HospitalInspections.org

Based on review of facility documents and interview with staff (EMP) it was revealed that the hospital was providing care at an off-site location which was not approved by the State's licensing department nor on the hospital's current license.

Findings include:

The State of Maine Rules for the Licensing of Hospitals, 10-144 C.M.R. Ch 112 state:

2.8 Issuance of a license. The license issued by the department extends to the premises identified in the application.
2.9 Specifications of a license. The license must specify the following:

2.9.3 the location of the building(s),
2.9.7 the identification of each level of care, and
2.9.8 the identification of outpatient services.

Review of the facility's license, dated January 1, 2023, revealed that identification of the outpatient services and the location where the hospital was providing care using an agent (i.e. paramedics) acting under the guidance and on behalf of the hospital, was not listed on the hospital's license.

Review of an agreement, "Urgent Care Telehealth Services Agreement," signed by the president of the hospital on May 12, 2022, revealed an agreement between the hospital and a health services entity. The agreement revealed that the hospital "developed a telehealth program for the provision of remote access to physicians and nursing staff at other locations ... and desires to offer, the delivery of health care oversight and medical care through the telehealth program, directly to the patients of [the health services entity] seeking urgent care services after-hours at the [name of an unrelated Medicare certified facility]. The location in which the services would be provided was occurring after hours in space located in another Medicare certified facility. This facility was not related to the hospital or to this other health services entity. In addition, this location was not enrolled with the Centers for Medicare & Medicare Services (CMS) as a provider-based location of the hospital.

In an interview with the Vice President of Medical Affairs on May 6, 2024, at 9:45 AM he /she stated that the hospital is providing a telehealth physician consultation to the patients in [rural community]. He/she stated they (the patients) are being registered and the patients are being billed for the consultative service. He/she stated the patients are registered as outpatients of the hospital. Heshe stated that the registration occurs so the hospital can bill for the consultation, but they are not providing the service on site.

In an interview with the Associate Medical Director, Emergency Department on May 6, 2024, at 1:30 PM, he/she confirmed that the program at {rural community] is a service of St. Joseph Hospital where he/she and his/her colleagues are providing care through telehealth.

The hospital failed to operate in accordance with State licensure requirements.

Based on review of facility documents and interviews with staff (EMP), it was determined that the hospital failed to have an effective governing body to ensure adequate oversight over hospital operations as evidence by: failing to ensure that non-physician practitioners (i.e. paramedics), providing care on behalf of and as an agent of the hospital, were assessed for competency and acting within their scope of practice (A004 5); and failing to ensure that services provided under contract were furnished in accordance with the applicable conditions of participation requirements and hospital policies (A0083).

Cross reference:
§482.12(a) Governing Body: Medical Staff. The governing body must:
§482.12(e) Governing Body: Contracted Services

Based on review of medical records (MR), review of personnel files, review of facility documents, and interview with staff (EMP) it was revealed that the hospital failed to ensure that non-physician practitioners (i.e. paramedics), providing care on behalf of and under the supervision of the hospital, were assessed for competency and acting within their scope of practice.

Findings include:


Review of an agreement, "Urgent Care Telehealth Services Agreement," signed by the president of the hospital on May 12, 2022, revealed an agreement between the hospital and a health services entity. The agreement revealed that the hospital "developed a telehealth program for the provision of remote access to physicians and nursing staff at other locations ... and desires to offer, the delivery of health care oversight and medical care through the telehealth program, directly to the patients of [the health services entity] seeking urgent care services after-hours at the [name of an unrelated healthcare facility]. The location in which the services would be provided was occurring after hours in space located in another healthcare facility. This facility was not related to the hospital or to this other health services entity.

