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Based on record reviews and interviews, the hospital's governing body failed to ensure that the medical staff was accountable to them for the quality of care provided to one (1) of ten (10) records reviewed (Patient #6). Physician's failed to examine a diabetic patient's foot at an office visit on 4/1/2021 after it had been reported two (2) days prior that the patient's toe had dead tissue (eschar), was weeping fluid, and was blackish green in color at the tip of the toe and their was no review of this adverse event through the quality assessment and performance improvement program.

Finding:

The United States Centers for Disease Control and Prevention's ("US CDC's") website states "Cellulitis is a common bacterial skin infection that causes redness, swelling, and pain in the infected area of the skin. If untreated, it can spread and cause serious health problems ..." and "Doctors typically diagnose cellulitis infections by doing a physical examination and looking at the affected skin ...".

The hospital's Patient Safety Event Reporting and Management FAMILY MEDICINE CATEGORY, dated 2/28/2008", states " ... All employees and members of the Medical Staff are responsible for reporting actual and near miss events" and states A serious Safety Event (SSE), in any healthcare setting, is a deviation from generally-accepted practice or process that reaches the patient causes moderate to severe temporary or permanent harm or death."

Patient #6's medical records were review. This patient was a 75-year-old individual with a history of Type II diabetes, hyperlipidemia, and hypertension. On 3/29/2021, a Home Health Agency Registered Nurse ("RN") called the Central Maine Medical Center ("CMMC") Family Practice Residency program with two (2) concerns that he/she would like addressed at the patient's next appointment. One (1) of these concerns was related to the patient's toes on his/her right foot.

On 4/1/2021, the patient was seen at the CMMC Family Practice Residency program. The CMMC Family Practice Residency program is a program for training Family Practice Physicians; is part of the hospital; and Family Practice Residents are graduates of a medical or osteopathic medical school.

Resident Physician A, who saw the patient on 4/1/2021, documented the following related to the patient's right foot:
- On 3/29/2021, the Home Health Agency RN called and reported that the patient's right great toe and now his/her second toe next to it was weeping; there was no toenail; the patient's right great toe had any area of two and a half (2.5) by two and a half (2.5) area of "eschar and slough" [eschar means dead tissue; slough means dead skin tissue that may have a yellow or white appearance]; the area was "weeping serous sanguineous fluid" [meaning fluid with both serum and red blood cells]; the tip of the toe was blackish green in color; and there was redness all around wound;
- The patient's two (2) children were present at the appointment and one (1) of the children thought that both of the patient's feet were more red and swollen than usual;
- Under the Physical Exam Section of the note:
"Chronic venous stasis dermatitis noted in the LE [lower extremity] bilaterally, right extremity wrapped in gauze with area of dried pus appreciated above area approx. consistent with 2nd/3rd toe, erythema [meaning abnormal redness of the skin] appreciated up to the mid right shin, no evidence of tenderness to palpation, erythema appreciated on left lower extremity, no lesions appreciated on left foot."
- Under the Assessment/Plan Section of the note:
The differential diagnosis was "cellulitis, wound secondary to undiagnosed diabetes or PVD [peripheral vascular disease], osteomyelitis [meaning an infection in the bone]";
Given the report of 3/29/2021, there was a concern for osteomyelitis and this was discussed with the patient's children; if the patient's workup (meaning tests) was concerning for osteomyelitis, then the plan would be to recommend emergency department assessment; if the patient's workup was not concerning for osteomyelitis then the plan would be to continue management with wound care;
Given the lack of vital sign abnormalities, there was a low concern for systemic infection at that time;
A referral would be make for more frequent wound care assessments; and
Follow up appointment in one week;
- Blood tests and an X-Ray of the patient's right foot were ordered.

There was no evidence in the patient's record that the patient's foot was examined and visualized by Resident Physician A on 4/1/2021.

Since this patient was seen by a Resident Physician, it was required by the hospital's "Rules and Regulations of the Medical Staff" that an Attending Physician be on-site; provide direct supervision for all procedures and when requested by the Resident Physician or other personnel; and all Resident Physician entries in the medical record must have an accompanying attestation and co-signature. This attestation must "state the level of supervision provided, review of recent medical events and concurrence with findings as indicated in the Resident Physician entry and any additional findings or treatment recommendations should be included in the attestation."

On 4/1/2021, Attending Physician A documented the following in relation to the patient's office visit: "Resident doctors documentation and management reviewed. I agree with the above states assessment and plan as written."

There was no evidence in the patient's record that Attending Physician A examined the patient's right toes, discussed the appearance of the right foot or toes with Resident Physician A, or compared the examination on 4/1/2021 to that of what was reported by the Home Health Care Agency RN on 3/29/2021, two days before the office visit.

On 4/12/2021, the patient returned for a follow up visit for his/her right foot and was seen by Resident Physician B. Resident Physician B documented that the patient's right second toe had circumferential eschar; was gangrenous [death of body tissues due to lack of blood flow] with surrounding erythema and warmth extending into the dorsal foot; the right great toe was without a toenail and serosanguineous leakage; the gauze was attached and dried to the site; the patient was pulling away when the area was palpated; the patient had completed approximately seven (7) days of an antibiotic (the prescription had been sent on 4/2/2021); the X-Ray on 4/1/2021 had been negative for osteomyelitis; there were concerns for the infection to spread to the patient's right great toe; and it was suspected the patient would require intravenous antibiotics and possible toe amputation. The plan was to send the patient to the emergency department ("ED").

