DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X1) PROVIDER/SUPPLIER/CLIA
IDENTIFICATION NUMBER
(X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY COMPLETED
200020 A. BUILDING __________
B. WING ______________
10/09/2019
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP
YORK HOSPITAL 15 HOSPITAL DRIVE, YORK, ME, 03909
For information on the provider's plan to correct this deficiency, please contact the provider or the state survey agency.
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY SHOULD BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
0000 Initial Comments
09447 Federal Complaint #31632 Survey Dates: 10/7/19 to 10/9/19 Three Conditional Level Deficiencies Identified: - §482.12 Condition of Participation: Governing Body also know as A-0043 - §482.21 Condition of Participation: Quality Assurance and Performance Improvement also know as A-0263 - §482.22 Condition of Participation: Medical Staff also know as A-0338 Repeat Deficiencies Identified: - §482.12 Condition of Participation: Governing Body also know as A-0043 - §482.21 Condition of Participation: Quality Assurance and Performance Improvement also know as A-0263 - §482.22 Condition of Participation: Medical Staff also know as A-0338 On 10/7/19 through 10/9/19, a complaint investigation was conducted at York Hospital, an Acute Care Hospital, to evaluate compliance with 42 Code of Federal Regulations Part 482, Condition of Participations: Governing Body (§482.12), Quality Assurance and Performance Improvement (§482.12), and Medical Staff (§482.22). This survey determined the hospital was not in substantial compliance with 42 Code of Federal Regulations Part 482, Condition of Participations: Governing Body (§482.12), Quality Assurance and Performance Improvement (§482.12), and Medical Staff (§482.22). The following conditions and requirements were not met:
A0043 Governing Body
482.12
Corrected On: 12/08/2019
09447 Repeat Deficiency Based on documents reviewed and interviews, the Condition of Participation (CoP) for Governing Body was not met as evidenced by the Governing Body's failure to ensure that the Quality Assurance Performance Improvement (QAPI) Program had tracked an adverse patient event, analyzed the causes, and implemented preventive actions and mechanisms that included feedback and learning throughout the hospital for 1 of 1 adverse events (8/13/19); the failure to ensure that all Physicians, who provided care to patients in the hospital, were evaluated consistent with the "York Hospital Medical Staff, Bylaws, Rules & Regulations" for 1 of 1 Physicians; and the failure to ensure the Medical Staff enforced the York Hospital Bylaws to carry out its responsibilities. Findings: During a previous complaint survey, which was completed on 3/27/19, it was determined that a Vascular Surgeon, who was on call for the hospital, had performed surgery on a patient and was not licensed in the State of Maine to practice, the hospital's Medical Staff Bylaws had not been followed, and the hospital had not conducted a thorough review of this event to determine the root cause and ensure corrective measures were put in place to ensure this did not reoccur. As a result, the the hospital was cited for its failure to to ensure that its Quality Assessment 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. The hospital submitted a plan of correction, dated 4/19/19, that indicated the following: - A tracking log was being created to log any case that is raised for potential peer review referral as well as those that meet a trigger list criteria, the log would be monitored monthly, a standing agency item would be added to the monthly Peer Committee agenda to review cases that have been screened out and this new process would allow further provider monitoring to ensue that cases have been appropriately been triaged and reflected in the Peer Review Committee minutes. - The Medical Staff would be educated on the need for Maine licensure even in emergent situations; the Medical Bylaws would be revised to clarify that in all cases, including emergency situations, the providers at York Hospital must be legally be authorized (licensed) to practice within the State of Maine; all credentialed providers would attest that they understood Maine licensure requirements and process for emergency privileges; and the updated bylaws would be distributed to each remember of the Medical Staff, with a memo noting the specific requirement of Maine licensure. The POC indicated that the hospital would be in compliance with this regulation as of 5/10/19. During this complaint survey, it was determined the Condition of Participation for Governing Body was not met as evidenced by the following: a. COP: §482.21: CoP: QAPI Program also known as A-0263 -Based on document review and interviews, the Condition of Participation (CoP) for Quality Assessment and Performance Improvement was not met as evidenced by the hospital's failure to ensure that its Quality Assurance Performance Improvement (QAPI) Program had tracked an adverse patient event, analyzed the causes and implemented preventive actions, and mechanisms that included feedback and learning throughout the hospital for 1 of 1 adverse events (8/13/19). Please see A-0263 for details b. 