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Based on review of organizational documents, policies, procedures, protocols, medical records, and staff interview, it was determined the hospital failed to meet respiratory care services requirements as it related to organization of the department, a physician director, and delivery of services within approved and current medical staff directives and policies. This had the potential to negatively impact patient care. Findings include:

1. Refer to A-1152 as it relates to the failure of the hospital to ensure the organization of respiratory care services was appropriate to the scope and complexity of the services offered.

2. Refer to A-1153 as it relates to the failure of the hospital to ensure a physician director was appointed to the respiratory care services department.

3. Refer to A-1160 as it relates to the failure of the hospital to ensure services were consistently delivered in accordance with medical staff directives.

4. Refer to A-1161 as it relates to the failure of the respiratory services was consistently provided in accordance with hospital policy and within RT job description and competencies.

The cumulative effects of these negative systemic practices impeded the ability of the hospital to ensure respiratory service requirements were met.

Based on staff interview and review of the hospital's organizational chart, policies, procedures, protocols and references used in the respiratory therapy department, and MEC documents, it was determined the organization of the respiratory care services was not appropriate to the scope and complexity of the services offered. This was evidenced by a lack of qualified leadership, a failure to define in writing the scope of respiratory services provided by the hospital, outdated policies, and use of unapproved resources. It had the potential to interfere with delivery of patient care. Findings include:

The hospital's public website (http://siach.ernesthealth.com) was reviewed. It introduced the hospital's broad scope of services. It stated "We treat any patient requiring extended acute care, including those requiring intensive care, medically complex care, modified rehabilitation, ventilator/pulmonary care and wound care.

1. The hospital's organizational chart was reviewed. It placed the RT Manager under the supervision of the DNO, who in turn reported to the hospital's CEO. There was no organizational relationship between the RT Manager and physician oversite. This was confirmed by the RT Manager during an interview on 7/13/15 at approximately 10:29 AM.

The Respiratory Therapy Manager's job description, last revised 3/15, was consistent with the above referenced interview. It stated the Respiratory Therapy Manager reported directly to the CEO or DNO. No physician director was referenced. The Respiratory Therapy Manager confirmed the reporting schedule during an interview on 7/13/15 at approximately 10:29 AM

The Manager of Respiratory Therapy services was interviewed on 7/13/15 at appropriately 2:30 PM. She was asked who she contacted with questions or concerns related to respiratory therapy. She stated she used a variety of resources. She would generally contact the RN leader at corporate or other RT respiratory therapy managers at other hospitals within the health care system. If the staff pulmonologist was available she might ask him questions (he worked 2 weeks on and 2 weeks off). When asked if she consulted the general medical director, she stated she did not because he was the wound care director.

The Respiratory Manager was asked who attended respiratory department meetings. She stated "only respiratory therapists." There was no physician presence. There was no senior management presence, such as the DNO or CEO who the organizational chart indicated was responsible for respiratory therapy.

The organization of the respiratory department did not include immediate physician oversite. Senior leadership was not involved in respiratory care meetings.

2. The references and resources for the respiratory department were not clear. During an interview on 7/13/15 at approximately 2:30 PM, the Manager of Respiratory Therapy explained that she collected resources for respiratory staff and included the resources in the policy and procedure manual for staff reference. She stated she primarily used Egan's Fundamentals of Respiratory Care, Eighth edition, dated 2003, as a resource as well online information from the American Association for Respiratory Care.

The hospital's policy "Clinical Standards of Practice," (PC 010) was reviewed. It listed the approved resources for various departments. The respiratory resource was listed as "Lippincott Nursing Procedures (Sixth Edition 2012). Egan's Fundamentals of Respiratory Care, Eigth edition, dated 2003, was not included in the approved references.

3. The respiratory department's policy and procedure manual included undated protocols and procedures that did not document any medical staff approvals or include any reference. Example include:
- Tracheostomy Care (Cleaning inner cannula, stoma site, and trach ties)
- Tracheostomy Care (Speaking Valve)
- Tracheostomy Care (Button Insertion)
- Postural Drainage Therapy

Some respiratory policies and procedures and or protocols did not have evidence of appropriate medical staff approval.

3. The respiratory therapy department's policies and procedures were reviewed. They were included in a binder titled "Policies and Procedures" and presented to surveyors for review by the Manager of Respiratory Therapy.