On 4/12/2021, Attending Family Physician B documented the following in relation to the 4/12/2021 visit: "Patient seen, and relevant systems re-examined. Diagnosis and plan of care reviewed with [Resident Physician B], and with patient's caretaker. I agree with the assessment, documentation, and plan of care for this patient."

On 4/12/2021, Patient #6 was seen in the ED and was admitted to the hospital. On 4/13/2021, the patient underwent surgery and on 4/14/2021 died.

On 6/8/2021 at 3:25 PM, Resident Physician A was interviewed. She stated the patient was there with two (2) family members present; the family had multiple medical concerns with the primary one being the patient's foot which had bandages on it; she did not examine the patient's foot; and she dealt with what she could with the time she had available.

On 6/9/2021 at 7:00 PM and at 8:20 PM, the patient's two (2) children, who were present during the office visit of 4/1/2021, were interviewed separately. The following information was obtained during these interviews:
- Both children confirmed they were at the appointment;
- The dressing on his/her parent's foot had yellow pus drainage and blood on it;
- Resident Physician A did not look at his/her parent's foot;
- Resident Physician A stated that if she unwrapped his/her parent's foot she couldn't wrap it so nicely;
- Resident Physician A stated she would speak with her Supervisor; and
- They took their parent to have some blood tests and an X-Ray.

In addition, one (1) of the children stated he/she and his/her sibling asked Resident Physician A to look at the patient's foot on three (3) occasions during the visit and Resident Physician A did not look at his/her parent's foot.

On 6/10/2021 at 10:45 AM, Attending Physician A, who was the Attending Physician for the office visit of 4/1/2021, was interviewed. She confirmed she did not look at the patient's foot; she could not recall what Resident Physician A reported to her; when asked if the diagnosis of cellulitis can be made without looking at the skin, she stated "No"; and when asked how Resident Physician A verified pus under the bandage, she stated that Resident Physician A used the documentation from the Home Health Care Agency RN visit on 3/29/2021. She also confirmed that Resident Physician A did not ask for assistance with this patient.

On 6/10/2021 at 11:00 AM, Attending Family Physician B, who was the Attending Physician for the office visit of 4/12/2021, was interviewed. He stated he looked at the previous visit notes; there were several issues with primary concern being the elbow discomfort; issues with the foot were not at the top of the list; the patient's foot was being followed by wound care; he did not remember discussing how the foot looked at the previous visit; and he did not request a case review of the care provided on 4/1/2021 including the failure to remove the bandage covering the skin and toes.

On 6/10/2021 at approximately 1:49 PM, Resident Physician A, who was the Resident Physician for the office visit of 4/1/2021, was interviewed again. She confirmed the patient's two (2) family members were present; she confirmed she did not remove the gauze or visualize the appearance of the toes of the right foot; and she made her diagnosis based on information that was provided by the family and the home health agency nurse's call from 3/29/2021.

On 4/15/2021, the hospital completed an "Encounter Entry Report: Focus Study: MORTALITY CMMC". There was no evidence that Patient #6's visit at CMMC Family Practice Residency program was included as part of the Mortality Review.

On 6/10/2021 at approximately 7:45 AM, the System Director of Quality ("Director") was interviewed. The Director confirmed there was no review of Patient #6's office visit on 4/1/2021 in which the dressing covering of the patient's right foot, skin, and toes were not removed.

On 6/10/2021 at approximately 10:15 AM and again on 6/11/2021 at approximately 7:45 AM, the Program Director of the Family Practice Residency ("Program Director") was interviewed. She stated the following:
- "Faulty performance is reviewed by resident feedback, outcomes, and observations."
- "Resident Physician A should have taken off the gauze and looked at the patient's foot"
- "For medical decision making, a provider would be better informed by looking at the wound directly and completing timelines on the wound."
- "A chart review could have been done on this case for quality review. This case could benefit from a quality review."

During the 6/11/2021 interview, the Program Director acknowledged that Attending Physician A, Attending Physician B, and the Medical Director of the Residency (who was the Admitting Attending Physician) did not activate a chart review of the care the patient received during the office visit on 4/1/2021. She also stated that "They have not been concentrating on outpatient processes for Peer Review; reviews are mostly done on inpatient care; and their system did not find this chart and failed to identify a Sentinel Event."

On 6/10/2021 at approximately 2:37 PM and again on 6/11/2021 at approximately 1:09 PM, the Medical Director of the Family Practice Residency ("Medical Director") was interviewed. The Medical Director was the Inpatient Attending Physician for Patient #6. He stated the following:
- "We want to make things better, quality assurance is achieved by reviewing if the Resident [meaning the Resident Physician] meets standards";
- "We do this with M&M [Morbidity and Mortality reviews], chart reviews, and peer reviews";
- "The 4/1/2021 office visit was not sent for review."
- "The skin should be looked at";
- "We have opportunities to improve";
- "If the foot was seen on April 1, 2021 that would have been more ideal."';
- "The standard would be to examine skin when diagnosing cellulitis";
- "We want to ensure all measures are met."
- He "could not find any documentation that feedback was provided to Resident Physician A regarding examining the toe on the 4/1/2021 office visit - this would be an opportunity for growth.";
- "We have opportunities for improvement - M&M process, active dialogue between all preceptors and residents from all visits - this will be important."
- "We have no current policy on quality assurance."
- "We need to improve upon - to fix reporting process that an error occurred or if there is an opportunity to learn"; and
- "We own this error".

