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Based on record review, interview with clinical staff and administrative staff, and review of policy and procedure, the hospital failed to develop, implement, and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. The hospital's governing body failed to ensure that the program reflected the complexity of the hospital's organization and services; involved all hospital departments and services (including those services furnished under contract or arrangement); and focused on indicators related to improved health outcomes and the prevention and reduction of medical errors. The hospital failed to maintain and demonstrate evidence of its QAPI program for review by CMS as evidenced by:

1. The hospital's risk management and medical staff failed to accurately review and collect data in a timely and accurate manner for three incidents, Patient #1 and #2, and Patient #3. (Refer to A273)

2. The hospital failed to recognize the delay in treatment causing harm to two patients, Patient #1 and #2 and failed to recognize both cases as being adverse incidents. (Refer to A286)

3. The hospital's governing body failed to ensure medical staff, and administrative officials are responsible and accountable for ensuring the following:

(1) That an ongoing program for quality improvement and patient safety, including the reduction of medical errors, is defined, implemented, and maintained.

(2) That the hospital-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety and that all improvement actions are evaluated. (Refer to A309)

Based on record review, interview with clinical and administrative staff, and review of policy and procedure, the Risk Management failed to ensure the timely and accurate analysis of three complaints (Patient #1,#2, and #3) two of which were adverse incidents, out of 7 patients sampled.

Findings include:

According to the hospital policy, "Sentinel Event Never Event and Adverse Incident Response" accepted 1/31/2000 and revised 1/18/17, an Adverse incident is defined as, "An event over which healthcare personnel could exercise control and which is associated in whole or in part with medical intervention rather than the condition for which such intervention occurred," Which includes: "5. Resulting limitation or neurological physical or sensory function which continues after discharge from the facility", and, "any condition that requires the transfer of a patient within or outside the facility to a unit providing a more acute level of care due to the incident rather than the patient's condition prior to the adverse incident" According to the policy the goals of the policy are, "1. To have a positive impact in improving patient care, treatment, and services, and in preventing unintended harm ...3. To increase general knowledge about patient safety events, their contributing factors, and strategies for prevention ...5. Accomplish the full RCA [Root Cause Analysis] within 45 days of the knowledge of such an event." Under "Procedure" of the same policy reads, "Action plans are developed and implemented within 45 days of the RCA."

1. Review of Patient #1's medical record, and interviews with staff show:
A. Patient had a CT scan that was inaccurately read and reported to the ER. (Refer to A309)
B. A second read of the CT scan was completed after the patient was discharged and was never communicated from the Radiologist to the ER physician. The second reading of the CT scan showed the patient could not have developed a DVT in her iliac vein that was caused by thrombosis or inflammation around the gonadal vein. But, there was some care that needed to be followed with the patient either in or out of the hospital. (Refer to A309)
C. The patient/responsible party was never notified of the new diagnosis from the scan. (Refer to A1103)
D. A five day delay in treatment occurred. (Refer to A309)
E. When the patient came back to the ER she was diagnosed with a DVT in her left iliac vein. (Refer to A309)

F. She was transferred to a higher level of care due to the hospital not having a pediatric surgeon on staff and had surgeries and was placed in the ICU. (Refer to A309)
G. The second reading of the CT scan was also inaccurate and when results were read the third time, the information obtained from the CT scan would have shown the patient had a congenital defect that would have contributed to the patient developing DVT's in her iliac vein. This information was not obtained until 10 days after the test was completed and after a 5 day delay in treatment. (Refer to A309)
H. This information was never relayed to the patient/responsible party, which, caused the potential of the patient ending treatment from the DVT she had been treated for, and developing another DVT. (Refer to A309)
On 7/18/18 at approximately 11:08 a.m. the Director of Risk Management said the hospital was aware there was an incident on 9/14/17. The mother of Patient #1 complained in November of 2017 and the chart was reviewed by the Director of Radiology in December of 2017. After reviewing the case, the Peer Review recommended that all radiologists be educated on documenting who they speak to when calling the ER physician on 2/5/18.
On 7/18/18 at approximately 2:00 p.m., the Medical Director of the ER said if she had been given the amended CT report on 9/9/17 she would have sent the patient home to follow up with a physician.
On 7/19/18 at 9:07 a.m., Staff B, who is an experienced ER physician working at the facility was shown the CT scan report and was told about the assessment completed in the ER on 9/9/17. The ER physician said the first Addendum on the report showed inflammation in the gonadal vein or muscle near the vein. He said this would not be the cause of a DVT in the iliac vein because of the space between the iliac vein and the gonadal vein. Staff B said he would have admitted the patient and looked for infection or an abscess. He said the second addendum dated 9/19/17 showed Patient #1 had a congenital defect.

According to the article "May-Thumer Syndrome" by Omar Al-Nouri, DO, MS and Ross Milner, MD and found on the website "Vascular Disease Management", May-Thumer Syndrome is also called "Iliac Vein Compression Syndrome" and is a congenital defect that is a major factor in patients developing DVT's at a young age due to the iliac artery crossing over the iliac vein and compressing against it. The article says abdominal CT scanning is accurate in determining if there is left iliac vein compression. The article in the conclusion reads, "With Early recognition and aggressive management, May-Thumer Syndrome can be a well-managed disease."

One 7/19/18 at 5:00 p.m., the Chief Medical Officer said the first amendment to the CT scan report showed Patient #1 would have needed more testing. The Chief medical staff verified the second Amended report on 9/19/17 showed a congenital defect that could have contributed to Patient #1 developing a DVT in her leg. The Chief Medical Officer verified the CT scan had been read inaccurately two times by the same radiologist. He said the second amended report had not been looked at during peer review. The Chief Medical Officer said, "It will have to be looked at now."

On 7/23/18 at approximately 3:00 p.m., the Director of Risk Management said the hospital had not looked at this case as an adverse incident. When asked about the details of the investigation, the Director of Risk Management said this information was protected by the hospital's Patient Safety Organization. There was no indication by risk management or the medical staff that a Root Cause Analysis had been completed on Patient #1's incident.

2. Review of Patient #2's medical record shows he presented to the ER on 11/3/17 at 2:07 a.m., with a complaint to the triage nurse of swelling in "Bilateral" feet, which had started that night. The right foot was worse with a hematoma (clotted blood in the tissue). Vitals were obtained during triage. The patient's blood pressure was 177/66.

On 11/3/17 at 2:20 a.m., the ER nurse documented, "Hx [history] of diabetes. Patient has a hematoma on top of right started today post fall." Review of the physician's assessment shows no documentation the left foot was ever assessed. The blood pressure of 177/66 is documented on the ER physician's assessment. There is no documentation as to the patient having a history of hypertension.

Staff D, The ER physician documented, "the patient presents with a right foot injury. The onset was 4 days ago. The character of symptoms is pain and swelling. The degree at present is minimal." (Photographic evidence obtained).

The record shows Patient #2 was discharged at 3:18 a.m., on 11/3/17. Staff D documented, "Prescriptions will be given to patient by RN/staff and I reviewed possible side effects and interactions with the patient's home medications (if any)." The ER physician diagnosed Patient #2 with a fracture of the phalanx toe.

Review of the medical records show no orders for medications were ever written. There is no documentation of vital signs being taken again before the patient was discharged. There is no documentation the left foot was ever assessed while Patient #2 was in the ER by Staff D, or Staff E, the ER Licensed Practical Nurse.

Review of the policy, "Discharge From Emergency Department" accepted 02/92 and reviewed 4/18/18 reads, Ensure discharge instructions and prescriptions are written by the physician and an order for discharge has been placed. If discharge instructions include a change in the patient's home medication list, print two copies of the updated home medication list. Have the patient sign one copy to be scanned into the EMR...A complete set of vitals ...and a pain level will be obtained within 60 minutes of the patient's discharge."

Review of the policy, "Vital Signs Emergency Department" reads, Vital signs are measured at the time of the initial assessment, and at each subsequent reassessment and at discharge." The policy shows the normal range of systolic blood pressure for an adult is "90-160."

