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14701 179TH AVE SE

MONROE, WA 98272

GOVERNING BODY

Tag No.: A0043

Based on the findings detailed throughout this report, including interviews, review of medical records and review of hospital documents, including policies and procedures, it was determined that the Governing Body CONDITION IS NOT MET.


As evidenced by examples identified throughout the body of this report, the cumulative effect of these systemic problems resulted in the governing body failing to ensure that the the hospital provided adequate numbers of trained personnel to staff the Critical Care Unit (CCU) in a way that promoted safe patient care.

Reference deficiencies written at Tag A0385 - Nursing Services

NURSING SERVICES

Tag No.: A0385

Based on findings detailed throughout this report, it was determined that the hospital failed to ensure policy development and implementation with input and review from nursing leadership and, where appropriate, physicians.

Based on findings detailed throughout this report, it was determined that the hospital failed to assure training and orientation for adequate numbers of nursing staff, specifically in the Critical Care Unit.

As evidenced by examples identified throughout the body of this report, the cumulative effect of these systemic failures resulted in the hospital's inability to ensure that each patient received competent, adequate and timely care and was evidence that the Nursing Services Condition of Participation was NOT MET.


Reference deficiencies written under Tag 0386
Reference deficiencies written under Tag 0392

ORGANIZATION OF NURSING SERVICES

Tag No.: A0386

Based on interviews and review of nursing schedules and hospital documents, it was determined that the hospital failed to determine, and provide, the types and numbers of nursing personnel and staff necessary to provide nursing care for all areas of the hospital. The hospital's failure to do so resulted in the CCU being staffed with Registered Nurses (RNs) who did not have documented CCU clinical competencies to provide care in the CCU. The hospital failed to provide RNs with documented CCU clinical competencies to provide backup and relief for the RN assigned to the unit.

Findings include:

Staffing the Critical Care Unit (CCU) with Qualified Nurses


The Department of Health received a complaint that the hospital's CCU was staffed with only one registered nurse (RN), even when there were 2 patients in the unit. The complainant stated that the CCU nurses were not relieved for breaks or meal breaks by adequately trained and competent nurses, and that any available help was usually on the other side of the hospital. The complainant stated that the CCU nurse manager and the DON had been made aware of the concerns but no changes had been made to staffing.

On March 3, 2015 at approximately 10:20 am, a tour of the hospital's CCU was conducted by this investigator, accompanied by the hospital Director of Nursing (DON) and the CCU nurse manager. The CCU consisted of 4 patient care rooms. The CCU had 1 patient at the time of the tour, and the RN caring for the patient was from a staffing agency. The manager stated that s/he was the RN who was to provide backup and relief for the agency nurse.

When asked what her/his usual work times were, the manager stated that s/he worked Monday through Friday. S/he stated that s/he started work about 6:30 am and worked for 10 to 12 hours a day. When asked who backed up or relieved the CCU nurses when the manager was not available, the manager stated that the house supervisor took that role. The manager stated that the house supervisor was "ICU qualified". The DON stated that the nurses from the ambulatory care unit also relieved in the CCU, and they were qualified to work in the CCU.

The manager stated that s/he had no concerns or issues about staffing in the CCU, but 2 of the staff nurses had complained. When asked what the staff complaints were, the manager stated that the nurses complained of being "too busy".

The nurse manager stated that the CCU usually ran at about 50% occupancy, and for the month of December, 2014, the unit had approximately 12 patients total. Review of the RN staffing schedule for November 2014 through February 2015 revealed that the maximum number of RNs scheduled on any day was 2. The CCU manager stated that the RNs worked 12-hour shifts.

The agency nurse who was working in the CCU on March 3, 2015 was interviewed. S/he stated that s/he was scheduled to work in the hospital's CCU the next day as well, and had worked in the hospital's CCU for about 16 years as an agency nurse. The agency nurse stated that there was usually 1 RN in the CCU with a backup nurse from elsewhere. S/he stated that the backup nurses were the Emergency Department (ED) nurses and the ED charge nurse. The agency nurse stated that MSTU (medical/surgical/telemetry unit) nurses could be asked for help, but that did not happen often. S/he also stated that during the day time, the CCU nurse manager also provided backup for the CCU.