Based on record reviews and interviews, the medical staff failed to conduct a case review of Patient #6's office visit of 4/1/2021 despite at least three (3) Physicians being involved in the case and failed to ensure that an effective system to track outpatient medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that included feedback and learning throughout the hospital was in place.

Based on record reviews and interviews, the hospital failed to ensure a patient was free from neglect, which is a form of abuse, for one (1) of ten (10) patients reviewed (Patient #6). Concerns related to a diabetic patient's toes were reported by a Home Health Care Agency Registered Nurse ("RN") on 3/29/2021; the patient was seen at the outpatient office of the hospital two days later (4/1/2021); the patient's toes were not examined or visualized by the Physicians at the office visit on 4/1/2021; and eleven (11) days later the patient's toe was diagnosed as being gangrenous requiring amputation.

Finding:

The Centers of Medicare and Medicaid Services defines abuse as "the willful infliction of injury, unreasonable confinement, intimidation, or punishment, with resulting physical harm, pain, or mental anguish. This includes staff neglect or indifference to infliction of injury or intimidation of one patient by another. Neglect, for the purpose of this requirement [meaning 42 Code of Federal Regulations §482.13(c)(3) - A-0145], is considered a form of abuse and is defined as the failure to provide goods and services necessary to avoid physical harm, mental anguish, or mental illness."

Patient #6's medical records were review. This patient was a 75-year-old individual with a history of Type II diabetes, hyperlipidemia, and hypertension. On 3/29/2021, a Home Health Agency RN called the Central Maine Medical Center ("CMMC") Family Practice Residency program with two (2) concerns that he/she would like addressed at the patient's next appointment. One (1) of these concerns was related to the patient's toes on his/her right foot.

On 4/1/2021, the patient was seen at the CMMC Family Practice Residency program. The CMMC Family Practice Residency program is a program for training Family Practice Physicians; is part of the hospital; and the Family Practice Residents are graduates of a medical or osteopathic medical school.

Resident Physician A, who saw the patient on 4/1/2021, documented the following related to the patient's right foot:
- On 3/29/2021, the Home Health Agency RN called and reported that the patient's right great toe and now his/her second toe next to it was weeping; there was no toenail; the patient's right great toe had an area of two and a half (2.5) by two and a half (2.5) "eschar and slough" [eschar means dead tissue; slough means dead skin tissue that may have a yellow or white appearance]; the area was "weeping serous sanguineous fluid" [meaning fluid with both serum and red blood cells]; the tip of the toe was blackish green in color; and there was redness all around wound;
- The patient's two (2) children were present at the appointment and one (1) of the children thought that both of the patient's feet were more red and swollen than usual;
- Under the Physical Exam Section of the note:
· "Chronic venous stasis dermatitis noted in the LE [lower extremity] bilaterally, right extremity wrapped in gauze with area of dried pus appreciated above area approx. consistent with the second 2nd/3rd toe, erythema [meaning abnormal redness of the skin] appreciated up to the mid right shin, no evidence of tenderness to palpation, erythema appreciated on left lower extremity, no lesions appreciated on left foot."
- Under the Assessment/Plan Section of the note:
· The differential diagnosis was "cellulitis, wound secondary to undiagnosed diabetes or PVD [peripheral vascular disease], osteomyelitis [meaning an infection in the bone]";
· Given the report of 3/29/2021, there was a concern for osteomyelitis and this was discussed with the patient's children; if the patient's workup (meaning tests) was concerning for osteomyelitis, then the plan would be to recommend emergency department assessment; if the patient's workup was not concerning for osteomyelitis then the plan would be to continue management with wound care;
· Given the lack of vital sign abnormalities, there was a low concern for systemic infection at that time;
· A referral would be make for more frequent wound care assessments; and
· Follow up appointment in one week.
- Blood tests and an X-Ray of the patient's right foot were ordered.

Since this patient was seen by a Resident Physician, it was required by the hospital's "Rules and Regulations of the Medical Staff" that an Attending Physician be on-site; provide direct supervision for all procedures and when requested by the Resident Physician or other personnel; and all Resident Physician entries in the medical record must have an accompanying attestation and co-signature. This attestation must "state the level of supervision provided, review of recent medical events and concurrence with findings as indicated in the Resident Physician entry and any additional findings or treatment recommendations should be included in the attestation."

On 4/1/2021, Attending Physician A documented the following in relation to the patient's office visit: "Resident doctors documentation and management reviewed. I agree with the above states assessment and plan as written."

On 4/12/2021, the patient returned for a follow up visit for his/her right foot and was seen by Resident Physician B. At this visit, Resident Physician B examined the patient's toes and found the patient's second toe had circumferential eschar, was gangrenous (meaning death of body tissues due to lack of blood flow) and had surrounding erythema and warmth extending into the dorsal foot (meaning upper side of the foot); the patient's right great toe was without a toenail and serosanguineous leakage; the gauze was attached and dried to the site; and the patient was pulling away when the area was palpated. The patient was sent to the ED from the office and was admitted to the hospital. On 4/13/2021, the patient underwent surgery (amputation) and on 4/14/2021 died.

There was no evidence in the patient's record that the patient's foot was examined and visualized by Resident Physician A on 4/1/2021. In addition, there was no evidence that Attending Physician A examined the patient's right toes, discussed the appearance of the right foot or toes with Resident Physician A, or compared the examination on 4/1/2021 to that of what was reported by the Home Health Care Agency RN on 3/29/2021.

