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Based on information obtained through staff interviews and record reviews, the hospital failed to ensure that accountability and responsibility for the qualifications, conduct, and oversight of an individual's clinical practice was reviewed by an appropriate privileging body or clinical department.

Refer to Tags: A-0049 and A- 0338

Based upon staff interviews and record reviews, the hospital's Governing Body failed to ensure that the medical staff demonstrated accountability for the delineation of privileges for an individual who provides specialized care for patients who undergo cardiac procedures. Findings include:

Based on staff interview, it was confirmed that a job classification, a review of qualifications, and determination of responsibilities were not presented to the medical staff for credentialing, or to the Governing Body for approval, for an individual who has practiced as a member of a cardiac interventional team since 2003. For the past 7 years this individual, who is also an RN (RN #1), has not received a written evaluation, was not required to complete yearly mandatory competencies and has functioned without a job description in a role which the Governing Body was not aware existed.

Per interview on 1/12/11 at 11:00 AM, the Chief Medical Officer (CMO), who is responsible for the Institute of Quality as well as the Medical Staff, confirmed the Governing Body is "...extremely engaged in the credentialing process". The CMO also stated two members of the governing body attend every credentialing meeting, bringing all information back to the Governing Body for review and consideration prior to approval of any appointments or reappointments. The CMO confirmed the hospital medical staff are "...well aware" of the credentialing process and the Medical Bylaws. The Clinical Leader and/or Health Care Service Leader, also known as the Chair of a Department for each of the clinical services offered at the hospital, was identified by the CMO as the responsible person to ensure staff within their departments are privileged and/or have medical staff membership. At the time of this interview, the CMO stated the Governing Body was not aware of the issues related to RN #1, stating "...we missed this".

Per interview on 1/12/11 at 10:05 AM, the Health Care Service Leader/Chief of Cardiology confirmed RN #1's role on the cardiac arrhythmia service is "unique". The physician stated RN #1 was a highly skilled team member but "...a little unusual because s/he's not a provider; not a physician and not an advanced practice nurse". The Chief of Cardiology also stated "If we did not have [RN #1] we would need to have 2 Electrophysiologists... due to the complex ablations which require 2 people to work very closely in tandem with each other". However, despite the lack of credentialing, this individual was provided the opportunity to perform and assist the attending physician in highly technical interventional cardiac catheter ablation for atrial fibrillation (a technique used to destroy parts of the abnormal electrical pathway that is causing a heart rhythm problem). The Chief of Cardiology also confirmed RN #1 "...was not getting traditional oversight" for the clinical services s/he was specifically providing. In relation to the Governing Body's approval process and accountability of the medical staff to request a review for privileging RN #1, the Chief of Cardiology stated "...it had fallen within the cracks...". Per review, the Medical Staff Rules and Regulations, adopted 12/21/10, state "Health Care Service Leaders are responsible for ensuring that all members of the Medical Staff assigned to their service are subject to ongoing professional practice evaluations".

Per interview on 1/12/11 at 8:55 AM, the Manager of Medical Staff Operations (who is designated by the hospital to carry out the duties specified in the Medical Staff Bylaws) stated RN #1 should have been brought through the credentialing process as an "Allied Health Care Professional" (referencing Article IX of the Medical Staff Bylaws revisions approved/adopted 12/21/10). When informed RN #1 was not hired by the hospital in 2003, but continues to provide patient care as a member of the interventional cardiac catheter ablation team, the Manager acknowledged "...thus lies the problem". The process for credentialing involves several steps including a review of the application, in accordance with the Medical Staff Bylaws, before a professional is considered for employment and eventual recommendation to the Governing Body for credentialing and appointment. It was also confirmed by the Manager of the Medical Staff Operations that because RN #1 had not been appropriately credentialed, there was no ongoing process to assure his/her clinical competencies, normally reviewed during the reappointment process, every two years, as well as through a mid cycle evaluation to assure each appointee is meeting the minimal job requirements.

