HospitalInspections.org

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Based on observation, interview, and review of documents, the hospital failed to ensure a competency and skills validation was completed for perioperative support technologists II.
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Failure to ensure competency and skills validation for perioperative technologists, placed patients at risk for anesthesia complications due to unqualified staff participating in the anesthesia procedures.

Reference: WAC 246-827-0400 -Medical assistant-phlebotomist, "(1) Successful completion of a phlebotomy program through a postsecondary school or college accredited by a regional or national accrediting organization recognized by the U.S. Department of Education; or (2) Successful completion of a phlebotomy training program. The phlebotomy training program must be approved by a health care practitioner who is responsible for determining the content of the training and for ascertaining the proficiency of the trainee. The phlebotomy training program must include the following: (a) Training to include evaluation and assessment of knowledge and skills to determine entry level competency ...(c) Documentation of all phlebotomy training, duties, and responsibilities of the trainee must be completed, signed by the supervising health care practitioner and the trainee, and placed in the trainee's personnel file."

Findings include:
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1. A review of the hospital's job description titled, "Perioperative Support Technologist II (PST)," Effective: 05/16/14, listed the required certifications for this position, to include but not limited: "BLS, successful completion of the Swedish Medical Center Anesthesia Tech Training program within the first 90 days, Washington State Medical Assistant Phlebotomist certification acquired within 90 days of employment. ACLS, EMT, Paramedic, RT, Medical, prior HCA licensing preferred. Anesthesia Tech certification through ASATT preferred. ACLS/PALS required within 18 months."

2. During an interview, with Surveyor #4 on 04/05/17 at 10:45 AM, Staff B, PST Manager, stated, "We hire personnel based on their clinical experience and train staff on the job." And "based on their experience, the trainee's orientation may last from 3 days to 2 weeks." Each PST is certified by the state as a medical assistant phlebotomist. Staff C stated that the required phlebotomy training is completed by asking the trainee five clinical questions, then he/she observes the trainee once. After training and orientation is completed the anesthesia tech then submits the medical assistant phlebotomist application to the state for approval.

3. On 04/11/17 at 10:20 AM, Surveyor #4 reviewed the personnel files for operating room staff. A review of two PST staff (Staff D, Staff E) files showed no documented evidence of evaluation or assessment of their knowledge and skills to determine competencies as required.

4. The above findings were verified with Staff C, Administrative Director Clinical Education & Practice.

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37396

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Based on observation, interview, and document review, it was determined that the hospital failed to meet the requirements at 42 CFR 482.21 Condition of Participation for Quality Assessment and Performance Improvement.

Failure to systematically analyze adverse patient events, respond to hospital staff concerns can lead to missed identified adverse events, overlooked causes and missed opportunities to implement preventative actions.

Findings include:

Due to the scope and severity of the deficiencies detailed under 42 CFR 482.21 Conditions of Participation for Quality Assessment and Performance Improvement, the Condition of Participcation for Governing Body was NOT MET.

CROSS REFERENCE: Tag A- 263 ITEMS #1, #2, #3, #4

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Based on document review and interview, the hospital failed to ensure that physicians and licensed independent practitioners had evidence of required training regarding the use of restraints and seclusion.

Failure to ensure required training placed patients at risk for physical and psychological harm, loss of dignity, and violation of patient rights.

Findings include:

1. The hospital's policy titled, "Education/Orientation of Credentialed Practitioners Regarding the use of Restraint and Seclusion" dated 05/2016 stated "2. The application also contains a form, Regulatory Compliance Document (RCD), which includes the reference to the Restraint or Seclusion Management Clinical Procedure, and the applicant attests to the information received."

The policy further indicated that "5. Every two years credentialed practitioners are required to complete a reappointment application to maintain medical staff membership and privileges, contained in the reappointment application is the Regulatory Compliance Document (RCD), which includes the reference to the Restraint or Seclusion Management Clinical Procedure, and the applicant attests to the information received."

2. On 04/12/17, Surveyor #1 reviewed ten physician and two licensed independent practitioner (LIP) reappointment files. There was no attestation form or evidence of restraint training for the physicians and LIPs.

3. On 04/12/17, at 10:00 AM, Surveyor #1 interviewed the Director of Medical Staff Services (Staff L) regarding the initial and reappointment process for training credentialed practitioners. He/She stated that the hospital was in the process of implementing the attestation form for both the initial and reappointment credentialing process. He/She confirmed the files did not contain the attestation forms.
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Based on interview and document review, the hospital failed to ensure direct consultation regarding the quality of medical care with the leaders of the organized medical staff.

Failure to ensure direct consultation regarding the quality of medical care with the leaders of the organized medical staff, placed the hospital at risk for continued patient safety issues that could result in patient harm.

Findings include:

1. Throughout the course of the investigation, Surveyors #1 and #2 interviewed past and current leaders of the organized medical staff. Individuals interviewed indicated that the leaders of the organized medical staff did not have periodic direct consultations with the Swedish Board of Trustees. Individuals interviewed indicated they did not have an opportunity or avenue to address medical staff concerns regarding quality of care. Specifically, the individuals indicated they could not bring forward concerns regarding the Swedish Neurosciences Institute.

2. On 4/6/17, Surveyor #1 reviewed an email dated 10/29/2010 from the Providence Corporate Counsel (Staff S) to three Swedish non-physician staff members. This email stated that the role of the Board Quality Oversight Committee (QOC) "needs to stay informed about quality work of medical staffs". There email did not address the requirement for periodic direct consultation with the leaders of the organized medical staff.

3. On 4/11/17, Surveyor #1 reviewed the Charter for the "Board Quality Oversight Committee" approved May 25, 2010. The document did not address the requirement for periodic direct consultation with the leaders of the organized medical staff and the Swedish Board of Trustees. Minutes were not available for the 2013-2016 Swedish Board Quality Oversight Committee.

4. On 4/11/17, Surveyor #1 reviewed the 2013-2016 Swedish Board of Trustees minutes. The review did not reveal any evidence of periodic consultation with the leaders of the organized medical staff.

5. During the investigation, no policies and procedures addressing the requirement for periodic direct consultation with the Governing Body and the leaders of the organized medical staff were produced.

6. The above findings were verified by the interim Chief Executive Officer for Swedish Health System (Staff R), Director Medical Staff Services (Staff L) and the Chair of the Swedish Board of Trustees (Staff O).
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Based on interview and document review, the hospital failed to ensure that representatives of the organized medical staff participated in the development of the institutional plan and budget.

Failure to ensure representatives of the medical staff participated in the development of the institutional plan and budget created risk that critical patient services could be overlooked or lacking.

Findings include:

1. On 4/12/17, at 1:00 PM, Surveyor #1 interviewed the Chief Executive Officer for Swedish Seattle (Staff T). The interview revealed that representatives of the executive staff and Board of Trustees participated in the development of the institutional plan and budget. Representatives of the medical staff were not included in the process.

2. On 4/13/17, Surveyor #1 reviewed the 2016 Medical Executive minutes and the 2016 Board of Trustees minutes. The minutes did not contain evidence of involvement of representatives of the medical staff in the institutional plan and budget. Minutes were not available for the 2016 Swedish Board Medical Affairs Committee.
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Based on interview and document review, the hospital failed to ensure there was a mechanism to evaluate the quality of each contracted service.

Failure to ensure each contracted service performed in a safe and effective manner created risk for the hospital's ability to assess and correct any potential problems with the contracted service thus placing patients at risk of harm.

ITEM #1 EVALUATION OF CONTRACTED SERVICES

Findings include:

1.On 4/4/17, Surveyor #1 reviewed the policy, "Services Contracts: Selection and Evaluation" December 2016. The policy stated under Evaluating the Contract (1), "an auto-generated notification from the Contract Management system will notify the designated leader 120, 90, 60 and 30 days prior to the expiration date of the contract. This notification initiates the annual review of the designated contract that must be completed prior to the expiration date".