The medical record shows that on 11/6/17 Patient #2 returned to the ER with a chief complaint of "Right big toe fracture about one week ago; pt states was seen in ER last week and had x-rays done; now has oozing and blister to right big toe and toes." The ER physician assessed one wound to the left second toe." ...an open sore to left DIP [Distal Interphalangeal Joint] of the 2nd toe lateral aspect proximal to the great toe which is 90% slough, 10% granular tissue and mildly erythematous." X-rays were taken of both feet and multiple fractures were found in both feet. Patient #2 was diagnosed with "Cellulitis of bilateral feet and toes and multiple fractures in both feet". He was admitted to the facility for IV antibiotic therapy.

The H &P completed on 11/7/17 at 1:48 a.m., when the physician first assessed the patient there were dressings to "bilateral feet". The only wound assessed was the "Hematoma" on the right foot.

On 11/7/17 at 1:48 p.m., the physician that completed the H&P wrote an addendum which documented two wounds on the right foot and two wounds on the left foot. "Skin: right foot dorsal aspect with intact bullae probably hemorrhagic, with ulcers in between the 1st and 2nd toe, surrounding erythema, left foot with round ulcer to 1st and 2nd toe, see photos ... 1. Diabetic right foot ulcer due to E-coli, interdigital area 1st and 2nd to bilateral with surrounding cellulitis/right toe hemorrhagic bullae infected with proximal phalanx in a patient with diabetes insulin dependent with severe neuropathy. -Consult podiatrist -empiric antibiotics pending sensitivity -wound dressing ...2. Diabetes Mellitus ... 3. Chronic diastolic heart failure ... 4. Hypertension ..."

On 7/19/18 at approximately 12:10 p.m., the Director of Risk Management said the chart had been reviewed and it "did not seem right. "It was sent to Staff D. (the same physician that provided care for Patient #2 on the 11/3/17 visit) He reviewed the chart and said that appropriate care was given to Patient #2 on 11/3/17.

On 7/23/18 at approximately 3:00 p.m., the Director of Risk Management said the hospital had not looked at this case as an adverse incident. When asked about the details of the investigation, the Director of Risk Management said this information was protected by the hospitals "Patient Safety Organization". There was no indication by risk management or the medical staff that a Root Cause Analysis had been completed on Patient #2's incident.

3. On 11/13/17 Patient #3 complained, "Pt [patient] alleges physician "put a shot in the crack of my butt" and told the nurse, "wait 15 minutes, and discharge her" then he "gathered all the staff in a little hub the ambulance comes to and had them all watch me be wheeled out of the hospital knowing I had no way home."

On 7/19/18 review of Patient #3's medical record showed she had arrived at the ER by ambulance and had been discharged home unaccompanied. There is no documentation of what transportation the patient had taken home.

On 7/19/18 at 1:20 p.m., the Director of Risk Management reviewed the investigation completed by the ER nurse manager and said the Nurse Manager had reviewed the chart and that appropriate care had been given to Patient #3.

On 7/19/18 at 1:40 p.m., the Nurse Manager and the Nurse Manager of Emergency Services (NMES) were interviewed while they were reviewing the chart. The NMES verified she could not find documentation of how Patient #3 had gotten to her home unaccompanied when she had arrived at the ER in an ambulance. The NMES verified this was an issue that needed to be investigated and documented. The NMES said she had thought the issue of the complaint was the shot Resident #3 had received. After reading the complaint, the NMES verified the issue of the complaint was Patient #3 had thought staff treatied her disrespectfully and knowingly sending her out of the hospital without transportation home.

Based on record review, interview with clinical and administrative staff, and review of policy and procedure, the hospital's Quality Assurance Program failed to recognize the care provided to two patients (Patient #1, and #2) of 7 patients surveyed were adverse incidents, and failed to recognize the hospital could have exercised some control with medical intervention that in whole or in part contributed to harm of both patients (Patient #1 DVT, Patient #2 Cellulitis) and both patients had to be transferred to a higher levels of acute care due to the incidents.

Findings include:

According to the hospital policy, "Sentinel Event Never Event and Adverse Incident Response" accepted 1/31/2000 and revised 1/18/17, an Adverse incident is defined as, "An event over which healthcare personnel could exercise control and which is associated in whole or in part with medical intervention rather than the condition for which such intervention occurred", Which includes: "5. Resulting limitation or neurological physical or sensory function which continues after discharge from the facility," and, "any condition that requires the transfer of a patient within or outside the facility to a unit providing a more acute level of care due to the incident rather than the patient's condition prior to the adverse incident" According to the policy the goals of the policy are, "1. To have a positive impact in improving patient care, treatment, and services, and in preventing unintended harm ...3. To increase general knowledge about patient safety events, their contributing factors, and strategies for prevention ...5. Accomplish the full RCA [Root Cause Analysis] within 45 days of the knowledge of such an event." Under "Procedure" of the same policy reads, "Action plans are developed and implemented within 45 days of the RCA."

1. Review of Patient #1's medical record, and interviews with staff show:
A. Patient had a CT scan that was inaccurately read and reported to the ER. (Refer to A309)
B. A second read of the CT scan was completed after the patient was discharged and was never communicated from the Radiologist to the ER physician. The second reading of the CT scan showed the patient could not have developed a DVT in her iliac vein that was caused by thrombosis or inflammation around the gonadal vein. But, there was some care that needed to be followed with the patient either in or out of the hospital. (Refer to A309)
C. The patient/responsible party was never notified of the new diagnosis from the scan. (Refer to A309)
D. A five day delay in treatment occurred. (Refer to A309)
E. When the patient came back to the ER she was diagnosed with a DVT in her left iliac vein. (Refer to A309)

F. She was transferred to a higher level of care due to the hospital not having a pediatric surgeon on staff and had surgeries and was placed in the ICU. (Refer to A309)
G. The second reading of the CT scan was also inaccurate and when results were read the third time, the information obtained from the CT scan would have shown the patient had a congenital defect that would have contributed to the patient developing DVT's in her iliac vein. This information was not obtained until 10 days after the test was completed and after a 5 day delay in treatment. (Refer to A309)
H. This information was never relayed to the patient/responsible party, which, caused the potential of the patient ending treatment from the DVT she had been treated for, and developing another DVT. (Refer to A309)

On 7/18/18 at approximately 11:08 a.m. the Director of Risk Management said the hospital was aware there was an incident on 9/14/17. The mother of Patient #1 complained in November of 2017 and the chart was reviewed by the Director of Radiology in December of 2017. After reviewing the case, the Peer Review recommended that all radiologists be educated on documenting who they speak to when calling the ER physician on 2/5/18.

On 7/18/18 at approximately 2:00 p.m. The Medical Director of the ER said if she had been given the amended CT report on 9/9/17 she would have sent the patient home to follow up with a physician.

On 7/19/18 at 9:07 a.m. Staff B, who is an experienced ER physician working at the facility was shown the CT scan report and was told about the assessment completed in the ER on 9/9/17. The ER physician said the first Addendum on the report showed inflammation in the gonadal vein or muscle near the vein. He said this would not be the cause of a DVT in the iliac vein because of the space between the iliac vein and the gonadal vein. Staff B said he would have admitted the patient and looked for infection or an abscess. He said the second addendum dated 9/19/17 showed Patient #1 had a congenital defect.

According to the article "May-Thumer Syndrome" by Omar Al-Nouri, DO, MS and Ross Milner, MD and found on the website "Vascular Disease Management", May-Thumer Syndrome is also called "Iliac Vein Compression Syndrome" and is a congenital defect that is a major factor in patients developing DVT's at a young age due to the iliac artery crossing over the iliac vein and compressing against it. The article says abdominal CT scanning is accurate in determining if there is left iliac vein compression. The article in the conclusion reads, "With Early recognition and aggressive management, May-Thumer Syndrome can be a well-managed disease."

