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Based on documents reviewed and interviews, the Condition of Participation (CoP) for Governing Body was not met as evidenced by the hospital's failure to ensure that its Quality Assesment and Performance Improvement Program (QAPI) Program included a review and analysis of cause and recommended improvements for 1 of 1 cases reviewed; that all physicians complied with the hospital's Medical Staff Bylaws, Rules and Regulations 1 of 1 physicians reviewed; and that all physicians, who provided care to patients in the hospital, were evaluated consistent with the York Hospital, Medical Staff, Bylaws, Rules & Regulations and State Licensure requirements for 1 of 1 physicians.

Findings:

1. COP: §482.21: CoP: QAPI Program also known as A-0263 - Based on records reviewed and interviews, the CoP for QAPI was not met as evidenced by the hospital's failure to ensure that its QAPI Program included a review and analysis of cause and recommended improvements for 1 of 1 identified adverse events reviewed. Please see A-0263 for details

2. COP: §482.22 CoP: Medical Staff also known as A-0338 - Based on documents reviewed and interviews, the CoP for Medical Staff was not met as evidenced by the hospital's failure to ensure all physicians complied with the hospital's Medical Staff Bylaws, Rules and Regulations for 1 of 1 physicians reviewed. Please see A-0338 for details.

3. Standard: §482.21(a)(1), 482.21(a)(2), 482.21(c)(2), & 482.21(e)(3) - Patient Safety, Medical Errors & Adverse Events also known at A-0286 - Based on interviews and records reviewed, the hospital failed to ensure that its QAPI Program included a review and analysis of cause and recommended improvements for 1 of 1 identified adverse events reviewed. See A-0286 for details.

4. Standard: §482.22(a) Medical Staff also known as A-0339 - Based on documents reviewed and interviews, the hospital failed to ensure all physicians who provided care to patients in the hospital were evaluated consistent with the York Hospital, Medical Staff, Bylaws, Rules & Regulations and State Licensure requirements for 1 of 1 physicians. Please see A-0339 for details.


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

Based on records reviewed and interviews, the Condition of Participation (CoP) for Quality Assesment and Performance Improvement Program (QAPI) was not met as evidenced by the hospital's failure to ensure that its QAPI Program included a review and analysis of cause and recommended improvements for 1 of 1 identified adverse events reviewed.

Finding:

Standard §482.21(a)(1), 482.21(a)(2), 482.21(c)(2), & 482.21(e)(3) - Patient Safety, Medical Errors & Adverse Events - Based on interviews and records reviewed, the hospital failed to ensure that its QAPI Program included a review and analysis of cause and recommended improvements for 1 of 1 identified adverse events reviewed. See A-0286 for details.

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

Based on interviews and records reviewed, the hospital failed to ensure that its Quality Assesment and Performance Improvement Program included a review and analysis of cause and recommended improvements for 1 of 1 identified adverse events reviewed.

Finding:

On 9/14/2018, Physician #2 was in the Operating Room (OR) performing a "Distal Femur Osteotomy" surgical procedure when a bleeding complication occurred. The surgeon requested assistance with the bleeding and a determination was made to call for the on call Vascular Surgeon. The hospital did not have an on call Vascular Surgeon for the OR despite a telephhone interview with Physician #5 on 3/27/2019 in which he stated the type of bleeding that occurred in the 9/14/2018 surgical case "was a common complication". The hospital's OR staff obtained the hospital's Emergency Department Physician On-Call list and contacted Physician #1, the Vascular Surgeon who was listed as On Call for the Emergency Department. Physician #1 was not licensed in Maine and was not privileged or credentialed to provide care to York Hospital patients. Physician #1 did respond to the request for assistance of Physician #2 and did self-report herself to the Maine Board of Licensure in Medicine for practicing in Maine without a license.