Further review of the agreement revealed " ... Agreement with [the health services entity] ... subject to oversight by SJB [the hospital] ... Agreement ... 1.1. Engagement and Service. [the health services entity] herby retains SJB, and SJB herby agrees to be retained, as a designated provider of Telehealth Services to [the health services entity]. ... 1.2.2 SJB shall perform the following: 1.2.1 Provide ... clinical audio and video teleconsultation urgent care services to patients as requested and facilitated by [the health services entity] ... 1.2.2. ... delegate certain tasks ... to the [the health services entity] who facilitated the telehealth call to assist in providing Services to Patients under this agreement; ... 1.2.6 SJB shall perform Services by using interdisciplinary team of licensed and credentialed clinicians ("Providers") ... 1.3. [The health services entity] shall perform the following: 1.3.1 Evaluate the Patients seeking Services when [other Medicare certified facility] is closed to determine whether the Services are medically necessary and appropriate and, if so, facilitate the telehealth call; 1.3.2 Act under the clinical supervision of the SJB Providers at all times when providing Services under this agreement. 1.3.5 Provide information ... upon referral of Patients to SJB. ... This information will include ... (vi) any other pertinent data as reasonable required by SJB to treat Patients who have consented to [the health services entity] referral to SJB. ... Assist SJB providers with providing services at [other Medicare certified facility]. ... 5.1. Patient Records. Each Party shall maintain and provide access to pertinent medical records ... with respect to the Patient's health care ("Records") ... that are consistent with industry norms, ... and the requirements of applicable local, state, and federal law. ...".

The hospital website ( https://stjosephbangor.org/services/emergency-department/virtual-visits/) does provide notice and information to the public on the availability of "virtual visits" or telehealth services that the hospital does provide. Telehealth services are considered to be a real time, two-way audio/video communication between a physician or qualifies healthcare provider and a patient. The hospital website states, "Adults and children older than 5 are eligible for virtual visits." Additionally, the scope of practice for Maine licensed paramedics as evidenced by the Maine Emergency Medical Services (EMS) Prehospital Treatment Protocols does include the dispensing of Narcan to patients, but it does not include the labeling and/or dispensing of any other medications to patients to take home.

A review of the medical records for the medical care provided by the paramedics on behalf of the hospital at this offsite location at the direction of the hospital physician through virtual visits denoted that medications were dispensed to hospital patients as directed by the hospital physician. These records included the following:

1. The Medical record for patient #15 stated that a 5-year-old child "comes to the [healthcare] clinic with [his/her] mother ..." The parent stated the patient's eye is red and swollen. The record states, "The patient is registered via the St. Joe's ED for the telemedicine visit. The patient and [his/her] mother are questioned, and an exam of the patient is performed. The left eye is imaged by [hospital Emergency Department physician] with my [paramedic] assistance using the bluminator (vision testing device) with white light. The patient is prescribed Sulfacetamide 10% ophthalmic by [hospital Emergency Department physician] which is obtained from the medication closet and labeled for the patients use. Absolute and relative contraindications are reviewed with the dosage obtained from [hospital Emergency Department physician]. Instructions are given by [hospital Emergency Department physician] The [parent] is asked to bring the patient to an ED if symptoms worsen, or if they do not improve in the next few days."

2. The medical record for patient #2 was reviewed which documented, "[Adult] patient who presents to the [healthcare] Clinic via the red phone (the red phone is a telephone inside a red box on the outside of the healthcare building. It is marked by a sign that states, "After hours tele-urgent care. Pick up the phone inside the red box to connect directly to a paramedic. If unanswered Dial 911 on the pay phone for free. This is an acute care clinic staffed 24 hr/day by a paramedic in conjunction with a physician via telemedicine.") with a complaint of a possible infected left foot. [He/she] states that [he/she] fell yesterday at home injuring [his/her] right knee, [he/she] was seen at the [Federally Qualified Healthcare Clinic] yesterday for this injury, the practitioner advised [him/her] that if [his/her] knee didn't get better, reduce swelling, to return. The right knee has progressed and no longer has edema. Now however [his/her] left foot hurts and has a pink/red mark approximately the size of a half dollar on the dorsal aspect halfway between the toes and ankle ...Patient ambulates to the clinic room on his own, gait is altered suggesting a painful left foot ...Telemedicine visit is initiated with St. Joseph's hospital ED, [hospital Emergency Room physician] sees the patient via iPad and examines the foot with my (paramedic) assistance. [hospital Emergency Room physician] obtains history and vital signs from the patient and me (paramedic). [hospital Emergency Room physician] feels that there is a possible infection of the left foot at the site of the pain, he prescribes Keflex 500mg every 6 hours for the patient. A starter dose of 2 pills is dispensed by this Paramedic, with the patient taking the first dose while at the clinic. A prescription for the remainder is sent to [pharmacy] in Skowhegan as this is the patient's choice of pharmacy."