2. On 4/4/17, at 10:35 AM Surveyor #1 interviewed the Contracts Support Coordinator (Staff K) and the Manager, Corporate Compliance (Staff V). The interview revealed that each contract was to be reviewed annually by the designated contract owner using the "Contract Evaluation: Patient Care Services" form. Upon completion of this form, the form was to be sent to the Contract Support Coordinator (Staff K) to be uploaded into the Contract Management System.

3. On 4/4/17, Surveyor #1 reviewed the contract for psychiatric services provided by a local hospital. The contract was originally signed in 2005. There was no annual review completed for the past three years.

4. On 4/4/17, Surveyor #1 reviewed the contract for professional services provided by Group Health Permanente. The contract was signed 2/29/16 with an expiration date of 2/28/17 with an automatic renewal. There was no annual review completed for the contract.

5. The above findings were confirmed by the Contracts Support Coordinator (Staff K) and Manager, Corporate Compliance (Staff V).

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Based on Interview and document review, the hospital failed to ensure the contracted services were included in the overall hospital quality assessment and improvement plan.

Failure to ensure contracted services were included in the overall hospital quality assessment and improvement plan created risk for the services not be performed in a safe and effective manner.

ITEM #2 QUALITY ASSESSMENT AND PERFORMANCE IMPROVEMENT PLAN

Findings include:

1. On 4/4/17, Surveyor #1 reviewed the "Swedish Quality Management System Plan" approved March 1, 2017. The plan did not include quality data and evaluation of contracted services.

2. On 4/11/17, Surveyor #1 reviewed the Charter for the "Board Quality Oversight Committee" approved May 25, 2010. The document stated under "3. Performance Oversight....Assure that the performance of outsources services meets the quality standards of the organization".

3. On 4/11/17, Surveyor #1 reviewed the 2016 Swedish Hospital Quality and Safety Committee minutes, 2016 Swedish Board Quality and Safety Committee minutes, and 2016 Swedish Board of Trustees minutes. Minutes were not available for the 2016 Swedish Board Quality Oversight Committee. The review revealed that quality data and evaluation of contracted services were not present in the minutes.

4. On 4/6/17 at 10:10am, Surveyor #1 interviewed the Director Quality Management System (Staff P). He/She confirmed that the Swedish Quality Management System plan for 2017 did not address contracted services. He/She stated that the hospital had developed but not implemented a process for quality data and evaluation of contracted services to be submitted to the Swedish Hospital Quality and Safety committee. This would then be reported up to the Swedish Board Quality and Safety Committee, the Swedish Board Quality Oversight Committee and then the Swedish Board of Trustees. The plan was to implement this process in 2017.

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Based on record review and review of policy and procedure, the hospital failed to demonstrate that it implemented immediate safety measures by ensuring a timely emergency call (Code Blue) for a patient that had a respiratory arrest.

Failure to do so created risk for injury and resulted in a poor resuscitation outcome and subsequent patient death.

Findings include:

1. In review of hospital policy titled, "Code Blue: Adult" (Approved January 2011) it stated on page 1 of 11, "A Code Blue is initiated to activate the response team for any medical emergency, as outlined by policy, whether the patient, visitor or staff member is in need of cardiopulmonary resuscitation (CPR) or any other urgent medical assistance."

On page 3 of 11, it stated under "All Staff", "Responsible for notifying the operator by telephone..."Under Staff RN (patient's primary care nurse) it stated "1. Identify unresponsiveness and call for Code Blue. . . .Intitiate use of breathing device or resuscitation bag with oxygen at 15 liters per minute.on page 4 "Under Emergency Department Physician" it stated for Cherry Hill: ". . . anesthesia calls the nursing supervisor to verify if airway management is needed. On page 5 under "Respiratory Care Practitioner it stated, "Manage airway" and "Help oversee adequate oxygen delivery." Under anesthesiologist for Cherry Hill it stated, "Call nursing supervisor to ask if intubation is needed." Many other responder duties were also identified.

The policy did not provide information about required response time from identification of the problem until the time that a Code Blue was called and/or the expected response times of designated responders. Codes for cardiopulmonary resuscitation require full and immediate response.

2. Patient #1 was admitted on 2/10/14 for multilevel spine fusion surgery and a foramen magnum decompression (surgery on bone at the base of the skull). On the day of surgery and on his/her first post-operative day, the patient complained of a sensation of difficulty breathing, severe pain and nausea. His/her lower jaw was in a forward and fixed position and the patient was unable to open her/his his mouth with normal range of motion. The patent had a respiratory arrest in the afternoon on 2/11/14.

On 2/11/14 at 10:57 AM, a speech language pathologist (SLP) (Staff # AA) evaluated the patient. He/she noted the patient positioning on her/his left side due to breathing difficulty when in a back lying position. He/she also noted an "Abnormal under-bite [jaw] occlusion, new to patient since surgery. Unable to open mouth ...Unable to open mouth more than 1 cm [centimeter]". In the "Impairments/Functional Limitation" section, the SLP noted "Mandibular positioning affecting breathing and swallow." He/she also noted problems with movement of oral secretions and other swallowing abnormalities. A plan was made to proceed with single feedings of ice chips and to see the patient the next day. The record did not contain information about discussing findings with other members of the health care team.

3. On 5/2/17 at 1:30 PM Surveyor #3 interviewed two family members (#1 and #2) who noted that immediately after surgery (on a medical surgical floor) that the patient's lower jaw was in a fixed and forward position, not present before surgery. They were aware that the patient had a sensation of difficulty breathing and were concerned about that. The patient had communicated the sense of breathing difficulty with staff members accordingly.

a. On 5/11/17 at 1:00 PM Surveyor #3 interviewed the speech and language therapist that cared for Patient #1 on 4/11/14. The therapist recalled that he/she could not examine the patient's throat because the patient could not open his/her mouth for an examination. The SLP further stated the patient's teeth were fully clenched and he/she could not move an oral swab beyond the outside of the teeth.

When asked if he/she communicated the outcome of his/her evaluation with any team members, the therapist stated he/she notified the patient's nurse. When asked if he/she would directly notify a physician in a situation like this, the therapist stated that during that time period he/she was not comfortable calling physicians (and at times unaware of whom to call) and tended not to do that. He/she thought other team members already knew about the patient's problem because it was "so obvious".

b. In an interview between Surveyor #2 with the advanced registered nurse practitioner (ARNP) (Staff Y) on 4/18/17 at 11:00 AM, the nurse stated that he/she was the sole hospital provider present at the bedside when the patient stopped breathing. The ARNP asked the charge nurse (Staff II) for an "ambu bag" for oxygen delivery and requested that he/she call a "Code Blue". The ARNP stated that he/she subsequently asked for anesthesia to be paged. Then a respiratory therapist (Staff BB) arrived prior to other team members and assisted (unsuccessfully) in trying to establish oxygen exchange for the patient. Subsequently, a NCCU MD (Staff Z) arrived who was also not able to ventilate the patient.

There was no documentation from respiratory therapy staff (2) present for the initial resuscitation ventilation efforts until the Code Blue team documentation began at 1:36 PM.

c. Family Member #1 was present in the NCCU when the patient had a respiratory arrest (stopped breathing). Family Member #1 stated that the event occurred at exactly 1:27 PM. Another family member (#2) reported he/she ran into the hallway immediately (at 1:26 PM) and called out to a staff member at the desk that help was needed because the patient could not breathe. The family member was told by a female staff member that "help" was "on the way". Several minutes later, Family Member #1 inquired of staff about why the code team had not arrived.