On 3/27/2018 at 3:27 PM, during a telephone interview with the Executive Director of the Maine Board of Licensure in Medicine, the surveyor was informed that the Board of Medicine does have a process to issue an emergency Maine license. The Executive Director of the Maine Board of Licensure in Medicine stated, "Depending upon the circumstances, the Board of Licensure in Medicine can issue an emergency 100-day license within 24 hours. It can be done in as little time as an hour. Any hospital in Maine should know that the Board can issue this type of license - and do so quickly." He stated, "Surgery has to do with appropriate planning, especially in the chance that things could go wrong" and added that they [York Hospital] should have a plan A, B, and or C in place for just these situations. In addition, the Executive Director of the Maine Board of Licensure in Medicine provided the surveyor with information that stated, "Unless licensed by the board, an individual may not practice medicine or surgery or a branch of medicine or surgery or claim to be legally licensed to practice medicine or surgery or a branch of medicine or surgery within the State by diagnosing, relieving in any degree or curing, or professing or attempting to diagnose, relieve or cure a human disease, ailment, defect or complaint, whether physical or mental, or of physical and mental origin, by attendance or by advice, or by prescribing or furnishing a drug, medicine, appliance, manipulation, method or a therapeutic agent whatsoever or in any other manner unless otherwise provided by statutes of this State."

On 3/27/2019 at 3:48 PM, a telephone interview was conducted with the Hospital's Chairmen of Peer Review regarding a review of this case and the hospital bylaws. The Chairmen of Peer Review stated that he reviewed what he had recalled by memory regarding the case involving the intervention of a Vascular Surgeon who came to help one of their Orthopedic Surgeons when bleeding occurred during surgery that occurred on 9/14/2018. When asked by a surveyor if a case review or peer review was done regarding this case, he stated, the "Patient did well; Physician #2 has been on staff for four plus years with no prior complications during any other procedures/no previous concerns; The situation is not something that had come up in the past; "If I felt there were concerns regarding the process we would have done a root cause analysis or a case review... this was only an incident not a repetitive problem or process issue...decided that a Physician with no Maine license provided surgery in an emergency...situation was treated as an isolated incident...patient had a good outcome...and this was considered a 'common complication".

On 3/28/2019 at 12:54 PM, during a telephone interview with the Director of Surgical Services, he stated that he heard from someone that there was going to be peer review regarding the case but he has never been contacted by anyone since. He stated that he has not been made aware that any changes in the process were made as a result of the unusual case.

As of 3/27/2019, the surveyor was unable to find any evidence to indicate that a thorough review of this adverse event occurred to determine the root causes and corrective measures to ensure there is not a reoccurrence. The statement of "this was only an incident not a repetitive problem or process issue", by the Hospital's Chairmen of Peer Review, fails to address how the hospital will ensure that on call providers are in compliance with Medical Staff bylaws and that all surgeries being conducted have appropriate resources and expertise to deal with the potential surgical complications.

Based on documents reviewed and interviews, the Condition of Participation (COP) for Medical Staff was not met as evidenced by the hospital's failure to ensure all physicians complied with the hospital's Medical Staff Bylaws, Rules and Regulations for 1 of 1 physician's reviewed.

Finding:

On 03/27/2019, the Medical Staff, Bylaws, Rules & Regulations were reviewed and revealed the following:

"Article II: Medical Staff Membership

- Section 1: Medical Staff Appointment stated, Appointment to the Medical Staff of York Hospital is a privilege which shall be extended only to competent professionals who continuously meet the qualifications, standards, and requirement set forth in these Bylaws, Rules & Regulations, and associated policies of the Medical Staff and Hospital... In addition, all Medical Staff - are required to comply with all applicable State and Federal laws, with the Bylaws, Rules and Regulations, and Policies of the Medical Staff and with any applicable departmental or divisional rules, regulations, and policies.

- Section 2: Qualifications for Membership

A. Only providers with Doctor of Medicine or Doctor of Osteopathy Degrees, Dentists, Oral Surgeons, Podiatrists, or RNFA's, NP's, PA's, CNM's, FNP's, ANP's, and APRN's, holding a license to practice in the State of Maine, who can document their current licensure, background, experience, relevant training and or licensure, judgement, individual character, and demonstrated current competence, physical and mental capabilities and health status, adherence to the ethics of their profession, and ability to work with others with sufficient adequacy to assure the Medical Staff and the Board of Trustees that any patient treated by them in the Hospital will be given a high degree of patient care, shall be considered for appointment to the Medical Staff.

- Section 5: Emergency Privileges

Regardless of his or her delineated privileges and Staff status, in the case of an emergency situation, any reactionary present shall be expected to do everything in his or her power, within the scope of his or her license, to save the life or limb of a patient, including calling for such consultations or assistance as may be quickly available. For these purposes an emergency is defined as a condition in which the life or limb of a patient is in immediate jeopardy and in which delay in treatment would substantially increase the threat and their is no reasonable or safe alternative to making such an emergency appointment in order to assure appropriate patient care."