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 record reviews and interviews, the hospital failed to ensure that its Quality Assurance Performance Improvement (QAPI) Program had tracked an adverse patient event, analyzed the causes and implemented preventive actions, and mechanisms that included feedback and learning throughout the hospital for 1 of 1 adverse events (8/13/19). Please see A-0286 for details. c. COP: §482.22 CoP: Medical Staff also known as A-0338 - 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 that all Physicians, who provided care to patients in the hospital, were evaluated consistent with the "York Hospital Medical Staff, Bylaws, Rules & Regulations" for 1 of 1 Physicians and that the Medical Staff enforced the York Hospital Bylaws to carry out its responsibilities. Please see A-0338 for details. d. Standard: §482.22(a) §482.22(a) Standard: Eligibility and Process for Appointment to Medical Staff also known as A-0339 - Based on document review and interviews, the hospital failed to ensure that all Physicians, who provided care to patients in the hospital, were evaluated consistent with the "York Hospital Medical Staff, Bylaws, Rules & Regulations" for 1 of 1 Physicians. Please see A-0339 for details. e. Standard: §482.22(c) Standard: Medical Staff Bylaws also known as A-0353 - Based on document review and interviews, the facility failed to ensure that the Medical Staff enforced the York Hospital Bylaws to carry out its responsibilities for 1 of 1 physicians. Please see A-0353 for details. The cumulative effect of these deficient practices resulted in noncompliance with this CoP.
A0263 QAPI
482.21
Corrected On: 12/08/2019
09447 Repeat Deficiency Based on document review and interviews, the Condition of Participation (CoP) for Quality Assessment and Performance Improvement was not met as evidenced by the hospital's failure to ensure that its Quality Assurance Performance Improvement (QAPI) Program had tracked an adverse patient event, analyzed the causes and implemented preventive actions, and mechanisms that included feedback and learning throughout the hospital for 1 of 1 adverse events (8/13/19). Finding: During a previous complaint survey, which was completed on 3/27/19, it was determined that a Vascular Surgeon, who was on call for the hospital, had performed surgery on a patient and was not licensed in the State of Maine to practice, the hospital's Medical Staff Bylaws had not been followed, and the hospital had not conducted a thorough review of this event to determine the root cause and ensure corrective measures were put in place to ensure this did not reoccur. As a result, the the hospital was cited for its failure to ensure that its Quality Assessment and Performance Improvement Program included a review and analysis of cause and recommended improvements for 1 of 1 identified adverse events. The hospital submitted a plan of correction, dated 4/19/19, that indicated a tracking system to log all peer review referrals would be created, the log would be monitored monthly to check the status of each case; and a standing agenda item would be added to the monthly Peer Review Committee to review cases. The POC indicated that the hospital would be in compliance by 4/11/19. During this complaint investigation survey, it was determined the Condition of Participation for Quality Assurance and Performance Improvement was not met as evidenced by the following: 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 record reviews and interviews, the hospital failed to ensure that its Quality Assurance Performance Improvement (QAPI) Program had tracked an adverse patient event, analyzed the causes and implemented preventive actions, and mechanisms that included feedback and learning throughout the hospital for 1 of 1 adverse events (8/13/19). See A-0286 for details. The cumulative effect of this deficient practice resulted in noncompliance with this CoP.