The family members stated from that time forward until the code team arrived, an ARNP (Staff Y) attempted to ventilate the patient with a bag/valve/mask but was unable to move oxygen into the patient's lungs. After other team members arrived, Family Member #1 stated that there were 3 or more physicians in the room for greater than 5-10 minutes before a procedure (cricothyrotomy) was performed in the patient's windpipe to restore blood oxygen levels.

4. In review of the medical record for Patient #1 titled, "Code Blue Documentation" the individuals who responded to the Code Blue response were not identified as a means to determine the adequacy of the response. There were several gaps in information related to progression of events and the patient response to those events.

The record indicated that the Code Blue documentation was initiated at 1:36 PM; which was one minute before the hospital operator system recorded calling the Code Blue (1:37 PM); and which was 9 minutes after the patient stopped breathing per the time report of Family Member #1. Oxygen exchange was restored at 1:49 PM per a procedure (cricothyrotomy [temporary airway placement in the windpipe]); which was 13 minutes after the code call was initiated and 22 minutes after the patient stopped breathing. The Code Blue resuscitation event was recorded as concluded at 1:53 PM.

5. In review of a hospital document titled, "Code Blue Huddle" for the event described above, several fields were left blank. "Under overall effectiveness of interventions" the section for "Other interventions completed in a timely manner? Please list other interventions" was left blank. The section for "Initial Rhythm" (heart rhythm) was left blank. The section titled "Precode Signs and Symptoms" was left blank including, "Failure to respond to treatment".

a. On 4/4/17 at 11:00 AM Surveyor #3 interviewed the Nurse Manager of the NCCU (Staff JJ) about the outcome of the Code Blue Huddle (team meeting to discuss resuscitation process needed improvements). The manager stated that the team huddle process did not identify any significant care issues related to the code, except for better labeling of the content of the drawers of the Difficult Airway Cart. Per Staff JJ, it was identified that the cart was at the room and ready for use during the resuscitation effort and there was not a delay in retrieving its contents.

When asked if the hospital staff engaged in any other reviews of how emergency care was executed, he/she stated that nothing else occurred involving hospital staff, including a formal root cause analysis (deep level case review to identify gaps in care).

b. On 4/10/17 at 3:30 PM Surveyor #3 interviewed a physician (Staff KK) who responded to the code with another physician. The physician stated that the cricothyrotomy kit was not called for until the patient's oxygen levels began to decline even though it had been established that the patient could not be intubated (tube placement into mouth, down throat into upper airway) due to jaw closure.

He/she stated that some time could have been saved by having the cricothyrotomy kit available in anticipation of its need. Additionally, he/she started that "frontline staff" should have "escalated" clinical information to the NCCU care team earlier. (However, the day nurse (Staff X) assigned to care for the patient was in contact with the NCCU team [ARNP and others] regarding the patient's complaints up to the time of the respiratory arrest.)

c. On 5/17/17 at 10:45 AM during an interview between Surveyor #3 and a RN (Staff II) in the NCCU, the nurse stated that the recorder for codes in the hospital was the charge nurse on another unit (3E). He/she thought 3E nurses already had responsibility to oversee the care of 39 patients and may not be routinely be readily available to assume emergent duties for Code Blue events throughout the hospital.

The nurse also stated he/she did not recall why a percutaneous tracheostomy was not emergently placed for the patient to restore oxygen levels.
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Based on record review and review of policy and procedure, the hospital failed to ensure that orders for the type of restraints were completed prior to applying restraints for 3 of 9 patients (Patients #2, #3, #4).

Failure to do so created risk for restricting patient movement without a medical order and for related patient injury.

Findings include:

1. In review of facility policy titled, "Restraint and Seclusion Management" (Approved November 2016) on page 4 of 12 in the "LIP" [licensed independent provider] section, item 2 specified the components of a restraint order. The 5th bulleted item identified the need for "The type of restraint device(s)/seclusion to be initiated".

2. In review of medical records the following omissions were noted for patients after cardiac surgery:

a. Patient #2 was admitted to 12/7/16, had a cardiac valve replacement and an order for physical restraints for the initial post-operative period. The type of restraint(s) was not identified and staff placed wrist restraints on the patient.

b. Patient #3 was admitted on 3/7/17 had the same type of surgery and there was a similar omission in the order for the restraint type. The staff placed wrist restraints on the patient.

c. Patient #4 was admitted on 3/12/16 and had coronary artery bypass surgery and had an order for physical restraints for the initial post-operative period. The type of restraint(s) was not identified and staff placed wrist restraints on the patient.
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37396

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Based on interview, record review, document review, and review of the hospital's quality program, the hospital failed to ensure that the program measured and analyzed adverse patient events, and failed to focus on physician/staff concerns related to the Neuroscience Institute operations.

Failure to systematically analyze adverse patient events, respond to hospital staff concerns can lead to missed identified adverse events, overlooked causes and missed opportunities to implement preventative actions.

Findings include:

1. Failure to analyze and provide feedback to managers when electronic quality variance reports (eQVRs) were completed.

2. Failure to develop and implement policies, procedures, and process that supports a "Culture of Safety" within the hospital.

3. Failure to implement preventative action plus develop a feedback mechanism for Medical Staff Fellows (physicians undergoing advanced specialty training) following an adverse event.

4. Failure to ensure that a harmful clinical event was identified and treated as an adverse event.

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Based on interview, record review and review of hospital policies and procedures, the hospital failed to analyze and provide feedback to managers when electronic quality variance reports (eQVRs) were completed.

Failure to analyze the eQVRs places the hospital at risk for continued care delivery issues which could impact patient safety and result in patient harm and death.

ITEM#1-ANALYSIS OF ADVERSE EVENTS

Findings include:

1. The hospital policy titled, "Electronic Quality Variance Reporting (eQVR) System", "Clinical and Administrative Policy" approved January 2013 showed that "The eQVR is the tool Swedish Medical Center (SMC) uses to document deviations from established processes and expected outcomes that negatively impact, or have the potential to negatively impact the care and safety of its patients"..."Managers of the area where the variance occurs are responsible for communicating with their supervisors and other departments that are involved in the event"..."To facilitate organizational learning, the department of Quality & Patient Safety manages the database and produces data to improve decision making".

2. The hospital job description titled, "Patient Safety Officer" job summary stated "Provides consultation, education, and administrative leadership related to patient safety, risk reduction, and loss prevention efforts".

3. Surveyor #2 reviewed thirty-six eQVRs with a date range from January 2013 through February 2017. Thirty of thirty-six eQVRs reviewed revealed while the eQVRs were referred on for either medical staff review or peer review which involved nursing staff there was no final determination of the outcome and if any preventive actions might prevent a reoccurrence of the incident.

4. On 3/23/17 at 7:33 AM a licensed nurse (Staff F) was interviewed by Surveyor #2. Staff F stated the eQVRs were completed by staff and managers but the supervisors did not provide feedback to direct care staff and managers about the actions taken to concerns brought about by the eQVRs.

a. On 3/23/17 at 11:05 AM a licensed nurse (Staff G) was interviewed by Surveyor #2. Staff G stated staff and managers would fill out the eQVRs but would not hear from supervisors about any investigation or actions in relation to the eQVRs.

5. On 4/4/17 at 10:00 AM a licensed nurse (Staff H) was interviewed by Surveyor #2. Staff H verified the above findings. Staff H stated managers were looking at the reports but no one higher up with the safety committee was analyzing the concerns consistently due to poor staffing in the safety department. Staff H stated managers can make referrals to Physician Peer review committee or the nursing department but the managers do not have the authority to make changes to improve patient care processes.

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Based on interview and document review, the hospital failed to develop and implement policies, procedures and processes that supported a "Culture of Safety" within the hospital.