On 3/27/2019, the Bylaws Of York Hospital, adopted as amended on June 30, 2016 were reviewed and revealed the following:

"ARTICLE X, MEDICAL STAFF

- Section 2. Bylaws, Rules and Regulations.

The Board of Trustees holds the Medical Staff responsible for the development, adoption and periodic review of the Medical Staff Bylaws and Rules and Regulations that are consistent with Hospital Policy and with any applicable legal or other requirements."

On 3/27/2019, the "On Call Physicians Policy" was reviewed and revealed the following:

- "The list of on-call physicians must be composed of physicians who are currently members of the medical staff and they have hospital privileges. They physicians on staff participate in the Emergency Department coverage as scheduled or as required by the Medical Staff Bylaws. The list must be up-to-date and accurately reflect the current privileges of the physician's on-call."

On 3/27/2019 at 9:40 AM, an interview with the Chief Medical Officer (CMO) was conducted and she stated "I wasn't aware that Maine Licensure was necessary for granting Emergency privileges"; "I am new and inexperienced" and "I didn't even think of it [Maine Licensure]."

On 3/27/2019 at 9:50 AM, an interview with the Registered Nurse - Director of Surgical Services was conducted and she stated the following:

- "The On-Call Schedule does not specify if the provider listed is privileged or not" and there is a place in their computer system, in the P-drive, under medical records ("I think") that provides an updated record of those Physicians who are "privileged".

- On the evening of 9/14/2018, the Surgical Circulator called her questioning if Physician #1 was considered 'privileged' at York Hospital; the Surgical Circulator told her that Physician #2, had requested a Vascular Physician for assistance during his surgery due to an emergent situation involving bleeding; and that the Surgical Circulator was inquiring about what leader was on call because he/she didn't recognize Physician #1's name and needed guidance as to how to proceed.

- She contacted the Chief Nursing Officer (CNO) first, explained the situation, asking him if he knew of Physician #1's status and if Physician #1 was privileged to treat patients in the hospital. The CNO shared that he knew Physician #1 was not privileged at York Hospital and was not licensed in the State of Maine.

- The CNO had been in contact with the Chief of Surgery.

- She called the Physician Director of Surgical Services, who had been in contact with the Anesthesiologist on the Surgical case in question.

- After everyone had discussed the situation, the decision was made that, "this was an Emergency situation, we need to do the right thing for the patient, and do/deal with the paperwork after".

- There has not been any changes in any policies, procedures, and/or education that she was made aware of.

- She was not involved in any case review regarding this case. The "Administration took over the rest of the logistics".

On 3/27/2019 at 10:21 AM, a telephone interview with the CMO was conducted regarding the physician call list and the medical staff bylaws. She stated, "That just because the Physician's name is on the September 14, 2018 York Hospital On Call Schedule, it doesn't necessarily mean that the physician is privileged"; "Typically the list is used for the Emergency Department. The Emergency Department would call a Physician on the list if they needed that particular specialty and get direction"; and "It is unusual for the call to the Physician to come from the Operating Room".

On 3/27/2019 at 10:25 AM, a telephone interview with the General Surgeon (Physician #3), was conducted and he stated the following:

- On the evening of 9/14/2018 he was on call, and was in the hospital, when he heard from the Surgical Circulator that Physician #2 needed assistance due to some bleeding during the surgery Physician #2 was conducting.

- After he scrubbed in, he saw there was a tourniquet on, and there was good control of the situation at that time. He added, "I'm not a Vascular Surgeon, not sure about all of that, especially regarding blood flow to a patient's limb...it's not my specialty".

- A decision was made between himself and Physician #2 that it would be best to have a Vascular Surgeon called to come assist as soon as possible. The patient was already opened up and they decided it was best to have someone come to them versus transferring the patient. It was felt that a transfer was too risky.

- He knew that both the Physician Director of Surgical Services and the Chief of Surgery, as well as hospital administration were called and that a decision was made to approve Physician #1 to assist in this surgical case.

On 3/27/2019 at 11:27 AM, an interview with the Orthopedic Surgeon (Physician #2) was conducted and he stated the following:

- On the evening of 9/14/2019, he was "in the Operating Room performing a "Distal Femur Osteotomy" when the Femur bone blade went too posterior"; there is a protector device to prevent this and protect the popliteal vessels, but he suddenly saw blood oozing; he wasn't sure if it was arterial or venous so he applied a tourniquet.

