administrative staff failed to ensure Staff DD ED Provider/PA (Attending Physician) documented the time of patient consent and the name/signature of the person who explained the procedure(s) to the patient or guardian.

k. Review of the medical record for Patient #32 revealed:

1) The face sheet, dated 2/22/24, for Patient #32's medical record identified Staff E ED Physician as the attending physician of the patient.

2) On 2/22/24, the CAH's administrative staff failed to ensure Staff E ED Physician (Attending Physician) documented the time of patient consent and the name/signature of the person who explained the procedure(s) to the patient or guardian.

l. Review of the medical record for Patient #33 revealed:

1) The face sheet, dated 3/29/24, for Patient #33's medical record identified Staff O ED Physician as the attending physician of the patient.

2) On 3/29/24, the CAH's administrative staff failed to ensure Staff O ED Physician (Attending Physician) documented the time of patient consent and the name/signature of the person who explained the procedure(s) to the patient or guardian.

m. Review of the medical record for Patient #34 revealed:

1) The face sheet, dated 4/12/24, for Patient #34's medical record identified Staff GG ED Physician as the attending physician of the patient.

2) On 4/12/24, the CAH's administrative staff failed to ensure Staff GG ED Physician (Attending Physician) documented the time of patient consent and the name/signature of the person who explained the procedure(s) to the patient or guardian.

n. Review of the medical record for Patient #35 revealed:

1) The face sheet, dated 4/25/24, for Patient #35's medical record identified Staff DD ED Provider/PA as the attending physician of the patient.

2) On 4/25/24, the CAH's administrative staff failed to ensure Staff DD ED Provider/PA (Attending Physician) documented the time of patient consent and the name/signature of the person who explained the procedure(s) to the patient or guardian.

Based on policy review, observation, and staff interviews, the CAH's administrative staff failed to provide adequate safeguards to maintain the confidentiality of clinical records.

Failure to implement appropriate protective measures to prevent unauthorized access to clinical records could result in unauthorized use of protected health information (PHI) and the erosion of patient confidence in confidentiality.

Findings include:

1. Review of the policy "Secure Filing of Medical Records" revealed:

a. "Medical records housed within the hospital shall be kept in secure areas at all times. Medical records shall not be left unattended in areas accessible to unauthorized individuals."

b. "File rooms located in Burgess Health Center remains [sic] locked at all times and accessed only by the Health Information Management Department staff or nursing supervisors for patient care."

2. On 5/15/24 at 11:30 AM, a tour of an on-site record storage facility revealed the presence of a substantial quantity of insufficiently secured patient medical records and personnel files stacked in cardboard boxes absent any mechanism to prevent individuals with access to the facility from inappropriately accessing the clinical records.

3. On 5/15/24 at 11:45 AM, an interview with Staff AA (Maintenance Mechanic) revealed a number of maintenance personnel possess keys to either of two locked entrances of the storage facility, which housed a variety of other items in which said personnel may routinely enter the facility to obtain, as well as a remote control to enable entry through a third overhead door.

The cumulative effect of these deficient practices resulted in a substantial quantity of clinical records remaining accessible to unauthorized individuals with no reason to retain access to said records.