Failure to have policies and processes that support a non-punitive/culture of safety approach to staff reporting unsafe working situations risks events which can result in patient harm and or death.

ITEM #2-CULTURE OF SAFETY

Findings include:

1. Review of the Swedish Medical Center document titled, "Code of Conduct" dated January 2015, showed that: "Disruptive Behaviors ...workforce members, medical staff members and allied health professionals are expected to treat others with respect and courtesy and to conduct themselves in a professional manner". The document showed under Leadership responsibilities "model ethical behavior and foster a culture of transparency by listening and being receptive to workforce members' and others' concerns about integrity and compliance -related matters".

2. Swedish Medical Center document titled "Employee Behavioral Standards" dated January 2008 showed that "The overriding spirit of these policies and expectations is to define and create a community that is positive and supportive of our patients and each other". The document showed in "Population Covered: All SMC (Swedish Medical Center) employees, contract employees, physicians, and temporary staff".

3. Review of the "Medical Staff Rules and Regulations" dated November 27, 2013 showed in "Section XXXIII Practitioner Behavior, 23.1.1 Medical Staff Members are expected to behave in a professional manner, showing respect to other individuals within Swedish Medical Center without exception. This is a basic tenet required to foster a culture of safety within the Hospital". The document further stated in 23.1. "Possible violations of this policy will be promptly investigated with the Hospital and Medical Staff taking appropriate corrective and remedial actions up to and including termination of membership and privileges. In addition, Medical Staff Members who are employees of Swedish are subject to all Hospital policies, including without limitation, the Non-Discrimination and Progressive Corrective Action policies".

4. Throughout the course of the investigation, Surveyors #1 and #2 interviewed past and current leaders of the organized medical staff. Individuals interviewed indicated the concerns regarding Staff I's professional behavior had been present since 2014. Staff I was credentialed as a member of the Medical Staff and employed as a physician by Swedish Health System. Examples of the behavior included yelling, shouting, swearing, sarcastic, and belittling behavior toward staff and threatening to fire staff. These concerns were attempted to be brought forth to Swedish Hospital Administration and the Swedish Board of Trustees without success.

5. On 4/11/17, Surveyors #1 and #2 reviewed the peer review file of a physician (Staff I). The file contained a memo dated 7/17/2014 from the leaders of the organized medical staff. The memo indicated there were 17 reports of unprofessional behavior over a period of 5 months. The memo stated that after a meeting with Staff I, the medical staff leaders "were disinclined to attempt corrective action plan...because of....lack of support by Swedish Administration".

6. On 4/11/17, Surveyors #1 and #2 reviewed the employment file of a physician (Staff I). There was no documentation of any behavior concerns present in the file.

7. A review of a document titled, "Cherry Hill SNI Surgical Program" showed that the cranial and spine surgical cases increased 102.4% from 2012 to 2016. The document showed that the case mix index (a measure of acuity of cases) increased 32.4% from 2012-2016. A review of the Swedish Board of Trustees minutes for 2013-2016 did not indicate a strategic or operational plan for the anticipated increase in volume and acuity.

8. Throughout the course of the investigation, Surveyors #1, #2, and #4 interviewed past and current employees of the neurosurgical operating area. These interviews reflected that Swedish Hospital administration had not promoted a "Culture of Safety" in addressing concerns with the increased surgical volume and other practices such as lack of supervision of medical staff/education fellows (physician undergoing advanced training) in the neurosurgical operating area and lack of participation of some attending neurosurgeons in the surgical Safety Pause (required briefing before the start of each surgery).

a. Individuals interviewed revealed ineffective communication between administration and physicians as well as between administration and direct care staff in the neurosurgical operating area. Staff members feared punishment and retaliation for voicing concerns. Staff members stated they were frequently bullied and intimidated for voicing concerns about the working conditions in the neurosurgical operating area. Staff members who voiced concerns were told "this is how it will be" and "we just have to make it work".

b. On 4/25/17 at 12:58 PM, Surveyor #2 interviewed Staff W, a licensed nurse. Staff W stated negative tension in neurosurgical operating area started towards the end of 2014. Administration was made aware of the issues; however, no one took charge to fix the situation. Surgeries were increasing in volume with no increase in staff which caused frustration for the staff and physicians. Issues with physician behavior (in particularly with Staff I) escalated and could have been addressed through the normal process for employed physicians. Instead some physicians (including Staff I) from the Swedish Neurosciences Institute reported directly to the system Chief Executive Officer (Staff RR). Hospital staff did not feel they had access to the system Chief Executive Officer to voice their concerns.

9. A review of Human Resources data for physicians from 2013-2017 associated with the Swedish Neurosciences Institute, revealed 23 physicians had either left employment with Swedish Health System and/or resigned from the medical staff.

10. A document titled, "Swedish Health Services 2016 Clinic and Hospital Experience Executive Summary" (a physician and midlevel provider engagement survey) was reviewed. This review revealed that the hospital physician engagement score for the Swedish Neurosciences Institute was 2.67 on a scale of 1-5 with 5 being the highest. The Swedish Neurosciences Institute physicians scored the lowest of any physician department at Swedish Cherry Hill hospital. The overall mean score for hospital physician engagement at Swedish Cherry Hill was 4.06.

The clinic physician engagement score for the Swedish Neurosciences Institute physicians was 2.90 on a scale of 1-5 with 5 being the highest. The clinic physician engagement score for the Swedish Neurosciences Institute physicians was the lowest for the Swedish health system. The overall mean score for clinic physician engagement at Swedish Cherry Hill was 3.97.

11. Human Resources data for staff in the neurosurgical operating area for September 2013 through April 2017 was reviewed. This review revealed 25 direct care staff had transferred or terminated employment from the neurosurgical operating area. Of the 25 staff, 17 had transferred elsewhere within the Swedish system and 8 had terminated employment due to job dissatisfaction/personal reasons.

12. Documents titled "Caregiver Survey Check In" (an employee engagement survey) for 2015 and 2016 were reviewed. This survey scored employees on their engagement in the workplace on a 4 part scale from highly engaged, detached, unsupported and disengaged. This review revealed that in 2015, 28% of employees in the neurosurgical operating area scored as disengaged in the workplace and 24% scored as highly engaged. In 2016, 57% of employees in the neurosurgical operating area scored as disengaged in the workplace with zero percent scoring as highly engaged. This was the lowest of any department at the Swedish Cherry Hill Campus.

13. The document titled, "Neuro/Spine Surgical Team Culture Assessment Initiative Report" dated January 13, 2016 was reviewed. The document revealed that internal interviews were conducted in September to November 2015 with 34 staff and 10 physicians to determine "root causes to issues raised" and "to identify gaps in perceptions" regarding the neurosurgical operating area. The review revealed 4 key findings:

a. "The team as a whole is not aligned to becoming a world-class, internationally renowned Neurological Institute".

b. "Dysfunctional behaviors and lack of agreements on how to behave are creating challenges in working together".

c. "Numerous examples of confusion with operational practices, in addition to over scheduling of nurses, puts patients at risk".

d. "The team lacks a formal communication structure that ensures information is shared and connections are created".

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37396

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Based on interview and document review, the hospital failed to implement preventative action and a feedback mechanism for Medical Staff Fellows (physicians undergoing advanced specialty training) following an adverse event.

Failure to implement preventative action and feedback following an adverse event, risked patient safety by not providing an opportunity for improvement by individual providers.