The 7/19/18 at 5:00 p.m. The Chief Medical Officer said the first amendment to the CT scan report showed Patient #1 would have needed more testing. The Chief medical staff verified the second Amended report on 9/19/17 showed a congenital defect that could have contributed to Patient #1 developing a DVT in her leg. The Chief Medical Officer verified the CT scan had been read inaccurately two times by the same radiologist. He said the second amended report had not been looked at during peer review. The Chief Medical Officer said, "It will have to be looked at now."

On 7/23/18 at approximately 3:00 p.m., the Director of Risk Management said the hospital had not looked at this case as an adverse incident. When asked to provide documentation or verbally read what the peer review and what risk had investigated, and how they had come to their conclusions, and recommendation The Director of Risk Management said that this was protected information and she could not disclose that aspect of the investigation.

2. Review of Patient #2's medical record shows he presented to the ER on 11/3/17 at 2:07 a.m., with a complaint to the triage nurse of swelling in "Bilateral" feet, which had started that night. The right foot was worse with a hematoma (clotted blood in the tissue). Vitals were obtained during triage. The patient's blood pressure was 177/66.

On 11/3/17 at 2:20 a.m., the ER nurse documented, "Hx [history] of diabetes. Patient has a hematoma on top of right started today post fall." Review of the physician's assessment shows no documentation the left foot was ever assessed. The blood pressure of 177/66 is documented on the ER physician's assessment. There is no documentation as to the patient having a history of hypertension.

Staff D, The ER physician documented, "the patient presents with a right foot injury. The onset was 4 days ago. The character of symptoms is pain and swelling. The degree at present is minimal." (Photographic evidence obtained).

The record shows Patient #2 was discharged at 3:18 a.m. on 11/3/17. Staff D documented, "Prescriptions will be given to patient by RN/staff and I reviewed possible side effects and interactions with the patient's home medications (if any)." The ER physician diagnosed Patient #2 with a fracture of the phalanx toe.

Review of the medical records show no orders for medications were ever written. There is no documentation of vital signs being taken again before the patient was discharged. There is no documentation the left foot was ever assessed while Patient #2 was in the ER by Staff D, or Staff E, the ER Licensed Practical Nurse.

Review of the policy, "Discharge From Emergency Department" accepted 02/92 and reviewed 4/18/18 reads, Ensure discharge instructions and prescriptions are written by the physician and an order for discharge has been placed. If discharge instructions include a change in the patient's home medication list, print two copies of the updated home medication list. Have the patient sign one copy to be scanned into the EMR...A complete set of vitals ...and a pain level will be obtained within 60 minutes of the patient's discharge."

Review of the policy, "Vital Signs Emergency Department" reads, Vital signs are measured at the time of the initial assessment, and at each subsequent reassessment and at discharge." The policy shows the normal range of systolic blood pressure for an adult is "90-160."

The medical record shows that on 11/6/17 Patient #2 returned to the ER with a chief complaint of "Right big toe fracture about one week ago; pt states was seen in ER last week and had x-rays done; now has oozing and blister to right big toe and toes." The ER physician assessed one wound to the left second toe." ...an open sore to left DIP [Distal Interphalangeal Joint] of the 2nd toe lateral aspect proximal to the great toe which is 90% slough, 10% granular tissue and mildly erythematous." X-rays were taken of both feet and multiple fractures were found in both feet. Patient #2 was diagnosed with "Cellulitis of bilateral feet and toes and multiple fractures in both feet". He was admitted to the facility for IV antibiotic therapy.

The H &P completed on 11/7/17 at 1:48 a.m., when the physician first assess the patient there were dressings to "bilateral feet." The only wound assessed was the "Hematoma" on the right foot.

On 11/7/17 at 1:48 p.m., the physician that completed the H&P wrote an addendum which documented two wounds on the right foot and two wounds on the left foot. "Skin: right foot dorsal aspect with intact bullae probably hemorrhagic, with ulcers in between the 1st and 2nd toe, surrounding erythema, left foot with round ulcer to 1st and 2nd toe, see photos ... 1. Diabetic right foot ulcer due to E-coli, interdigital area 1st and 2nd to bilateral with surrounding cellulitis/right toe hemorrhagic bullae infected with proximal phalanx in a patient with diabetes insulin dependent with severe neuropathy. -Consult podiatrist -empiric antibiotics pending sensitivity -wound dressing ...2. Diabetes Mellitus ... 3. Chronic diastolic heart failure ... 4. Hypertension ..."

On 7/19/18 at approximately 12:10 p.m., the Director of Risk Management said the chart had been reviewed and it "did not seem right." It was sent to Staff D. (the same physician that provided care for Patient #2 on the 11/3/17 visit) He reviewed the chart and said that the appropriate care was given to Patient #2 on 11/3/17.

On 7/23/18 at approximately 3:00 p.m., the Director of Risk Management said the hospital had not looked at this case as an adverse incident. When asked to provide documentation or verbally read what the peer review and what risk had investigated, and how they had come to their conclusions, and recommendations the Director of Risk Management said that this was protected information and she could not disclose that aspect of the investigation.

Based on record review, interview with clinical and administrative staff, and review of policy and procedure, the hospital Governing Body failed to ensure the timely and accurate analysis of two adverse incidents, (Patient #1, and #2) of 7 patients sampled and failed to ensure an accurate and timely analysis of one incident of seven patients sampled. and failed to ensure Medical staff conducted appropriate and accurate peer reviews in a timely manner.

Findings include:

According to the hospital policy, "Sentinel Event Never Event and Adverse Incident Response" accepted 1/31/2000 and revised 1/18/17, an Adverse incident is defined as, "An event over which healthcare personnel could exercise control and which is associated in whole or in part with medical intervention rather than the condition for which such intervention occurred", Which includes: "5. Resulting limitation or neurological physical or sensory function which continues after discharge from the facility", and, "any condition that requires the transfer of a patient within or outside the facility to a unit providing a more acute level of care due to the incident rather than the patient's condition prior to the adverse incident" According to the policy the goals of the policy are, "1. To have a positive impact in improving patient care, treatment, and services, and in preventing unintended harm ...3. To increase general knowledge about patient safety events, their contributing factors, and strategies for prevention ...5. Accomplish the full RCA [Root Cause Analysis] within 45 days of the knowledge of such an event." Under "Procedure" of the same policy reads, "Action plans are developed and implemented within 45 days of the RCA."

1. Review of the medical record shows Patient #1 presented on 9/9/17 to the emergency services department complaining of left lower quadrant pain going to the left groin and hip. Patient #1 rated her pain as a 9 out of 10, with 10 being the worst pain.

On 9/9/17 at 9:48 a.m. a Computerized Tomography (CT) scan was ordered of the abdomen and pelvis with intravenous (IV) contrast.

On 9/9/17 at 1:14 p.m. the CT scan was read as, "no signs of inflammation in the abdomen or pelvis. The reason for the patient's pain is not diagnosed."

The medical record shows Patient #1 was discharged home from the Emergency Room (ER) on 9/9/17 at 2:00 p.m.,

On 9/9/17 at 4:52 p.m., Staff A, Radiologist added an addendum to the CT report which read, "Questionable Haziness is noted along the left gonadal vein and left Psoas muscle, axial images 43, and 53. Needs clinical correlation. Thrombophlebitis of the left Gonadal vein and/or inflammation of the left Psoas muscle are in the differential. This information was discussed with the ER physician at about 4:45 PM I apologize for the inconvenience."

On 7/18/18 at 11:10 a.m., the Director of Risk Management (DRM) said there had been a lack of communication between Radiology and the ED and the Addendum was not communicated to the Emergency Department (ED). She said Patient #1 had returned to the ER on 9/14/17 and an ultrasound of the left leg was done and a DVT was found. The Patient was transferred to a pediatric vascular surgeon in another hospital because the facility did not provide that service. The DRM said there was documentation Staff A had spoken to the physician but the two physicians and the Nurse Practitioner involved in the case do not admit to being spoken to by Staff A.

On 7/18/18 at 12:20 p.m., the Director of Radiology said Staff A had spoken to an ER physician but there is no way to tell from Staff A's documentation who he had spoken to. The Director said he believed it was a standard of care for radiologists to document who the physician was they had spoken to.