On 6/9/2021 at 7:00 PM and at 8:20 PM, the patient's two (2) children, who were present during the office visit of 4/1/2021, were interviewed separately. The following information was obtained during these interviews:
- The dressing on his/her parent's foot had yellow pus drainage and blood on it;
- Resident Physician A did not look at his/her parent's foot;
- Resident Physician A stated that if she unwrapped his/her parent's foot she couldn't wrap it so nicely;
- Resident Physician A stated she would speak with her Supervisor; and
- They took their parent to have some blood tests and an X-Ray.

In addition, one (1) of the children stated he/she and his/her sibling asked Resident Physician A to look at the patient's foot on three (3) occasions during the visit and Resident Physician A did not look at his/her parent's foot.

On 6/8/2021 at 3:25 PM, Resident Physician A was interviewed. She stated the patient was there with two (2) family members present; the family had multiple medical concerns with the primary one being the patient's foot which had bandages on it; she did not examine the patient's foot; and she dealt with what she could with the time she had available.

On 6/10/2021 at 10:45 AM, Attending Physician A, who was the Attending Physician for the office visit of 4/1/2021, was interviewed. She confirmed she did not look at the patient's foot; she could not recall what Resident Physician A reported to her; when asked if the diagnosis of cellulitis can be made without looking at the skin, she stated "No"; and when asked how Resident Physician A verified pus under the bandage, she stated that Resident Physician A used the documentation from the Home Health Care Agency RN visit on 3/29/2021.

On 6/10/2021 at approximately 1:49 PM, Resident Physician A, who was the Resident Physician for the office visit of 4/1/2021, was interviewed again. She again confirmed the patient's two (2) family members were present; she again confirmed she did not remove the gauze or visualize the appearance of the patient's toes of the right foot; and she made her diagnosis based on information that was provided by the family and the Home Health Agency RN's call from 3/29/2021.

Based on the above information, on 3/29/2021, Patient #6, who was diabetic, was reported to have a two and a half (2.5) by two and a half (2.5) area of "eschar and slough" on his/her patient's right great toe; the area was "weeping serous sanguineous fluid"; the tip of the toe was blackish green in color; and there was redness all around wound. On 4/1/2021, the patient was seen by Resident Physician A who did not examine the resident's toe and she based her assessment and diagnosis on observations made by the Home Health Agency RN that had been made two (2) days prior. Attending Physician A, who was responsible for overseeing Resident Physician A on 4/1/2021, did not examine the patient's right toes, discuss the appearance of the right foot or toes with Resident Physician A, or compare the examination on 4/1/2021 to that of what was reported by the Home Health Care Agency RN on 3/29/2021. The failure to examine this diabetic patient's toes, after reports of eschar, slough, weeping, a color change (blackish green) at the tip, and redness meets the definition of neglect.

Based on document review and interviews, the Condition of Participation ("CoP") for Quality Assessment and Performance Improvement Program was not met. The hospital failed to ensure there was a system to track outpatient adverse patient events, analyze their causes, and implement preventive actions and mechanisms that included feedback and learning throughout the hospital.

Finding:

Standard §482.21(a)(1) and 482.21(a)(2) - Program Scope, 482.21(c)(2) - Program Activities and 482.21(e)(3) - Executive Responsibilities - Based on record reviews and interviews, the hospital failed to ensure there was a system to track outpatient adverse patient events, analyze their causes, and implement preventive actions and mechanisms that included feedback and learning throughout the hospital as evidenced by one (1) of one (1) adverse event reviewed. See A-0286 for details.

The cumulative effect of this deficient practice resulted in noncompliance with this CoP.

Based on record reviews and interviews, the hospital failed to ensure there was a system to track outpatient adverse patient events, analyze their causes, and implement preventive actions and mechanisms that included feedback and learning throughout the hospital as evidenced by one (1) of one (1) adverse event reviewed.

Finding:

The United States Centers for Disease Control and Prevention's ("US CDC's") website states "Cellulitis is a common bacterial skin infection that causes redness, swelling, and pain in the infected area of the skin. If untreated, it can spread and cause serious health problems ..." and "Doctors typically diagnose cellulitis infections by doing a physical examination and looking at the affected skin ...".

The hospital's Patient Safety Event Reporting and Management FAMILY MEDICINE CATEGORY, dated 2/28/2008", states " ... All employees and members of the Medical Staff are responsible for reporting actual and near miss events" and states A serious Safety Event (SSE), in any healthcare setting, is a deviation from generally-accepted practice or process that reaches the patient causes moderate to severe temporary or permanent harm or death."

Patient #6's medical records were review. This patient was a 75-year-old individual with a history of Type II diabetes, hyperlipidemia, and hypertension. On 3/29/2021, a Home Health Agency Registered Nurse ("RN") called the Central Maine Medical Center ("CMMC") Family Practice Residency program with two (2) concerns that he/she would like addressed at the patient's next appointment. One (1) of these concerns was related to the patient's toes on his/her right foot.

On 4/1/2021, the patient was seen at the CMMC Family Practice Residency program. The CMMC Family Practice Residency program is a program for training Family Practice Physicians; is part of the hospital; and Family Practice Residents are graduates of a medical or osteopathic medical school.