The Respiratory department policies and procedure manual included policies that had been initially approved in 2007 and 2008. There was no evidence the policies had been reviewed or revised since the dates listed on the policies. Examples include, but were not limited to, the following policies and procedures:

- Respiratory care, dated 10/07
- Code Blue, dated 10/07
- DNR, dated 10/07
- Invasive ventilation, dated 10/07
- Withholding/withdrawing Life Sustaining Treatment, dated 10/07
- Medications brought from home, dated 10/07
- Oxygen Therapy Protocol, dated 12/08
- Critical response values, dated 10/07
- Respiratory care equipment, dated 10/07
- Rental equipment, dated 10/07
- Electrical cords and adapters, dated 10/07
- Equipment failure and replacement, dated 10/07
- Private owned equipment, date 10/07
- Medical equipment management plan, dated 01/08

The dates of the policies were confirmed by the Respiratory Manager during interview on 7/13/15 at at approximately 11:49 AM. She stated she was not aware of any additional review or revisions.

A policy was requested related to how often policies were expected to be reviewed. The Corporate Director of Quality and Risk Management was interviewed on 7/14/15 at approximately 9:00 AM. She stated there was no specific hospital policy that stated the required frequency for policy review, however it was the practice of the hospital to review policies annually. It was a part of the MEC annual schedule.

The Corporate Director of Quality and Risk Management provided a generic schedule of MEC tasks according to quarter of each year for surveyor review. The third quarter topic agenda included policy and procedure review. It stated "A summary (written or oral) of a review of all policies. A listing (index or table of contents) should be provided. Policies changed over the year would be presented."

Documentation was requested to verify the annual review of policies occurred as referenced on the sample topic agenda. The Corporate Director of Quality and Risk Management stated, during an interview on 7/14/15 at approximately 4:30 PM, she had not been able to locate documentation in the MEC meeting minutes of the annual review of policies.

The hospital's overall Medical Director was interviewed on 7/14/15 at 4:00 PM. He stated that when he started working as the general medical director about 14 months prior, he was given a stack of papers to sign off on. He stated he looked them over, "not every page," and could not remember if he signed off on them.

Respiratory policies were not current. The hospital did not have a reliable process to ensure respiratory policies were reviewed on a regular basis.


4. The scope of respiratory services was not clearly defined in writing.

a. The hospital's policies and procedures. They did not describe in writing the scope of the diagnostic and/or therapeutic respiratory care services offered by the hospital. This was confirmed by the Manager of Respiratory Services during an interview on 7/13/15 at approximately 10:30 AM. She stated the respiratory department's scope of services were reflected in the hospital's RT job descriptions and in the AARC position statement (not a hospital document). She stated she was not aware of any specific written description of services.

b. The Corporate Director of Quality & Risk Management provided a document for review, "Plan for the Provision of Patient Care," (HP.020), dated 10/07. She stated it defined the scope of respiratory care services. The document stated "J. SCOPE OF SERVICE - The hospital has defined the scope of service for the inpatient department of the hospital. The scope of care/service includes the types and ages of patients served, hours of operations, procedures, and processes of each department and/or services provided (See attached Addendums 1a and 1b)." The referenced addendums were reviewed.

Addendum A referenced "SCOPE OF SERVICE." It stated "Procedures include medical management, rehabilitation therapy (physical therapy, speech therapy, and occupational therapy), respiratory therapy, dietary service, and pharmacy. The documents did not specifically define the scope of diagnostic and therapeutic respiratory services offered by the hospital. Addendum B did not reference scope of services.

There was insufficient organization and physician oversite of the respiratory services department.

Based on staff interview and review of administrative documents, it was determined the hospital did not have a physician director of respiratory care services, either on a full-time or part-time basis. This resulted in a lack of direction for the respiratory services department. It had the potential to interfere with quality and safety of patient care. Findings include:

Upon arrival for a complaint investigation on 7/13/15, an individual was introduced as the Director of Respiratory Therapy. The sign outsider her door said "Director." When asked for a position description, a job description was provided for the "Manager of Respiratory Therapy." On the second day of the survey, 7/14/15, the Director clarified she was the Manager, although she had thought she was serving in the role of manager and director. She stated she had been in the respiratory management role for "about a year"and the individual she replaced had been an RT. During an interview on 7/14/15 at 9:22 AM, she stated she has not seen a physician in the director position since the hospital opened.

The DNO was interviewed on 7/13/15 at 12:03 PM. He initially identified a hospital pulmonologist as the Director of critical care, including respiratory services. After review of the physician's credentialing file, he stated he had been mistaken, that the pulmonologist was a staff physician rather than a director.