When a credential file was requested for RN #1, surveyors were provided with a Faculty Evaluation file from an affiliated University through which the hospital has an agreement for educational programs. RN #1's most recent reappointment (dated 3/1/2010) was as a Research Associate. RN #1 stated in the Faculty reappointment application that his/her responsibilities included teaching, research and services professionally related: "Involved in mapping and ablating complex atrial and ventricular arrhythmias. Assisting the faculty Electrophysiologists extends the capability of the service. If I were not present then 2 Electrophysiologists would be required for each procedure". In addition, when RN #1 was first being considered for the role s/he is presently functioning in, the Director of Cardiac Electrophysiologists stated in a letter to the Chief of Cardiology, dated May/2003 " [His/her]participation in clinical EP (electrophysiology) procedures will be under the direct supervision of an EP faculty with credentials to perform EP procedures". No credentialing was ever brought forth, at that time or in the 7 years since, to the Medical Staff, nor was a request for a review of the RN's eligibility brought to the Governing Body for review as referenced in the Medical Staff Bylaws Article IX 9.1

Per interview on 1/13/11 at 2:54 PM, the Director of Cardiac Electrophysiology confirmed RN #1's title was Research Associate and is a "Primary assist in ablation procedures where (the RN) performs essentially every aspect of the procedure. (RN #1) performs ablations". The Director further stated RN#1 would be accountable to the Director who is then accountable to the Chief of Cardiology. However the Director added " I' am not sure that is the way it is; it isn't in writing; it's just the way I understood it to be."

Based on interview and record review, hospital staff failed to implement the Grievance policy in response to an unresolved patient complaint for Patient #1. Findings include:

Per record review, during an outpatient physician visit following a clinical procedure performed at the hospital's Cardiac Catheter Lab, Patient #1 had expressed concerns to the participating physician (Physician #1), regarding care and services provided during the procedure. The medical record revealed information that indicated that although Physician #1 had attempted to address the patient's concerns, s/he was aware that the patient was clearly not satisfied with the physician's response and attempt to resolve the issues identified. Despite the knowledge that s/he was unable to resolve the patient's complaint, there was no evidence that Physician #1 had referred the complaint on to Patient/Family Advocacy for further review, in accordance with the facility's policy. The policy, titled Customer Feedback Policy, stated under the Complaints section: 3. Staff persons receiving the complaint shall: "Refer complaints...if the staff person does not have the knowledge or authority to resolve the complaint or if the staff person is unable to resolve the complaint to the complainant's satisfaction."

During interview, at 9:56 AM on 1/13/11, the Manager of Patient/Family Advocacy confirmed that the complaint voiced to Physician #1 had not been referred to their department.

During a telephone interview at 2:54 PM on 1/13/11, Physician #1 confirmed that Patient #1 had not been satisfied with his/her response to the patient's complaints, and further confirmed that s/he had not referred the complaint to Patient/Family Advocacy, acknowledging that; "...it never crossed my mind" but "...that's a good idea."

Based on staff interview and record review, the facility failed to identify a significant quality deficient practice involving the ongoing clinical practice of an individual for whom there was no appropriately defined accountability and responsibility for the delineation of that clinical practice. Findings include:

Based on information obtained through staff interviews and record reviews, there was an ongoing failure over a 7 year period from 2003 through 1/13/11, to identify the lack of accountability and responsibility for the conduct and oversight of the clinical practice of an individual (RN #1) who held a current RN license and who performed specialized clinical services for patients in the Cardiac Cath Lab. Although RN #1 began to participate in clinical practice in 2003 with no defined job classification, no review of qualifications or determination of to whom s/he would be accountable to for their practice, the hospital failed to identify these issues. In addition, although RN #1 continues, to date, to participate in the same clinical role as a member of a cardiac interventional team, the facility has continuously failed to identify and recognize that for the past 7 years this individual has not received a written evaluation, was not required to complete yearly mandatory competencies and has functioned without a job description in a role which the Governing Body was not aware existed.

The Nurse Manager for Cath and Invasive Cardiology during interview on the afternoon of 12/20/10, stated RN #1 was not a hospital employee and did not fall under nursing purview for oversight of their clinical practice, but was, instead, under the direct supervision of one of the cardiologists. Per interview on 1/11/11 at 2:25 PM the VP of Nursing Operations stated that the Nurse Manager for Cath and Invasive Cardiology had recently started to look at RN #1's role from an RN scope of practice and found it was indeed different than what the nurses in the cardiac lab were doing. The VP of Nursing Operations further stated that it was his/her understanding that RN #1 was only involved in the technical aspect of the procedure; not performing nursing duties; but only performing those aspects of ablation that the VP of Nursing Operations had, inaccurately, assumed RN #1 had been credentialed to perform by the Medical Staff.
Per interview on 1/12/11 at 10:05 AM the Health Care Service Leader/Chief of Cardiology confirmed RN #1's role on the cardiac arrhythmia service is "unique". The physician stated RN #1 was a highly skilled team member but "...a little unusual because [RN #1 is] not a provider; not a physician and not an advanced practice nurse". However, despite the lack of credentialing, this individual was provided the opportunity and responsibility to perform and assist the attending physician in highly technical interventional cardiac catheter ablations (a technique used to destroy parts of the abnormal electrical pathway that is causing a heart rhythm problem). The Chief of Cardiology also confirmed RN #1 "...was not getting traditional oversight" for the clinical services h/she was specifically providing. In relation to the Governing Body's approval process and accountability of the medical staff to request a review for privileging for RN #1, the Chief of Cardiology stated "...it had fallen within the cracks...".