The hospital was asked to provide evidence of CCU competency training for 7 RNs identified as caring for patients in the CCU. Included in the review was the agency nurse who was on duty March 3, 2015 and the CCU nurse manager

Review of the "Critical Care Unit Structure Standards", approved on 2/10/2015, revealed the following:
"The Critical Care Unit is designed to function 24-hours-a-day, 365 days-a-year. In the event that there are no patients in the unit, a qualified CCU nurse will be available to open the unit as needed...
'''all RNs assigned to care for patients in the CCU will be PACU/ED/CCU [post-anesthesia care unit/emergency department/critical care unit] trained and have performed CCU orientation and competencies...".

No evidence of current and documented critical care skills was presented for any of the nurses whose files were reviewed, and the DON confirmed that no nurses in the hospital had documented evidence of critical care competencies verified in 2015, 2014 or 2013. The DON stated that the CCU nurse manager was "working on this". The DON confirmed that none of the charge nurses, none of the MSTU nurses and none of the ED nurses were oriented to CCU and none had demonstrated and verified clinical competencies in the unit. The DON stated "no nurse in the hospital has gone through a CCU competency program developed by this hospital".

Based on interviews and review of policies and procedures, it was determined that the hospital failed to assure that the Director of Nursing (DON) approved all policies and procedures pertaining to nursing care provided in the hospital, and failed to assure adequate types of nursing personnel necessary to provide nursing care for all areas of the hospital. The hospital's failure to do so resulted in the implementation of policies and procedures to guide nursing practice, which had not had input and review from nursing leadership and/or physicians for the patient care policies.

Findings include:

Policies and Procedures

On March 3 and 4, 2015, the following policies were reviewed:

-Plan for the Provision of Patient Care. Owner listed as hospital's Risk Manager (RM)
-Professional Licensure/Nursing. Owner listed personnel in Information Technology
-Assessment and Plan of Care. Owner listed as RM
-Medication Administration and Documentation. Owners listed as RM, CCU nurse manager and a third, unknown person
-Administration of Blood Products. Owner listed as laboratory manager

The RM stated that s/he did not have any clinical background and that her/his role in the development of the policies was administrative only, and by that s/he meant that s/he kept the policies on file and sent them back to the originator of the policy. S/he stated that s/he did not know what happened to the policies after that.

None of the above policies and procedures contained documentation that the DON had reviewed and approved the policies.

The hospital was asked to provide any pre-established care guidelines or protocols and the directives to staff on how to implement the guidelines/protocols.

The following pre-established CCU protocols were reviewed:
-Arterial Line Placement: Measurement of Arterial Pressure, Obtaining a Blood Sample, Care and Removal Arterial Line Placement: Measurement of Arterial Pressure, Obtaining a Blood Sample, Care and Removal. Owners were listed as the RM and the CCU nurse manager
-Cardiac Monitoring, Continuous. Owners were listed as the RM and the CCU nurse manager
-Cardiac Output: Intermittent Bolus Thermodilution Method. Owners were listed as the RM and the CCU nurse manager
-Cardiac Output: Thermodilution Method. Owners were listed as the RM and the CCU nurse manager
-Enteral Feeding. Owners were listed as the RM and an unknown second party
-Hemodynamic Monitoring Protocol. Owners were listed as the RM and the CCU nurse manager
-Patient Care Documentation in CCU: Management of. Owners were listed as the RM and the CCU manager
-Temporary External Pacing. Owners were listed as the RM and the CCU nurse manager
-Thoracentesis. Owners were listed as the RM and the CCU nurse manager
Thrombolytic Therapy: Nursing Protocol

None of the policies and procedures had documentation that the DON had been involved in the development of the policies, had reviewed the policies or approved the policies.