3. The medical record for patient #7, a 2-year-old child with a fever and ear pain, was revied and it documented, "[Patient #7 presents to the clinic with [his/her] mother ... [He/she] interacts age appropriate for a 2-year-old and is apprehensive but lets me [paramedic] examine [him/her] with [his/her] mother holding [him/her]. [His/her] right ear is visualized with an otoscope and a picture is taken for telemedicine. The ear appears grossly red and irritated. Possible right ear infection. Telemedicine visit with hospital Emergency Department is established ... Video and audio link is established, and vital signs and exam findings are given to [hospital Emergency Room physician] ...The patient is prescribed Amoxicillin 250mg/5ml, a dose of 9ml three times a day for 10 days. The patient is prescribed 150 ml of Amoxicillin upon reconstitution 250mg/5ml from the [outside organization pharmacy]. A prescription is called in to [Patient's pharmacy] for the remainder of the dosing. The mother is given the prescription medication and instructed to follow the package instructions for reconstitution with 110 ml of water along with the dosing instructions. [The mother] is instructed to look at her email to access "MyChart" and obtain the written discharge instructions. The mother is instructed by [hospital Emergency Room physician] to watch for fever reduction in a few days, continue with Tylenol as directed, and if the symptoms of ear pain do not get better in the next 2 to 3 days to see a provider in person.

In addition, review of personnel files revealed that the hospital did not maintain any personnel files for the paramedics who were providing care as an agent of and on behalf of the hospital under this Agreement. There was no evidence that the hospital performed competency evaluations of the paramedics to ensure that they were competent to complete the tasks they were being delegated by the physician. In addition, the hospital failed to identify that the labeling and dispensing of medications is not within a paramedics' scope of practice; paramedics are only authorized to dispense Narcan under their Maine EMS Paramedic license.

Based on review of medical records (MR), facility documents and interview with staff, it was determined that the hospital failed to ensure that services provided under contract were furnished in accordance with the applicable conditions of participation requirements and hospital policies.

Findings include:

Review of an agreement, "Urgent Care Telehealth Services Agreement," signed by the president of the hospital on May 12, 2022, revealed an agreement between the hospital and a health services entity. The agreement revealed that the hospital "developed a telehealth program for the provision of remote access to physicians and nursing staff at other locations ... and desires to offer, the delivery of health care oversight and medical care through the telehealth program, directly to the patients of [the health services entity] seeking urgent care services after-hours at the [name of an unrelated healthcare facility]. The location in which the services would be provided was occurring after hours in space located in another healthcare facility. This facility was not related to the hospital or to this other health services entity.

Further review of the agreement revealed " ... Agreement with [the health services entity] ... subject to oversight by SJB [the hospital] ... Agreement ... 1.1. Engagement and Service. [the health services entity] herby retains SJB, and SJB herby agrees to be retained, as a designated provider of Telehealth Services to [the health services entity]. ... 1.2.2 SJB shall perform the following: 1.2.1 Provide ... clinical audio and video teleconsultation urgent care services to patients as requested and facilitated by [the health services entity] ... 1.2.2. ... delegate certain tasks ... to the [the health services entity] who facilitated the telehealth call to assist in providing Services to Patients under this agreement; 1.2.3 Assume responsibility for billing services for Patients to third-party insurance or other sources through SJB's business office ... 1.2.4 Provide [the health services entity] with clinical documentation of Patients provided Services hereunder if required treatment or billing purposes ... 1.2.5 Assume responsibility for maintenance of confidentiality of records that are in SJB's possession ... 1.2.6 SJB shall perform Services by using interdisciplinary team of licensed and credentialed clinicians ("Providers") ... 1.3. [The health services entity] shall perform the following: 1.3.1 Evaluate the Patients seeking Services when [other Medicare certified facility] is closed to determine whether the Services are medically necessary and appropriate and, if so, facilitate the telehealth call; 1.3.2 Act under the clinical supervision of the SJB Providers at all times when providing Services under this Agreement. 1.3.3 Assist and facilitate providing to each Patient, or the Patient's responsibility part, all applicable SJB notices of privacy practices, policies and procedures, SJB consents made available to [the health services entity] by SJB. [The health services entity] will further obtain and tender to SJB any original consents, acknowledgements or authorizations required for SJB's compliance with applicable laws, rules and regulations. 1.3.5 Provide information ... upon referral of Patients to SJB. ... This information will include ... (vi) any other pertinent data as reasonable required by SJB to treat Patients who have consented to [the health services entity] referral to SJB. ... 1.3.7 Provide SJB's staff with reasonable ongoing access to or copies of records of patients receiving Services ... 1.3.9 Provide SJB's staff with support with Patient chart reviews and vitals, as needed; 1.3.10 Assist SJB providers with providing services at [other Medicare certified facility]. ... 2.4 Quality Assurance. Each Party shall cooperate with the other Party in quality assurance, administration, and in performance activities ... 5.1. Patient Records. Each Party shall maintain and provide access to pertinent medical records ... with respect to the Patient's health care ("Records") ... that are consistent with industry norms, ... and the requirements of applicable local, state, and federal law. ...".