On 7/18/18 at approximately 12:40 p.m., the Director of ER said there was a policy that if there was a discrepancy with a radiology report the radiologist would immediately contact the ordering physician and speak physician to physician. The Director of ER said if she had been given the amendment she would have sent the patient home to follow-up with her primary care physician.

On 7/18/18 at approximately 1:10 p.m., Staff A said he had reread the CT scan and spoken with a physician in the ER on 9/9/17 at 4:45 p.m. He does not remember who the physician was he had spoken with. He said he did not know the Advanced Registered Nurse Practitioner (ARNP) who had ordered the test. Staff A said he was not aware if it was a policy to document who he had spoken with over the phone. He said from now on he would try "as much as possible" to document who he speaks to.

On 7/19/18 at 9:07 a.m. Staff B, who is an experienced ER physician working at the facility was shown the CT scan report and was told about the assessment completed in the ER on 9/9/17. The ER physician said the first Addendum on the report showed inflammation in the gonadal vein or muscle near the vein. He said this would not be the cause of a DVT in the iliac vein because of the space between the iliac vein and the gonadal vein. Staff B said he would have admitted the patient and looked for infection or an abscess. He said the second addendum dated 9/19/17 showed Patient #1 had a congenital defect.

According to the article "May-Thumer Syndrome" by Omar Al-Nouri, DO, MS and Ross Milner, MD and found on the website "Vascular Disease Management", May-Thumer Syndrome is also called "Iliac Vein Compression Syndrome" and is a congenital defect that is a major factor in patients developing DVT's at a young age due to the iliac artery crossing over the iliac vein and compressing against it. The article says abdominal CT scanning is accurate in determining if there is left iliac vein compression. The article in the conclusion reads, "With Early recognition and aggressive management, May-Thumer Syndrome can be a well-managed disease."

On 7/19/18 at 4:10 p.m., Patient #1's mother said, "Who told you she had a congenital defect." Patient #1's mother said she had taken her daughter to the ER on 9/9/17 and the ER sent her daughter home with a diagnosis of fecal retention. She said she was never told about the 1st amendment to the radiology report. She said if she had been told she would not have allowed her daughter to lay in pain for 5 days thinking she had constipation. She said her daughter developed a DVT that extended from her thigh to her knee in the vein. She said due to the hurricane none of the physician's offices were open. She had a neighbor who was a physician. He assessed her on 9/14/17 and told her to take her daughter back to the ER and get an ultrasound to check for a DVT. She said her daughter had developed a DVT that extended from her thigh to her knee in the vein within those 5 days. Her daughter was transferred to another hospital for a pediatric vascular surgeon to treat her. She had three surgeries to remove the blood clot and was placed in intensive care. When her daughter was released from the hospital she was given 6 months of Lovenox shots to prevent her blood from clotting. The anticoagulant therapy was ending so just to be on the safe side she took her a Vascular Interventionist. He diagnosed her daughter with May-Thumer Syndrome. The mother was told by the specialist her daughter's iliac vein was 67% blocked. The mother was told she could stay on anti-coagulants or surgically put a stent in the vein. After some consideration a stent was placed. The surgeon told the mother of Patient #1 at the time the stent was placed the iliac vein was 100% blocked. Patient #1's mother said she was never told by the facility or the hospital that had removed her daughter's blood clot her daughter had May-Thurmer Syndrome which would have continued to cause blood clots to develop in her iliac vein.

At 4:10 p.m., the Director of Diagnostic Services reviewed the medical record and found on 9/19/17 the addendum which showed the defect had been faxed to the primary care physician's office, and to the hospital were the patient was transferred for surgery. There had not been a physician to physician call or any contact with the patient's guardian. The Director said, "Once the patient leaves the facility we do not speak with the patient."

Review of the policy "Diagnostic Results Follow-up" approved 8/84 and reviewed 5/2018 reads, "If there are any discrepancies in the reading, the Radiologist will immediately contact the ED [Emergency Department] Physician. If an actual discrepancy exists, the Emergency Department staff will contact the patient to ensure appropriate follow up as directed by the ED physician... All abnormal laboratory or other diagnostic testing reports received after a patient's discharge will be reviewed by the Emergency Department physician who will determine the appropriate follow-up required".

On 7/23/18 at approximately 3:00 p.m., Staff A said the reason he had re-read the CT scan on 9/19/17 was the patient had come back to the ER with a DVT in her iliac vein. He had questioned whether the inflammation he had seen on 9/9/18 was in the gonadal or the iliac vein. He said at that time he had amended the report to show the iliac vein was being compressed on 9/19/17. When staff A was asked if he was aware of the facility policy for reporting discrepancies on reports he said, "Refresh my memory." Staff A said, "I don't know what you would have wanted me to do. On 9/19/17 Patient #1 already was being treated for a DVT in her iliac vein. I did not feel the need to contact the physician." Staff A said the standard of care for a DVT was 6 months of anticoagulant therapy. He verified Patient #1's anticoagulant therapy would have ended with a potential for patient #1 to develop another DVT in her iliac vein due to the defect he had seen on the third time he had read the CT test results on 9/19/17.

2. Review of Patient #2's medical record shows he presented to the ER on 11/3/17 at 2:07 a.m., with a complaint to the triage nurse of swelling in "Bilateral" feet, which had started that night. The right foot was worse with a hematoma (clotted blood in the tissue). Vitals were obtained during triage. The patient's blood pressure was 177/66.

On 11/3/17 at 2:20 a.m., the ER nurse documented, "Hx [history] of diabetes. Patient has a hematoma on top of right started today post fall." Review of the physician's assessment shows no documentation the left foot was ever assessed. The blood pressure of 177/66 is documented on the ER physician's assessment. There is no documentation as to the patient having a history of hypertension.

Staff D, The ER physician documented, "the patient presents with a right foot injury. The onset was 4 days ago. The character of symptoms is pain and swelling. The degree at present is minimal." (Photographic evidence obtained).

The record shows Patient #2 was discharged at 3:18 a.m., on 11/3/17. Staff D documented, "Prescriptions will be given to patient by RN/staff and I reviewed possible side effects and interactions with the patient's home medications (if any)." The ER physician diagnosed Patient #2 with a fracture of the phalanx toe.

Review of the medical records show no orders for medications were ever written. There is no documentation of vital signs being taken again before the patient was discharged. There is no documentation the left foot was ever assessed while Patient #2 was in the ER by Staff D, or Staff E, the ER Licensed Practical Nurse.

Review of the policy, "Discharge From Emergency Department" accepted 02/92 and reviewed 4/18/18 reads, Ensure discharge instructions and prescriptions are written by the physician and an order for discharge has been placed. If discharge instructions include a change in the patient's home medication list, print two copies of the updated home medication list. Have the patient sign one copy to be scanned into the EMR...A complete set of vitals ...and a pain level will be obtained within 60 minutes of the patient's discharge."

Review of the policy, "Vital Signs Emergency Department" reads, Vital signs are measured at the time of the initial assessment, and at each subsequent reassessment and at discharge." The policy shows the normal range of systolic blood pressure for an adult is "90-160".

The medical record shows that on 11/6/17 Patient #2 returned to the ER with a chief complaint of "Right big toe fracture about one week ago; pt states was seen in ER last week and had x-rays done; now has oozing and blister to right big toe and toes." The ER physician assessed one wound to the left second toe." ...an open sore to left DIP [Distal Interphalangeal Joint] of the 2nd toe lateral aspect proximal to the great toe which is 90% slough, 10% granular tissue and mildly erythematous." X-rays were taken of both feet and multiple fractures were found in both feet. Patient #2 was diagnosed with "Cellulitis of bilateral feet and toes and multiple fractures in both feet". He was admitted to the facility for IV antibiotic therapy.

The H &P completed on 11/7/17 at 1:48 a.m., when the physician first assessed the patient there were dressings to "bilateral feet." The only wound assessed was the "Hematoma" on the right foot.