Resident Physician A, who saw the patient on 4/1/2021, documented the following related to the patient's right foot:
- On 3/29/2021, the Home Health Agency RN called and reported that the patient's right great toe and now his/her second toe next to it was weeping; there was no toenail; the patient's right great toe had any area of two and a half (2.5) by two and a half (2.5) area of "eschar and slough" [eschar means dead tissue; slough means dead skin tissue that may have a yellow or white appearance]; the area was "weeping serous sanguineous fluid" [meaning fluid with both serum and red blood cells]; the tip of the toe was blackish green in color; and there was redness all around wound;
- The patient's two (2) children were present at the appointment and one (1) of the children thought that both of the patient's feet were more red and swollen than usual;
- Under the Physical Exam Section of the note:
· "Chronic venous stasis dermatitis noted in the LE [lower extremity] bilaterally, right extremity wrapped in gauze with area of dried pus appreciated above area approx. consistent with 2nd/3rd toe, erythema [meaning abnormal redness of the skin] appreciated up to the mid right shin, no evidence of tenderness to palpation, erythema appreciated on left lower extremity, no lesions appreciated on left foot";
- Under the Assessment/Plan Section of the note:
· The differential diagnosis was "cellulitis, wound secondary to undiagnosed diabetes or PVD [peripheral vascular disease], osteomyelitis [meaning an infection in the bone]";
· Given the report of 3/29/2021, there was a concern for osteomyelitis and this was discussed with the patient's children; if the patient's workup (meaning tests) was concerning for osteomyelitis, then the plan would be to recommend emergency department assessment; if the patient's workup was not concerning for osteomyelitis then the plan would be to continue management with wound care;
· Given the lack of vital sign abnormalities, there was a low concern for systemic infection at that time;
· A referral would be make for more frequent wound care assessments; and
· Follow up appointment in one week;
- Blood tests and an X-Ray of the patient's right foot were ordered.

There was no evidence in the patient's record that the patient's foot was examined and visualized by Resident Physician A on 4/1/2021.

Since this patient was seen by a Resident Physician, it was required by the hospital's "Rules and Regulations of the Medical Staff" that an Attending Physician be on-site; provide direct supervision for all procedures and when requested by the Resident Physician or other personnel; and all Resident Physician entries in the medical record must have an accompanying attestation and co-signature. This attestation must "state the level of supervision provided, review of recent medical events and concurrence with findings as indicated in the Resident Physician entry and any additional findings or treatment recommendations should be included in the attestation."

On 4/1/2021, Attending Physician A documented the following in relation to the patient's office visit: "Resident doctors documentation and management reviewed. I agree with the above states assessment and plan as written."

There was no evidence in the patient's record that Attending Physician A examined the patient's right toes, discussed the appearance of the right foot or toes with Resident Physician A, or compared the examination on 4/1/2021 to that of what was reported by the Home Health Care Agency RN on 3/29/2021, two days before the office visit.

On 4/12/2021, the patient returned for a follow up visit for his/her right foot and was seen by Resident Physician B. Resident Physician B documented that the patient's right second toe had circumferential eschar; was gangrenous [death of body tissues due to lack of blood flow] with surrounding erythema and warmth extending into the dorsal foot; the right great toe was without a toenail and serosanguineous leakage; the gauze was attached and dried to the site; the patient was pulling away when the area was palpated; the patient had completed approximately seven (7) days of an antibiotic (the prescription had been sent on 4/2/2021); the X-Ray on 4/1/2021 had been negative for osteomyelitis; there were concerns for the infection to spread to the patient's right great toe; and it was suspected the patient would require intravenous antibiotics and possible toe amputation. The plan was to send the patient to the emergency department ("ED").

On 4/12/2021, Attending Family Physician B documented the following in relation to the 4/12/2021 visit: "Patient seen, and relevant systems re-examined. Diagnosis and plan of care reviewed with [Resident Physician B], and with patient's caretaker. I agree with the assessment, documentation, and plan of care for this patient."

On 4/12/2021, Patient #6 was seen in the ED and was admitted to the hospital. On 4/13/2021, the patient underwent surgery and on 4/14/2021 died.

On 6/8/2021 at 3:25 PM, Resident Physician A was interviewed. She stated the patient was there with two (2) family members present; the family had multiple medical concerns with the primary one being the patient's foot which had bandages on it; she did not examine the patient's foot; and she dealt with what she could with the time she had available.

On 6/9/2021 at 7:00 PM and at 8:20 PM, the patient's two (2) children, who were present during the office visit of 4/1/2021, were interviewed separately. The following information was obtained during these interviews:
- Both children confirmed they were at the appointment;
- The dressing on his/her parent's foot had yellow pus drainage and blood on it;
- Resident Physician A did not look at his/her parent's foot;
- Resident Physician A stated that if she unwrapped his/her parent's foot she couldn't wrap it so nicely;
- Resident Physician A stated she would speak with her Supervisor; and
- They took their parent to have some blood tests and an X-Ray.

In addition, one (1) of the children stated he/she and his/her sibling asked Resident Physician A to look at the patient's foot on three (3) occasions during the visit and Resident Physician A did not look at his/her parent's foot.

On 6/10/2021 at 10:45 AM, Attending Physician A, who was the Attending Physician for the office visit of 4/1/2021, was interviewed. She confirmed she did not look at the patient's foot; she could not recall what Resident Physician A reported to her; when asked if the diagnosis of cellulitis can be made without looking at the skin, she stated "No"; and when asked how Resident Physician A verified pus under the bandage, she stated that Resident Physician A used the documentation from the Home Health Care Agency RN visit on 3/29/2021. She also confirmed that Resident Physician A did not ask for assistance with this patient.