Review of the hospital's website (https://stjosephbangor.org/services/emergency-department/virtual-visits/ ) revealed that the hospital offers virtual visits for patients unable or "unwilling" to go to their provider's office. Further review of the website revealed a "Frequently Asked Questions" section which included patients who could be treated virtually, but what conditions could not be treated virtually, and how to schedule a "Virtual Visit". The website states "Adults and children older than 5 are eligible for virtual visits." However, the following conditions are unable to be treated virtually: "chest pain, bleeding/lacerations, abdominal/pelvic pain, breathing difficulty/shortness of breath, Stroke Symptoms/Weakness, Paralysis, Confusion; STD (Sexually Transmitted Disease)/ Pregnancy Concerns, Worker's Comp Conditions and Mental Health Crisis." To schedule a "Virtual Visit" the individual may call their primary provider's office or the hospital's "Urgent Care."


A review of the medical records for the medical care provided by the paramedics on behalf of the hospital at this offsite location at the direction of the hospital physician through virtual visits denoted that care was provided to 10 children not older than the age of 5 and 16 patients with bleeding and lacerations contrary to the hospital's public statements that these visits are not eligible for virtual visits. These records included the following:

1. The medical record for patient #9 was reviewed which documented the following:
"A [adult-patient #9] presented to the clinic with lacerations on [his/her] left third and fourth digits ... At this time, we initiated a telemedicine visit. I [paramedic] spoke to [hospital emergency room physician] prior to registering the patient to let her know to expect us to appear on her "doxyme" account [hospital telemedicine account] and let her know the extent of the injuries ...After the registration process and irrigation was finished, [hospital Emergency Room physician] was able to view the lacerations and approved the closure of the laceration on the third digit by using simple interrupted sutures, 5.0 ethilon, in a dissecting fashion. [hospital Emergency Room physician] also stated that with the lack of tissue present on the 4th digit, there was nothing to be sutured. [hospital Emergency Room physician] request that the fourth digit be treated with a light amount of bacitracin and covered with clean, dry, sterile dressing. 3rd digit: the site was prepped with povidone iodine and draped in a usual fashion. A total of four (4) simple interrupted sutures were used for wound closure. Distal neurovascular status remained unchanged. Patient was able to tolerate the procedure with no issues. Post closure, [hospital Emergency Room physician] was able to perform a visual inspection approving of our work and asked to cover with light amount of bacitracin and dry sterile dressing. As this was being done, [hospital Emergency Room physician] reviewed the discharge paperwork with patient."


2. The medical record for patient #17, a 4-year-old child, was revied which documented, "Pt presented to [the] Health Center with minor laceration to forehead. [Patient'] mother present and reports the [Patient] was climbing onto a bar stool at home and pulled the stool over onto [his/her] head. Mother denies LOC (loss of consciousness) in patient. Patient reportedly up to date on all immunizations, but mother will call PCP to confirm on Monday morning. Pt presents calm and cooperative in no apparent distress. Pt has a 0.5 cm laceration just below the hair line on left side of forehead. Patient denies other injury. Patient AOx4 (Alert and oriented x4). Skin WPD (warm, pink, dry). Airway:intact. Breathing: normal, non-labored, equal chest expansion. Circulation: bleeding controlled at time of patient arrival. Spinal: assessment completed, see worksheet. SJH (St. Joseph Hospital) contacted, and patient presented to [hospital Emergency Room physician] for potential telemedicine consultation. [hospital Emergency Room physician] agreed the patient appeared appropriate and telemedicine initiated. Neurovascular status assessed pre and post procedure and found to be intact. Patient wound irrigated, cleansed, and draped per protocol. skin adhesive applied with good effect. Wound management reassessed by [hospital Emergency Room physician] and discharge instructions for wound care and follow up provided. Patient was provided directions on how to obtain written discharge instructions and an opportunity to ask questions. Band-Aid applied. Telemedicine visit terminated and patient discharged per protocol."