Per interview on 1/12/11 at 8:55 AM, the Manager of Medical Staff Operations (who is designated by the hospital to carry out the duties specified in the Medical Staff Bylaws) stated RN #1 should have been brought through the credentialing process as a "Allied Health Care professional" (referencing Article IX of the Medical Staff Bylaws revisions approved/adopted 12/21/10). S/he also confirmed that because RN #1 had not been appropriately credentialed, there was no ongoing process to assure his/her clinical competencies, normally reviewed during the reappointment process, every two years, as well as through a mid cycle evaluation to assure each appointee is meeting the minimal job requirements.

Based upon staff interviews and record reviews, the Condition of Participation: Medical Staff was not met as evidenced by the medical staff's failure to implement the Medical Bylaws for the delineation of privileges for an individual who provides specialized care for patients who undergo invasive cardiac procedures. Findings include:

Based on staff interview, it was confirmed that a job classification, a review of qualifications, and a determination of responsibilities were not presented to the medical staff for credentialing, or to the Governing Body for approval for an individual (RN #1), who has practiced as a member of a cardiac interventional team since 2003. For the past 7 years, RN #1 has not received a written evaluation, was not required to complete yearly mandatory competencies and has functioned without a job description. In addition, the Governing Body was not aware that the role existed.

Per interview on 1/12/11 at 11:00 AM, the Chief Medical Officer (CMO) who is responsible for the Institute of Quality, confirmed that the Medical Staff did not initiate the process for delineation of clinical privileges for RN #1 in accordance with the credentialing process identified in their Bylaws. The CMO stated the Governing Body is "...extremely engaged in the credentialing process", and that two members of the Governing Body attend every credentialing meeting bringing all information back to the Governing Body for review and consideration prior to approval of any appointments or reappointments. The CMO confirmed the medical staff are "...well aware" of the credentialing process and the Medical Bylaws. The Health Care Service Leader, also known as the Chair of a Department for each of the clinical services offered at the hospital, was identified by the CMO as the responsible person to ensure staff within their departments are privileged and/or have medical staff membership. At the time of this interview, the CMO stated the Governing Body was not aware of the issues related to RN #1, stating "...we missed this" and "This is surprising to me".

Per interview on 1/12/11 at 10:05 AM the Health Care Service Leader/Chief of Cardiology confirmed RN #1's role on the cardiac arrhythmia service is "unique". The physician stated RN #1 was a highly skilled team member but was not a provider; not a physician and not an advanced practice nurse. However, despite the lack of credentialing, this individual was provided the opportunity and responsibility to perform and assist the attending physician in highly technical interventional cardiac catheter ablations (a technique used to destroy parts of the abnormal electrical pathway that is causing a heart rhythm problem). The Chief of Cardiology also confirmed RN #1 "...was not getting traditional oversight" for the clinical services h/she was specifically providing. In relation to the Governing Body's approval process and accountability of the medical staff to request a review for privileging for RN #1, the Chief of Cardiology stated "...it had fallen within the cracks...".

Per interview on 1/12/11 at 8:55 AM, the Manager of Medical Staff Operations (who is designated by the hospital to carry out the duties specified in the Medical Staff Bylaws) stated RN #1 should have been brought through the credentialing process as a "Allied Health Care Professional" (referencing Article IX of the Medical Staff Bylaws revisions approved/adopted 12/21/10). When informed RN #1 was not hired by the hospital in 2003, but continues to provide patient care as a member of the interventional cardiac catheter ablation team, the Manager acknowledged "...thus lies the problem". The process for credentialing involves several steps, including a review of the application in accordance with the Medical Staff Bylaws before a professional is considered for employment and eventual recommendation for credentialing and appointment. It was also confirmed by the Manager of Medical Staff Operations that because RN #1 had not been appropriately credentialed, there was no ongoing process to assure his/her clinical competencies, normally reviewed during the reappointment process every two years, as well as through a mid cycle evaluation ensuring the minimal job requirements were met.