A0286 Patient Safety
482.21(a), (c)(2), (e)(3)
Corrected On: 11/22/2019
09447 Repeat Deficiency Based on record reviews and interviews, the hospital failed to ensure that its Quality Assurance Performance Improvement (QAPI) Program had tracked an adverse patient event, analyzed the causes and implemented preventive actions, and mechanisms that included feedback and learning throughout the hospital for 1 of 1 adverse events (8/13/19). Finding: During a previous complaint survey, which was completed on 3/27/19, it was determined that a Vascular Surgeon, who was on call for the hospital, had performed surgery on a patient and was not licensed in the State of Maine to practice, the hospital's Medical Staff Bylaws had not been followed, and the hospital had not conducted a thorough review of this event to determine the root cause and ensure corrective measures were put in place to ensure this did not reoccur. As a result, the the hospital was cited for its failure to ensure that its Quality Assessment and Performance Improvement Program included a review and analysis of cause and recommended improvements for 1 of 1 identified adverse events. The hospital submitted a plan of correction, dated 4/19/19, that indicated a plan would be put into place to ensure that all adverse events would be put through the peer review process and they indicated that they would have measures in place to be in compliance by 4/11/19. On 8/15/19, the hospital reported an incident in which the father of a pregnant patient wanted to participate in a Cesarean Section (C-Section) by "scrubbing in". It was believed that the patient's father, who is a Physician, participated as a Surgical Assistant and not as a family member being present at the birth of the child. The hospital indicated the father was not licensed in the State of Maine and they were not positive that he held a valid medical license. Patient #1's medical record was reviewed and indicated the patient presented to the hospital for a scheduled C-Section and requested her father be allowed to be present in the Operating Room (OR) for the birth. The "IntraOperative Case Report", dated 8/13/19 at 8:37 AM and signed by OR Nurse #5, indicated patient's father was the "Surgeon Assist." However, the "York Hospital Operative Report", completed by the attending Surgeon (Physician #2) indicated, under the section Assistant, "none". On 10/7/19 at 1:26 PM, Physician #1, who was the Anesthesiologist, was interviewed regarding the presence of Patient #1's father in the OR on 8/13/19. He stated the following: "I was present. I was the Anesthesiologist on the case...in retrospect, I should have been concerned as I am the last gatekeeper.". "I asked Physician #2 if the patient's father had temporary privileges and Physician #2 said that the CEO [Chief Executive Officer} needed to be contacted...I did not close the loop with Physician #2...the need for Maine licensure was not up front with me...the father did touch the patient and then baby..I'm sorry..I'm in the wrong." On 10/7/19 at 2:33 PM, Physician #2, who was the attending Surgeon, was interviewed. She stated the following: "Physician #1 called me the morning of the surgery [8/13/19] about the patient's father being in the OR because someone was concerned...I was not thinking about anything except two years ago the same scenario occurred and I got permission for the father to be in on the birth..in hindsight I didn't revisit the situation..in my mind the father was not assisting..the father did touch a retractor and he took the baby and gave it to Patient #1...it is an unusual request and my fault for fighting for my patient...I never even thought there would be an issue due to two years ago it was okay...if someone had come to me with concerns...it was like they were waiting for me to do something wrong...in my mind the father had a medical license and he did the same as a student would do...I'm 100% responsible...I allowed him to scrub..I didn't really think about it." On 10/7/19 at 1:35 PM, the OR Director of Nursing was interviewed. She stated the following: one of her staff had texted her with concerns about an unknown individual scrubbing in to assist Physician #2 with a C-Section on 8/13/19; the staff person reported her concerns to Physician #1 about 6:45 AM on 8/13/19; the Physician stated that the individual was only going to observe; she then spoke to the Acting Chief Nursing Officer; they went to see the CEO; the CEO stated to them that he did not grant privileges; and he was not aware of the situation. The OR Director of Nursing also stated that the Scrub Technician told her that the father of the patient participated in the surgery by holding retractors in the incision site and suctioning the