3. The medical record for patient #16, an adult, was revied which documented, "[Adult] presented with a dog bite to [his/her] right hand. The patient utilized the red phone in order to contact me (paramedic). I (paramedic) met the patient at the front door and escorted [him/her] into the telemedicine room. The patient had [his/her] hand wrapped with gauze and medical tape controlling the bleeding. Once in the telemedicine room, the injury was exposed and examined showing one significant punctuated/laceration to the dorsal side of [his/her] right hand proximal (nearest) to [his/her] thumb measuring approximately 2 cm with two small superficial puncture wounds in close proximity. The patient's vital signs were also taken, stable as noted ... The on-call telemedicine provider, [hospital Emergency Room physician], was contacted in order to set up a telemedicine visit. [hospital Emergency Room physician] requested that the wound be cleaned and photographed with images sent to him prior to the telemedicine visit. [hospital Emergency Room physician] request was fulfilled, and the patient was registered. Once the telemedicine visit was initiated, [hospital Emergency Room physician] was able to perform his assessment/evaluation. [hospital Emergency Room physician] requested that I(paramedic) do a delayed primary closure consisting of irrigation with tap water for five minutes. The wound was explored to its depths with no finding of foreign bodies or evidence of deep tissue injuries. Direct pressure was held for a short period of time controlling the bleeding. Once the bleeding was under, iodine is used to clean the wound one last time before the delayed primary closure which consisted of bacitracin ointment and covered with clean dry gauze. Patient was neurovascular intact prior to and post wound management. The patient was able to tolerate the procedure without any immediate complications and [hospital Emergency Room physician] approved of the wound closure. [hospital Emergency Room physician] then ordered amoxicillin-clavulanate 875mg with one dose to be given and one dose to be dispensed and taken in 12 hours from the first dose. [hospital Emergency Room physician] also ordered a tetanus vaccine (TDAP) be given. [hospital Emergency Room physician] calculated the correct dosage and reviewed absolute and relative contraindications of both medications. A visual confirmation of both medications was performed with [hospital Emergency Room physician] before administration. Amoxicillin-Clavulanate (RX#...) was given orally with water and the TDAP (RX#...) was given as an IM injection in left deltoid, both with no complications. [hospital Emergency Room physician] reviewed the discharge instructions with the patient. Patient stated that [he/she] understood the discharge instructions and had no further questions. Discharge instructions were faxed to the clinic for the patient. The patient was then discharged. No further entry.


The Governing Body meeting minutes, dated March 30, 2023, documented, "the hospital President shared two videos regarding the recent DNV visit and a collaborative project with [non-hospital health entity] regarding care for a remote area in [rural location]. Discussion regarding next steps for programming like the [rural location] project are expected as this program has the potential to serve as a model for other rural areas to have services not previously available to them, via telemedicine."

The hospital does not have a written policy regarding the provision of telehealth services but does establish hospital policy by publicly posting criteria on its website for who can be treated by telehealth and what types of medical conditions are not eligible for treatment by telehealth.

In an interview with the Vice President of Medical Affairs on May 6, 2024, at 9:45 AM he/she stated that the hospital is providing a telehealth physician consultation to the patients in [rural community]. He/she stated they (the patients) are being registered and the patients are being billed for the consultative service. He/she stated the patients are registered as outpatients of the hospital. He/she stated that the registration occurs so the hospital can bill for the consultation, but they are not providing the service on site.

In an interview with the Associate Medical Director, Emergency Department on May 6, 2024, at 11:07 AM he/she stated that the [the health services entity] and the town rent a room in the [name of an unrelated Medicare certified facility]. He/she stated it is a separate location and the intent of that is that this is an open-door urgent care. He/she stated he/she approached the hospital administration about contracting with [the health services entity] to provide the doctors to do the telehealth visits.