The RM stated that after s/he reviewed the policies and procedures, the policies were not sent to anyone else, except for the CCU policies. For the CCU policies, the process was supposed to be that the policies were sent back to the CCU nurse manager, who then took the policies forth to the appropriate committees and physicians for their input and approval. The RM stated that no physicians had approved policies for approximately the past 3 years, and the hospital had not had a Chief Medical Officer for about one year, and there was no Medical Director for the CCU.

Lack of Supervisory Oversight for the CCU

The complainant stated that on one occasion, the CCU had been staffed with 1 RN, although there were 2 intubated patients in the CCU. The complainant stated that one of the patients had self-extubated (removed her/his own airway from her/his throat) and the RN had had to deal with that incident, in addition to caring for the second intubated patient.

One March 3, 2015, the hospital was asked to provide all incident reports regarding self-extubations from November 1, 2014 through the present day. The hospital's Director of Quality stated that no self-extubations had been reported.

A list of patients was requested for all patients who had been in the CCU from December 1, 2014 through the present. Medical records were selected for review, and included in the review were patients whose care days in the CCU had overlapped. Review of 10 medical records revealed that 1 of 2 patients in the CCU on a specific day had removed her/his own airway. After identifying the patient, and the date of the incident, no incident report could be located.

The CCU nurse manager stated that s/he was aware of the incident. When asked to describe her/his follow up, and investigation of the events, the manager stated that s/he had talked with the nurse who had cared for the patient. The manager stated that the nurse caring for the patient had left one of the patient's hands unrestrained while the nurse cleaned her/his own hands. During that period of time, the patient removed her/his own airway. The manager confirmed that s/he had not documented her/his conversation with the nurse, had not checked for an incident report, or quality report on the event, and had not reviewed the nurse's documentation around the event. The manager also confirmed that s/he had not had conversations with other CCU nurses to ascertain if they were following safe practices with intubated patients.

When asked to find the nurse's note of the event, as well as the nurse's notification of the patient's physician, the manager confirmed that the medical record contained no evidence of the event, other than a note by a respiratory therapist which had been made approximately 3 hours after the event occurred.

The nurse manager stated that s/he did not track patient safety events in the CCU such as self-extubations, infections identified while the patient was in the CCU, falls or other such issues. When asked to describe the clinical indicators utilized in the CCU, the manager described review of physician orders and patient satisfaction surveys.

The issue of documentation of clinical competencies was discussed with the CCU nurse manager. The manager stated that the lack of documented clinical competencies did not concern her/him and s/he thought this was "primarily a documentation" issue.

The failure of the hospital to provide adequate numbers of qualified RNs, the failure of the hospital to adhere to it's own structure standards, the failure of the hospital to develop policies and procedures developed and implemented with input and approval from nursing leadership, and physicians when appropriate, and the failure of the hospital to assure nursing supervision and safe practices in the CCU resulted in an unsafe care setting in the CCU. All patients of the CCU were placed at risk for harm and the potential for death.

STAFFING AND DELIVERY OF CARE

Tag No.: A0392

Based on interview and review of hospital documents, it was determined that the hospital failed to assure adequate numbers of licensed registered nurses, supervisory and staff personnel for each nursing unit. The hospital's failure to do so resulted in an unsafe care setting in the Critical Care Unit, which placed the health and safety of all patients at risk.

Findings include:

Staffing the Critical Care Unit with Qualified Nurses

Based on interviews and review of nursing schedules and hospital documents, it was determined that the hospital failed to determine, and provide, the types and numbers of nursing personnel and staff necessary to provide nursing care for all areas of the hospital.

The Department of Health received a complaint that the hospital's Critical Care Unit (CCU) was only staffed with one registered nurse (RN), even when there were 2 patients in the unit. The complainant stated that the CCU nurses were not relieved for breaks or lunch by adequately trained and competent nurses. The complainant stated that the CCU nurse manager and the DON had been made aware of the concerns, primarily concerns about safe patient care related to a lack of adequate numbers of qualified CCU nurses, but no changes had been made to staffing.