baby's nose upon delivery. On 10/8/19 at 2:24 PM, the Director of Interventional Imaging/Cardiac Catheter Laboratory/Intensive Care Unit, who was the Acting Chief Nursing Officer at the time, was interviewed. He stated the following: the Director of Family Care approached him and said there was a potential that a father of a C-Section patient was going to participate in the delivery of a baby; "I said hell no...ethically and professionally no"; he went to see the CEO to ask him if privileges had been given to the father of Patient #1; the CEO said no; and that the CEO indicated he had no conversation with Physician #2. He then stated that he went to the OR and watched a gentleman start to scrub with Physician #2; he then went back to the CEO and asked if he should go into the OR; and he was told no by the CEO. He stated that later the OR staff told him that the father of the patient had held a retractor and suctioned the baby. On 10/8/19 at 12:16 PM, OB Nurse #1 was interviewed. She stated the following: "People were confused about what to do...it was unclear if he [Patient#1's father] had privileges...when the Director of Family Care asked Physician #2 about this the physician replied "it's taken care of""..the procedure was performed and the father definitely had his hands on [the patient] to assist Physician #2, and he was the first one to pick up the baby...I then put the baby in the warmer and the Dad left." On 10/8/19 at 12:33 PM, OB Nurse #2 was interviewed. She stated, "I knew the patient's father was going to assist and I wondered if this was allowed...I could see that the father was assisting...I saw his hands on the patient's belly and he handled instruments." On 10/8/19 at 12:49 PM, an interview was conducted with OR Nurse #3. She stated the following: when she became aware of an unknown individual "scrubbing in" to assist Physician #2 with a C-Section, she went immediately to her supervisor; she also brought her concerns to Physician #1 who said that Physician #2 was working on temporary privileging with the CEO; and at 7:30 AM, as the procedure was about to begin, Physician #1 announced to the room that Physician #2 was working on the privileging issue and they could begin. She stated she observed the patient's father apply a retractor to the incision site, apply pressure to the patient's belly to assist Physician #2, and Patient' #1's father was the first to touch and present the baby. On 10/8/19 at 1:05 PM, a Certified Surgical Technician was interviewed. She stated the following: she was told by an OR Nurse that there was going to be a Physician scrubbing in; she asked if this Physician was licensed and credentialed; and someone said that Physician #2 was contacting the CEO for temporary privileges. She stated, "He [father of Patient #1] was on the patient's left side and pulled the fascia apart...I handed him the blue bulb and he suctioned the baby...he was an assist...I handed him a Kelly clamp too." On 10/8/19 at 2:03 PM, the Director of Family Care was interviewed. She stated the following: she was informed by another nurse that an unknown individual was "scrubbing in" to assist Physician #2 with a C-Section scheduled for 7:30 AM that morning [8/13/19]; she contacted the Acting Chief Nursing Officer (ACNO); and "I then phoned Physician #2 for clarification and Physician #2 said there would be three people scrubbing in and if the OR staff had any questions they could call her." On 10/8/19 at 2:24 PM, the Director of Interventional Imaging/Cardiac Catheter Laboratory/Intensive Care Unit, who was the Acting Chief Nursing Officer [ACNO] at the time, was interviewed. He stated the following: the Director of Family Care approached him and said there was a potential that a father of a C-Section patient had was going to participate in the delivery of a baby; "I said hell no...ethically and professionally no."; he went to see the CEO to ask him if privileges had been given to the father of Patient #1; the CEO said no; and that the CEO indicated he had no conversation with Physician #2. He then stated that he went to the OR and watched a gentleman start to scrub with Physician #2; he then went back to the CEO and asked if he should go into the OR; and her told no by the CEO. He stated that later the OR staff told him that the father of the patient had held a retractor and suctioned the baby. On 10/9/19 at 8:00 AM, OR Nurse #4 was interviewed. She stated the following: she was informed that the father of a C-Section patient would be scrubbing in to assist Physician #2; she immediately went to the Director of Family Care and together they examined the York Hospital Privileging list and determined that the individual did not have privileges, temporary or otherwise; she