On 11/7/17 at 1:48 p.m., the physician that completed the H&P wrote an addendum which documented two wounds on the right foot and two wounds on the left foot. "Skin: right foot dorsal aspect with intact bullae probably hemorrhagic, with ulcers in between the 1st and 2nd toe, surrounding erythema, left foot with round ulcer to 1st and 2nd toe, see photos ... 1. Diabetic right foot ulcer due to E-coli, interdigital area 1st and 2nd to bilateral with surrounding cellulitis/right toe hemorrhagic bullae infected with proximal phalanx in a patient with diabetes insulin dependent with severe neuropathy. -Consult podiatrist -empiric antibiotics pending sensitivity -wound dressing ...2. Diabetes Mellitus ... 3. Chronic diastolic heart failure ... 4. Hypertension ..."

On 7/19/18 at approximately 12:10 p.m., the Director of Risk Management said the chart had been reviewed and it "did not seem right." It was sent to Staff D. (the same physician that provided care for Patient #2 on the 11/3/17 visit) He reviewed the chart and said that appropriate care was given to Patient #2 on 11/3/17.

On 7/23/18 at approximately 3:00 p.m., the Director of Risk Management said the hospital had not looked at this case as an adverse incident. When asked to provide documentation or verbally read what the peer review and what risk had investigated, and how they had come to their conclusions, and recommendations the Director of Risk Management said that this was protected information and she could not disclose that aspect of the investigation.

3. On 11/13/17 Patient #3 complained, "Pt [patient] alleges physician "put a shot in the crack of my butt" and told the nurse, "wait 15 minutes, and discharge her" then he "gathered all the staff in a little hub the ambulance comes to and had them all watch me be wheeled out of the hospital knowing I had no way home."

On 7/19/18 review of Patient #3's medical record showed she had arrived at the ER by ambulance and had been discharged home unaccompanied. There is no documentation of what transportation the patient had taken home.

On 7/19/18 at 1:20 p.m., the Director of Risk Management reviewed the investigation completed by the ER nurse manager and said the Nurse Manager had reviewed the chart and the appropriate care had been given to Patient #3.

On 7/19/18 at 1:40 p.m., the Nurse Manager and the Nurse Manager of Emergency Services (NMES) were interviewed while they were reviewing the chart. The NMES verified she could not find documentation of how Patient #3 had gotten to her home unaccompanied when she had arrived at the ER in an ambulance. The NMES verified this was an issue that needed to be investigated and documented. The NMES said she had thought the issue of the complaint was the shot Resident #3 had received. After reading the complaint, the NMES verified the issue of the complaint was Patient #3 had thought staff treating her disrespectfully and knowingly sending her out of the hospital without transportation home.

On 7/23/18 at approximately 3:00 p.m., the Director of Risk Management said the Governing Body receives a report of the number and types of incidents that occur at the hospital and the recommendations for actions from the physicians but they do not receive a report of how risk management, and peer review comes to its conclusions of the incident investigations.

Based on record review, interview with clinical and administrative staff, and review of policy and procedure, the hospital failed to have a medical staff which is responsible for the quality of medical care provided to patients by the hospital. The Medical Staff failed to demonstrate its accountability through its conduct of reappraisals [assessments], including peer reviews, its approval of policies and procedures as required under other conditions of participation and its leadership participation in the organization and implementation of the hospital's quality assessment and performance improvement program required in accordance with §482.21. as evidenced by:

1. Failing to have peer review assess all aspects of Patient #1's medical record before making recommendations. (Refer to A347).

2. Failing to recognize the harm that was caused to patient #1 by having a 5 day delay in treatment because of two inaccurate radiology readings that were not completed in a timely manner and were not communicated to Patient #1/Responsible Party for further follow-up care. (Refer to A347).

3. Failing to follow though with the recommendation to instruct all radiologists to document who the physician is they are speaking with when completing a physician to physician call to an Emergency Room Physician, and failing to update the policy with that information. (Refer to A347).

4. Failing to recognize Patient #1 had a adverse incident/unanticipated event and failing to disclose this to the Patient #1/Responsible Party. (Refer to A347).

4. Failing to recognize the harm caused to Patient #2 because of the lack of assessment and treatment and that harm was an adverse incident and a unanticipated event. (Refer to A347).

5. Failing to disclose to Patient #2 the adverse event/unanticipated outcome. (Refer to A347).

Based on interview and record review the hospital medical staff failed to provide quality medical care to to patients (Patient #1 and Patient #2) which resulted in one patient (Patient #1) developing a DVT and being transferred to a higher level of care outside the hospital, and one patient (Patient #2) having a delay in treatment and developing Cellulitis in both his feet and being transferred to an acute level of care within the hospital. The Medical staff failed to accurately and in a timely manner peer review both adverse incidents and failed to disclose to both patients the outcomes.

Findings include:

1. Review of the medical record shows Patient #1 presented on 9/9/17 to the emergency services department complaining of left lower quadrant pain going to the left groin and hip. Patient #1 rated her pain as a 9 out of 10, with 10 being the worst pain.

On 9/9/17 at 9:48 a.m., a Computerized Tomography (CT) scan was ordered of the abdomen and pelvis with intravenous (IV) contrast.

On 9/9/17 at 1:14 p.m., the CT scan was read as, "no signs of inflammation in the abdomen or pelvis. The reason for the patient's pain is not diagnosed."

The medical record shows Patient #1 was discharged home from the Emergency Room (ER) on 9/9/17 at 2:00 p.m.

On 9/9/17 at 4:52 p.m., Staff A, Radiologist added an addendum to the CT report which read, "Questionable Haziness is noted along the left gonadal vein and left Psoas muscle, axial images 43, and 53. Needs clinical correlation. Thrombophlebitis of the left Gonadal vein and/or inflammation of the left Psoas muscle are in the differential. This information was discussed with the ER physician at about 4:45 PM I apologize for the inconvenience."

On 7/18/18 at 11:10 a.m., the Director of Risk Management (DRM) said there had been a lack of communication between Radiology and the ED and the Addendum was not communicated to the Emergency Department (ED). She said Patient #1 had returned to the ER on 9/14/17 and an ultrasound of the left leg was done and a DVT was found. The Patient was transferred to a pediatric vascular surgeon in another hospital because the facility did not provide that service. The DRM said there was documentation Staff A had spoken to the physician but the two physicians and the Nurse Practitioner involved in the case do not admit to being spoken to by Staff A.

Review of the policy "Diagnostic Results Follow-up" approved 8/84 and reviewed 5/2018 reads, "If there are any discrepancies in the reading, the Radiologist will immediately contact the ED [Emergency Department] Physician. If an actual discrepancy exists, the Emergency Department staff will contact the patient to ensure appropriate follow up as directed by the ED physician... All abnormal laboratory or other diagnostic testing reports received after a patient's discharge will be reviewed by the Emergency Department physician who will determine the appropriate follow-up required."

On 7/18/18 at 12:20 p.m., the Director of Radiology said Staff A had spoken to an ER physician but there is no way to tell from Staff A's documentation who he had spoken to. The Director was not aware if there was a policy that radiologists document who they spoke to when reporting physician to physician to the ER physician. After being informed the policy did not say physicians should document who they spoke with, The Director of Radiology said, "We need to change that policy."

On 7/18/18 at approximately 12:40 p.m., the Director of ER said there was a policy that if there was a discrepancy with a radiology report the radiologist would immediately contact the ordering physician and speak physician to physician. The Director of ER said if she had been given the amendment she would have sent the patient home to follow-up with her primary care physician.

On 7/18/18 at approximately 1:10 p.m., Staff A said he had reread the CT scan and spoken with a physician in the ER on 9/9/17 at 4:45 p.m. He does not remember who the physician was he had spoken with. He said he did not know the Advanced Registered Nurse Practitioner (ARNP) who had ordered the test. Staff A said he was not aware if it was a policy to document who he had spoken with over the phone. He said from now on he would try "as much as possible" to document who he speaks to.