On May 7, 2024, Associate Medical Director, Emergency Department confirmed that the hospital did not review the credentials of the paramedics, the [the health services entity] is responsible for credentialing the paramedics. He/she stated the hospital credentials the physicians who provide the telehealth services.

Based on review of facility documents and interviews with staff (EMP), it was determined that the hospital failed to consistently implement and maintain an effective, ongoing hospital-wide, data driven quality assessment and performance improvement (QAPI) as evidence by failing to: collect data to monitor the effectiveness and safety of services and quality of care being provided by paramedics, acting on behalf of and under the direction of the hospital, at an off-site location (A0273).

Cross reference:

§§482.21(a), 482.21(b)(1), 482.21(b)(2)(i), & 482.21(b)(3) Data Collection & Analysis

Based on review of facility documents and interviews with staff (EMP), it was determined that the hospital failed to collect data to monitor the effectiveness and safety of services and quality of care being provided by paramedics, acting on behalf of and under the direction of the hospital, at an off-site location.

Findings include:

Review of an agreement, "Urgent Care Telehealth Services Agreement," signed by the president of the hospital on May 12, 2022, revealed an agreement between the hospital and a health services entity. The agreement revealed that the hospital "developed a telehealth program for the provision of remote access to physicians and nursing staff at other locations ... and desires to offer, the delivery of health care oversight and medical care through the telehealth program, directly to the patients of [the health services entity] seeking urgent care services after-hours at the [name of an unrelated healthcare facility]. The location in which the services would be provided was occurring after hours in space located in another healthcare facility.

1. Review of medical record for patient #15 revealed the patient presented to an off-site location on January 6, 2024. Further review of the medical record revealed that the paramedic contacted the hospital, and the hospital physician instructed the paramedic to administer and then dispense Sulfacetamide 10% ophthalmic.

2. Review of medical record for patient #2 revealed the patient presented to an off-site location on October 7, 2022. Further review of the medical record revealed that the paramedic contacted the hospital, and the hospital physician instructed the paramedic to administer and then dispense Keflex 500mg oral medication.

3. Review of medical record for patient #7 revealed the patient presented to an off-site location on May 12, 2023. Further review of the medical record revealed that the paramedic contacted the hospital, and the hospital physician instructed the paramedic to administer and then dispense Amoxicillin 250mg/5ml oral medication.

4. Review of medical record for patient #9 revealed the patient presented to an off-site location on May 19, 2023. Further review of the medical record revealed that the paramedic contacted the hospital, and the hospital physician instructed the paramedic to administer Lidocaine 1% injection and perform a digital block and after irrigating the wound to suture the lacerations.

5. Review of medical record for patient #17 revealed the patient presented to an off-site location on November 6, 2022. Further review of the medical record revealed that the paramedic contacted the hospital, and the hospital physician instructed the paramedic to administer and then dispense Amoxicillin 250mg/5ml oral medication.

6. Review of medical record for patient #16 revealed the patient presented to an off-site location on January 5, 2024. Further review of the medical record revealed that the paramedic contacted the hospital, and the hospital physician instructed the paramedic to administer and then dispense amoxicillin-clavulanate 875mg oral medication.

In an interview with Associate Medical Director, Emergency Department on May 7, 2024, at 12:18 PM he/she stated that he/she conducts a Quality Assurance review of the physician services/consult services provide by the hospital and that the [the health services entity] conducts reviews of the paramedic services through a non-hospital QA committee called a Clinical Practice Committee.

In an interview with the Senior Director of quality and Clinical on May 6, 2024, at 10:20 AM, the surveyors were informed that the hospital QA Committee has not incorporated the care and services being provided by [the health services entity] into the hospital's overall QA program. Surveyors were informed that the hospital only reviews the physician's engagement with the patient.FThe hospital's QA program has not evaluated the quality of on-site care being provided to hospital patients, the provision and storage of medications to hospital patients. The Associate Medical Director, Emergency Department stated that the hospital does not contract the paramedics to do skills for them, the paramedics contract with the hospital to do telehealth visits. Additionally, the Associate Medical Director, Emergency Department stated the evaluation and the guidance for the intervention is being provided by the hospital. He/she stated the actual intervention is being performed by someone who has an independent license.