On March 3, 2015 at approximately 10:20 am, a tour of the hospital's CCU was conducted by this investigator, accompanied by the hospital DON and the CCU nurse manager. Four (4) CCU rooms were observed. The CCU had 1 patient, and the RN caring for the patient was from a staffing agency. The manager stated that s/he was the nurse who was backup and relief for the agency caring for the patient.

When asked what her/his usual work times were, the manager stated that s/he worked Monday through Friday. S/he stated that s/he started work about 6:30 am and worked for 10 or 12 hours a day. When asked who backed up or relieved the CCU nurses when the manager was not available, the manager stated that the house supervisor took that role. The manager stated that the house supervisor was "ICU qualified". The DON also stated that the nurses from the ambulatory care unit also relieved in the CCU.

On March 4, 2015, the ED nurse manager was interviewed. The nurse manager was asked to describe how the ED nurses supported the CCU nurses. S/he state that the ED charge nurses always had 2 to 10 patients to care for, and when s/he was at work, she also took care of ED patients. S/he stated that the ED did not always have nurses to call in to work when the ED was short-staffed. S/he also stated that the ED did not always have nurses available to send to the CCU when called to help. The ED nurse manager confirmed that the ED charge nurses had not been through CCU training. S/he stated that the CCU was on the other side of the hospital from the ED, and the CCU nurses did not have a way to call for help because there was not a unit secretary in the CCU. S/he stated that on occasion, the CCU nurses had summoned help by pressing the code blue button.

The CCU nurse manager stated that s/he had no concerns or issues about staffing in the CCU, but 2 of the staff nurses had complained. When asked what the staff complaints were, the manager stated that the nurses complained of being "too busy". The manager confirmed that there was not unit secretary or assistive personnel in the unit.

The agency nurse who was in the CCU on March 3, 2015 was interviewed. S/he stated that s/he was scheduled to work in the hospital's CCU the next day as well, and had worked there for about 16 years as an agency nurse. The agency nurse stated that there was usually 1 RN in the CCU with backup. S/he stated that the backup nurses were the Emergency Department (ED) nurses and the ED charge nurse.
The agency nurse stated that MSTU (medical/surgical/telemetry unit) nurses could be asked for help, but that did not happen often. S/he also stated that during the day time, the CCU nurse manager was a backup nurse.

The hospital was asked to provide evidence of CCU competency training for 7 RNs identified as caring for patients in the CCU. Included in the review was the agency nurse who was on duty March 3, 2015 and the CCU nurse manager. No evidence of current and documented critical care skills was presented for any of the nurses whose files were reviewed.

The DON provided transcribed minutes of the CCU Staff Meeting, dated January 20, 2015. The CCU nurse manager is documented as being the recorder of the minutes.

The minutes documented multiple issues and concerns regarding CCU staffing. Included in the minutes were the following comments:
"Numerous issues were expressed r/t not feeling supported by the MSTU RSC [charge nurses] with specific issues being: feel that specifically on the weekends, there is not enough staff/supervisory staff working so that when CCU needs help they are told by the RSC that MSTU "too busy", no CNA available, no relief for lunches, slow in getting support help with patient needs, i.e., in/out of bed, bathes [sic], turning patients, new admit and getting HUC [hospital unit coordinator] help...

One nurse is documented as having stated "she has asked for help so many times and it did not come that she is not asking for help anymore..."

The DON is documented as having stated "...[s/he] appreciates it and understands what they are saying and then discussed and explained that they [sic] RSCs have a difficult job managing the patient flow and resources available for caring for the patients, sometimes limited because of various reason [sic]. Yes they should get help and the RSC's will need to send that help when requested, but that also the CCU staff have the rapid response of Code Blue activation if they need help immediately..."

The DON and the Department of Health (DOH) survey manager independently provided the complaint investigator with a copy of an email between the two. The email chain was initiated by the DON on January 26, 2015 and was sent to a person in the Nursing Commission, who forwarded the communication to the DOH survey manager.