On 6/10/2021 at 11:00 AM, Attending Family Physician B, who was the Attending Physician for the office visit of 4/12/2021, was interviewed. He stated he looked at the previous visit notes; there were several issues with primary concern being the elbow discomfort; issues with the foot were not at the top of the list; the patient's foot was being followed by wound care; he did not remember discussing how the foot looked at the previous visit; and he did not request a case review of the care provided on 4/1/2021 including the failure to remove the bandage covering the skin and toes.

On 6/10/2021 at approximately 1:49 PM, Resident Physician A, who was the Resident Physician for the office visit of 4/1/2021, was interviewed again. She confirmed the patient's two (2) family members were present; she confirmed she did not remove the gauze or visualize the appearance of the toes of the right foot; and she made her diagnosis based on information that was provided by the family and the home health agency nurse's call from 3/29/2021.

On 4/15/2021, the hospital completed an "Encounter Entry Report: Focus Study: MORTALITY CMMC". There was no evidence that Patient #6's visit at CMMC Family Practice Residency program was included as part of the Mortality Review.

On 6/10/2021 at approximately 7:45 AM, the System Director of Quality ("Director") was interviewed. The Director confirmed there was no review of Patient #6's office visit on 4/1/2021 in which the dressing covering of the patient's right foot, skin, and toes were not removed.

On 6/10/2021 at approximately 10:15 AM and again on 6/11/2021 at approximately 7:45 AM, the Program Director of the Family Practice Residency ("Program Director") was interviewed. She stated the following:
- "Faulty performance is reviewed by resident feedback, outcomes, and observations";
- "Resident Physician A should have taken off the gauze and looked at the patient's foot";
- "For medical decision making, a provider would be better informed by looking at the wound directly and completing timelines on the wound"; and
- "A chart review could have been done on this case for quality review. This case could benefit from a quality review".

During the 6/11/2021 interview, the Program Director acknowledged that Attending Physician A, Attending Physician B, and the Medical Director of the Residency (who was the Admitting Attending Physician) did not activate a chart review of the care the patient received during the office visit on 4/1/2021. She also stated that "They have not been concentrating on outpatient processes for Peer Review; reviews are mostly done on inpatient care; and their system did not find this chart and failed to identify a Sentinel Event."

On 6/10/2021 at approximately 2:37 PM and again on 6/11/2021 at approximately 1:09 PM, the Medical Director of the Family Practice Residency ("Medical Director") was interviewed. The Medical Director was the Inpatient Attending Physician for Patient #6. He stated the following:
- "We want to make things better, quality assurance is achieved by reviewing if the Resident [meaning the Resident Physician] meets standards";
- "We do this with M&M [Morbidity and Mortality reviews], chart reviews, and peer reviews";
- "The 4/1/2021 office visit was not sent for review"
- "The skin should be looked at";
- "We have opportunities to improve";
- "If the foot was seen on April 1, 2021 that would have been more ideal."';
- "The standard would be to examine skin when diagnosing cellulitis";
- "We want to ensure all measures are met";
- He "could not find any documentation that feedback was provided to Resident Physician A regarding examining the toe on the 4/1/2021 office visit - this would be an opportunity for growth";
- "We have opportunities for improvement - M&M process, active dialogue between all preceptors and residents from all visits - this will be important";
- "We have no current policy on quality assurance";
- "We need to improve upon - to fix reporting process that an error occurred or if there is an opportunity to learn"; and
- "We own this error".

Based on the above information, the hospital failed to conduct a case review of a potential serious medical error despite at least three (3) attending physicians being involved in the case; ensure the hospital's Quality Department reviewed this patient's care on 4/1/2021; and ensure that the hospital had an effective system to track outpatient medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that included feedback and learning throughout the hospital.

Based on document review and interviews, the Condition of Participation ("CoP") for Medical Staff. The hospital failed to ensure that an adthere was a system to track outpatient adverse patient events, analyze their causes, and implement preventive actions and mechanisms that included feedback and learning throughout the hospital.

Finding:

Standard §482.22(b) - Medical Staff Organization and Accountability - Based on record reviews and interviews, the hospital failed to ensure that the medical staff was accountable to the governing body for the quality of care provided to one (1) of ten (10) records reviewed. This failure was demonstrated by the failure of the medical staff to examine a diabetic patient's foot at an office visit on 4/1/2021 after it had been reported two (2) days prior that the patient's toe had dead tissue (eschar), was weeping fluid, and was blackish green in color at the tip of the toe and the failure of a review of this adverse event through their quality assessment and performance improvement program. See A-0347 for details.

The cumulative effect of this deficient practice resulted in noncompliance with this CoP.

Based on record reviews and interviews, the hospital failed to ensure that the medical staff was accountable to the governing body for the quality of care provided to one (1) of ten (10) records reviewed. This failure was demonstrated by the failure of the medical staff to examine a diabetic patient's foot at an office visit on 4/1/2021 after it had been reported two (2) days prior that the patient's toe had dead tissue (eschar), was weeping fluid, and was blackish green in color at the tip of the toe and the failure of a review of this adverse event through their quality assessment and performance improvement program.