ITEM #3 REVIEW OF PATIENT DEATH WITH PHYSICIANS-IN-TRAINING

Findings include:

1. A review of a medical record (Patient #5) revealed that the patient was 32 years old and diagnosed with a Chiari Malformation Type 1 (a structural abnormality of the cerebellum, the part of the brain that controls balance). The patient was admitted for a sub-occipital craniectomy (a procedure where a part of the skull is removed to allow a swelling brain to expand) and C1 laminectomy (a procedure where a portion of the vertebral bone is removed) for decompression of the Chiara malformation on 2/11/16.

During surgery, significant cerebellar swelling was noted. A computerized tomography (CT) scan performed immediately post-surgery showed a right acute subdural hematoma (bleeding in the brain). The patient was immediately returned to the operating room for a second surgical procedure to remove the hematoma in the brain. A magnetic resonance imaging (MRI) scan completed on 2/18/16 showed multiple strokes. The patient subsequently expired on 2/22/16.

2. An electronic variance report was generated regarding the return to the operating room. The Surgical Quality Review Committee reviewed the patient death as per the process outlined in the Swedish Medical Staff Bylaws.

3. On 5/16/17 the peer review file for the attending physician (Staff SS) of Patient #5 was reviewed by Surveyors #1 and #2. The review revealed the following:

a. A letter dated 9/16/16 was sent to the attending physician (Staff SS) by the Chair of the Surgery Quality Review Committee. The letter indicated that there were concerns about the possible placement of the pin head holder by the Medical Staff Fellow (Staff TT).

4. On 5/16/17 at 9:00 AM, Surveyors #1 and #2 interviewed the Director of Medical Staff Services (Staff L), the Graduate Medical Fellowship Program Coordinator (Staff VV), and the Administrative Director for Medical Staff Services (Staff Q). The interview revealed that documentation of improvement opportunities from the peer review process were placed in the attending physician's file. There was not a process for documentation of improvement opportunities for an individual Medical Staff Fellow.

5. The above information was confirmed by the Administrative Director for Medical Staff Services (Staff Q) and the Graduate Medical Fellowship Program Director (Staff UU).

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Based on record review and interview, the facility failed to ensure that a clinical event was identified and managed as an adverse event.

Failure to do so created risk that the need for corrections and improvements in patient care will not occur and may affect future patients.

ITEM #4 - IDENTIFICATION OF A PATIENT ADVERSE EVENT FOR CONDUCTING AN ANALYSIS

Findings include:

1. In review of hospital policy and procedure titled, "Adverse Events: Investigation, Analysis and External Reporting (Approved March 2013; time frame of reference) it defined the purpose of a "root cause analysis" (RCA) as indicated in situations where harmful events occurred when a high priority fact review needed to occur. It further stated that "RCAs are initiated as soon as a harmful. . .event is identified, and full participation is expected. . . .The time frame from initiation of the RCA to review and approval by the RCA Review Committee is no more than 45 days. "The policy further defined operational steps to determine the root cause, implement performance improvements and oversight."

2. Patient #1 was 23 year old admitted on 2/10/14 for multilevel spine fusion surgery and a foramen magnum decompression (surgery on bone at the base of the skull). On the day of surgery and on his/her first post-operative day, the patient complained of a sensation of difficulty breathing, severe pain and nausea. His/her lower jaw was in a forward and fixed position and the patient was unable to open his/her mouth with normal range of motion. The patient had a respiratory arrest in the afternoon on 2/11/14.

A nurse practitioner (Staff Y) and Family Members #1 and #2 were at the patient's bedside when he/she suddenly ceased breathing after requesting to be orally suctioned. Per Family Member #1 the patient was determined to be unable to breath at 1:27 PM and per Family Member #2 the event occurred at 1:26 PM. A Code Blue page was initiated overhead in the hospital at 1:37 PM. During the period from 1:26-1:27 PM until 1:37 PM staff members were unsuccessful in ventilating the patient. Oxygen levels were restored at 1:49 PM via a procedure into the windpipe. The patient had a prolonged period inadequate oxygenation during that time period and it was determined that meaningful recovery of brain function was not probable. Subsequently, the family chose to withdraw supportive care and the patient died in the hospital on 2/20/14.

3. a. On 4/4/17 at 11:00 AM Surveyor #3 interviewed the Nurse Manager of the NCCU (Staff JJ) about the Code Blue Huddle (team meeting to discuss resuscitation process for gaps in care ) related to Patient #1. The manager stated that the team huddle process did not identify any significant care issues related to the code, except for labeling of the drawer content of the Difficult Airway Cart. It was identified that the cart was at the room and ready for use during the resuscitation effort and there was not a delay in retrieving its contents.

When asked if the hospital staff engaged in a formal root cause analysis (deep level case review to identify gaps in care), he/she stated the an RCA was not performed.

b. On 4/7/17 at 9:15 AM Surveyor #3 interviewed two Patient Safety Officers (Staff OO and PP). Staff PP stated that the records of the Patient Safety Officer (PSO) in 2014 (Staff QQ) indicated that Staff QQ sent a communication to a physician stating a need to discuss the case of Patient #1. There were no other related records. Staff QQ was responsible for safety at 2 downtown hospitals. Staff QQ left the organization subsequent to the communication and the hospital did not replace the PSO's position for an extended period of time.

During that same time period in 2014, the hospital had an interim Chief Nursing Officer who was not available for interview

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Based on record review and interview, the hospital failed to demonstrate that accurate and complete information for patient care was available for use in the medical record to all subsequent patient care providers, including for use in urgent and emergent circumstances.

Failure to do so created risk that data required for clinical decision making was not readily accessible to all providers caring for the patient and could result in poor patient outcome(s).

ITEM #1-INITIAL HISTORY & PHYSICIAL

Findings include:

The following information pertained to Patient #1 who was admitted on 2/10/14 for multilevel spine surgery and decompression of the foramen magnum (lower skull bone removal).

1. In review of Article XIII: History and Physical [H&P] in the Medical Staff Bylaws (November 27, 2013) defined the required content of a history and physical. The requirement section listed expected content, "as appropriate" or "when warranted" The "Pre-Op History and Physical" for Patient #1 contained the following irregularities:

a. The history and physical written in letter format addressed to an out-of-state referring physician rather than being organized in history and physical format for routine clinical reference.

b. The patient was identified as 19 year old. He/She was 23 years old.

c. The document identified that the patient had Ehlers-Danlos Syndrome. However, condition subtype(s) were not included. (There are several distinct sub-types of the syndrome with different clinical features.)

d. The medical history section was not complete. It did not address some medical problems in the head-neck region (surgical area) including, but not limited to, the patient history of temporomandibular joint (TMJ) problems (affecting jaw joint function) and mast cell activation disorder (MCAD-allergic condition). It was later determined that the patient had an extensive TMJ history which affected his/her airway opening.

e. The allergy information did not include dietary allergies which the patient had and did not mention of the mast cell activation disorder (allergic condition).

f. Under the patient's history it was noted that he/she had experienced cardiogenic syncope (losing consciousness due to heart function).The H&P did not include assessment cardiopulmonary status (only required "as appropriate") besides recording of vital signs.

g. The H&P did not include mention the patient's Chiari Malformation (medical condition in the lower, back part of the brain) and plan for a foramen magnum decompression (surgical procedure at the base of the skull bone) which was performed per the operative report (and consented to by the patient per signature). (Other related descriptions in different parts of the operative report included "craniocervical decompression" and "suboccipital craniectomy".)

h. The document was signed as written by the attending physician (Staff I) on 01/24/14 at 2:30 PM, then recorded as written by a certified Physician Assistant Provider (Staff CC) "for" Staff I on 2/9/14 at 6:26 PM and then co-signed by the physician (Staff I) 6 minutes later.

2. The hospital document titled, "Delineation of Privileges PA Certified" as a part of "Core Privileges", an admitting history and physical was required to be co-signed by the attending when performed by a physician assistant. However, there were no provisions made for Certified PAs re-authoring a physician history and physical prior to the physician signing the same clinical note again.