- The General Surgeon (Physician #3), was in the hospital and scrubbed in to see if he could help him.

- He and Physician #3 decided that neither of them were comfortable moving forward not knowing if this was arterial or a venous bleed and a request was made for a Vascular Surgeon to be called in to assist them in the operating room with this case.

- They didn't recognize the Vascular Surgeon's name on the On Call list; the Surgical Circulator called some different administration staff and found out that this particular on call Vascular Surgeon was not privileged or licensed in the State of Maine; and he then called and spoke to the Chief of Surgery and the decision was made to "get the Vascular Surgeon there and deal with the consequences after".

- Physician #2 stated that he has not been involved in any case review regarding this case since it happened.

On 3/27/2019 at 3:27 PM, a telephone interview with the Executive Director of the Maine Board of Licensure in Medicine was conducted and he stated the following:

- "Depending upon the circumstances, the Board of Licensure in medicine can issue an emergency 100-day license within 24 hours. It can be done in as little time as an hour. Any hospital in Maine should know that the Board can issue this type of license - and do so quickly."

- "Surgery has to do with appropriate planning, especially in the chance that things could go wrong" and added that they [York Hospital] should have a plan A, B, and or C in place for just these situations.

The Executive Director of the Maine Board of Licensure also provided the surveyor information which he quoted from the 32 M.R.S.A. §3270, Licensure required (Medical Board Statute). "Unless licensed by the board, an individual may not practice medicine or surgery or a branch of medicine or surgery or claim to be legally licensed to practice medicine or surgery or a branch of medicine or surgery within the State by diagnosing, relieving in any degree or curing, or professing or attempting to diagnose, relieve or cure a human disease, ailment, defect or complaint, whether physical or mental, or of physical and mental origin, by attendance or by advice, or by prescribing or furnishing a drug, medicine, appliance, manipulation, method or a therapeutic agent whatsoever or in any other manner unless otherwise provided by statutes of this State."

On 3/28/2019 at 12:54 PM, a telephone interview with the Director of Surgical Services was conducted and he stated the following:

- On the evening of 9/14/2018 he was out of town when the CNO texted him that "Physician #2 had a case on the table, there was significant bleeding, and he needed support for the bleeding [Vascular Surgeon]."

- "I immediately texted the Anesthesiologist working on the case and asked his perspective. The two surgeons that were involved felt it was out of their scope of practice."

- The CNO told him that the Vascular Surgeon on call, Physician #1, was not licensed in the State of Maine nor did she have privileges at York Hospital (though her copartners in the same practice did).

- "I gave them emergency privileges to help the patient".

- He heard from someone that there was going to be peer review regarding the case but he has never been contacted by anyone since.

- He has not been made aware that any changes in the process were made as a result of the unusual case.


The cumulative effect of the deficient practices resulted in noncompliance with this Condition of Participation.

Based on documents reviewed and interviews, the hospital failed to ensure all physicians who provided care to patients in the hospital were evaluated consistent with the York Hospital, Medical Staff, Bylaws, Rules & Regulations and State Licensure requirements for 1 of 1 physicians.

Finding:

On 03/27/2019, the Medical Staff, Bylaws, Rules & Regulations were reviewed and revealed the following:

"Article II: Medical Staff Membership

- Section 1: Medical Staff Appointment stated, Appointment to the Medical Staff of York Hospital is a privilege which shall be extended only to competent professionals who continuously meet the qualifications, standards, and requirement set forth in these Bylaws, Rules & Regulations, and associated policies of the Medical Staff and Hospital... In addition, all Medical Staff - are required to comply with all applicable State and Federal laws, with the Bylaws, Rules and Regulations, and Policies of the Medical Staff and with any applicable departmental or divisional rules, regulations, and policies.

- Section 2: Qualifications for Membership

A. Only providers with Doctor of Medicine or Doctor of Osteopathy Degrees, Dentists, Oral Surgeons, Podiatrists, or RNFA's, NP's, PA's, CNM's, FNP's, ANP's, and APRN's, holding a license to practice in the State of Maine, who can document their current licensure, background, experience, relevant training and or licensure, judgement, individual character, and demonstrated current competence, physical and mental capabilities and health status, adherence to the ethics of their profession, and ability to work with others with sufficient adequacy to assure the Medical Staff and the Board of Trustees that any patient treated by them in the Hospital will be given a high degree of patient care, shall be considered for appointment to the Medical Staff.