spoke with Physician #1 and was told that a conversation with Physician #2 would happen; from outside the OR she observed the patient's father scrubbing in, then adjust his glasses, and saw him using retractors on the patient's abdomen. On 10/9/19 at 10:20 AM, another interview, via telephone, was conducted with Physician #2. She was asked how soon it was known that Patient #1 wanted her father to be involved in the C-Section on 9/13/19 and she stated that she knew on 8/7/19. When asked if there had been a conversation with Physician #1 about the patient's father being in on the C-Section, Physician #2 stated, "I recall a phone conversation with Physician #1 and a phone conversation with the Director of Family Care about Patient #1's blood pressure. She stated that the Director of Family Care did not talk about the situation regarding the patient's father, just the patient's blood pressure. On 10/9/19 at 10:46 AM, another interview was held with the Director of Family Care to clarify some issues. The Director was asked if she had called Physician #2 about the fact that the father of Patient #1 had not been credentialed and she stated, "I called Physician #2 about 6:45 AM, before the patient left the Unit after I checked for credentials online and there were none...another nurse had paged Physician #2 and when the phone rang I answered it...I said the patient's father is assisting and Physician #2 said, "none of my business" and that if the OR had a problem they could call her directly...it was a bad connection and whatever else she said was garbled." On 10/9/19 at 11:10 AM, the CEO was interviewed. He stated, "I wasn't concerned that the patient's father would be observing and I had no indication that the patient's father would participate...the Acting Chief Nursing Officer told me that the father was scrubbing in but I thought everyone scrubbed in...he also told me that the father broke scrub by touching his glasses...I had no idea that two members of this medical staff would allow this to happen [an unlicensed and not privileged individual]...the absurdity that the two staff members let it happen." On 10/9/19/19 at 1:34 PM, the Director of Quality was interviewed. When asked why the Quality Committee had not addressed the incident on 8/13/19, he stated, "We wanted to wait until the full investigation was completed and we had the recommendations from the Peer Review Committee." When asked if the Peer Review Committee had met yet, he stated no but this month. Based on the above information, on 8/13/19, the hospital identified that this incident occurred. However, as of 10/9/19, 57 days later, the Quality Committee had not thoroughly analyzed the incident and implemented preventative actions to ensure this situation did not reoccur.
A0338 Medical Staff
482.22
Corrected On: 12/08/2019
09447 Repeat Deficiency 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 that all Physicians, who provided care to patients in the hospital, were evaluated consistent with the "York Hospital Medical Staff, Bylaws, Rules & Regulations" for 1 of 1 Physicians and that the Medical Staff enforced the York Hospital Bylaws to carry out its responsibilities. Findings: During a previous complaint survey, which was completed on 3/27/19, it was determined that a Vascular Surgeon, who was on call for the hospital, had performed surgery on a patient and was not licensed in the State of Maine to practice and the hospital's Medical Staff Bylaws had not been followed. As a result, the the hospital was cited for its failure to ensure all physicians complied with the hospital's "Medical Staff Bylaws, Rules and Regulations" for 1 of 1 physicians reviewed. The hospital submitted a plan of correction, dated 4/19/19, that indicated the hospital would be in compliance with this regulation by 4/30/19. During this complaint survey, it was determined, the Condition of Participation for Medical Staff was not met as evidenced by the following: a. Standard §482.22(a) - Eligibility and Process for Appointment to Medical Staff also known as A-0339 - Based on document review and interviews, the hospital failed to ensure that all Physicians who provided care to patients in the hospital were evaluated consistent with the "York Hospital Medical Staff, Bylaws, Rules & Regulations" for 1 of 1 Physicians. Please see A-0339 for details. b. Standard §482.22(c) - Medical Staff Bylaws also known as A-0353 - Based on document review and interviews, the facility failed to ensure that the Medical Staff enforced the York Hospital Bylaws to carry out its responsibilities for 1 of 1 Physicians. Please see A-0353 for details. The cumulative effects of these deficient practices resulted in noncompliance with this Condition of Participation.