On 7/19/18 at 9:07 a.m., Staff B, who is an experienced ER physician working at the facility was shown the CT scan report and was told about the assessment completed in the ER on 9/9/17. The ER physician said the first Addendum on the report showed inflammation in the gonadal vein or muscle near the vein. He said this would not be the cause of a DVT in the iliac vein because of the space between the iliac vein and the gonadal vein. Staff B said he would have admitted the patient and looked for infection or an abscess. He said the second addendum dated 9/19/17 showed Patient #1 had a congenital defect.

According to the article "May-Thumer Syndrome" by Omar Al-Nouri, DO, MS and Ross Milner, MD and found on the website "Vascular Disease Management", May-Thumer Syndrome is also called "Iliac Vein Compression Syndrome" and is a congenital defect that is a major factor in patients developing DVT's at a young age due to the iliac artery crossing over the iliac vein and compressing against it. The article says abdominal CT scanning is accurate in determining if there is left iliac vein compression. The article in the conclusion reads, "With Early recognition and aggressive management, May-Thumer Syndrome can be a well-managed disease."

On 7/19/18 at 4:10 p.m., Patient #1's mother said, she had taken her daughter to the ER on 9/9/17 and the ER sent her daughter home with a diagnosis of fecal retention. She said she was never told about the 1st amendment to the radiology report. She said if she had been told she would not have allowed her daughter to lay in pain for 5 days thinking she had constipation. She said her daughter developed a DVT that extended from her thigh to her knee in the vein. She said due to the hurricane none of the physician's offices were open. She had a neighbor who was a physician. He assessed her on 9/14/17 and told her to take her daughter back to the ER and get an ultrasound to check for a DVT. She said her daughter had developed a DVT that extended from her thigh to her knee in the vein within those 5 days. Her daughter was transferred to another hospital for a pediatric vascular surgeon to treat her. She had three surgeries to remove the blood clot and was placed in intensive care. When her daughter was released from the hospital she was given 6 months of Lovenox shots to prevent her blood from clotting. The anticoagulant therapy was ending so just to be on the safe side she took her a Vascular Interventionist. He diagnosed her daughter with May-Thumer Syndrome. The mother was told by the specialist her daughter's iliac vein was 67% blocked. The mother was told she could stay on anti-coagulants or surgically put a stent in the vein. After some consideration a stent was placed. The surgeon told the mother of Patient #1 at the time the stent was placed the iliac vein was 100% blocked. Patient #1's mother said she was never told by the facility or the hospital that had removed her daughter's blood clot her daughter had May-Thurmer Syndrome which would have continued to cause blood clots to develop in her iliac vein.

At 4:10 p.m., the Director of Diagnostic Services reviewed the medical record and found on 9/19/18 the addendum which showed the defect had been faxed to the primary care physician office, and to the hospital were the patient was transferred for surgery. There had not been a physician to physician call or any contact with the patient's guardian. The Director said, "Once the patient leaves the facility we do not speak with the patient."

On 7/23/18 at approximately 3:00 p.m. Staff A said the reason he had re-read the CT scan on 9/19/17 was the patient had come back to the ER with a DVT in her iliac vein. He had questioned whether the inflammation he had seen on 9/9/17 was in the gonadal or the iliac vein. He said he at that time he had amended the report to show the iliac vein was being compressed on 9/19/17. When staff A was asked if he was aware of the facility policy for reporting discrepancies on reports he said, "Refresh my memory." Staff A said, "I don't know what you would have wanted me to do. On 9/19/17 Patient #1 already was being treated for a DVT in her iliac vein. I did not feel the need to contact the physician." Staff A said the standard of care for a DVT was 6 months of anticoagulant therapy. He verified Patient #1's anticoagulant therapy would have ended with a potential for patient #1 to develop another DVT in her iliac vein due to the defect he had seen on the third time he had read the CT test results on 9/19/17.

On 7/19/18 at 5:00 p.m., the Chief Medical Officer said the first amendment to the CT scan report showed Patient #1 would have needed more testing. The Chief medical staff verified the second Amended report on 9/19/17 showed a congenital defect that could have contributed to Patient #1 developing a DVT in her leg. The Chief Medical Officer verified the CT scan had been read inaccurately two times by the same radiologist. He said the second amended report had not been looked at during peer review. The Chief Medical Officer said, "It will have to be looked at now."

On 7/23/18 at approximately 3:00 p.m., the Director of Risk Management said the hospital had not looked at this case as an adverse incident. When asked about the details of the investigation, the Director of Risk Management said this information was protected by the hospitals Patient Safety Organization. There was no indication by risk management or the medical staff that a Root Cause Analysis had been completed on Patient #1's incident.

According to the hospital policy, "Sentinel Event Never Event and Adverse Incident Response" accepted 1/31/2000 and revised 1/18/17, an Adverse incident is defined as, "An event over which healthcare personnel could exercise control and which is associated in whole or in part with medical intervention rather than the condition for which such intervention occurred", Which includes: "5. Resulting limitation or neurological physical or sensory function which continues after discharge from the facility", and, "any condition that requires the transfer of a patient within or outside the facility to a unit providing a more acute level of care due to the incident rather than the patient's condition prior to the adverse incident" According to the policy the goals of the policy are, "1. To have a positive impact in improving patient care, treatment, and services, and in preventing unintended harm ...3. To increase general knowledge about patient safety events, their contributing factors, and strategies for prevention ...5. Accomplish the full RCA [Root Cause Analysis] within 45 days of the knowledge of such an event." Under "Procedure" of the same policy reads, "Action plans are developed and implemented within 45 days of the RCA."

According to the "Medical Staff Rules and Regulations" 5.3.1 Page 22, "Definition-An unanticipated outcome is a result that differs significantly from the anticipated results of a treatment or procedures, or an outcome which meets the definition of a sentinel event [harm] or a medical error." Under 5.3.3 of the Medical Staff Rules and Regulations page 22 and 23, "Information That Should be Provided to the Patient/Representative-Patients and their designated representative(s) will be informed of the occurrence of the unanticipated outcomes in a truthful and compassionate manner This disclosure soul include:

a. The time, place, circumstances, and definite consequences of the adverse out come for the patient to the extent known;
b. The proximate cause of the adverse outcome if known;
c. An apology that the adverse outcome occurred;
d. Assurance that a full analysis will take place;..."

2. Review of Patient #2's medical record shows he presented to the ER on 11/3/17 at 2:07 a.m. with a complaint to the triage nurse of swelling in "Bilateral" feet, which had started that night. The right foot was worse with a hematoma (clotted blood in the tissue). Vitals were obtained during triage. The patient's blood pressure was 177/66.

On 11/3/17 at 2:20 a.m., the ER nurse documented, "Hx [history] of diabetes. Patient has a hematoma on top of right started today post fall." Review of the physician's assessment shows no documentation the left foot was ever assessed. The blood pressure of 177/66 is documented on the ER physician's assessment. There is no documentation as to the patient having a history of hypertension.

Staff D, The ER physician documented, "the patient presents with a right foot injury. The onset was 4 days ago. The character of symptoms is pain and swelling. The degree at present is minimal." (Photographic evidence obtained).

The record shows Patient #2 was discharged at 3:18 a.m., on 11/3/17. Staff D documented, "Prescriptions will be given to patient by RN/staff and I reviewed possible side effects and interactions with the patient's home medications (if any)." The ER physician diagnosed Patient #2 with a fracture of the phalanx toe.

Review of the medical records show no orders for medications were ever written. There is no documentation of vital signs being taken again before the patient was discharged. There is no documentation the left foot was ever assessed while Patient #2 was in the ER by Staff D, or Staff E, the ER Licensed Practical Nurse.

Review of the policy, "Discharge From Emergency Department" accepted 02/92 and reviewed 4/18/18 reads, Ensure discharge instructions and prescriptions are written by the physician and an order for discharge has been placed. If discharge instructions include a change in the patient's home medication list, print two copies of the updated home medication list. Have the patient sign one copy to be scanned into the EMR...A complete set of vitals ...and a pain level will be obtained within 60 minutes of the patient's discharge."