The hospital's pulmonologist was interviewed on 7/14/15 at 11:15 AM. He stated he tried to be helpful and answer respiratory questions when he was available. He explained he worked a schedule of 2 weeks on and 2 weeks off. He stated he did not direct the respiratory department and did not have any administrative responsibilities, such as attending respiratory meetings or other oversite. He stated the hospital had been looking for another pulmonologist for a couple of years since the prior one left but had not been successful in locating one. When asked how the respiratory needs of patients with complex respiratory needs were met when he was not available, he stated the hospital did their best to assign hospitalists with comfort in respiratory issues to cover the hospital in his absence, and if necessary, patients would be transferred out to an acute care hospital.

During a phone interview on 7/13/15 at approximately 1:30 PM, the Corporate Director of Quality and Risk Management identified the hospital's general Medical Director as having oversite of the entire hospital, including the respiratory therapy department.

The general Medical Director was interviewed on 7/14/15 at 4:00 PM. When asked if he was the Director of Respiratory Services, he stated he was not the Director of Respiratory Services. He stated he had been the general Medical Director for about 14 months and had been the Director of Wound Services for years since the hospital opened. He stated he spent about 2 hours per week in the general Medical Director role, mostly handling physician to physician issues. He stated he directed the wound service during the rest of his time with the hospital. He explained that the individual who had been the general Medical Director before he took the position had been a pulmonologist and had provided direction to the respiratory department. He stated the hospital had been trying to recruit a pulmonologist for some time without success.

Portions of the medical staff bylaws, dated 6/19/13, were reviewed. The bylaws included, but were not limited to, the following information:

- ARTICLE 2 DEFINITIONS - 2.18 "A Medical Staff physician member employed by or under a contractual agreement or otherwise servicing the hospital to provide medical direction in a specific clinical unit or function of the hospital. Responsibilities may include both administrative and clinical duties.

- ARTICLE 9 CLINICAL ORGANIZATIONAL OF THE MEDICAL STAFF -
9.3 MEDICAL DIRECTORS

A. SELECTION: Medical Directors will be Board Certified, or have affirmatively established comparable competence through the credentialing process.

B. RESPONSIBILITIES: Each Medical Director shall:

1. Determine and manage the clinically related and administrative activities within his/her program.

2. Where Program Rules and Regulations are desired, shall be accountable for the development and implementation of those Rules and Regulations, ensuring that they support the overall Performance Improvement Plan of the Hospital, directly pertaining to professional medical care within their Program. Shall submit such Program Rules and Regulations to the Medical Executive Committee.

3. Develop and implement programs for orientation of new members, credentials review and privileges, delineation for initial appointment and reappointment, continuing medical education utilization review, concurrent evaluation of practice, and retrospective evaluation of practice;

4. Continuously assess and improve the quality of care, treatment and services, and maintain quality improvement programs as appropriate.

5. Transmit to the appropriate authorities as required in these Bylaws, the Programs recommendations concerning appointment, reappointment, delineation of clinical privileges, and disciplinary action;

6. Recommend the criteria for clinical privileges that are relevant to the care provided in the Program;

7. Assess and recommend to the relevant Hospital authority space issues, resource needs, and off-site sources for needed safe patient care, treatment, and services not provided by the Program or the organization;

8. Recommend a sufficient number of qualified and competent persons to provide care, treatment, and services;

9. Determine the qualifications and competence of personnel who are not licensed independent practitioners and who provide patient care, treatment, and services;

10. Maintain continuing surveillance of the professional performance of all members with clinical privileges with the program with appropriate documentation thereof;

11. Assist in developing and enforcing hospital policies and procedures that guide and support the provision of care, treatment andservices; the Medical Staff Bylaws, Rules and Regulations; and the requirements and Rules and Regulations (if any) of the Program;

12. Integrate the Program into the primary functions of the organization;

13. Coordinate and integrate interdepartmental and intradepartmental services;

14. Implement within the Program actions take by the Medical Executive Committee;

15. Perform such other duties commensurate with his/her office as may from time to time be assigned by the President of the Medical Staff, the Medical Executive Committee or the Governing Body;

16. Report to the Medical Staff on all professional and administrative activities within their program; and

17. Establish such committees, task forces, or other mechanisms are necessary and desirable to perform properly the functions assigned to it.

The hospital did not have a qualified director appointed to or fulfilling the roles and functions of a medical director for the respiratory service.