ITEM #2 - ANESTHESIA NOTES IN THE MEDICAL RECORDS

1. A pre-anesthesia note per a phone call for Patient #1 dated 2/7/14 at 12:34 PM listed the procedure as "fusion occiput to C2" which was not planned for the patient. (The patient consented to a fusion from the occipital region of the skull to C4 [4th neck vertebrae] and a foramen magnum decompression.) The patient history of TMJ problems and the mast cell activation disorder was not listed. The physical exam was not completed by the physician (stated that it would be done by nursing staff) and the "Results Review" section was left blank stating that there were not results to review.

2. The Anesthesia Pre-op Evaluation note dated 2/10/14 at 7:41 AM listed the procedure correctly but it did not include information about the patient's TMJ problem or MCAD. It noted that the patient's temporomandibular joint width was greater than 3 finger breaths (normal mouth opening). No blood pressure was recorded as part of the pre-operative vital signs.

ITEM #3 INTRAOPERATIVE RECORD

The intraoperative record listed the procedure to be performed as a fusion from the occiput to C2. The actual planned procedure was the fusion from the occiput to C4 and a foramen magnum decompression.

ITEM #4 - PROGRESS NOTES DURING INPATIENT STAY 5E

1. During an interview with Surveyor #3 on 5/1/17 at 1:30 PM, Family Member #1 stated that he/she noticed immediately after surgery and upon the patient's arrival to the floor from the recovery room to 5E that Patient #1's jaw was in a fixed position with an under-bite that was not present prior to surgery. Also noted was that the patient had severe nausea and pain at that time. The patient told Family Members #1 and #2 that his/her symptoms were poorly controlled in the recovery room. The medical record did not reflect that portion of the patient's experience in the recovery area.

While on 5E, nursing noted several symptoms including abnormal airway sounds, reported difficulty breathing, nausea and severe pain. Family Members #1 and #2 stated that during that time period the patient forcibly vomited 2 times after quick self-positioning to side lying position to maintain breathing. The family was concerned because the patient was unable to open his/her jaw normally. The medical record did not include information about the patient vomiting.

Additionally, Family Members #1 and #2 reported that the patient was wearing a rigid cervical (neck) collar which the patient found extremely uncomfortable and it appeared to be ill-fitting for the patient's smaller frame size. At that time, the patient was wearing an adult sized rigid cervical collar. (Subsequently when the patient was comatose, he/she was measured for proper fit for another collar. It was determined then that he/she required a pediatric-sized collar.)

2. On 2/11/14 at 7:06 PM a nurse (Staff DD) on the medical surgical floor recorded that a rapid response had been called for Patient #1 (within 1 hour of arrival from the recovery room). He/she recorded paging several providers prior to initiating an overhead "Rapid Response" announcement due to patient reported symptoms.

The record also did not include information that the patient vomited forcefully twice during that time period per care by the nurse (Staff DD).

The record did not contain information that the patient was wearing a rigid cervical collar (per Family Members #1 and #2) or information about placement of the collar. An order for placement of a cervical collar could not be located for the time period.

After the rapid response event the patient's rigid cervical collar was removed by a neurosurgery medical education resident-fellow (Staff HH). The medical record did not provide information about use of the medical supply (cervical collar) and/or its subsequent removal around the time of the rapid response.

ITEM #5 - PROGRESS NOTES BY RESPIRATORY THERAPY(RT)

1. On 2/11/14 at 8:17 PM, a note was entered in the record by a respiratory therapist (RT) (Staff EE) for care rendered on 2/10/14 at 8:00 PM (late entry). The therapist stated that a RN called him/her to the room for treatment of shortness of breath. The patient was lying on his/her left side and the RT attempted to suction the upper airway but stated he/she was unable due to patient "discomfort". The therapist stated the plan was for "no further attempts to suction per MD recommendation".

There was not a reference to which physician provided that instruction and there were no related physician orders accordingly. There was not a notation of the patient's narrowed jaw opening and/or misalignment.

2. On 2/11/14 at 7:24 AM another respiratory therapist (Staff BB) noted the patient's respiratory symptoms and the side effect of a respiratory medication, nausea. There was not a notation of the patient's narrowed jaw opening and/or misalignment.

3. On 4/11/17 at 10:30 AM Surveyor #3 interviewed a respiratory therapist (Staff BB) that cared for Patient #1 during his/her hospital stay. The therapist stated that he/she cared for the patient during a rapid response on 2/10/14. The therapist assessed the patient to have no airway distress and reported that oxygen level were within normal limits. He/she did not find the situation to be clinically urgent at the time of the assessment.

Staff BB also provided routine and emergent care on the day the patient had a respiratory arrest. At the time during the patient's respiratory arrest on 4/11/14, the respiratory therapist reported that the patient's airway was "non-existent" during attempts at ventilation and described his/her inability to deliver oxygen to the patient due to the extent of airway blockage. The therapist described the response team as "blindsided" by the nature of the respiratory arrest. He/she did not identify any patient care activities that may have improved the outcome, except better labeling of the drawers of the Difficult Airway Cart. .

4. The medical record did not contain information about registered respiratory therapist emergency interventions immediately preceding and during the Code Blue event.

ITEM #6 - ICU MD NOTE

On 2/10/14 at 8:26 pm a physician (Staff FF) note indicated that that patient had "complex cervical spine fusion" but did not mention the craniectomy (skull bone removal). There was not a notation of the patient's narrowed jaw opening and misalignment.

ITEM #7 - ICU RN DOCUMENTATION

1. On 4/12/14 at 11:00 AM Surveyor #3 interviewed a nurse (Staff X) who took care of Patient #1 on the day shift of 2/11/14. He/she recalled that the night shift nurse (Staff GG) reported that the patient seemed to get relief from a sensation of throat tightness from receiving decadron (a potent anti-inflammatory). Staff X recalled that the family understood that treatment with decadron was under consideration for the patient among neurosurgical team members. Information about the discussion/consideration of the medication therapy could not be located in the medical record.

2. On 2/11/14 at 6:32 AM a NCCU nurse (Staff GG) noted inhaled treatment for the patient's respiratory symptoms. The nurse noted that the patient needed a formal swallow evaluation however, there was no notation of the patient's narrowed jaw opening and/or misalignment. The record included information that the patient's voice was hoarse (can occur after intubation in the OR), tongue position was normal and the benefit from decadron (anti-inflammatory medication above).

On 2/11/14 at 8:00 AM, 10:00 AM and 12:00 AM, record entries by a NCCU nurse (Staff X) indicated that the Patient #1's symptoms included "throat swollen". At 8:00 AM and 12:00 PM, entries indicated "painful swallow". Other entries indicated that the patient had inconsistent stridor and a hoarse voice. The nurse was in communication with the charge nurse and the intensivist ARNP about the patient's symptoms. The nurse (Staff X) requested that the ARNP (Staff Y) come to the patient's bedside for symptom evaluation, which occurred.

ITEM #8 - NEURO CRITICAL CARE HISTORY & PHYSICIAL EXAM & PROGRESS NOTE

1. A medical record note written on 2/11/14 at 7:25 AM by an ARNP (Staff Y) caring for the patient in the NCCU (patient transferred there after rapid response) identified that the patient had a multilevel cervical spine fusion but did not include information about the surgical bone removal at the base of the skull. Additionally in the history section, TMJ problems were not listed. Another note by the provider that day indicated that the patient "reported difficulty with swallowing and jaw movement."