Review of the policy, "Vital Signs Emergency Department" reads, Vital signs are measured at the time of the initial assessment, and at each subsequent reassessment and at discharge." The policy shows the normal range of systolic blood pressure for an adult is "90-160".

The medical record shows that on 11/6/17 Patient #2 returned to the ER with a chief complaint of "Right big toe fracture about one week ago; pt states was seen in ER last week and had X-rays done; now has oozing and blister to right big toe and toes." The ER physician assessed one wound to the left second toe. " ...an open sore to left DIP [Distal Interphalangeal Joint] of the 2nd toe lateral aspect proximal to the great toe which is 90% slough, 10% granular tissue and mildly erythematous." X-rays were taken of both feet and multiple fractures were found in both feet. Patient #2 was diagnosed with "Cellulitis of bilateral feet and toes and multiple fractures in both feet". He was admitted to the facility for IV antibiotic therapy.

The H &P completed on 11/7/17 at 1:48 a.m. when the physician first assessed the patient there were dressings to "bilateral feet." The only wound assessed was the "Hematoma" on the right foot.

On 11/7/17 at 1:48 p.m., the physician that completed the H&P wrote an addendum which documented two wounds on the right foot and two wounds on the left foot. "Skin: right foot dorsal aspect with intact bullae probably hemorrhagic, with ulcers in between the 1st and 2nd toe, surrounding erythema, left foot with round ulcer to 1st and 2nd toe, see photos ... 1. Diabetic right foot ulcer due to E-coli, interdigital area 1st and 2nd to bilateral with surrounding cellulitis/right toe hemorrhagic bullae infected with proximal phalanx in a patient with diabetes insulin dependent with severe neuropathy. -Consult podiatrist -empiric antibiotics pending sensitivity -wound dressing ...2. Diabetes Mellitus ... 3. Chronic diastolic heart failure ... 4. Hypertension ..."

On 7/19/18 at approximately 12:10 p.m., the Director of Risk Management said the chart had been reviewed and it "did not seem right". It was sent to Staff D. (the same physician that provided care for Patient #2 on the 11/3/17 visit) He reviewed the chart and said that the appropriate care was given to Patient #2 on 11/3/17.

Review of the incident report shows the incident was known by the hospital on 11/3/17. Recommendations for all ER physicians from peer review were not completed until July of 2018.

On 7/23/18 at approximately 3:00 p.m., the Director of Risk Management said the hospital had not looked at this case as an adverse incident. When asked about the details of the investigation, the Director of Risk Management said this information was protected by the hospitals Patient Safety Organization. There was no indication by risk management or the medical staff that a Root Cause Analysis had been completed on Patient #2's incident.

Based on record review, interview with clinical and administrative staff, and review of policy and procedure, the hospital failed to meet the emergency needs of patients in accordance with acceptable standards of practice by failing to ensure that all services provided in the Emergency Services Department (ESD) were integrated and provided the appropriate care.

1. The hospital failed to read radiology testing results in an accurate and timely manner causing a delay of treatment of 5 days for Patient #1. During that delay in time Patient #1 developed a Deep Vein Thrombosis and had to be transferred to a higher level of care for surgical intervention. (Refer to A1103).

2. The hospital failed to read radiology testing results accurately and timely to inform the guardian of Patient #1 of a congenital defect that had the potential to continue to cause the development of Deep Vein Thrombosis to an under aged child. (Refer to A1103).

3. The hospital failed to read the radiology reports accurately and report multiple fractures on Patient #2's right foot. (Refer to A1103).

4. The hospital failed to accurately assess and treat the bilateral feet of Patient #2 in assessing fracture bones and wounds and treating Patient #2 for a existing infection and ensure prescription medications were ordered and given to Patient #2. (Refer to A1103).

5. The hospital failed to ensure Patient #2's was assessed and treated for hypertension before being discharged from emergency services. (Refer to A1103)

6. The hospital failed to ensure all wounds were assessed on Patient #2's feet bilaterally in a accurately and timely manner when Patient #2 was assessed in the Emergency Services Department when he returned to the second time for treatment of his wounds. (Refer to A1103).

Based on interview and record review the hospital failed to provide emergency services in providing an accurate and timely radiology report from the radiology department to the emergency room department. This resulted in one patient (Patient #1) of 7 patients reviewed having a delay of 5 days in treatment, which resulted in Patient #1 developing a Deep Vein Thrombosis (DVT) in the left iliac vein. This resulted in the patient being transferred to a hospital which provided pediatric surgery, and Patient #1 having three separate operations to remove the DVT. The Facility failed to inform Patient #1's guardian, of 7 patients reviewed, of a 2nd radiology report discrepancy, completed after the patient was transferred to a higher level of care, which showed a congenital defect which had a potential to cause DVT's resulting in a potential for Patient #1 to develop another DVT after her anticoagulant therapy had ended. The facility failed to provide communication within the emergency services department for one patient (Patient #2). The facility failed to provide prescriptions for treatment, and failed to fully assess Patient #2 before discharging him home. A lack of assessment and treatment resulted in the patient returning to the ER in three days with pain in both feet, and cellulitis and caused the patient to be admitted to the facility and treated with intravenous antibiotics.

Findings include:

Review of the medical record shows Patient #1 is a minor child who presented on 9/9/17 to the emergency services department complaining of left lower quadrant pain going to the left groin and hip. Patient #1 rated her pain as a 9 out of 10, with 10 being the worst pain.

On 9/9/17 at 9:48 a.m. a Computerized Tomography (CT) scan was ordered of the abdomen and pelvis with intravenous (IV) contrast.

On 9/9/17 at 1:14 p.m. the CT scan was read as, "no signs of inflammation in the abdomen or pelvis. The reason for the patient's pain is not diagnosed."

The medical record shows Patient #1 was discharged home from the Emergency Room (ER) on 9/9/17 at 2:00 p.m.

On 9/9/17 at 4:52 p.m. Staff A, Radiologist added an addendum to the CT report which read, "Questionable Haziness is noted along the left gonadal vein and left Psoas muscle, axial images 43, and 53. Needs clinical correlation. Thrombophlebitis of the left Gonadal vein and/or inflammation of the left Psoas muscle are in the differential. This information was discussed with the ER physician at about 4:45 PM I apologize for the inconvenience."

On 7/18/18 at 11:10 a.m. the Director of Risk Management (DRM) said there had been a lack of communication between Radiology and the ED and the Addendum was not communicated to the Emergency Department (ED). She said Patient #1 had returned to the ER on 9/14/17 and an ultrasound of the left leg was done and a DVT was found. The Patient was transferred to a pediatric vascular surgeon in another hospital because the facility did not provide that service. The DRM said there was documentation Staff A had spoken to the physician but the two physicians and the Nurse Practitioner involved in the case do not admit to being spoken to by Staff A.

On 7/18/18 at 12:20 p.m. The Director of Radiology said Staff A had spoken to an ER physician but there is no way to tell from Staff A's documentation who he had spoken to. The Director said he believed it was a standard of care for radiologists to document who the physician was they had spoken to.

On 7/18/18 at approximately 12:40 p.m. The Director of ER said there was a policy that if there was a discrepancy with a radiology report the radiologist would immediately contact the ordering physician and speak physician to physician. The Director of ER said if she had been given the amendment she would have sent the patient home to follow-up with her primary care physician.

On 7/18/18 at approximately 1:10 p.m. Staff A said he had reread the CT scan and spoken with a physician in the ER on 9/9/17 at 4:45 p.m. He does not remember who the physician was he had spoken with. He said he did not know the Advanced Registered Nurse Practitioner (ARNP) who had ordered the test. Staff A said he was not aware if it was a policy to document who he had spoken with over the phone. He said from now on he would try "as much as possible" to document who he speaks to.