Finding:

The United States Centers for Disease Control and Prevention's ("US CDC's") website states "Cellulitis is a common bacterial skin infection that causes redness, swelling, and pain in the infected area of the skin. If untreated, it can spread and cause serious health problems ..." and "Doctors typically diagnose cellulitis infections by doing a physical examination and looking at the affected skin ...".

The hospital's Patient Safety Event Reporting and Management FAMILY MEDICINE CATEGORY, dated 2/28/2008", states " ... All employees and members of the Medical Staff are responsible for reporting actual and near miss events" and states A serious Safety Event (SSE), in any healthcare setting, is a deviation from generally-accepted practice or process that reaches the patient causes moderate to severe temporary or permanent harm or death."

Patient #6's medical records were review. This patient was a 75-year-old individual with a history of Type II diabetes, hyperlipidemia, and hypertension. On 3/29/2021, a Home Health Agency Registered Nurse ("RN") called the Central Maine Medical Center ("CMMC") Family Practice Residency program with two (2) concerns that he/she would like addressed at the patient's next appointment. One (1) of these concerns was related to the patient's toes on his/her right foot.

On 4/1/2021, the patient was seen at the CMMC Family Practice Residency program. The CMMC Family Practice Residency program is a program for training Family Practice Physicians; is part of the hospital; and Family Practice Residents are graduates of a medical or osteopathic medical school.

Resident Physician A, who saw the patient on 4/1/2021, documented the following related to the patient's right foot:
- On 3/29/2021, the Home Health Agency RN called and reported that the patient's right great toe and now his/her second toe next to it was weeping; there was no toenail; the patient's right great toe had any area of two and a half (2.5) by two and a half (2.5) area of "eschar and slough" [eschar means dead tissue; slough means dead skin tissue that may have a yellow or white appearance]; the area was "weeping serous sanguineous fluid" [meaning fluid with both serum and red blood cells]; the tip of the toe was blackish green in color; and there was redness all around wound;
- The patient's two (2) children were present at the appointment and one (1) of the children thought that both of the patient's feet were more red and swollen than usual;
- Under the Physical Exam Section of the note:
· "Chronic venous stasis dermatitis noted in the LE [lower extremity] bilaterally, right extremity wrapped in gauze with area of dried pus appreciated above area approx. consistent with 2nd/3rd toe, erythema [meaning abnormal redness of the skin] appreciated up to the mid right shin, no evidence of tenderness to palpation, erythema appreciated on left lower extremity, no lesions appreciated on left foot."
- Under the Assessment/Plan Section of the note:
· The differential diagnosis was "cellulitis, wound secondary to undiagnosed diabetes or PVD [peripheral vascular disease], osteomyelitis [meaning an infection in the bone]";
· Given the report of 3/29/2021, there was a concern for osteomyelitis and this was discussed with the patient's children; if the patient's workup (meaning tests) was concerning for osteomyelitis, then the plan would be to recommend emergency department assessment; if the patient's workup was not concerning for osteomyelitis then the plan would be to continue management with wound care;
· Given the lack of vital sign abnormalities, there was a low concern for systemic infection at that time;
· A referral would be make for more frequent wound care assessments; and
· Follow up appointment in one week;
- Blood tests and an X-Ray of the patient's right foot were ordered.

There was no evidence in the patient's record that the patient's foot was examined and visualized by Resident Physician A on 4/1/2021.

Since this patient was seen by a Resident Physician, it was required by the hospital's "Rules and Regulations of the Medical Staff" that an Attending Physician be on-site; provide direct supervision for all procedures and when requested by the Resident Physician or other personnel; and all Resident Physician entries in the medical record must have an accompanying attestation and co-signature. This attestation must "state the level of supervision provided, review of recent medical events and concurrence with findings as indicated in the Resident Physician entry and any additional findings or treatment recommendations should be included in the attestation."

On 4/1/2021, Attending Physician A documented the following in relation to the patient's office visit: "Resident doctors documentation and management reviewed. I agree with the above states assessment and plan as written."

There was no evidence in the patient's record that Attending Physician A examined the patient's right toes, discussed the appearance of the right foot or toes with Resident Physician A, or compared the examination on 4/1/2021 to that of what was reported by the Home Health Care Agency RN on 3/29/2021, two days before the office visit.

On 4/12/2021, the patient returned for a follow up visit for his/her right foot and was seen by Resident Physician B. Resident Physician B documented that the patient's right second toe had circumferential eschar; was gangrenous [death of body tissues due to lack of blood flow] with surrounding erythema and warmth extending into the dorsal foot; the right great toe was without a toenail and serosanguineous leakage; the gauze was attached and dried to the site; the patient was pulling away when the area was palpated; the patient had completed approximately seven (7) days of an antibiotic (the prescription had been sent on 4/2/2021); the X-Ray on 4/1/2021 had been negative for osteomyelitis; there were concerns for the infection to spread to the patient's right great toe; and it was suspected the patient would require intravenous antibiotics and possible toe amputation. The plan was to send the patient to the emergency department ("ED").

On 4/12/2021, Attending Family Physician B documented the following in relation to the 4/12/2021 visit: "Patient seen, and relevant systems re-examined. Diagnosis and plan of care reviewed with [Resident Physician B], and with patient's caretaker. I agree with the assessment, documentation, and plan of care for this patient."

On 4/12/2021, Patient #6 was seen in the ED and was admitted to the hospital. On 4/13/2021, the patient underwent surgery and on 4/14/2021 died.