A0339 Eligibility & Process For Appt To Med Staff
482.22(a)
Corrected On: 12/08/2019
09447 Repeat Deficiency Based on document review and interviews, the hospital failed to ensure that all Physicians who provided care to patients in the hospital were evaluated consistent with the "York Hospital Medical Staff, Bylaws, Rules & Regulations" for 1 of 1 Physicians. Finding: During a previous complaint survey, which was completed on 3/27/19, it was determined that a Vascular Surgeon, who was on call for the hospital, had performed surgery on a patient and was not licensed in the State of Maine to practice and the hospital's Medical Staff Bylaws had not been followed. As a result, the the hospital was cited for its failure to ensure all physicians, who provided care to patients in the hospital, were evaluated consistent with the "York Hospital, Medical Staff, Bylaws, Rules & Regulations" for 1 of 1 physicians. The hospital's plan of correction (POC), dated 4/19/19, indicated the following: the Medical Staff would be educated on the need for Maine licensure even in emergent situations; the Medical Bylaws would be revised to clarify that in all cases, including emergency situations, the providers at York Hospital must be legally be authorized (licensed) to practice within the State of Maine; all credentialed providers would attest that they understood Maine licensure requirements and process for emergency privileges; and the updated bylaws would be distributed to each remember of the Medical Staff, with a memo noting the specific requirement of Maine licensure. The POC indicated that the hospital would be in compliance with this regulation by 5/10/19. On 8/15/19, the hospital reported an incident in which the father of a pregnant patient wanted to participate in a Cesarean Section (C-Section) by "scrubbing in". It was believed that the patient's father, who is Physician, participated as a Surgical Assistant and not as a family member being present at the birth of the child and the father was not licensed in the State of Maine and they were not positive that he held a valid medical license. The "York Hospital 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 professional who continuously meet the qualifications, standards, and requirements et 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 Regulations, and Policies of the Medical Staff and any other 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 charter, 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 ensure the Medical Staff and the Board of Trustees that any patient treated by them in Hospital will be given a high degree of patient care, shall be considered for appointment to the Medical Staff. The "York Hospital Privileging & State Licensure Attestation" forms, signed by Physician #1 on 4/22/19 and signed by Physician #2 on 4/16/19, were reviewed. The forms stated, "I acknowledge that I understand that all Qualified Medical Providers (QMP) caring for patients at York Hospital are required to be licensed in the State of Maine. This includes circumstances involving Emergency and Temporary Privileging." On 10/7/19 at 1:26 PM, Physician #1, who was the Anesthesiologist, was interviewed regarding the presence of Patient #1's father in the OR on 8/13/19. He stated the following: "I was present. I was the Anesthesiologist on the case...in retrospect, I should have been concerned as I am the last gatekeeper.". "I asked Physician #2 if the patient's father had temporary privileges and Physician #2 said that the CEO [Chief Executive Officer} needed to be contacted...I did not close the loop with Physician #2...the need for Maine licensure was not up front with me...the father did touch the patient and then baby..I'm sorry..I'm in the wrong." On 10/7/19 at 2:33 PM, Physician #2, who was the attending Surgeon, was interviewed. She stated the following: "Physician #1 called me the morning of the surgery [8/13/19] about the patient's father being in the OR because someone was concerned...I was not thinking about anything except two years ago the same scenario occurred and I got permission for the father to be in on the birth..in hindsight I didn't revisit the situation..in my mind the father was not assisting..the father did touch a retractor and he took the baby and gave it to Patient #1...it is an unusual request and my fault for fighting for my patient...I never even thought there would be an issue due to two years ago it was okay...if someone had come to me with concerns...it was like they were waiting for me to do something wrong...in my mind the father had a medical license and he did the same as a student would do...I'm 100% responsible...I allowed him to scrub..I didn't really think about it." On 10/8/19 at 1:05 PM, a Certified Surgical Technician was interviewed. She stated the following: she was told by an OR Nurse that there was going to be a Physician scrubbing in; she asked if this Physician was licensed and credentialed; and someone said that Physician #2 was contacting the CEO for temporary privileges. She stated, "He [father of Patient #1] was on the patient's left side and pulled the fascia apart...I handed him the blue bulb and he suctioned the baby...he was an assist...I handed him a Kelly clamp too." On 10/9/19 at 10:31 AM, the Chief Medical Officer was interviewed. When asked why the POC, dated April 19, 2019, apparently wasn't working, she stated, "I think we are as puzzled as you are...it is an unusual situation...additionally the basic criteria for temporary privileges would not have been met anyway...we are looking at potential remedies..we have talked about disciplinary action; who can scrub and who cannot; people related to a patient being involved in the care; and continue to look to get clear guidance regarding should family care for a patient."