- Section 5: Emergency Privileges

Regardless of his or her delineated privileges and Staff status, in the case of an emergency situation, any reactionary present shall be expected to do everything in his or her power, within the scope of his or her license, to save the life or limb of a patient, including calling for such consultations or assistance as may be quickly available. For these purposes an emergency is defined as a condition in which the life or limb of a patient is in immediate jeopardy and in which delay in treatment would substantially increase the threat and their is no reasonable or safe alternative to making such an emergency appointment in order to assure appropriate patient care."

On 3/27/2019, the Bylaws Of York Hospital, adopted as amended on June 30, 2016 were reviewed and revealed the following:

"ARTICLE X, MEDICAL STAFF

- Section 2. Bylaws, Rules and Regulations.

The Board of Trustees holds the Medical Staff responsible for the development, adoption and periodic review of the Medical Staff Bylaws and Rules and Regulations that are consistent with Hospital Policy and with any applicable legal or other requirements."

On 3/27/2019, the "On Call Physicians Policy" was reviewed and revealed the following:

- "The list of on-call physicians must be composed of physicians who are currently members of the medical staff and they have hospital privileges. They physicians on staff participate in the Emergency Department coverage as scheduled or as required by the Medical Staff Bylaws. The list must be up-to-date and accurately reflect the current privileges of the physician's on-call."

On 3/27/2019 at 9:40 AM, an interview with the Chief Medical Officer (CMO) was conducted and she stated "I wasn't aware that Maine Licensure was necessary for granting Emergency privileges"; "I am new and inexperienced" and "I didn't even think of it [Maine Licensure]."

On 3/27/2019 at 9:50 AM, an interview with the Director of Surgical Services was conducted and she stated the following:

- The Surgical Staff rarely use the York Hospital On Call Schedule and it is used mostly by the Emergency Staff

- The On Call Schedule does not specify if the provider listed is privileged or not.

- There is a place in their computer system, in the "P-drive", under medical records ("I think") that provides an updated record of those Physicians who are "privileged"; the medical staff office updates the list at least monthly; and "It's not easy to find though"

- Usually if a Surgeon requires the assistance of another Physician that Surgeon would ask to have a specific colleague called, not necessarily one that is on the 'On Call Schedule'.

On 3/27/2019 at 10:21 AM, a telephone interview with the CMO was conducted and she stated the following:

- "Just because the Physician's name is on the September 14, 2018 York Hospital On Call Schedule, it doesn't necessarily mean that the physician is privileged"

- "Typically the list is used for the Emergency Department; the Emergency Department would call a Physician on the list if they needed that particular specialty and get direction"

- "It is unusual for the call to the Physician to come from the Operating Room".

On 3/27/2019 at 11:27 AM, an interview with the Orthopedic Surgeon (Physician #2) was conducted and he stated the following:

- Neither Physician #3 nor himself recognized the Vascular Surgeon's name on the On-Call list

- The Surgical Circulator called some different administration staff and found out that this particular on call Vascular Surgeon was not privileged or licensed in the State of Maine

- He spoke to the Chief of Surgery

- The decision was made to "get the Vascular Surgeon there and deal with the consequences after"

- He has not been involved in any case review or peer review regarding this case since it happened.

On 3/28/2019 at 12:54 PM, a telephone interview with the Physician Director of Surgical Services was conducted and he stated the following:

- On the evening of 9/14/2018 the Chief Nursing Officer texted him about the situation where Physician #2 needed support for bleeding in the Operating Room

- "I immediately texted the Anesthesiologist working on the case and asked his perspective"

- "The two surgeons that were involved felt it was out of their scope of practice"

- The Chief Nursing Officer told him that the Vascular Surgeon on call (Physician #1) was not licensed in the State of Maine nor did she have privileges at York Hospital like her copartners in the same practice did

- He knew that the Chief of Surgery was also involved

- "I gave them emergency privileges to help the patient"

- He heard from someone that there was going to be peer review regarding the case but he has never been contacted by anyone since

- He has not been made aware that any changes in the process were made as a result of the unusual case

- He provided no explanation as to why the hospital's Medical Staff policies were not followed or explained why the physician on call list did not contain licensed and privileged providers consistent with the Medical Staff policies.