2. On 4/18/17 at 11:00 AM Surveyor #3 interviewed the ARNP noted above. The practitioner stated that he/she was not aware that the patient had a history of TMJ problems (affecting the function of jaw/mouth opening) and that he/she did not ask the patient to open her/his mouth. The practitioner did not recall evaluating the patient's mouth or jaw function during care that day (before the respiratory arrest) or did not recall addressing pain symptoms.

ITEM #9 - NEUROSURGERY PROGRESS NOTE

On 2/11/14 at 10:00 AM a neurosurgical progress note by a medical educational resident-fellow (neurosurgical residency not yet completed) (Staff HH) was listed as the author and co-signed by the attending neurosurgeon (Staff I), at the exact same time. The patient was reported to feel better and still had mild difficulty breathing. The notes did not indicate that the patient had a narrowed jaw opening and/or misalignment. The note indicated that the patient had a cervical spine fusion but did not mention the surgical craniectomy (skull bone removal) performed in the area of the base of the skull.

ITEM #10 - SPEECH & LANGUAGE EVALUATION

1. On 2/11/14 at 10:57 AM, a speech language pathologist (SLP) (Staff # AA) evaluated the patient. The speech pathologist noted the patient positioning on his/her left side due to breathing difficulty when in a back lying position. He/she also noted an "Abnormal under-bite [jaw] occlusion, new to patient since surgery. Unable to open mouth ...Unable to open mouth more than 1 cm [centimeter]". In the "Impairments/Functional Limitation" section, the SLP noted "Mandibular positioning affecting breathing and swallow." He/she also noted problems with movement of oral secretions and other swallowing abnormalities. A plan was made to proceed with single feedings of ice chips and to see the patient the next day. The record did not contain information about discussing findings with other members of the health care team.

2. On 4/11/17 at 1:00 PM Surveyor #3 interviewed the SLP. He/she recalled that he/she could not examine the patient's throat because the patient could not open his/her mouth for an examination. The SLP further stated the patient's teeth were fully clenched and s/he could not move an oral swab beyond the outside of the teeth.

When asked if he/she communicated the outcome of his/her evaluation with any team members, the SLP stated he/she notified the patient's nurse. When asked if he/she would directly notify a physician in a situation like this, the SLP stated that during that time period he/she was not comfortable calling physicians (and at times was uncertain whom to call) and tended not to do that. The SLP thought other team members already knew about the patient's problem because it was "so obvious".

ITEM #11 CODE BLUE & RELATED PROCEDURAL DOCUMENTATION

1. Hospital records indicated that the hospital operators activated the Code Blue paging system at 1:37 PM on 2/11/14 for room 201 (correct room) to at least 19 pagers (excluding spiritual care).

2. In an interview on 5/1/17 at 1:30 PM between Surveyor #1 and Family Member #1, he/she indicated that Patient #1 suddenly took his/her last breath at exactly 1:27 PM; and Family Member #2 notes that the event occurred at 1:26 P.M. That information was not recorded anywhere in the medical record (critically important information for decision making about resuscitation strategy).

Additionally, immediately when the patient stopped breathing, Family Member #2 ran out of the room to the nurses' station and reported that help was needed because the patient could not breathe. Someone at the desk replied that "help" was "on the way".

Between 1:27 PM and 1:36 PM, there were unsuccessful attempts to oxygenate the patient with a bag/valve/mask. The medical record did not reflect that activity. During that interim period, Family Member #1 recalled feeling panicky because the Code Blue team took "so long" to arrive.

3. On 5/17/17 at 10:45 Surveyor #3 interviewed a charge nurse (Staff II) in the NCCU on the day Patient #1 had a respiratory arrest. The nurse stated that he/she was aware of the patient's difficulty breathing and painful swallow from the patient's nurse (Staff X) and understood the patient's nurse was in active communications with the intensivist team. The charge nurse (Staff II) called the Code Blue on 2/11/14 for Patient #1 within seconds of the request. He/she did not recall the time the Code Blue call was placed and he/she did not record that information in the medical record. The nurse recalled that he/she was near the patient's room when the ARNP (Staff Y) asked him/her to call a Code Blue. He/she recalled that the Code Team's arrival response to the code was "fast". The nurse also recalled failed and prolonged attempts by several providers to oxygenate and intubate the patient due to airway and/or jaw opening restrictions.

4. A roster of responders and/or arrival times to the Code Blue were not present in the code documentation. The first entry was timed at 1:36 PM (at least 9 minutes after the patient was observed to take his/her last successful breath by Family Member #1). There were several absent and/or delayed clinical entries on the Code Blue record sheet. Additionally, the time of the cricothyrotomy was recorded at 1:49 PM on the code sheet although it was not clear from the record whether the tracheostomy or cricothyrotomy placement occurred then. A progress note in the chart indicated that the safety pause for the cricothyrotomy occurred at 3:12 PM (probable time error; the code sheet stated that the code concluded at 1:53 PM).

The record was left blank in the section titled, "Initial Rhythm" (cardiac) and showed that chest compression started at 1:49 PM. There was no data recorded about patient oxygenation from 1:44 PM until 1:50 PM (a prolonged time span during emergency resuscitation).

ITEM #12 AUTOPSY REPORT

1. In the report finalized 3/14/14 at 2:10 PM, the chronology of the patient's stay (when the patient transferred to ICU level care) was not accurate. The autopsy consent included examination of the "head". The "Post-Mortum Restrictions" were recorded as "Head and neck (primarily upper airway)". Per the autopsy report, the "head" was not examined.

2. On 5/5/17 at 2:45 PM during an interview between Surveyor #3 and Family Members #1 and #2, the family expressed displeasure with the scope of the autopsy. Additionally, they stated that the surgeon (Staff I) who ordered the autopsy did not discuss options/implications specific to the scope of the autopsy with them. They did not think that the scope of the autopsy answered their question(s) about the likely cause of death.
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Based on interview and review of hospital policies and procedures the facility failed to review current policies for methicillin resistant Staphylococcus aureus (MRSA) and methicillin sensitive Staphylococcus aureus (MSSA) and revise as needed.

Failure to review and keep policies current potentially places patients at risk for not receiving the appropriate testing to identify possible infections in a timely manner.

Findings include:

1. The policy titled "MRSA and MSSA Screening for Adult Pre-Surgical Patients", was approved December 2010 with the next review to be done December 2013. The review was not completed in December 2013.

2. The policy titled "MRSA Screening for Patients Over the Age of Two Admitted to the ICU (intensive care unit)", was approved June 2013 with the next review to be done June 2016. The review was not completed in June 2016

3. On 5/15/2017 at 1:00 PM during an interview with Surveyors #1 and #2, Staff U, the infection control manager verified the above.

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Based on observation and review of hospital policies and procedures, the hospital failed to ensure that all hospital staff members followed the hospital's policy regarding hand hygiene.

Failure to perform hand hygiene while providing patient care risks transmission of infectious diseases to patients and caregivers.

Findings include:

1. The hospital's policy and procedure titled, "Hand Hygiene: Handwashing and Hand Antisepsis" (Approved: April 2012), showed that hospital staff will perform hand hygiene following: many tasks including: "after contact with a source of microorganisms ...inanimate objects that are likely to be contaminated in the vicinity of the patient ...."

2. On 4/6/17 at 9:20 AM, Surveyor #4 observed the beginning of an open cardiac surgical procedure in operating room #17. Staff A, a Perfusionist, was observed opening sterile medical equipment and handing off to sterile scrubbed personnel. Staff A, then was observed touching a large bag containing trash, opened the bag and drop materials into the bag, no hand hygiene was performed after touching the bag. He/she then went on to touch a trash container and without proper hand hygiene, proceeded to provide care to the anesthetized patient.

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Based on document review and interview, the hospital failed to ensure surgical privileges for Medical Education Fellows (physicians undergoing advanced specialty training) was clearly delineated and available in the surgical services department.