On 6/8/2021 at 3:25 PM, Resident Physician A was interviewed. She stated the patient was there with two (2) family members present; the family had multiple medical concerns with the primary one being the patient's foot which had bandages on it; she did not examine the patient's foot; and she dealt with what she could with the time she had available.

On 6/9/2021 at 7:00 PM and at 8:20 PM, the patient's two (2) children, who were present during the office visit of 4/1/2021, were interviewed separately. The following information was obtained during these interviews:
- Both children confirmed they were at the appointment;
- The dressing on his/her parent's foot had yellow pus drainage and blood on it;
- Resident Physician A did not look at his/her parent's foot;
- Resident Physician A stated that if she unwrapped his/her parent's foot she couldn't wrap it so nicely;
- Resident Physician A stated she would speak with her Supervisor; and
- They took their parent to have some blood tests and an X-Ray.

In addition, one (1) of the children stated he/she and his/her sibling asked Resident Physician A to look at the patient's foot on three (3) occasions during the visit and Resident Physician A did not look at his/her parent's foot.

On 6/10/2021 at 10:45 AM, Attending Physician A, who was the Attending Physician for the office visit of 4/1/2021, was interviewed. She confirmed she did not look at the patient's foot; she could not recall what Resident Physician A reported to her; when asked if the diagnosis of cellulitis can be made without looking at the skin, she stated "No"; and when asked how Resident Physician A verified pus under the bandage, she stated that Resident Physician A used the documentation from the Home Health Care Agency RN visit on 3/29/2021. She also confirmed that Resident Physician A did not ask for assistance with this patient.

On 6/10/2021 at 11:00 AM, Attending Family Physician B, who was the Attending Physician for the office visit of 4/12/2021, was interviewed. He stated he looked at the previous visit notes; there were several issues with primary concern being the elbow discomfort; issues with the foot were not at the top of the list; the patient's foot was being followed by wound care; he did not remember discussing how the foot looked at the previous visit; and he did not request a case review of the care provided on 4/1/2021 including the failure to remove the bandage covering the skin and toes.

On 6/10/2021 at approximately 1:49 PM, Resident Physician A, who was the Resident Physician for the office visit of 4/1/2021, was interviewed again. She confirmed the patient's two (2) family members were present; she confirmed she did not remove the gauze or visualize the appearance of the toes of the right foot; and she made her diagnosis based on information that was provided by the family and the home health agency nurse's call from 3/29/2021.

On 4/15/2021, the hospital completed an "Encounter Entry Report: Focus Study: MORTALITY CMMC". There was no evidence that Patient #6's visit at CMMC Family Practice Residency program was included as part of the Mortality Review.

On 6/10/2021 at approximately 7:45 AM, the System Director of Quality ("Director") was interviewed. The Director confirmed there was no review of Patient #6's office visit on 4/1/2021 in which the dressing covering of the patient's right foot, skin, and toes were not removed.

On 6/10/2021 at approximately 10:15 AM and again on 6/11/2021 at approximately 7:45 AM, the Program Director of the Family Practice Residency ("Program Director") was interviewed. She stated the following:
- "Faulty performance is reviewed by resident feedback, outcomes, and observations."
- "Resident Physician A should have taken off the gauze and looked at the patient's foot"
- "For medical decision making, a provider would be better informed by looking at the wound directly and completing timelines on the wound."
- "A chart review could have been done on this case for quality review. This case could benefit from a quality review."

During the 6/11/2021 interview, the Program Director acknowledged that Attending Physician A, Attending Physician B, and the Medical Director of the Residency (who was the Admitting Attending Physician) did not activate a chart review of the care the patient received during the office visit on 4/1/2021. She also stated that "They have not been concentrating on outpatient processes for Peer Review; reviews are mostly done on inpatient care; and their system did not find this chart and failed to identify a Sentinel Event."

On 6/10/2021 at approximately 2:37 PM and again on 6/11/2021 at approximately 1:09 PM, the Medical Director of the Family Practice Residency ("Medical Director") was interviewed. The Medical Director was the Inpatient Attending Physician for Patient #6. He stated the following:
- "We want to make things better, quality assurance is achieved by reviewing if the Resident [meaning the Resident Physician] meets standards";
- "We do this with M&M [Morbidity and Mortality reviews], chart reviews, and peer reviews";
- "The 4/1/2021 office visit was not sent for review."
- "The skin should be looked at";
- "We have opportunities to improve";
- "If the foot was seen on April 1, 2021 that would have been more ideal."';
- "The standard would be to examine skin when diagnosing cellulitis";
- "We want to ensure all measures are met."
- He "could not find any documentation that feedback was provided to Resident Physician A regarding examining the toe on the 4/1/2021 office visit - this would be an opportunity for growth.";
- "We have opportunities for improvement - M&M process, active dialogue between all preceptors and residents from all visits - this will be important."
- "We have no current policy on quality assurance."
- "We need to improve upon - to fix reporting process that an error occurred or if there is an opportunity to learn"; and
- "We own this error".

Based on record reviews and interviews, the hospital failed to conduct a case review of Patient #6's office visit of 4/1/2021 despite at least three (3) attending physicians being involved in the case and failed to ensure that an effective system to track outpatient medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that included feedback and learning throughout the hospital was in place. These failures demonstrate the medical staff has failed to be accountable to the governing body for the quality of the medical care provided to Patient #6.