On 7/19/18 at 9:07 a.m. Staff B, who is an experienced ER physician working at the facility was shown the CT scan report and was told about the assessment completed in the ER on 9/9/17. The ER physician said the first Addendum on the report showed inflammation in the gonadal vein or muscle near the vein. He said this would not be the cause of a DVT in the iliac vein because of the space between the iliac vein and the gonadal vein. Staff B said he would have admitted the patient and looked for infection or an abscess. He said the second addendum dated 9/19/17 showed Patient #1 had a congenital defect.

According to the article "May-Thumer Syndrome" by Omar Al-Nouri, DO, MS and Ross Milner, MD and found on the website "Vascular Disease Management", May-Thumer Syndrome is also called "Iliac Vein Compression Syndrome" and is a congenital defect that is a major factor in patients developing DVT's at a young age due to the iliac artery crossing over the iliac vein and compressing against it. The article says abdominal CT scanning is accurate in determining if there is left iliac vein compression. The article in the conclusion reads, "With Early recognition and aggressive management, May-Thumer Syndrome can be a well-managed disease."

On 7/19/18 at 4:10 p.m. Patient #1's mother said, she had taken her daughter to the ER on 9/9/17 and the ER sent her daughter home with a diagnosis of fecal retention. She said she was never told about the 1st amendment to the radiology report. She said if she had been told she would not have allowed her daughter to lay in pain for 5 days thinking she had constipation. She said her daughter developed a DVT that extended from her thigh to her knee in the vein. She said due to the hurricane none of the physician's offices were open. She had a neighbor who was a physician. He assessed her on 9/14/17 and told her to take her daughter back to the ER and get an ultrasound to check for a DVT. She said her daughter had developed a DVT that extended from her thigh to her knee in the vein within those 5 days. Her daughter was transferred to another hospital for a pediatric vascular surgeon to treat her. She had three surgeries to remove the blood clot and was placed in intensive care. When her daughter was released from the hospital she was given 6 months of Lovenox shots to prevent her blood from clotting. The anticoagulant therapy was ending so just to be on the safe side she took her a Vascular Interventionist. He diagnosed her daughter with May-Thumer Syndrome. The mother was told by the specialist her daughter's iliac vein was 67% blocked. The mother was told she could stay on anti-coagulants or surgically put a stent in the vein. After some consideration a stent was placed. The surgeon told the mother of Patient #1 at the time the stent was placed the iliac vein was 100% blocked. Patient #1's mother said she was never told by the facility or the hospital that had removed her daughter's blood clot her daughter had May-Thurmer Syndrome which would have continued to cause blood clots to develop in her iliac vein.

At 4:10 p.m., the Director of Diagnostic Services reviewed the medical record and found on 9/19/17 the addendum which showed the defect had been faxed to the primary care physician's office, and to the hospital were the patient was transferred for surgery. There had not been a physician to physician call or any contact with the patient's guardian. The Director said, "Once the patient leaves the facility we do not speak with the patient."

Review of the policy "Diagnostic Results Follow-up" approved 8/84 and reviewed 5/2018 reads, "If there are any discrepancies in the reading, the Radiologist will immediately contact the ED [Emergency Department] Physician. If an actual discrepancy exists, the Emergency Department staff will contact the patient to ensure appropriate follow up as directed by the ED physician... All abnormal laboratory or other diagnostic testing reports received after a patient's discharge will be reviewed by the Emergency Department physician who will determine the appropriate follow-up required".

On 7/23/18 at approximately 3:00 p.m. Staff A said the reason he had re-read the CT scan on 9/19/17 was the patient had come back to the ER with a DVT in her iliac vein. He had questioned whether the inflammation he had seen on 9/9/18 was in the gonadal or the iliac vein. He said he at that time he had amended the report to show the iliac vein was being compressed on 9/19/17. When staff A was asked if he was aware of the facility policy for reporting discrepancies on reports he said, "Refresh my memory". Staff A said, "I don't know what you would have wanted me to do. On 9/19/17 Patient #1 already was being treated for a DVT in her iliac vein. I did not feel the need to contact the physician." Staff A said the standard of care for a DVT was 6 months of anticoagulant therapy. He verified Patient #1's anticoagulant therapy would have ended with a potential for patient #1 to develop another DVT in her iliac vein due to the defect he had seen on the third time he had read the CT test results on 9/19/17.

2. Review of Patient #2's medical record shows he presented to the ER on 11/3/17 at 2:07 a.m. with a complaint to the triage nurse of swelling in "Bilateral" feet, which had started that night. The right foot was worse with a hematoma (clotted blood in the tissue). Vitals were obtained during triage. The patient's blood pressure was 177/66.

On 11/3/17 at 2:20 a.m., the ER nurse documented, "Hx [history] of diabetes. Patient has a hematoma on top of right started today post fall." Review of the physician's assessment shows no documentation the left foot was ever assessed. The blood pressure of 177/66 is documented on the ER physician's assessment. There is no documentation as to the patient having a history of hypertension.

Staff D, The ER physician documented, "the patient presents with a right foot injury. The onset was 4 days ago. The character of symptoms is pain and swelling. The degree at present is minimal." (Photographic evidence obtained).

The record shows Patient #2 was discharged at 3:18 a.m., on 11/3/17. Staff D documented, "Prescriptions will be given to patient by RN/staff and I reviewed possible side effects and interactions with the patient's home medications (if any)." The ER physician diagnosed Patient #2 with a fracture of the phalanx toe.

Review of the medical records show no orders for medications were ever written. There is no documentation of vital signs being taken again before the patient was discharged. There is no documentation the left foot was ever assessed while Patient #2 was in the ER by Staff D, or Staff E, the ER Licensed Practical Nurse.

Review of the policy, "Discharge From Emergency Department" accepted 02/92 and reviewed 4/18/18 reads, Ensure discharge instructions and prescriptions are written by the physician and an order for discharge has been placed. If discharge instructions include a change in the patient's home medication list, print two copies of the updated home medication list. Have the patient sign one copy to be scanned into the EMR...A complete set of vitals ...and a pain level will be obtained within 60 minutes of the patient's discharge."

Review of the policy, "Vital Signs Emergency Department" reads, Vital signs are measured at the time of the initial assessment, and at each subsequent reassessment and at discharge." The policy shows the normal range of systolic blood pressure for an adult is "90-160".

The medical record shows that on 11/6/17 Patient #2 returned to the ER with a chief complaint of "Right big toe fracture about one week ago; pt states was seen in ER last week and had xrays done; now has oozing and blister to right big toe and toes." The ER physician assessed one wound to the left second toe. " ...an open sore to left DIP [Distal Interphalangeal Joint] of the 2nd toe lateral aspect proximal to the great toe which is 90% slough, 10% granular tissue and mildly erythematous." X-rays were taken of both feet and multiple fractures were found in both feet. Patient #2 was diagnosed with "Cellulitis of bilateral feet and toes and multiple fractures in both feet". He was admitted to the facility for IV antibiotic therapy.

The H &P completed on 11/7/17 at 1:48 a.m., when the physician first assessed the patient there were dressings to "bilateral feet." The only wound assessed was the "Hematoma" on the right foot.

On 11/7/17 at 1:48 p.m., the physician that completed the H&P wrote an addendum which documented two wounds on the right foot and two wounds on the left foot. "Skin: right foot dorsal aspect with intact bullae probably hemorrhagic, with ulcers in between the 1st and 2nd toe, surrounding erythema, left foot with round ulcer to 1st and 2nd toe, see photos ... 1. Diabetic right foot ulcer due to E-coli, interdigital area 1st and 2nd to bilateral with surrounding cellulitis/right toe hemorrhagic bullae infected with proximal phalanx in a patient with diabetes insulin dependent with severe neuropathy. -Consult podiatrist -empiric antibiotics pending sensitivity -wound dressing ...2. Diabetes Mellitus ... 3. Chronic diastolic heart failure ... 4. Hypertension ..."

On 7/19/18 at approximately 12:10 p.m., the Director of Risk Management said the chart had been reviewed and it "did not seem right." It was sent to Staff D. (the same physician that provided care for Patient #2 on the 11/3/17 visit) He reviewed the chart and said that the appropriate care was given to Patient #2 on 11/3/17.