The email chain started with the following questions and comments from the DON:
"We would like some guidance regarding our current structure-we want to continue to offer critical care service to our community...
This is our current scenario:
-We have one CCU nurse on duty or on call 24/7
-Our med/surg/CCU manager is CCU trained...
My question is: are ED and PACU trained nurses, who all have ACLS [advanced cardiac lifesaving skills] considered the second "licensed nurses skilled and trained in critical care"?

On February 2, 2015, the DOH survey manager responded to the DON with the following:
"WAC 246-320i-261 Critical or Intensive Care Services states the following:
...If providing a critical care unit or services, hospitals must:
(1) Define the qualifications and oversight of staff delivering critical or intensive care services;
(2) Assure at least two licensed nurses skilled and trained in critical care, on duty and in the hospital at all times..."

On March 4, 2015, the DON confirmed that no nurses in the hospital had documented evidence of critical care competencies verified in 2015, 2014 or 2013. The DON stated that the CCU nurse manager was "working on this". The DON confirmed that none of the charge nurses, none of the MSTU nurses and none of the ED nurses were oriented to CCU and none had demonstrated and verified clinical competencies in the unit. The DON stated "no nurse in the hospital has gone through a CCU competency program developed by this hospital".

Availability of Respiratory Therapists

The Cardiopulmonary Structure Standards were reviewed. No approved date was noted and the policy owner was listed as the Risk Manager. The policy/standard stated that Respiratory Therapists (RT) were on call between 2 am and 6 am, which was confirmed by interview by the DON, CCU nurse manager and the Emergency Department (ED) nurse manager all confirmed the time that RTs were not routinely scheduled as 2 to 6 am.

The DON and the CCU nurse manager stated that under certain circumstances, including when CCU patients were intubated, RTs were required to stay on the premises. When asked to provide documentation of that requirement, the DON referenced a memorandum issued by the ED nurse manager on 5/30/2014. The memorandum was to "nursing staff, administrative supervisors", with a copy to respiratory therapists, the CCU nurse manager, the MSTU/CCU nurse manager and the CON.

The memo stated in part:
"Starting June 1st, Respiratory Therapy will be on call 3.5 hours nightly 0230 - 0600. This memo is meant to serve as a guideline for when to call the on call Therapist in. (Or when to ask them to stay)...If a patient is in respiratory/cardiac distress and the Physician feels intubation, C-pap or Bi-pap will be needed.
If a patient is admitted who is on a ventilator..."

Discussion was held with the DON that the memo came from the ED nurse manager and did not have apparent physician input and did not state when RT was required to be on premises, but was a "guideline".

The patient identified in the complaint as having self-extubated was noted by a RT as having done so at approximately 2:25 am, a time when RT was not routinely staffed in-house. The CCU manager stated that RT was supposed to be in-house when a patient was intubated. The manager was asked to show documentation as to the presence of a RT in-house at the time the patient self-extubated, and was unable to do so. The manager stated that the RT note timed at approximately 5:30 am, showed that the RT was in before the regularly scheduled shift start of 6 am, but confirmed that it did not document the presence of an RT at 2:30 am.

The Director of Respiratory Therapy was identified as the ED nurse manager. On interview, the nurse manager confirmed that s/he was not also a RT. S/he stated that s/he relied on the RTs for clinical expertise. The ED manager confirmed that RTs were on call from 2 to 6 am, and were supposed to be at the hospital within 30 minutes of being called. The RT schedules for November and December, 2014, and January and February, 2015 were reviewed with the ED nurse manager. The schedule reflected that on January 6, 2015, there was no RT coverage due to sick calls and the ED nurse manager did all breathing treatments on the MSTU (medical/surgical telemetry unit), and there were no patients in the CCU. On January 9th, the night RT called in sick, and RNs did all breathing treatments. On February 28, 2015, RNs did all breathing treatments in the hospital due to sick calls by RTs.