A0353 Medical Staff Bylaws
482.22(c)
Corrected On: 12/08/2019
09447 Based on document review and interviews, the facility failed to ensure that the Medical Staff enforced the York Hospital Bylaws to carry out its responsibilities for 1 of 1 physicians. Finding: The "York Hospital 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 professional who continuously meet the qualifications, standards, and requirements et 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 Regulations, and Policies of the Medical Staff and any other 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 charter, 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 ensure the Medical Staff and the Board of Trustees that any patient treated by them in Hospital will be given a high degree of patient care, shall be considered for appointment to the Medical Staff. The "York Hospital Privileging & State Licensure Attestation" forms, signed by Physician #1 on 4/22/19 and signed by Physician #2 on 4/16/19, were reviewed. The forms stated, "I acknowledge that I understand that all Qualified Medical Providers (QMP) caring for patients at York Hospital are required to be licensed in the State of Maine. This includes circumstances involving Emergency and Temporary Privileging." On 10/7/19 at 1:26 PM, Physician #1, who was the Anesthesiologist, was interviewed regarding the presence of Patient #1's father in the OR on 8/13/19. He stated the following: "I was present. I was the Anesthesiologist on the case...in retrospect, I should have been concerned as I am the last gatekeeper.". "I asked Physician #2 if the patient's father had temporary privileges and Physician #2 said that the CEO [Chief Executive Officer} needed to be contacted...I did not close the loop with Physician #2...the need for Maine licensure was not up front with me...the father did touch the patient and then baby..I'm sorry..I'm in the wrong." On 10/7/19 at 2:33 PM, Physician #2, who was the attending Surgeon, was interviewed. She stated the following: "Physician #1 called me the morning of the surgery [8/13/19] about the patient's father being in the OR because someone was concerned...I was not thinking about anything except two years ago the same scenario occurred and I got permission for the father to be in on the birth..in hindsight I didn't revisit the situation..in my mind the father was not assisting..the father did touch a retractor and he took the baby and gave it to Patient #1...it is an unusual request and my fault for fighting for my patient...I never even thought there would be an issue due to two years ago it was okay...if someone had come to me with concerns...it was like they were waiting for me to do something wrong...in my mind the father had a medical license and he did the same as a student would do...I'm 100% responsible...I allowed him to scrub..I didn't really think about it." On 10/8/19 at 12:16 PM, OB Nurse #1 was interviewed. She stated the following: "People were confused about what to do...it was unclear if he [Patient#1's father] had privileges...when the Director of Family Care asked Physician #2 about this the physician replied "it's taken care of""..the procedure was performed and the father definitely had his hands on [the patient] to assist Physician #2, and he was the first one to pick up the baby...I then put the baby in the warmer and the Dad left." On 10/8/19 at 1:05 PM, a Certified Surgical Technician was interviewed. She stated the following: she was told by an OR Nurse that there was going to be a Physician scrubbing in; she asked if this Physician was licensed and credentialed; and someone said that Physician #2 was contacting the CEO for temporary privileges. She stated, "He [father of Patient #1] was on the patient's left side and pulled the fascia apart...I handed him the blue bulb and he suctioned the baby...he was an assist...I handed him a Kelly clamp too." On 10/9/19 at 10:46 AM, another interview was held with the Director of Family Care to clarify some issues. The Director was asked if she had called Physician #2 about the fact that the father of Patient #1 had not been credentialed and she stated, "I called Physician #2 about 6:45 AM, before the patient left the Unit after I checked for credentials online and there were none...another nurse had paged Physician #2 and when the phone rang I answered it...I said the patient's father is assisting and Physician #2 said, "none of my business" and that if the OR had a problem they could call her directly...it was a bad connection and whatever else she said was garbled." On 10/9/19 at 11:10 AM, the CEO was interviewed. He stated, "I wasn't concerned that the patient's father would be observing and I had no indication that the patient's father would participate...the Acting Chief Nursing Officer told me that the father was scrubbing in but I thought everyone scrubbed in...he also told me that the father broke scrub by touching his glasses...I had no idea that two members of this medical staff would allow this to happen [an unlicensed and not privileged individual]...the absurdity that the two staff members let it happen."