Based on staff interview and review of policies and procedures, it was determined the hospital failed to ensure services were consistently delivered in accordance with medical staff directives. This had the potential to interfere with quality and safety of patient care. Findings include:

1. Policies and procedures for the delivery of respiratory care services were reviewed in coordination with the Manager of Respiratory Therapy.

The respiratory department's policy and procedure manual included undated protocols and procedures that did not document any medical staff approvals or include any reference. Example include:
- Tracheostomy Care (Cleaning inner cannula, stoma site, and trach ties)
- Tracheostomy Care (Speaking Valve)
- Tracheostomy Care (Button Insertion)
- Postural Drainage Therapy

2. The hospital's policy "Clinical Standards of Practice," (PC 010) was reviewed. It listed the approved resources for various departments. The respiratory resource was listed as "Lippincott Nursing Procedures (Sixth Edition 2012).

The Manager of Respiratory Therapy was interviewed on 7/13/15 at approximately 2:30 PM. She stated the respiratory department primarily used Egan's Fundamentals of Respiratory Care, Eighth edition, dated 2003.

Egan's Fundamentals of Respiratory Care, Eigth edition, dated 2003, was not included in the approved references.

Some respiratory policies, procedures, protocols, and references were not based on medical staff directives.

Based on staff interview and review of policies and procedures, medical records, job descriptions and personnel competency requirements, it was determined the hospital failed to ensure respiratory services were provided in accordance with hospital policy, RT job description, and personnel competencies for 1 of 5 patients (#2) receiving respiratory services whose records were reviewed. This resulted in delivery of care without documented competencies. It had the potential to interfere with quality and safety of patient care. Findings include:

The "Respiratory Care" policy (PC 205), dated 10/07, was reviewed. The policy included, but was not limited to, the following information:

- The purpose of the policy is to outline the respiratory care services provided to patients.

- ONLY those procedures approved within the job description, competency assessments, and policy may be provided.

- Respiratory care procedures will be performed as directed by the clinical practice manual/resource approved by the medical staff.

- Respiratory care will be provided in a manner that meets hospital policy.

This policy was not followed related to Patient #2, as outlined below:

Patient #2 was a 70 year old female who was admitted to the hospital on 6/21/15 for care after being transferred from another hospital for complications in weaning her off a ventilator. The medical records indicated Patient #2 had a tracheostomy which decannulated and subsequently exhibited signs of a non-healing stoma.

A physician's order, dated 7/08/15 at 10:20 AM, stated "Microclense [sic] wet to dry 2 x 2 packed in superficial opening of tracheostomy and then cover with Allevyn Foam dressing - RT to change daily."

The Manager of Respiratory Services was interviewed on 7/13/15 at 9:45 AM. When asked if there was respiratory standard of practice for stoma care, as ordered for Patient #2, she stated that there was not a respiratory standard of care because the procedure was typically done by nursing, RTs did not typically do wound care once a trach is removed and it was not typical to pack a stoma. She stated the circumstance was unique and the care was provided based on a physician's order, not based on a respiratory standard of practice.

The RT job description, "Respiratory Therapist," last revised 10/06/05, was reviewed. Post trach wound care was not addressed as a respiratory care procedure. This was confirmed by the Manager of Respiratory services during an interview on 7/13/15 that began on 9:45 AM.

A generic "Initial Clinical Competency" checklist for respiratory therapists was reviewed. The list of respiratory procedures verified for competency did not include post-trach wound care. This was confirmed by the Manager of Respiratory Therapy during an interview on 7/13/15 that began on 9:45 AM.

An RT note in Patient #2's record, dated 7/08/15 at 2:30 PM, documented "Foam placed on pt trach as written per MD. Family concerned - explained RT will do stoma care per orders." The RT was interviewed by telephone on 7/14/15 at 10:45 AM. When asked if she had been familiar with this wound procedure or had received any training in the procedure, she stated she had never seen a stoma packed before and typically wound care was done by nursing. She stated she had not been trained in this particular type of stoma care and it was not a respiratory standard of practice.

A second RT documented doing the wound care procedure on 7/09/15 at 3:30 PM and 7/10/15 at 9:05 AM. The RT was interviewed on 7/13/15 at approximately 11:50 AM. He stated a physician did the procedure with him two times and showed him how to do the procedure.

The RT Manager was asked if any other RTs in the department were trained in the procedure, she replied "No, only the one" on 7/15/15 at 11:15 AM.

A procedure was assigned to RT personnel for Patient #2 that was not consistent with a respiratory care standard of practice, the RT job description, or required competencies in accordance with the requirements specified in hospital policy.