Based on staff interviews and record review, the facility failed to delineate responsibility and accountability for the clinical nursing practice of an individual who held a current RN (Registered Nurse) license and who performed specialized clinical services for patients in the Cardiac Cath Lab. Findings include:

Per interview at 1:33 PM on 12/20/10, RN #1 stated that s/he had worked in the Cardiac Cath Lab assisting in the performance of cardiac ablation procedures since 2003. The RN stated that cardiac ablations are performed by a team of individuals including a physician, nurses and at times an anesthesiologist, who is present when the patient is undergoing an Atrial Fibrillation ablation.. S/he further stated that the role in which s/he worked was similar to that of "a first assist in surgery" and it takes a team to do the procedure. The nurse further stated one team member manipulates the catheter, another member is running the stimulator and another is creating the 3-D image on the computer. RN #1 confirmed he is the only nurse involved in this specific procedure.

The Nurse Manager for Cath and Invasive Cardiology stated, during interview on the afternoon of 12/20/10, that RN #1's was not a hospital employee and did not fall under nursing purview for oversight of their clinical practice, but was, instead, under the direct supervision of one of the cardiologists.
Per interview on 1/11/11 at 2:25 PM, the VP of Nursing Operations stated that the Nurse Manager for Cath and Invasive Cardiology had recently started to look at RN #1's role from an RN scope of practice and found it was different than what the nurses in the cardiac lab were doing. S/he further stated that it was his/her understanding that RN #1 was only involved in the technical aspect of the procedure; not performing nursing duties; but only performing those aspects of ablation that the VP of Nursing Operations had, inaccurately, assumed RN #1 had been credentialed to perform by the Medical Staff.
Per interview at 2:19 PM on 1/11/11, the Director for Clinical Services and Training stated that s/he had been employed in the role of Supervisor of the Cardiology Practice in 2003 at the time that RN #1 was being considered for a position in the Cardiac Catheter Lab. S/he stated that there had been discussion, at that time, of where RN #1 would fit, as there was a very clear research component to his/her role and eventually s/he was placed in a research associate role with the affiliated university.

Based on observation, interview and record review, the infection control department failed to ensure the maintenance of a sanitary environment on McClure I in the Cardiac Catheterization/ Ablation special procedure room. Findings include:

During a tour of the Cardiac Catheterization/ Ablation special procedure room on 1/12/11 at 2:10 PM, the floor was soiled with debris and a reddish brown stain of unknown origin was noted on the base of a monitor stand positioned beside the procedure table. The nurse manager for cardiac catheterization and invasive cardiology stated, at that time, that nursing staff is responsible for cleaning the room in between cases, and at the end of each day dedicated housekeeping staff would provide daily terminal care of the room in the evening. A follow up tour of the same room was conducted on 1/13/11 at 8:17 AM, prior to the first scheduled procedure of the day. Despite the fact that Nurse #2, present during the morning tour, confirmed that housekeeping had been in the room because the trash had been emptied, the floor was still soiled and there was debris and a build up of grime around the columns supporting the procedure table. The rest of the floor still had debris including packing stickers and stains, and there was a layer of dust surrounding all 4 sides of a ridge on the gas column where the anesthesia equipment is stored and utilized. In addition, the stain on the base of the monitor equipment stand, initially noted during tour on the afternoon of 1/12/11, remained. When surveyors asked to have the base of the stand cleaned, the nurse educator for the Cardiac Cath Lab who was present during the observations, failed to don gloves and, using a disinfectant wipe towel, cleaned the stain from the stand with bare hands. It was agreed the stain was either Betadine solution or blood.

Also observed during the morning tour, there were cables attached to cardiac mapping equipment, used during the ablation procedure, that were noted to be stained with dried blood. The nurse acknowledged it is the responsibility of the nursing staff to clean the cables after each procedure and commented that "...the cables do not touch the patients..." However, staff who handle the cables could then conceivably touch the patient and other environmental surfaces within the room, potentially contaminating everything touched.

The Training and Development Supervisor for Environmental Services confirmed on 1/13/11 at 8:40 AM, that the room required deep cleaning and what was observed on the floors especially around the special procedure table had been there for "...definitely more than one day".

Per interview, on 1/13/11 at 12:27 PM, the Infection Control Manager confirmed Environment of Care safety audits are conducted throughout the hospital, twice yearly, and that the most recent inspection/audit of the Cardiac Catheterization/Ablation special procedure room was completed on 12/2/10. When informed of the observations made earlier in the day, the comment by one of the nurses in the Cath lab regarding blood found on cables and the failure of another nurse to wear gloves when cleaning unknown substance on an environmental surface, the Infection Control Manager stated it was "...concerning".

Reference: CDC/HICPAC Guidelines for the Disinfection and Sterilization in Healthcare Facilities 2008/Disinfection of Healthcare Equipment.