Failure to ensure surgical privileges were clearly delineated created a risk of patient safety for inadequate supervision for surgical procedures.

ITEM #1 - MEDICAL EDUCATION FELLOWS SUPERVISION

Findings include:

1. The Swedish Health System Medical Staff Rules and Regulations, dated March 22, 2017, section XVIII, showed that "Procedures performed by Residents and Fellows must be adequately supervised in order to meet accreditation requirements and to assure patient safety".

2. The document titled, "Swedish Graduate Medical Education for 2017-2018", #35, showed that "Classification of Supervision: To ensure resident supervision and appropriate progressive responsibility, supervision must be classified as follows....Direct Supervision- the attending physician is physically present with the resident and patient. Indirect Supervision-the attending physician is a) physically within the site of patient care and immediately available to provide Direct Supervision or b) immediately available by telephone and/or electronic means, and is available to provide Direct Supervision. Oversight- the attending physician is available to provide review and feedback following the delivery of care".

3. On 5/16/17 at 9:00 AM, Surveyors #1 and #2 interviewed the Director of Medical Staff Services (Staff L), the Graduate Medical Fellowship Program Coordinator (Staff VV), and the Administrative Director for Medical Staff Services (Staff Q). The interview revealed that the hospital had two types of Medical Fellows (physicians undergoing advanced specialty training). The interview revealed the following:

a. Medical Staff Fellows were credentialed and privileged through the medical staff process. The privileges for each Medical Staff Fellow (including specific surgical privileges) were available to all staff through an on-line system called "E-Prev".

b. Medical Education Fellows were not credentialed and privileged through the medical staff process. They were under an affiliation agreement for graduate medical education with an associated university. There was an on-line system called "New Innovations" that listed each Medical Education Fellow and which procedures required direct, indirect supervision or oversight by the attending physician. The procedures listed were predominately those done outside of the operating area. There was not a list of specific surgical procedures that could be done by each Medical Education Fellow. Nor was there information about the required level of supervision (direct supervision, indirect supervision or oversight) by the attending physician.

4. The above information was confirmed by the Administrative Director for Medical Staff Services (Staff Q) and the Graduate Medical Fellowship Program Director (Staff UU).

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Based on interview and review of hospital documents, the hospital failed to ensure surgical staff were informed of an on-line site that specifies surgical privileges for each training fellow and which surgical procedures or specific tasks require attending surgeon supervision in the operating room (OR).

Failure to inform surgical staff of each training fellow's surgical privileges or direct/indirect OR supervision can lead to a training surgeon working outside their scope of privileges resulting in a negative surgical outcome or even death.

ITEM #2 - MEDICAL FELLOWS SURGICAL PRIVILEGES ROSTER

Findings include:

1. Review of the hospital's document titled, "Swedish Neuroscience Institute Neurosurgery Fellows: 2014-2015," showed pictures of each training fellow, followed by his/her name, surgical service, and/or lists the fellow as a Medical Educational Fellow (direct supervision). Medical Staff Fellows were not identified. No other information is contain in this document.

2. During an interview on 04/04/17 at 11:25 AM, with Surveyor #4 and Staff MM, Peri-operative Interim Director, the director stated that a list of all surgeons and their privileges are available "on line to staff 24/7."

3. During an interview with Surveyor #4 and an OR nurse, on 5/16/17 at 9:30 AM, Staff NN stated that he/she was not aware of the two different types of training fellows (Medical Staff & Medical Education) at their hospital or aware of the on line site that contained the roster of each training fellow's surgical privileges or direct/indirect OR supervision.
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Based on record review, hospital policy and interview, the hospital failed to ensure that a patient's consent for surgery was completed in a timely and accurate manner.

Failure to do so created risk for lack of understanding what and when a patient consented to a particular surgery, including those for whom medical complications resulted in death.

Findings include:

1. In review of hospital policy titled, "Informed Consent For Surgery Or Other Invasive Procedural Treatment" (September 2009) on page 1 it stated, the purpose of the policy was to ensure that informed consent was complete, timely and correctly obtained. There was no definition for "timely" (i.e. time frame for validity). It also stated under the patient or patient representative section; "signs/dates /times the form, documenting acceptance of informed consent. In the next section under "SMC [Swedish Medical Center] clinical staff" it stated they verified completion of the consent form."

2. In review of a form titled, "Consent for Surgery or Other Invasive Procedural Treatment" (Revised 03/11) for Patient #1, it was signed by the patient but there was no date or time noted by the signature. It was signed by the physician (Staff I) and dated as 1/24/14 (time not included). The consent was for a surgery titled, "Occiput-cervical fusion to C-4 with foramen magnum decompression".

The Medical Staff Rules and Regulations (November 27, 2013) were also reviewed for content related to timing of patient consents and information could not be located accordingly.

3. On 5/1/17 at 1:30 PM during an interview between Surveyor #3 and Family Member #1, the family member reported that during the consent process between the surgeon (Staff I) and the Patient #1 there was not an in depth discussion about surgical treatment for the patient's Chiari Malformation (foramen magnum decompression). However, there was discussion about hardware placement strategies to minimize risk of injury to blood vessels given the patient's individual anatomy.

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Based on record review and review of hospital documents, the hospital failed to ensure surgical staff documented tasks that were conducted by a training practitioner (fellow) other than the primary attending surgeon, as outlined in hospital procedure.

Failure to provide complete medical information can lead to the patient care provider's inability to make assessments of the patient's condition, to support diagnosis, to describe the patient's progress, in planning the patient's care, and in making decisions on the provision of care to the patient.

Findings include:

1. Record review of the hospital's document titled, "RULES AND REGULATIONS
OF SWEDISH HEALTH SERVICES," dated 01/28/15/ shows that the medical record must reflect the nature of the supervising Attending Practitioner contact with the patient and supervision of the care...Documentation of the procedure is the responsibility of both the Resident or Fellow and the supervising Attending Practitioner.

2. Review of Patient #5's medical record revealed the following:

a. A 32 year old patient who underwent a cervical level #1 Laminectomy (surgery that creates space by removing the lamina, the bony part that covers the spinal canal), on 02/11/15. The operative note showed the patient was placed in a prone (face down) position and his/her head positioned in a skull clamp.

b. The operative note lists an Attending surgeon (Staff SS), a Medical Staff Fellow (Staff TT), and a Medical Education Fellow (Staff WW) that participated in the patient's surgical procedure. The anesthesiologist's note showed the patient was placed under general anesthesia and ready at 11:42 AM.

c. At 12:21 PM, the surgical nurse's note showed the patient's skull was pinned into the skull clamp and positioned for surgery (Staff TT).

d. At 12:36 PM, the anesthesiologist (Staff LL) wrote that the "incision" was performed by a "neurosurgical fellow."

e. At 2:18 PM, the attending surgeon ( Staff SS) entered the OR.

f. At 2:30 PM, it was observed that the patient's blood pressure and heart rate dropped with swelling of the brain.

g. At 3:24 PM, the patient was immediately taken to the radiology department where testing showed a right hematoma (bleeding under the skull) that required a second surgery to take out the blood from the brain. Review of inter-operative notes did not show the absence or presence of the attending surgeon in the second surgical procedure.

h. The patient was taken to the critical care unit at 7:18 PM. The patient remained critically ill, unresponsive and later passed away.

i. The attending surgeon's operative note revealed no documentation related to his/her supervision of the Fellow's surgical technique during the critical portion of either surgery, or the surgery safety pause.

3. During an interview on 05/15/17 at 1:00 PM, Staff LL, Anesthesiologist, stated that he administered anesthesia to Patient #5 during both neuro surgeries. Staff LL stated that the Attending surgeon was not present during the second surgery, to remove the identified blood under the skull.

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