The lack of adequate numbers of available nurses, the lack of nurses with documented CCU competencies and the lack of available RT coverage on a 24-hour basis resulted in a lack of consistent and reliable staff for critical care patients, especially those who might have respiratory crises. The hospital's failure to assure adequate personnel placed all CCU patients at risk for harm to health and possible death. The lack of adequate numbers of RTs and RNs placed all patients in the hospital at risk for harm to health and possible death, since RNs could be called at any time from their regularly assigned duties to assist in the CCU.

Reference deficiency cited at Tag 0386

RN SUPERVISION OF NURSING CARE

Tag No.: A0395

Based on interview and review of documents, it was determined that the hospital failed to assure that nursing care for each hospital patient was supervised and evaluated by a registered nurse (RN). The hospital's failure to do so placed all patients in the hospital at risk for negative health outcomes.

Findings include:

On March 4, 2015, the Director of Nursing (DON) was asked to provide the policy and procedure which described the requirement that all nursing care was supervised and evaluated by a RN. The DON stated that no policy was found. Structure standards were provided and reviewed, but were not found to contain that directive. The DON also stated that the hospital operated with an all-RN nursing staff, except for an addiction recovery unit, which utilized some non-RN personnel.

PATIENT CARE ASSIGNMENTS

Tag No.: A0397

Based on interview and review of hospital documents, it was determined that the hospital failed to assure that a registered nurse (RN) assigned the nursing care of each patient to other nursing personnel in accordance with the patient's needs and the specialized qualifications and competence of the nursing staff available. The hospital's failure to do so placed all patients who received nursing care at risk for negative health outcomes.

On March 4, 2015, the Director of Nursing (DON) was asked to provide the policy and procedure which described the requirement that all nursing care was assigned by a RN. The DON stated that no policy was found. Structure standards were provided and reviewed, but were not found to contain that directive that nursing case was assigned only by RNs. The DON also stated that the hospital operated with an all-RN nursing staff, except for an addiction recovery unit, which utilized some non-RN personnel.

SUPERVISION OF CONTRACT STAFF

Tag No.: A0398

Based on interview and review of hospital documents, it was determined that the hospital failed to assure adequate supervision and evaluation of the clinical activities of non-employee nursing personnel.
The hospital's failure to do so resulted in at least 1 agency RN, who worked in the Critical Care Unit (CCU), not having verified credentials. The hospital's failure to do so placed all patients in the hospital, and specifically the CCU, at risk for negative health outcomes due to inadequately supervised and evaluated non-employee nurses.

Findings include:

On March 4, 2015, the Director of Nursing (DON) was asked to provide the policy and procedure that described the process for the supervision and evaluation of non-employee nursing personnel. The DON stated that the hospital did not have such a policy.

On March 3, 2015, an agency RN was observed providing care to 1 patient in the CCU. The RN was the only RN in the CCU, and the CCU manager stated that s/he was the RN who was to provide back up and relief for the agency nurse. The agency RN stated that s/he had worked as an agency nurse at the hospital for 16 years and was scheduled to work in the CCU the following day, as well.

Review of personnel files revealed that the RN did not have verified and documented competencies to work in the CCU. The lack of such competencies for the agency nurse was confirmed by the DON.

ACCEPTING VERBAL ORDERS FOR DRUGS

Tag No.: A0408

Based on interview and review of hospital policy, it was determined that the hospital failed to designate which practitioners were authorized to accept verbal orders. The hospital's failure to do so placed patients at risk for harm due to incorrect medications or treatments, accepted by personnel unauthorized to accept such orders.

Findings include:

On March 4, 2015, the DON was asked to provide documentation of how the hospital utilized verbal orders. The DON provided the policy and procedure "Medication Administration and Documentation" which stated:
"6. Verbal orders are not allowed except in the case of emergency or during the performance of a procedure and must be verified by read-back, which is documented as "VORB" in the EMR [electronic medical record]."

The DON confirmed that there were no additional policies or written guidelines regarding the use of verbal orders, and no documentation which described who was authorized to issue and who was authorized to receive verbal orders.